cyrilzakka/clinical-trials huggingface dataset:
Innovative Rehabilitation: Integrating VR-Based Sensorimotor Training Into Comprehensive Neck Rehabilitation

The research aims to treat chronic non-specific neck pain using virtual reality (VR) technologies with sensory-motor training. Chronic neck pain is widespread and highly prevalent in Egyptian society due to many factors, such as sitting for long periods in front of a computer or smartphone, which leads to a decline in productivity at work and a constant feeling of fatigue. This problem is considered one of the widespread health problems that affect individuals of all ages and greatly affect their daily lives.

This project was chosen based on the growing awareness of the need to search for innovative solutions to this health problem that hinders productivity and affects the general comfort of individuals.

The reserch aims to integrate sensory-motor therapy with virtual reality, which helps patients improve movement and flexibility and reduce pain. It does this by simulating exciting interactive environments that engage their attention and help them relieve pain away from traditional treatment methods.

Virtual reality, a novel form of technology, is gaining attention in the medical field for its potential to aid inpatient rehabilitation. This experience will immerse the patient in an interactive and engaging journey. Virtual reality feedback can assist patients with chronic musculoskeletal pain by offering them various sensory and motor tasks to enhance their postural control.

Moreover, virtual reality offers a distracting experience that aids in reducing patients' pain and emotional distress. Using a specialized device on their head (Head-mounted device) (HMD) or screen, patients can participate in computer-based exercises as part of virtual reality physical therapy.

Combining virtual reality with comprehensive sensorimotor training can be beneficial in treating chronic neck pain.

Eligibility Criteria:
Inclusion Criteria:

1. Fifty patients diagnosed with mechanical neck pain between 18- and 40 years old with mechanical neck pain.
2. Patients with pain intensity scores (\>3) on the visual analog scale (VAS; 0-100mm) for an average of three weeks before the study.
3. Neck Disability Index (NDI) scoring 20%-60% (\>6) (moderate to severe disability).

Exclusion Criteria:

1. Any history of lower extremity or spine trauma or surgery, recognized and observable spinal deformity, neurological disorders, cervical fracture/dislocation, whiplash injuries, neurological/cardiovascular/respiratory disorders affecting patients' physical performance, or inability to provide informed consent.
2. Benign paroxysmal positional vertigo (BPPV), as confirmed by the Dix Hallpike test.
3. Pregnancy.
4. Patients who had received physical therapy interventions for neck pain within three months preceding the study were also ineligible for participation and were excluded.
Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions

Study to compare the pharmacokinetics and pharmacodynamics of VHX-896 and iloperidone and evaluate the safety and tolerability of VHX-896 and iloperidone in patients with schizophrenia or bipolar I disorder under steady state conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 to 65 years of age (inclusive)
* Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type, according to the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition, Text Revision (DSM-5-TR)
* Patients must be symptomatically stable and on a stable treatment with an oral atypical antipsychotic at an adequate dose (3 months prior to enrollment) and not suffer from acute increase of their psychosis or be hospitalized within the past 2 months

Exclusion Criteria:

* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* Cytochrome P450 2D6 (CYP2D6) poor metabolizers and use of prescription medication or OTC medication that strongly inhibits CYP2D6 or CYP3A4 or induces CYP3A4 within 5 half-lives of baseline
Use of the Insulin Pump in Cystic Fibrosis Patients With Impaired Glucose Tolerance or CFRD and in Type 1 Diabetes Patients.

We hypothesize use of the insulin pump will improve body weight, lean body mass, whole body protein turnover, hepatic glucose production (HGP), and blood sugar control in CF patients with impaired glucose tolerance or patients with CF related diabetes (CFRD). We further hypothesize that HGP is also elevated in children/adolescents with type 1 diabetes and that the insulin pump will result in decreased HGP.

The insulin pump provides standard treatment for many patients with type 1 and type 2 diabetes and has been proven to be more effective in blood glucose control than subcutaneous injections. However, the pump has not been utilized for CF related diabetes. The insulin pump is connected to the patient via a small plastic catheter. The catheter is inserted with a 24 gauge needle (in a fashion similar to an IV catheter) just under the skin. The catheter is then changed every three days. The patient wearing the pump may then give himself or herself a "bolus dose" of insulin every time he or she eats, without needing to give a shot. A further advantage of the pump is that a very low dose of basal insulin may be given throughout the day. This low dose of insulin mimics the normal pancreas and may be especially advantageous for the insulin deficient CF patient. It is likely that bolus dosing will improve high HGP and will be more effective than subcutaneous insulin. Furthermore, continuous basal insulin will likely improve protein catabolism.

This is a pilot study to determine efficacy of the insulin pump. Each subject will be provided with the pump and with all materials needed for use with the pump. Each patient will also be provided with a glucose meter and test strips. He/she will be asked to wear the pump for six months and to check his/her blood sugar levels three to four times per day. Prior to the pump placement and at the end of six months, each patient will undergo the following measurements: 1) whole body protein turnover using the stable isotope \[1-13C\] leucine; 2) DEXA scan for measurement of lean body mass; 3) anthropometric measurements; 4) Hemoglobin A1c.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis patients aged 12-32 years
* Impaired glucose tolerance or CFRD defined as fasting blood glucose (FBG) and post-prandial blood glucose (pp) equal to: FBG \<126 and pp 151-200, or FBG \<126 and pp \>200, or FBG \>126 and pp \>200.
* Type 1 diabetes control patients aged 12-32 years.

Exclusion Criteria:

* Colonization with Burkholderia cepacia
* currently on corticosteroid medication
* pregnant
* medically unstable
* Unable to understand the insulin pump directions
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects

Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug.


Eligibility Criteria:
Inclusion Criteria:

1. Have an established diagnosis of Type 2 Diabetes as determined by the investigator.
2. Females will be postmenopausal for at least 1 year with documented FSH \> 30 IU/L.

Exclusion Criteria:

1. Hypertriglyceridemia \> 500 mg/dL at screening.
2. BMI \> 40 kg/m2.
3. Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening.
4. History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids.
5. Current treatment or treatment within 30 days or five half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational protocol.
Side Effects of Newer Antipsychotics in Older Adults

This study will compare four atypical antipsychotic medications in terms of the risk of specific side effects each of them presents in middle-aged and elderly individuals.

Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals.

Participants in this open-label study will be randomly assigned to receive one of three atypical antipsychotic medications: aripiprazole; olanzapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication

Exclusion Criteria:

* N/A
Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study

The primary objective will be to study changes in putamen structural connectivity in healthy teens with meditation training. Hypothesis: Putamen structural node strength will increase in the training group compared to controls.

R61 Go/No-Go Criteria. Detect an effect size (a threshold of Cohen's d \> 0.20) in changes of the primary mechanistic outcome (Putamen structural node strength) by the described meditation training in 100 healthy adolescents that are 14-18 years old and retain at least 80% of randomized participants for primary outcome measurement at the end of the study regardless of adherence to the intervention.

The secondary objective will be to study changes in emotional problems in healthy teens with meditation training. Hypothesis: There will be a significant decrease in emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ) in the training group compared to controls.

Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the efficacy and safety of the investigator's innovative mindfulness meditation intervention (Training for Awareness Resilience and Action \[TARA\]) on the primary outcome (Putamen structural node strength) and secondary outcome (emotional problems measured with the Strengths and Difficulties Questionnaire \[SDQ\]) in healthy adolescents between the ages of 14 to 18 years old.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male adolescents, 14-18 years old
* Fluency in English

Exclusion Criteria:

* Subjects younger or older than 14-18 years old.
* Subjects who are not healthy. Subjects who are taking any psychotropic medication.
* MRI contraindications (ferromagnetic objects on or inside the body, e.g., braces) and pregnancy.
* Not allowable: Current mindfulness training (e.g. MBSR, MBCT, DBT) and/or practice with a typically sitting meditation or yoga of 20 or more minutes two or more times per week within 60 days prior to study entry.
* Potential adolescent subjects with current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to the study requirements will be excluded and not allowed to enter the study.
* Potential subjects with an inability or unwillingness to give written informed assent or whose legal guardian/representative are unable or unwilling to give written informed consent will be excluded and not allowed to enter the study.
Efficacy of TaVNS Versus Sham Stimulation in Reduing Depressive Symptoms in Patients with Epilepsy: a Multi-center, Double-blinded, Randomized, 20-week, Parallel-arm, Superiority Study

The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥18
* Confirmed diagnosis of epilepsy (based on 2014 definition by ILAE)
* Having comorbidity with mild-moderate depression (confirmed diagnosis by a psychiatrist)
* Willing and able to provide informed conset

Exclusion Criteria:

* Those experiencing status epilepticus or frequent seizures requiring emergency medication within the year prior to recruitment
* Those with severe depression or anxiety who are in urgent need of psychiatric care
* Those who are imminently suicidal or unable to keep themselves safe
* Those experiencing severe cognitive difficulties with day-to-day memory, attention, and ability to learn basic information
* Those having a pacemaker, a invasive vagus nerve stimulator, or a metal implant
* The pinna is not suitable for earplugs
* Pregnancy
Clinical Trial Readiness Network FSHD France: Prospective 24 Months MRI Study

The overall aim of this study is to hasten drug development for facioscapulohumeral muscular dystrophy (FSHD). Recent breakthroughs in FSHD research have identified the primary disease mechanism as the aberrant expression of a normally silenced gene, DUX4, resulting in a toxic gain-of-function. This disease mechanism is particularly amenable to knock-down of DUX4 using epigenetic strategies or RNA therapies, as well as to other interventions targeting the downstream effects of DUX4 expression. There are many drug companies actively working towards disease-targeted therapies, and two clinical trials either under way now, or planned to start in early Fall 2016. However, meetings with industry, advocacy groups, and FSHD researchers have identified several gaps in the clinical trial arsenal, and clinical trial planning as a major goal for the community. Consequently, there is an urgent need to establish the tools necessary for the conduct of currently planned and expected therapeutic trials in FSHD.

To this end, the researchers propose to develop two novel clinical outcome assessments (COA), a composite functional outcome measure (FSH-COM) and skeletal muscle biomarker, electrical impedance myography (EIM). In addition there is broad consensus a better understanding of the relationship of genetic and demographic features to disease progression will be necessary for enumerating eligibility criteria.

The specific aims are to: 1. Determine the multi-site validity of the COAs, 2. Compare the responsiveness of new COAs to other FSHD outcomes and determine the minimal clinically meaningful changes, and 3. establish FSHD cohort characteristics useful for determining clinical trial eligibility criteria. To achieve these aims, the Nice University Hospital is conducting a monocentric, prospective, 18 month study on 30 subjects.


Eligibility Criteria:
Inclusion Criteria

* Genetically confirmed FSHD1 or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring 63
* Age 18-75 years
* Symptomatic limb weakness
* Patient able to walk alone or with a walking aid.
* Manual Muscle Testing (MMT) score ≥ 4 for one of the lower limb muscles
* Patient affiliated to the social security system
* Patient giving written consent after written and oral information.
* If taking over the counter supplements willing to remain consistent with supplement regimen throughout the course of the study

Exclusion Criteria

* Cardiac or respiratory dysfunction (deemed clinically unstable, or would interfere with safe testing in the opinion of the Investigator)
* Orthopedic conditions that preclude safe testing of muscle function
* Regular use of available muscle anabolic/catabolic agents such as corticosteroids, oral testosterone or derivatives, or oral beta agonists
* Use of an experimental drug in an FSHD clinical trial within the past 30 days
* Pregnancy.
* Contraindication for muscle MRI
* Any major comorbidity
Validation of Brain Oxygenation Monitor on Pediatric Patients

The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal organs (StO2). This is a measure of the amount of oxygen carried by the blood within the internal organs. In addition the study will assess the degree of similarities between StO2 and mean mixed venous oxygen saturation - a measure of the amount of oxygen carried in the blood returning to the heart.

NIRS cerebral oximeters are FDA-approved devices used to measure oxygen saturation within the brain, in a similar manner to pulse oximeters that measure the oxygen saturation in the finger tip. The sensor pads are placed on the surface of the forehead and shine near-infrared light through the skull and brain tissue from which the brain tissue oxygen saturation is estimated. The same principles can be applied when the sensor pads are placed over the internal organs of the abdomen, for example, the liver. Currently the only way to accurately measure the oxygen saturation of internal organs is by the invasive placement of intravenous lines into the blood vessels of that organ. This study will determine if the NIRS sensors can reliably estimate the tissue oxygen saturation non-invasively by placing the pad over the skin of the abdomen.

The study will be conducted in pediatric patients who are undergoing cardiac catheterization, a procedure in which invasive lines are placed in order to get information about the heart. The procedure is always conducted under general anesthesia. During the cardiac catheterization procedure blood samples are routinely taken for oxygen saturation analysis. In the study two oximeter sensor pads will be placed on the forehead (one on each side) and two further oximeter sensor pads will be placed on the abdominal wall. The oxygen saturation values from all oximeter sensors will be recorded continuously throughout the cardiac catheterization procedure and will be compared to the oxygen saturation values from the blood samples. In addition to the routine blood samples taken as part of the cardiac catheterization, one blood sample will be taken when the invasive line is within the right hepatic (liver) vein.

The information from this study will determine how well the oximeter sensors estimate the oxygen saturation of both the internal organs (StO2) and the blood returning to the heart (mean mixed venous oxygen saturation).

Eligibility Criteria:
Inclusion Criteria:

* ≤ 18 years old
* ≥ 2.5 kg and ≤ 40 kg weight
* Undergoing cardiac catheterization at Duke pediatric cardiac catheterization laboratory

Exclusion Criteria:

* Known structural neurologic or craniofacial disease
* Arterial catheter placement not part of planned catheterization procedure
* Anemia (hemoglobin \< 10 g/dl)
Evaluating the Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients

In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups were compared.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older who undergo colonoscopy.

Exclusion Criteria:

* 1)No pathological result.
* 2) No or invalid contact information.
* 3) The surveillance interval cannot be determined according to the surveillance guidelines, including poor bowel preparation, colorectal cancer or suspicious malignance, surgery or colorectal ESD history, those who fail to complete colonoscopy due to unbearable, pathological indications of not polyps, hamartoma or lymphoma polyps, history of ulcerative colitis, and so on.
* 4) Has participated in other clinical trials, signed the informed consent form and is in the surveillance period of other clinical trials.
* 5) Have drug or alcohol abuse or psychological disorder in the past five years.
* 6）Pregnancy.
* 7）Not suitable for recruitment after investigator evaluation because of other high-risk conditions.
The Role and Intervention of TGF-β in Abdominal Radiation Injury

This project aims to investigate the relationship between radiation-induced the relationship between elevated peripheral blood TGFβ and complications of radiotherapy,and to analysis of changes in peripheral blood TGFβ levels after abdominal radiotherapy and its relationship with radiotherapy complications.Simultaneously,Patients who underwent abdominal radiotherapy were given captopril (sustained release) to block TGFβ,Whether it can reduce peripheral blood TGFβ levels and reduce radiotherapy complications,to explore the protective effect of blocking TGFβ secretion on normal tissues after radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form for this study has been signed
2. Age 18-70 years old, gender is not limited，Pathological diagnosis of patients with advanced malignant tumors，Radiotherapy indications；
3. BED (α/β=10)≥50；ECOG score 0-2；Blood routine：WBC≥3.5×109/L,GRAN≥2.0×109/L,Hb≥90g/L，PLT≥100×109/L;
4. Liver function: ALT or AST ≤ 2.5 times the normal high value (ULN)；Bilirubin ≤ 1.5 × ULN, serum APK ≤ 2.5 × ULN;
5. Renal function：Serum creatinine ≤1.5×ULN, and creatinine clearance ≥60ml/min
6. No organ transplant history
7. Women of childbearing age must undergo a urine pregnancy test within 7 days prior to initiation of treatment and the results are negative and not in lactation
8. Male and female patients of childbearing age agreed to adopt a reliable method of contraception before entering the trial and during the study until 30 days after stopping the drug.

Exclusion Criteria:

1. Patients undergoing chemotherapy or targeted therapy at the same time
2. Long-term use of ACEI or ARB drugs for hypertension
3. This radiotherapy site has been treated with radiotherapy；Combined with severe heart disease or major organ failure
4. Have a history of drug abuse or alcohol addiction
5. Combined active infection
6. Combined with severe malnutrition or severe anemia
7. Human immunodeficiency virus (HIV) infection
8. During pregnancy or lactation
9. Those who are unable to tolerate or may be allergic to the drugs used in this study；Persons without civil capacity or limited capacity for civil conduct；
10. Researchers believe that it is not suitable for inclusion