louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02218957: Extended Pouch Roux-en-Y Gastric Bypass Study
Official title: Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Bariatric surgery
Roux-en-Y Gastric Bypass
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 130
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: Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.

The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction.

The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.


Eligibility criteria: Inclusion Criteria:

Patient eligible for bariatric surgery according Fried guidelines

Primary Gastric bypass

* BMI 35 - 40 with a comorbidity
* or BMI \> 40

Exclusion Criteria:

* Exclusion criteria for bariatric surgery (Fried Guidelines)
* Patients with language problems that interveins to follow medical advises
* Genetic diseases that intervens to follow medical advises
* Chronic bowel diseases
* Nephrologic (MDRD \<30) of liver diseases (AST/ALT more than twice the norm)
* Pregnancy

Primary outcomes:
measure: Weight reduction
timeFrame: 2 years
Secondary outcomes:
measure: Change in comorbidities
timeFrame: 2 years
measure: Change in comorbidities
timeFrame: 2 years
Other outcomes:
measure: Complications
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital Arnhem
name: Jens Homan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01819857: Droperidol and Cardiac Repolarization
Official title: The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Repolarization
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: For many years droperidol has been used in prophylaxis and therapy of PONV. Information that it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those data didn't base on solid examinations confirming torsadogenic action of droperidol. It is known that droperidol prolongs time of repolarisation, but there wasn't any data confirming its impact on transmural dispersion of repolarisation. Only estimation both of those actions in one time allows to define for sure arrhythmogenic role of droperidol.

The aim of this study was to answer the questions:

6. Does droperidol make an significant prolongation of heart repolarisation, expressed as corrected QT interval?

1. Does droperidol cause increase of transmural dispersion of repolarisation?
2. Does possible torsadogenic acting of droperidol depend on dose of drug?
3. Does ondansetron cause changes of electrical heart function, suggesting its possibilities to induce TdP tachycardia?
4. What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in people not suffering from cardiovascular diseases?


Eligibility criteria: Inclusion Criteria:

* age 18-60 years
* sex: males
* ASA score I or II

Exclusion Criteria:

* treatment with drugs influencing cardiac repolarization
* coronary artery disease
* heart insufficiency NYHA\>1
* serum electrolyte disturbances
* hypersensitivity to droperidol and/or ondansetron

Primary outcomes:
measure: Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value
timeFrame: 20 minutes
Secondary outcomes:
measure: Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms
timeFrame: 20 min
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Medical University of Gdansk
Study officials:
References:
Clinical trial NCT00635557: Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme
Official title: Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Recurrent
Relapsed
Glioblastoma
Multiforme
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.


Eligibility criteria: Inclusion Criteria:

* Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
* Prior treatment with radiotherapy and temozolomide
* Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
* Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
* Have a Performance Scale of Karnofsky \> 60%, ECOG \< 2 or WHO \< 2
* If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week

Exclusion Criteria:

* Hypersensitivity to Cremophor EL
* Have evidence of current/active intratumor hemorrhage by MRI
* Have greater than second relapse
* Have had prior treatment with platinum-based chemotherapy
* Have cardiovascular disease
* Have cerebrovascular disease
* Have uncontrolled hypertension
* Have a cardiac ejection fraction \< 50%
* Have Troponin-I elevated above the normal range

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: After each cohort is enrolled and all subjects have completed 1 cycle
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Cycle 1 only
measure: Antitumor activity
timeFrame: Screening, end of each cycle, end of study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
Study officials:
affiliation: Myrexis Inc.
name: Andrew P. Beelen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05491057: Treatment Patterns of Neratinib in HER2+ EBC in China
Official title: A Multicenter, Open-label, Single-arm, Non-interventional Study to Investigate the Treatment Patterns of Nerlynx® (Neratinib) in HER2-positive Early-stage Breast Cancer in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients assigned extended adjuvant treatment with neratinib for 12 months for their HER2-positive, early-stage breast cancer.

Brief summary: This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent approved by the reviewing Ethics Committee (EC).
* Adult patients (≥18 years of age, no upper limit).
* Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease.

Exclusion Criteria:

* Presence of any contraindication with regard to the neratinib treatment.
* Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).

Primary outcomes:
measure: Duration of Treatment
timeFrame: 12 months of treatment
measure: Treatment holds and permanent discontinuations time
timeFrame: 12 months of treatment
Secondary outcomes:
measure: Patient demographics
timeFrame: Baseline
measure: Patient characteristics
timeFrame: Baseline
measure: Time to treatment
timeFrame: Baseline
measure: Prior adjuvant treatments
timeFrame: Baseline
measure: Dose adjustments
timeFrame: 12 months of treatment
measure: Dose intensity
timeFrame: 12 months of treatment
measure: Concomitant medication
timeFrame: 12 months of treatment
measure: Incidence of AESI
timeFrame: 12 months of treatment
measure: Type of AESI
timeFrame: 12 months of treatment
measure: Severity of AESI
timeFrame: 12 months of treatment
measure: action taken for AESI
timeFrame: 12 months of treatment
Other outcomes:
measure: Time of recurrence
timeFrame: 12 months of treatment； 12 months of follow-up
measure: Recurrent site
timeFrame: 12 months of treatment； 12 months of follow-up
measure: Recurrent size
timeFrame: 12 months of treatment； 12 months of follow-up
measure: QoL - EQ-5D-5L
timeFrame: 12 months of treatment
measure: QoL - FACIT D
timeFrame: 12 months of treatment
Locations:
city: Shanghai
country: China
facility: Medical Affair
Study officials:
References:
Clinical trial NCT04614857: Correlation Between Cardiopulmonary Metabolic Cost and Lower Limb Muscle Activity
Official title: Correlation Between Cardiopulmonary Metabolic Cost and Lower Limb Muscle Activity During Inclined Treadmill Gait in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait
Keywords: Muscle activity
Cardiopulmonary metabolic cost
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study was to determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.

Detailed description: The purpose of this study was to determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.

Metabolic energy expenditure and muscle activity are measured simultaneously.

Eligibility criteria: Inclusion Criteria:

* Between 65 and 84 years elderly without neurological effects
* Ability to independent gait at least 16% inclined treadmill
* High levels of physical performance (SPPB \> 7)

Exclusion Criteria:

* Severe visual impairment or dizziness that increases the risk of falls
* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery, history of congestive heart failure, documentedserious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy,severe aortic stenosis, angina or dyspnea at rest or during activities ofdaily living)
* Difficult to understand experimental tasks because of extremely severe cognitive impairment
* Recent acute injuries such as fractures within 6 months, or experience in orthopedic surgery such as artificial joint replacement
* Acute injuries such as fractures within 6 months or orthopedic surgery such as artificial joint replacement

Primary outcomes:
measure: Change on metabolic energy expenditure
timeFrame: 1 hour
Secondary outcomes:
measure: Change on muscle activity
timeFrame: 1 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim J, Lee HJ, Lee SH, Lee J, Chang WH, Ryu GH, Kim YH. Correlation between cardiopulmonary metabolic energy cost and lower-limb muscle activity during inclined treadmill gait in older adults. BMC Geriatr. 2021 Aug 23;21(1):469. doi: 10.1186/s12877-021-02401-9.
Clinical trial NCT00644657: The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization
Official title: The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Chest Pain
Keywords: Platelets, platelet aggregation inhibitors
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-03-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.

Detailed description: Platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The change in the percentage of platelets that are coated platelets will be determined.

Eligibility criteria: Inclusion Criteria:

* Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention

Exclusion Criteria:

* Acute coronary syndrome
* Unable to tolerate clopidogrel

Primary outcomes:
measure: The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty
timeFrame: 24 hours after the administration of clopidotrel
Secondary outcomes:
measure: The Percentage of Coated Platelets After Coronary Angiography and/or PCI
timeFrame: 6 hrs after procedure
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: VA Medical Center, 1F187
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Eliot Schechter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04815057: The Effects of Wellness Training Given to Fifth Grade Students During the Covid-19 Epidemic Period
Official title: The Effects of Wellness Education Given to 5th Grade Students During the Covid-19 Pandemic Process on Their Quality of Life and Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: wellness
adolescent
quality of life
physical activity
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study conducted an experimental study with a randomized control group to decide on the quality of life and physical activity of the Wellness education for fifth grade students during the Covid-19 pandemic process.

Detailed description: After the population and sample calculations were made, the students who had their pre-tests were randomized to the Wellness Education Group and the Control Group. In this study conducted in two state secondary schools affiliated to Kırşehir Provincial Directorate of National Education, the experimental group was given Wellness training. No intervention was made to the control group. Four weeks after the training, the students were post-tested and the data were analyzed.

In order not to affect the groups from the practices to be made, first of all, schools were randomized and the schools were divided into Wellness Education Group and Control Group with a closed envelope lot method. Prof. Dr. Erol Güngör Secondary School (Group I) Wellness Education Group has been assigned to Kırşehir Merkez Yunus Emre Secondary School (Group II) Control Group. Experimental and control groups in order to reduce selection bias and control variables that may have an effect on outcome variables; A randomized assignment was made by a statistician who did not know the names and characteristics of the students. In determining the students to be included in the study; Student lists and the Excel 2016 program were used, and Simple Random Sampling was performed. The student lists assigned to the groups by the expert were submitted to the researcher before the initiatives started.

Eligibility criteria: Inclusion Criteria:

* Being a fifth grade student,
* Not having any physical or mental disability,
* Agree to participate in research,
* Not allowed to participate in research by their parents.

Exclusion Criteria:

-

Primary outcomes:
measure: Turkish child physical activity questionnaire
timeFrame: 3month
Secondary outcomes:
measure: quality of life scale for children
timeFrame: 3 month
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Second School
Study officials:
References:
Clinical trial NCT01184157: Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections
Official title: Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia
Gonorrhea
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-08-18
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women randomized to home-based screening will be more likely to complete screening.


Eligibility criteria: Inclusion Criteria:

* Participant in Contraceptive CHOICE cohort study
* Using a long-acting reversible method of contraception
* Completed baseline clinical survey in the Contraceptive CHOICE cohort study

Exclusion Criteria:

* Living outside the United States at time of annual STI screening

Primary outcomes:
measure: Number of tests received
Secondary outcomes:
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: Jeffrey Peipert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home compared with clinic-based screening for sexually transmitted infections: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1311-1318. doi: 10.1097/AOG.0b013e3181fae60d.
Clinical trial NCT02796157: A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: bioresorbable vascular scaffold, drug eluting stent, coronary artery disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 950
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.


Eligibility criteria: Inclusion Criteria:

* Age 19-85 years
* Patients with ischemic heart disease requiring PCI
* Significant coronary de novo lesion (stenosis \>50% by quantitative angiographic analysis) requiring stent ≥28 mm in length based on angiographic estimation
* Reference vessel diameter of 2.5 to 3.75 mm by operator assessment

Exclusion Criteria:

* Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
* Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
* Contraindication or hypersensitivity to anti-platelet agents or contrast media
* Treated with any metallic stent or BVS within 3 months at other vessel
* Cardiogenic shock
* Left ventricular ejection fraction \<40%
* Pregnant women or women with potential childbearing
* Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
* Inability to understand or read the informed content

Primary outcomes:
measure: Incidence of composite of major adverse cardiovascular events
timeFrame: 1 year after PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Seo J, Ahn JM, Hong SJ, Kang DY, Hong SJ, Her AY, Kim YH, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Park SJ, Park DW, Hong MK. Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings. Am J Cardiol. 2020 Jun 1;125(11):1624-1630. doi: 10.1016/j.amjcard.2020.02.031. Epub 2020 Mar 15.