louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00987896: Megachannel Device for Advanced Colonoscopy
Official title: A Novel Endoscopic Device (Megachannel™) For Repeated Right Colonic Access During Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Polyps Right Colon
Large Polyp Right Colon
Suspected Polyp Right Colon
Keywords: colonoscopy
polypectomy
NOTES
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-10-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Megachannel is a newly developed colonic access system allowing rapid and multiple passes of the colonoscope to the right colon.

The investigators want to conduct a multinational study to evaluate the safety and clinical feasibility of placing a 100 cm Megachannel prototype in the right colon.

Detailed description: Patients scheduled for colonoscopy with suspected right colonic polypoid lesions will be included. The prototype will loaded onto a 160 cm lower GI endoscope and introduced via colonoscopic guidance. Time to cecum, total investigation time, clinical feasibility and complications will be recorded.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for colonoscopy with suspected large or multiple polys in the right colon

Exclusion Criteria:

* previous abdominal surgery
* history or currently diagnosed intra-abdominal cancer
* patients presenting with unstable angina
* drug abusers
* pregnant women
* patients with known colonic strictures

Primary outcomes:
measure: Safety and clinical feasibility of performing colonoscopy with megachannel
timeFrame: during every single colonoscopy in the study
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Arnulf Ferlitsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silberhumer GR, Birsan T, Noda W, Unger E, Mayr W, Lang S, Prager G, Gasche C. Design and instrumentation of new devices for performing appendectomy at colonoscopy (with video). Gastrointest Endosc. 2008 Jul;68(1):139-45. doi: 10.1016/j.gie.2008.02.024. Epub 2008 May 2.
citation: Ferlitsch A, Silberhumer GR, Noda W, Birsan T, Desai D, Kumar A, Rao GV, Khakar A, Gomez NA, Gasche C. A novel endoscopic device for repeated right-side colonic access during colonoscopy (with video). Gastrointest Endosc. 2010 May;71(6):1052-5. doi: 10.1016/j.gie.2009.12.059.
Clinical trial NCT00976196: Platelet Hyperreactivity Project
Official title: Platelet Hyperreactivity Project: A System Biology Approach of High On-treatment Platelet Reactivity in Aspirin-treated Cardiovascular Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Reactivity
Keywords: Aspirin
Blood platelets
proteomics
Platelet reactivity
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic atherothrombotic patients treated with aspirin.

Brief summary: The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients.

Detailed description: The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients using a system biology approach that include proteomics analysis of selected platelet sub-fractions in patients displaying extreme phenotype.

Main objective:

* to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients

Secondary objectives:

* to characterize the platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin
* to determine genetic polymorphisms associated with platelet hyperreactivity

Eligibility criteria: Inclusion Criteria:

* Documented symptomatic ischemic atherothrombotic disease treated by aspirin.

Exclusion Criteria:

* Known platelet disorder
* Chronic treatment by antiplatelet drugs other than aspirin
* Chronic anticoagulant treatment
* Chronic non steroidal anti-inflammatory drug treatment
* Active cancer
* Treatment with serotonin reuptake inhibitors

Primary outcomes:
measure: proteome profile of platelet hyperreactivity
timeFrame: cross sectional
Secondary outcomes:
measure: platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin
timeFrame: cross sectional
Other outcomes:
measure: genetic polymorphisms associated with platelet hyperreactivity
timeFrame: cross sectional
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
affiliation: University of Geneva
name: Pierre Fontana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03439696: Needlescopic-assisted Uniportal vs Uniportal VATS
Official title: Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lung Cancer Metastatic
Bullous Disease Lung
Nodule Solitary Pulmonary
Mediastinal Tumor
Keywords: Thoracoscopy
VATS
Needlescopy
Uniportal
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.


Eligibility criteria: Inclusion Criteria:

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema

Primary outcomes:
measure: Pain scale POD 3
timeFrame: 3 days
measure: Pain scale POD 5
timeFrame: 5 days
measure: Hospital stay
timeFrame: 14 days
measure: Post-operative 3 month neuralgia
timeFrame: 3 months
measure: Post-operative 6 month neuralgia
timeFrame: 6 months
Secondary outcomes:
measure: Cost
timeFrame: 14 days
measure: Surgical time
timeFrame: 1 day
measure: Surgical bleeding
timeFrame: 1 day
measure: Opioid using dosage
timeFrame: 14 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Hsin-Chu Branch
state: Hsin-Chu County
Study officials:
affiliation: National Taiwan University Hospital Hsinchu Branch
name: Chiu-kuei Nien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02235896: Reducing CVD Risk in African Americans Faith Communities
Official title: Cardiovascular Disease Prevention Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease Risk Factors
Keywords: risk factors, African American, lipids, blood pressure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The ultimate goal of our partnership with local African-American churches is to implement an effective, multi-component intervention to increase awareness of the critical importance of healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the American Heart Association (AHA) prevention strategy, \&quot;Life's Simple 7\&quot; to address the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes, cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy consists of a community-based participatory research approach that involves focus groups to assess participant knowledge and beliefs about CVD risk factors prior to program initiation. We will also determine participant dietary and exercise practices, knowledge and perceptions related to healthy lifestyle and chronic diseases, demographic/health status information, health care utilization, biometrics (weight, blood pressure, blood tests for glucose and cholesterol, etc.) and attitudes about medical research at baseline, program completion and 6-month follow-up.

Detailed description: Church goers will undergo, baseline assessment of knowledge attitudes and behavior survey as it relates to CVD risk and anthropomorphic measurements. A 3 month experiential educational program will be provided at 2 locations. At 6 months after baseline a followup measure will be obtained

Eligibility criteria: Inclusion:

* Age \>18 yrs,
* able to consent

Primary outcomes:
measure: Knowledge, attitudes about CVD and CVD risk
timeFrame: 1 year
measure: Behavior change
timeFrame: 1 year
Secondary outcomes:
measure: CVD Risk factors
timeFrame: 1 year
measure: Attitudes about participation in Research
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sharonne Hayes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brewer LC, Morrison EJ, Balls-Berry JE, Dean P, Lackore K, Jenkins S, Cohen C, Johnson J, Ellis F, Mangum DC, Hayes SN, Patten C. Preventing cardiovascular disease: Participant perspectives of the FAITH! Program. J Health Psychol. 2019 Oct;24(12):1710-1723. doi: 10.1177/1359105317695878. Epub 2017 Feb 1.
Clinical trial NCT03165396: Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With MCI
Official title: The Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment, Mild
Keywords: mild cognitive impairment
Lead sponsor: The Third Central Clinical College of Tianjin Medical University
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: According to the inclusion and exclusion criteria, elderly patients undergoing elective orthopedic surgery were randomly divided into four groups. The different combinations of propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients become wide-awake, and 3 days, 7 days, and 3 months after surgery, the patient's cognitive function was evaluated using a professional cognitive scale and other indicators. Finally, statistical analysis.


Eligibility criteria: Inclusion Criteria:

* Elective orthopaedic surgery
* American Society of Anesthesiologists physical status: II

Exclusion Criteria:

* Neurological diseases that may affect cognitive function (e.g., subdural hematoma)
* Hypothyroidism
* Alcoholic dementia

Primary outcomes:
measure: Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ）
timeFrame: Change from Baseline Apolipoprotein J at 7 days
Secondary outcomes:
measure: Evidence of clinically cognitive function decline ：Soluble CD14（sCD14）
timeFrame: Change from Baseline Soluble CD14 at 7 days
measure: Mini mental Examination(MMSE)
timeFrame: preoperative 24 hours ， 7 days post surgery
measure: Montreal Cognitive Assessment（MoCA)
timeFrame: preoperative 24 hours ，7 days post surgery
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Third Central Hospital of Tianjin
state: Tianjin
Study officials:
References:
Clinical trial NCT02784496: Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis
Official title: Open-Label Roll-Over Study to Assess the Long-Term Safety and Efficacy of Ruxolitinib in Subjects With Myelofibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelofibrosis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-05-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial studies the long-term side effects of ruxolitinib in treating patients with myelofibrosis. Collecting data about the long-term safety and tolerability of ruxolitinib may better help future patients with myelofibrosis.

Detailed description: PRIMARY OBJECTIVES:

I. To collect long term safety and tolerability data in patients with myelofibrosis previously treated with ruxolitinib on protocol 2007-0169.

OUTLINE:

Patients continue to receive ruxolitinib orally (PO) once daily (QD) or twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.

Eligibility criteria: Inclusion Criteria:

1. Currently enrolled in study 2007-0169 and benefiting from therapy as determined by treating physician
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment of this study
3. Ability and agreement to attend protocol-specified visits at the study site
4. Able to comprehend and willing to sign the informed consent form
5. Negative pregnancy test in females of childbearing potential; male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose; acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner's vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test 7 days before first study treatment

Exclusion Criteria:

1. none

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 3 years
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: Prithviraj Bose
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03950596: Macroscopic and Molecular Changes in Knee Muscular-tendon Unit in Response to Acute Resistant Load
Official title: Macroscopic and Molecular Changes in Knee Muscular-tendon Unit in Response to Acute Resistant Load
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quadriceps Muscle
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-05-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to determine the influence of acute resistance exercises on anatomical and biological changes in the quadriceps muscle and tendons of the knee


Eligibility criteria: Inclusion Criteria:

* Non-professional athletes
* Pass heart/lung endurance tests
* Pass ergometrics testing

Exclusion Criteria:

* Have been injured
* Had physiotherapy for back or lower limbs in past 6 months
* Orthopedic surgery in lower limbs

Primary outcomes:
measure: Genetic Changes in Knee Muscle and Tendon
timeFrame: One year
measure: Ultrasound Changes in Knee Muscle and Tendon
timeFrame: One year
measure: Biopsy Changes in Knee Muscle and Tendon
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT02970396: Self-management for People With Epilepsy and a History of Negative Health Events
Official title: Self-management for People With Epilepsy and a History of Negative Health Events (SMART)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an investigation of adult individuals with epilepsy, and involves educational and behavioral interventions intended to enhance treatment adherence and self-management.

The investigators are adapting a self-management intervention that they developed in a previous study to individuals with epilepsy and a history of negative health events (NHEs), such as accidents and emergency department (ED) visits, diminished quality of life and poor mental well-being. The intervention "Self-management for people with epilepsy and a history of negative health events (SMART)" is intended to reduce NHEs and improve quality of life in people with epilepsy associated with historically disadvantaged groups.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy
* Negative health event within the last 6 months
* Able to provide written consent and participate in study procedures

Exclusion Criteria:

* Immediate risk of self-harm
* Dementia
* Pregnancy
* Unable to read/understand English

Primary outcomes:
measure: Change in number of negative health events
timeFrame: baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
References:
Clinical trial NCT06801496: The Application of Gastric Bypass Stents in Patients with Weight Regain After Laparoscopic Sleeve Gastrectomy：a Feasibility Study
Official title: The Application of Gastric Bypass Stents in Patients with Weight Regain After Laparoscopic Sleeve Gastrectomy：a Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity and Obesity-related Medical Conditions
Weight Regain
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals planning to undergo bariatric surgery in China-Japan Friendship Hospital

Brief summary: This study is based on the National Center for Integrated Traditional Chinese and Western Medicine, utilizing the centralized advantages of our department and integrating multiple disciplines (general surgery, endocrinology, nutrition, sports, and traditional Chinese medicine). It focuses on the effectiveness of gastric bypass stents in treating patients with postoperative obesity after laparoscopic sleeve gastrectomy, as well as in patients with simple obesity. This will improve the prognosis of patients and reduce the medical burden.


Eligibility criteria: Inclusion Criteria:

* 1、For those with simple obesity, BMI ≥ 32.5, or 27.5 ≤ BMI \< 32.5, who have difficulty controlling their condition with lifestyle modifications and medical treatment, and who meet at least two criteria for metabolic syndrome components, or have comorbidities.

  2、For those with simple obesity, 27.5 ≤ BMI \< 32.5, and with male waist circumference ≥ 90 cm, female waist circumference ≥ 85 cm, and imaging studies suggesting central obesity.

  3、For those with type 2 diabetes, BMI ≥ 27.5, who still have some residual insulin secretion capacity.

Exclusion Criteria:

* 1、Non-obese type 1 diabetes; 2、Those for whom the purpose of treatment is T2DM, but whose pancreatic beta-cell function is largely lost, with a BMI \< 25.0; 3、Age \< 16 years or age \> 65 years; 4、Pregnant women with diabetes and patients with certain special types of diabetes; 5、Those with a cognitive disorder or immature intelligence, and who cannot control their behavior; 6、Those whose expectations for the surgery are not realistic; 7、Those unwilling to assume the risks of potential surgical complications; 8、Those unable to comply with postoperative dietary and lifestyle changes, showing poor compliance; 9、Those in poor general health, who are unable to tolerate general anesthesia or surgery.

Primary outcomes:
measure: weight
timeFrame: Before bariatric surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital, Beijing, Beijing
Study officials:
References:
Clinical trial NCT00527696: Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
Official title: Randomized Clinical Trial Comparing TVT SECUR System (TVT S) and Trans Vaginal Obturator Tape (TVT-O) for Surgical Management of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2007-09-11
Enrollment: 106
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.

Exclusion Criteria:

* Women with predominantly symptoms of urge urinary incontinence
* Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery
* Detrusor overactivity on cystometrogram at urodynamic testing
* Previous surgery for incontinence
* Intrinsic sphincter deficiency (MUCP\<20 cm H2O or Q -tip \<30o)
* Voiding dysfunction with postvoid residual \>100 cc

Primary outcomes:
measure: Objective cure as defined by the cough test at one year from surgery
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
affiliation: St. Boniface Hospital
name: Ken D Maslow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maslow K, Gupta C, Klippenstein P, Girouard L. Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence. Int Urogynecol J. 2014 Jul;25(7):909-14. doi: 10.1007/s00192-013-2312-7. Epub 2014 Jan 23.