louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01131442: Immunological Change and the Single Nucleotide Polymorphism (SNP) in Children With Irritable Bowel Syndrome (IBS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Children
Keywords: immune
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: out patient clinics in the hospital

Brief summary: Currently, the pathophysiology of Irritable bowel syndrome( IBS) remains unclear . The purpose of this study is want to investigate the immunological changes in the children with IBS.

Detailed description: Irritable bowel syndrome (IBS) is a highly prevalent functional gastrointestinal disorder.Many children suffered from this disease and had impact on their daily life. However, the underlying pathophysiologic mechanisms remain to be elucidate. Dysregulation of the gut immune system is considered an important pathophysiology. We want to investigate the immunological changes in the IBS children.

Eligibility criteria: Inclusion Criteria:

* (5-18y/o) with IBS,
* All patients had chronic or relapsing symptoms of IBS consistent with the ROME II criteria

Exclusion Criteria:

* A history of psychologic disorders, probiotics, anti-inflammatory, analgesic, or immunosuppressive medication (nonsteroidal anti-inflammatory drugs, steroids) within the past 3 months were excluded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memeorial Hospital
Study officials:
References:
citation: Hua MC, Chao HC, Yao TC, Lai MW, Huang JL; PATCH Study Group. Investigation of interleukin-10 promoter polymorphisms and interleukin-10 levels in children with irritable bowel syndrome. Gut Liver. 2013 Jul;7(4):430-6. doi: 10.5009/gnl.2013.7.4.430. Epub 2013 Jun 11.
citation: Hua MC, Lai MW, Kuo ML, Yao TC, Huang JL, Chen SM. Decreased interleukin-10 secretion by peripheral blood mononuclear cells in children with irritable bowel syndrome. J Pediatr Gastroenterol Nutr. 2011 Apr;52(4):376-81. doi: 10.1097/MPG.0b013e3181fd9816.
Clinical trial NCT04590742: Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
Official title: Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disturbance
Total Joint Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty


Eligibility criteria: Inclusion Criteria:

1. Patients who undergo unilateral primary total joint arthroplasty
2. Patient willing and able to complete postoperative surveys

Exclusion Criteria:

1. Patients who undergo revision total joint arthroplasty
2. Patients who undergo bilateral total joint arthroplasty
3. Patients currently taking melatonin supplementation
4. Patient has history of substance abuse (drug or alcohol)
5. Patient is a workman's comp patient or patient has current litigation pending
6. Patient has an allergy to melatonin
7. Patient has a history of delirium/psychiatric/depression/on antidepressants
8. Patient has a history of insomnia/ on sleep aid medication
9. Anyone on warfarin
10. Sleep apnea
11. Patient discharged to SNF or rehab
12. Patients who have inflammatory conditions
13. Shift work or night work

Primary outcomes:
measure: Patient Sleep Quality
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01222442: To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart
Official title: A Single-centre, Randomised, Double-blind, Double-dummy, Placebo Controlled, 4-way Crossover Phase I Study to Investigate the Effect of 2 Single Doses (400 μg and 1200 µg) of Inhaled AZD3199 on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Lung Disease
Keywords: Respiratory disease
Bronchiolitis
Emphysema
Lung disease causing persistent narrowing of the airways
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to evaluate the effect of AZD3199 on the electrical activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known. Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years (inclusive)
* Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg.
* Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.
* Be able to inhale from the Turbuhaler inhaler according to given instructions.

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings at screening examination
* History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalaemia, or family history of long QT syndrome).
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Primary outcomes:
measure: To investigate the effect of AZD3199 on the QT interval
timeFrame: Throughout the study
Secondary outcomes:
measure: To investigate the effect of AZD3199 on additional electrocardiogram variables
timeFrame: Throughout the study
measure: To assess the pharmacokinetics of single doses of AZD3199.
timeFrame: Throughout the study
measure: To evaluate the safety and tolerability of single doses of AZD3199.
timeFrame: Throughout the study
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
state: UK
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Carin Jorup, MD
role: STUDY_DIRECTOR
affiliation: Quintiles Drug Research Unit at Guy's Hospital, London
name: Leonard Siew, MB CHB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03728842: Spontaneous Regression in Metastatic Melanoma and Renal Cell Carcinoma
Official title: Blood Drawing for Study of Peripheral Blood T-lymphocytes and Other Parameters in Patients With Metastatic Melanoma and Renal Cell Cancer With Spontaneous Regression
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma; Renal Cell Carcinoma
Keywords: metastatic disease
spontaneous regression
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic melanoma and renal cell cancer and spontaneous regression.

Brief summary: The purpose of this study is to collect blood and clinical data from patients with metastatic melanoma and renal cell cancer who have experienced spontaneous regression for studies of immune response and other factors that may influence these occurrences.

Detailed description: Spontaneous regression in patients with metastatic cancer is an incredibly rare event. It has been described after infection in cancer patients and also rarely in patients with renal cell cancer (usually after resection of the renal primary) and, less commonly, in patients with metastatic melanoma.

Primary Objective To collect peripheral blood from patients with metastatic melanoma and renal cell cancer and spontaneous regression for studies of immune response and other studies.

Secondary Objective To collect clinical data from subjects registered to this study. Clinical data collection will include demographics and cancer characteristics, history and treatment.

Eligibility criteria: Inclusion Criteria

1. ≥ 18 years old at the time of informed consent
2. Ability to provide written informed consent and HIPAA authorization
3. Patients must have metastatic melanoma or renal cell cancer with spontaneous regression.
4. Willingness to undergo phlebotomy for research blood samples

Exclusion Criteria

1. Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety
2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Primary outcomes:
measure: Number of blood samples collected
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Theodore Logan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02894242: The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Official title: The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2016-09-09
Enrollment: 22
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: This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

Detailed description: A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.

Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing nasal pillows user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant

Primary outcomes:
measure: Ease of use
timeFrame: 2 weeks in home
measure: Acceptability
timeFrame: 2 weeks in home
Secondary outcomes:
measure: Objective leak data
timeFrame: 2 weeks in home
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher and Paykel Healthcare
city: Hastings
country: New Zealand
facility: Hawkes Bay Fallen Soldiers' Memorial Hospital
Study officials:
affiliation: Sponsor Employee
name: Sarah Gunson, Bsc PgDip
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01643642: Cost- Effectiveness Study of Brief Interventions for Mood and Anxiety Disorders
Official title: A Efficacy and Cost-effectiveness Study of a Brief Interventions for Mood and Anxiety Disorders: Brief Intake, Treatment and Routine Outcome Monitoring (ROM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Anxiety Disorder
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: GGZ Rivierduinen
First posted: 2012-07-18
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares both clinical effectiveness and cost-effectiveness of a brief, intensified therapy and diagnostic method for patients with mood and/or anxiety disorders with Treatment As Usual (TAU) at five outpatient Mental Healthcare Centers in the Netherlands.


Eligibility criteria: Inclusion Criteria:

* Male of female adolescents
* Adolescents aged between 18 to 65 year
* Adolescents main complaint: Mild to moderate anxiety and/or mood disorders with or without psychiatric and/or somatic co-morbidity
* Adolescents with proper understanding of the Dutch language.

Exclusion Criteria:

* Adolescents with current psychotic or bipolar traits,
* Adolescents with homicidal or suicidal risk
* Adolescents with severe social disfunctioning
* No proper understanding of the Dutch language

Primary outcomes:
measure: Effectiveness of the intervention
timeFrame: approximately 3 years (start: march 2010).
Secondary outcomes:
measure: Cost-effectiveness intervention
timeFrame: approximately 3 years (start: march 2010).
Other outcomes:
Locations:
city: South Holland
country: Netherlands
facility: Rivierduinen
Study officials:
References:
citation: Meuldijk D, Carlier IV, van Vliet IM, van Veen T, Wolterbeek R, van Hemert AM, Zitman FG. The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice. Contemp Clin Trials. 2016 Mar;47:131-8. doi: 10.1016/j.cct.2015.12.021. Epub 2016 Jan 5.
Clinical trial NCT01739842: Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment
Official title: Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Alcohol Consumption
Cerebral Blood Flow
Keywords: Alcohol consumption
Kudzu extract
Cerebral blood flow
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to test whether treatment with kudzu extract will increase the rate at which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).


Eligibility criteria: Inclusion Criteria:

* Capable of understanding and complying with the protocol
* Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, no psychopathologies)
* Body Mass Index between 18-30, inclusive
* Age 21-40 years
* Moderate alcohol drinkers (less than 20 drinks/week)
* Have a stable living situation with current postal address
* No contraindications to MR scanning (see MR scanning exclusion criteria below)

Exclusion Criteria:

* Concurrent diagnosis of Axis I disorder
* Current or past alcohol dependence; may meet criteria for alcohol abuse. Other drug dependence acceptable only if greater than 3 years.
* Current drug abuse (other than alcohol or marijuana abuse). Past drug abuse is acceptable.
* Subjects cannot be actively seeking treatment for any drug or alcohol dependence.
* Subjects cannot use marijuana more than once a week. Marijuana abuse/dependence are acceptable if the use criteria is met.
* Maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions.
* Tobacco use greater than 10 cigarettes per day
* History of major head trauma resulting in cognitive impairment or history of seizure disorder
* Heavy caffeine use (greater than 500 mg on a regular, daily basis)
* For female volunteers, a positive pregnancy test

Primary outcomes:
measure: Rate at which alcohol enters the brain
timeFrame: 2.5 hours after drug administration
Secondary outcomes:
measure: Impact of alcohol and kudzu on resting state networks (RSN).
timeFrame: 2.5 hours after drug administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00265642: Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C
Official title: Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic
irbesartan
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Sanofi
First posted: 2005-12-15
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 examine the efficacy of irbesartan on the progression of liver fibrosis in adult patients with chronic hepatitis C.

The expected total enrollment is 200 patients. Patients who meet the study criteria and accept to participate at this study will take by day one tablet of 150 mg of treatment (irbesartan or placebo) during two years. The assessment of efficacy will be make by evaluation of area of liver fibrosis and blood markers of liver fibrosis

Detailed description: The results of several studies suggests than the AT1 receptor antagonists of angiotensin II have inhibitory effects on TGF-beta 1 production and can limit the progression of liver fibrosis.

Therefore, the angiotensin II could be another mediator of the synthesis of the extra-cellular matrix at the hepatic level, opening new perspectives with the antagonists of angiotensin II receptors drugs (ARA2/sartans).

This study is a randomized, double blind, multi-center, parallel assignment, and efficacy study.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 75 years
* liver biopsy performed (less 18 month before inclusion), fibrosis score F2,F3 or F3+ in Metavir classification,
* patients without antiviral therapy
* contraindication to anti viral treatment
* non responders or relapsers patients to past antiviral treatment

Exclusion Criteria:

* hepatocellular carcinoma
* HIV
* alcool abuser
* cirrhosis
* anti-fibrotic treatment
* pregnancy or breast feeding

Primary outcomes:
measure: Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24
timeFrame: at M24
Secondary outcomes:
measure: Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry)
timeFrame: at M24
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers, Service d'hépato-gastroentérologie
Study officials:
affiliation: CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09
name: Paul Cales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inserm U707 France
name: Fabrice Carrat, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03238742: The Efficacy of Xuebijing Injection on Sepsis
Official title: The Efficacy of Xuebijing Injection in Adult Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Keywords: Xuebijing Injection, morality, sepsis
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: National Health and Family Planning Commission, P.R.China
First posted: 2017-08-03
Enrollment: 1817
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

Detailed description: The purpose of this placebo-controlled study is to determine if Xuebijing Injection treatment provides significant mortality reduction improvement in patients with sepsis compared with placebo treatment in patients receiving the current standard of care for sepsis. This study will also assess the effectiveness of Xuebijing Injection in reducing 28-day mortality in patients with sepsis.

Eligibility criteria: Inclusion Criteria:

Patients will be eligible for inclusion if all of the inclusion criteria are met

1. Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM)
2. 18≤ age ≤75years
3. 2 ≤SOFA ≤13
4. obtain informed consent

Exclusion Criteria:

1. Diagnosis of sepsis for more than 48 h;
2. Pregnant and lactating women;
3. Severe primary disease including unrespectable tumours, blood diseases and Human Immunodeficiency Virus (HIV);
4. Severe liver and kidney dysfunction (single liver or kidney SOFA score ≥ 3 points);
5. Use of an immunosuppressant or having an organ transplant within the previous 6 months;
6. Participating in other clinical trials in the previous 30 days.

Primary outcomes:
measure: All-Cause Mortality
timeFrame: 28 Days after randomization
Secondary outcomes:
measure: Death in ICU
timeFrame: 28 Days after randomization
measure: SOFA score
timeFrame: Day 0,3,6 after randomization
measure: APACHEⅡ
timeFrame: Day 0,3,6 after randomization
measure: Duration of mechanical ventilation
timeFrame: 28 days after randomization
measure: ICU stay
timeFrame: 28 days after randomization
measure: Concentration of C-reactive protein
timeFrame: 0,3,6days after randomization
measure: Concentration of Procalcitonin
timeFrame: 0,3,6 days after randomization
measure: Percentage of Human Leukocyte Antigen-DR
timeFrame: 0，6 days after randomization
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Qiu Haibo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu S, Yao C, Zhang J, Yang Y, Qiu H; EXIT-SEP Investigators. Efficacy of Xuebijing Injection for Sepsis (EXIT-SEP): protocol for a randomised controlled trial. BMJ Open. 2019 Aug 28;9(8):e028664. doi: 10.1136/bmjopen-2018-028664.