louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06942065: Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty
Official title: Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Muscle Atrophy
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 25
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 present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty

Detailed description: The present study evaluated the impact of blood flow restriction training in the context of three-week outpatient rehabilitation following TKA, in accordance with the guidelines of the German Pension Insurance System. The in-rehabilitation and post-rehabilitation muscle status, strength, knee functionality, impairments in daily life and subjective pain perception were measured.

Eligibility criteria: Inclusion Criteria:

* Physical Fitness for Rehabilitation
* Primary TKA surgery
* BMI \< 35

Exclusion Criteria:

* Sickle Cell Anemia
* Vascular Intervention on the lower extremities
* Open Wounds

Primary outcomes:
measure: Postoperative Pain
timeFrame: Pre- to 6 weeks Post Rehabilitation
measure: Muscle Strength
timeFrame: Pre- to 6 weeks Post Rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
state: NRW
Study officials:
References:
Clinical trial NCT00618865: Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy
Official title: Omega-3 Polyunsaturated Fatty Acids in Women With Major Depressive Disorders During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Keywords: Omega-3 Fatty Acids
Major Depressive Disorder
Pregnancy
Women during pregnancy and after childbirth are more vulnerable to psychiatric disorders
Pharmacotherapy for depression during pregnancy is a clinical dilemma.
Omega-3 polyunsaturated fatty acids (PUFAs) might be a promising alternative of treatment for pregnant women with depression.
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
First posted: 2008-02-20
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients with major depressive disorder during pregnancy and breast-feeding.


Eligibility criteria: Inclusion Criteria:

* Eligible participants were pregnant women, aged 18 to 40 years, with major depressive disorder onset between their 16th week (second trimester) and 32nd week (third trimester) of gestation at the Department of Obstetrics.

Exclusion Criteria:

* Subjects were excluded with a DSM-IV diagnosis of bipolar disorders, psychotic disorders, substance abuse or dependence for at least 3 months, or any Axis-II diagnosis of borderline or antisocial personality disorder.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Su KP, Huang SY, Chiu TH, Huang KC, Huang CL, Chang HC, Pariante CM. Omega-3 fatty acids for major depressive disorder during pregnancy: results from a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2008 Apr;69(4):644-51. doi: 10.4088/jcp.v69n0418.
Clinical trial NCT05105165: Regulatory Mechanism of Orphanin FQ in Patients With Chronic Ischemic Heart Failure
Official title: Correlation Between Serum Orphanin FQ and β1-AR Autoantibodies in Patients With Chronic Ischemic Heart Failure and Its Regulatory Mechanism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During the study period, patients in the Department of Cardiology of the second hospital of Shanxi Medical University were admitted.

Brief summary: β 1 adrenergic autoantibody on cardiomyocytes β 1 adrenergic receptor increased the occurrence of malignant arrhythmia in patients with chronic heart failure, accelerated myocardial cell damage, and participated in sudden cardiac death. Our team found for the first time that endogenous orphanin enkephalin promotes arrhythmia after acute myocardial ischemia in rats, and its mechanism includes PKC pathway, regulation of action potential duration and cell membrane surface β 1 adrenoceptor internalization disorder. At the same time, N / OFQ can regulate the level of immune factors, and immune factors participate in the formation of β1-aa. This study will be verified by clinical observation and animal experiments: first, N / OFQ, IL-6 and chronic ischemic heart failure, and β 1-aa; second, relationship between IL-6 gene 572G / C polymorphism and chronic ischemic heart failure correlation of β 1-aa production; last, objective to verify whether N / OFQ is involved in the regulation of IL-6 on chronic ischemic heart failure by knocking out N/ OFQ gene in the animal model of chronic ischemic heart failure. So as to clarify the mechanism of myocardial cell and extracellular injury, and find a new target for the treatment of chronic heart failure.


Eligibility criteria: Inclusion Criteria:

* Chronic heart failure patients with reduced ejection fraction due to ischemic heart disease.

Exclusion Criteria:

* Restrictive or hypertrophic cardiomyopathy, hypertensive cardiomyopathy, acute myocarditis, acute coronary syndrome or acute myocardial infarction in the last 2 months, valvular disease (except mitral regurgitation secondary to left ventricular dilation).

Primary outcomes:
measure: Serum orphanin FQ was determined by enzyme linked immunosorbent assay
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00965965: Comprehensibility of Colorectal Cancer Screening Educational Materials: Effects on Patient Knowledge and Motivation
Official title: Effects of Comprehensibility of Colorectal Cancer Screening Educational Materials on Patient Knowledge and Motivation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: health behavior
randomized controlled trials
self-efficacy
patient education
comprehension
mass screening
prevention and control
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: California Academy of Family Physicians
First posted: 2009-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether a newly developed patient education document concerning colorectal cancer screening will be better understood and have greater effects on patient knowledge of and motivation for screening than a standard educational document.


Eligibility criteria: Inclusion Criteria:

* Receive primary care at one of the participating outpatient offices
* Age 50-75
* Able to read and speak English
* Adequate vision, hearing, and hand function to read printed documents, communicate with research staff, answer questionnaires, and otherwise participate
* Not up to date for colorectal cancer screening (defined as fecal occult blood test within 1 year, flexible sigmoidoscopy within 5 years, or colonoscopy within 10 years)

Primary outcomes:
measure: Comprehension of randomly assigned educational document
timeFrame: Immediately after receiving randomly assigned study intervention (that same day)
Secondary outcomes:
measure: Colorectal cancer screening knowledge
timeFrame: Immediately after receiving randomly assigned study intervention (that same day)
measure: Self-efficacy for undergoing colorectal cancer screening
timeFrame: Immediately after receiving randomly assigned study intervention (that same day)
measure: Perceived barriers to undergoing colorectal cancer screening
timeFrame: Immediately after receiving randomly assigned study intervention (that same day)
measure: Readiness to undergo colorectal cancer screening
timeFrame: Immediately after receiving randomly assigned study intervention (that same day)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Tonantzin Rodriguez, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06539065: The Effects of VR Interactive Games on Balance and Quality of Life Enhancement for Elderly in the Community
Official title: The Effects of VR Interactive Games on Balance and Quality of Life Enhancement for Elderly in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: VR
Balance
Quality of life
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to learn about the effectiveness of the incorporating VR interactive games into exercise courses of the elderly in the community.The main questions It aims to answer are: can It improve their balance ability and the quality of life.

Participants will receive a Twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription, While the control group will follow the original iInstructor-led exercise intervention as the course content.

Detailed description: Both groups will undergo three sessions per week, one hour per session, for a total of 12 weeks and 36 sessions of intervention. Before and after competing all sessions, the effectiveness of this intervention will be assessed.

Some physical assessments will be done by all participants such as 2-minute step, right chair sit and reach, left chair sit and reach to compare if any difference between two groups. and participants will do a questionaire to evaluate the psychological and environmental quality of life.

Eligibility criteria: Inclusion Criteria:

1. Aged 65 or above
2. Capable of communicating in Mandarin or Taiwanese, and willing to participate in interviews or complete questionnaires
3. Free of mobility impairments

Exclusion Criteria:

1. Stroke with sequelae of mobility impairments
2. Parkinson's disease
3. Motor neurone disease
4. Severe Cardio-vascular disease
5. Degenerative joint disease with flare-ups in past three months
6. With a lower limb joint surgery in past 3 months
7. Vertigo

Primary outcomes:
measure: Balance ability
timeFrame: Physical assessment done 2 weeks before and 2 weeks after 12 weeks courses
measure: Life quality
timeFrame: Questionnaire done 2 weeks before and 2 weeks after 12 weeks courses
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei medical University
Study officials:
affiliation: Taipei Medical University
name: Chueh-Ho Lin, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01886365: Computerized Tight Glycemic Control in Cardiac Surgery
Official title: Perioperative Glycemic Control With a Computerized Algorithm vs. Conventional Glycemic Control in Cardio-surgical Patients Undergoing Cardiopulmonary Bypass With Blood Cardioplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: Computer based glycemic control, insulin, blood glucose
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: B. Braun Melsungen AG
First posted: 2013-06-25
Enrollment: 75
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 debate about tight glycemic control (TGC) in the operating room and on the intensive care unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due to high blood glucose levels during operations and subsequent high rates of sternal wound infections. We showed in a feasibility study that early computer based insulin therapy starting in the operating room is a safe therapy that allows to better warrant normoglycemia in patients undergoing major cardiac surgery with the use of blood cardioplegia.

Detailed description: Patients are enrolled and randomized into 3 groups. Start of therapy is determined as the beginning of cardiopulmonary bypass. Group A: Therapy with computer-based algorithm and measurement of blood glucose every 30 min. Group B: Measurement of blood glucose every 15 min using the identical computer-based algorithm. Group C: Conventional therapy using a fixed insulin dosing scheme. End of therapy is defined as discharge from ICU.

Eligibility criteria: Inclusion Criteria:

* patients over 18 scheduled for elective cardiac surgery with the use of cardiopulmonary bypass and blood cardioplegia

Exclusion Criteria:

* under 18 years of age, or if patients had a premedical history of steroid therapy

Primary outcomes:
measure: Time within a blood glucose corridor of 80 - 150 mg/dl
timeFrame: From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.
Secondary outcomes:
measure: Hypoglycemic events
timeFrame: From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs.
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Germany
name: Daniel A Reuter, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Punke MA, Goepfert MS, Kluge S, Reichenspurner H, Goetz AE, Reuter DA. Perioperative glycemic control with a computerized algorithm versus conventional glycemic control in cardiac surgical patients undergoing cardiopulmonary bypass with blood cardioplegia. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1273-7. doi: 10.1053/j.jvca.2014.04.017.
Clinical trial NCT04696874: Spectrum of Epididymis and Vas Deferens Anomalies Among Children With Cryptorchidism
Official title: Spectrum of Epididymis and Vas Deferens Anomalies Among Children With Cryptorchidism: A Retrospective Multi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epididymal Cyst
Vas Deferens; Anomaly
Keywords: epididymal cyst
duplicated vas deferens.
curled vas deferens
vanished testis
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 22
Sex: MALE
Minimum age (years): 8
Maximum age (years): 125
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We retrospectively collected data from patients with anomalies of the epididymis or vas deferens. These anomalies were discovered incidentally during operative intervention for cryptorchidism

Brief summary: : Data was collected retrospectively from six centers providing care for patients with undescended testicles from September 2017 to February 2019. All patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.

Detailed description: Background: Epididymal and vas deferens anomalies are not rare among children with cryptorchidism. They may affect fertility following orchiopexy.

Material and Methods: Data was collected retrospectively from six centers providing care for patients with undescended testicles from September 2017 to February 2019. All patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.

Eligibility criteria: Inclusion Criteria:

- All included cases had photographic documentation.

Exclusion Criteria:

* cases without photographic documentation.

Primary outcomes:
measure: collection of cases
timeFrame: one and half year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sarah Magdy Abdelmohsen
state: P.O.Pox. 11331
Study officials:
affiliation: Aswan University
name: Sarah M Abdelmohsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01046474: Reducing Beverages and Sugar and Increasing Physical Activity in Public School Adolescents From Brazil
Official title: Preventing Excessive Weight Gain by Reducing Carbonated Beverage and Sugar Consumption and Increasing Physical Activity Among Public School Adolescents From the Metropolitan Area of Rio de Janeiro
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sugar Intake
Beverage Intake
Fruit Intake
Beans Intake
Physical Activity
Keywords: school children
body mass index
sugar intake
beverage intake
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio de Janeiro
First posted: 2010-01-12
Enrollment: 600
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.

Detailed description: Specific objectives are:

1. To compare total, lean, and fatty body mass variation in adolescents aged 11 to 14, from 7th and 8th grades from schools under intervention and from the ones not subjected to the intervention program.
2. To compare sweetened beverages consumption and sugar intake before and after the intervention in both groups of schools.
3. To evaluate the impact of the intervention on the selling of sweetened beverages in the cafeterias.
4. To compare change in family expenditures with sweetened beverages and sugar.

Eligibility criteria: Inclusion Criteria:

* 5th grades

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Body mass index
timeFrame: one year
Secondary outcomes:
measure: Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean
timeFrame: one year
Other outcomes:
Locations:
city: Duque de Caxias
country: Brazil
facility: 20 Schools of Metropolitan Area
state: Rio de Janeiro
Study officials:
References:
citation: Cunha DB, de Souza Bda S, Pereira RA, Sichieri R. Effectiveness of a randomized school-based intervention involving families and teachers to prevent excessive weight gain among adolescents in Brazil. PLoS One. 2013;8(2):e57498. doi: 10.1371/journal.pone.0057498. Epub 2013 Feb 25.
Clinical trial NCT05657574: A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 228
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of CKD-391 and CKD-331 in patients with primary hypercholesterolemia

Detailed description: Participants were randomly assigned in a 1:1:1:1 ratio to the following groups: combination therapy of D377 and CKD-331, D377, CKD-331, and D086. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 19 years of age
* Primary hypercholesterolemia
* Patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator

Exclusion Criteria:

* Secondary hypercholesterolemia
* Conditions / situations such as:

  1. Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels
  2. Severe renal impairment or active liver disease
* History of hypersensitivity or allergies to investigational drugs or drug of similar chemical classes.
* History of drug abuse or alcoholism within 24 weeks before screening
* Any surgical or medical condition which might significantly affect the absorption, distribution, metabolism, or excretion of investigational drugs
* Patients who have been taken with other investigational drugs within 8 weeks before screening

Primary outcomes:
measure: Percent Change
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: SeungHwan Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05788874: Study of 18F-FAPI Applied to Gastrointestinal Cancer
Official title: Comparative Study of 18F-FAPI and 18F-FDG PET/CT for Gastrointestinal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Cancer
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis
* Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG

Brief summary: Comparison of tumor volume, number, and SUVmax of different primary foci (gastric, duodenal, and colon cancer), lymph node metastases (neck and supraclavicular, mediastinal, abdominal, and pelvic), and distant metastases (brain, lung, liver, bone, pleura, and peritoneum) detected by 18F-FAPI versus 18F-FDG PET/CT imaging.


Eligibility criteria: Inclusion Criteria:

* Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis
* Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG

Exclusion Criteria:

* The diagnosis can be clarified by 18F-FDG PET/CT examination
* The presence of recurrence or metastasis can be clarified by 18F-FDG PET/CT examination

Primary outcomes:
measure: SUVmax
timeFrame: 1 day (During the inspection)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: