cyrilzakka/clinical-trials huggingface dataset:
Rhythmic-Based Training with Immersive Mirror Visual Feedback for Neuro-Rehabilitation

In the proposed study, the investigators assumed that rhythmic-based training with immersive mirror visual feedback will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either rhythmic-based training with immersive mirror visual feedback, or mirror therapy on the upper extremity function and brain activity of the stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke with unilateral side involved;
* A score of Mini-mental state examination greater than 24 for proving higher mental function
* Time of onset \> 6 months before treatment begins; and
* Premorbid right-handedness.

Exclusion Criteria:

* Severe vision and hearing impairment;
* Major cognitive-perceptual deficit;
* Other brain disease.
Evaluating a Latrine Use Intervention in Odisha, India

The objective of this research is to evaluate an intervention focused on increasing latrine use in rural Odisha India. The present study builds off of previous research, which resulted in the design of an intervention to increase latrine use. This research evaluates the intervention designed to determine if significant increases in latrine use are observed among those who received the intervention compared to those that did not. Qualitative research will supplement trial data collection to help explain findings and understand perceptions of the intervention.

The objective of this research is to evaluate an intervention focused on increasing latrine use in rural Odisha India. The present study builds off of previous research, which resulted in the design of an intervention to increase latrine use. This research evaluates the intervention designed to determine if significant increases in latrine use are observed among those who received the intervention compared to those that did not. Qualitative research will supplement trial data collection to help explain findings and understand perceptions of the intervention.

For trial data collection, household members will be engaged in a survey that asks questions about the household, the latrine use practices of their family members, and may include additional questions about social norms attitudes, and other factors influencing latrine use.

Investigators will carry out two discrete qualitative research activities both digitally recorded: in depth interviews (IDIs) and focus group discussions (FGDs). Topics to be covered during the qualitative research include: perceptions of the intervention, reasons for using/not using latrines, motivations for sanitation behaviors.

The primary objective of the study is to evaluate a multi-level, theoretically informed intervention designed to increase latrine use for defecation among all members of households that currently own a latrine.

Eligibility Criteria:
Villages located in rural Puri district, Odisha India

Inclusion Criteria:

* Estimated 60% latrine coverage or higher
* At least 75 households
* Have a village leader willing to participate

Exclusion Criteria:

* Considered open-defecation free (ODF)
* Participants under the age of 18 will not be targeted for research-related activities, like interviews and discussions, though we will ask caregivers or other household members to provide in information about the sanitation-related behaviors of children under age 18.
Effect of MiniGo As Add-on to Oral Laxatives for Children with Constipation and Fecal Incontinence

The goal of this clinical trial is to compare combination therapy with low volume trans anal irrigation (TAI) and oral laxatives to monotherapy with oral laxatives in children with functional constipation and fecal incontinence.

The main questions it aims to answer are:

* Can more efficient treatment be achieved with aforementioned combination therapy?
* Does the well-being of the children change, when they are well treated for their symptoms?
* Is low-volume trans anal irrigation a tolerable treatment method for children?

Participants will be randomized into 2 groups, where one group is treated with current standard treatment of PEG (oral laxatives), and the other group is treated with PEG + daily low volume TAI.

Functional constipation and retentive fecal incontinence is a prevalent health issue in children. The current standard treatment regimen in Denmark consists mainly of behavioral interventions and oral laxative treatment. This treatment leaves a large group of non-responders. Suffering from constipation and fecal incontinence has a negative impact on well-being in children, wherefore treatment of this condition should be improved.

Earlier literature shows that trans anal irrigation (TAI) is an effective means of managing these symptoms, both in children and adults. However, conventional high volume TAI is time consuming (up to 45 minutes-an hour daily) and a cause of discomfort, or even pain. This can lead to low compliance and treatment failure.

Low volume TAI has the potential of bringing about all the positive effects of TAI, but with less time consumption (only few minutes daily) and less discomfort.

In this clinical trial, we will compare how children with functional constipation and fecal incontinence respond to treatment with 1) oral laxatives (PEG) alone versus 2) PEG and low volume TAI with the MiniGo-irrigation system.

The intervention period is 6 weeks, and the treatment takes place at home.

Eligibility Criteria:
Inclusion Criteria:

* age 4-14 years
* medical history with fecal incontinence \>1/week on a non-neurogenic but retentive basis (fulfills ROME-IV-criteria)
* non-responsive after min. 2 months treatment with polyethylene glycols and behavioral interventions (set times for toilet use)

Exclusion Criteria:

* Hirschsprungs disease
* anorectal malformations
* use of medications known to cause constipation (eg. anticholinergics)
* former use of low or high volume TAI or enemas

Contraindications for use of MiniGo-irrigation device:

* known stenosis of the rectum or intestinal tract
* colorectal cancer prior to surgical removal
* acute inflammatory bowel disease
* acute diverticulitis
* within 3 months of surgical procedures in the rectum or intestinal tract
* within 4 weeks of endoscopic polypectomy
* ischemic colitis
Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization

The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing ovarian tumors can select patients who can benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. The results obtained are very promising. This study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.

The management of pelvic gynecological cancers (PGC) is based on the determination of the extension in order to guide the treatments. The biology of PGC is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing of ovarian tumors allows selection of patients who may benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify factors that predict recurrence of these cancers. The results have obtained are very promising, but if coordinator team have at our disposal fundamental and translational data related to the prognosis of PGCs, the coordinator team lack access to a biological collection of these cancers that would allow us to test our hypotheses and to develop personalized medicine related to the clinico-biological characteristics of the patients.

Endometriosis is the 1st cause of chronic pelvic pain (25-40% of women suffering during sexual intercourse) and represents the 1st cause of school and work absenteeism. Unfortunately, it is under-diagnosed and too often inappropriately managed. It is considered that 10 to 15% of the female population of reproductive age has endometriosis. This incidence reaches 50% in women with infertility. There are many similarities between deep endometriosis and pelvic cancers, whether on a physiopathological, epidemiological or clinical level. There are therefore many similarities in the surgical management as well as in the research strategies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pelvic gynecological cancer posed on initial histological analysis or during recurrence;
* Or diagnosis of endometriosis on histology or imaging
* Age ≥ 18 years;
* Affiliation to the general social security scheme;
* Consent signed.

Exclusion Criteria:

* Refusal of the patient;
* Non-affiliation to the general social security scheme.
EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus

Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.


Eligibility Criteria:
Clinical inclusion criteria:

* Age ≥18 years
* DM type I or II based on the definitions of the American Diabetes Association
* Angiographically proven CAD
* Angina pectoris, equivalent symptoms, and/or positive stress test, and/or instantaneous flow reserve ≤0.86, and/or fractional flow reserve ≤0.80
* Negative pregnancy test in women with childbearing potential

Angiographic inclusion criteria:

* De-novo lesion in at least one native coronary artery
* Luminal diameter reduction 50-99% assessed by visual estimation
* Target reference vessel diameter 2.5 - 4.0 mm

Clinical exclusion criteria:

* Limited long-term prognosis with a life-expectancy \<12 months
* Contraindications to antiplatelet therapy
* Known allergy against cobalt chrome, everolimus, or polylactic acid

Angiographic exclusion criteria:

* Target lesion located in the left main trunk
* Severe calcification of the target lesion as determined by angiography
* In-stent restenosis
* Bifurcation lesion with planned two-stent strategy
* Chronic total occlusion
* Indication for CABG
Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery

To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery

To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery.Prospective research.One eligible eye from patients having cataract surgery performed using the 3-D head-up technique were included in the study as an experimental group,in the meanwhile eyes performed cataract surgery by traditional microsurgery included as a control group.All eyes in the study are operated by the same doctor. Corneal incision form,corneal endothelial cell density and best corrected visual acuity are included to evaluate the results of cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnose age-related cataract;
2. Plan to perform phacoemulsification of cataract with intraocular lens implantation;
3. Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;
4. Able to understand and independently fill in the informed consent form and postoperative follow-up plan.

Exclusion Criteria:

1. Cataract caused by other reasons;
2. Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;
3. Corneal diseases, corneal endothelial cells \<1800/mm2;
4. Small palpebral fissure;
5. Those with a history of glaucoma, uveitis, eye trauma or eye surgery;
6. Those who cannot cooperate with the inspection and have not completed the one-month follow-up
Prevention of Acute Kidney Injury in Cardiac Surgery Patients

Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients following cardiac surgery, and at least 50% of patients with underlying renal insufficiency. Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk of developing post-operative AKI. The purpose of the current study is to determine if intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is effective at preventing post-operative AKI in patients with baseline kidney insufficiency and who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis is that an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic saline in reducing the incidence of post-operative AKI in cardiac surgery patients with a preoperative glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.

This is a randomized, placebo-controlled, prospective, double-blinded. The study will take place at Community Medical Center in Scranton, Pennsylvania. The inclusion criteria are patients undergoing elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass and having a baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation. Patients will be excluded from the study if they have cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump), end-stage kidney disease requiring dialysis, received an infusion of sodium bicarbonate on the same day as cardiac surgery, or if they are enrolled in a separate clinical research trial. This trial will involve two treatment groups. Group one will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution using the same infusion regimen as described above for isotonic saline. The primary efficacy outcome of the study will be the incidence of AKI postoperatively. Acute kidney injury will be defined as an increase in serum creatinine concentration by at least 25% from baseline or an absolute increase of 0.5 mg/dL at any time within the first five postoperative days.

Eligibility Criteria:
Inclusion Criteria:

* elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass
* baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation

Exclusion Criteria:

* cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump)
* end-stage kidney disease requiring dialysis
* received an infusion of sodium bicarbonate on the same day as cardiac surgery
sST2 and Cardiac Surgery

Evaluation of the prognosis value of sST2 dosed before cardiac surgery on prognosis of long terme prognosis after cardiac surgery.

The patients where initialy recruted for another cohort named micro-SIRS and inflammation but the gaved their consent to analyse the blood samples for other studies


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80
* cardiac surgery includind coronary arterial bypass of valvular surgery

Exclusion Criteria:

* other surgery
Barriers to Effective Weight Loss in Overweight Adolescents

The current study aims to investigate the impact of a comprehensive, team-based, family-centered, lifestyle modification program on body weight, metabolic abnormalities, fitness measures, and self-esteem in overweight adolescents beginning the study at ages 11-18 years. The intensive program will uniquely include a "team" structure and a component designed to address the role of parental modeling in effective lifestyle changes. By comparing the demographic, psychosocial, and metabolic characteristics of adolescents according to the degree of weight loss, the study will also more fully characterize the barriers that prevent successful participation in an intensive lifestyle modification program.

The study will annually enroll 100 - 200 adolescent male and female subjects between 11 and 18 years of age with a BMI \> the 85th percentile and one parent. Adolescents enrolled in the study, will participate in a structured exercise program and meet regularly with a dietitian and behavior specialist for nutrition education and review and update of progress and goals. The study is designed for 2 years of participation with data collection points at baseline, 3 months, 6 months, 1 year and 2 years. Data collected from adolescents include demographic information anthropometric information (height, weight, blood pressure, temperature, pulse, percent body fat); assessments of nutritional knowledge, food choices and dietary intake; assessments of activity and fitness level of behavioral status (depression, self-esteem, self-confidence, satisfaction with life, happiness, perspectives on health, exercise and diet, family environment, quality of life, body awareness, teasing, social efficacy, self-perception, coping mechanisms), assessments of sleep time and quality and physiological and medical data (including blood and urine tests)

Parents will accompany their children to the nutrition and behavior support visits, and attend 12 group educational sessions to learn skills and strategies to help their children adopt healthier eating and exercise behaviors. Data collected from parents will include demographic, anthropometric measures (height, weight, blood pressure, temperature, pulse, percent body fat); and assessments of activity level, dietary intake and eating habits, behavioral status, child-feeding practices, and understanding of their child.

Eligibility Criteria:
Inclusion Criteria:

* Age between 11 and 18
* BMI at or above the 85th percentile for age and sex
* At least one adult in the household who is committed to come to the program meetings

Exclusion Criteria:

* Previous enrollment in VCU IRB 3354
* Underlying genetic, neurologic, endocrine, or metabolic conditions that preclude weight loss with conventional diet and exercise programs
* Weight greater than 400 pounds
* Pregnancy in female adolescent subjects
* Inability to understand program instructions due to language barrier or a mental disability
* Primary residence outside a 30 mile radius program facility.
* Primary participating parent, if female, cannot be pregnant during the period corresponding to the parents intervention.
BFRT for Severe Lower Extremity Muscle Atrophy

Muscle weakness or atrophy is a common condition following acute and chronic musculoskeletal injuries. Strength training is an imperative component in clinical rehabilitation of musculoskeletal injuries. Heavy exercise loads (approximately 70% of one repetition maximum) is necessary to elicit muscle hypertrophy and strength gains. However, patients with severe muscle atrophy are frequently unable to tolerate these loads due to pain. Blood flow resistance training with low resistance loads may be used to safely develop muscle strength.

Blood flow restriction training (BFRT) is a safe type of low intensity resistance exercise that has demonstrated enhanced muscle growth, muscle strength, oxygen delivery and utilization (VO2Max). With BFRT, lighter loads can be used to build muscle while sparing the joints from heavy loading and without overly fatiguing the central nervous system.

The objectives of BFRT are 1) to increase the effectiveness of physical therapy, 2) safely increase muscle mass, reduce arterial stiffness, increase bone density, increase Vo2Max, improve carotid arterial compliance and enhance response of the autonomic nervous system, 3) improve muscle endurance in 1/3 the time, improve strength and hypertrophy after surgery, improve muscle recruitment and increase anabolic growth signaling.

Eligibility Criteria:
Inclusion Criteria:

* Patients with \> 20% deficit in isometric quadriceps and/or hamstrings strength
* Patients willing to complete at least 9 BFRT training sessions
* Patients willing to provide informed consent (or parental consent)

Exclusion Criteria:

* Pregnancy
* History of varicose veins
* History of blood clots or active blood clot
* Taking oral contraceptives
* History of heart attack
* Unstable cardiac disease
* Taking heart failure medication
* Uncontrolled hypertension (\> 140/90)
* Uncontrolled tachycardia (\> 100 bpm)
40 Hz Transcranial Alternating Current Stimulation for Inducing Gamma Oscillations

This study aims to compare the efficacy of different 40 Hz tACS protocols in entraining gamma oscillations, which are linked to various cognitive functions and play a significant role in cognitive impairments like Alzheimer's disease. Specifically, it examines the effects of 40 Hz tACS applied to frontal brain regions versus fronto-temporal regions on gamma oscillations and working memory in healthy elderly individuals.


Eligibility Criteria:
Inclusion Criteria:

* healthy elderly between 50-80 years of age
* normal or corrected to normal eye vision
* right-handed
* non-smokers
* at least 70 % accuracy in working memory training task

Exclusion Criteria:

* history of neurological or psychiatric disorders including seizures or epilepsy,
* Taking CNS, blood pressure and other medications
* having metal implants in the head and neck
* significant cognitive decline meassured by The Montreal Cognitive Assessment (MoCA)