louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03898518: The Effects of a Jump Rope Exercise Program on Body Composition and Self-efficacy in Obese Adolescent Girls
Official title: The Effects of a 12-week Jump Rope Exercise Program on Body Composition, Insulin Sensitivity, and Academic Self-efficacy in Obese Prehypertensive Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Blood Pressure
Abdominal Obesity
Self Efficacy
Adiposity
Insulin Sensitivity
Keywords: adolescence
exercise
body composition
insulin sensitivity
obesity
academic self-efficacy
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Chonnam National University
name: University of Nebraska
First posted: 2019-04-02
Enrollment: 48
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: exercise intervention group, control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to examine the impact of a 12-week jump rope exercise program on body composition, blood pressure, insulin resistance, and academic self-efficacy in prehypertensive adolescent obese girls. Forty-eight prehypertensive adolescent obese girls participated in this study. The girls were randomly divided into the jump rope exercise intervention group (EX, n=24) and control group (CON, n=24). The EX group performed a jump rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks (sessions 50 minutes in duration). The CON group did not participate in any structure or unstructured exercise protocol. Blood pressure, body fat percentage, waist circumference, blood glucose and insulin, homeostatic model assessment - insulin resistance, and Academic Self-Efficacy were measured before and after the 12-weeks study.


Eligibility criteria: Inclusion Criteria:

* prehypertensive
* sedentary (no regular exercise training or physical activity within the last year)
* no weight loss diet during the last six months
* obese

Exclusion Criteria:

* pregnancy
* chronic disease
* daily medication use

Primary outcomes:
measure: Body Fat
timeFrame: 12 weeks
measure: Blood Pressure
timeFrame: 12 weeks
measure: Body Mass
timeFrame: 12 weeks
measure: Height
timeFrame: 12 weeks
measure: Waist Circumference
timeFrame: 12 weeks
measure: Lean Body Mass
timeFrame: 12 weeks
measure: Glucose
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: Homeostatic Model Assessment - Insulin Resistance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03715218: Impact of Mothers Touch Program to Improve Maternal Health After Birth
Official title: Indian Postpartum Care: A-randomised Trial to Improve Maternal Health Six Weeks After Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Depression
Quality of Life
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
name: Mothers Touch Foundation, India
First posted: 2018-10-23
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: After the child birth most women experience major health issues such as depression, severe fatigue, back pain, perineal pain, mastitis, urinary or faecal incontinence, sexual problems and relationship problems with partners. That all lead to poorer emotional and mental health and factors contributing isolation, exhaustion and physical health problems.

'Sava Mahina (6-week period) is a traditional practice for postpartum women in India, which include special diet, lifestyle and supportive care. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of Indian postpartum care on women.


Eligibility criteria: Inclusion Criteria:

* Primigravida
* Healthy pregnancy
* Consent to participate

Exclusion Criteria:

* Mental Health diagnosis
* Severe depression or psychosis
* Substance abuse

Primary outcomes:
measure: Change in Post-natal depression
timeFrame: 6 weeks following child birth
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: 6 weeks following child birth
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Reserach Institute
state: Rajasthan
Study officials:
affiliation: Mothers Touch Foundation, India
name: Rekha Chaudhari
role: STUDY_CHAIR
affiliation: Warwick Research Services
name: Neha Sharma
role: PRINCIPAL_INVESTIGATOR
affiliation: Mothers Touch Foundation, India
name: Sangram Birje
role: STUDY_DIRECTOR
affiliation: Mothers Touch Foundation, India
name: Aparna Chaudhari
role: STUDY_DIRECTOR
References:
citation: Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.
Clinical trial NCT04743518: Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
Official title: Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis
cardiovascular risk
CIMT
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 100
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: An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.


Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis evolving for at least 6 months,
* Patient older than 18 years,
* Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib,
* Written informed consent.

Exclusion Criteria:

* Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period,
* Patients with a cardiovascular event such as myocardial infarction and stroke,
* Diabetic patient,
* Pregnant women,
* Minor
* people unable to give their consent to participate

Primary outcomes:
measure: variation of carotid intima media thickness (CIMT) between the 3 patient groups
timeFrame: at the end of month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03695718: Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest
Official title: Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-Of-Hospital Cardiac Arrest
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
First posted: 2018-10-04
Enrollment: 1057
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sustained ROSC from OHCA

Brief summary: The aim of this study is to construct multi-center post-cardiac arrest care registry that can be used for data warehousing and clinical research.

Detailed description: This registry prospectively enrolls adults patients survived out-of-hospital cardiac arrest in 3 academic hospital emergency departments.

Registered data can be used for quality control and clinical research to reduce post-cardiac arrest syndrome-related mortality.

Eligibility criteria: Inclusion Criteria:

* Patients aged 20 years old or older who presents to the ED of the participating hospitals with any of the following criteria:

  1. Sustained ROSC from OHCA at pre-hospital level
  2. Sustained ROSC from OHCA at the ED of the participating hospitals after ACLS
  3. Patients sustained ROSC from OHCA and transferred from other hospital to the ED of the participating hospitals for post-cardiac arrest care

Exclusion Criteria:

* Age less than 20 years old
* Patients with advanced directives not to deliver aggressive organ supportive management

Primary outcomes:
measure: Survival
timeFrame: 1-year
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28-day
measure: 28-day CPC
timeFrame: 28-day
measure: 6-month CPC
timeFrame: 6-month
measure: 1-year CPC
timeFrame: 1-year
measure: Organ support treatment (mechanical ventilation)
timeFrame: Hospital discharge (non-survivors) or 1-year (survivors)
measure: Organ support treatment (renal replacement therapy)
timeFrame: Hospital discharge (non-survivors) or 1-year (survivors)
measure: ICU length of stay
timeFrame: Hospital discharge (non-survivors) or 1-year (survivors)
measure: Hospital length of stay
timeFrame: Hospital discharge (non-survivors) or 1-year (survivors)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
Study officials:
affiliation: Seoul National University Boramae Hospital
name: Jonghwan Shin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04254718: Digital Storytelling in the NICU
Official title: Preliminary Pilot Study of Digital Storytelling in the NICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bereavement
Keywords: NICU
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our long-term goal is to reduce suffering and long-term negative consequences for families in the Neonatal Intensive Care Unit (NICU). The overall purpose of this study is to test feasibility of a legacy intervention for NICU parents.

Detailed description: Specific aims are:

(1) To determine the feasibility of a legacy intervention for NICU parents; and (2) to determine the feasibility of psychosocial instruments for NICU parents. We will recruit parents (N = 12) of 6 infants in the NICU who have received a palliative care consultation and expected to die by 1 year of age based on provider report. We will use a one-group pre- and post-test design. The intervention will be delivered by the PI or trained study staff conducting video-taped interviews with parents in private NICU rooms to create a digital story about their infant. The videographer will use the video and music selected by parents to create a digital story about the infant. The final digital story is provided to parents on a DVD or unlisted (private) YouTube link to keep. Parents will complete electronic psychosocial measures at enrollment (baseline/pre-intervention) and post-intervention.

Eligibility criteria: Inclusion Criteria:

* Parents of infants in the NICU who have received a palliative care consult and expected to die by 1 year of age based on provider report:

  * Parent caregivers (ages 18 years and up) of infants
  * Parents will be defined as the legal guardians who act in the role of the infant's primary and secondary parent caregivers based on parent self-report.
* Able to speak and understand English
* Absence of cognitive impairment

Primary outcomes:
measure: Change in PROMIS Anxiety survey (short form)
timeFrame: Baseline and 1 month
measure: Change in PROMIS Depression Survey (short form)
timeFrame: Baseline and 1 month
measure: Change in PROMIS Sleep Disturbance survey (short form)
timeFrame: Baseline and 1 month
measure: Change in PROMIS Meaning and Purpose survey (short form)
timeFrame: Baseline and 1 month
measure: Change in Benefit Finding Scale
timeFrame: Baseline and 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nolensville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Terrah Akard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05942118: Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
Official title: A Monocentric, Prospective, Randomized Clinical Study Comparing ROLL (Radioguided Occult Lesion Localization) With Magnetic Markers for Preoperative Localization of Non-palpable Breast Lesions in Patients Undergoing Breast Conservative Surgery.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Non-palpable breast lesion
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 262
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients with non-palpable lesions candidated for surgery

Brief summary: Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. Scientific evidence supports the efficacy of the new "wire-free" techniques, which appear to be comparable to the WGL in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. There is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. In particular, no randomized trials of comparison between ROLL and magnetic seed localization are currently available. The aim of this randomized study is to compare ROLL with magnetic seed to assess their efficacy for non-palpable breast lesions' localization.


Eligibility criteria: Inclusion Criteria:

* Female;
* Non-palpable breast lesions;
* Indication to lesion's surgical excision (lumpectomy, quadrantectomy)
* Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5);
* Written informed consent.

Exclusion Criteria:

* Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle aspiration (C2);
* Clinically palpable breast lesion;
* Breast lesion localization for planned neoadjuvant chemotherapy.

Primary outcomes:
measure: Free-surgical margins
timeFrame: 3 years
Secondary outcomes:
measure: Excess breast resection
timeFrame: 3 years
measure: Surgery Time
timeFrame: 3 years
measure: Hospitalization days
timeFrame: 3 years
measure: Complications
timeFrame: 3 years
measure: Reintervention
timeFrame: 3 years
measure: Cost-effectiveness analysis
timeFrame: 3 years
measure: Follow up
timeFrame: 5 years after enrollment
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri SpA
state: Lombardia
Study officials:
References:
Clinical trial NCT00335218: Fat Distribution in Healthy Early Postmenopausal Women
Official title: A Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled, Two-arm, Phase IV Study to Investigate the Influence of a Continuous Combined Estrogen-progestin Regimen Containing 2 mg Estradiol Valerate and 2 mg Dienogest (Climodien® / Lafamme®) on the Fat Distribution in Otherwise Healthy Early Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Postmenopause
Keywords: Early postmenopausal state
Climacteric symptoms
Hormone replacement therapy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-06-09
Enrollment: 67
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Healthy early postmenopausal women
* BMI between 25 and 30

Exclusion Criteria:

* Contra-indication(s) for hormone treatment
* Metabolic diseases
* Concomitant medication with influence on lipid metabolism

Primary outcomes:
measure: Individual relative change of abdominal visceral fat measured by magnetic resonance imaging
timeFrame: Baseline and after 24 weeks of treatment
Secondary outcomes:
measure: Parameters of body composition and lipid metabolism
timeFrame: Baseline and after 24 weeks of treatment
measure: Adverse events collection
timeFrame: During whole study period
Other outcomes:
Locations:
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01362218: Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol
Official title: Cardiovascular Fixed Combination Pill ASR: Pharmacodynamic Clinical Trial of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril (Cardiovascular Polypill); LDL Cholesterol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Elevated LDL Cholesterol
Lead sponsor: Ferrer Internacional S.A.
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged ≥18 and \<75 years.
* Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid lowering drug for the last 4 weeks.
* LDL-cholesterol ≥130 and ≤220 mg/dL.
* Systolic blood pressure ≥120 and \<160 mmHg and diastolic blood pressure ≥70 and \<100 mmHg.
* Provide written informed consent.

Exclusion Criteria:

Primary outcomes:
measure: Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.
timeFrame: Day 56
Secondary outcomes:
measure: • Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period.
timeFrame: Day 56
measure: • Difference in HDL-cholesterol levels between the basal and the final visit of treatment period.
timeFrame: Day 56
measure: • Difference in total cholesterol levels between the basal and the final visit of treatment period.
timeFrame: Day 56
measure: • Difference in triglyceride levels between the basal and the final visit of treatment period
timeFrame: Day 56
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
Clinical trial NCT00985218: In Vitro Human Embryo Culture System
Official title: In Vitro Human Embryo Culture System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infertility
Keywords: infertility
embryo development
Lead sponsor: Incept BioSystems, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the development of human embryos grown in a conventional culture dish to those grown in a new embryo culture device known as the SMART System.

Detailed description: This study is a multi-center, randomized, performance study.

Eligibility criteria: Inclusion Criteria - All recruited subjects must meet all of the following inclusion criteria to be enrolled in the study:

1. Female 21 to 35 years of age inclusive
2. First or second IVF cycle
3. Not pregnant
4. No physical abnormalities that would adversely affect oocyte retrieval
5. Male factor is acceptable
6. ICSI is acceptable
7. 10 zygotes or more

Exclusion Criteria- Potential subjects are excluded from the study if any of the following conditions exist:

1. The sperm were retrieved using TESE or MESA
2. The embryos were created with either donor oocytes or donor sperm.
3. Medical condition precluding a safe pregnancy
4. Medical condition disqualifying the subject from safely participating in the study in the judgment of the investigator

Primary outcomes:
measure: rate of development of human embryos
timeFrame: Day 3 (t=72 hrs)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pacific Fertility Center
state: California
city: Clearwater
country: United States
facility: Florida Fertility Institute
state: Florida
city: Mount Pleasant
country: United States
facility: Southeastern Fertility Center
state: South Carolina
city: San Antonio
country: United States
facility: Fertility Center of San Antonio
state: Texas
Study officials:
affiliation: Fertility Center of San Antonio
name: Thomas B Pool, Ph.D., HCLD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pacific Fertility Center
name: Joseph Conaghan, Ph.D., HCLD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southeastern Fertility Center
name: Rodney Wade, BSA, MS, ELD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Fertility Institute
name: Kelvin L Fry, B. SC.
role: PRINCIPAL_INVESTIGATOR
References: