cyrilzakka/clinical-trials huggingface dataset:
MiHA-loaded PD-L-silenced DC Vaccination After Allogeneic SCT

Allogeneic stem cell transplantation (allo-SCT) is a potent treatment, and sometimes the only curative treatment for aggressive hematological malignancies. The therapeutic efficacy is attributed to the graft-versus-tumor (GVT) response, during which donor-derived CD8+ T cells become activated by recipient minor histocompatibility antigens (MiHA) presented on dendritic cells (DC). Consequently, these alloreactive donor T cells clonally expand, acquire effector functions and kill MiHA-positive malignant cells. However, in a substantial number of patients persistence and recurrence of malignant disease is observed, indicating that insufficient GVT immunity is induced. This is reflected by our observation that not all patients develop a productive CD8+ T cell response towards MiHA mismatched between the recipient and donor. We found that the PD-1/PD-L1 co-inhibitory pathway is involved in dampening MiHA-specific CD8+ T cell expansion and function post-transplantation. Therefore, a promising strategy to induce or boost GVT immune responses is pre-emptive or therapeutic vaccination with ex vivo-generated donor DCs loaded with MiHA that are exclusively expressed by recipient hematopoietic cells and their malignant counterparts. In contrast to pre-emptive donor lymphocyte infusion (DLI) with polyclonal donor T cells, this MiHA-DC vaccination approach has less risk of inducing graft-versus-host disease (GVHD) and the potency to induce more efficient GVT-associated T cell immunity. In addition, the potency of this DC vaccine will be further enhanced by interference with the PD-1/PD-L1 co-inhibitory pathway, using siRNA mediated PD-L1/PD-L2 silencing.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML, myelodysplasia (MDS), ALL, CML (accelerated or blast phase), CLL, MM, malignant NHL or HL, who underwent HLA-matched allo-SCT
* Patients positive for HLA-A2 and/or HLA-B7
* Patients positive for HA-1, LRH-1 and/or ARHGDIB transplanted with corresponding MiHA-negative donor
* Patients ≥18 years of age
* WHO performance 0-2
* Witnessed written informed consent

Exclusion Criteria:

* Life expectancy \< 3 months
* Severe neurological or psychiatric disease
* Progressive disease needing cytoreductive therapy
* HIV positivity
* Patients with acute GVHD grade 3 or 4
* Patients with severe chronic GVHD
* Patients with active infections (viral, bacterial or fungal) that require specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment
* Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
* Severe pulmonary dysfunction
* Severe renal dysfunction (serum creatinine \> 3 times normal level)
* Severe hepatic dysfunction (serum bilirubin or transaminases \> 3 times normal level)
* Patients with known allergy to shell fish
Diabetes Remission After RYGBP and RYGBP With Fundus Resection

The goal of this randomized clinical trial is to evaluate glycemic control in patients with morbid obesity and type 2 diabetes after Roux-en-Y gastric bypass (RYGBP) and RYGBP with fundus resection. The main questions to answer are:

* Rate of diabetes remission and the role of the gastrointestinal hormones
* Whether fundus resection leads to improved glycemic control

Patients will randomly undergo typical RYGBP or RYGBP with fundus resection. Gastrointestinal hormones profile \[ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), glucagon\], glucose levels and insulin response will be measured preoperatively, at 6 months and at 12 months, during 120-min OGTT.


Eligibility Criteria:
Inclusion Criteria:

* morbid obesity (ΒΜΙ ≥ 40)
* type II diabetes mellitus (T2DM)
* duration of T2DM shorter than 8 years

Exclusion Criteria:

* pregnancy
* type 1 diabetes
* previous gastrointestinal surgeries
* alcohol consumption
* depression
* no compliance
Candin Safety & Efficacy Study for the Treatment of Warts

The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).

The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.

Eligibility Criteria:
Inclusion Criteria:

* Must have at least 3 and not more than 10 common warts not located on the palms or digits
* Positive DTH response to Candin® required

Exclusion Criteria:

* No previous medical treatment for warts other than OTC
* No immunocompromising medical conditions or medicines allowed
* No preexisting inflammatory conditions at treatment site allowed
Right Ventricle Morphology and Hemodynamics in BrS

The study purpose is to evaluate the morphological, functional and electrophysiological characteristics of the right ventricle before and after ajmaline in patients diagnosed with Brugada syndrome as well as to correlate CMR findings and substrate size.

All consecutive patients with either spontaneous or ajmaline-induced BrS-ECG pattern will be screened. A total of 30 BrS patients and 30 normal age, sex and BSA matched normal controls will be selected and enrolled. Patients will perform cardiac magnetic resonance imaging to evaluate and compare morphological and functional characteristics of the 2 groups before and after ajmaline. BrS patients will also perform a standardized programmed ventricular stimulation protocol and electroanatomical mapping to determine the substrate size.

Eligibility Criteria:
Inclusion Criteria:

* Brugada syndrome with either spontaneous or ajmaline- induced type 1 ECG pattern
* Indication to ajmaline testing and programmed ventricular stimulation
* Age \> or equal to 18 years
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Contraindication to CMRI or to ajmaline
* Live espectance \< 12 months
A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

To evaluate the efficacy of oral ganciclovir in preventing progression to cytomegalovirus (CMV) disease (e.g., CMV retinitis, gastrointestinal CMV disease) in CMV-infected people with HIV infection and CD4 lymphocyte counts \<= 100 cells/mm3. To evaluate the efficacy of this drug in reducing morbidity associated with coinfection by both CMV and HIV.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical or ophthalmic nucleoside analogs.

Patients must have:

* Confirmation of HIV infection.
* Documented CMV infection.
* No past or present CMV disease (e.g., retinitis, colitis, esophagitis).
* Adequate visualization of the retina of both eyes by ophthalmologist.
* CD4 count \<= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count \<= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication).
* Inability to comply with protocol.

Concurrent Medication:

Excluded:

* The following nucleoside analogs:
* IV ganciclovir, IV acyclovir for more than 2 weeks total duration, oral acyclovir at doses \> 1000 mg/day, vidarabine, amantadine hydrochloride, cytarabine, idoxuridine.
* FIAU, FIAC, foscarnet, CMV hyperimmune globulin, IV immune globulin, CMV monoclonal antibody, HPMPC.
* Imipenem-cilastatin (Primaxin).

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir.

Prior Medication:

Excluded within the past 60 days:

Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC.
Effect of Educational Program About Preconception Care on Knowledge and Attitude of Adolescents University Students

This quasi-experimental study used a pre-test-post-test design to assess the effectiveness of the teaching program. A sample of 400 students from El Mansoura University was selected using a simple random sample. The participants were given a pre-test questionnaire to evaluate their knowledge and attitude towards PCC. The educational program consisted of a single session, which included a lecture, pictures, videos, and discussions. The post-test was administered immediately after the program


Eligibility Criteria:
Inclusion Criteria:

* The study included males and females from the targeted colleges.
* Students from grade 1 to grade 4.
* Students who accepted to participate in the study.

Exclusion Criteria:

* Students from the medical sector.
* Students who refused to participate were excluded from the study.
Dieta Mediterranea e Sindrome Dell'Intestino Irritabile in Pazienti Pediatrici

The goal of this observational study is to observe pediatric patients with IBS (irritable bowel syndrome). The main question it aims to answer are:

* adherence to the Mediterranean diet of children with IBS
* in patients not adhering to the Mediterranean diet, evaluate the efficacy of the nutritional intervention Participants will be visited, blood samples will be taken, abdomen ultrasound and they will answer questionnaires.

The goal of this observational study is to observe pediatric patients with IBS (irritable bowel syndrome). the diagnosis of IBS will be placed in reference to the Rome IV criteria. To make a diagnosis, at least 2 of:

* abdominal pain for at least 4 days per month associated with one or more of: pain associated with bowel movements, change in bowel frequency, change in stool consistency must be present.
* In children with constipation, pain persists as the constipation resolves.
* The symptoms are not explained by another medical condition. Participants will be visited, blood samples will be taken, abdomen ultrasound if necessary will be performed and they will answer questionnaires.

The main question it aims to answer are:

* adherence to the Mediterranean diet of children with IBS
* in patients not adhering to the Mediterranean diet, evaluate the efficacy of the nutritional intervention. if BMI between 5 and 85, nutritional education will be carried out for a healthy and correct diet. If BMI between 85 and 95 or greater than 95, personalized Mediterranean food scheme.

Eligibility Criteria:
Inclusion Criteria:

- diagnosis of IBS, based on Rome IV criteria.

Exclusion Criteria:

* use of NSAIDs in the last 3 months;
* allergies or intolerances;
* recent diagnosis (last 3 months) of bacterial or parasitic infections of the gastrointestinal tract;
* psychiatric diseases;
* chronic inflammatory diseases of the gastrointestinal tract.
Measurements of Kidney Perfusion After Transplantation by Intraoperative Fluorescence Angiography

Aim of this clinical study is to establish a novel technique, the so called intraoperative fluorescence angiography, for kidney graft perfusion visualization during the transplant procedure.

Additional to the common transplant procedure, measurements of the graft perfusion should be established in two ways. Firstly, each kidney should be measured by a common duplex ultrasound measurement to assess the resistance index (RI) in the three poles of the kidney (upper, middle, lower pole). Secondly, intraoperative fluorescence angiography is going to be performed. Therefore, the camera of the fluorescence angiography system (SPY Elite System, Novadaq, USA) is positioned over the organ, and the fluorescence dye (ICG) is applicated intravenously. The aim will be to correlate the fluorescence angiography findings with the RIs and therefore to establish valuable fluorescence parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving kidney transplantation
* Deceased donor and living donor transplantations

Exclusion Criteria:

* Allergy against indocyanine green
* Iodine allergy
* Contrast allergy
* Penicillin allergy
* Allergic diathesis
* Liver insufficiency
* Pregnancy
* Hyperthyreosis
* Pulmonary arterial hypertension
Socio-Clinical Factors Associated With Self-Management in Parkinson's Disease

Self-management focuses on the behaviors that people with chronic disease use in order to maintain and improve their health and well-being and includes aspects such as medical and lifestyle management. Parkinson's disease (PD) is a chronic, progressive, incurable neurodegenerative disorder that affects motor and non-motor function. Engagement in self-management behaviors and high activation may be effective tools in fighting the long-lasting burden of the disease. The goal of the current study was to explore socio-clinical factors that associate with specific self-management behaviors and patient activation among patients with Parkinson's disease. PwP were recruited from the Movement Disorders Institute, Department of Neurology, Rambam Health Care Campus. Eligible patients were assessed for cognitive status and filled questionnaires regarding socio-clinical factors included age, gender, severity of motor and non -motor symptoms, family and social support. Data about the comorbidities were retrieved from electronic medical records

n Parkinson's disease (PD), implementation of self-management strategies together with high patient activation may be an effective tool in fighting the long-lasting burden of the disease, but little is known about its determinant.

The aims of this study, conducted among patients with PD are to (1) test the association between socio-clinical factors that includes age, gender, cognitive status, comorbidities, disease severity (motor and non-motor symptoms) and social support and SMBs including utilization of rehabilitative treatments (an aspect of medical management), physical activity (an aspects of lifestyle management), and patient activation, and (2) to develop predictive model for each of these three aspects of SMB, based on socio-clinical factors that includes age, gender, cognitive status, comorbidities, disease severity (motor and non-motor symptoms) and social support.

A cross-sectional study of 100 patients that attend a Movement Disorder Clinic with PD will be conducted. Participation will include one evaluation session of approximately 90 minutes. Information about socio-clinical characteristics and self-management behaviors will be collected using demographic questionnaires, standard questionnaires and from electronic medical records. Regression model will test the association between sociodemographic characteristics and self-management behaviors and patient activation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD
* Age \> 18

Exclusion Criteria:

• Mini Mental State Exam\<20
Safety and Efficacy Evaluation of S (+) - Ketamine in Children

A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in children in perioperative settings.

Children often suffer acute pain,awakening delirium, anxiety and depression after operation which may affect the recovery of children. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese children undergoing surgery.

Objective:

To evaluate the analgesic effect of perioperative administration of S (+) - ketamine on postoperative acute pain in children undergoing surgery, and explore the effects of S (+) - ketamine on postoperative awakening delirium, postoperative anxiety and depression mood ,as well find the best usage, including dose, timing, compatibility, and type of operation.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≤17 years;
2. Scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery , ear surgery or other surgeries under general anesthesia;
3. ASA physical status I～Ⅲ;
4. The informed consent form was signed by the patients or the guardians.

Exclusion Criteria:

1. The expected length of hospital stay of the patient is less than 48h;
2. Patients expected to be admitted to the ICU after surgery;
3. Patients expected to return to the ward with tracheal catheter after surgery;
4. Be allergic to S (+) - ketamine;
5. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
6. Patients with congenital heart disease or severely developmental retardation;
7. Patients with any of the following contraindications of S (+) - ketamine:

   1. Patients with risk of serious rise of blood pressure or intracranial pressure;
   2. Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;
   3. Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);
   4. Patients with untreated or undertreated hyperthyroidism.
Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods

Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.

The GI is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as they have a lower impact on blood glucose concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose profiles and energy regulation in Asians. Healthy, normal-weight and overweight, Chinese males will be recruited. There will be two sessions (consisting of three days for each session) where they will consume either a high or low glycaemic index dinner at home and a high or low GI breakfast, lunch and snack on the next day (in the whole body calorimeter). There will be at least five days in between the two sessions. Their glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period, while substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch and snack). This study specifically attempts to see whether the inclusion of a low GI sweetener in a mixed meal sequence can impact blood glucose levels and energy regulation in Asians. The study is important in that it will enable us to compute the rate of fat oxidation and how it is influenced when subjects are fed a mixed meals modulated to be high GI (increased glucose excursions) or low GI (moderated glucose) over 24 hours in healthy Asians. Obesity and diabetes rates are increasing exponentially in Asian populations and Singapore is no exception. Devising ways and means to staunch the escalation is therefore a priority. The findings of the research will contribute towards the long-term objectives of developing dietary guidelines for weight and glycaemic control. The study data will also be important for the provision of practical food-based advocacy for better weight and glycaemic control in Asians.

Eligibility Criteria:
Inclusion Criteria:

* Chinese, male
* Age between 21-40 years
* Body mass index between 17 to 28 kg/m2
* Normal blood pressure (\<140/80 Hgmm)
* Fasting blood glucose \< 6 mmol/L

Exclusion Criteria:

* Having any metabolic diseases (such as diabetes, hypertension etc)
* One prescription medication
* Partaking in sports at the competitive and/or endurance levels
* Allergic/intolerant to any of the test foods
* Intentionally restricting food intake
* Smoking
Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with suspected kidney cancer with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI)

This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Eligible patients will include anyone who has suspected kidney cancer and is scheduled for surgery, up to an anticipated total of 40 participants. Subject participation will be only for the day of CEUS study. There will be no follow-up period for this study. However, if results are encouraging, a longitudinal observational study may follow, and these same subjects would be eligible for enrollment. Eligible subjects will undergo a contrast enhanced ultrasound.

Following completion of imaging, all CEUS, MRI (within 4 months) and B-mode (at time of CEUS) US studies will be de-identified. Blinded radiologists will interpret images and provide an overall assessment of risk of malignancy to each kidney using the Bosniak criteria for each kidney lesion present. The Bosniak criteria places cystic lesions into one of 5 categories (I, II, IIF, III and IV) based on lesion characteristics. CEUS based diagnosis will be compared to the diagnoses on routine B-mode US and contrast-enhanced MRI.

Eligibility Criteria:
Inclusion Criteria:

* A suspected diagnosis of kidney cancer with a solid or partially solid lesion and planned surgical nephrectomy within 3 months before surgery
* Able to provide informed consent
* Willing to comply with protocol requirements
* At least 18 years of age

Exclusion Criteria:

* Critically ill or medically unstable or in an intensive care setting and whose critical course during a potential observation period would be unpredictable
* Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®)
* Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure \>90mmHg), or adult respiratory distress syndrome
* Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives
* Unstable cardiopulmonary disease including any of the following:

  * Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
  * Unstable angina
  * Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation)
  * Myocardial infarction within 14 days prior to the date of proposed microbubble administration.
* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained the same day as the CEUS, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
* Obesity that limits obtainment of acceptable images