louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01167673: The Effect of Coltect (Selenium, Curcumin and Green Tea) on Irritable Bowel Syndrome
Official title: A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
selenium
curcumin
green tea
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Irritable bowel syndrome (IBS) causes many symptoms, including abdominal pain, irregular bowel movements and bloating. It may be caused by loe degree inflammation of the intestine. The ingredients of coltect which contains green tea, selenium, and curcumin have been proven very safe and have anti inflammatory and anti oxidant activity. The aim of the study is to see whether the use of Coltect can improve symptoms in IBS patients.

Detailed description: The etiology of Irritable bowel syndrome is unknown but some evidence suggests it may be caused by a certain degree of inflammation, another theory is that intestinal flora has an influence on IBS. Coltect combines 3 ingredients: green tea, selenium and curcumin, all of which have been shown to have anti inflammatory and anti oxidant activity. the aim of the study is to investigate if use of coltect can improve symptoms in IBS patients

Eligibility criteria: Inclusion Criteria:

* IBS as defined by the Rome III criteria
* for those above age 40 a colonoscopy within the last 5 years
* no new treatment in the last 2 weeks
* not receiving any antibiotics in the last 2 weeks

Exclusion Criteria:

* any large abdominal operation (such as colectomy) in the past
* a known disease of the gastrointestinal tract
* any significant debilitating disease such as sever heart failure, un controlled diabetes,

Primary outcomes:
measure: improvement of IBS symptoms and quality of life
timeFrame: 10 weeks
Secondary outcomes:
measure: change in bacterial stool flora
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Gastroenterology institute Meir Hospital
Study officials:
affiliation: Meir MC
name: Timna Naftali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05681273: Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.
Official title: A Phase I Study to Evaluate the Drug-Drug Interaction of Chiglitazar With Empagliflozin，Atorvastatin and Valsartan in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: T2DM
Lead sponsor: Chipscreen Biosciences, Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and safety profiles of Chiglitazar with Empagliflozin，Atorvastatin and Valsartan in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 and 45 years, inclusive;
* 19.0≤BMI≤26.0 kg/m2. Weight of male ≥50 kg and Weight of female ≥ 45 kg.

Exclusion Criteria:

* History of clinically significant allergy or atopic allergic disease, or allergy to the study drug;
* Previous surgery may affect drug absorption, distribution, metabolism and excretion; or have suffered from gastrointestinal, liver and kidney diseases that can affect drug absorption or metabolism in the past 6 months;
* History of tuberculosis;
* Frequent infection history in the past year, or serious infections leading to hospitalization within 3 months before administration;
* untreated diarrhea, or diarrhea within 7 days before administration;
* Any drugs, vitamin products or herbal medicine used within 1 month before administration;
* History of drug abuse;
* Participated in clinical trial within 3 months before administration;
* Blood donation or massive blood loss within 3 months before the first administration;
* Pregnant or lactating women;
* Regular drinking history; or took any alcoholic products within 48 hours before administration; or positive alcohol test;
* Regular smoking history within 3 months before administration or cannot quit smoking during the trial;
* GFR\<80 mL/min;
* Abnormal results of laboratory examination,vital signs, 12 lead ECG, physical examination and chest X-ray;
* Systolic blood pressure\<90 or ≥ 140 mmHg, diastolic blood pressure\<60 or ≥ 90 mmHg;
* Other situations that are not suitable for participate the study.

Primary outcomes:
measure: Cmax
timeFrame: up to 72 hours
measure: AUC0-t and AUC0-inf
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Hongrong Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04516031: Transversus Abdominis Muscle Release Versus Mesh Only Repair in the Treatment of Complex Ventral Wall Hernia
Official title: Posterior Component Separation With Transversus Abdominis Muscle Release Versus Mesh Only Repair in the Treatment of Complex Ventral Wall Hernia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Ventral
Hernia Incisional
Hernia, Abdominal
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 59
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: This trial was designed as a prospective randomized, controlled, intervention, with two parallel groups, and a primary endpoint of recurrence during 12 months' follow-up after initial treatment, with the randomization, was performed by an online software a 1:1 allocation.

Detailed description: Eligibility Criteria

* both sexes
* aged between 18 and 65 years old
* presented complex ventral wall hernia or incisional hernia

Exclusion

* pregnant
* patients on steroid therapy
* underwent their hernia repair on an emergency basis

Interventions

* Eligible patients were randomized in equal proportions between "Mesh Only Repair" and "Posterior Component Separation with Transversus Abdominis Muscle Release"

Eligibility criteria: Inclusion Criteria:

* patients with complex ventral-wall and incisional hernia

Exclusion Criteria:

* pregnant female
* steroid therapy
* emergency basis

Primary outcomes:
measure: Hernia recurrence
timeFrame: after 12 months
Secondary outcomes:
measure: Morbidity
timeFrame: 30 days postoperative
measure: Mortality
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine Mansoura University
Study officials:
affiliation: Mansoura University
name: Mostafa Shalaby, MD, MSc, PhD
role: STUDY_DIRECTOR
References:
citation: Rabie M, Abdelnaby M, Morshed M, Shalaby M. Posterior component separation with transversus abdominis muscle release versus mesh-only repair in the treatment of complex ventral-wall hernia: a randomized controlled trial. BMC Surg. 2022 Sep 20;22(1):346. doi: 10.1186/s12893-022-01794-7.
Clinical trial NCT02807831: A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children
Official title: A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Executive Function
Language
Preschool Child
Keywords: Executive Function
Language
Preschool child
Development
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-06-21
Enrollment: 582
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: environmental influences in the first years of life have a great impact on adulthood. Adequate environmental stimulation in the first years of life positively influence cognitive, emotional and neurological development. Studies show that high quality education for 3 to 6 years old children are cost-effective for diverse outcomes, such as socioemotional and cognitive development, as well as school performance. However, it is not clear why specific types of interventions are most effective on school readiness, an important precursor of literacy status and later life outcomes. Objectives: adapt to the Brazilian context two well-known intervention programs: (1) executive functions training developed by Diamond, and (2) oral language skills based on the Nuffield Programme developed by Snowling and colleagues. Methods: a randomized controlled trial involving 720 children (4 to 5 years old) allocated to three groups: (1) adapted school curriculum focusing on executive functions training, (2) adapted school curriculum focusing on oral language skills training, and (3) regular school curriculum.


Eligibility criteria: Inclusion Criteria:

* Schools interested in the intervention program
* Preschool children (4 to 6 years old)

Exclusion Criteria:

* Presence of any sensory impairment
* Intellectual disability

Primary outcomes:
measure: Change in school readiness
timeFrame: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Secondary outcomes:
measure: Change in inhibitory control
timeFrame: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
measure: Change in working memory
timeFrame: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
measure: Change in oral language skills
timeFrame: Beginning of the school year (baseline) and at the end of the school year (post intervention, 7 to 8 months later)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02507531: INCA: Intracranial Aneurysm Treatment With NeXsys
Official title: INCA: Intracranial Aneurysm Treatment With NeXsys
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Cerus Endovascular, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion

Detailed description: Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion. Target aneurysms are small unruptured aneurysms in the anterior and posterior circulation.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years at screening
* Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
* IA appears suitable for NeXsys device
* Patient willing to comply with study requirements
* Patient able to understand and sign a study-specific informed consent form

Exclusion Criteria:

* Ruptured IA
* Any other IA that requires treatment in the next year
* IA width \>10 mm
* IA neck \>9 mm
* IA has important flow from its base such that occluding the IA would cause stroke
* Target IA contains any device (e.g., coils)
* Inability to access the target IA with microcatheter
* Any congenital or iatrogenic coagulopathy
* Platelet count \<50,000/microliter
* Known allergy to platinum, nickel or titanium
* Known allergy to contrast agents
* Stenosis of the target IA's parent vessel \>50%
* Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent)
* Taking any anticoagulants (e.g., warfarin)
* Pregnant or planning pregnancy in the next 2 years
* Other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.)
* Participating in another study with investigational devices or drugs

Primary outcomes:
measure: Safety: occurrence of major ipsilateral stroke or neurologic death
timeFrame: 3-6 months
measure: Ability of the investigator to place the device in an acceptable position in the target IA, judged at the time of placement, with no migration or change in position of the device at 3-6 month angiogram.
timeFrame: 3-6 mo
Secondary outcomes:
measure: Occlusion status of the target IA at 30 days, 3-6 months, 1 year and 5 years as judged by an independent physician using the Raymond classification system.
timeFrame: 30 days, 3-6 months, 1 year and 5 years
measure: Occurrence rate of any neurologic or vascular adverse event related to the target IA or device placement procedure
timeFrame: Beginning of index procedure to end of index procedure (approximately 1 hour, maximum 3 hours)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Clinico ENERI
Study officials:
References:
Clinical trial NCT02839031: Cognitive-Behavioral Therapy (CBT) in Children With Diabetes
Official title: Assessment of a Cognitive-behavioral Group Intervention in Children With Diabetes Mellitus and Their Parents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: diabetes mellitus
glycaemia
cognitive-behavioral treatment
coping
parents
children
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 57
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. Development of adaptive coping strategies may be improved by focused parent and children training. This study assesses a cognitive behavioral treatment (CBT) for children/adolescents with diabetes and their parents in comparison with standard health educational interventions. The investigators main aim is to verify that the CBT program improves overall balance of glycaemia better than phone contact without CBT content (control group). Secondary objectives are expected improvements of health-related quality of life and coping styles in parents and children.


Eligibility criteria: Inclusion Criteria:

* Children and teenagers from 6 years-old to 18 years-old
* Having diabetes treated by insulin for at least 1 year
* Followed in pediatric diabetology department of Arnaud de Villeneuve Hospital in University Hospital of Montpellier
* Study Inform Consent signed by both children and parents

Exclusion Criteria:

* Children with developmental delay, severe mental disorders or language delay
* Non French-speaking family
* Children who does not live with at least one of his/her parents
* Children whose residence is not compatible with frequent visits at University Hospital of Montpellier
* Clinical status not compatible with study questionnaires assessment.

Primary outcomes:
measure: Glycated hemoglobin (HbA1c) level
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
References:
Clinical trial NCT01476631: Step Down Colon Cancer Risk
Official title: Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adenomatous Polyps
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis 1: Exercise will decrease serum markers in a dose response manner.

Hypothesis 2: Participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months.

Detailed description: Primary Aim: To conduct a dose response pilot trial of low (30 min/day) or high (60 min/day) dose exercise in men and women at increased risk of colon cancer. The major outcomes are changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2.

Secondary Aim. To compare changes in the secondary outcome of physical activity over three months.

Eligibility criteria: Inclusion Criteria:

* aged 50 to 80
* no personal cancer history
* found to have an adenomatous polyp upon colonoscopy at BJH/WUSM in the previous six months
* no contraindications to beginning an exercise program
* no previous diagnosis of familial polyposis syndromes
* no previous diagnosis of ulcerative colitis or Crohn's disease;

Exclusion Criteria:

* Participants who are regular NSAID users will be excluded as this may interfere with the measurement of inflammatory marker outcomes. Regular use is defined as taking 80mg or more per day of aspirin, ibuprofen, naproxen or other NSAID 5 or more days of the week.

Primary outcomes:
measure: Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner.
timeFrame: 3 months
Secondary outcomes:
measure: Participants in the 60 minute intervention will have significantly higher physical activity levels (measured by pedometer and accelerometer) than those in the 30 minute intervention at three months.
timeFrame: 3 months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kathleen Y. Wolin, ScD, FACSM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolin KY, Fagin C, James AS, Early DS. Promoting physical activity in patients with colon adenomas: a randomized pilot intervention trial. PLoS One. 2012;7(7):e39719. doi: 10.1371/journal.pone.0039719. Epub 2012 Jul 13.
Clinical trial NCT00913731: Quality Project to Evaluate and Validate the FAST-O Rating Scale
Official title: Quality Project to Evaluate and Validate the FAST-O Rating Scale (Fast ASessment in Acute Treatment of Psychosis-Observation)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Psychotic Symptoms
Keywords: Psychotic symptom assessments
Observational assessments of patients with acute psychotic symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute psychotic symptoms attending the acute ward or psychiatric intensive care unit

Brief summary: The purpose of this project is to test the reliability of the FAST-O Rating Scale in patients at acute wards or psychiatric intensive care units.


Eligibility criteria: Inclusion Criteria:

* Patients with acute psychotic symptoms attending the acute ward or psychiatric intensive care unit

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Reliability test of the FAST-O rating scale based on observational symptom ratings of patients with acute psychotic diseases
timeFrame: Each patients symtoms will be rated on 2 occasions, by 2-3 raters, each. First is made within 24 hrs of admission to acute psychiatric care, secondis made 14 +/- 2 days after admittance, or earlier if the patient is discharged.
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Research Site
city: Kristianstad
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Ystad
country: Sweden
facility: Research Site
Study officials:
affiliation: Medical Department
name: Eva Dencker Vansvik
role: STUDY_DIRECTOR
affiliation: Rättspsyk, UMAS, Malmö
name: Eva Lindström
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02118831: Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF
Official title: Systemic Pharmacokinetics Following Intravitreal Injections of Ranibizumab, Bevacizumab or Aflibercept in Patients With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Age-related Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion
Keywords: macular degeneration
diabetic macular edema
vein occlusion
vascular endothelial growth factor
Lead sponsor: California Retina Consultants
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent for participation in this study
* Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection

Exclusion Criteria:

* Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
* Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
* Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
* Subjects with history of vitrectomy

Primary outcomes:
measure: Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses
timeFrame: Up to 4 months
Secondary outcomes:
measure: Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)
timeFrame: baseline and month 4
Other outcomes:
Locations:
Study officials:
affiliation: California Retina Consultants
name: Robert L Avery, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: California Retina Consultants
name: Melvin D Rabena, BS
role: STUDY_DIRECTOR
References:
citation: Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41. doi: 10.1136/bjophthalmol-2014-305252. Epub 2014 Jul 7.