louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00979901: Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 1577
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.


Eligibility criteria: Inclusion Criteria:

* Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
* Patient is a nonsmoker and has been a nonsmoker for at least 1 year
* Patient is in good general health

Exclusion Criteria:

* Patient is hospitalized
* Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
* Patient intends to move or vacation away during the study
* Patient has had any major surgery within 4 weeks of study start
* Patient is a current or past abuser of alcohol or illicit drugs
* Patient has been treated in an emergency room for asthma in the past month
* Patient had an upper respiratory infection with in 3 weeks prior to study start

Primary outcomes:
measure: Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks
timeFrame: Baseline and Week 2
measure: Patient's Global Evaluation of Allergic Rhinitis at Week 2
timeFrame: Week 2
measure: Physician's Global Evaluation of Allergic Rhinitis at Week 2
timeFrame: Week 2
measure: Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2
timeFrame: Week 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice MP, Reiss TF; Montelukast Spring Rhinitis Study Group. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002 Jul;32(7):1020-8. doi: 10.1046/j.1365-2222.2002.01422.x.
Clinical trial NCT00697801: Study of MAP0010 in Asthmatic Children and Adolescents
Official title: A Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
First posted: 2008-06-16
Enrollment: 208
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.


Eligibility criteria: Inclusion Criteria:

* Male or female asthmatic children/adolescents
* 1 to 18 years of age
* FEV1 greater than or equal to 50% predicted normal (where obtainable)
* Stable but symptomatic
* Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.

Exclusion Criteria:

* Any other significant childhood illness.
* Participated in any investigational clinical trial within the 30 days prior to screening.
* Use of any corticosteroid within 2 weeks of screening.
* Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
* Use of inhaled long acting bronchodilators.
* Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening.
* Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
* History suggestive (or diagnosis) of other concomitant lung disease.

Primary outcomes:
measure: Change From Baseline in Daytime Composite Symptom Score
timeFrame: baseline, week 6
measure: Change From Baseline in Nighttime Composite Symptom Score
timeFrame: baseline, week 6
Secondary outcomes:
measure: Change From Baseline in FEV1% Predicted
timeFrame: baseline, week 6
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03010501: Effect of Energy Density Over 5 Days in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-01-05
Enrollment: 56
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. The primary aim is to determine the effect of varying the energy density of foods served over 5 days on energy intake in preschool children. It is hypothesized that mean daily energy intake will be greater when children are served higher energy dense foods over 5 days than when served lower energy dense foods over the same period. Additionally, it is hypothesized that daily energy intake in the conditions with higher and lower energy densities will begin to converge across the 5-day period.


Eligibility criteria: Inclusion Criteria:

* Attending one of the designated daycare centers

Exclusion Criteria:

* Food Allergies
* Food restrictions
* Health Issues that Preclude Participation
* Not available for duration of the study

Primary outcomes:
measure: Differences in Food and Beverage Intake by Energy
timeFrame: Days 1-5 in Weeks 1, 2, and 3
measure: Differences in Food and Beverage Intake by Weight
timeFrame: Days 1-5 in weeks 1, 2, and 3
Secondary outcomes:
measure: Differences in Food and Beverage Intake by Energy Density
timeFrame: Days 1-5 in weeks 1, 2, and 3
Other outcomes:
Locations:
city: University Park
country: United States
facility: Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Barbara J Rolls
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238601: Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping
Official title: Breast Implant Shell Geometry and Edge Scalloping: A Study Using the Upright MRI Machine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Augmentation
Keywords: Breast augmentation
Lead sponsor: Ideal Implant Incorporated
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 18
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 20-50 who previously had primary breast augmentation or replacement of existing breast implants.

Brief summary: The purpose of this study is to determine how different types of breast implants contour to the chest wall.


Eligibility criteria: Inclusion Criteria:

* had previous primary breast augmentation
* had previous replacement of breast implants
* has Baker Class I breast implant capsule

Exclusion Criteria:

* has scar capsule contracture around the breast implants of Baker Class II-IV
* is pregnant or may be pregnant
* has possibility or previous history of metallic foreign body

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04064801: Red Cell Distribution Width as a Predictor of Mortality in Acute Methanol Poisoning
Official title: Red Cell Distribution Width as a Predictor of Mortality in Acute Methanol Poisoning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methanol Poisoning
Keywords: Alcohol, red blood cell distribution width, methanol poisoning, prognosis
Lead sponsor: Adana Numune Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-08-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute methanol toxicity who were diagnosed and treated at the Adana City Training and Research Hospital

Brief summary: The study aimed to investigate the association between RDW and in-hospital mortality in methanol poisoning.

Detailed description: RDW values have been found to be an independent predictor of the prognosis among patients with heart diseases, stroke,community-acquired pneumonia (CAP), pulmonary embolism, chronic obstructive pulmonary disease (COPD), septic shock, and acute pancreatitis.

Eligibility criteria: Inclusion Criteria:

All patients aged ≥18 years who were admitted to emergency departments from January 2019 to January 2020 on account of acute methanol intoxication.

Exclusion Criteria:

Incomplete data, Malignancy, Severe anaemia, History of erythrocyte transfusion last 6 weeks

-

Primary outcomes:
measure: Hospital mortality
timeFrame: 7 day
measure: Need for mechanical ventilation
timeFrame: 7 day
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
Study officials:
References:
Clinical trial NCT01623401: A Phase 1, Open-Label, 10 Day Safety Study
Official title: Phase 1, Open-Label, Ophthalmology and Neurology Safety Study of Oral 200 mg TR-701 FA Once Daily for 10 Days in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701 FA once daily for 10 days and will include ophthalmologic and neurologic assessments.

Detailed description: This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701 FA once daily for 10 days (Days 1 through 10) and undergo safety evaluations including ophthalmologic and neurologic assessments before (Screening or Day -1), 1 day after final study drug administration (Day 11 or earlier if a subject discontinues treatment), and 2 to 4 weeks after the last study drug administration (Late Follow-up Visit).

Eligibility criteria: Inclusion Criteria:

* Healthy males and females ≥ 18 and ≤ 65 years of age with no clinically significant abnormalities identified by a detailed medical history
* Female subjects must be nonpregnant, nonlactating, and either postmenopausal for at least 2 years, surgically sterile for at least 90 days, abstinent, or agree to use contraception from 1 week prior to Day -1 until 30 days after leaving the study center.
* Male subjects must be surgically sterile, abstinent, or agree to use contraception from Day -1 until 30 days after leaving the study center
* BMI ≥ 18.0 kg/m2 and ≤ 35.0 kg/m2

Exclusion Criteria:

* Hypersensitivity to oxazolidinones or any component in the formulation
* History or current significant ophthalmologic or neurologic condition that would adversely affect the clinical assessments or confound the interpretation of the data (e.g., dense cataracts, macular degeneration, retinitis pigmentosa)
* Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result
* Known genetic condition related to mitochondrial disease or dysfunction

Primary outcomes:
measure: Safety
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Trius Investigator Site 001
state: Texas
Study officials:
affiliation: Trius Therapeutics
name: Philippe G Prokocimer, MD
role: STUDY_CHAIR
References:
citation: Fang E, Munoz KA, Prokocimer P. Characterization of Neurologic and Ophthalmologic Safety of Oral Administration of Tedizolid for Up to 21 Days in Healthy Volunteers. Am J Ther. 2017 Mar/Apr;24(2):e227-e233. doi: 10.1097/MJT.0000000000000534.
Clinical trial NCT01194401: An Observational Study on Long-Term Effectiveness and Safety of RoActemra/Actemra (Tocilizumab) in Daily Practice in Patients With Rheumatoid Arthritis (ICHIBAN)
Official title: A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Long-term Effectiveness and Safety of Tocilizumab in Patients With Active Rheumatoid Arthritis in Daily Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-03
Enrollment: 3404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with inadequate response or intolerant to DMARDs and anti-TNF

Brief summary: This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active moderate to severe rheumatoid arthritis
* Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists
* Prescription of RoActemra/Actemra according to label

Exclusion Criteria:

N/A

Primary outcomes:
measure: Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6
timeFrame: 5 years
Secondary outcomes:
measure: Time to DAS28 remission
timeFrame: 5 years
measure: Proportion of patients with good or moderate response according to EULAR criteria
timeFrame: 5 years
measure: Time to good or moderate response according to EULAR criteria
timeFrame: 5 years
measure: Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness)
timeFrame: 5 years
measure: Dose-modifications and discontinuations of RoActemra/Actemra
timeFrame: 5 years
measure: Safety: Incidence of adverse events
timeFrame: 5 years
measure: Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria)
timeFrame: 5 years
measure: Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events)
timeFrame: 5 years
Other outcomes:
Locations:
city: Osnabrück
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03915301: Effective Postoperative Pain Treatment After Sternotomy. Comparison of the Erector Spinae Plane Block vs Conventional Opioid Treatment
Official title: VUSCH/PostOperativePainTreatment1
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain Reliefe
Lead sponsor: Pavol Jozef Safarik University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients after cardiac surgery

Brief summary: Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery

Detailed description: Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery. In group "A" will be erector spinae plane block provided in the thoracic part of the body, under ultrasound control. In the group B will be analgesia provided by Pethidine. Numerical pain score will be recorded every 2 hours, also usage of analgetics will be recorded in both groups.

Eligibility criteria: Inclusion Criteria:

* Postoperative state after cardiac surgery, Serious pain NRS 8-10

Exclusion Criteria:

* disagreement

Primary outcomes:
measure: Satisfaction with pain treatment assessed by the numerical rating scale VAS
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kosice
country: Slovakia
facility: East Slovak Institute for Cardiovascular Diseases
Study officials:
References:
Clinical trial NCT02259101: RCT of CBT for Insomnia With PLWHA
Official title: A Randomized Controlled Trial of Cognitive Behavior Therapy for Insomnia With Persons Living With HIV/AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
HIV
Aids
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will consist of a randomized controlled trial (RCT) comparing a known efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.

Detailed description: The purpose of this study is to test whether a group cognitive-behavioral treatment program for insomnia (CBT-I) will help adults diagnosed with HIV to improve the quantity (number of hours) and the quality of their sleep. The PI will compare adults who participated in the CBT-I program to adults who participated in a Sleep Hygiene group, a common treatment for insomnia. The PI will look at the overall quality of life, and number of hours and quality of sleep of adults who participated in the CBT-I program versus adults in the Sleep Hygiene group. Also, the PI will draw blood to compare how the body responds to medical illnesses between adults in the CBT-I program to adults in the Sleep Hygiene group.

Eligibility criteria: Inclusion Criteria:

* English-speaking individuals
* over the age of 18 years old with a diagnosis of HIV or AIDS who is receiving medical care at the Grady Health System's Infectious Disease Program (IDP)
* study subjects must meet the criteria for primary or secondary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
* must experience difficulty initiating or maintaining non-restorative sleep for at least l month (DSM- IV-TR)
* the sleep disturbance causes clinically significant impairment or distress in important areas of functioning
* sleep efficiency of less than 85%, sleep disturbances that occur three or more days per week, and sleep latency (i.e., time awake after sleep onset greater than 30 minutes)

Exclusion Criteria:

* current substance dependence (within the past six months)
* active psychosis
* Bipolar I and II disorders
* neurocognitive impairment and/or a current diagnosis of dementia
* lack of independent housing
* previous participation in a CBT-I program
* employment in a job requiring shift work that impairs the ability to establish a regular sleep schedule

Primary outcomes:
measure: Insomnia Symptoms
timeFrame: baseline, up to 5 weeks post-intervention
Secondary outcomes:
measure: Quality of Life
timeFrame: baseline, up to 5 weeks post-intervention
measure: Blood Sample
timeFrame: baseline, up to 5 weeks post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital/Infectious Disease Program
state: Georgia
Study officials:
affiliation: Emory University
name: Amit Shahane, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123901: The Effect of Walking Meditation Training on Glycemic Control and Vascular Function in Patients With Type 2 Diabetes
Official title: THE EFFECT OF WALKING MEDITATION TRAINING ON GLYCEMIC CONTROL AND VASCULAR FUNCTION IN PATIENTS WITH TYPE 2 DIABETES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Mind and body Exercise
Flow mediated dilation
Diabetes
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Walking Meditation training would yield more favorable adaptations than walking alone in improving glycemic control and vascular function in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria included type 2 diabetes (as defined by the American Diabetes Association), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, and no previous exercise training in the past 6 months. All participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.

Exclusion Criteria:

* Participants were excluded if they dropped out or completed less than 80% of the training schedule.

Primary outcomes:
measure: Change from baseline in glycemic control
timeFrame: Baseline, Week 12
measure: Change from baseline in vascular reactivity
timeFrame: baseline, week 12
Secondary outcomes:
measure: Change from baseline in stress indicators
timeFrame: Baseline, Week 12
measure: Change from baseline in physical fitness
timeFrame: Baseline, Week 12
measure: Change from baseline in Peripheral arterial stiffness
timeFrame: Baseline, Week 12
measure: Change from baseline in ankle-brachial index.
timeFrame: Baseline, Week 12
measure: Change from baseline in blood chemistry
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Prapadang
country: Thailand
facility: The Primary Health Promoting Hospital
state: Samut Prakan
Study officials:
affiliation: Faculty of Sports Science, Chulalongkorn University
name: Daroonwan Suksom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitranun W, Deerochanawong C, Tanaka H, Suksom D. Continuous vs interval training on glycemic control and macro- and microvascular reactivity in type 2 diabetic patients. Scand J Med Sci Sports. 2014 Apr;24(2):e69-76. doi: 10.1111/sms.12112. Epub 2013 Sep 17.