louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02999139: Analytic, Prospective Cohort Study of Athletes Enrolled in an Exercise Training Intervention
Official title: Analytic, Prospective Cohort Study of Athletes Enrolled in an Exercise Training Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Training
Keywords: Injury
Prevention
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 633
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and females age 6 and over.

Brief summary: Participants who train at The Micheli Center for Sports Injury Prevention, will undergo testing of muscular strength, range of motion, flexibility, aerobic capacity and muscular endurance. They will complete training with a certified trainer and injury prevention specialist until their specific goals are meet. Upon completion of training, they will fill out an injury questionnaire every three months for five to ten years.


Eligibility criteria: Inclusion Criteria:

* Males, Females, age 6 and over

Exclusion Criteria:

* younger than 6 years old

Primary outcomes:
measure: Injury
timeFrame: After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.
Secondary outcomes:
measure: Training Habits
timeFrame: After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.
measure: Muscular Strength
timeFrame: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
measure: Aerobic Capacity
timeFrame: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
measure: Anaerobic Capacity
timeFrame: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
measure: Range of Motion
timeFrame: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
Other outcomes:
Locations:
city: Waltham
country: United States
facility: The Micheli Center for Sports Injury Prevention
state: Massachusetts
Study officials:
References:
Clinical trial NCT01779739: Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy
Official title: Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Function
Keywords: vaginal prolapse
sexual function
sexual dysfunction
prolapse surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 44
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. We hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.


Eligibility criteria: Inclusion Criteria:

* sexually active
* genital hiatus measured between 4 and 6 centimeters
* desires sexual function
* undergoing vaginal repair with native tissues
* agrees to use vaginal estrogen for 12 months after surgery

Exclusion Criteria:

* genital hiatus \> 6 cm
* planned obliterative procedure
* perineal body length \<0.5cm
* disrupted external anal sphincter

Primary outcomes:
measure: Change in sexual function as measured by validated questionnaire
timeFrame: 6 months and 12 months after surgery
Secondary outcomes:
measure: Prolapse recurrence
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest
name: Candace Y Parker-Autry, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Holly E Richter, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04472039: Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
Official title: Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema, Cystoid
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having undergone pars plana vitrectomy with membrane peeling and periocular application of triamcinolone acetonide at the end of surgery between June 2019 and January 2020 at the department of Ophthalmology of the Hanusch Hospital in Vienna, Austria, were selected for the study

Brief summary: Aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

Detailed description: Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. Nevertheless, there are about 10% of patients having intraretinal cystoid changes after surgery with potential for disturbance of visual acuity. The aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

Eligibility criteria: Inclusion Criteria:

* presence of an ERM
* indication for membrane peeling defined as significant loss of vision and/or metamorphopsia due to the ERM
* application of periocular triamcinolone acetonide at the end of surgery
* at least one follow-up examination present in the patient's history

Exclusion Criteria:

* macular edema caused by conditions other than ERM (such as choroidal neovascularization, diabetic macular edema, etc.)

Primary outcomes:
measure: Intraretinal cystoid changes
timeFrame: 3 months
Secondary outcomes:
measure: intraocular pressure (IOP)
timeFrame: 3 months
measure: distance corrected visual acuity
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01886339: SNIF (Sniff Nasal Inspiratory Force) Reference Values Of Mediterranean Population
Official title: SNIF (Sniff Nasal Inspiratory Force) REFERENCE VALUES OF MEDITERRANEAN POPULATION.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy People Programs
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 439
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: SNIF test has been described as a method to explore the diaphragmatic function. But there are no defined the reference values of this test in healthy population. The investigators' hypothesis is that there is a variation on SNIF values in Mediterranean population depending on gender, age and anthropometric variables such as height and weight.

The investigators will analyze 1000 SNIF test of healthy people. The investigators will divide in 5 groups of age (20-30, 30-40, 40-50, 50-60, 60-70) and in each group the investigators will study 100 men and 100 women.

All the subjects will perform a forced spirometry, maximal inspiratory pressure (MIP) and SNIF. If spirometry and MIP are correct the investigators will consider that person has a correct diaphragmatic function and strength. Then the investigators will measure the SNIF test. With all of these SNIF values the investigators will try to achieve the reference values of this test in the different groups of age in Mediterranean population. And the investigators will compare SNIF with MIP.

Cross multicentric study. Hospitals involved: Hospital de Bellvitge, Hospital del Mar, Hospital Parc Taulí, Hospital de la Santa Creu i Sant Pau (coordinator center) and Hospital de la Vall d'Hebrón.


Eligibility criteria: Inclusion Criteria:

* Healthy people with spirometry and MIP values in the reference range
* Age between 20 and 70 years old
* Caucasian race

Exclusion Criteria:

* Rhinitis
* Nasal obstruction
* Frequent episodes of epistaxis
* Ongoing cold

Primary outcomes:
measure: SNIF test
timeFrame: Basal
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT05424939: Management of Obstructive Colon Tumors in Istanbul
Official title: Management of Obstructive Colon Tumors in Istanbul: Multicenter Prospective Observational Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Tumor Obstruction
Emergencies
Quality of Life
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 500
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: Adults who underwent surgery with a clinical and radiological diagnosis of obstructive colon tumors at any stage will be included in the study.

Brief summary: The aim of this study is to evaluate the outcome of obstructive colon cancer surgery in terms of days-to-starting adjuvant therapy and quality of life.


Eligibility criteria: Inclusion Criteria:

* Acute intestinal obstruction due to colon cancer either preoperatively or intraoperatively detected
* Clinical findings of obstruction (Abdominal distention and pain, nausea or vomiting, and absence of bowel movements) confirmed by abdominal x-ray or CT

Exclusion Criteria:

* Benign diseases
* Emergency surgery due to bleeding, perforation and other non-obstructive situations
* Recurrent colon tumors
* Rectal cancer

Primary outcomes:
measure: Time-to-starting chemotherapy
timeFrame: 1 year
Secondary outcomes:
measure: Mortality
timeFrame: 3 months
measure: Morbidity
timeFrame: 3 months
measure: Colorectal cancer-specific quality of life (EORTC QLQ - CR29) at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University Bahcelievler Hospital
city: Istanbul
country: Turkey
facility: Medipol Mega Hospital
Study officials:
affiliation: Medipol University
name: Osman Civil, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01892839: Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis
Official title: Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hemodialysis keeps patients with renal failure alive but does not restore normal health. Retention of chemicals that bind to plasma proteins and are therefore poorly removed by dialysis may contribute to ill health in patients receiving conventional treatment. This proposal will test the effect of a new method designed to improve the removal of protein-bound solutes during dialysis. The effects on blood chemical levels of two different dialysis prescriptions will be tested in patients already undergoing nocturnal in-center hemodialysis three times weekly.


Eligibility criteria: Inclusion Criteria:

* stable on nocturnal in-center dialysis located close to Stanford University and VA Palo Alto

Exclusion Criteria:

* recent use of antibiotics
* gastrointestinal disease

Primary outcomes:
measure: Plasma levels of the chemical p-cresol sulfate
timeFrame: Participants will be followed for 2-3 weeks on different dialysis prescriptions and plasma chemical levels will be measured at the end of this period.
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Satellite Redwood City
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: PAIRE
name: Timothy W Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04807439: A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System
Official title: A U.S. Post-Approval Study of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System Evaluating the SYNERGY XLV (MEGATRON) Stent System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Heart Diseases, Coronary
Coronary Artery Disease
Cardiovascular Diseases
Keywords: Drug-Eluting Stents
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients include those with atherosclerotic coronary lesions with vessel diameters that can appropriately be treated with a SYNERGY Megatron stent according to the commercially approved SYNERGY IFU and the site's local standard of care.

Brief summary: This is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the SYNERGY XLV (MEGATRON) Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 28 mm in length (by visual estimate) in native coronary arteries ≥3.50 mm to ≤5.00 mm in diameter (by visual estimate). This Post Approval study is a cohort associated with the Evolve 4.5/5.0 (SYNERGY LV) Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT03875651.


Eligibility criteria: Inclusion Criteria:

* Patient requires treatment with a SYNERGY XLV (Megatron) stent

Exclusion Criteria:

* Planned treatment with a non-SYNERGY stent

Primary outcomes:
measure: Target Lesion Failure (TLF) rate
timeFrame: 12 Months
Secondary outcomes:
measure: Clinical endpoints
timeFrame: At Hospital Discharge (typically 1-2 days post index procedure), and at 6 months, 12 months, 2 years
measure: Periprocedural endpoints
timeFrame: At Hospital Discharge (typically 1-2 days post index procedure)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Baylor Heart and Vascular Hospital
name: Robert C Stoler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02518139: A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease, COPD
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2015-08-07
Enrollment: 1060
Sex: ALL
Minimum age (years): 40
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 measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.


Eligibility criteria: Inclusion Criteria:

* Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

* Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Primary outcomes:
measure: Adverse Events: Frequency and Severity
timeFrame: Baseline to Day 365
Secondary outcomes:
Other outcomes:
Locations:
city: Easley
country: United States
facility: Palmetto Medical Research Associates L.L.C
state: South Carolina
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25.
citation: Donohue JF, Kerwin E, Sethi S, Haumann B, Pendyala S, Dean L, Barnes CN, Moran EJ, Crater G. Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2019 Jul;153:38-43. doi: 10.1016/j.rmed.2019.05.010. Epub 2019 May 23.
Clinical trial NCT03069339: Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis
Official title: Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 330
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: Study Design: Open labeled randomized controlled trial. The study will be conducted on patients attending outpatient or admitted to admitted to Department of Hepatology from January 2017 to December 2018 at ILBS, New Delhi


Eligibility criteria: Inclusion Criteria:

* Liver Cirrhotics between 18-70 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging.)
* CTP ≥ 7-15 (Child's B/C)
* Small esophageal varices with RCS and large esophageal varices (\>5 mm)
* No history of previous bleed

Exclusion Criteria:

* Malignancy-HCC, PVT
* Child A
* MELD \>35
* Contraindications to β blockers.
* Platelet count \< 30,000/mm3
* Previous endoscopic variceal treatment. (Beyond 21 days)
* Patients having an indication for TIPS or requiring more than 1 therapeutic ascitic tapping/month
* Post TIPS, Shunt surgery
* Acute kidney injury (Sr.Cr\>1.5mg/dl)
* Non cirrhotic portal hypertension
* Acute on chronic liver failure

Primary outcomes:
measure: Reduction in the incidence of first variceal bleed at 1 year.
timeFrame: 1 year
Secondary outcomes:
measure: Overall and bleed related Survival in all the 3 groups
timeFrame: 1 year
measure: Bleed related Survival in all the 3 groups
timeFrame: 1 year
measure: Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups
timeFrame: 1 year
measure: Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups
timeFrame: 1 year
measure: Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups
timeFrame: 1 year
measure: Incidence of Acute Kidney Injury (AKI) in all the 3 groups
timeFrame: 1 year
measure: Incidence of Shock in all the 3 groups
timeFrame: 1 year
measure: Incidence of new ascites in all the 3 groups
timeFrame: 1 year
measure: HVPG response at 1year in all the 3 groups
timeFrame: 1 year
measure: Treatment related side effects in all the 3 groups
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
References: