louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00552565: Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: IBS, IBS-D, R-verapamil, Arverpamil, Rezular
Lead sponsor: AGI Therapeutics, Inc.
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 711
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.

Detailed description: We have fulfilled our enrollment requirements for this study.

This study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. The study will be open to both women and men. At screening the patient will be assessed to see if they meet the Rome III criteria for IBS-D. After screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. Patients will complete daily telephone diaries during the run-in and double-blind phases of the study. Patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study.

Patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ARDIS-3).

Eligibility criteria: Inclusion Criteria:

* fulfilling Rome III criteria for IBS-D

Exclusion Criteria:

* major cardiovascular disease
* psychiatric illness except mild or moderate depression
* pregnancy
* presence of other GI disease that could explain IBS-like symptoms
* history of major gastric, hepatic, pancreatic or intestinal surgery or perforation

Primary outcomes:
measure: Adequate Relief
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PPD
state: North Carolina
Study officials:
References:
Clinical trial NCT02236065: Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders
Official title: A Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Cerebral Palsy
Amyotrophic Lateral Sclerosis
Parkinson's Disease
Keywords: Umbilical cord blood
Granulocyte-colony stimulating factor
Brain injury
Neurodegenerative disorder
Efficacy
Safety
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open label trial is conducted to investigate the efficacy and safety of the combination therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor (G-CSF) for patients with brain injury or neurodegenerative disorders.

Detailed description: Current treatments for brain injury or neurodegenerative disorders are palliative rather than curative. Preclinical and some clinical studies suggest that UCB and G-CSF can be used as restorative approach for such disorders.

Eligibility criteria: Inclusion Criteria: should be included one of the 4 disorders

* Brain injury: onset duration over 12 months, Age: 19 years or over
* Cerebral palsy: spastic, dyskinetic or ataxic, Age: 19 years or over
* Parkinson's disease: modified Hoehn and Yahr stage 2.5, 3, 4, Age: 30 to 75 years
* ALS: definite of possible ALS, progression during the past 6 months, Age: 19 to 65

Exclusion Criteria:

* Uncontrolled pulmonary, renal dysfunction at enrollment
* Uncontrolled seizure
* Malignant cancer
* Possibility of hypersensitivity to drugs used in this study
* Contraindication to the study intervention or assessment
* Pregnant or breast feeding women
* Non-compliance with the study visits specified in the protocol

Primary outcomes:
measure: Changes in Berg Balance Scale
timeFrame: Baseline - 1 month - 3 months - 6 months
measure: Changes in the Level of Disability
timeFrame: Baseline - 1 month - 3 months - 6 months
measure: Changes in Standardized Gross Motor Function
timeFrame: Baseline - 1 month - 3 months - 6 months
measure: Changes in Motor Performance
timeFrame: Baseline - 1 month - 3 months - 6 months
measure: Changes in ALSFRS-R
timeFrame: Baseline - 1 month - 3 months - 6 months
measure: Changes in UPDRS
timeFrame: Baseline - 1 month - 3 months - 6 months
Secondary outcomes:
measure: Changes in Brain MRI
timeFrame: Baseline - 6 months
measure: Changes in Brain PET
timeFrame: Baseline - 6 months
measure: Number of adverse events and participants with those adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04119765: Plasma Oxalate in Patient With Short Bowel
Official title: Plasma Oxalate in Patient With Short Bowel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Hyperoxaluria
Hyperoxalemia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 47
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: type II short bowel patient

Brief summary: Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. Not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. Plasma oxalate shouldn't increase theoretically in these patients. However recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria. The aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Type II short bowel for more than 6 months
* Affiliated to a social health care

Exclusion Criteria:

* Primary hyperoxaluria
* Other type of short bowel than type II
* Minor patient or major patient protected by the law

Primary outcomes:
measure: Plasma oxalate rate (oxalemia)
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Nephrology Department, Edouard Herriot Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Sandrine Lemoine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05475665: Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients
Official title: A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase # Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 157
Sex: ALL
Minimum age (years): 19
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 evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy


Eligibility criteria: Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Patients with Essential Hypertension
* Other inclusion applied

Exclusion Criteria:

* Orthostatic hypotension with symptom
* Other exclusion applied

Primary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure (mmHg)
timeFrame: Week 8
Secondary outcomes:
measure: Change form baseline in mean sitting systolic blood pressure (mmHg)
timeFrame: Week 4
measure: Change form baseline in mean sitting diastolic blood pressure (mmHg)
timeFrame: Week 4, 8
measure: Responder rate
timeFrame: Week 4, 8
measure: Target blood pressure reach rate
timeFrame: Week 4, 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
References:
Clinical trial NCT03926065: Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children
Official title: Lunchtime Meal Feeding Study for 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: 2019-04-24
Enrollment: 67
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to determine the effect of varying both the palatability and portion size of vegetables served to preschool children at a meal on the outcomes of food and energy intake at the meal.


Eligibility criteria: Inclusion Criteria:

* Children who are enrolled in a scheduled classroom of the designated childcare centers

Exclusion Criteria:

* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who will not be present at the childcare center for all of the scheduled study days

Primary outcomes:
measure: Difference Between Interventions in Vegetable Intake
timeFrame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Secondary outcomes:
measure: Difference Between Interventions in Food Intake
timeFrame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
measure: Difference Between Interventions in Meal Energy Intake
timeFrame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
measure: Difference Between Interventions in Meal Energy Density
timeFrame: One meal per week for each intervention (Study weeks 1, 2, 3, and 4)
Other outcomes:
measure: Preference of Vegetables Served at the Meal
timeFrame: Study week 5
measure: Liking of All Foods Served at the Meal
timeFrame: Study week 5
measure: Ranking of All Foods Served at the Meal
timeFrame: Study week 5
Locations:
city: University Park
country: United States
facility: Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
citation: Diktas HE, Roe LS, Keller KL, Sanchez CE, Rolls BJ. Promoting vegetable intake in preschool children: Independent and combined effects of portion size and flavor enhancement. Appetite. 2021 Sep 1;164:105250. doi: 10.1016/j.appet.2021.105250. Epub 2021 Apr 6.
Clinical trial NCT01379365: Cryo-Touch III Refinement Study Investigational Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Facial Wrinkles
Skin Aging
Keywords: wrinkle rhytid aging
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.


Eligibility criteria: Inclusion Criteria:

* Age 30-70 years
* Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 2 in animation on the 5-point Wrinkle Scale (5WS)\*
* Subject has signed institutional review board (IRB)-approved informed consent form

Exclusion Criteria:

* Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising
* Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
* The investigator is unable to substantially lessen facial lines by physical separation
* Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months
* Subject is participating in another facial cosmetic research study

Patient has any of following conditions:

* History of facial nerve palsy
* Marked facial asymmetry
* Ptosis
* Excessive dermatochalasis
* Deep dermal scarring
* Thick sebaceous skin
* History of neuromuscular disorder
* Chronic dry eye symptoms
* Allergy or intolerance to lidocaine
* Other local skin condition (eg, skin infection) at target treatment site
* Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation

Primary outcomes:
measure: Wrinkle Severity and incidence of device-related serious adverse events
timeFrame: Up to 4 months
Secondary outcomes:
measure: Wrinkle Severity
timeFrame: Up to 4 months
measure: Independent Assessment
timeFrame: Up to 4 months
measure: Global assessment
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: The Aesthetics Research Center
state: California
Study officials:
References:
Clinical trial NCT04455165: Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement
Official title: Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement Operated at Dijon University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Lead sponsor: Centre Hospitalier La Chartreuse
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient operated for aortic valve replacement with or without associated cardiac surgery from 2009 in Dijon University Hospital

Brief summary: Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution. The primary disease process for which patients are referred remains aortic stenosis. But more and more, we met older patients with both aortic stenosis and other cardiac pathology (coronary artery disease, other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is however important to have medical data and statistics in order to better understand the factors influencing morbi-mortality and thereby to continue this improvement.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 y-o who underwent aortic valve replacement

Exclusion Criteria:

* None

Primary outcomes:
measure: 30 days mortality incidence rates
timeFrame: 30 days
Secondary outcomes:
measure: 30 days morbidity incidence rates
timeFrame: 30 days
measure: Long-term morbimortality incidence rates
timeFrame: 10 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Cardiovascular and thoracic surgery Unit - Dijon University Hopital
Study officials:
affiliation: Centre Hospitalier Universitaire Dijon
name: Marie-Catherine MORGANT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03521765: Quality of Life in Colorectal Cancer Survivors
Official title: Occupational Therapy Interventions Based on Cancer Education on Quality of Life for Colorectal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: quality of life
occupational therapy
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: BACKGROUND:

Colorectal cancer (CRC) and its treatment affect CRC survivors' quality of life (QoL), emotional distress and activities of daily living (ADL). It is assumed that occupational therapy interventions based on cancer education may be a feasible approach.

Aim To examine the effect of using cancer education based on healthy lifestyle by occupational therapist on QoL, emotional distress, ADL and healthy lifestyle behaviors in CRC survivors.

Methods Participants with CRC were designed as a two-group controlled trial, and a single-blind randomized controlled trial was conducted. These participants were randomly assigned to either an OT intervention or a non-intervention group (in a 1:1 ratio). Those participants in the OT intervention group were given a consultation based on a CRC education handbook by an occupational therapist for discharge preparation and on 1-month, 3-month follow-up clinic; the non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation. The primary outcome was the change in QoL measured using WHOOQOL-BREF. Secondary outcomes were changes in emotional distress, ADL and healthy lifestyle behaviors. Outcomes were examined in baseline (discharge preparation), 1-month and 3-months follow-up clinic.


Eligibility criteria: Inclusion Criteria:

* (1) had a new diagnosis of CRC and were suffering from cancer for the first time, (2) had undergone CRC hospitalization (surgical) treatments, (3) were able to communicate in Mandarin or Taiwanese.

Exclusion Criteria:

* Participants re-admitted within three months after discharge were excluded.

Primary outcomes:
measure: WHOQOL-BREF(the World Health Organization Quality of Life-BREF)
timeFrame: 10 min
Secondary outcomes:
measure: Brief Symptom Rating Scale (BSRS-5)
timeFrame: 3 min
measure: Barthel Index (BI)
timeFrame: 5 min
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
state: No.138,Sheng Li Road
Study officials:
References:
citation: Yang SY, Wang JD, Chang JH. Occupational therapy to improve quality of life for colorectal cancer survivors: a randomized clinical trial. Support Care Cancer. 2020 Mar;28(3):1503-1511. doi: 10.1007/s00520-019-04971-2. Epub 2019 Jul 4.
Clinical trial NCT05047965: An Investigational Scan (MRI With Dixon Based Sequences) in Detecting Prostate Cancer
Official title: Evaluation of MRI With Dixon Based Sequences in the Detection of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-09-17
Enrollment: 65
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial studies the use of magnetic resonance imaging (MRI) with Dixon based imaging sequences in detecting prostate cancer. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Researchers hope to learn if using a modified MRI scan technique with Dixon based imaging sequencing will help to produce better images of prostate cancer than the standard of care MRI scan technique.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate prospectively the accuracy of Dixon based sequences in detection of intraprostatic tumor nodules.

II. Determine the sensitivity, specificity, positive and negative predictive value of Dixon based sequences in assessment of extraprostatic tumor extension and lymph node involvement.

SECONDARY OBJECTIVES:

I. Compare the accuracy of Dixon based sequences versus multiparametric diffusion weighted imaging including diffusion tensor imaging in tumor detection and extraprostatic extension.

II. Compare the accuracy of Dixon based sequences in detection of transition zone tumors.

III. Determine the optimal scanning parameters for Dixon based sequences in the imaging of prostate adenocarcinoma.

OUTLINE:

Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven prostate cancer patients who are scheduled to undergo prostatectomy.
* Patient who is scheduled to have a clinically indicated staging endorectal prostate MRI exam.
* Patients who have signed their informed consent form to undergo the study.

Exclusion Criteria:

* Known prior hormone ablation or radiation therapy (pelvic or prostate).
* Patients who do not want to undergo prostatectomy and prefer other therapy or surveillance.
* Contraindication to conventional MR imaging (e. g. metal implants, pace maker, etc.).

Primary outcomes:
measure: Detection of at least one or more prostate lesions with Dixon sequencing
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ganeshan Dhakshina Moorthy
role: PRINCIPAL_INVESTIGATOR
References: