cyrilzakka/clinical-trials huggingface dataset:
Zinc Supplementation on Cellular Immunity in Thalassemia Major

Randomized controlled trial was conducted in post-splenectomy patients aged \>12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered.

Thalassemia refers to a hereditary anaemic condition that occurs due to a single gene disorder resulting in a defect in globin production. Infection is an important cause of morbidity and mortality among thalassemia patients worldwide. Thalassemia patients are more prone to infection. Mechanism of this susceptibility is related to altered immune response compounded by splenectomy procedures common in patients with thalassemia. Zinc on the other hand plays important role in immune responses. This study aims to identify zinc supplementation to cellular immunity of splenectomized patients.

Randomized controlled trial was conducted in post-splenectomy patients aged \>12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered. Anamnesis, physical examination, and laboratory results such as peripheral blood, ferritin, transferrin saturation, serum zinc, immunologic markers for cellular immunity (lymphocyte count, CD4+ and CD8+ T lymphocyte count and functions) are evaluated at the start and end of the 12-week study.

Improvement in immune response is defined as an increase in the T lymphocyte count and CD4+ T lymphocyte count, decrease in CD8+, and increase in the CD4+/CD8+ ratio.12 The mean reference value for CD4+/CD8+ ratio is 1.4 (SD 0.6).15 CD4+ T lymphocyte function refers to its ability to synthesize IL-2 and TNF-α following exposure to 100 µL phytohaemagglutinin with proportions measured using flow cytometry. Meanwhile, CD8+ T lymphocyte function refers to its ability to synthesize IL-2 and TNF-α following exposure to 100 µL phytohaemagglutinin measured using flow cytometry.

The frequency of blood transfusion is calculated from the medical records of the subjects during the past 1 year, which is grouped as follows:

1. Seldom receive blood transfusions, if within a time period of one year the subject received blood transfusions of \< 1 time.
2. Sometimes receive blood transfusions, if within a time period of one year the subject received blood transfusions of 2 - 3 times.
3. Often receive blood transfusions, if within a time period of one year the subject received blood transfusions of \> 4 times.

Analysis was conducted using Statistical Package for Social Sciences (SPSS) version 20.0. Changes in immunologic parameters between the two groups that are numeric will be analysed using paired t-test for variables with a normal distribution, and Mann-Whitney test for numeric variables with non-normal distributions.

Eligibility Criteria:
Inclusion Criteria:

* Thalassemia major patients
* Age \> 12 years
* Agreed to participate and signed the informed consent
* No other comorbidity beside thalassemia

Exclusion Criteria:

* HIV positive patients
* Those in steroid medication
Ideal Drainage Output of Post-operative Neck Suction Drain

A precautionary measure that is frequently used after a neck surgery is the usage of suction drains, which allow the evacuation or air and fluids accumulated at the site of the surgery using negative pressure. Theoretically this helps promote better healing of the wound. Usage of suction drains, however, requires keeping some patients hospitalized after surgery for drain surveillance while they could have otherwise been discharged to safely begin their convalescence at home. In other cases, patient hospitalisation can be prolonged by the usage of suction drains, because surgeons wait for the output of the drain to fall below a certain quantity before removing them. This of course results in additional costs to the health system. The quantity below which the drain output should fall before drain removal is however not something agreed upon in the medical literature and is generally based on a surgeon's personal experience or that of the institution in which they practice. It would be important to better define this value, since prolonged usage of suction drains is not risk-free. Indeed, they constitute, among other things, an access for bacteria to cause an infection to develop inside the neck, which compromises wound healing and may result in more pronounced scarring. This study aims to compare a frequently used output value (30 mL per 24 hours) with a more permissive one of 50 mL per 24 hours. The investigators will look more specifically at wound complications, length of hospitalisation and cost-effectiveness for the health system. This study will recruit patients undergoing neck surgery at the Centre Hospitalier de l'Université de Montréal to compare both of these suction drain output values.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older of age
* Patient having undergone neck surgery at the CHUM
* Patient operated by an Ear Nose and Throat - Head and Neck surgeon at the CHUM
* Patient with at least one suction drain left post-operatively

Exclusion Criteria:

* Non-suction drain (e.g. capillarity)
* Free-flap reconstruction cases
* Patient with past surgical history of neck dissection
* Patient with pas medical history of radiation therapy in the head and neck
Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors

The goal of the Cardiovascular Health Equity Through Food (CHEF) program is to make it easier for participants and families to cook and eat healthy foods during and following childhood cancer treatment with the long-term goal of supporting heart health.

This is a proof-of-concept study to test the CHEF intervention by utilizing survey, interview, and medical record data from participants with cancer to determine the intervention's impact on cardiovascular-relevant outcomes and to identify optimal implementation strategies for the intervention.

The research study procedures include screening for eligibility, questionnaires, and a brief interview.

Participation in this research study is expected to last 6 months.

It is expected about 17 participants/families will participate in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Child with any primary cancer diagnosis (non-relapsed, non-secondary malignancy) who has received cancer-directed therapy that includes chemotherapy and/or radiation therapy;
* Child is within one of the following time windows:

  1. Among those receiving chemotherapy, any time from start of last planned cycle of chemotherapy until 12 months from completion of chemotherapy;
  2. Among those receiving radiation therapy alone or radiation and surgery, any time from completion of radiation until 12 months post completion;
* Child has 1 or more cardiovascular risk factor (defined as any of: body mass index ≥ 85th percentile; systolic or diastolic blood pressure ≥90th percentile; dyslipidemia \[triglycerides ≥150 mg/dL, total cholesterol ≥200 mg/dL, LDL cholesterol ≥130 mg/dL, HDL cholesterol ≤40 mg/dL\]; impaired glucose metabolism \[fasting glucose ≥100 mg/dL, hemoglobin A1c ≥5.7%\]; anthracycline exposure ≥100 mg/m2; or any radiation exposure to chest, brain, thoracic spine, or total body);
* Child is ≤18 years of age at time of enrollment, or over 18 years of age but under medical guardianship;
* Parent/guardian screened positive for food insecurity.\* \*Assessed through validated 2-item food insecurity screen.

Exclusion Criteria:

* Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
* Foreign national family receiving cancer care as an embassy-pay patient.
Study of Two Complementary and Alternative Medical Treatments for Maintenance of Weight Loss

The goal of this study is to pilot test in a group of overweight-obese individuals the feasibility and acceptability and indications of efficacy of two CAM treatments, qigong, and acupressure-TAT, for improving long term maintenance of weight loss.

The prevalence of obesity is at epidemic proportions, 60% of US adults are overweight or obese. Obesity contributes to chronic diseases (diabetes, cardiovascular disease \[CVD\], hypertension, cancer, and osteoarthritis) and to escalating health care costs. Weight loss can have a substantial impact on reducing these conditions. Substantial efforts have been made in developing effective short-term weight loss programs using behavioral treatments. However, long-term maintenance of weight loss continues to be problematic - many individuals regain the weight lost within a year. Innovative intervention options are critically needed to help people successfully maintain weight loss and to fight the obesity epidemic. Complementary and alternative medicine (CAM) approaches-mind-body, energy healing, and Traditional Chinese Medicine (TCM) approaches may hold great promise for helping improve the maintenance of weight loss.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25-35 kg/m 2
* Reside in Portland metropolitan area
* Willing to complete the 12-week weight loss program
* Willing to accept random assignment to one of the three maintenance treatment conditions
* Willing to provide informed consent

Exclusion Criteria:

* Medical conditions or treatments that would be contraindicated using a diet \& exercise weight loss treatment
* Cancer
* Significant GI disease inappropriate for diet and physical activity intervention
* Diabetes dependent on insulin or oral hypoglycemic medications
* Psychiatric hospitalization in past 2 years
* Conditions that require limitation of physical activity
* Congestive Heart Failure
* Cardiovascular Disease (stroke, MI, CABG, ASCVD)
* Taking weight loss medications currently or within past 6 months
* Previous history of complementary or alternative medicine (CAM) weight loss treatment
* Current acupressure, or Qi Gong, or acupuncture
* Reported consumption of more than 21 alcoholic drinks per week
* Planning to leave the area prior to the end of the program
* Body weight change \> 10 pounds in the 6 months prior to Screening visit one
* Pregnant, breast feeding, or planning pregnancy prior to the end of participation
* Current participation in another clinical trial
* Investigator discretion for safety or adherence reasons
* Household member of another CAM WT participant
* Unavailable for group sessions
Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism

The present study will evaluate the effects on glucose, ketones and other blood biomarkers, cognition, quality of life, physical activity and well-being of a reduced carbohydrate diet paired with a ketogenic product for 2 months in a population living in a senior residence. This study follows the KetoHome (fall 2022) and SAGE (fall 2023) projects which assessed the feasibility, acceptability and effectiveness of a reduced carbohydrate intervention alone.


Eligibility Criteria:
Inclusion Criteria:

* Older men or women in a senior residence;
* Understand, read and write French;
* Have sufficient visual and hearing acuity to pass cognitive tests;
* Available during the intervention period

Exclusion Criteria:

* Body mass index \< 20;
* T1 diabetic;
* T2 insulin-dependent diabetic;
* MMSE \< 20;
* Weight loss \>10% in the last 6 months involuntary or voluntary;
* Known and uncontrolled hypoglycemia;
* Moderate to severe digestive illnesses that can be aggravated by dietary changes;
* Severe dysphagia;
* Supplementation with MCT oil, ketone salts, ketone esters, adherence to the ketogenic diet, reduced carbohydrate diet, intermittent fasting or other diet or supplements that can significantly increase ketones in the last month;
* Participation in other interventional research projects on nutrition or aimed at metabolic change simultaneously.
* Medical condition that could prevent the participant from completing the study in the opinion of the doctor
aCGH Impacts Survival in Plasma Cell PTLD

Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date, there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.


Eligibility Criteria:
Inclusion Criteria:

* WHO classification 2008 as monomorphic PCM (plasma cell myeloma) or PLL (plasmacytoma like lesion) / PTLD (post transplantation lymphoproliferative disorders).

Exclusion Criteria:

* Other than PCM or PLL PTLD at diagnosis
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)

Patients without a documented history of Atrial Fibrillation (AF) and will undergo a valve or Coronary Artery Bypass Graft (CABG) procedure with direct visual access to the Left Atrial Appendage (LAA) will be eligible to participate. Patients enrolled will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who develop Post-operative Atrial Fibrillation (POAF) and receive the AtriClip will be followed for 365 days post index procedure.

Patients without a documented history of AF but who present with a CHA2DS2- VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) of =\> 2 and HASBLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) of =\> 2 and will undergo a valve or CABG (structural heart) procedure with direct visual access to the LAA will be eligible to participate based upon the inclusion and exclusion criteria defined in this protocol. Up to 2000 patients will enroll at up to 40 sites and will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who not develop Post-operative Atrial Fibrillation (POAF) will be followed for 30 days for safety. Subjects who develop POAF and receive the AtriClip will be followed for 365 days post index procedure.

Eligibility Criteria:
Inclusion Criteria:

Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:

* Age \> 18 years male or female.
* Scheduled for any non-mechanical valve and/or CABG (structural heart) procedure where direct access to the LAA is expected.
* No documented preoperative AF.
* CHA2DS2-VASc score of =\> 2.
* HASBLED score of =\> 2.
* Acceptable surgical candidate, including use of general anesthesia.
* Willing and able to provide written informed consent.

Exclusion Criteria:

Patients satisfying the following criteria will not be eligible for participation:

* Redo cardiac surgery.
* Mechanical heart valve or other anticipated or current requirement for anticoagulation therapy during the post-operative (30 day) period.
* Hypercoagulability conditions that may confound the study.
* Ejection Fraction \< 30.
* Left Atrium \> 6 cm.
* Severe Diastolic Dysfunction.
* Requires anticoagulation therapy.
* Patient had a stroke/cerebrovascular accident (CVA) within previous 30 days prior to signing informed consent.

Intra-Operative Exclusion Criteria

* Presence of thrombus in the left atrium or LAA.
* LAA tissue is deemed friable or has significant adhesions (as evaluated by the surgeon) near or on the LAA making AtriClip placement overly risky.
* Left atrial appendage is outside the range of manufacturer's recommendations - width \< 29mm or \> 50mm.
* Direct visualization access is not available for AtriClip placement.
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.


Eligibility Criteria:
Inclusion Criteria:

* The participant is a male or female child aged ≥7 and \<12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
* The participant must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
* The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
* The participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
* For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form.
* For participants who turned 18 years during the lead-in study 12710A; the participant has signed the Informed Consent Form.

Exclusion Criteria:

* The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
* The participant has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Other protocol-defined inclusion and exclusion criteria may apply
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants

The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablets co-administered with canagliflozin in healthy fed and fasted participants.


Eligibility Criteria:
Inclusion Criteria:

* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
* Before randomization, a woman must be either Not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception (failure rate of less than \[\<\]1 percent \[%\] per year when used consistently and correctly) throughout the study
* All women must have a negative urine pregnancy test at Screening and on Day -1 of each Treatment Period
* Body mass index (BMI) (weight \[kg\]/height\^2 \[m\]2) between 18 and 30 kg/m\^2 (inclusive), and body weight not less than 50 kilogram (kg)
* Blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, systolic and no higher than 90 mmHg diastolic at Screening or Day -1 of each Treatment Period
* Normal renal function evidenced by estimated Glomerular Filtration Rate (eGFR) greater than or equal to (\>=90) milliliters per minute (mL/min)/1.73m\^2 using the Modification of Diet in Renal Disease Study (MDRD) equation as defined in the protocol

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis as assessed by the investigator at Screening or Day -1 of the first Treatment Period
* Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) (Screening only) as assessed by the investigator at Screening or on Day -1 of the first Treatment Period as deemed appropriate by the investigator
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, hormonal contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
* History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis

Chronic kidney disease (CKD) is a major public health problem worldwide, with a significant increase in the number of patients treated with dialysis and renal transplantation. Hemodialysis (HD) is the most widely used dialysis therapy in the world, and adequate vascular access is required. The central venous catheter (CVC), although not considered the ideal vascular access, is still widely used. Its use has a strong relation with access-related infection, whether it is an exit orifice (IES), a tunnel and the most severe, the bloodstream (BSI). Consequently CVC contributes to patients' morbidity and mortality in HD, as well as to the high cost of hemodialysis treatment.

To compare the use of 0.1% topical gentamicin with the use of placebo in the exit site (ES) of tunneled catheters in patients in chronic HD regarding the reduction in IES and BSI rates and to identify the induction of bacterial resistance to gentamicin.

A randomized, double-blind clinical trial comparing the use of 0.1% gentamicin versus placebo in the ES of tunnelled catheters for hemodialysis in the prevalence and density of incidence of IES and BSI. Patients will be allocated into two groups randomly: Group 1 (control): Patients using placebo ointment in ES; Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES.

Eligibility Criteria:
Inclusion criteria:

* incident and prevalent patients on hemodialysis
* Tunnelled catheter implant within 90 days of study initiation

Exclusion Criteria:

* patients under 18 years of age
* pregnant women
* other types of access for dialysis other than tunnelled catheters
* course of infection at the time of initiation of the study.