cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Rehabilitation Protocol for Sensory-motor Rehabilitation After a Stoke

Introduction: Stroke is the second leading cause of death in Europe. In the case of stroke survival (almost 70%), only 25% of patients recover completely, while the remaining 75% will undergo a rehabilitation phase that varying from months to years. The main consequences of a stroke include motor disability of the upper limbs, which involves a partial or complete inability to move the right or left limb, depending on the damaged hemisphere. Furthermore, the motor deficit distorts the proprioception of the body and the embodiment ability of the injured limb. This could be rehabilitated through the paradigm of body illusion that modulates the motor rehabilitation. The present protocol aims to investigate the effectiveness of a Virtual Reality system for sensorimotor and proprioception upper limb deficit compared to a traditional upper limb rehabilitation program.

Method: This study has a randomized and controlled design with control and experimental groups, a 1:1 allocation ratio, and 4 measurement times: pre-intervention, immediately after the intervention, and two follow-ups (at 6 and 12 months). The inclusion criteria are: (a) Being 18 to 85 years old, both males and females; (b) Suffering from ischemic or hemorrhagic stroke; (c) The stroke event must have occurred from two to eighteen months before recruitment; (d) Patients must have moderate to severe upper limb motor deficit, and the alteration of sensorimotor and proprioception abilities of the injury upper limb; (e) Patients must understand and sign the written consent for enrolment. The rehabilitation last four weeks with three sessions per week at Bellaria Hospital of Bologna (Italy). The VR protocol uses two types of technology: immersive and non-immersive, and the control group follow the traditional rehabilitation program.

Ethics and dissemination: The protocol was accepted by the Local Ethics Committee (ASL_BO n. 0115481) and the clinical trial was promoted.

Randomized control trial with active groups.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 to 85 years old (both male and female)
* Suffering from ischemic or hemorrhagic stroke
* Time since the stroke from 2 to 18 months before recruitment
* Severe upper limb motor deficit established by a score of ≤ 80 on the Motricity Index
* Alteration of sensorimotor and proprioception abilities of the injury upper limb (failure in 3 proofs up to 4 of the Thumb Location Test)
* Understand and sign the written consent for enrolment

Exclusion Criteria:

* Severe cognitive and behavioral disorders or a state of confusion defined by temporal and/or spatial disorientation detected during an ordinary conversation (evaluate through 4AT)
* Severe upper limb motor deficit (score Motricity Index Scale: gripper \<11, elbow flexion \<14, shoulder abduction \<14)
* Verbal comprehension ability (score \<2 at Token Test)
* Severe spatial neglect ( score of \>3 at Barrage test)
Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders

This is a phase II, single-center study to evaluate the efficacy of a novel cytoreductive regimen followed by CD34+E- selected T cell depleted allogeneic stem cell (or soybean agglutinated and E-rosetted BM) transplant as treatment for patients with acute and chronic leukemias, lymphoma and myelodysplstic syndrome/PNH. The impact of the change in conditioning regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and mortality and disease free survival will be assessed.

The purpose of this study is: (1) to try to kill any cancer or precancer cells that are in your body, and to reduce the side effects of a transplant, which we have seen in our previous studies, (2) to see if this treatment with a new recipe of radiation and chemotherapy can suppress your immune system enough for the stem cells to 'take' and grow, (3) to see if the specially prepared stem cells can grow in you without a problem called graft-versus-host disease (GvHD) occurring.

One of the major side effects of any stem cell transplant is a condition known as graft vs. host disease or GVHD. GVHD is an immune reaction caused by certain cells from the transplanted stem cells called T-lymphocytes (or T-cells). The T-cells from your donor may see your organs as foreign and attack them. New ways to remove the T-cells from the stem cells before the transplant are being used to try and prevent GVHD. In some studies, the removal of T-cells from the stem cells has been successful for many patients in preventing both short-term (acute) and long-term (chronic) forms of GVHD. However, the removal of T-cells may increase the chance that the new bone marrow developing from the stem cells will be rejected or will not function well. Rejection of the transplant means that some of your own cells have survived the chemo and radiation therapy, and are attacking the new bone marrow cells. This condition can be lifethreatening because of an increased risk of infections and bleeding and would require your getting more treatment and additional stem cells. Studies like this one are designed to find better ways to avoid GVHD without increasing the risk of other problems such as graft rejection.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven acute or chronic leukemia, non Hodgkins and lymphoblastic lymphoma or myelodysplastic syndrome
* HLA 6/6 or 5/6 antigen matched related or unrelated donor
* creatinine = normal or if not, CrCl \> 60 ml/min/1.73ml
* total bilirubin \< 2.5, AST \< 2xnl, cardiac function \> 50%
* pulmonary function - asymptomatic or if not DLCO \> %50% (corrected for Hgb)
* Karnofsky performance status \> 70%
* negative pregnancy test (where applicable)
* signed informed consent of patient and donor.

Exclusion Criteria:

* Pregnancy or lactation
* unwillingness to comply with protocol treatment or follow-up
* uncontrolled infection
* HIV or HTLV positivity
* active CNS/skin disease
Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients

The goal of this clinical trial is to learn if drug Faricimab works to treat nAMD, DME or RVO in adults. It will also learn about the safety of drug Faricimab. The main questions it aims to answer are:

Does drug Faricimab can improve the best-corrected visual acuity of participants? What medical problems do participants have when inject drug Faricimab? Participants will inject drug Faricimab every month for 3 months. Visit the clinic once every 2 weeks for checkups.

Intravitreal anti-vascular endothelial growth factor (VEGF) therapies are used to treat retinal vascular diseases such as neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). However, the clinical effectiveness of such therapies is often suboptimal, often resulting in poor treatment adherence due to the burden of frequent monitoring and injection therapy (every 4-8 weeks). Different approaches have been investigated to improve outcomes in such diseases, including modification of dosing regimens to reduce treatment burden and continued research to identify new drug targets. Angiopoietin-2 (Ang-2) has been implicated in the pathogenesis of several retinal vascular diseases, including nAMD and DME, and has therefore been identified as a potential new target.

Faricimab (faricimab-svoa; Vabysmo), a bispecific antibody that inhibits both VEGF-A and Ang-2, was developed by Roche/Genentech. Dual-pathway inhibition may provide stronger and longer-lasting efficacy in the treatment of retinal vascular disease. Faricimab is administered via intravitreal injection. It is the first bispecific antibody designed for intraocular use. In January 2022, faricimab was approved in the United States for the treatment of participants with nAMD or DME. And in March 2024, faricimab began to be approved for use in the treatment of patients in our clinic.

Therefore, investigators collected participants who were injected with Faricimab in the clinic and conducted follow-up visits to evaluate the therapeutic efficacy and application prospect of Faricimab in the clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese patients aged 18 years or older and of any gender;
2. Patients who have been diagnosed with nAMD, DME or RVO by OCT, FFA, ICGA or OCTA;
3. Patients whose decision to receive treatment with faricimab was made prior to and independent of study participation;
4. Patients who have received at least one treatment with faricimab during the course of the study;
5. have signed an informed consent form.

Exclusion Criteria:

1. Active ocular inflammation or suspected active ocular infection in either eye;
2. Receipt of any other anti-VEGF therapy after faricimab;
3. Patient is unable to provide clinical data (visual acuity and OCT images) within 2 weeks (14 days) prior to receiving the initial faricimab injection;
4. Currently participating in any other clinical trial.
Sampling Biomarkers in Meniscus Injury to the Knee

The diagnosis of clinically-significant meniscal tears of the knee remains challenging, and it is unknown why only some injuries become painful. The limitations of diagnostic magnetic resonance imaging result in arthroscopy that is not always beneficial. Elucidation of biochemical pathways underlying pain in this condition may aid patient selection for surgery and provide pharmacotherapeutic targets. Cytokines may be involved in pain following meniscus injury and diagnostic cytokine assay may help physicians differentiate patients that may benefit from arthroscopy from those that may not.

Lavage of the operative and contralateral knee for comparison was performed under anesthesia prior to arthroscopy by the infusion of sterile saline into the knee joint followed by the immediate withdrawal into the syringe. Sixteen asymptomatic control subjects also contributed knee samples. The concentrations of 17 inflammatory cytokines/chemokines were measured using a multiplexed immunoassay panel. Pre-operative magnetic resonance imaging findings and cytokine assay results were compared to "gold-standard" intraoperative findings.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with knee pain \< 6 months with acute onset who had failed conservative treatment and elected for arthroscopic management. Indications for surgery included the presence of mechanical symptoms on history, a physical examination positive for McMurray's maneuver or joint line tenderness or both32, absence of severe joint space narrowing on plain radiography1 33, and the presence of grade III signal changes on MRI35 in an anatomic location consistent with the history and physical examination.

Exclusion Criteria:

* Less than 18 years old.
* Recent (within three months) intra-articular corticosteroid injection and past or current medical history of autoimmune disease (i.e. rheumatoid arthritis).
* In addition, no patients involved in a worker's compensation claim or personal injury litigation were enrolled in the study.
Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)

The purpose of this study is to characterize the multiple myeloma (MM) participants with symptomatic relapse and/or refractory disease in Spain.

Adult participants with a diagnosis of MM who have received at least one previous treatment line and have experienced symptomatic relapse and/or refractory disease in the previous 6 months, who are still in follow-up at the time of the study visit will be observed in this study.

The study will look into sociodemographic data, current clinical and therapeutic data, clinical data relative to the latest relapse and clinical data at diagnosis and previous relapses will be collected.

The study will enroll approximately 350 patients.

This multi-center trial will be conducted in a total of 30 public sites in Spain. The overall time to collect data will be approximately 1 year from June 2017 to May 2018.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of MM and has received at least one previous treatment line.
* Have experienced symptomatic relapse and/or refractory disease in the 6 months before the study.
* Has continued in follow-up at the time of the study visit.
* Is currently treated in the site who have clinical records available.
* Is capable of understanding and completing the questions in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), and EORTC Multiple Myeloma Module (QLQ-MY20) questionnaires.

Exclusion Criteria:

• Participants who do not agree to participate in the study or who do not give written informed consent.
Neonatal Transcatheter Cardiac Interventions at Sohag University Hospital

This study is performed to assess the safety, efficacy and outcome of transcatheter cardiac interventions in neonates with critical congenital heart disease at Sohag University Hospital

This study includes neonates with critical congenital heart diseases that require early interventions Patients with untreated sepsis and coagulopathy are excluded.

Methods:

A) Clinical data: age, body weight and oxygen saturation B) Echocardiographic data: cardiac anatomical diagnosis. C) Catheterization data: vascular access, description of the defects, type of the device used, fluoroscopy time, radiation time, related complications and added interventions in the same setting.

D) Procedural details:

* All procedures will be performed under general anesthesia. procedures will be performed are;

  1. Balloon atrial septostomy.
  2. PDA stent implantation.
  3. Pulmonary valvuloplasty.
  4. Aortic valvuloplasty.
  5. Balloon angioplasty of coarctation.
  6. PDA device closure for preterm neonates.

     E) Post-procedure details:
* All the patients will be transferred to NICU.
* Prophylactic antibiotic therapy will be given to all patients.
* In patients with PDA stent; heparin infusion will be maintained for at least for 24-48 hours then acetylsalicylic acid: Dose; 5mg/kg/day will be added when oral feeding could be established until undergoing second-stage palliation or repair.

Eligibility Criteria:
Inclusion Criteria:

* Neonates with critical congenital heart diseases that require early intervention

Exclusion Criteria:

* Untreated sepsis and coagulopathy.
Revascularization of Total or Sub-total Occluded Peripheral Arteries With ByCross® Device. Post Market Clinical Followup

Post market clinical follow up of Bycross® device.

A prospective, multi-center, non-randomized, observational, post market clinical follow-up study of the ByCross® device to evaluate the safety, technical performance and effectiveness of the ByCross® device and effectiveness of the procedure using the device and adjunctive therapy.

The ByCross® is a single use, disposable, minimal invasive aspiration rotational atherectomy device. The ByCross® is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. In cases that the artery is completely blocked such that opening is not possible with currently available solutions and the procedure cannot be completed, the device is capable of crossing the blocked lesion without guiding wire and enables the completion of the procedure in a safe and effective manner, thus potentially eliminating the need for open bypass surgery. The ByCross® can be used in several pathologies: calcified atheroma, old and fresh thrombus and in stent restenosis at peripheral arteries including iliac

Eligibility Criteria:
Inclusion Criteria:

* Subject has documented symptomatic chronic peripheral vascular disease at a vessel below the aorta bifurcation
* Candidate for percutaneous intervention
* Severely stenotic occlusion target vessel (stenosis ≥70%)
* Subject has been informed on the nature of the study and has provided informed consent
* Subject is capable of meeting study requirements including presences at follow-up visits

Exclusion Criteria:

* Patient anatomy excludes use of BYCROSS® device
* Vessels of the cardiopulmonary, coronary or cerebral circulations
* Undersized vessel diameters (\<3mm)
* Perforation of the vessel distally or proximally to the occlusion segment prior atherectomy
* Subintimal position of the guiding catheter or the guidewire
* Use in stents or stent grafts if the guidewire has become threaded at any point in the wire mesh of stent or stent graft or the lining of the stent graft
* Target is at vessel segment which includes tortuous course with radius of curvature \<= 40mm
* Access pathway includes tortuous course with radius of curvature \<= 25mm, in specific extremely sharp aortic bifurcation
* In aneurysmatically altered iliac vessel segments
* If the introducer sheath, the guide catheter, the guidewire or the BYCROSS® sustains any visible damage, especially kinking
* In the fracture areas of broken stents
* Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure
* Persistent vasospasm
* During use of a defibrillator on the patient
Training Adaptations With and Without Ventilatory Training Device

This project aims to assess the effectiveness of using a Respiratory Muscle Training (RMT) device during high-intensity functional training (HIFT) to improve fitness and ventilatory parameters. Primary outcome measures include aerobic, anaerobic, and HIFT measures. Secondary measures include sleep, affect, and mood state questionnaires. Participants will be randomized into one of two groups: with the RMT device and without the RMT device.

This study assesses the impact of a ventilatory training device, similar to a sports mouth guard worn during exercise, on various performance outcomes. The main questions it aims to answer are:

* Does the device improve fitness parameters: high-intensity functional training, anaerobic capacity, anaerobic peak and mean power output, maximal oxygen uptake, ventilatory threshold, and blood lactate responses to training?
* Does the device improve spirometry measures?

Researchers will compare 6 weeks of training with the ventilatory training device to those without the training device.

Participants will:

* Take part in a total of 8 weeks of study-related activity.
* Complete six total one- to two-hour pre- and post-testing sessions, which include a maximal oxygen uptake test, high-intensity functional training, body composition, spirometry, anaerobic power and capacity testing.
* Complete six weeks of 45-minute high-intensity functional training, three days per week.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 and 35 (inclusive) who participate in at least 150 minutes per week of physical activity.
* Have not participated in HIFT training in the last 6 months.
* Provided written and dated informed consent to participate in the study.
* In good health as determined by medical history and is cleared for exercise.
* Participant will be asked about dietary supplementation use within the past 6 months.

  * If participant began taking a supplement within the past month, subject will be asked to discontinue supplement use followed by a 2-week washout prior to participation.
  * In all other cases, we will request that participant maintain supplement use.

Exclusion Criteria:

* Any musculoskeletal injuries that would prevent exercising.
* Any metabolic disorder including known electrolyte abnormalities, diabetes, uncontrolled thyroid disease, adrenal disease or hypogonadism.
* Any inborn error of metabolism.
* History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
* Participants with a personal history of heart disease, high blood pressure (systolic \>140 mm Hg \& diastolic \>90 mm Hg),
* Participants who are pregnant, planning to become pregnant, or lactating.
A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties

The purpose of this study is to determine if medication designed to improve memory will help patients with Multiple Sclerosis (MS) who are experiencing memory problems using fMRI to track brain activity.

Donepezil HCI (Aricept®) is an FDA-approved drug now used to enhance memory in patients with Alzheimer's disease. The aim of this project is to examine the effects of Donepezil HCI (Aricept®) on memory induced brain activation patterns in the context of a double-blind, crossover trial of patients with multiple sclerosis (MS). We will perform task activation experiments involving two cognitive domains. The proposed work on MS patients should yield new information regarding functional anatomic relationships during cognitive activity, and how these relationships change as a function of drug treatment.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years of age and experiencing some forgetfulness
* Diagnosed with MS, currently taking Rebif® and experiencing mild memory problems
* Participants will have stable medication dosages 1 month prior to testing
* With no past or present neurological disorders (e.g. head trauma, seizures, encephalitis, stroke) except MS
* With no known medical illnesses (e.g. diabetes, uncontrolled hypertension, arthritis)
* With no psychiatric illness
* With no current substance abuse
* Females should not be pregnant or nursing
* With no metallic devices in the body or claustrophobia

Exclusion Criteria:

* Previous history of CNS disturbance other than MS
* Severe motor or visual impairment that might interfere with the cognitive activation tasks
* Prescribed psychoactive medications
* Memory deficits caused by other significant neurological disease or psychiatric disorder
* Active malignancy within one year of study participation
* Known human immunodeficiency virus (HIV)
* Current diagnosis of unstable glaucoma; history of myocardial infarction
* Symptomatic Coronary Artery Disease within the last 12 months or evidence of ongoing ischemia or uncontrolled atrial or ventricular arrhythmias as shown by ECG; poorly controlled or labile hypertension
* History of epilepsy or other seizure disorder within the past 12 months
* Allergy or hypersensitivity to amphetamines or other sympathomimetic amines