louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03642405: Drug-induced Repolarization ECG Changes
Official title: Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long QT Syndrome
ADHD
Depression
Death
Death, Sudden, Cardiac
Romano-Ward Syndrome
Pathologic Processes
Heart Arrest
Electrocardiogram: Electrical Alternans
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Arrhythmias, Cardiac
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Genetic Disease
Genetic Syndrome
Qt Interval, Variation in
Psychiatric Disorder
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 150
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: 50 Patients treated with Methylphenidate 50 Patients treated with Methylphenidate and QT-prolonging SSRI 50 Patients treated with Methylphenidate and a non QT-prolonging SSRI

Brief summary: Studies have shown that the risk of developing heart arrhythmias, is increased in patients receiving medication for Attention-deficit hyperactivity disorder (ADHD) and depression. The QT-interval on a electrocardiogram (ECG) is often used to assess the patients risk of developing heart arrhythmias. The QT-interval defines the hearts electrical resting period and a long interval is linked to an increased risk of developing heart arrhythmias. In this project the investigators wish to examine possible side-effects in patients receiving medication for ADHD and depression and their dynamic QT-interval changes, by analysing the ECG changes that occur during "Brisk Standing".


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Patients treated with Methylphenidate
* Patients treated with Methylphenidate and QT-prolonging SSRI
* Patients treated with Methylphenidate and a non QT-prolonging SSRI

Exclusion Criteria:

* Patients considered in an unstable phase in their psychiatric condition
* Patients that are not able to understand the information regarding the trial, or who are unable to cooperate.

Primary outcomes:
measure: ECG changes
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
References:
Clinical trial NCT01711905: Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers
Official title: Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency of Vitamin D3
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2012-10-22
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status

Detailed description: It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* age between 18 and 70 years
* informed consent

Exclusion Criteria:

* use of antihypertensive medication
* use of vitamin d or calcium supplements
* known renal, inflammatory or malignant diseases
* hypercalcemia or hypercalciuria
* participation in other clinical studies
* use of tanning booths during the study
* pregnancy or lactating period

Primary outcomes:
measure: 25-hydroxyvitamin D3
timeFrame: after 12 weeks of supplementation
Secondary outcomes:
measure: atherosclerotic risk factors
timeFrame: after 12 weeks of supplementation
measure: inflammation
timeFrame: after 12 weeks of supplementation
measure: hyperlipidemia
timeFrame: after 12 weeks of supplementation
Other outcomes:
Locations:
city: Halle/Saale
country: Germany
facility: Naturwissenschaftliche Fakultät III
state: Sachsen-Anhalt
Study officials:
affiliation: Institut für Agrar- und Ernährungswissenschaften
name: Gabriele I Stangl, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Lehmann U, Riedel A, Hirche F, Brandsch C, Girndt M, Ulrich C, Seibert E, Henning C, Glomb MA, Dierkes J, Stangl GI. Vitamin D3 supplementation: Response and predictors of vitamin D3 metabolites - A randomized controlled trial. Clin Nutr. 2016 Apr;35(2):351-358. doi: 10.1016/j.clnu.2015.04.021. Epub 2015 May 19.
Clinical trial NCT06952205: Efficiency of Function-oriented Taping Application in Low Back Pain Patients
Official title: Efficiency of Function-oriented Taping Application in Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Kinesiophobia
Keywords: Rigid taping
Functional taping
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of this study is to determine the efficiency of functional tape application to patients with acute or subacute low back pain. 40 patients with acute-subacute low back pain were divided into two groups: control and experimental group. To control group, McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied. To experimental group, functional taping were applied in addition of these treatments. Range of Motion (ROM), Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia (TSK) and The Oswestry Disability Index (ODI) were evaluated preand post-treatment and datas were analyzed with statistical methods. In analysis; p value was accepted p\<0,05 for t test and Mann Whitney U test process. In the measurements that compared the improvement of both groups, based on pre- and post-treatment evaluations; improvement in the experimental group was significantly higher in all of these parameters of ROM, VAS, TSK and ODI than in the control group (p\<0,05). The use of functional rigid taping in patients with acute and subacute low back pain provided a statistically significant improvement in all measured values of patients and provide better results than the control group. However, there is a need for comparative new studies in order to measure the effectiveness of rigid taping in a more accurate way.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 20 and 65
* Being literate in Turkish
* Having lower back pain for less than 3 months
* Informed Consent Form for taping application to have been signed

Exclusion Criteria:

* Allergic reaction on the skin
* Hypertension, Type 2 diabetes mellitus (DM) and Presence of accompanying systemic disease other than hypercholesterolemia
* Not being able to communicate
* Using corsets and similar supports
* Having a body mass index \> 30
* Use of antidepressant and myorelexan medication

Primary outcomes:
measure: Range of Motion
timeFrame: through study completion, an average of 2 weeks.
measure: Pain intensity
timeFrame: through study completion, an average of 2 weeks.
measure: Degree of kinesiophobia
timeFrame: through study completion, an average of 2 weeks
measure: Disability Index
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar Üniversity Physiotherapy and Rehabilitation Department
state: Ümraniye
Study officials:
References:
Clinical trial NCT01740505: HealthySteps: Exercise for Older Adults With Mobility Limitation
Official title: HealthySteps: A Pilot Randomized Controlled Trial of Exercise to Improve Walking Energetics, Fatigue, and Activity in Older Adults With Mobility Limitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Keywords: energy cost of walking
energy metabolism
aged
older adult
exercise
gait
walking
aerobic
motor skill
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: Drummond Foundation
First posted: 2012-12-04
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare three different exercise programs in older adults who report difficulty walking and will determine if the programs improve walking.


Eligibility criteria: Inclusion Criteria:

* Men and women who live in the lower mainland (greater Vancouver) area of British Columbia
* Aged 65 years or older
* Living independently in their own home
* Report mobility limitation, defined as any difficulty walking one-quarter mile (about 2-3 blocks) outside on level ground or climbing one flight of stairs (about 10 steps) without resting because of a health or physical problem

Exclusion Criteria:

* Have a current medical condition for which exercise is contraindicated
* Have participated in an exercise intervention study in the past 6 months
* Do not have adequate cognitive function to provide informed consent and participate fully in the study
* Do not speak and understand English fluently

Primary outcomes:
measure: energy cost of walking
timeFrame: 12 weeks
measure: fatigue and fatigability
timeFrame: 12 weeks
measure: daily activity
timeFrame: 12 weeks
measure: life-space mobility
timeFrame: 12 weeks
measure: endurance
timeFrame: 12 weeks
measure: physical function
timeFrame: 12 weeks
Secondary outcomes:
measure: energy cost of walking
timeFrame: 24 weeks
measure: fatigue and fatigability
timeFrame: 24 weeks
measure: daily activity
timeFrame: 24 weeks
measure: life-space mobility
timeFrame: 24 weeks
measure: endurance
timeFrame: 24 weeks
measure: physical function
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute
state: British Columbia
Study officials:
affiliation: Simon Fraser University; Vancouver Coastal Health Research Institute, Centre for Hip Health and Mobility
name: Dawn C Mackey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02888405: Effects of Acute Dietary Changes on Estimates of Body Composition
Official title: Effects of Acute Dietary Changes on Estimates of Body Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Body Composition
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The present study sought to investigate the effects of acute dietary changes on estimates of body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of carbohydrate) were examined.


Eligibility criteria: Inclusion Criteria:

* Generally healthy
* Recreationally active (\>150 min/week of moderate or vigorous physical activity)
* Pre-menopausal with regularly occurring menstrual cycles over past 6 months (in females only)

Exclusion Criteria:

* Failure to meet inclusion criteria
* Commencement or cessation of taking the dietary supplement creatine within the past month
* Pregnant or may become pregnant during the study
* Known or suspected food allergy to any items used in study
* Presence of medical condition that could reasonably be negatively affected by participation

Primary outcomes:
measure: Dual-energy X-ray Absorptiometry Output
timeFrame: 2 days
measure: Bioelectrical Impedance Analysis Output
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06906705: High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics
Official title: High Frequency Ultrasound Imaging for Intraoperative Lymph Nodal Assessment in Gynecological Cancer: From Image-guided Surgery to Radiomics Applications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecologic Cancer
Keywords: ovarian cancer
endometrial cancer
cervical cancer
vulvar cancer
HFUS
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Canon Medical Systems Europe B.V
First posted: 2025-04-02
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to the Gynecology Oncology Unit in Fondazione Policlinico A. Gemelli

IRCCS, Italy, Rome with a diagnosis of gynecological malignancy requiring surgical lymph nodes harvest will be evaluated for the enrolment.

Brief summary: Lymph node assessment is crucial in gynecological cancers (ovarian, endometrial, cervical, and vulvar), as nodal involvement significantly impacts prognosis and treatment. Despite high morbidity, systematic lymphadenectomy has been widely used for staging and treatment planning. However, in most cases, lymph nodes are free from metastasis, making the procedure unnecessary and exposing patients to severe complications such as lymphedema and infections.

Sentinel lymph node (SLN) evaluation has emerged as a less invasive alternative, reducing unnecessary lymphadenectomies. However, SLN techniques face challenges, including detection failures, inaccurate frozen section analysis, and imaging limitations like false negatives in FDG PET/CT scans. The need for improved intraoperative imaging techniques is emphasized to enhance lymph node assessment, minimize surgical risks, and better tailor treatment approaches.


Eligibility criteria: Inclusion Criteria:

* Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer)
* Need for nodal excision (staging or cytoreductive reasons)
* 18-99 years old
* Absence of contemporary lymphatic diseases
* Absence of previous oncological disease in the last 5 years
* Willingness to participate in the study and to provide informed consent

Exclusion Criteria:

* Previous radiotherapy treatments
* Previous chemotherapy treatments

Primary outcomes:
measure: Evaluation of HFUS Accuracy in Detecting Lymph Node Metastases in Gynecological Cancer
timeFrame: Days 20
Secondary outcomes:
measure: Minimum Size Detection Limit of HFUS Imaging
timeFrame: 2 minutes
measure: Development of a Radiomic Algorithm for Lymph Node Assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli
name: Antonia Carla Testa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666405: Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
Official title: A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Fecal Incontinence
Keywords: Fecal Incontinence
Bowel Incontinence
Lead sponsor: Uroplasty, Inc
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).

Detailed description: Pilot Study

Eligibility criteria: Inclusion Criteria:

* Patient history of chronic FI of more than staining for at least 6 months; staining defined as less than the size of a 25¢ piece (quarter)
* Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback, medical management, etc.)

Exclusion Criteria:

* Pregnancy or intention to become pregnant during the course of the study
* Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain stimulator, etc.)
* Clinically significant neurological diseases or nerve damage impacting tibial nerve or pelvic floor function
* Prone to excessive bleeding or bleeding diathesis

Primary outcomes:
measure: Effectiveness
timeFrame: 18 weeks
measure: Safety
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Center for Colorectal Surgery
state: California
city: Minneapolis
country: United States
facility: Minnesota Colon and Rectal Surgery Associates, Ltd.
state: Minnesota
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Houston
country: United States
facility: Colorectal Surgical Asociates
state: Texas
city: Spokane
country: United States
facility: Providence Health and Services
state: Washington
Study officials:
References:
Clinical trial NCT02749305: Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs
Official title: Comparative Effectiveness of Metabolic and Bariatric Surgical Procedures Using Patient Reported Outcome Measures (PROMs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Metabolic Surgery
Weight Reduction
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 11146
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients. The data will be used in conjunction with clinical outcomes to determine quality, safety, and comparative effectiveness of various metabolic and bariatric procedures.


Eligibility criteria: Inclusion Criteria All preoperative metabolic and bariatric surgery patients with a scheduled metabolic and bariatric surgery at a participating center are eligible for inclusion.

Postoperative metabolic and bariatric surgery patients must have had their surgery within the preceding year at a participating center.

Exclusion Criteria Metabolic and bariatric surgery patients without an already scheduled surgery date at a participating center.

Postoperative metabolic and bariatric surgery patients who are more than 1 year postop from a participating center.

Primary outcomes:
measure: Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10
timeFrame: preoperatively and annually postoperatively
measure: Patient-reported Obesity-related Problems
timeFrame: preoperatively and annually postoperatively
measure: Patient-reported Obesity and Weight-loss Quality of Life
timeFrame: preoperatively and annually postoperatively
measure: Patient-reported comorbidities
timeFrame: annually postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Greene ME, Grieco A, Evans-Labok K, Ko CY, Hutter MM. First report of outcomes from the patient-reported outcome measures program in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program. Surg Obes Relat Dis. 2024 Feb;20(2):173-183. doi: 10.1016/j.soard.2023.09.010. Epub 2023 Sep 15.
citation: Greene ME, Goldman RE, Hutter MM. Selection of patient-reported outcomes measures for implementation in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program. Surg Obes Relat Dis. 2023 Aug;19(8):897-906. doi: 10.1016/j.soard.2023.01.031. Epub 2023 Feb 9.
citation: Grieco A, Greene ME, Ko CY, Cohen ME, Evans-Labok K, Fraker T, Hutter MM. Evaluating agreement between clinic- and patient-reported outcomes for weight and co-morbidities at 1 year after bariatric surgery. Surg Obes Relat Dis. 2023 Apr;19(4):309-317. doi: 10.1016/j.soard.2022.10.001. Epub 2022 Oct 11.