cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Blood Flow Restriction in Postoperative Rehabilitation for Anterior Cruciate Ligament Injuries. A Pilot Study.

The goal of this clinical trial is to evaluate the effectiveness of adding Blood Flow Restriction (BFR) therapy to a standardized rehabilitation protocol in patients undergoing postoperative rehabilitation following anterior cruciate ligament (ACL) repair surgery.

The main questions it aims to answer are:

Does combining BFR therapy with a standardized rehabilitation protocol improve functional recovery compared to rehabilitation alone?

Does the addition of BFR therapy enhance muscle strength and reduce recovery time in patients after ACL repair surgery?

Participants will undergo their assigned rehabilitation protocol and will be assessed prior to and after the intervention to determine if the addition of BFR therapy to the standard rehabilitation programme significantly improves functional recovery, muscle strength, and overall rehabilitation outcomes following ACL repair surgery.

Anterior Cruciate Ligament (ACL) reconstruction is a common surgical intervention following ligament rupture, particularly among athletes engaged in pivoting sports such as soccer, handball, volleyball, and skiing. Despite surgical advances, up to 35% of athletes fail to return to their pre-injury level within two years post-surgery, with factors such as fear of re-injury and neuromuscular deficits playing a significant role.

This randomized controlled trial evaluates the efficacy of integrating Blood Flow Restriction (BFR) therapy into standard rehabilitation protocols after ACL reconstruction. Participants aged 18-45 years, recovering from ACL surgery, will be randomized into two groups: a control group following the standard rehabilitation protocol and an experimental group combining BFR therapy with rehabilitation. BFR involves applying controlled vascular restriction to the proximal limb using automated devices during low-intensity resistance exercises, aiming to enhance strength and neuromuscular recovery safely.

The intervention spans 12 weeks, primarily focusing on the strength and neuromuscular control phase of rehabilitation. Outcomes will include measures of pain, fear of movement, functional performance, and readiness to return to sport. Evaluations will be conducted at baseline and at 2, 6 and 12 weeks post-surgery. The study seeks to determine whether BFR accelerates recovery, improves functional outcomes, and facilitates a safer, more effective return to athletic activities.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 45 years.
* Patients who have undergone anterior cruciate ligament (ACL) reconstruction surgery

Exclusion Criteria:

* Cardiovascular comorbidities
* Severe metabolic disorders or postoperative complications
* Previous joint disorders requiring surgery on the affected leg
* Pregnancy
* Coagulation disorders
Esophageal High Resolution Manometry and Dysphagia

Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two different techniques are available: the conventional manometry and the high resolution manometry. The second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female older than 18 years
* Patient with unexplained dysphagia
* Patient without cause of dysphagia on eso-gastro-duodenal endoscopy
* Patient referred for esophageal manometry
* Patient with health insurance
* Informed consent signed

Exclusion Criteria:

* Patient younger than 18 years
* Allergy to one component of manometry catheter
* Drug intake which can modify the esophageal motricity within 12 hours preceding the realization of the manometry
* Patient unable to give his consent or legally incompetent
* Patient non qualified according to the investigator
* Patient refusal or absence of informed consent signed
* Concomitant participation to another study
Multi-site Animal Assisted Intervention for Children With DD and Their Family Dog

The study purpose is to evaluate a novel multidisciplinary approach to fostering a therapeutic partnership between the participants with developmental disabilities and the participants family dog. This will culminate in an Animal Assisted Intervention aimed at increasing activity levels, enhancing social support, and increasing feeling of responsibility and wellbeing within this population.

The goal of this proposal is to evaluate a large scale novel multidisciplinary approach to fostering atherapeutic partnership between adolescents with developmental disabilities (DD) and the participants family dog. The investigators will evaluate imitative 'Do As I Do' (DAID) training into a unique Animal Assisted Intervention (AAI) aimed at increasing activity levels, enhancing social support by promoting a stronger dog-human bond, and increasing feelings of responsibility and wellbeing within this population.

The investigators propose to address the critical need for empirical evaluation of novel theoretically based multi-site animal assisted interventions through the following specific aims.

Specific Aim 1: To evaluate a novel multi-site DAID dog training intervention to promote physical activity in adolescents with developmental disabilities.

Specific Aim 2: To evaluate the impact of a multi-site DAID intervention on the adolescent's quality of life and feelings of social wellbeing.

Specific Aim 3: To evaluate the impact of a multi-site DAID intervention on the child-dog relationship and mutual wellbeing.

Participant Population: Adolescent participants with a developmental disability, between the ages of 10-17 years will be recruited through community-based programs/organizations associated with children with DDs in around our sites. A DD will be confirmed through parent report (e.g., initial recruitment conversations, and documented through the initial demographic questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* Age 10-17 years
* Developmental disability (per parental report)
* Possesses family dog
* Participant can follow basis instructions.

Exclusion Criteria:

* Cannot follow basic instructions.
* Non english-speakers.
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients

This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients


Eligibility Criteria:
Inclusion Criteria:

* Korean Males and females aged 18 to 65 years.
* Recipients of first, living unrelated or living related non-HLA identical donor kidney
* Transplant, treated with cyclosporine microemulsion (Cs-ME) as primary immunosuppressant.
* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication but at least for four months after randomization, even where there has been a history of infertility.

Exclusion Criteria:

* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
* Kidneys from cadaveric donors or HLA identical living related donors.
* Patients with any known hypersensitivity to enteric coated Mycophenolate sodium (EC-MPS) or other components of the formulation (e.g. lactose).
* Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \<1,500/mm3, and/or leukocytopenia (\<4,000/mm3 ), or hemoglobin \< 6g/dL .
* Patients who have received any investigational drug within 30 days prior to study entry.
* Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
* Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.
* Patients with clinically significant infection requiring continued therapy.
* Known positive HIV status.
* Positive HBsAg test, or Hepatitis C positive with advanced liver disease or with clinical or pathological diagnosis of cirrhosis.
* Evidence of drug and/or alcohol abuse

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of an Intimate Partner Violence Screening-Intervention

The purpose of the study is to evaluate a multi-faceted intimate partner violence (IPV) screening/intervention targeting abused women who are seen for prenatal care in obstetrics-gynecology clinics or general medical care in internal medicine clinics. The intervention is based on our clinical experience and review of the literature which suggests: 1) IPV can vary and no one pattern exists for all women; 2) recovery from abuse usually occurs over time and not necessarily immediately after it is first detected; 3) women have gone down many different paths leading to an abusive relationship and there is no single path to recovery; 4) for screening/interventions to be credible and ultimately disseminated they must respond to the complexity of the patient stories clinicians see everyday when caring for women experiencing IPV and 5) busy obstetricians/internists/clinicians are unlikely to effectively screen and treat women experiencing IPV unless they are supported by other personnel trained to address IPV as well.

The intervention also is based on recommendations of IPV experts and on the theory of chronic disease management that recognizes that the best outcomes are achieved when: 1) patients are educated and given the support and skills to set their own goals and make their own choices; 2) multidisciplinary teams work better than programs focused only on physician behavior; 3) active monitoring of progress is essential; 4) active coping styles using a range of therapeutic modalities are available and 5) a stepped approach is utilized with those not making progress or with more severe problems receiving the greatest intensity of services.

The screening/intervention will be available to each abused woman for approximately three to six months. Patients in the evaluation study will be surveyed at the following time points: baseline, 1 week, 1 month, 3 months, 6 months, and for the partial cohort that starts early, 9 months. Additionally, a sample of nonabused women will be surveyed at baseline to serve as a referent group.

Our primary hypotheses are, that compared to usual care, abused women receiving the intervention will have a reduction in levels of IPV, decreases in depression and nonspecific physical symptoms, increase in functional health status, increase in safety behaviors, increase in help seeking for issues related to IPV, and reduction of general medical services.


Eligibility Criteria:
Inclusion Criteria:

Females Ages 18 to 45 years Seen at study sites for primary care during study periods Speaks English Able to separate from accompanying person(s) Willing to participant

Exclusion Criteria:

Too ill to participate Unable to separate from accompanying person(s) Unable to speak English Refuse to participant
Questioning Patients About Adverse Medical Events

This trial studies whether 3 different methods of asking patients about adverse medical events in a clinical trial affects the rate of reported side effects.

214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplasia were randomly assigned to 3 different methods of adverse event ascertainment after a 1-month placebo run-in visit. Two methods of ascertainment were open ended questions, and 1 was a checklist. Patients were blinded to group assignment, but investigators were aware (single blind). All patients had taken placebo for one month, but had been told it was a study drug (single blind).

Eligibility Criteria:
Inclusion Criteria:

* Male, age \> 49, American Urological Association Symptom Index \> 8
* Max urine flow rate \> 4 and \< 15

Exclusion Criteria:

* prior prostate cancer or surgery
* use of medications that affect urination
* severe concomitant illness
Anti-VEGF Therapy for Subfoveal Hemorrhage in Patients With Neovascular Age-Related Macular Degeneration

This study will define the limits of subretinal hemorrhage parameters that are consistent with a good visual outcome with aggressive anti-VEGF treatment in patients with neovascular age-related macular degeneration (NVAMD).

The purpose of this study is to define the limits of subretinal hemorrhage parameters that are consistent with a good visual outcome with aggressive anti-vascular endothelial growth factor (anti-VEGF) treatment, thereby providing guidance as to when it is reasonable to treat with anti-VEGF and when it is necessary to displace the hemorrhage in addition to treating with anti-VEGF.

This is a prospective study that will enroll 98 patients with subretinal hemorrhage in the fovea \[also known as subfoveal hemorrhage (SFH)\] secondary to neovascular AMD at the Wilmer Eye Institute, Johns Hopkins Hospital (Downtown campus and all other Eye Care Network clinics). The primary endpoint is at month 12 and the secondary endpoint is at month 24. The duration of the study is 24 months.

Study visits will include a baseline visit, then monthly visits for 12 months, followed by standard care treatment visits in the second year until month 24. The patients will be stratified into two groups based on standard of care management: 1. Patients receiving intravitreal (IVT) anti-VEGF injections; 2. Patients undergoing SFH displacement followed by IVT anti-VEGF injections. Patients will receive monthly anti-VEGF injection for 12 months, followed by anti-VEGF at standard of care treatment interval during months 12-24; or SFH displacement (at investigators' discretion) followed by monthly IVT anti-VEGF injections for 12 months, and standard of care treatment interval during months 12-24.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age 50 years or older
* Presence of subretinal hemorrhage (SRH) involving the fovea in patients with NVAMD including polypoidal choroidal vasculopathy (PCV)

Exclusion Criteria:

* SFH in the study eye due to causes other than NVAMD
* Media opacity due to concurrent vitreous hemorrhage or cataracts that preclude adequate imaging
* Substantial loss of VA due to condition other than AMD
* Limited visual potential from substantial atrophy or fibrosis in fovea
* Poor visual potential with known permanent reduction in visual acuity prior to SFH
Study of Neuroplasticity on Depressed Patients : Modulation of MEP Induced by Theta Burst Stimulation

Neuroplasticity is supposed to be altered in patients suffering from a Major Depressive Disorder (MDD). Transcranial Magnetic Stimulation is a medical device which measures cerebral plasticity. Several parameters of cortical excitability are available for that purpose. These parameters are altered on patients wth MDD and these modifications are corrected after treatment. Therefore results in the studies are very heterogeneous. Theta Burst Stimulation (TBS) is a type a Transcranial Magnetic Stimulation (TMS) protocol and can induce cerebral plasticity. The cerebral plasticity induced by TBS was measured on a group of patients suffering from Asperger's disease (ASD) versus a control group. The plasticity was significantly different in patients with ASD. The aim of our study is to study the neuroplasticity induced by TBS on a patients with MDD.

The study is lead with patients suffering from a MDD. All patients are drug free. Patients are compared to a control group of healthy subjects The protocol has 2 sessions. During the first session, After determining the parameters of stimulation (stimulated target : part of the left motor cortex responsible for the contraction of the right first dorsal interosseous muscle ; Activity Motor Threshold (AMT) ; Intensity of Stimulation providing a Motor Evoked Potential (MEP) with an Amplitude of 1mV (MEP 1mV)), a Baseline consisting of 15 MEP (intensity MEP 1mV) is measured. Then each subjet receive a TBS protocol (cTBS or iTBS) (intensity of stimulation 80% of AMT). After receiving the stimulation, sets containing 10 MEP are regularly measured by each subject.

During a second session, the same protocol is done again with the other TBS stimulation (cTBS or iTBS) the subject didn't get during the first session.

A neuronavigation device is used to determine precisely the area of stimulation.

Eligibility Criteria:
Inclusion Criteria:

Subjects with MDD

* MDD according to definition provided by the DSM V
* No antidepressant Healthy Controls
* No present psychiatric disease

Exclusion Criteria:

* depression with Melancholic features
* pregnancy
* contra indication in the use of TMS (personal history of epilepsy, deep brain stimulation, vague nerve stimulation, pace maker, intracerebral lesion, pieces of metal Inside of the brain)
* diseases with neurological effects (multiple sclerosis, Parkinson disease, HIV...)
Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain

The aims this study is to explore the effect of a GLP-1 receptor agonist on the degree of brain activation and connectivity obtained by functional magnetic resonance imaging in lean and obese type 2 diabetes

Fifteen lean \[BMI(body mass index) less than 23 kg/m2\] type 2 diabetes subjects and fifteen obese (BMI more than 26 kg/m2) subjects with type 2 diabetes treated by diet and/or metformin, SU(sulfonylurea), DPP4-inhibitors(Dipeptidyl peptidase-4 inhibitor) will be recruited. Every subject will be studied on 2 separate days in random order with 1-2 week intervals. These participants will be injected either normal saline or 10 mcg of lixisenatide in a cross-over fashion. Neuroimaging composed with resting-12-min, visual stimulation task-12-min, T1-5-min, and diffusion tensor image-12-min will be proceeded. Ad lib buffet will be provided to every participant and the intake will be measured. Surveys about appetite and mood will be done before and after neuroimaging test and buffet eating.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 23kg/m2 or BMI ≥ 26kg/m2
* participants with diabetes treated by diet or oral antidiabetic drug, HbA1c less than 8.5%

Exclusion Criteria:

* Those who diagnosed by Type 1 diabetes
* History of insulin therapy
* Aspartate aminotransferase(AST) or Alanine transaminase(ALT) \>2.5 times of upper normal reference range
* Estimated Glomerular Filtration Rate(eGFR) \<30 mL/min/1.73m2
* Those who can't be performed MRI
Association of Epicardial Adipose Tissue Volume Axnd Radiodensity With Coronary Artery Calcification in Patients With HFpEF

Recruiting patients who were diagnosed with HFpEF. Using Non-contrast CT to measure the total Agatston coronary artery calcification score, epicardial adipose tissue volume and attenuation. Analysing the correlation between them.

The study enrolled patients who were diagnosed with HFpEF and admitted to the Cardiology Department of the First Affiliated Hospital of Chongqing Medical University. Using Non-contrast CT to measure the total Agatston coronary artery calcification score, epicardial adipose tissue volume and attenuation. Finally, analysing the correlation between them.

Eligibility Criteria:
Inclusion Criteria:

* Typical symptoms and signs of heart failure
* Left ventricular ejection fraction≥50%
* HFA-PEFF score≥5

Exclusion Criteria:

* severe myocarditis, malignant tumors, liver or renal insufficiency, severe valvular heart disease, and received a bypass surgery or other open-heart surgery
Evaluation of Symptoms, Complications and Side Effects of Adding Medications Continuously To Subcutaneous Infusion (Hypodermoclysis) In Home Care Hospice Patients

Background: Terminal patients are often unable to swallow and need medications to control symptoms. In these cases medications are administered continuously and subcutaneously by a syringe driver. A syringe driver is an expensive and sophisticated equipment to operate. Hypodermoclysis is a useful and easy alternative used in the homecare setting for hydration.

Objectives:

1. To assess the level of symptoms control by the administration of morphine, metoclopramide and midazolam by hypodermoclysis versus by a syringe driver.
2. To assess the complications and side effects of infusing these medications continuously by hypodermoclysis versus by a syringe driver.

Methods: Patients in the homecare setting who meet the criteria for parentral infusion and suffer: pain, vomit/nausea and/or agitation will be recruited for the study.

A double blind crossover methodology will be used. Each patient will serve as both intervention and control, and both patient and medical staff will be blinded to the medication route administration. A research nurse will administer the medications. Crossover will take place 48 hours thereafter. A research assistant will conduct evaluation of symptoms and side effects for a period of 4 days. A sample size of 27 patients will be included in the study (calculated for a significance level of 95% and power of 80%).


Eligibility Criteria:
Inclusion Criteria:

* Patients in the home care unit that need medication/s continuously subcutaneously with symptoms level of 6 or higher on a visual analogue scale (VAS) for that symptom.

Exclusion Criteria:

1. Patients and caregivers that refuse to participate.
2. Every occasion when the infusion period will be less than 48 hours.
3. Every occasion when the patient and/or main care giver are not able to provide reliable information by the judgment of the medical staff person or research worker.
4. Patients that will need other medications subcutaneously that are not included in the study during their study treatment period.