Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT00116558
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2005-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Treatment of Amyotrophic Lateral Sclerosis (ALS) With Nutrition and Non-Invasive Positive Pressure Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ejkas@uky.edu', 'phone': '859-218-5061', 'title': 'Edward J. Kasarskis, M.D., Ph.D.', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Compliance with NIPPV intervention is limited due to technical difficulties in obtaining BiPAP download data from some sites. This was due to variability in the local respiratory therapists engaged by commercial respiratory therapy companies.'}}, 'adverseEventsModule': {'timeFrame': '3 years, 4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Combined Arms', 'description': 'Sincere efforts were made to locate per arm data, but these data are no longer available. All adverse events are reported as one arm/group.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 62, 'seriousNumAtRisk': 153, 'deathsNumAffected': 19, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Abdominal Distension', 'notes': 'Dates: 3/20/2007 Status: Unresolved at 48 Weeks Description: Abdominal distension Intensity: moderate Relationship to study: possible', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Lab', 'notes': 'Dates: 5/2/2006 8/21/2006 Status: Resolved Description: Abnormal Lab Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergy', 'notes': 'Dates: 4/17/2007 4/22/2007 Status: Ended Description: Allergy Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle Sprain', 'notes': 'Dates: 9/6/2006 Status: Ended Description: Ankle Sprain Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'notes': 'Dates: 3/27/2007 Status: Unresolved at 48 Weeks Description: Arthritis Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'notes': 'Dates:: 6/3/2006 Status: Unresolved at 48 weeks Description: Back Pain Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blister', 'notes': 'Dates: 4/1/2008 Status: Unresolved at 48 Weeks Description: Blister Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Clot', 'notes': 'Dates: 1/28/2008 Status: Unresolved at 48 Weeks Description: Blood Clot Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'notes': 'Dates: 1/20/2008 2/10/2008 Status: Ended Description: Bronchitis Intensity: moderate Relationship to study: possible', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruise', 'notes': 'Dates: 5/11/2006 5/11/2006 Status:Ended Description: Bruise Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning Sensation', 'notes': 'Dates: 7/23/2007 Status: Continuing Description: PAIN Burning Sensation Intensity: severe Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold', 'notes': 'Dates: 8/9/2007 8/15/2007 Status: Ended Description: Cold Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon Polyp', 'notes': 'Dates: 2/1/2006 2/1/2006 Status: Ended Description: Colon Polyp Intensity: mild Relationship: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Concussion', 'notes': 'Dates: 2/6/2006 2/6/2006 Status: Ended Description: Concussion Intensity: severe Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestion', 'notes': 'Dates: 7/21/2006 7/31/2006 Status: Resolved Description: Congestion Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'notes': 'Dates: 7/3/2007 7/8/2007 Status: Ended Description: Conjunctivitis Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'notes': 'Dates: 2/1/2006 6/1/2006 Status: Resolved Description: Constipation Intensity: moderate Relationship to study: not likely', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'notes': 'Dates: 7/4/2007 7/4/2007 Status: Ended Description: Contusion Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'notes': 'Dates: 9/7/2006 Status: Ended Description: Cough Intensity: moderate Relationship: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Rectal Tone', 'notes': 'Dates: 6/4/2007 Status: Continuing Description: Decreased Rectal Tone Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'notes': 'Dates: 3/5/2008 Description: Dehydration Intensity: mild Relationship to study: not likely', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental', 'notes': 'Dates: 4/17/2006 Status: Ended Description: Dental Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'notes': 'Dates: 3/1/2008 Status: Unresolved at 48 Weeks Description: Dermatitis Intensity: mild Relationship to study: possible', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': 'Dates: 2/10/2007 2/10/2007 Status: Ended Description: Diarrhea Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'notes': 'Dates: 10/15/2006 11/14/2006 Status: Resolved Description: Diverticulitis Intensity: severe Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Dates: 1/15/2006 Status: Ended Description: Dizziness Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Eye', 'notes': 'Dates: 10/15/2007 Description:Dry Eye Intensity: mild Relationship to study: probable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'notes': 'Dates: 6/15/2006 Status: Unresolved at 48 Weeks Description: Dysphagia Intensity: mild Relationship to study: not likely', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Infection', 'notes': 'Dates: 10/1/2006 10/26/2006 Status: Resolved Description: Ear Infection Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'notes': 'Dates: 10/24/2006 Status: Unresolved at 48 Weeks Description: Edema Intensity: mild Relationship to study: not likely', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'notes': 'Dates: 4/13/2007 4/13/2007 Status: Ended Description: Fall Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Dates: 11/1/2005 Status: Unresolved at Discontinuation Description: Fatigue Intensity: severe Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'notes': 'Dates: 1/18/2007 3/29/2007 Status: Resolved Description: Fracture Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'notes': 'Dates: 9/25/2006 10/2/2006 Status: Ended Description: Gastritis Intensity: severe Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucination', 'notes': 'Dates: 9/13/2006 9/16/2006 Status: Ended Description: Hallucination Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Dates: 1/18/2006 3/1/2006 Status: Ended Description: Headache Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercarbia', 'notes': 'Dates: 11/6/2006 Status: Continuing Description: Hypercarbia Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'notes': 'Dates: 1/11/2008 Status: Unresolved at 48 Weeks Description: Hypertension Intensity: mild Relationship to study: not likely', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'notes': 'Dates: 11/4/2006 11/4/2006 Status: Ended Description: Hypotension Intensity: mild Relationship to Study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': 'Dates: 10/26/2007 11/4/2007 Status: Ended Description: Infection Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee Sprain', 'notes': 'Dates: 6/30/2007 7/13/2007 Status: Ended Description: Knee Sprain Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'notes': 'Dates: 2/5/2007 2/5/2007 Status: Ended Description: Laceration Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lesion', 'notes': 'Dates: 3/30/2007 5/7/2007 Status: Ended Description: Lesion Intensity: mild Relationship to study: definite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nosebleed', 'notes': 'Dates: 11/1/2007 Status: Continuing Description: Nosebleed Intensity: mild Relationship to study: probable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteopenia', 'notes': 'Dates: 9/4/2006 Status: Unresolved at 48 Weeks Description: Osteopenia Intensity: mild Relationship to study: not likely', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PEG', 'notes': 'Dates: 6/29/2006 7/1/2006 Status: Ended Description: PEG Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Dates: 11/20/2006 12/18/2006 Status: Resolved Description: Pain Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'Dates: 11/1/2007 Status: Unresolved at 48 Weeks Description: Pneumonia Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post Nasal Drip', 'notes': 'Dates: 3/31/2006 Status: Unresolved at 48 Weeks Description: Post Nasal Drip Intensity: severe Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pressure Sores', 'notes': 'Dates: 11/28/2006 11/30/2006 Status: Resolved Description: Pressure Sores Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RADS', 'notes': 'Dates: 1/17/2007 4/30/2007 Status: Ended Description: RADS Intensity: mild Relationship: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'notes': 'Dates: 8/15/2005 Status: Unresolved at 48 Weeks Description: Rash Intensity: mild Relationship to study: not likely', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'notes': 'Dates: 2/25/2007 2/25/2007 Status: Ended Description: Shortness of Breath Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder Pain', 'notes': 'Dates: 1/23/2006 1/25/2006 Status: Ended Description: Shoulder Pain Intensity: severe Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sialorrhea', 'notes': 'Dates: 2/10/2006 Status: Unresolved at 48 Weeks Description: Sialorrhea Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Infection', 'notes': 'Dates: 4/1/2007 4/7/2007 Status: Ended Description: Sinus Infection Severity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Throat', 'notes': 'Dates: 10/12/2006 Status: Unresolved at 48 Weeks Description: Sore Throat Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spasm (Respiratory)', 'notes': 'Dates: 1/19/2007 1/19/2007 Status: Resolved Description: Spasm Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach Upset', 'notes': 'Dates: 4/29/2006 5/1/2006 Status: Ended Description: Stomach Upset Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTI', 'notes': 'Dates: 3/14/2006 3/24/2006 Status: Ended Description: UTI Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urgent Bowel Movements', 'notes': 'Dates: 2/1/2006 Status: Unresolved at Discontinuation Description: Urgent Bowel Movements Intensity: mild Relationship to study: possible', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Frequency', 'notes': 'Dates: 6/11/2007 6/24/2007 Status: Ended Description: Urinary Frequency Intensity: moderate Relationship to study: not likely', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': 'Dates: 10/18/2005 10/18/2005 Status: Ended Description: Vomiting Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'notes': 'Dates: 2/1/2006 Status: Unresolved at Discontinuation Description: Weakness Intensity: mild Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Loss', 'notes': 'Dates: 8/8/2005 3/13/2006 Status: Ended Description: Weight Loss Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'notes': 'Dates: 11/6/2006 Status: Resolved Description: Wheezing Intensity: moderate Relationship to study: not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'ALS Progression', 'notes': 'Dates: 5/5/2007 5/25/2007 Status: Resolved Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Moderate Relationship to study: Unrelated Description: Treatment and Evaluation of ALS Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration', 'notes': 'Dates: 5/11/2008 5/12/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Mild Relationship to study: Unrelated Description: Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration Pneumonia', 'notes': 'Dates: 6/10/2007 6/19/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Presumed Aspiration Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder malignancy/UTI', 'notes': 'Dates: 8/22/2007 9/5/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Possible bladder malignancy and UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Clot', 'notes': 'Dates: 8/21/2005 9/1/2005 Status:Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Blood Clot Behind right knee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrest', 'notes': 'Dates: 4/4/2006 4/4/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to Study: Unrelated Description: Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colonic Bleed', 'notes': 'Dates: 1/15/2007 1/29/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship: Unrelated Description: Left Colonic Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Concussion', 'notes': 'Dates: 2/7/2007 2/7/2007 Status: Resolved Reason for Qualifying: Life-threatening Intensity: Moderate Relationship to Study: Unrelated Description: Concussion as result of Automobile Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Dates: 6/2/2006 6/2/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to Study: Unrelated Description: No Information Given', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty Breathing', 'notes': 'Dates: 5/21/2007 5/27/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Difficulty breathing due to Sialorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislodged PEG Tube', 'notes': 'Dates: 6/30/2007 Status: Continuing at discontinuation Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Dislodged PEG Tube and Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Distended Abdomen', 'notes': 'Dates: 8/24/2005 8/29/2005 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Distended Abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'notes': 'Dates: 3/11/2008 3/11/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'notes': 'Dates: 4/9/2007 Status: Continuing at discontinuation Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Increased Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Failure to Thrive', 'notes': 'Dates: 7/23/2007 8/10/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Diagnosed as failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip Fracture', 'notes': 'Dates: 4/25/2006 5/4/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Left Hip Fracture Resulting From Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia, hypomagnesia, and antythmia', 'notes': 'Dates: 12/15/2007 12/17/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Hypokalemia, hypomagnesia, and antythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': 'Dates: 10/3/2007 10/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Severe infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irregular Heartbeat', 'notes': 'Dates: 1/18/2008 2/17/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Irregular Heartbeat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'notes': 'Dates: 9/9/2007 11/4/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Debridement and Closure of Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver Cancer Diagnosis', 'notes': 'Dates: 11/4/2005 Status: Continuing at discontinuation Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Severe Relationship to Study: Unrelated Description: Liver Cancer Diagnosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loculated right pleural effusion', 'notes': 'Dates: 7/27/2007 8/2/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Loculated right pleural effusion and possible Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'notes': 'Dates: 8/30/2007 8/31/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Apparent Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'PEG Procedure Complications', 'notes': 'Dates: 5/11/2006 5/12/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Complications from PEG Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peg Replacement', 'notes': 'Dates: 3/14/2008 3/18/2008 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Mild Relationship to study: Unrelated Description: PEG replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'Dates: 3/6/2008 3/19/2008 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Emboli and pneumonia', 'notes': 'Dates: 9/3/2006 10/5/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Pulmonary emboli and pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Complications', 'notes': 'Dates: 10/7/2006 10/7/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to study: Unrelated Description: Respiratory Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'notes': 'Dates: 9/28/2007 9/28/2007 Status: Resolved Reason for qualifying: Requiring or prolonging Hospitalization Intensity: Severe Relationship to study: Unrelated Description: continued respiratory decline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'notes': 'Dates: 10/3/2007 10/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Severe Sepsis around PEG Tube', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath', 'notes': 'Dates: 10/2/2006 Status: Continuing at discontinuation Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Severe Relationship: Unrelated Description: Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subarachroid Hemmorrhage and Contusion', 'notes': 'Dates: 3/14/2007 3/16/2007 Status: Resolved Reason for Qualifying: Resulting in death Severe Relationship to Study: Unrelated Description: Sub-arachnoid Haemmorrhage and Contusion Resulting from fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subdural Hematoma', 'notes': 'Dates: 6/11/2007 6/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Subdural Hematoma from fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transitional Cell Carcinoma', 'notes': 'Dates: 9/6/2007 9/23/2007 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to study: Unrelated Description Small bowel obstruction, transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptance Rate of Early Non-invasive Positive Pressure Ventilation (NIPPV) Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care NIPPV and Nutritional Monitoring', 'description': 'Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.'}, {'id': 'OG001', 'title': 'Standard of Care NIPPV', 'description': 'Participants with 50-74% predicted forced vital capacity (FVC).'}, {'id': 'OG002', 'title': 'Early NIPPV Intervention', 'description': 'Participants with \\>80% predicted forced vital capacity (FVC).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Percentage of patients attempting to use NIPPV therapy within six weeks of initial offer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not obtained from the "Standard of Care NIPPV and Nutritional Monitoring" arm.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Survival With Early Versus Standard of Care NIPPV Treatment', 'timeFrame': 'one year', 'description': 'Duration of patient survival', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Compliance With NIPPV Treatment', 'timeFrame': 'one month', 'description': 'Number of hours of NIPPV use per month', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Daily Energy Expediture (TDEE) of ALS Patients', 'timeFrame': 'Duration of study (approximately 1 year)', 'description': 'Total daily energy expenditure (TDEE) with be measured using the dual labeled water (DLW) method', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tolerance of NIPPV Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care NIPPV and Nutritional Monitoring', 'description': 'Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.'}, {'id': 'OG001', 'title': 'Standard of Care NIPPV', 'description': 'Participants with 50-74% predicted forced vital capacity (FVC).'}, {'id': 'OG002', 'title': 'Early NIPPV', 'description': 'Participants with \\>80% predicted forced vital capacity (FVC).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'one month', 'description': 'Percent of patients achieving tolerance (\\>4hr/night NIPPV after 2-3 week titration period) determined by actual usage data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected for the "Standard of Care NIIPPV and Nutritional Monitoring" arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care NIPPV and Nutritional Monitoring', 'description': 'Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.'}, {'id': 'FG001', 'title': 'Standard of Care NIPPV', 'description': 'Participants with 50-74% predicted forced vital capacity (FVC).'}, {'id': 'FG002', 'title': 'Early NIPPV', 'description': 'Participants with \\>80% predicted forced vital capacity (FVC).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care NIPPV and Nutritional Monitoring', 'description': 'Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.'}, {'id': 'BG001', 'title': 'Standard of Care NIPPV', 'description': 'Participants with 50-74% predicted forced vital capacity (FVC).'}, {'id': 'BG002', 'title': 'Early NIPPV Intervention', 'description': 'Participants with \\>80% predicted forced vital capacity (FVC).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.0', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '60.8', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '56.2', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '58.6', 'spread': '11.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-11', 'studyFirstSubmitDate': '2005-06-29', 'resultsFirstSubmitDate': '2010-03-15', 'studyFirstSubmitQcDate': '2005-06-29', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-11', 'studyFirstPostDateStruct': {'date': '2005-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Survival With Early Versus Standard of Care NIPPV Treatment', 'timeFrame': 'one year', 'description': 'Duration of patient survival'}, {'measure': 'Compliance With NIPPV Treatment', 'timeFrame': 'one month', 'description': 'Number of hours of NIPPV use per month'}, {'measure': 'Total Daily Energy Expediture (TDEE) of ALS Patients', 'timeFrame': 'Duration of study (approximately 1 year)', 'description': 'Total daily energy expenditure (TDEE) with be measured using the dual labeled water (DLW) method'}, {'measure': 'Tolerance of NIPPV Treatment', 'timeFrame': 'one month', 'description': 'Percent of patients achieving tolerance (\\>4hr/night NIPPV after 2-3 week titration period) determined by actual usage data.'}], 'primaryOutcomes': [{'measure': 'Acceptance Rate of Early Non-invasive Positive Pressure Ventilation (NIPPV) Treatment.', 'timeFrame': '6 weeks', 'description': 'Percentage of patients attempting to use NIPPV therapy within six weeks of initial offer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['amyotrophic lateral sclerosis', 'ALS', "Lou Gehrig's disease", 'nutrition', 'NIPPV', 'non-invasive positive pressure ventilation', 'percutaneous endoscopic gastrostomy', 'PEG'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '24522445', 'type': 'BACKGROUND', 'citation': 'Kasarskis EJ, Mendiondo MS, Matthews DE, Mitsumoto H, Tandan R, Simmons Z, Bromberg MB, Kryscio RJ; ALS Nutrition/NIPPV Study Group. Estimating daily energy expenditure in individuals with amyotrophic lateral sclerosis. Am J Clin Nutr. 2014 Apr;99(4):792-803. doi: 10.3945/ajcn.113.069997. Epub 2014 Feb 12.'}, {'pmid': '29243507', 'type': 'BACKGROUND', 'citation': 'Scagnelli CN, Howard DB, Bromberg MB, Kasarskis EJ, Matthews DE, Mitsumoto HM, Simmons Z, Tandan R; ALS Nutrition-NIPPV Study Group. Hydration measured by doubly labeled water in ALS and its effects on survival. Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):220-231. doi: 10.1080/21678421.2017.1413117. Epub 2017 Dec 15.'}, {'pmid': '21271789', 'type': 'RESULT', 'citation': 'Kasarskis EJ, Mendiondo MS, Wells S, Malguizo MS, Thompson M, Healey M, Kryscio RJ; ALS Nutrition/NIPPV Study Group. The ALS Nutrition/NIPPV Study: design, feasibility, and initial results. Amyotroph Lateral Scler. 2011 Jan;12(1):17-25. doi: 10.3109/17482968.2010.515225.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of the study are to determine the energy balance and evaluate the nutritional status of patients with ALS, and to investigate the use of NIPPV as respiratory support to treat patients with ALS.', 'detailedDescription': "Studies to date indicate that percutaneous endoscopic gastrostomy (PEG)-insertion of a feeding tube in the stomach-and non-invasive positive pressure ventilation (NIPPV)-mechanically assisted or generated breaths delivered through a tightly fitting nasal or facial mask-improve survival in amyotrophic lateral sclerosis (ALS), even when introduced late in the disease.\n\nDr. Kasarskis and his research team believe early intervention with these treatments may improve patients outcome even further. However, many issues regarding the early use of these treatments prevent the design of a phase III clinical trial to test this hypothesis. Common to both NIPPV and nutrition is a lack of a reliable indicator of early respiratory or nutritional insufficiency. With respect to nutrition, reliable and cost effective methods are needed to determine a patient's energy (i.e. caloric) requirements at different stages of the illness to establish a basis for recommending PEG on the adequacy of energy intake. For NIPPV, factors that influence acceptance and tolerability of this therapy, and measurements of early respiratory dysfunction need to be identified.\n\nThe purposes of this trial are to develop and validate strategies to improve tolerability of NIPPV, identify factors that influence acceptance of NIPPV, and evaluate measures of early respiratory failure, other than percentage of forced vital capacity (FVC). Researchers will also develop and validate methods to determine energy balance in and evaluate the nutritional status of patients with ALS that will be applicable to a multi-center phase III study of nutrition and NIPPV.\n\nThe study will be conducted at 11 other sites across the country. Some study sites will focus on the nutritional aspects of the trial while the other sites will focus on NIPPV treatment. A total of 220 patients will be studied over 2 years.\n\nEnrollment will end on June 30, 2007. The last patient was followed clinically until June 30, 2008. The study remained open for sample analysis, data analysis, and assessment of vital status until the completion of funding on November 30, 2009."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing and able to give informed consent.\n* If women of childbearing age, must be non-lactating and surgically sterile or using an effective method of birth control (double-barrier or oral contraception) and have a negative pregnancy test.\n* Minorities: All races and ethnic backgrounds.\n* Disease inclusion: Clinically possible/definite/probable, or laboratory supported probable, sporadic or familial ALS according to the revised Escorial criteria.\n* Onset of progressive weakness within 60 months prior to study.\n* Willing to return for visits as scheduled and adhere to protocol requirements.\n\nFVC Criteria\n\n* NIPPV Arm: Best-sitting FVC between 50% and 95% of predicted normal.\n* Nutrition Arm: Best-sitting FVC \\>50% of predicted normal.\n\nExclusion Criteria:\n\n* Untreated or unstable hyper or hypothyroidism, untreated or unstable asthma, unstable angina, advanced liver or renal disease, advanced cancer, untreated diabetes or chronic obstructive pulmonary disease (COPD).\n* Diagnosis of other motor neuron or other neurological disorder that mimics ALS.\n* Diagnosis of other neurodegenerative disease (i.e., Parkinson's disease, Alzheimer's disease, etc.)\n* Inflammatory bowel disease or malabsorption syndrome.\n* Use of NIPPV, mechanical ventilation, or tracheostomy at the time of consent.\n* Inability to adhere to study visit schedule or lack of reliable caretaker if participant requires one.\n* Pregnant or lactating woman."}, 'identificationModule': {'nctId': 'NCT00116558', 'briefTitle': 'Early Treatment of Amyotrophic Lateral Sclerosis (ALS) With Nutrition and Non-Invasive Positive Pressure Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Early Treatment of Amyotrophic Lateral Sclerosis With Nutrition and Non-Invasive Positive Pressure Ventilation', 'orgStudyIdInfo': {'id': 'R01NS045087', 'link': 'https://reporter.nih.gov/quickSearch/R01NS045087', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01NS045087', 'link': 'https://reporter.nih.gov/quickSearch/R01NS045087', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early NIPPV Intervention', 'description': 'Participants with \\>80% predicted forced vital capacity (FVC).', 'interventionNames': ['Device: Early NIPPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care NIPPV', 'description': 'Participants with 50-74% predicted forced vital capacity (FVC).', 'interventionNames': ['Device: Standard NIPPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care NIPPV and Nutritional Monitoring', 'description': 'Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.', 'interventionNames': ['Device: Standard NIPPV']}], 'interventions': [{'name': 'Early NIPPV', 'type': 'DEVICE', 'otherNames': ['BiPAP (Bilevel Positive Airway Pressure)'], 'description': 'Early intervention with non-invasive positive pressure ventilation (NIPPV) at 80% forced vital capacity (FVC).', 'armGroupLabels': ['Early NIPPV Intervention']}, {'name': 'Standard NIPPV', 'type': 'DEVICE', 'otherNames': ['BiPAP (Bilevel Positive Airway Pressure)'], 'description': 'Standard of care non-invasive positive pressure ventilation (NIPPV) at 50% forced vital capacity (FVC).', 'armGroupLabels': ['Standard of Care NIPPV', 'Standard of Care NIPPV and Nutritional Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas-San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '54505', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Edward Kasarskis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edward Kasaraskis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Edward Kasaraskis', 'investigatorAffiliation': 'University of Kentucky'}}}}