cyrilzakka/clinical-trials huggingface dataset:
Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT

The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clear diagnosis of hematologic disease, weighing ≥30kg, aged 18-60, of any gender and race;
* Willing to undergo haploidentical hematopoietic stem cell transplantation;
* Voluntarily participate in this study;
* Each subject must sign an informed consent form (ICF) indicating their understanding of the purpose and procedures of the study, and their willingness to participate. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member.

Exclusion Criteria:

* Those with severe organ dysfunction or diseases, such as heart, liver, kidney, and pancreatic diseases;
* Patients who cannot tolerate CD25 monoclonal antibody treatment;
* Subjects and/or authorized family members who refuse allo-HSCT treatment;
* Any life-threatening diseases, physical conditions, or organ system dysfunctions that the researcher believes may jeopardize the safety of the subject and pose unnecessary risks to the study; drug dependence; uncontrolled mental illness in subjects; cognitive dysfunction;
* Those who have participated in other similar clinical studies within the past 3 months;
* Those deemed unsuitable for inclusion by the researcher (such as patients expected to be unable to adhere to treatment due to financial issues, etc.).
AZD8529 Multiple Ascending Dose Study in Healthy Subjects

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after multiple ascending doses


Eligibility Criteria:
Inclusion Criteria:

* Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30months of the first administration of investigational prod
* Plasma donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Immunity Against AAV in Crigler Najjar Patient

The proposed research protocol aims at addressing these points by pre-screening CN patients for their AAV serology in link with their medical history and current medical status. A first objective is to assess the presence of neutralizing AAV antibodies in the serum of CN patients.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a Crigler-Najjar syndrome
* The molecular diagnosis has been confirmed by UGT1A1 gene DNA sequencing

Exclusion criteria:

* The patient is liver transplanted
* The patient is suffering from severe associated pathologies precluding further enrolment in a future interventional clinical study
A Food Effect Study of JAB-21822 in Healthy Subjects

The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of JAB-21822 following single dose administration with and without a meal

This is an open-label,randomized, 2-cycle,2-period crossover,food effect study. On Day 1 of each period, subjects will receive a single oral dose of JAB-21822 administered either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for JAB-21822 will be collected predose and postdose. There will be a washout period between doses.

Eligibility Criteria:
Inclusion Criteria:

* Male or female , between 18 and 45 years of age
* Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg；BMI within the range of 19 to 25 kg/m2, inclusive
* No clinically significant abnormalities identified in the judgement of investigator at screening
* Written informed consent prior to any study specific procedures

Exclusion Criteria:

* History of clinically significant disease or disorder
* History of interstitial pneumonia, pulmonary fibrosis, and other interstitial lung diseases
* History of dysphagia or any gastrointestinal disease that would potentially alter absorption of drug
* COVID-19 positive at screening or baseline
* Allergic to JAB-21822 and any of the tablet's ingredients, history of hypersensitivity or allergy to drug or food
* Received surgical procedure within 3 months at screening
* Blood donation within the 3 months or planing to donate during the study
* Participated in another clinical trial of biological agents within 6 months at screening, or any other clinical trial within 3 months at screening
* History of drug abuse or positive urine drug test
* Received the vaccine within 3 months at screening or planning to receive during the study
* Overtake of achole,tea and coffee prior to first dosing and unable to control during the study
* Special dietary requirements or unable to control during the study
* HIV, HBV, HCV, and syphilis positive
* Pregnant or breast-feeding women or positive of blood pregnancy test
* Subjects who are considered to be unacceptable in this study under the opinion of the investigator
Effects of 3D-printed on Lower Extremity Biomechanics in Individuals With Knee Osteoarthritis

The purposes of this study are: (1) to determine the kinematics, kinetics, and muscle co-activation ratio of level walking and stair negotiation under three different conditions (shoes only, shoes embedded 3D printed insoles, and shoes embedded 5-degree lateral wedges), (2) to build a detailed patient-specific knee model via MR images and musculoskeletal model, then, evaluate the compressive forces acting on the medial aspect of the knee during level walking and stair negotiation.

This study is a cross-sectional study with patients serving as their own control. The investigators will recruit 20 patients with knee osteoarthritis. Using motion capture system, force plates, wireless EMG to capture the motion data of patients during walking and stair negotiation in each condition.

Eligibility Criteria:
Inclusion Criteria:

* Medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
* Aged from 50 to 70 years

Exclusion Criteria:

* Neuromuscular illness (e.g., Parkinson disease, Neuropathy)
* Predominant lateral or patella-femoral OA
* Previous of planned hip or knee replacement
* Hip or ankle arthritis
* Rheumatoid arthritis
* Unable to walk without a cane or walker
* Unable to walk up and down the stairs
Blood Levels of Local Anaesthetic in Knee Arthroplasty

The primary goal is to evaluate ropivacaine blood concentrations during and after local anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee replacement surgery. The investigators plan to measure these levels by testing blood samples taken over a timed period.

This will allow us to confirm whether the current regimen of local anaesthetic use is within safe limits.

Local anaesthetic (LA) toxicity may occur when the blood levels of a drug become particularly high. There is a need to confirm that the technique is safe to use. In addition, journal case reports may only describe serious side-effects of toxicity such as abnormal heart rhythms whilst more subtle clinical signs are rarely reported.

The investigators would like to study whether or not toxic levels may be approached in some patients or whether more subtle toxicity symptoms and signs are missed. For example, irregular heartbeat, low blood pressure or confusion/agitation.

Therefore, the investigators intend to study ropivacaine blood levels in patients receiving a total knee replacement in the Golden Jubilee National Hospital. A series of timed samples will be taken during the perioperative period. The anaesthesia and surgery will be performed as routine and no new treatment will be involved. Patient demographics, ropivacaine blood levels and clinical observations following LA administration will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients greater than 65 years of age

Exclusion Criteria:

* Patients with a known sensitivity/allergy to ropivacaine or amide-type local anaesthetics
* Patients who are not suitable for the Caledonian technique
* Patients who refuse or are unable to give consent
* Patients undergoing bilateral hip replacements
* Patients with known heart, liver or kidney failure
High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation

The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the antibody works against a very small amount of neuroblastoma (minimal residual disease) that is left in the bone marrow.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
* High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System,89 i.e., stage 4 with (any age) or without (\> or = to 18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
* The patients are post-stem cell transplantation and in first CR/VGPR, including no measurable MIBG-avid soft tissue tumor assessable for response.
* Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

* Creatinine \> 3.0 mg/dL
* ALT, AST and Alkaline Phosphatase \> 5.0 times the upper limit of normal
* Bilirubin \> 3.0 mg/dL
* Patients with grade 3 or higher toxicities (using the CTCAE v3.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. Patients must have normal blood pressure for age.
* Progressive disease
* History of allergy to mouse proteins.
* Active life-threatening infection.
* Human anti-mouse antibody (HAMA) titer \>1000 Elisa units/ml.
* Inability to comply with protocol requirements
Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates

The aim of this study to assess platelet activation during 5 days storage of platelet concentrates prepared by different techinques .

Platelet transfusion is a lifesaving procedure that is carried out to prevent bleeding or stop ongoing bleeding in patients with low platelet count or functional platelet disorders. There are minimum thresholds at which platelets are transfused in these patients, as not all low levels of platelet warrants a transfusion. Platelet is a scarce resource as processing, preparing, and transfusing it requires a great deal of precision and effort to maintain a certain quality. This activity highlights the use of platelet transfusion by the interprofessional team (1).

Platelets play an integral role in hemostasis by its response to vascular injury. The relevance of platelet component therapy was better understood in the 1950s and 1960s when severe and fatal hemorrhagic complications of chemotherapy in leukemia were studied

The collected blood units were randomly assigned to two groups:

1. Non-filtered platelet concentrates (NF-PC group).
2. leukocyte-depleted platelet concentrates (LD-PC group). P-selectin (CD62p) is a type of glycoprotein stored in the Weibel-Palade bodies of vascular endothelial cells and platelet α-granules. Activated CD62P is a transmembrane protein expressed on the platelet surface. During platelet activation, the expression of CD62P on the surface of the cell membrane is dramatically increased in PCs without leukocyte depletion, due to the presence of WBCs and cytokines ,and is accompanied by an increase in the expression level of plasma soluble CD62

Eligibility Criteria:
Inclusion Criteria:

* Donors who met criteria of Egyptian National Transfusion services
* Donors who had not taken any antiplatelet drugs for two weeks prior to donation
* pre-collection platelet count ≥200×109 /L.
* Blood grouping.
* Serological assays for all blood donors (HBsAgs, HCV antibodies, HIV Ag/Ab Syphilis antibodies) on Architect i 2000 SR or Centaur XPT (chemoluminescence).

Exclusion Criteria:

* Donors who not met criteria of Egyptian National Transfusion services
* Donors who had taken any antiplatelet drugs for two weeks prior to donation
* pre-collection platelet count \<200×109 /L.
* Reactive serology
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

A prospective, multi-center, randomized, controlled, blinded trial of subjects implanted with VNS Therapy. Active treatment and no stimulation control are randomized, at least two weeks after implantation and observed for 12-months.

After completing the 12 month endpoint in the RCT portion of the study, all RECOVER subjects will transition into the prospective, open-label, longitudinal portion of the study. Subjects in the control arm of RECOVER will be activated after completing the 12 month endpoint.

After completion of enrollment in the RCT portion or meeting of interim success criterion (whichever comes first), up to 5,800 new subjects may enroll directly into the open-label,prospective, longitudinal study. These subjects will participate in the study for approximately 5 years.

The study has been designed in accordance with The Centers for Medicare and Medicaid Services coverage with evidence development (CED) decision entitled "Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) (CAG-00313R2).

Eligibility Criteria:
Inclusion Criteria:

The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.

The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.

The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.

Patients must maintain a stable medication regimen for at least four weeks before device implantation.

Exclusion Criteria:

Current or lifetime history of psychotic features in any MDE;

Current or lifetime history of schizophrenia or schizoaffective disorder;

Current or lifetime history of any other psychotic disorder;

Current or lifetime history of rapid cycling bipolar disorder;

Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;

Current suicidal intent; or

Treatment with another investigational device or investigational drugs.
Assesment of the Metabolomic Signature in COVID-19 Patients

Metabolomics is the analysis of small molecules in a biological sample (cells, tissues or biological fluids). It can potentially detect very sensitively any change related to a pathology or exposure to a toxic agent. The analyses are fast, inexpensive and therefore applicable in routine, particularly in health care. Given the emergence of this new disease, COVID-19, there is a real need to better understand the pathophysiological mechanisms of SARS-CoV-2 infection. In this context, metabolomics could have a place and could lead to the development of interesting diagnostic or prognostic tools. The objective of this study is to identify, through the analysis of biological samples (blood and urine), whether there is a metabolomic signature in patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* patient over 18 years of age
* affiliated to a social security scheme
* consultant in the emergency department and/or being hospitalized for suspected SARS CoV infection
* confirmation, after medical examination, of the need for a biological examination (this will negate the need for additional venipuncture)

Exclusion criteria:

* Patient who do not meet inclusion criteria
* Person subject to a guardianship order
* Opposition to the use of the data or samples (withdrawal of non-opposition) / Sponsor's or investigator's decision
Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis

Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD prophylaxis of PTCy 40 versus 50.

Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. In the clinical setting, reduced dose of PTCY (40mg/kg) was used for patients over 60 or with high HCT-CI and the overall incidence of acute GVHD was similar to PTCY 50mg/kg but chronic GVHD was slightly increased. To confirmed our observation, in this study, a prospective multiple-center randomized comparison is planned to evaluate the clinical outcomes of reduced dose of PTCY (40mg/kg) versus 50mg/kg as GVHD prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematological malignancies
* Patients undergo allogeneic stem cell transplantation from haplo-identical donors
* Patents with informed consent provided

Exclusion Criteria:

* Patients with active infection ()bacteria, fungal or viral)
* Patients with liver, renal and cardiac dysfunction not suitable for undergoing allogeneic stem cell transplantation.
Effect of Gastric Bypass on Patients With Type 2 Diabetes and/or Dyslipidemia

This is a retrospective review of patients who have undergone bariatric surgery at VUMC and who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that gastric bypass significantly improves diabetes 6-12 months after surgery. The investigators are interested in looking at the longer term results after surgery.

Review and record changes in the subject's medication. subjects vitals: weight, blood pressure, and fasting blood values, which include:

* HbA1c
* Fasting blood glucose
* Fasting Insulin
* Lipid Panel ( total cholesterol, LDL, HDL and triglycerides) were obtained.

Eligibility Criteria:
Inclusion Criteria:

Patients who have had diabetes and/or dyslipidemia prior to gastric by-pass. -

Exclusion Criteria:Patients who have had type 2 diabetes that was diet controlled at time of surgery; and debilitated patients who are unable to come in for a physical exam.

-
High Intensity Interval Training and Rheumatoid Arthritis

The overall objective is to determine whether High Intensity Interval Training (HIIT) has potential to improve disease activity scores for Rheumatoid Arthritis (RA) patients. By reducing inflammation and modifying immune function HIIT may offer a substantial paradigm shift in RA care, especially in older persons with RA who experience aging related-immunesenescence, increased systemic inflammation and greater physical inactivity than young persons. Prior to embarking on a large scale trial of HIIT-induced disease modification, this pilot study aims to demonstrate that HIIT can produce measurable responses in disease activity scores and peak VO2in persons undergoing routine pharmacologic treatment for RA.


Eligibility Criteria:
Inclusion Criteria:

* Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs.
* History of fulfilling 2010 ACR/EULAR Classification Criteria for RA
* Able to walk on a treadmill
* Not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting.
* No medication changes within the last three months.
* Willing to forego knee joint injections, regular NSAID use, and use acetaminophen for any necessary analgesia during the course of the intervention.
* No current (within the last three weeks) pharmacologic therapy with corticosteroids.

Exclusion Criteria:

* Coronary artery disease
* Diabetes mellitus
* Chronic obstructive pulmonary disease
* Absolute contra-indications to exercise: Recent (\<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
* Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, Wilson's disease, osteonecrosis, knee replacement.
* Contraindicated Medicine: ticlopidine, clopidogrel, dipyridamole, warfarin, heparin, enoxaparin and other blood thinners.
Incidence and Factors Associated With Double-J Urinary Stent Infection (IJJ)

The aim of the study was to determine the incidence and factors associated with double-J urinary stent infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a double-J stent placement or change in the hospital

Exclusion Criteria:

* renal transplants less than one year old
Investigating Project of the Functional C13 Test "Pilot Study"

The aim of this pilot study is to evaluate the validity and reproducibility of a functional test "Test C13" ureogenesis to measure in vivo, using the methodology Laboratory of Metabolic Diseases of "Cliniques Universitaires Saint-Luc"


Eligibility Criteria:
Inclusion Criteria:

* healthy or with a disorder of the urea cycle

Exclusion Criteria: