louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01538030: Perinatal Outcome After Premature Rupture of Membranes
Official title: Perinatal Outcomes According to Amniotic Fluid Indez After Premature Rupture of Membranes. A Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Membranes
Premature Rupture
Keywords: Fetal membranes, premature rupture
Cesarean section
Perinatal mortality
Neonatal sepsis
Amniotic Fluid Volume
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients between 24-34 weeks of gestation with a confirmed diagnosis of premature rupture of membranes.

Brief summary: Premature rupture of membranes is an important cause of neonatal morbidity and mortality, mainly because of the complications associated with this pathology (oligohydramnios, cord compression or prolapse, infection). When rupture of the membranes occur the risk of cord compression increases but there is little evidence regarding this complication and amniotic fluid volume. The investigator's focus are the perinatal outcomes according to amniotic fluid volume (\< 5 or \>5).


Eligibility criteria: Inclusion Criteria:

* Gestational age between 24-34 weeks.
* Confirmed diagnosis of premature rupture of membranes.

Exclusion Criteria:

* Twin pregnancies.
* Obstetric pathologies that require immediate termination of pregnancy (severe preeclampsia, abruptio placenta, cord prolapse).
* Termination of pregnancy (whatever the reason) before complete corticoid treatment.
* Incomplete recollection of all data required for analysis.

Primary outcomes:
measure: Cesarean section rate
timeFrame: 5 months
Secondary outcomes:
measure: Perinatal mortality
timeFrame: 5 months
measure: Neonatal sepsis
timeFrame: 5 months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
References:
Clinical trial NCT01015430: A Study With RO4917523 in Patients With Fragile X Syndrome
Official title: A Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Safety and Tolerability, and Exploratory Efficacy and Pharmacodynamic Effects Study of RO4917523 in Adult Patients With Fragile X Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fragile X Syndrome
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind multiple ascending dose study will evaluate the safety and tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome. The patients will be randomized to receive either active drug or placebo. The anticipated time on study treatment is 6 weeks. The target sample size is \<100 patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18 to 50 years of age
* Fragile X Syndrome
* IQ less than 75
* Reliable caregiver

Exclusion Criteria:

* Current psychosis or presumption of psychosis
* History of suicidal behavior or considered a high suicidal risk
* Severe self-injurious behavior
* Any unstable medical condition other than Fragile X Syndrome (e.g. hypertension, diabetes)
* Current seizure disorder

Primary outcomes:
measure: Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters
timeFrame: AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43
Secondary outcomes:
measure: Efficacy: Behavior and cognition assessments
timeFrame: Every 2 weeks throughout study
Other outcomes:
Locations:
city: Sacramento
country: United States
state: California
city: Decatur
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02241330: Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status
Official title: Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zinc Deficiency
Keywords: Zinc
deficiency
biofortification
wheat
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: HarvestPlus
First posted: 2014-09-16
Enrollment: 284
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this research is to test the efficacy of Zn biofortified wheat in increasing Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* generally healthy

Exclusion Criteria:

* unhealthy

Primary outcomes:
measure: Change of plasma zinc values from baseline to endpoint and two months post intervention
timeFrame: day 0, random between day 0 and 6 month, 6 month and random between 6 months and 2 months post-intervention
Secondary outcomes:
measure: Change in the Inflammation marker from baseline to the end of the intervention, as well as post-intervention
timeFrame: day 0, random during the intervention, month 6, and random 2 months post intervention
measure: Change in the chronic inflammation marker from baseline to 6 months and 2 month post intervention
timeFrame: day 0, random during the intervention, month 6, and random 2 months post intervention
measure: Change in Iron status from baseline to the end of the intervention and 2 months post-intervention
timeFrame: day 0, random during the intervention, month 6, and random 2 months post intervention
measure: Change in Iron status from baseline to the end of intervention, and within two months post-intervention
timeFrame: day 0, random during the intervention, month 6, and random 2 months post intervention
measure: New Zn biomarkers
timeFrame: day 0, random during the intervention, month 6, and random 2 months post intervention
measure: New potential Zn biomarkers in buccal cells
timeFrame: day 0, random during the intervention, month 6, and random 2 months post intervention
measure: Characterization of gut microflora
timeFrame: baseline, endpoint (6 months)
measure: Anthropometry
timeFrame: baseline (day 0), endpoint (6 months)
measure: morbidity
timeFrame: throughout the study
Other outcomes:
Locations:
city: Bangalore
country: India
facility: St John's Research Institute
state: Karnataka
Study officials:
affiliation: ETHZ
name: Michael B Zimmermann, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
affiliation: St John's Research Institute, Bangalore
name: Anura V Kurpad, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05571930: Outcomes of Secondary Endovascular Aortic Repair After Initial Frozen Elephant Trunk Procedure
Official title: Outcomes of Secondary Endovascular Aortic Repair After Initial Aortic Cross Replacement by a Frozen Elephant Trunk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoraco-abdominal Aneurysm
Aortic Dissection
Lead sponsor: University Paul Sabatier of Toulouse
Sponsor class: OTHER
Collaborators: name: Jean Porterie, MD
name: Thibaut Boisroux, MD
name: Bertrand Marcheix, MD, PhD
name: Jean Baptiste Ricco, MD, PhD
name: Xavier Chaufour, MD, PhD
First posted: 2022-10-07
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with aortic cross replacement by FET who are indicated for a secondary connexion in emergency :

Aortic type A dissection with organ malperfusion Defect in the expansion of the FET module

or in chronical evolution: Type 1 and Type 2 Thoracoabdominal aneurysm (TAAA) with a diameter at \> 6 cm Aneurysmal evolution of the false lumen of a dissected aorta.

Brief summary: Objective Complex aortic pathology has been revolutionized with the use of hybrid prostheses such as the Thoraflex® Hybrid Frozen Elephant Trunk (FET). The aim of this study was to evaluate the midterm results of secondary extension of the FET by thoracic endovascular aortic repair (TEVAR). Few data are present in the literature regarding the outcomes of this secondary treatment.

The investigators perform a prospective study between 2015 and 2022 in a tertiary aortic center on all consecutive patients having undergone TEVAR after FET implantation. The TEVAR endograft covered most of the 10 cm FET module with 2 to 4 mm oversizing. All patients were monitored by computerized angiography (CTA) at 6-month and yearly thereafter.

The aim of this study was the feasibility of theses secondary connexion and the mid term outcomes of the endovascular treatment.


Eligibility criteria: Inclusion Criteria:

Patient with aortic cross replacement by FET and

* Type 1 and Type 2 Thoracoabdominal aneurysm (TAAA) with a diameter at \> 6 cm or
* an aortic dissection, Type A (TAAD) or Type B (TBAD) with either organ malperfusion due to compression of the true channel or aneurysmal evolution of the dissected aorta, or
* A defect in the expansion of the FET module

Exclusion Criteria:

* No aortic cross replacement by FET

Primary outcomes:
measure: Absence of endoleak after secondary connexion
timeFrame: yearly thereafter up to 5 years
Secondary outcomes:
measure: Feasibility of the secondary connexion
timeFrame: During the surgery
measure: Absence of endoleak after secondary connexion
timeFrame: early thereafter up to 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04136730: Effects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.
Official title: Effects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2019-10-23
Enrollment: 126
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effects of home-based resistance exercise training, compared to a control group, on body composition, muscle strength and glycaemic control in people with type 2 diabetes.

Half participants will be in the home-based exercise group and half in the control group.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosed type 2 diabetes
* No changes in anti-diabetic medication in the last 3 months

Exclusion Criteria:

* Not currently or in the past year participating in any vigorous aerobic activity (\>1h per week) or any resistance exercise.
* BMI of 45 or higher
* Blood pressure of 160/100mmHg or higher
* Currently receiving insulin therapy

Primary outcomes:
measure: Glycated Haemoglobin concentration (mmol/mol)
timeFrame: Change from baseline to 32 weeks
Secondary outcomes:
measure: Fat-free mass
timeFrame: Change from baseline to 32 weeks
measure: Short performance physical battery test
timeFrame: Change from baseline to 32 weeks
Other outcomes:
measure: Grip strength
timeFrame: Change from baseline to 32 weeks
measure: One rep max
timeFrame: Change from baseline to 32 weeks
measure: Push up test
timeFrame: Change from baseline to 32 weeks
measure: BMI
timeFrame: Change from baseline to 32 weeks
measure: Body fat
timeFrame: Change from baseline to 32 weeks
measure: Visceral fat
timeFrame: Change from baseline to 32 weeks
measure: Physical activity levels
timeFrame: Change from baseline to 32 weeks
measure: Quality of life score
timeFrame: Change from baseline to 32 weeks
Locations:
city: Kuwait City
country: Kuwait
facility: Dasman Diabetes Institute
Study officials:
affiliation: Dasman Diabetes Institute
name: Ebaa AlOzairi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al Ozairi E, Alsaeed D, Taliping D, Jalali M, El Samad A, Mashankar A, Taghadom E, Guess N, Gill JMR, Sattar N, Gray C, Welsh P, Gray SR. Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength. Trials. 2020 Jun 22;21(1):557. doi: 10.1186/s13063-020-04480-2.
Clinical trial NCT02334930: Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors
Official title: Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PEComa
Hemangioma
Keywords: propranolol
betablocker
angiogenesis
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry for Health and Solidarity, France
name: National Cancer Institute, France
First posted: 2015-01-08
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will have biopsy or surgery for PEComa or vascular pediatric tumor (RICH, NICH, hemangioma or pyogenic granuloma)

Brief summary: PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological similarities were seen between PEComa and infantile hemangioma. Propranolol is highly efficient to treat infantile hemangioma and we believe that this drug can also be useful for the treatment of PEComa.

Purpose : to understand the mechanism of action of propranolol in PEComas and related pediatric vascular lesions and to select possible novel targets of betablockers in vascular tumors related to PEComas by using YAP oncogene activation as a molecular marker


Eligibility criteria: Inclusion Criteria:

* patients who will have biopsy or surgery for PEComa or vascular pediatric tumor (RICH, NICH, hemangioma or pyogenic granuloma)
* A free, informed and written consent will be established

Exclusion Criteria:

* none

Primary outcomes:
measure: YAP cellular expression by immunohistochemistry study on collected tissues
timeFrame: At inclusion (day 0)]
Secondary outcomes:
measure: Beta adrenergic receptors expression by immunohistochemistry study on collected tissues
timeFrame: At inclusion (day 0)]
measure: Study of Hippo/YAP pathway expression by western-blot, and correlation with propranolol efficacy
timeFrame: At inclusion (day 0)]
measure: Study of MAP/kinases pathway expression by western-blot, and correlation with propranolol efficacy
timeFrame: At inclusion (day 0)]
measure: Study of PKA/AMPc pathway expression by western-blot, and correlation with propranolol efficacy
timeFrame: At inclusion (day 0)]
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References:
Clinical trial NCT05726630: Clinical Study of Divozilimab in Patients With Systemic Scleroderma
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Systemic Scleroderma
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2023-02-14
Enrollment: 152
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: The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active systemic scleroderma according to the ACR/EULAR 2013 criteria with a modified Rodnan skin score (mRSS) of 10 to 20. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value. Subjects will be randomized to divozilimab or placebo group.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of "systemic scleroderma" in accordance with the ACR/EULAR 2013 classification.
* Modified Rodnan skin score (mRSS) from 10 to 20.
* FVC ≥ 40 % of the due value.

Exclusion Criteria:

* Induced scleroderma.
* Silicone implants/protheses.
* Digital ulcers with signs of infection or indications for any amputation.
* Blood biochemistry or hematological abnormalities at screening.
* FEV1/FVC \< 0.7 and FEV1\< 50 % at screening.
* History of threatment with anti-CD20 monoclonal antibodies.

Primary outcomes:
measure: Change in the modified Rodnan Skin Score (mRSS) from baseline
timeFrame: week 24
Secondary outcomes:
measure: Change in the modified Rodnan Skin Score (mRSS) from baseline
timeFrame: week 48
measure: Change in the FVC (forced vital capacity) from baseline
timeFrame: week 48
measure: Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline
timeFrame: week 48
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical hospital
city: Saint Petersburg
country: Russian Federation
facility: Clinical Rheumatology Hospital №25
city: Saint Petersburg
country: Russian Federation
facility: North-Western state Medical University named after I.I. Mechnikov
Study officials:
References:
Clinical trial NCT06961630: Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
Official title: A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Myocardial Injury After Noncardiac Surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot study is to assess enrollment feasibility of a randomized trial of direct oral anticoagulant and high-intensity statin therapy versus usual care in patients with Myocardial Injury after Noncardiac Surgery (MINS). The primary aims of this study are to assess feasibility, study drug adherence, and optimize study design (entry criteria, study endpoints, sample size calculation, site selection) and recruitment strategies for the future multicenter randomized clinical trial studying biomarker-based care in post-operative patients at elevated cardiovascular (CV) risk.


Eligibility criteria: Inclusion Criteria:

1. Adults ≥45 years
2. Underwent major non-cardiac surgery requiring ≥1 overnight inpatient stay in the prior 14 days
3. Myocardial injury after noncardiac surgery, defined as a post-operative troponin ≥ 99th percentile upper reference limit \[URL\], with rise/fall \>20% indicative of acute myocardial injury.
4. Ability to provide informed consent

Exclusion Criteria:

1. Expected survival \<6 months
2. Hemorrhagic disorder
3. Surgeon feels it is unsafe to initiate low-dose anticoagulation within 14 days of surgery
4. Indication for oral anticoagulation at discharge
5. Indication for dual antiplatelet therapy at discharge
6. Patient already receiving or planned to receive moderate or high-intensity statin
7. Contraindication to high-intensity statin
8. Contraindication to rivaroxaban
9. End stage kidney disease on hemodialysis
10. Acute liver failure or decompensated cirrhosis
11. Pregnancy

Primary outcomes:
measure: Percentage of pills taken at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Quality of Life (QOL) questionnaires completed at Month 6
timeFrame: Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nathaniel R. Smilowitz, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05638230: Relative Importance of Cardiovascular Risk Factors and Echocardiographic Parameters Affecting Left Atrial Strain
Official title: Relative Importance of Cardiovascular Risk Factors and Echocardiographic Parameters Affecting Left Atrial Strain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure, Diastolic
Heart Failure, Preserved Ejection Fraction
Keywords: left atrial reservoir strain
HFA-PEFF
LA strain
Heart failure with preserved ejection fraction (HFpEF)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 2500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visited a cardiovascular center clinic for dyspnea and chest discomfort and who underwent echocardiography were enrolled for participants suspected of having heart failure with preserved ejection fraction.

Brief summary: The goal of this observational study is to learn about left atrial reservoir strain in patients with heart failure with preserved ejection fraction. The main questions it aims to answer are:

* Usefullness of LARS as a predictor of high HFA-PEFF diagnostic algorithm scores (≥5)
* The relative importance of LARS in variables including each component of HFA-PEFF and traditional cardiovascular risk factors.


Eligibility criteria: Inclusion Criteria:

* Participants with ICD-10 code of heart failure (I50) from August 2021 to July 2022
* 20-year-old or higher age
* Participants who are available to measure left atrial reservoir strain

Exclusion Criteria:

* Left ventricular ejection fraction \<50%
* Supraventricular arrhythmia (e.g. atrial flutter/fibrillation, atrial tachycardia)
* Participants who are given pacemaker or ICD implantation procedure

Primary outcomes:
measure: Statistical significant of LA reservoir strain to estimate high HFA-PEFF score (≥5)
timeFrame: through study completion, an average of 1 year
measure: Relative importance of left atrial reservoir strain
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Minkwan Kim
state: Gyeonggi
Study officials:
References: