louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04853966: The Effects of Physical Activity Tele-Counseling Intervention in Post-COVID-19 Conditions
Official title: The Effects of Physical Activity Tele-Counseling Intervention on Physical Activity, Functional Performance, and Quality of Life in Post-COVID-19 Conditions: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It has been found that physical activity recommendations with telerehabilitation in different disease groups improve the functional capacity, physical activities and mental health of the patients as much as the supervised exercise programs. However, there are no studies in the literature that provide online physical activity counseling in COVID-19 patients, and evaluate the effect of physical activity counseling on physical activity level, quality of life, physical performance, fatigue, kinesophobia, pain, dyspnea, mental health and behavior change levels. For this reason, this study aimed to evaluate the effect of online physical activity counseling on physical activity level, quality of life, physical performance, fatigue, kinesophobia, pain, dyspnea, mental health and behavior change level in COVID-19 patients.


Eligibility criteria: Inclusion Criteria:

* Individuals who have suffered COVID-19 and have passed at 3 months after the Polymerase Chain Reaction (PCR) test turned negative
* Volunteering to participate in the research

Exclusion Criteria:

* Having another diagnosed respiratory or cardiac problem
* Having infections during the evaluation
* Having a skeletal-muscular disease that may affect the evaluation results
* Having neurological and psychiatric problems
* Individuals with restrictions that prevent being physically active during the evaluation and counseling program.
* Pregnant individuals

Primary outcomes:
measure: Physical activity level
timeFrame: seven days
measure: General Quality of Life
timeFrame: five minutes
Secondary outcomes:
measure: Physical performance
timeFrame: ten minutes
measure: Dyspnea during daily living activities
timeFrame: two minutes
measure: Behaviour change level
timeFrame: five minutes
measure: General Pain
timeFrame: one minute
measure: Fear of movement
timeFrame: three minutes
measure: Fatigue
timeFrame: Two minutes
measure: Mental Health
timeFrame: three minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Emek
Study officials:
References:
Clinical trial NCT01566266: Gut Flora and Lipid Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: gut flora
antibiotics
lipid metabolism
LDL cholesterol
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: It is well known that metabolic responses to diet and drugs are affected by genetic and environmental factors. Still, a large part of differences in responses between individuals remains unexplained. To increase our understanding of individual differences, more and more attention is paid to the role of intestinal microbiota. Not only energy and glucose may be related to the microbiota, but also lipid metabolism. This is not surprising as lipid metabolism, glucose metabolism, and obesity are closely linked.

There is substantial evidence from in particular animal studies that the gut microbiota is related to lipid and lipoprotein metabolism. However, there is less evidence to what extent modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.


Eligibility criteria: Inclusion Criteria:

* aged between 18-70 years
* serum total cholesterol: 5-8mmol/L

Exclusion Criteria:

* serum triacylglycerol \> 3.0mmol/L
* use of oral anticonceptives
* pregnant or breastfeeding women
* kidney insufficiencies
* unstable body weight
* allergy to antibiotics
* treatment with cholesterol-lowering drugs
* use of medication or a medically prescribed diet
* active cardiovascular disease
* abuse of drugs
* more than 21 alcohol consumptions per week for men and 14 consumptions for women
* use of an investigational product within the previous 30 days
* not willing to stop the consumption of products rich in plant stanol or sterol esters 3 weeks before start of the study
* use of gastric acid inhibitors, laxantia, prebiotica, probiotica and antibiotica for at least one month before the start of the study and during the study

Primary outcomes:
measure: LDL-cholesterol
timeFrame: Measure change between day 1 and day 8
Secondary outcomes:
measure: Lipid metabolism
timeFrame: Measure change between day 1 and day 8 (HDL-cholesterol, triglycerides)
measure: Glucose metabolism
timeFrame: Measure change between day 1 and day 8
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Ronald Mensink, Prof. Dr. Ir.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01480466: Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care
Official title: Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Body mass index
Weight
Primary care
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Boston Medical Center
First posted: 2011-11-29
Enrollment: 65278
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Overweight and obesity are highly significant clinical and public health issues, affecting more than two-thirds of adults in this country; however, primary care clinicians often do not document overweight or obesity or discuss weight management with their patients. The objectives of the proposed research are to develop and evaluate a set of tools within electronic health records (EHRs) to assist primary care clinicians with the diagnosis and treatment of overweight and obesity and to help patients manage their weight.


Eligibility criteria: Inclusion Criteria:

* All adult patients (ages \>= 20 years) who have a visit at a primary care practice at Brigham and Women's Hospital during the intervention period

Primary outcomes:
measure: weight change over 6 months
timeFrame: Baseline, 6 months
measure: weight change over 12 months
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Documentation of height
timeFrame: Baseline, 6 months, 12 months
measure: Documentation of weight
timeFrame: Baseline, 6 months, 12 months
measure: Documentation of body mass index
timeFrame: Baseline, 6 months, 12 months
measure: Diagnosis of overweight and obesity
timeFrame: Baseline, 6 months, 12 months
measure: Management of overweight and obesity
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
measure: Primary care clinician attitudes about management of overweight and obesity
timeFrame: baseline, 12 months
measure: Patient attitudes and behaviors around weight management
timeFrame: baseline, 6 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Heather J Baer, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baer HJ, Wee CC, DeVito K, Orav EJ, Frolkis JP, Williams DH, Wright A, Bates DW. Design of a cluster-randomized trial of electronic health record-based tools to address overweight and obesity in primary care. Clin Trials. 2015 Aug;12(4):374-83. doi: 10.1177/1740774515578132. Epub 2015 Mar 25.
Clinical trial NCT05979766: Manual Lymphatic Drainage vs Marian Clark Drainage in Pcs
Official title: Effects of Manual Lymphatic Drainage Versus Marian Clark Drainage on Pain and Disability in Patients With Pelvic Congestion Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Congestive Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 26
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pelvic congestion syndrome is a debilitating and potentially life threatening disorder of the pelvic region there is a constant hindrance in patient's daily professional and personal life due to the chronic pain. it can provide a definite way to improve pelvic congestion and quality of life. In this way it can benefit a large percentage of community females suffering from pelvic congestion syndrome and disability. This can grow at large length in favour of patients, clinicians and overall women health.

Detailed description: As per researcher's knowledge there are limited researches in which efficacy of manual lymphatic drainage in pelvic congestion syndrome are analyzed furthermore my comparative intervention i.e Marian Clark drainage is a rarely used osteopathic technique and not much studies have been conducted on it. This study helped to in identifying the effect of manual lymphatic drainage versus Marian Clark drainage on pain and disability in patients with pelvic congestion syndrome.

Eligibility criteria: Inclusion Criteria:

* Multiparous women
* Age ranging 20 to 50
* Ovarian veins \>4mm in diameter on Ultrasound Chronic pelvic pain/pressure for more than 6 months.
* Dull, aching or "dragging" pain in the pelvis or lower back, particularly on standing and worse around the time of your menstrual period.
* Pelvic pain that worsens as the day goes on, particularly if much time is spent standing dyspareunia
* Swollen veins in pelvic region, butt, thighs, vulva and vagina.
* Associated Irritable bladder/Irritable bowel present

Exclusion Criteria:

* Pelvic pain due to other organic cause like uterine fibroids, Endometriosis, Ovarian cyst pelvic pain due to neurological or musculoskeletal disorder
* Uterine prolapse
* Pelvic cancer

Primary outcomes:
measure: Manual lymphatic drainage
timeFrame: 6 months
measure: Marian clark drainage
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Neelam Muneeb, Ms
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06508866: Timing And Typology of ConducTIon disturbanCes During TAVI
Official title: Timing And Typology of ConducTIon disturbanCes During TAVI: the TACTIC-TAVI Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis, Severe
Keywords: TAVI
Pacemaker
aortic stenosis
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is a retrospective and prospective registry aiming to observe intra-procedural conduction disturbances in patients undergoing TAVI for severe aortic stenosis. Patients will have no alteration to standard post-procedural management and will their have usual follow-up. There are four key time points: 1) pre-procedure 2) intra-procedure 3) post-procedure 4) discharge. The electrocardiogram will be assessed at timepoints 1-3 and requirement for permanent pacemaker insertion by timepoint 4.

Brief summary: The TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational. The registry is planned to continue until the calculated sample size is achieved.

Detailed description: All patients since February 2023 treated successfully with TAVI until the study endpoint will be deemed suitable for inclusion in the registry. The registry will:

1. collect the baseline clinical features of the study population.
2. evaluate the electrocardiogram (ECG) and contrast tomography (CT) scan parameters.
3. collect procedural characteristics including type and timing of any conduction disturbance
4. collect follow-up data including post-procedural ECG, echocardiographic and clinical outcomes.

Eligibility criteria: Inclusion Criteria:

Patients successfully undergoing transcatheter aortic valve implantation for native severe aortic stenosis.

-

Exclusion Criteria:

1. Presence of previously implanted permanent cardiac pacemaker.
2. Valve-in-valve procedures.
3. No pre-procedural electrocardiogram is available.
4. No pre-procedural contrast CT TAVI is available.
5. Enrollment in another clinical trial.
6. Patients aged less than 18 years old.
7. Patients who do not consent for their data to be included in the registry.
8. Failed transcatheter aortic valve deployment. -

Primary outcomes:
measure: Prediction of new requirement for permanent pacemaker after TAVI
timeFrame: 0-24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Istituo Clinico Humanitas
state: Milano
Study officials:
affiliation: Humanitas Research Horspital
name: Antonio Mangieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02685566: Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
Official title: A Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Adequacy of the Fujifilm Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) Reader Training Program - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Mammography
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.

Detailed description: For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.

Eligibility criteria: Inclusion Criteria:

* Female subjects participating in FMSU004A protocol with known clinical status

Exclusion Criteria:

* Subjects with unknown clinical status not participating in FMSU004A protocol.

Primary outcomes:
measure: Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization.
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging, Limited (SMIL)
state: Arizona
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Rochester
country: United States
facility: Elizabeth Wende Breast Care, LLC (EWBC)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - at Chapel Hill
state: North Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Fujifilm Medical Systems USA, Inc.
name: Robert M Uzenoff
role: STUDY_DIRECTOR
References:
Clinical trial NCT03531866: Evaluation Study of Web-based Resource for Youth
Official title: Web-based Resource for Youth About Clinical Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Healthy
Lead sponsor: Innovation Research & Training
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-22
Enrollment: 91
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate DigiKnowIt News, a web-based resource to educate youth about pediatric clinical research. Youth will be randomly assigned to one of three groups (1. Intervention Version A; 2) Intervention Version B; 3) Wait-list control).

Detailed description: Compared to the high numbers of clinical trials with adults, there are far fewer clinical trials with children and adolescents; highlighting the need for more clinical trials with pediatric populations. Lacking in the area of pediatric clinical research are resources to educate children and adolescents about clinical research in fun, interactive, and developmentally appropriate ways. Thus, a web-based resource, DigiKnowIt News, was developed for youth aged 8 to 14 years to educate youth about participating in pediatric clinical trials. The web-based resource includes video spotlights, investigations, and electronic comic books. The purpose of this study is to conduct a randomized controlled trial to determine the effectiveness of the web-based resource and examine its impact on youths' knowledge about pediatric clinical trials, self-efficacy about making decisions about participation in clinical research, and positive attitudes towards participation.

Eligibility criteria: Inclusion Criteria:

* Within the ages of 8 and 14 years of age

Exclusion Criteria:

* Does not speak English fluently, does not have access to a computer or tablet with internet connection, and or has participated in a clinical trial after kindergarten.

Primary outcomes:
measure: Change in Knowledge about Clinical Research
timeFrame: 2 weeks
measure: Change in Attitudes toward Clinical Research
timeFrame: 2 weeks
measure: Change in Self-Efficacy for Making Decisions
timeFrame: 2 weeks
Secondary outcomes:
measure: Changes in Initiative-Taking
timeFrame: 2 weeks
measure: Changes in Hope
timeFrame: 2 weeks
measure: Changes in Parent-Child Communication
timeFrame: 2 weeks
measure: Consumer Satisfaction
timeFrame: 1 day
Other outcomes:
Locations:
city: Durham
country: United States
facility: innovation Research & Training
state: North Carolina
Study officials:
affiliation: Innovation Research & Training
name: Alison Parker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovation Research & Training
name: Tracy Scull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03033966: Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis
Official title: Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Venous Thrombosis
Keywords: Cerebral Oximetry
Cerebral Venous Thrombosis
Decompressive Craniectomy
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Cerebral venous thrombosis for Decompressive craniectomy

Brief summary: Cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes following acute brain injury as proved in Traumatic Brain Injury/Sub Arachnoid Haemhorrhage literature. How the brain injury affects cerebral oxygenation in patients with CVT is not currently known. Some of the factors that can affect cerebral oxygenation in patients with CVT are Hemoglobin, PO2, PCO2, Cerebral Perfusion Pressure (or MAP) and change in Intracranial Pressure after Decompressive Craniectomy. This study is designed to study how these factors affect cerebral oxygenation and impact of Decompressive Craniectomy on the cerebral oxygenation.


Eligibility criteria: Inclusion Criteria:

-Patients diagnosed with cerebral venous thrombosis, undergoing decompressive craniectomy.

Exclusion Criteria:

* Patients on inotropic support
* Systolic blood pressure \< 90 mmHg
* Haemoglobin oxygen saturation \<95%
* Refusal of consent
* Age \<16 and \> 65 years
* Known history of diabetes or hypertension
* Pregnancy
* Any contraindication for application of cerebral oximetry sensors

Primary outcomes:
measure: Ipsilateral Regional Cerebral Oxygen Saturation
timeFrame: From Recruitment till 48 hours postoperative (end of study)
Secondary outcomes:
measure: Contralateral Regional Cerebral Oxygen Saturation
timeFrame: From Recruitment till 48 hours postoperative (end of study)
measure: Systolic Blood Pressure
timeFrame: From Recruitment till 48 hours postoperative (end of study)
measure: Glasgow coma scale score
timeFrame: From Recruitment till 48 hours postoperative (end of study)
measure: Arterial blood gas measurement
timeFrame: From Recruitment till 48 hours postoperative (end of study)
measure: Haemoglobin
timeFrame: From Recruitment till 48 hours postoperative (end of study)
Other outcomes:
Locations:
city: Bangalore City
country: India
facility: NIMHANS
state: Karnataka
Study officials:
References: