cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality and Neurostimulation for Early Stroke Rehabilitation

Stroke is one of the leading causes of disability, leaving millions of individuals each year impaired with lasting motor and sensory impairments. In the subacute phase, which goes from the first week to 3 months post-stroke, the patient has the highest recovery, which could be boosted by proper technologies intended for the rehabilitation of the patients. The impairments that the patients experience are extremely heterogeneous and go from muscle weakness to spasticity of the paretic side of the body. Beyond motor deficits, stroke survivors also suffer from sensory impairment (they do not properly feel with the paretic side of their body), impaired body representation (misjudging the size, position, and movement of their affected limb), which can further hinder recovery.

Traditional rehabilitation primarily targets motor function, often without considering at all the role of sensory feedback and body perception in the recovery process. However, growing evidence suggests that the combination of multiple sensory modalities towards a multifaceted rehabilitation can enhance neuroplasticity and improve rehabilitation outcomes.

To address this, the investigators have developed a novel rehabilitation approach that integrates immersive virtual reality (VR) with transcutaneous electrical nerve stimulation (TENS). This system allows stroke patients to interact with a virtual environment while receiving synchronized tactile stimulation, reinforcing sensorimotor integration. Unlike conventional therapy, which relies on passive or repetitive exercises, this approach engages patients in active, goal-oriented movements, tailored to their individual recovery progress.

By focusing on the subacute stroke population, this project aims to leverage the brain's heightened plasticity during early recovery to maximize functional improvements. The VR-based intervention will adapt to each patient's motor abilities, providing real-time feedback to encourage precise movements and enhance sensory processing. Through this multisensory experience, the investigators seek to improve not only motor control but also sensory and body representation measures.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of ischemic or hemorrhagic stroke
* In the subacute phase (from 7 days to 3 months from last stroke onset)
* Fugl-Meyer-Upper Extremity (FMUE) scale for the motor part: FMUE ≥ 10
* Ability to sit in an upright position
* Age between 18 and 80 years

Exclusion Criteria:

* Other neurological or physical impairment or mental condition that, in the judgment of the investigator, does not allow participation in the study.
* Mini-Mental State Examination (MMSE) \< 24
* Epilepsy
* Nausea, headaches or fatigue due to VR-generated environment ("virtual reality motion sickness")
* Peripheral nerve damage in the affected arm or hand
* Pacemaker or other electronic implants
Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial.

This study is design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial. Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

* Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0-1M0)
* Schedule to undergo either partial or radical nephrectomy as part of treatment plan
* ECOG performance status of 0 or 1
* Adequate organ and marrow function defined by study-specified laboratory tests
* Agree to comply with scheduled visits, treatment plans, lab tests and other study procedures
* Do not have any other cancers in the 5 yr preceding diagnosis of their renal cancer

Exclusion Criteria:

* Patients who have received other systems for anti-tumor treatment
* Patients who have previously received targeted or immunotherapy
* Need for urgent or emergent nephrectomy to relieve symptoms
* Current use of immunosuppressive agents
* Pregnant or breastfeeding women
* History of autoimmune disease or syndrome
Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Major Abdominal Surgeries

This study will be conducted to evaluate efficacy of ultrasound guided modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) for postoperative analgesia in major abdominal surgeries in comparison to subcostal transverse abdominis plane (SCTAP) block.

It is hypothesized that M-TAPA block will be advantageous to SCTAP block as a promising effective alternative for analgesia for major abdominal surgeries with fewer side effects.

Postoperative pain management for major abdominal surgeries can reduce postoperative respiratory dysfunction and promote early mobilization. Traditionally, opioids have been used to manage postoperative pain. However, an increasing awareness of opioid-related adverse events including respiratory depression, paralytic ileus, and sedation, has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia. As such, outcomes associated with the transverse abdominis plane block are of increasing interest. A modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) is a novel analgesic technique that involves local anesthetic injection into the lower aspect of the chondrium. It can block thoracoabdominal nerves at T5 in cephalic direction and down to T11-T12 in caudal direction and may be an effective analgesic for major abdominal surgeries.

The aim of this study is to assess the quality of pain relief in patients who will undergo major abdominal surgery receiving either (M-TAPA) block or (SCTAP) block by comparing and evaluating the differences between the two techniques.

This prospective, randomized, comparative clinical study will include 80 patients who will be scheduled for major abdominal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from all subjects in the study after ensuring confidentiality. Eligible patients will be randomly assigned to 2 equal groups (M-TAPA group and SCTAP group) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) I and II patients.
* Scheduled for elective major abdominal surgeries.

Exclusion Criteria:

* Patient's refusal.
* Altered mental status or un-cooperative patients.
* History of known sensitivity to the used anesthetics.
* Bleeding or coagulation diathesis.
* Infection at the injection site.
A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects

Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.

36 subjects received a single dose of STS101, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 5-period crossover manner.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age at the time of enrollment.
* Signed the informed consent document.
* Subject judged to be healthy by a qualified physician

Exclusion Criteria:

* Abnormal physical findings of clinical significance at the screening examination
* Significant abnormal laboratory values at the Screening Visit.
* Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.
Effectiveness of the Treatment of Tension-type Headache With Manual and Manipulative Therapy

Background. Tension-type headache (TTH) is the most common form of primary headache and it is a real problem for the subjects suffering from it. Until now, physiotherapy treatments have included different techniques combined together, without establishing which of them is more effective.

Objective. The purpose of this study is to know the effectiveness of manipulative and manual therapy treatments, with regard to pain perception and neck mobility in patients with tension-type headache.

Methods: A double-blind, randomized clinical trial was conducted, with 84 patients diagnosed with tension-type headache, divided into three treatment groups -manual therapy, manipulative therapy, and a combination of both techniques-, and a placebo control group. Four treatment sessions were administered during four weeks, with post-treatment assessment, and follow-up at one month. Cervical ranges of motion were assessed (CROM device), as well as pain perception (McGill Pain Questionnaire), and frequency and intensity of headaches (weekly register).


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 65 years
* Diagnosis of frequent ETTH and CTTH
* Having headache episodes on more than 1 day per month
* Headache episodes lasting from 30 minutes to 7 days
* Headaches having at least 2 of the following characteristics:

  * Bilateral location of pain
  * Pressing non pulsating quality
  * Mild or moderate intensity
  * Not aggravated by physical activity
* Sufferers may present photophobia, phonophobia, nausea or vomiting
* Headache may be associated with pericranial tenderness
* Suffering from TTH for over 3 months
* Subjects being under pharmacological control

Exclusion Criteria:

* Patients with infrequent ETTH, and patients with probable TTH in its frequent and infrequent forms.

  * Headache that is aggravated by head movements.
  * Metabolic or musculoskeletal disorders with symptoms similar to headache
  * Previous neck trauma
  * Vertigo, dizziness, arterial hypertension.
  * Joint stiffness, arteriosclerosis or advanced degenerative osteoarthritis
  * Patients with heart devices
  * Patients in process of pharmacological adaptation
  * Excessive emotional tension
  * Neurological disorders
  * Laxity of neck soft tissues
  * Radiological alterations
  * General hypermobility or hyperlaxity
  * Joint instability
  * Pregnancy
Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes

The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin in adolescents with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol.The study hypothesizes that simvastatin and ezetimibe/simvastatin will be safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.

Cardiovascular disease is the leading cause of death in people with type 1 diabetes mellitus (T1DM) and since atherosclerosis begins in childhood, data to inform clinicians as to appropriate dyslipidemia treatment in this high-risk population are of great public health importance. In this trial of lipid-lowering medications (Zocor \[simvastatin\], a statin, compared to Vytorin \[ezetimibe/simvastatin\], a combination of a statin and Zetia, a medication that blocks cholesterol absorption) will be performed in patients ages 12-18 years with LDL ≥ 130 mg/dl, consistent with current ADA guidelines. The study hypothesizes that Zocor and Vytorin will be safe in adolescents with T1DM and will lower LDL-cholesterol at 6 months compared to baseline. In a two-arm design, Vytorin will lower LDL-c more than monotherapy with Zocor.

Eligibility Criteria:
Inclusion Criteria:

* 12-18 years of age with Type 1 Diabetes and seen at the Barbara Davis Center for Childhood Diabetes
* Positive diabetes auto-antibodies or provider diagnosed Type 1 Diabetes
* LDL \> 130 mg/dl.

Exclusion Criteria:

* Familial hypercholesterolemia, Triglycerides (TG) \> 400mg/dl
* Type 1 Diabetes of less than three-month duration
* HbA1c\>9.5%
* Abnormal thyroid function
* Abnormal Creatine Kinase (CK) values (defined as \> 10 times the upper limit of normal)
* Abnormal liver function tests (ALT/AST) (defined as \>3 times the upper limit of normal)
* Pregnancy, and patients on oral contraceptives
* All resources are in English. Spanish speakers will not be available for the follow-up calls.
Effect of MEDiterranean Diet on the microBIOME of Individuals With Type 2 Diabetes

Dysbiosis of gut microbiota is associated with the pathophysiology of type 2 diabetes. Mediterranean diet has been indicated as a dietary pattern that promote the integrity of gut barrier and that has positive impact in the metabolic control of subjects with type 2 diabetes. This is a 12-week, single-arm clinical study that aims to evaluate if the effect of Mediterranean diet in metabolic control of these subjects is mediated by gut microbiota. Subjects will receive personalized nutrition counseling where Mediterranean diet will be promoted.


Eligibility Criteria:
Inclusion Criteria:

* Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;
* Ages 40-80 years;
* Non-smoker;
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Diabetes diagnosed before 40 years old;
* Changes in oral glycaemic-control medications in the last 3 months;
* Subjects with HbA1c levels under 6.4% or above 10%;
* Subjects under insulinotherapy;
* Subjects under corticotherapy;
* Subjects with triglycerides levels above 4.52 nmol/L (400 mg/dL);
* Intake of antibiotics in the last 12 weeks;
* Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS.
SD, IL-13 Production Rate in IPF

The purpose of this study is to investigate how QAX576 affects levels of interleukin 13 (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 40 and 80 years with a confirmed diagnosis of idiopathic pulmonary fibrosis
* Both men and women must be on non-childbearing potential. Additional information regarding this requirement is available at screening.
* Capability to meet certain lung function tests at screening
* Non-smokers
* No participation in another clinical study within 4 weeks of study start.

Exclusion Criteria:

* Certain medical conditions may exclude candidates from participation.
* Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
* Past medical personal or close family history of clinically significant ECG abnormalities
* Connective tissue disorders
* Active infection or history of systemic parasitic infection
* Known hypersensitivity to the drug.
* History of immunocompromise, including a positive HIV test result.
* History of drug or alcohol abuse within 12 months of study start
* Any condition that may compromise patient safety
Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation

Easy Care study wants to demonstrate a correlation between intra-CPR infrared quantitative pupillometry and return of spontaneous circulation (ROSC).

Neurological pupil index (NPi) will be used alone and in association with end-tidal CO2.

At the arrival of medicalised rescue team on the emergency scene, patient will be screened for including criteria. In case of eligibility pupillometry will be collected each eye in the following frame time:

* T 0: time of enrolling
* T 1: after first cycle of resuscitation (approximatively 2 minutes following guidelines)
* T 2 ... Tn: every cycle of CPR (or every 2 minutes if intubated patient) bilateral pupillometry will be collected
* T end: the last pupillometry at ROSC time or death. All pupillometry mesures will be obtained from a technician not trained to interpret NPi index. This to maintain blindness during resuscitation efforts.

Data will be collected in anonymous web-based database passwords protected. For the survivors patients enrolled, data collecting continue in Intensive Care Unit (ICU) as neuroprognostication exams (biomarkers, imaging, neurophysiology). Blind follow up will be obtained from ICU as described in secondary outcome section

Eligibility Criteria:
Inclusion Criteria:

* Not traumatic cardiac arrest in pre-hospital setting (OHCA)
* unexpected OHCA
* Lombardy region territory

Exclusion Criteria:

* Traumatic Brain injury
* Cerebrovascular emergecies at computer tomography (CT) scan after hospital admission
* Peripheral or cortical blindness
* One or both eyes loss
* Iris palsy or known peripheral anisocoria
* No indication for resuscitation
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.


Eligibility Criteria:
Key Inclusion Criteria:

* Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods:

  * ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance prior to the screening visit)
  * ≥ 3 months (if there is no documented or suspected NRTI resistance prior to the screening visit)
* Documented plasma HIV-1 ribonucleic acid (RNA) \< 50 copies/mL during treatment with DTG+F/TAF or DTG+F/TDF (for a minimum period of ≥ 6 or ≥ 3 months, as applicable) preceding the screening visit
* Plasma HIV-1 RNA levels \< 50 copies/mL at screening visit
* Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
* No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed virologic failure
* Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection are permitted to enroll

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir

This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2, all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study treatment is up to 20 days.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers, 18 to 55 years of age, inclusive
* Body weight \>/= 55 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2
* Healthy non-smoking subjects. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Medical history without major recent or ongoing pathology
* Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration

Exclusion Criteria:

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* Any history of clinically significant disease or condition
* Positive for drugs of abuse at screening or prior to admission to the clinical site
* Positive for hepatitis B, hepatitis C or HIV infection
* Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
* Use of hormonal contraceptives (e.g. birth control pill, patches, or injectable, implantable devices) within 30 days before the first dose of study medication
* Use of an investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
* History of drug-related allergy reaction
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average
Families and Pediatric Cardiac Surgery Multidisciplinary Teams: How Well Do We Communicate

Purpose:

-To evaluate the peri-operative communication between families and the pediatric cardiac surgery team.

Method:

-In this study the investigators plan to utilize structured interview and survey of parents/legal guardians and health care providers of children undergoing cardiac surgery in the United States of America.

Every day clinicians face challenges when attempting to negotiate their way through dialogues with families whose children require surgical intervention in the near future. The area of clinician-patient communication with pediatric families is under-researched and highlights a pressing clinical problem. There are several adult studies that describe the content and nature of patient-physician communications at the time of cardiac surgery. However, there are no studies that evaluate the communications between nursing, physicians, and pediatric patient's families at the time of cardiac surgery. Further knowledge in this area is valuable in that a disparity between the these groups can lead to medical error, damage the clinician-patient relationship and provide grounds for dissatisfaction, complaints, or claim. This research will provide insight into what patient's families value in their communications with the medical team and assist the medical community in better meeting our children's families needs.

Eligibility Criteria:
Inclusion Criteria:

* Primary language is English
* \> 18 years age
* Nurse, physician, physician assistant, or parent / legal guardian of a pediatric patient who requires cardiothoracic surgery at the North Carolina Children's Hospital.

Exclusion Criteria:

* Primary language is not English. The interviewers all speak English as their primary language. People whose primary language is other than English will only be excluded if they do not have the ability to converse in English with the interviewers.
* \<18 years of age. The parent / legal guardian must be of age to be the primary caregiver able to make decisions for their child.
* People with an intellectual or mental impairment that prohibits their capacity to make medical decisions for their child. Our research aims to investigate the relationship between the parent / legal guardians of pediatric cardiac surgery patients who interact with the pediatric cardiac surgery multidisciplinary team. These individuals must have sufficient mental capacity to be able to provide consent for their child to undergo surgery. Individuals with intellectual or mental impairment that prohibits their ability to give consent are therefore excluded.