cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Supplementation in Children With Sickle Cell Disease

Children aged 6 months to 12 years of age will be randomised to receive vitamin D 60,000IU once a month for 3 months or a placebo. The vitamin D will be in form of granules supplied in sachets. The primary study outcomes will be incidence of hospitalisation and change in vitamin D levels following supplementation. Secondary outcomes will include incidence of vaso-occlusive crisis (VOC), acute severe respiratory illness, Vitamin D related Severe adverse events and requirements for blood transfusion

BACKGROUND: More than 75% of all children with sickle cell anemia (SCA) are born in sub-Saharan Africa annually. The hallmark of SCA is haemolytic anaemia and or pain crisis that often require hospitalisation. Interventions to reduce the complications, which are prerequisites for frequent hospitalisations, are needed urgently. Vitamin D deficiency is common in children with SCA and is associated with recurrent vaso-occlusive crisis, blood transfusion, hospitalisation and infections. Routine vitamin D supplementation is not practiced in the care of sickle cell disease patients yet it has been associated with improved bone health and bone mineral density, reduced chronic pain and improved quality of life.

HYPOTHESIS: Vitamin D supplementation will lead to a lower incidence of hospitalisation than placebo in Ugandan children with SCA.

METHODS: The study will be a randomized, placebo-controlled, double blind clinical trial in which 331 Ugandan children with SCA aged 6 months to 12 years inclusive will receive vitamin D (60,000IU granules monthly) and another 331 a placebo (identical to vitaminD in appearance) for 3 months. The primary study outcome will be incidence of hospitalisation. Secondary outcomes will include incidence of vaso-occlusive crisis (VOC), acute severe respiratory illness, Vitamin D related Severe adverse events and requirements for blood transfusion IMPACT: If this trial shows a reduction in hospitalisation, it will be the basis for a multi-site pre-post intervention clinical trial to assess real-world safety and efficacy of Vitamin D in African children with SCA. The monthly administration is easy, and since vitamin D is inexpensive, this trial has the potential to improve the health of hundreds/ thousands of African children with SCA through reduction of infection-related morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Documented sickle cell disease (HbSS supported by hemoglobin electrophoresis results) attending Mulago Hospital Sickle Cell Clinic)
2. Age range of 6 months to 12 years, inclusive, at the time of enrolment
3. Weight at least 5.0 kg at the time of enrolment
4. Willingness to comply with all study-related treatments, evaluations, and follow-up

Exclusion Criteria:

1. Known other chronic medical condition (e.g., HIV, malignancy, Renal \& liver disease, active clinical tuberculosis)
2. Severe acute malnutrition determined by impaired growth parameters as defined by WHO weight for length/height less than -3SD.
3. Evidence of Vitamin D supplementation in the past one month (by prescription or drug sample)
MINDSpeed Food and Brain Training RCT

The purpose of this study is to learn how foods high in polyphenols and brain training exercises affect older adults' cognitive performance

Adults with low education who give informed consent will complete a baseline cognitive assessment and then be randomized to one of four arms: 1) MIND foods and cognitive training, 2) MIND foods and control training, 3) control foods and cognitive training, or 4) control foods and control training.

All interventions are conducted through applications running on a tablet computer device that we will provide to all participants for the study duration. Cognitive training is delivered through the online BrainHQ program from Posit Science, Inc. The foods will be shown on the tablet device in an online shopping format. Selected foods will be prepared and delivered by the study team.

Active intervention will last for 12 weeks. After the 12-weeks, free food deliveries will cease but participants who were allocated to cognitive training will continue to have access to BrainHQ. Those in the MIND food arms will be encouraged to maintain MIND food consumption.

Eligibility Criteria:
Inclusion criteria:

* age 60 years or older,
* ≤ 12 years of education,
* English speaking,
* Marion County (and immediately surrounding counties) resident, with steady/fixed residence to receive food deliveries
* natural-born US citizen.

Exclusion criteria:

* living in nursing home
* self-reported diagnosis of dementia, Alzheimer's disease (AD), cancer with short life expectancy, multiple sclerosis, epilepsy, schizophrenia, bipolar disorder, Parkinson disease; current chemotherapy or radiation therapy; history of brain tumor, brain surgery, brain infection; stroke or myocardial infarction within the past 12 months
* current alcohol consumption ≥8 drinks per week for women or ≥15 drinks per week for men;
* poor vision (self-reported difficulty reading a newspaper) or color blind;
* low communicative ability (examiner rated) that would interfere with interventions and assessments;
* prior involvement in similar cognitive training studies;
* unable or unwilling to provide blood sample at Baseline
* tumor, hemorrhage, aneurysm, hydrocephalus, or other significant clinical finding from Baseline brain MRI
Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India

Hypertension is a leading cause of morbidity and mortality globally. Although multiple drugs are frequently used to treat it, in the South Asian context, evidence is lacking on best drug combinations. This trial aims to compare efficacy of three single-pill combinations of two anti-hypertensive agents on 24-hour ambulatory systolic blood pressure among 1968 individuals with hypertension. The trial is a single-blind randomized controlled trial spread across 37 hospitals in India.

Single Pill combinations (SPCs): 1) Amlodipine + Perindopril, 2) Perindopril + Indapamide, 3) Amlodipine + Indapamide

This is a multi-centre, individual randomized single-blind, parallel group, three-armed superiority trial to compare the efficacy of three different single-pill combinations of antihypertensive therapies (Amlodipine/Perindopril, Perindopril/Indapamide, and Amlodipine/Indapamide)on 24-hour ambulatory BP levels in Indians.

Eligibility Criteria:
Inclusion Criteria:

1. Age 30-79 years AND
2. Sitting clinic values\* of SBP ≥140 mmHg and \<160 mmHg on one antihypertensive agent OR
3. Sitting clinic values\* of SBP ≥150 mmHg and \<180 mmHg on no antihypertensive treatment \* Mean of the last 2 of 3 readings.

Exclusion Criteria:

1. Congestive heart failure (clinically defined).
2. Patients with a history of intolerance to any of the study medications for example angioedema or dry cough with Angiotensin-converting enzyme inhibitors.
3. Serum creatinine levels greater than 132.6µmol/l (1.5mg/dl)
4. 4. History of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome).
5. History of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit).
6. Severe hepatic impairment
7. Treatment with agents causing torsades de pointes
8. Lactation
9. Contraindications to any of the investigational medicinal products as per the summaries product characteristics of drugs studied
10. Known or suspected secondary hypertension.
11. Any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study.
12. Pregnancy or those of child-bearing age who are not taking reliable contraception.
13. History of Gout.
14. Serum potassium \< 3.5mmol/L at screening.

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Inflammatory Response During Anesthesia and Surgery

The purpose of this study is to investigate the effects of total intravenous anesthesia versus volatile anesthesia on the perioperative inflammatory response during and after major surgery.

Patients undergoing major surgical procedures, in particular those undergoing cardiac surgery, develop a severe inflammatory response in up to 50% of cases leading to increased mortality and morbidity. The inflammatory response depends on the surgical procedure and on patient related factors like genetic predisposition and co morbidities. However, in vitro studies showed that the type and duration of general anaesthesia also influences the extent of perioperative inflammation.

Comparison: total intravenous anesthesia by propofol is compared to volatile anesthesia by isoflurane with respect to development of perioperative inflammatory response.

The IRAS study is a single centre study, executed in the University Medical Centre Utrecht, The Netherlands. Four different patient groups are included. 1) Patients undergoing coronary artery bypass grafting (CABG) with use of cardiopulmonary bypass (CPB), 2) patients undergoing aorta aneurysm repair via endovascular approach and 3) via conventional open procedure, and 4) patients undergoing surgery for replacement of implantable cardioverter defibrillator (ICD).

The IRAS is a prospective, randomized clinical trial. Patients are randomly assigned to a intravenous or a balanced anaesthesia technique. Peripheral blood samples are drawn before, during and up to 72h after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years and planned for elective Coronary Artery Bypass Grafting (CABG), aorta surgery or Implantable Cardioverter Defibrillator (ICD) replacement

Exclusion Criteria:

* Emergency operations
* Patients undergoing combined or re-do procedures
* Patients who are diagnosed with or undergoing treatment for a steroid or hormone disorder, excluding diabetes
* Patients suffering from chronic inflammatory diseases
* Patients suffering form current infections
* Patients currently treated with steroids
* Patients undergoing treatment or care for a malignancy
* Patients participating in another study that may interfere with the endpoints of the IRAS trial
Effects of Repeated Memory Training on Memory Function and Addiction Related Processes

Prospective memory is the ability to implement an intention to the future (e.g. remember to take medication, attend a scheduled meeting), and has receive little attention in addiction. The investigators propose that prospective memory plays a critical, yet unrecognized, role in major human behavior change such as that required in addiction treatment. This study will determine the preliminary efficacy of prospective memory training in improving memory and executive functions while reducing illicit drug use in methadone patients. Participants will be randomly assigned to one of three conditions: an experimental memory training program or one of two comparator memory training programs.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-55; provision of written consent
* Enrolled in a substance use treatment program
* Sex with ≥ 2 partners in the last 30 days and sex without a condom on at least one occasion in the last year

Exclusion Criteria:

* Severe psychiatric conditions associated with psychosis or any unstable psychiatric condition
* History of medical, psychiatric, or neurological conditions associated with significant cognitive impairment
Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix

The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Age ≥ 18 years
* Willingness to sign informed consent and to participate in the study
* Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.
* Tooth gap of ≥ 8 mm.
* Presence of natural or artificial opposing dentition
* Sufficient vertical interocclusal space of an implant restoration (7mm)
* Bounded by natural and periodontally stable teeth
* Treatment plan must include tooth replacement with an implant or tooth-supported fixed dental prosthesis.

Exclusion Criteria:

* Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
* Severe bruxism, clenching habits, or presence of oro-facial pain
* Uncontrolled diabetes mellitus (HbA1c \>7.0)
* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
* Any active oral or systemic acute infections
* Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
* Severe hematologic disorders
* Any other diseases or medications that may compromise normal wound healing
* Pregnancy or nursing mother
* Contraindications and limitations of the MD as described in the instructions for use: during pregnancy or lactation, children, presence of acute infection in the surgical area, patients with known sensitivity to porcine material or collagen allergies.
* Vulnerable subjects
* Known or suspected non-compliance
* Drug or alcohol abuse
* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc.
* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
* Enrolment of the PI, his/her family members, employees and other dependent persons
Effect of Cognitive Therapy on Immunosuppressive Treatment Compliance and Motivation

The study aims to analyze the effects of Mindfulness-Based Cognitive Therapy (MBCT) on the motivation levels and compliance with immunosuppressive therapy of post-liver transplant recipients.

H1-0: MBCT has no effect on the compliance of recipients to immunosuppressive therapy after liver transplantation.

H1-1: MBCT has an effect on the compliance of recipients to immunosuppressive therapy after liver transplantation.

H2-0: MBCT has no effect on increasing the motivation of recipients after liver transplantation.

H2-1: MBCT has an effect on increasing the motivation of recipients after liver transplantation.

Experimental group Data collection tools will be applied to the patients in the experimental group before the MBCT intervention. The 60 patients in the experimental group will be divided into six subgroups, each consisting of 10 patients. MBCT will be applied by Expert Clinical Psychologist Aybüke İğdir, who has received special training in the field. There will be a group facilitator among the MBCT trainers. The group facilitator is a psychologist with postgraduate education and experience in MBCT. The MBCT intervention will be applied to each subgroup of the experimental group on different days. During the MBCT intervention, eight consecutive sessions will be held with the themes of "Mindfulness and Autopilot", "Living in Our Mind", "Focusing on the Distracted Mind", "Recognizing Hate", "Allowing", "Thoughts Are Not Real", "How Can I Best Take Care of Myself?" and "Maintaining and Expanding New Learning". The theme of Maintaining and Expanding New Learning includes special techniques that patients can apply for medication compliance. There will be one MBCT session per week and therefore the MBCT program will continue for eight weeks. After the eight-week MBCT program ends, no intervention will be applied to the patients in the experimental group for the next month based on similar studies in the literature and at the end of this one month, in the posttest phase, these patients will be applied the scales once again.

Control group Data collection tools will be applied to patients in the control group as part of the pre-test. Patients with questions will be allowed to direct their questions to the researchers. After these questions are answered, no intervention will be made to the control group and patients in the control group will not be contacted at any time for the next three months. After three months, patients in the control group will be invited to the outpatient clinic and the scales will be applied to these patients once more during these outpatient clinic visits to collect post-test data.

Eligibility Criteria:
Inclusion Criteria:

* Applying to the outpatient clinic for routine follow-up after liver transplantation,
* Receiving immunosuppressive treatment for at least one month after liver transplantation,
* Being 18 years old or older,
* Not having a communication barrier,
* Agreeing to participate in the study.

Exclusion Criteria:

* Having any hearing or mental problems
* Wanting to leave the study
Tilt Cardiopulmonary Resuscitation With a Feedback Device

According to the European Resuscitation Council (ERC) Guidelines for patient to a depth of approximately 5-6 cm on a firm and flat surface when possible. However, Cardiopulmonary resuscitation (CPR) performers may need to continue the chest Resuscitation 2010, CPR performers should compress the sternum of a compression in an oblique direction, such as in elevators. For a pregnant patient in cardiac arrest, the 2010 ERC Guidelines recommend that the performer place the patient in a left-lateral tilt of 15 - 30° using a firm wedge to support the pelvis and thorax because the pregnant uterus can compress the inferior vena cava. We hypothesized Smartphone based chest compression feedback app would improves quality of CPR in an angulated surface.


Eligibility Criteria:
Inclusion Criteria:

* Healthy person
* \> 18 years old
* Basic life support educated person

Exclusion Criteria:

* Cardiovascular disease
* Musculoskeletal disease
* Psychiatric disease
* Pregnant
* \> 65 years old
Core Stabilization Training in Elite Athletes

The studies in the literature have not sufficiently investigated the effects of core stabilization training on anaerobic performance. Therefore, this study was planned to comparatively investigate effects of progressive core stabilization training applied to elite athletes on anaerobic capacity, anaerobic performance, and fatigue.

In taekwondo, weightlifting, badminton, and volleyball sports branches, strong relationships between sports performance, anaerobic strength and fatigue parameters have been also shown. It is clear of the necessity of developing anaerobic capacity using various exercises in these elite athletes. However, the studies conducted to date have not sufficiently investigated the effects of core stabilization training on anaerobic performance and fatigue with more objective methods and enough sample sizes. This study was planned to comparatively investigate effects of progressive core stabilization training applied to elite athletes on anaerobic capacity, anaerobic performance, and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* being between 18-25 of age,
* actively keeping on a similar technical workout season program,
* volunteering to participate in the study,
* having at least five years of professional sports history and
* being an elite athlete in taekwondo, weightlifting, volleyball, or badminton branches

Exclusion Criteria:

* having had any pathological condition and/or surgical procedure of the column vertebral and extremities within the last three months,
* having had any serious orthopedic or systemic condition that could prevent doing and continuing exercises
* discontinuing exercise training for more than three sessions.
Microbiome in Pulmonary Tuberculosis, Non-tuberculous Mycobacterial Pulmonary Diseases, Lung Cancer and Hemoptysis

Microbiome in lower respiratory diseases is not sufficiently known yet. The objective of this study is to investigate microbiome in patients who present with hemoptysis, and those with pulmonary tuberculosis, non-tuberculous mycobacterial pulmonary disease (NTM-PD), and lung cancer, analyzing respiratory specimen acquired by bronchoscopic approach.

Subjects who were going to undergo bronchoscopy for hemoptysis or suspected lower respiratory diseases including endobronchial tuberculosis (Tb), NTM-PD, or endobronchial lung cancer (LC) were enrolled after informed consents.

Subjects who were supposed to receive bronchoscopy to rule out endobronchial lesions were also enrolled as control group (ctrl) after informed consents. In those control group, endobronchial tuberculosis, malignancy or other certain respiratory diseases was not clearly suspected.

Before acquiring respiratory specimens, bronchoscopic channels were washed to acquire negative control in all cases of groups.

In Tb group and LC group, specimens of normal bronchial mucosa near suspicious endobronchial lesion were obtained with protected brush (PB), then specimens of abnormal bronchial mucosa in suspicious endobronchial lesion with PB. After acquiring respiratory specimens of PB, bronchial washing was done in suspicious endobronchial lesion.

In NTM-PD group, specimens of bronchial mucosa in bronchus of suspicious NTM-PD with PB. After acquiring respiratory specimens of PB, bronchial washing was done in bronchus of suspicious NTM-PD.

In hemoptysis group, bronchial washing was done in bronchus of ongoing bleeding.

In control group, specimens of bronchial mucosa in predetermined random bronchus (not bronchus with suspicious endobronchial lesion) with PB. After acquiring respiratory specimens of PB, bronchial washing was done in the same bronchus.

Microbiome in lower respiratory species was analyzed using 16S rRNA sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent bronchoscopy for hemoptysis, OR
* Patients who underwent bronchoscopy for suspicious endobronchial pulmonary tuberculosis observed on chest computed tomography, OR
* Patients who underwent bronchoscopy for suspicious non-tuberculous mycobacterial pulmonary disease (NTM-PD) observed on chest computed tomography, OR
* Patients who underwent bronchoscopy for suspicious endobronchial lung cancer observed on chest computed tomography, OR
* Patients who underwent bronchoscopy to rule out endobronchial lesion which did not seem to be typical for any criteria of pulmonary diseases including tuberculosis, NTM-PD or lung cancer on chest computed tomography

Exclusion Criteria:

* Other malignancy, infection or serious diseases of neural, cardiovascular, renal, hepatobiliary, gastrointestinal, hemotologic or respiratory system
* Use of any antibiotic within a month
* Vulnerable volunteer
* Subject's rejection
Etanercept SFP in RA Patients

Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA
* Naïve to etanercept therapy
* Able to self-inject investigational product or have a designee who can do so
* Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria
* Receipt of Corticosteroids\> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product
* Receipt of MTX witin 30 days of 1st dose of investigational product
* Receipt of an other investigational drug within 30 days of 1st dose
* Receipt of TNF inhibitor therapy within 90 days of 1st dose
* Receipt of cyclophosphamide within 6 mo of 1st dose
* Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet
* Current use of insulin
* gnificant concurrent medical condition