louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06248294: PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)
Official title: PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation: The PROSPERO-TAVI Multi Center, International Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bicuspid-related Aortopathy
Aortic Stenosis
Keywords: BAV
TAVI
Aortopathy
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve

Brief summary: Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery. Although historically excluded from the main randomized clinical trials, patients with native bicuspid aortic valve (BAV) are commonly treated in daily TAVI practice. Indeed, several observational studies reported similar outcomes of TAVI in BAV patients compared to tricuspid aortic valve (TAV) patients. Notably, BAV is frequently associated with aortic dilatation (20% to 84% of BAV patients). Surgical patients usually undergo concomitant aortic root replacement if aortic diameter exceed 50 mm (5). TAVI patients do not undergo treatment of the concomitant aortopathy, but currently there is a paucity of data regarding the progression of the aortopathy after AS treatment (6,7).

The main aim of this ambispective, multicenter study is to evaluate the progression of the bicuspid valve-associated aortopathy in patients undergoing TAVI by computed tomography angiography (CTA) assessment at follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing TAVI with native BAV from January 2018 to December 2019

Exclusion Criteria:

* Patients undergoing TAVI without native BAV
* Patients receiving first generation TAVI device
* Patients undergoing TAVI before January 2018 or after December 2019

Primary outcomes:
measure: Absolute difference in maximum aortic diameters at multiple levels of ascending aorta
timeFrame: 5 years
Secondary outcomes:
measure: Death, stroke or rehospitalization for heart failure
timeFrame: 5 years
measure: Aortic events leading to urgent intervention or elective aortic root replacement
timeFrame: 5 years
measure: Bioprosthesis dysfunction (HALT or RLM at 4-D CTA assessment)
timeFrame: 5 years
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico - San Marco
Study officials:
References:
Clinical trial NCT03095794: Social Decision-making (SOCIAL-DECISION)
Official title: Brain Mechanism of Social Decision-making
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 145
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate neural mechanism of healthy humans underlying group decision making and compare it with that of individual decision-making. Using functional neuroimaging technology combining with computational modeling, we examine how the human brain process social information to make a decision within a group, which often guides humans to make a better decision using collective wisdom.


Eligibility criteria: Inclusion Criteria:

* healthy human adult
* normal vision

Exclusion Criteria:

* depression
* potential addiction to alcohol/ nicotine

Primary outcomes:
measure: Brain activation associated with decision-making (fMRI, non-invasive measure)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: CH le Vinatier
Study officials:
affiliation: CH le Vinatier
name: Caroline DEMILY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01483794: Epidemiology, Costs and Psychosocial Consequences of Genital Warts in Valparaiso, Chile
Official title: Genital Warts: Studies for Establishing Epidemiological Profile, Psychosocial Consequences and Costs of Disease in Attendants to the Sexual Health Clinic of the Public Health Service of Valparaiso and San Antonio, Chile.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Condylomata Acuminata
Keywords: genital warts
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the public sexual health clinic of Valparaiso, Chile

Brief summary: This is an observational study looking at the characteristics of patients consulting for genital warts in the first semester 2010 at the public sexual health clinic of Valparaiso, Chile. The objectives are: to have an epidemiological profile, estimating cost of the disease for the health system and the patient and analyzing possible psychosocial consequences of the condition for the patients.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 years of age or older
* Having being diagnosed with genital warts
* Consulting the sexual health clinic only for genital warts
* Patients accepting to be included in the study

Exclusion Criteria:

* Immunodeficiency
* HIV positive
* Having being diagnosed with cancer or pre-cancerous lesions
* Pregnancy
* Presenting a sexual transmissible infection other than genital warts.

Primary outcomes:
measure: Number of Participants with altered psychosocial tests as a Measure of impact of presenting genital warts.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Valparaiso
country: Chile
facility: Sexual Health Clinic,
state: Quinta Region
city: Valparaiso
country: Chile
facility: Sexual Health Clinic
state: Quinta Region
Study officials:
affiliation: University of Valparaiso, Chile
name: Carolina San Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05278494: Dextromethorphan for Treatment of Postoperative Pain
Official title: A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan Compared to Placebo for the Treatment of Postoperative Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-operative Pain
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Perioperative Dextromethorphan compared to Placebo for the Treatment of Postoperative Pain

Detailed description: There is extensive preclinical evidence that dextromethorphan has an analgesic effect in patients with pain of traumatic origin. The primary objective is to of this study is to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing total knee arthroplasty (TKA).

This is a single-institution, multi-dose, randomized, placebo-controlled, trial to evaluate the efficacy of perioperative dextromethorphan compared to placebo for postoperative pain in patients undergoing TKA. Male and/or female patients will be randomized to either dextromethorphan treatment group (n = 80) or placebo group (n= 80).

Patients will receive 60 mg oral dextromethorphan (or matching placebo) preoperatively, as well as 30 mg 8- and 16-hours postoperatively.

Eligibility criteria: Main Inclusion Criteria:

* Patients Age ≥18 planning to undergo total knee arthroplasty
* ASA classes I - III

Main Exclusion Criteria:

* BMI ≥ 35
* History opioid abuse
* History of intractable vomiting after previous surgery

Primary outcomes:
measure: Post-op opioid use
timeFrame: 24 hours
Secondary outcomes:
measure: Subjective pain
timeFrame: preoperatively and 6, 12, 24, and 48 hours postoperatively
measure: Postoperative opioid consumption
timeFrame: at 48 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
Study officials:
References:
Clinical trial NCT00156494: Attitudes About Smoking: A Telephone Survey
Official title: "Attitudes About Smoking" A Telephone Survey of Parents of Young Urban Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Halcyon Hill Foundation
name: Rochester City School District
name: The Children's Institute
First posted: 2005-09-12
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children in the Rochester City School District

Brief summary: This study involves telephone surveys of parents of young urban children with and without asthma to assess attitudes about smoking including personal smoking bans in their homes and cars, and beliefs about public policies regarding smoking.


Eligibility criteria: Inclusion Criteria:

* Child with asthma OR a matched child without asthma from the Rochester City School District

Exclusion Criteria:

* Non-english speaking family / parent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jill S Halterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05184894: A Study of Acute Kidney Injury in Care Transitions
Official title: AKI in Care Transitions (ACT) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research is being done to develop materials and processes that will help facilitate education and kidney care coordination for AKI survivors.


Eligibility criteria: Inclusion Criteria:

- Participants will be recruited from those identified by a developed electronic health record list of patients with stage III AKI (severe) during a hospitalization based on serum creatinine rise or urine output decline from Olmsted County.

Exclusion Criteria:

* Dementia.
* Non-English speaking.
* Expected to be dismissed to a skilled nursing facility or hospice at discharge.
* Expected to need dialysis at discharge.
* Primary Care Transitions Program enrollment.
* Transplant recipients within 100 days of transplant.
* Can only have one time enrollment.

Primary outcomes:
measure: Number of Subjects to Complete the ACT Program
timeFrame: 30 days after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Erin Barreto, PharmD, RPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05186194: The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.
Official title: The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures in Chinese Recruits.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Fracture
Vitamin d
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to find whether supplemental vitamin d and calcium can reduce the incidence of stress fractures in recruits. These high-risk recruits undergo intensive training which elevated bone turnover, which requires adequate level of vitamin D and calcium in order to support bone health. It is hypothesized that supplemental vitamin d and calcium will decrease the occurrence of stress fractures.


Eligibility criteria: Inclusion Criteria:

* Recruits newly enlisted at a training base in September 2021.
* Agree to accept relevant inspections and serological research, and sign an informed consent form.

Exclusion Criteria:

* Suffer from diabetes, osteomyelitis and other diseases.
* Suffer from claustrophobia and other MRI examination contraindications.
* Long-term use of glucocorticoids, non-steroidal anti-inflammatory drugs or calcium, vitamin D.
* A history of kidney disease.
* Allergic to any ingredient of the medicine.

Primary outcomes:
measure: Stress fracture
timeFrame: 3 months after the start of the basic military training.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Orthopedics, Xijing Hospital, The Air Force Medical University
state: Shanxi
Study officials:
References:
Clinical trial NCT01088594: A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers
Official title: A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: urinary sodium excretion
Pioglitazone
Rosiglitazone
Methodological study
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-03-17
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A single centre, open, randomized, placebo controlled, 3 period cross-over study to evaluate the effects of single oral doses of pioglitazone 45mg, rosiglitazone 8mg and placebo on urinary sodium excretion in 12 healthy male volunteers


Eligibility criteria: Inclusion Criteria Volunteers with Body Mass Index 18.0-28.0 kg/m2 Exclusion Criteria Clinically relevant medical history

Primary outcomes:
measure: Time-course urinary sodium excretion calculated on the Day 1 of each study period
timeFrame: 0-6 hours
measure: Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period
timeFrame: 0-6 hours
Secondary outcomes:
measure: Sodium clearance on Day 1 of each study period
timeFrame: 0-6 hours
measure: Creatinine clearance calculated on Day 1 of each study period
timeFrame: 0-6 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: S337.1.004 Site #
Study officials:
affiliation: Solvay Pharmaceuticals
name: Claire Nee
role: STUDY_DIRECTOR
References:
Clinical trial NCT04361994: The GErman Italian Spanish Takotsubo (GEIST) Registry
Official title: The GErman Italian Spanish Takotsubo (GEIST) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Takotsubo Syndrome
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: University of Foggia
First posted: 2020-04-24
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: Diagnosed according to the current diagnostic recommendations at the time of clinical presentation

Brief summary: GEIST is a multicenter, international observational registry of patients with Takotsubo syndrome. Data regarding the clinical profile (demographic characteristics, clinical presentation, laboratory measures, electrocardiography /echocardiography / coronary angiography parameters, treatment and medication), in-hospital course and complications and short-/long-term outcome are collected prospectively and retrospectively to increase the understanding of the disease.

Detailed description: The open-ended, multicenter, international GEIST registry collects data from patients with Takotsubo syndrome during the index hospitalization and follow-up. Furthermore, long-term outcome data are acquired with structured telephone interviews, in case patients do not undergo regular outpatient visits in the participating study centers. The GEIST registry retrospectively includes data, which have already been collected, and prospectively continues to enroll patients with newly diagnosed Takotsubo syndrome.

Eligibility criteria: Inclusion Criteria:

* Patients with Takotsubo syndrome

Exclusion Criteria:

* Non

Primary outcomes:
measure: All-cause mortality
timeFrame: Day 0
measure: All-cause mortality
timeFrame: 3 Month
measure: All-cause mortality
timeFrame: 6 Month
Secondary outcomes:
measure: In-Hospital complications
timeFrame: Day 0
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universität zu Lübeck
state: Schleswig-Holstein
city: Foggia
country: Italy
facility: University of Foggia
Study officials:
References:
citation: Stiermaier T, Walliser A, El-Battrawy I, Patz T, Mezger M, Rawish E, Andres M, Almendro-Delia M, Martinez-Selles M, Uribarri A, Perez-Castellanos A, Guerra F, Novo G, Mariano E, Musumeci MB, Arcari L, Cacciotti L, Montisci R, Akin I, Thiele H, Brunetti ND, Nunez-Gil IJ, Santoro F, Eitel I. Happy Heart Syndrome: Frequency, Characteristics, and Outcome of Takotsubo Syndrome Triggered by Positive Life Events. JACC Heart Fail. 2022 Jul;10(7):459-466. doi: 10.1016/j.jchf.2022.02.015. Epub 2022 May 4.
citation: El-Battrawy I, Santoro F, Stiermaier T, Moller C, Guastafierro F, Novo G, Novo S, Mariano E, Romeo F, Romeo F, Thiele H, Guerra F, Capucci A, Giannini I, Brunetti ND, Eitel I, Akin I. Incidence and Clinical Impact of Right Ventricular Involvement (Biventricular Ballooning) in Takotsubo Syndrome: Results From the GEIST Registry. Chest. 2021 Oct;160(4):1433-1441. doi: 10.1016/j.chest.2021.04.072. Epub 2021 May 27.
Clinical trial NCT07004894: Effects of Neuromuscular Reeducation Versus Friction Massage in Lateral Epicondylitis
Official title: Effects of Neuromuscular Reeducation Versus Friction Massage in Lateral Epicondylitis: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: This study is a randomised control trial and the purpose of this study is to determine the effects of neuromuscular reeducation versus friction massage in lateral epicondylitis.

Detailed description: Participants will be recruited into their respective groups using a coin toss method. Lateral epicondylitis will be assessed using the following tests:

Cozen's test Maudsley's test Mills test

Eligibility criteria: Inclusion Criteria:

1. Diagnosed cases of lateral epicondylitis
2. Age 25-50 years
3. Both genders
4. Postive tests; cozens, maudsley's, mills (at least any of 2)

Exclusion Criteria:

1. Recent elbow fractures or dislocations
2. Elbow joint instability
3. Active joint disease
4. Open wounds around elbow joints

Primary outcomes:
measure: Lateral Epicondylitis Pain
timeFrame: Variable will be assessed at pre and post treatment for the total interval of 4 weeks.
measure: Range of Motion
timeFrame: Variable will be assessed at pre and post treatment for the total interval of 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References:
Clinical trial NCT06886360: Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)
Official title: An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Primary Sclerosing Cholangitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 120
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: Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis


Eligibility criteria: Inclusion criteria:

1. Signed informed consent.
2. Males or females ≥ 18 years.
3. Patient has previously been diagnosed with PSC, has participated in the previous NUC 5/PSC trial and has completed the DBE phase with Visit 22, or has prematurely terminated the DBE phase before this trial has been started, or has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy\*. (\*Lack of efficacy as defined in the NUC-5/PSC trial.)

Exclusion Criteria:

1. History or presence of chronic alcoholic consumption (daily consumption \> 30 g in men, \> 20 g in women).
2. Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug.
3. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient's safety.
4. History of liver transplantation or patient listed for transplantation.

Primary outcomes:
measure: Occurrence of treatment emergent adverse events
timeFrame: 72 weeks from enrollment to end of treatment
measure: Occurrence of serious treatment emergent adverse events
timeFrame: 72 weeks from enrollment to end of treatment
measure: Occurrence of severe treatment emergent adverse events
timeFrame: 72 weeks from enrollment to end of treatment
measure: Occurrence of adverse drug reactions
timeFrame: 72 weeks from enrollment to end of treatment
measure: Occurrence of unexpected treatment emergent adverse events
timeFrame: 72 weeks from enrollment to end of treatment
measure: Occurrence of treatment emergent adverse events leading to study withdrawal
timeFrame: 72 weeks from enrollment to end of treatment
measure: Occurrence of adverse events leading to death
timeFrame: 72 weeks from enrollment to end of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna, dept. of Internal Medicine III
name: Michael Trauner, MD
role: PRINCIPAL_INVESTIGATOR
References: