louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03858920: The Liver in the World Trade Center Health Program General Responder Cohort and Controls
Official title: The Liver in the World Trade Center Health Program General Responder Cohort and Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Steatosis of Liver
NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-03-01
Enrollment: 340
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort.

Brief summary: This project investigates whether exposure to the World Trade Center Attack is a risk factor for liver injury.

Detailed description: This is a prospective cross-sectional study of liver disease in individuals who meet the United States Preventive Services Task Forces guidelines for lung cancer screening because they are between 55 and 80 years of age and have a 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years. Liver disease will be compared between individuals who are members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort. The basic objective is to determine whether exposure to the WTC attack increased liver disease.

Data will be obtained from the World Trade Center Data Center, from Mount Sinai Medical records, EPIC, the data warehouse, and from data collected by the Lung Cancer Screening Program of Dr. Henschke. Results of genetic tests that relate to liver disease will be collected from the medical record.

Eligibility criteria: Inclusion Criteria:

* Male or Female between 55 and 80 years of age
* 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years.
* Individuals who are members of the World Trade Center General Responder Cohort or Subjects who meet the United States Preventive Services Task Forces guidelines for lung cancer screening

Exclusion Criteria:

* None

Primary outcomes:
measure: FibroScan- Controlled Attenuation Parameter (CAP) scores
timeFrame: Day 1
measure: Attenuation Hounsfeld units signal intensity in low -dose non-contrast CT scan
timeFrame: Day 1
measure: Fibroscan
timeFrame: Day 1
Secondary outcomes:
measure: Relationship between WTC exposure and liver fat
timeFrame: Day 1
measure: Composite score for Fibrosis and Steatosis
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrea Branch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01082120: Investigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes Mellitus
Official title: Open, Randomized, Phase I Study in Subjects With Type 2 Diabetes Mellitus Treated With Metformin to Evaluate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Pioglitazone
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether administration of AZD1656 will affect the pharmacokinetics of Pioglitazone and vice versa in patients with Type 2 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed Type 2 Diabetes Mellitus for at least 1 year and treated with metformin alone or metformin and one other oral anti-diabetic drug
* Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria:

* Impaired renal function
* Clinically significant illness or clinically relevant trauma.

Primary outcomes:
measure: To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of AUC (0-24) and Cmax.
timeFrame: Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
Secondary outcomes:
measure: To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of tmax, t1/2 and CL/F.
timeFrame: Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
measure: To evaluate the pharmacokinetics of the AZD1656 and its metabolite, when AZD1656 is administered with and without pioglitazone, by assessment of AUC(0 24), Cmax and tmax.
timeFrame: Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
measure: To evaluate the pharmacokinetics of the Pioglitazone metabolite hydroxyl pioglitazone, when pioglitazone is administered with and without AZD1656, by assessment of AUC(0-24), Cmax and tmax.
timeFrame: Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca
name: Stanko Skrtic
role: STUDY_DIRECTOR
affiliation: Profil Institute for Clinical Research, Inc.
name: Elaine Watkins, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mirjana Kujacic
role: STUDY_CHAIR
References:
Clinical trial NCT00910520: Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 548
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 purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
* Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

* Overactive Bladder caused by neurological condition
* Patient has predominance of stress incontinence
* History or evidence of pelvic or urological abnormality

Primary outcomes:
measure: Change From Baseline in Number of Daily Episodes of Urinary Incontinence
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Number of Daily Micturition Episodes
timeFrame: Baseline, Week 12
measure: Change From Baseline in Volume Voided Per Micturition
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Laguna Hills
country: United States
state: California
city: Gent
country: Belgium
city: Prague
country: Czech Republic
city: Tubingen
country: Germany
city: Warsaw
country: Poland
city: Moscow
country: Russian Federation
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Castejon N, Khalaf K, Ni Q, Cuervo J, Patrick DL. Psychometric properties of the incontinence utility index among patients with idiopathic overactive bladder: data from two multicenter, double-blind, randomized, Phase 3, placebo-controlled clinical trials. Health Qual Life Outcomes. 2015 Aug 1;13:116. doi: 10.1186/s12955-015-0306-5.
citation: Sievert KD, Chapple C, Herschorn S, Joshi M, Zhou J, Nardo C, Nitti VW. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014 Oct;68(10):1246-56. doi: 10.1111/ijcp.12443. Epub 2014 Apr 22.
citation: Chapple C, Sievert KD, MacDiarmid S, Khullar V, Radziszewski P, Nardo C, Thompson C, Zhou J, Haag-Molkenteller C. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013 Aug;64(2):249-56. doi: 10.1016/j.eururo.2013.04.001. Epub 2013 Apr 10.
Clinical trial NCT00497120: A Combined Surgical and Medical Approach in Mild Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
Keywords: sleep apnea
snoring
acetazolamide
uvulopalatopharyngoplasty
daytime sleepiness
upper airway
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2007-07-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea.


Eligibility criteria: Inclusion Criteria:

* 5 ≤ Apnea Hypopnea Index (AHI) \< 20
* Socially disturbing snoring: Visual Analogue Scale (VAS)snoring \> 6/10
* Based on clinical examination and polysomnography, patient is regarded eligible for uvulopalatopharyngoplasty (UPPP)

Exclusion Criteria:

* Previous surgical treatment for sleep-disordered breathing.
* Periodic Limb Movement Disorder (PLMD) with arousals and other reasons possibly explaining the Excessive Daytime Sleepiness (EDS) based on Epworth Sleepiness Scale (ESS).
* Forced expiratory volume in 1 second (FEV1) \< 80 % pred.
* Echocardiography: ejectionfraction \< 35 % or dyastolic dysfunction grade 2 or more.

Primary outcomes:
measure: Polysomnographic parameters
Secondary outcomes:
measure: subjective sleepiness
measure: subjective snoring
measure: satisfaction
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05717920: A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)
Official title: The ADRO Trial: An Adaptive, 2-Part, Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Adults With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: eczema
atopic
adaptive
Aldeyra
ADX-629
Reactive aldehyde species (RASP)
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 2, multicenter, adaptive 2-part clinical trial designed to evaluate the safety and efficacy of ADX-629 alone and in combination with standard-of-care in adults with atopic dermatitis.

Detailed description: The trial is divided into 2 parts; the first part of the trial (Part 1) is open label, and the second part (Part 2) is randomized, double-blind, and placebo controlled.

In Part 1, approximately 10 subjects will receive open-label ADX-629 twice daily for 90 days.

In Part 2, approximately 40 subjects will be randomized to receive either ADX-629 or matching placebo twice daily for 90 days.

Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years of age
* History of atopic dermatitis, according to American Academy of Dermatology criteria, that has been present for at least 6 months
* Mild, moderate, or severe atopic dermatitis, defined as an IGA score of ≥2 at Baseline
* Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable

Exclusion Criteria:

* Presence of clinically significant kidney disease or an estimated gloverular filtration rate (eGFR) of less than or equal to 45 milliliters/min/1.73 m2 during screening
* History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial

Primary outcomes:
measure: Adverse Event (AE) Query
timeFrame: From Day 1 to Day 90
Secondary outcomes:
measure: Investigator Global Assessment (IGA) Score
timeFrame: From Day 1 to Day 90
Other outcomes:
Locations:
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
Study officials:
References:
Clinical trial NCT01843920: The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble
Official title: A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration Following Scleral Buckling and Pneumatic Retinopexy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleral Buckling
Keywords: eye
pneumatic retinopexy
topical
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 21
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: A controlled clinical study comparing the effect of topical aqueous suppressants on intraocular gas duration.

Detailed description: A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration following Scleral Buckling and Pneumatic Retinopexy

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Have undergone eye surgery including scleral buckling or pneumatic retinopexy for treatment of retinal detachment other condition at the discretion of the investigator.

Exclusion Criteria:

* Prior surgery to treat glaucoma.
* Current use of glaucoma eye drops.
* Absence of a lens in the eye or presence of a lens implant in front of the iris (colored part of your eye).
* Allergy or contraindication to any of the glaucoma drops being used in this study (e.g., sulfa allergy, asthma, chronic obstructive pulmonary disease (bronchitis or emphysema), slow heart rate).

Primary outcomes:
measure: Complete Resolution of Intraocular Gas Bubble
timeFrame: Following surgery, until gas bubble is gone. Up to 2 months.
Secondary outcomes:
measure: Number of Participants With Return of Intraocular Pressure to Normal Levels
timeFrame: Month 2
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Mid Atlantic Retina- Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Wills Eye Institute
name: Jason Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01339520: Diabetes Scorecard Educational Intervention Study
Official title: Use of a Card to Improve Risk Factor Control in Patients With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to see if the use of a diabetic scorecard during clinic visits can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and amount of exercise in adults over age 40 with uncontrolled Type II diabetes.


Eligibility criteria: Inclusion Criteria:

* Uncontrolled Type II diabetes (HbA1c ≥ 8%)

Exclusion Criteria:

* Type I Diabetes
* HbA1c \< 8%
* Inability to understand the diabetes scorecard due to condition (i.e. dementia, mental retardation, etc) or language barrier
* Pregnancy
* Planning to move within the next year

Primary outcomes:
measure: Change in total score
timeFrame: 9 months
Secondary outcomes:
measure: LDL-cholesterol
timeFrame: 9 months
measure: HbA1c
timeFrame: 9 months
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Medical Faculty Associates, George Washington University
state: District of Columbia
Study officials:
References:
citation: Irwig MS, Sood P, Ni D, Amass T, Khurana PS, Jayanthi VV, Wang L, Adler SM. A diabetes scorecard does not improve HbA(1c), blood pressure, lipids, aspirin usage, exercise and diabetes knowledge over 9 months: a randomized controlled trial. Diabet Med. 2012 Sep;29(9):1206-12. doi: 10.1111/j.1464-5491.2012.03610.x.
Clinical trial NCT05008120: Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder
Official title: Gut Microbiota in Major Depressive Disorders With and Without Rapid Eye Movement Behavior Disorder: Tracing a Subtype of Depression With Underlying Neurodegeneration
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gut Microbiota
Keywords: Major depressive
Neurodegeneration
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2021-08-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects of the current study would be recruited from our established cohort of patients with MDD (with and without RBD). Three groups of subjects are included in the current study, namely healthy control, patients with MDD only, and patients with MDD+RBD.

Brief summary: The purpose of this study is to identify the variations in gut microbiota compositions between two subtypes of major depressive disorder.

Detailed description: Objective: To identify the variations in gut microbiota compositions between two subtypes of major depressive disorder (MDD), namely those with and without REM sleep behavior disorder (RBD). To correlate the microbiota composition with depressive severity and prodromal markers of α-synucleinopathy.

Design: Case-control study Setting: Established clinical cohorts consisting of patients with comorbid MDD+RBD and MDD only and a group of sexand age-matched healthy control Participants: Patients with comorbid MDD+RBD (n=55), patients with MDD only (n=55), and healthy control (n=55).

Main outcome measures: The abundance and composition of gut microbiota, severity of depressive symptoms, and prodromal markers of α-synucleinopathy.

Eligibility criteria: Inclusion Criteria:

1. Age-and sex-matched with MDD+RBD subjects;
2. Free of psychiatric disorders based on M.I.N.I.;
3. Without a personal history or a family history of RBD or neurodegenerative diseases (i.e. dementia and PD)
4. Free of RBD symptoms or RWSA by vPSG

Exclusion Criteria:

1. Presence of narcolepsy and other neurodegenerative diseases that may give rise to RBD and RWSA;
2. Severe psychiatric illness that could not permit a valid written informed consent or otherwise is not suitable for participating in a study;
3. Use of antibiotics within one month and the use of probiotics within three days prior to sample collection;
4. Pre-existing or post-operation of gastrointestinal diseases (e.g. inflammatory bowel disease, gastrointestinal cancer).

Primary outcomes:
measure: Composition of gut microbiota
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Shatin Hospital
Study officials:
References:
Clinical trial NCT01069120: Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
Official title: A Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids
Keywords: Uterine Fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and efficacy study of 25 and 50 mg doses of Proellex

Detailed description: The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Eligibility criteria: Inclusion Criteria:

* At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
* Subject has a menstrual cycle lasting from 20 to 40 days.
* Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion Criteria:

* Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
* Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Primary outcomes:
measure: To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
timeFrame: During two 4 month treatment periods
Secondary outcomes:
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Tampa
country: United States
facility: Insignia Clinical Research (Tampa Bay Women's Center)
state: Florida
city: Houston
country: United States
facility: Advances in Health Inc
state: Texas
city: Houston
country: United States
facility: The Women's Hospital of Texas, Clinical Research Center
state: Texas
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre vanAS, PhD, Md
role: STUDY_DIRECTOR
References: