louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04361877: Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)
Official title: Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Prevention Behaviour
Keywords: COVID-19
cardiovascular prevention
physical exercise
risk factor
nutrition
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults over 18 years

Brief summary: The study aims to determine the impact of COVID-19 pandemic lockdown on cardiovascular prevention behaviour.

Detailed description: The COVID-19 pandemic resulted in a lockdown and social distancing in most countries all over the world. The impact of this national intervention on cardiovascular prevention behaviour (physical exercise, nutrition, smoking) is unknown. The COLA Trial aims to help clarifying these questions.

An online survey was distributed among bavarian students with standardized questions about physical activity, nutritional behavior, smoking and alcohol intake before and during lockdown.

Eligibility criteria: Inclusion Criteria:

healthy adults over 18 years

Exclusion Criteria:

any condition that does not allow physical activity

Primary outcomes:
measure: Change of physical activity
timeFrame: 14 days
Secondary outcomes:
measure: change of nutrition behaviour
timeFrame: 14 days
measure: semiquantitative change of alcohol intake
timeFrame: 14 days
measure: change of smoking behaviour
timeFrame: 14 days
measure: change of stress level
timeFrame: 14 days
measure: step count
timeFrame: 6 days
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University Hospital Munich (LMU Klinikum)
Study officials:
References:
citation: Steffen J, Schlichtiger J, Huber BC, Brunner S. Altered alcohol consumption during COVID-19 pandemic lockdown. Nutr J. 2021 May 11;20(1):44. doi: 10.1186/s12937-021-00699-0.
citation: Huber BC, Steffen J, Schlichtiger J, Brunner S. Altered nutrition behavior during COVID-19 pandemic lockdown in young adults. Eur J Nutr. 2021 Aug;60(5):2593-2602. doi: 10.1007/s00394-020-02435-6. Epub 2020 Dec 1.
Clinical trial NCT04586777: Effects of Transvertebral Direct Current Stimulation in Humans
Official title: Effects of Transvertebral Direct Current Stimulation in Humans
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Paraplegia and Tetraplegia
Keywords: neuroplasticity
transvertebral direct current stimulation
transspinal direct current stimulation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of non-invasive stimulation of the spinal cord in people with spinal cord injury.

Detailed description: This study will use a non-invasive form of spinal stimulation, called transvertebral direct current stimulation, or tvDCS. It currently is not clear what effects this type of stimulation has on the excitability of the brain and spinal cord in people with spinal cord injury. In this study, subjects will participate in 3 sessions, with at least 1 week in between sessions, during which they will get a different condition of tvDCS. We will test the excitability of the brain and spinal cord before and after tvDCS in each session.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years of age
* Motor incomplete spinal cord injury classified as B, C, or D by the American Spinal Injury Association Impairment Scale (AIS)
* More than 12 months post-injury
* Lesion at of above thoracic level T8
* Body mass index \<30 (in order to facilitate reliable location of body landmarks guiding stimulation)
* Severe gait deficit

Exclusion Criteria:

* Unstable cardiopulmonary conditions
* History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
* Cognitive deficits severe enough to preclude informed consent
* Positive pregnancy test of being of childbearing age and not using appropriate contraception
* Ferromagnetic material in the brain or in the spine (except for titanium for segmental fixation of the spine)
* Cardiac or neural pacemakers
* Fixed contractures in the lower extremities
* Uncontrolled diabetes
* Severe osteoporosis
* Severe spasticity
* Decubitus ulcers which interfere with harness support or walking
* Severe orthostatic hypotension

Primary outcomes:
measure: Change in corticospinal excitability
timeFrame: Immediately before tvDCS, Immediately after tvDCS
measure: Change in spinal cord excitability
timeFrame: Immediately before tvDCS, Immediately after tvDCS
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky at Cardinal Hill Rehabilitation Hospital
state: Kentucky
Study officials:
References:
Clinical trial NCT03988777: Magnetic Seed Localisation for Nonpalpable Breast Lesions
Official title: Magnetic Seed Localisation for Nonpalpable Breast Lesions: a Combined Retrospective and Prospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Breast Cancer
Keywords: Breast cancer
Nonpalpable breast lesions
Hooked-wire localisation
Magnetic seed localisation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2019-06-17
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes women (18+) with an impalpable breast lesion suitable for breast conserving surgery.

Brief summary: Screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. Multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades. Specifically, several alternatives to the golden standard hooked-wire technique have become available, of which magnetic seed localisation is one of the newest approaches. Since September 2018, Magseed® localisation is the standard of care for localising impalpable breast lesions in UZ Leuven. In this study, the oncological safety, the clinical safety and surgeon satisfaction of Magseed® localisation will be assessed and retrospectively compared to hooked-wire localisation.


Eligibility criteria: Inclusion Criteria:

* Breast conserving surgery with preoperative localisation
* Minimum 18 years old

Primary outcomes:
measure: Number of participant with device-related adverse events
timeFrame: Up to three weeks after surgical treatment
measure: Total breast volume resected during breast conserving surgery
timeFrame: Up to three weeks after surgical treatment
measure: Number of participants with positive surgical margins as assessed by pathological examination of the specimen
timeFrame: Up to three weeks after surgical treatment
measure: Re-operation rate due to positive surgical margins
timeFrame: Up to three weeks after surgical treatment
measure: Surgeon satisfaction based on a questionnaire
timeFrame: After surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
Clinical trial NCT06431477: Efficacy and Safety of Telmisartan Compared With Losartan
Official title: A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared With Losartan in Patients With Diabetic Nephropathy and Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetic Nephropathies
Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 98
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension

Detailed description: A Multi-center, Randomized, Open-label, Active comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared with Losartan in Patients with Diabetic Nephropathy and Hypertension

Eligibility criteria: Inclusion Criteria:

* Male of Female subjects aged ≥19 or \<75
* Type II Diabetes Mellitus subjects who have been taken medicine
* Subjects who have voluntarily decided to participate in this clinical trial and Signed ICF

Exclusion Criteria:

* Subjects with Type I Diabetes Mellitus
* Subjects with Primary hyper-aldosteronism
* Subjects with a history of drug or alcohol abuse or suspected patient within 1 year as of the time of screening
* Pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period
* Subjects who received other clinical trial drugs within 28 days of screening visit
* Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

Primary outcomes:
measure: Change rate from baseline in Spot-UACR(Albumin/Creatinine Ratio)
timeFrame: 24 weeks after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: BeomSeok Kim, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03910777: Usefulness of Early Warning Systems in Detecting Early Clinical Deterioration After Intensive Care Discharge
Official title: Usefulness of Early Warning Systems in Detecting Early Clinical Deterioration After Intensive Care Discharge
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Clinical Deterioration
Early Warning Score
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 390
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: 390 patients who were discharged from the intensive care unit over the age of 18 and who were taken back within 24 hours will be included.

Brief summary: The VitalPac Early Warning Score (VIEWS) scoring system, developed by Prytherch et al., Is an early warning system that aims to predict the first 24-hour mortality in emergency patients.

National early warning score (NEWS) is another early warning scoring system recommended by the Royal College of Physicians in London to detect early clinical deterioration in hospitalized patients.

The aim of this study was to determine the early clinical deterioration after ICU and hence the rate of admission to intensive care and to evaluate whether these two scoring systems can be used to determine early clinical deterioration in intensive care early discharge.


Eligibility criteria: Inclusion Criteria:

* over 18 years,
* discharged from the ICU and returned within 24 hours

Exclusion Criteria:

* under 18 years old, postoperative patients, pregnant women

Primary outcomes:
measure: Number of patients recovered due to early clinical deterioration within the first 24 hours after ICU discharge
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan University
Study officials:
References:
citation: Uppanisakorn S, Bhurayanontachai R, Boonyarat J, Kaewpradit J. National Early Warning Score (NEWS) at ICU discharge can predict early clinical deterioration after ICU transfer. J Crit Care. 2018 Feb;43:225-229. doi: 10.1016/j.jcrc.2017.09.008. Epub 2017 Sep 13.
citation: Cardoso FS, Karvellas CJ, Kneteman NM, Meeberg G, Fidalgo P, Bagshaw SM. Respiratory rate at intensive care unit discharge after liver transplant is an independent risk factor for intensive care unit readmission within the same hospital stay: a nested case-control study. J Crit Care. 2014 Oct;29(5):791-6. doi: 10.1016/j.jcrc.2014.03.038. Epub 2014 Apr 24.
Clinical trial NCT01546077: Placement of Perineural Catheters in the Popliteal Region
Official title: Comparison of Techniques for Placement of Perineural Catheters in the Popliteal Region
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Foot Surgery
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 40
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 purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of popliteal perineural catheters in comparison with the stimulating catheters. A non inferiority trial.


Eligibility criteria: Inclusion Criteria:

* adults
* BMI less than 30

Exclusion Criteria:

* known allergies to local anesthetics or other drugs used
* patient refusal
* any local or systemic contraindication to the use of popliteal block

Primary outcomes:
measure: consumption of local anesthetics
timeFrame: 36 hours PO
Secondary outcomes:
measure: pain scores
timeFrame: 36 hours postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Attikon Hospital
city: Rome
country: Italy
facility: Policlinico Tor Vergata
Study officials:
affiliation: Attikon Hospital
name: Tatiana F Sidiropoulou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Attikon Hospital
name: Theodosios Saranteas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Attikon Hospital
name: Georgia G Kostopanagiotou, MD, PhD
role: STUDY_CHAIR
References:
citation: Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. No abstract available.
Clinical trial NCT06270277: Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease
Official title: Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease: Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Psychosocial Impairment
Keywords: Inflammatory bowel diseases
Psychosocial condition
Crohn's disease
Ulcerative colitis
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 159
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescents with Inflammatory bowel diseases and healthy control group in same age will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ).
Primary purpose: DIAGNOSTIC

Brief summary: Inflammatory bowel disease (IBD) is a chronic condition that affects the psychosocial status and physical activities of children and their parents in many ways. Our study aimed to investigate the variability of disease-related quality of life and behavioral and emotional adjustment issues compared to a healthy control group among adolescents and their families diagnosed with IBD. Children with IBD and the healthy control group, as well as the parents of both groups, will administered the Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). The PedsQL is a scale used to assess physical and psychosocial functioning based on the individual's own experiences, commonly employed in clinical trials and quality improvement initiatives. The scale evaluates physical activity status and psychosocial functioning through questions related to emotional, social, and school-related issues.


Eligibility criteria: Inclusion Criteria:

* Aged between 8-17 years
* Diagnosed Inflammatory bowel disease
* Healthy adolescents aged between 8-17 years

Exclusion Criteria:

* Not obtaining informed consent
* Diagnosis of psychiatric disorder

Primary outcomes:
measure: Pediatric Quality of Life Inventory (PedsQL) score
timeFrame: 1 day after questionnaire
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 1 day after questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Research and Training Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital, Division of pediatric gastroenterology
name: Nafiye Urgancı, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00534677: The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed
Official title: Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Portal Hypertension
Cirrhosis
Hematemesis
Melena
Keywords: Variceal bleed
Cirrhosis
Vasoactive agents
Terlipressin
Octreotide
Safety & Efficacy
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 320
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: Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).

Detailed description: The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH).

This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.

Eligibility criteria: Inclusion Criteria:

* All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age

Exclusion Criteria:

* Ulcerative esophagitis,
* Mallory Weiss tear,
* Bleeding gastric or duodenal ulcers,
* Bleeding from gastric varices or portal hypertensive gastropathy and
* Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.

Primary outcomes:
measure: Safety & Efficacy
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Shahab Abid, FCPS, FACG
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Wasim Jafri, FRCP, FACG
role: STUDY_DIRECTOR
affiliation: Aga Khan University
name: Saeed S Hamid, FRCP, FACG
role: STUDY_DIRECTOR
affiliation: Aga Khan University
name: Salih Mohammad, FCPS; MACG
role: STUDY_DIRECTOR
References:
Clinical trial NCT06911177: Yeast Mannans and Stool Frequency
Official title: Efficacy of Yeast Mannan Supplementation on Increasing Stool Frequency in Generally Healthy Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Defecation Frequency
Keywords: yeast mannan
stool frequency
transit time
microbiota
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Findings from an open-label pilot study of 20 adults suggested that supplementation with 15 g/day of yeast mannans was highly tolerable and demonstrated specific modulation of the microbiota and increased stool frequency in a subset of subjects reporting ≤1 stool per day at baseline. The primary aim of this randomized, double-blind, controlled trial is to determine if yeast mannan supplementation at 12 g/day will increase stool frequency in generally healthy adults reporting ≤1 stool per day. Secondary aims will determine the effect of yeast mannans on intestinal transit time, gastrointestinal symptoms, fecal microbiota composition, and urinary and fecal metabolomics.


Eligibility criteria: Inclusion Criteria:

* Adults who report a stool frequency of ≤ 1 per day.
* Able to provide written informed consent in English.
* Willingness to consume 1 supplement (12 g of yeast mannans or control) daily for 28 days.
* Willingness to maintain their usual diet and physical activity patterns throughout the study and refrain from the consumption of any yeast-based foods (e.g. Marmite or Vegemite) or yeast extract supplements.
* Willing to comply with study procedures, including stool and urine colle

Exclusion Criteria:

* Stool frequency of \< 3 per week
* Yeast allergy
* Vegan dietary pattern
* Self-reported kidney disease
* Elite athletes or long-distance runners
* Use of antibiotic drugs within 1 month of screening
* Current use of laxatives or antidiarrheal medications
* Use of other investigational products within 3 months of the screening
* Previously or currently being treated for intestinal diseases or conditions, including irritable bowel disease (i.e., IBS-D or IBS-mixed), Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer.
* Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection).
* Current cancer treatment.
* Currently pregnant.

Primary outcomes:
measure: Defecation frequency
timeFrame: From enrollment to the end of treatment at 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Department of Food Science and Human Nutrition
state: Florida
Study officials:
References: