cyrilzakka/clinical-trials huggingface dataset:
Turmeric Anti-Inflammatory and Cell-Damage Trial

This trial will be conducted for the BBC. The aim of the project is to assess if consuming the spice turmeric every other day, in the amount consumed in a curry, can reduce cell damage and inflammation. The results of the project will be used to inform the TV program Trust Me I'm a Doctor.

100 volunteers will be recruited for a 6 week intervention. The study group will be divided into 3 arms, each with approximately. 33 participants; one arm will receive a placebo capsule, one arm will receive a capsule with 400mg of curcumin (corresponding to two teaspoons of turmeric powder). These treatments are done double-blind. A third arm is 'open label', these volunteers will receive a bag with at least 135g turmeric and be asked to add two teaspoon to their food. Participants will be asked to supplement their diet with turmeric (powder, capsule or placebo) every other day for six weeks.

Participants will be asked to attend the NU-Food research facility on 3 occasions. The first will be a screening session where participants will be given the option to discuss the project with a researcher. Participants will complete a screening questionnaire and sign an informed consent form. On the next visit, participants will arrive at the research facility at a pre-arranged time and firstly have their height and weight measured. Participants will then give 10ml of blood via venepuncture and asked to provide a 10ml spot urine sample. After this participants will be randomly allocated a treatment group (placebo, turmeric capsule or turmeric powder) and given instructions on dosage. After a 6 week treatment period, participants will return to the research facility, have their height and weight measured then give a second 10ml venous blood sample and provide a final spot urine sample. Each visit will take around 20 minutes.

The main outcomes of the trial are oxidative stress and inflammation tests which will be conducted by PB bioscience and an assessment of DNA methylation by University College London. Proteomics analysis will be conducted on Urine samples.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and over
* No pre-existing medical conditions
* not currently taking prescribed drugs or over the counter supplements
* Male and female

Exclusion Criteria:

* Any pre-existing medical condition
* Taking prescribed drugs or over the counter supplements
* Aged 17 years or under
* BMI \> 40mg/m2
* BP \> 160/120
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥28 kg/m2. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* For PAP s: Subjects who have received positive airway pressure (PAP) therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study.
* For non-PAP s:Subjects who are unable or unwilling to undergo PAP therapy. PAP must not have been used for at least 4 weeks prior to screening.
* For all subjects:

  1. Age ≥18 years at the time of signing informed consent.
  2. Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour.
  3. Body mass index (BMI) ≥28.0 kg/m² at screening.

Exclusion Criteria:

For PAPs：

* Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study
* Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study For all subjects：
* Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM).
* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline
* Have significant craniofacial abnormalities that may affect breathing at baseline
* Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
* Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study.
* Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
* Have achieved a \>5% change in body weight through diet and exercise alone for at least 12 weeks prior to screening.
the Health Crisis at the Healthcare Professionals, Careers and Non-careers, a Month After the Containment Period

The investigator wish to study, at a distance from the lifting of confinement (1 month), whether the psychological impact on professionals in nursing and non-nursing care establishments is associated with their living context (professional and personal situation) during confinement.

The context of confinement and of the global pandemic is a major source of stress for the entire population: separation of loved ones, loss of freedom, uncertainty about the infectious status, boredom. All of these factors can cause negative mental health consequences. Having little social contact was one of the factors increasing the negative psychological impact of confinement.

People suffering from psychological disorders are particularly vulnerable during quarantine periods. On March 17, 2020, the French government implemented national containment measures due to the Covid-19 epidemic.

Although the effects of containment have been studied for fragile populations, no study to date has focused on the specific population of healthcare facility staff. These caregivers have for the most part continued their professional activity, but they have been confronted with the fear of contracting or causing patients to contract Covid-19.

At a distance from the lifting of confinement (1 month), the investigator wish to study whether the highlighting of anxiety or depression in these healthcare professionals is associated with their context of life (professional and personal situation) during confinement

Eligibility Criteria:
Inclusion Criteria:

* Nursing and non-nursing care professionals

Exclusion Criteria:

* Refusal to participate
* Subject included in an interventional study
Care-HF CArdiac Resynchronization in Heart Failure

The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy.

813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)

Eligibility Criteria:
Inclusion Criteria:

* Heart failure for at least 6 weeks requiring loop diuretics
* Currently in NYHA class III/IV
* A high standard of pharmacological therapy
* LV systolic dysfunction and dilation (EF \<=35%; EDD \>30mm/height in metres)
* QRS \>=120 ms Dyssynchrony confirmed by echo if QRS 120-149 ms (Aortic pre-ejection delay \>140ms, Interventricular mechanical delay \>40 ms, Delayed activation of postero-lateral LV wall)

Exclusion Criteria:

* Age \< 18 years old or age \< legal age defined in the country in case different
* Chronic atrial fibrillation within 6 weeks prior to randomization;
* Impairment of left ventricular function not related to left ventricular systolic function
* Potentially reversible forms of cardiomyopathy:
* Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction,unstable severe angina or stroke within 6 weeks before randomization
* A conventional indication for bradyarrhythmia pacing exists;
* A conventional indication for an ICD exists
* A pacemaker or ICD has already been implanted;
* In-Patients requiring continuous intravenous therapy for Heart Failure;
* Life expectancy \< 1 year for disease unrelated to Heart Failure;
* Pregnancy or childbearing potential and not on reliable contraceptive;
* Mechanical tricuspid valve;
* Anticipated compliance problem or participation in another trial;
Pharmacists' Knowledge and Attitudes About ADRs Reporting and Pharmacovigilance Practice in Egyptian Hospitals

The present study has assessed the knowledge, attitude and practice of ADRs reporting among pharmacists, and the perceived factors that may influence reporting.

The practice and science of pharmacovigilance is described as the gathering, identification, monitoring, assessment, and prevention of adverse medication effects using pharmaceutical products. The term "pharmacovigilance" comes from the Greek words pharmakon (drug) and vigilare (vigilance) (monitor or keep an eye on). Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as "the science and practices relating to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems". PV assesses the risk-benefit profile of medicines in order to improve patient safety. As a result, adverse drug reaction (ADR) reporting is the bedrock of any PV system, and early detection and reporting of ADRs to regional or national drug-regulatory bodies is important.

ADRs are defined by the World Health Organization as an unpleasant and unexpected response to a medicine that occurs at levels usually employed in man for the prevention, diagnosis, or therapy of disease, or for the alteration of physiological function". Adverse drug reactions (ADRs) are major public health issues that have been linked to longer hospital stays and higher therapeutic costs. According to recent systematic reviews and meta-analyses of observational research, the rate of hospital admissions linked to ADRs is between 3-5 percent.

A number of factors have been linked to HCPs, particularly pharmacists, reporting ADRs. Several studies have indicated reasons for not reporting observed ADRs, and pharmacists have been polled to determine the most important facilitators and barriers to spontaneous reporting. The seven deadly sins were coined by Inman and later defined by Lopez-Gonzalez et al., into professional and personal traits, as well as knowledge and attitudes toward reporting. Pharmacists from throughout the world have highlighted a number of barriers to reporting ADRs, including a lack of time, the inability to correlate an adverse event (AE) to a specific medicine, and the absence of readily available reporting forms . It has also emphasized the necessity of educational measures to encourage ADR reporting, such as awareness lectures and workshops.

Egypt joined the WHO International Program for Drug Monitoring in 2001, but no concrete actions were done until 2009, when the Egyptian Pharmacovigilance Center was established (EPVC). Receiving ADR reports, detecting safety signals, sending frequent newsletters with pharmacovigilance (PV)-related updates, and conducting awareness training are only a few of EPVC's responsibilities.

Eligibility Criteria:
Inclusion Criteria:

- Pharmacist graduates

Exclusion Criteria:

undergrauate pharmacist

-
A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

This study is being conducted for the treatment of eligible participants who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Participants who have discontinued treatment from or have completed Study WA42293 and do not want to receive PRM-151 in this study, will be invited to enroll in survival follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

Exclusion Criteria:

* Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
* History of smoking within 3 months prior to the first visit in the OLE.
* History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
* History of severe allergic reaction or anaphylactic reaction to PRM-151.
* Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
* Prolonged corrected QT interval \> 450 ms (for men) or \> 470 ms (for women) based on the Fridericia correction formula.
* Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
Misoprostol for Reduction of Blood Loss During Fibroid Surgery

The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.

This is a trial of women undergoing fibroid surgery at a university-affiliated tertiary care center. Eligible participants will be randomized to receive preoperative 400ucg buccal (under the tongue) misoprostol or placebo on the basis of total fibroid volume, location, parity. Intra-operative blood loss will be compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Willing to have buccal administration of misoprostol or a placebo at least one hour pre-procedure.
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills
* Intraoperative use of vasopressin and uterine tourniquet is permissible
* Can have had prior Cesarean delivery

Exclusion Criteria:

* Patients who have had a prior abdominal myomectomy
* Post-menopausal women
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol
* Any cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Lung Deflation in Pediatric Subclavian Vein Catheterization

The subclavian vein (SCV) is a preferred site for placement of central venous catheter. However, pneumothorax is a major concern during subclavian venous catheterization. Lung deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the distance between the pleura and the SCV. The investigators evaluated the effect of lung deflation on the relative position between the pleura and the line of the imaginary needle pathway during supraclavicular and infraclavicular approach to the subclavian vein (SCV) using ultrasonography.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who were scheduled for elective operation under general anesthesia
* Neonates (0 \~ 1 mo), Infants (1 mo \~ 1 yr)

Exclusion Criteria:

* Structural anomalies of the chest wall
* History of lung and chest wall operations
* Prior central venous catheterization
* Upper respiratory tract infection, or pneumonia within 2 weeks
Effect of Carbonated Soft Drinks on Appetite-Regulation

Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified.

The investigators aim is to investigate the short-term effects of soft drinks (sugar-sweetened and artificially sweetened (aspartame)), milk and water on the concentration of circulating appetite-regulating hormones, the subjective sensations of hunger and satiety (measured by visual analogue scales) and energy intake. The study is a crossover, intervention trial with 24 overweight, healthy volunteers. The subjects will be tested on four separate days for four hours. Each test day a preload drink (sugar-sweetened soft drink, aspartame-sweetened soft drink, semi-skimmed milk or water) is served.

The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-50 years;
* BMI between 28-36 kg/m2;
* Weight stabile 3 months prior to the study inclusion;
* Less than 10 hours of weekly exercise.

Exclusion Criteria:

* Diabetes
* Allergic to phenylalanine or milk
* Smoking
* Pregnancy or breast-feeding
Effect of Nitric Oxide (NO) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation

In this study, the researchers propose to investigate the efficacy of inhaled nitric oxide to prevent ischemia-reperfusion (I/R) hepatocyte injury in patients who receive extended donor criteria(EDC)liver grafts based on changes in proteomic and metabolomic markers following revascularization of the donor graft.

In reviewing the literature, no uniform extended criteria donor classification exists. The characteristics most associated with liver graft failure appear to be cold ischemia time greater than 10 hours, warm ischemia time greater than 40 minutes, donor age \> 55 years of age, donor hospitalization \> 5 days, a donation after cardiac death (DCD) graft, and a split graft. The researchers will exclude warm ischemia time as this is impossible to predict prior to the transplantation. Any donor meeting at least one of the other criteria will be classified as an EDC donor.

Hypothesis 1: Inhaled nitric oxide will improve overall outcome of liver recipients after EDC liver transplantation

* Suppression of oxidative injury will improve graft function postoperatively as measured by International Normalized Ratio (INR) bilirubin, transaminases, and duration of hospital stay.

Hypothesis 2: The mechanisms of therapeutic efficacy of inhaled nitric oxide is based on reduction in post-reperfusion oxidative injury as readily measured by the detectable changes in the protein and metabolic profiles in plasma of patients treated with inhaled-NO

* Nuclear Magnetic Resonance (NMR)-based metabolic markers (xanthine end-products, lactate, and hepatic osmolytes) that are consistent with acute liver injury will be decreased in NO-treated recipients.
* Protein markers of reperfusion injury (argininosuccinate synthase (ASS) and estrogen sulfotransferase (EST-1) will be greater in the plasma of patients who are not treated with inhaled-NO
* Reduced oxidative injury will be reflected by a decrease in the number of mitochondrial peroxiredoxins isoforms and the number that are oxidized in NO-treated liver recipients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 69 years of age
* moderate to severe liver disease (MELD score 22 to 30)
* is receiving a extended donor criteria liver graft

Exclusion Criteria:

* undergoing multi-organ transplant
* 70 years or older
* diagnosed with hepatocarcinoma
* diagnosed with either hepatopulmonary syndrome or pulmonary hypertension
* pregnant
Evaluation of Brain Damage Due to Coronary Angioplasty in Percutaneous Intervention Patients

This study examines the formation mechanism and patient-related factors of silent cerebral infarcts, whose importance has become increasingly recognized in patients undergoing percutaneous coronary intervention.

This study was produced from the assistant's thesis and was previously accepted as a poster at EuroPCR 2020. We recently completed the full-length article.

This thesis study was supported by Ondokuzmayis University.

Eligibility Criteria:
Inclusion Criteria:

* CTO and Non-CTO patients undergoing percutaneous coronary intervention

Exclusion Criteria:

* baseline NSE elevation
* acute coronary syndromes or cardiac surgery within 4 weeks
* patients with a cerebrovascular accident
* intracranial hemorrhage
* and head trauma
* central nervous system tumor
* degenerative central nervous system disorders and neuroendocrine tumors