cyrilzakka/clinical-trials huggingface dataset:
Intake Duration Effects of Blackcurrant on Cardiovascular and Metabolic Responses

Study will examine the metabolic, physiological and cardiovascular changes by intake of New Zealand blackcurrant extract at rest and during moderate-intensity treadmill walking in healthy males.

The investigators will examine effects of acute intake, intermittent intake and chronic intake of New Zealand blackcurrant extract using indirect calorimetry and hemodynamic measurements.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smokers
* Not taking any supplements
* No known allergy to berries or berry products

Exclusion Criteria

* Sedentary
* Known high blood pressure
* Smoking
* On medication
Determinants of Vitamin K Metabolism

The purpose of this study is to learn how the body responds to different amounts of vitamin K in the diet in order to understand the roles that vitamin K may have in the body. We also need to determine if older adults need more or less vitamin K in their diet compared to younger adults in order to maintain normal body stores of vitamin K.

Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes the establishment of dietary recommendations for vitamin K, and the interpretation of results from clinical trials on vitamin K supplementation and bone health of women in a narrow age group. This study is the first to assess the role of dietary and other factors that influence the response to vitamin K status and bone turnover to vitamin K depletion and repletion in adults. This study also compares the absorption efficiency and body retention of vitamin K relative to current vitamin K status. Men and women \[21 younger (18-40y) and 21 older (55+y)\] will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d dietary vitamin K restriction period (10 ug/d), and ending with a 28d dietary vitamin K supplementation period (500 ug/d). Coagulation times will be monitored during the dietary restriction period. Serial measurements of vitamin K status markers and of bone turnover markers will show the response of vitamin K to dietary manipulation for both age groups under identically controlled dietary conditions. Deuterium-labeled vitamin K in collards will be used to compare the absorption of vitamin K during a vitamin K-deplete state to that of a vitamin K-replete state. Vitamin K is transported in triglyceride-rich lipoproteins, which may vary among individuals due to differences in adiposity and lipid homeostasis. Therefore, measurement of body composition by Dual Energy X-Ray Absorptiometry (DXA) and plasma lipids will provide insight into the role of lipids in absorption and transport of vitamin K. The findings of this study are critical for the interpretation of the epidemiologic and clinical data used to determine the protective role vitamin K may have in chronic disease prevention.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* kidney, GI, or liver disease requiring treatment
* prescribed osteoporosis medications in the previous 3 months
* use of acid reducers more than twice per week
* blood clotting disorder and/or abnormal clotting time
* warfarin or anticoagulant use in the previous 12 months
* diabetes
* smoking
* hormone therapy in the previous 3 months
* oral contraceptive use in the previous 3 months; pregnancy
* strict vegetarian diet
Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor

This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).


Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 years or greater
* participants actively listed for heart, lung and/or kidney transplant
* participants have already consented to receive HCV-viremic organs as part of the institution's clinical practice protocol (involves education and informed consent), and are able to sign informed consent for this research study.

Exclusion Criteria:

* participants who have a prior history of HCV infection regardless of treatment status, pre-existing human immunodeficiency virus (HIV) or hepatitis B virus (HBV) infection
* participants who are not able to sign informed consent for this research study
* participants who have not agreed to accept HCV+ organs as part of the UCSD clinical practice protocol
* participants who are listed for a liver transplant (either as a single organ or combined organ transplant).
Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19

Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.

This is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical trial to assess the efficacy and safety of two infusions of Wharton Jelly mesenchymal stromal cells (WJ-MSC) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. The study will enroll 30 patients who after signing the informed consent will be checked for inclusion and exclusion criteria. Patients will then be randomized (1:1) to one of the 2 treatment arms: Treatment A WJ-MSC/WJ-MSC; Treatment B Placebo/ Placebo. The 2 infusions will be administered endovenously on day 1 (D1) and on D3. Thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 Once the study is completed, controls will be established at 3 months, 6 months and 12 months as long-term follow-up.

The study treatments (A or B) will be added on top of the Standard of Care treatment prescribed by the attending physician. Each dose of MSC-WJ will consist of the intravenous administration of 1E6cells/Kg.

Recruitment will be competitive for the centers participating in the study. A Data Safety and Monitoring Board (DSMB) will be established to review safety and efficacy along the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Positive PCR fpr SARS-CoV-2
2. Intensive Care Unit admission for less than 3 days
3. Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg \< PaO2/FiO2 ≤ 200 mmHg)
4. Male or female, aged 18 to 70 years old
5. Signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email)

Exclusion Criteria:

1. Expected survival less than 3 days
2. Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
3. Neoplastic disease either active or without complete remission
4. Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
5. Pregnant or lactating women
6. Participation in another clinical trial with an experimental drug in the last 30 days
7. Other pathologies that, in medical judgment, contraindicate participation in the study
Effect of Cinnamon Powder Capsules on Body Composition

Obesity is a global health concern that significantly affects individuals, and its prevalence is still rising at an alarming rate. While various treatments are available, they often come with unwanted side effects. As a result, there is a growing interest in natural remedies including various herbs and spices such as cinnamon that have a favorable impact on overall health and disease conditions.

Obesity is a global health concern that significantly affects individuals, and its prevalence is still rising at an alarming rate. Pakistan is also experiencing an increasing prevalence of obesity, resulting in elevated morbidity, mortality, and healthcare costs. While various treatments are available, they often come with negative side effects that can reduce a patient's quality of life. Correspondingly, natural remedies have a kindle appeal that can enhance overall health and well-being. In Pakistani culture, natural condiments have been used for their health and therapeutic benefits. Cinnamon, an ancient spice commonly found in various regions, contains active ingredients that offer several health benefits. However, there is limited scientific data regarding the effects of cinnamon on body composition, especially among obese university students in Pakistan. Therefore, the current study aims to investigate the potential outcome of orally consuming cinnamon for weight management in obese university students in Pakistan. As a result, the study may provide effective evidence-based strategies for maintaining healthy body weight and exploring the potential use of cinnamon as a natural treatment option.

Eligibility Criteria:
Inclusion Criteria:

* Obese individuals (≥ 25 kg/m\^2)
* University students of all disciplines
* Participants of 18-28 years
* Both male and female

Exclusion Criteria:

* Morbid obesity (BMI ≥30 kg/m\^2)
* Disease conditions (such as cardiovascular diseases, diabetes, hypertension, renal disease, hypothyroidism, and hyperthyroidism)
The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation

This study evaluates the effectiveness of brushing and flossing sequence in the control of dental plaque and gingival inflammation.

Periodontal disease is the disease of the supporting dental tissues like alveolar bone,periodontal ligament cementum and gingiva. The most common form is plaque-induced gingivitis . Bleeding on gingival probing is one of the hallmarks of gingival inflammation.The removal of dental plaque is the most crucial action for preventing and treating gingival inflammation. Toothbrush along with toothpaste are still the most reliable means of plaque control. However, cleaning should be thorough and performed at regular intervals.

Toothbrush has a limited ability to reach all the areas around the tooth. Inter-dental areas are prone for plaque accumulation and gingival inflammation. Dental floss is one of the most effective tool in addition to tooth brush to remove inter-dental plaque. The sequence of using toothbrush and dental floss may influence the removal of dental plaque and consequently reducing the bleeding on probing of gingiva. There is conflicting evidence in the literature. The hypothesis of this study is that the sequence of brushing and flossing will not influence control of plaque control and gingival inflammation.

Eligibility Criteria:
Inclusion Criteria:

• Dental students of Dental school of Melaka-Manipal Medical College

Exclusion Criteria:

* Participants who had systemic diseases
* Gingivitis or periodontitis
* Use of antibiotics in the past 3 months,
* Pregnancy,
* Smoking
* Orthodontic appliances.
Corneal Toxicity in Patients Treated by Belantamab Mafodotin

Belantamab Mafodotin is the first antibody conjugate targeting B-cell maturation antigen (BCMA) in relapsed or refractory multiple myeloma (RRMM). It is used in multiple myeloma refractory to an immunomodulatory drug or proteasome inhibitor and refractory and/or intolerant to an anti-CD38 monoclonal antibody.

It has been found that the immunotherapy causes corneal side effects, Microcyst-like Epithelial Changes (MECs). They are round-shaped corneal inclusions that migrate from the peripheral cornea to the center, causing blurry vision, dryness and refractive shifts depending on their location and density.

This study aims at analysing the refractive shifts caused by Microcyst-like Epithelial Changes (MECs) and whether it can be used to monitor patients and facilitate their follow up.

Constitution of a French multicenter cohort.

Eligibility Criteria:
Inclusion Criteria:

* French patients with a refractory multiple myeloma and an ophthalmologic follow-up between January 2020 and February 2022
* Patients treated by Belantamab Mafodotin

Exclusion Criteria:

* Patients with more than 50% of missing ophthalmologic data.
Pilot Study Of The Effects Of Resveratrol On Endothelial Function In Subjects With Type 2 Diabetes Mellitus

Observational studies have shown that consumption of grapes and grape products such as red wine is associated with reduced cardiovascular risk. The mechanisms accounting for this benefit remain incompletely understood. Resveratrol is a component of grapes and red wine that has favorable effects on endothelial function in diabetic and obese animals. Resveratrol is available to people over-the-counter in health food stores and the internet as a dietary supplement.

The endothelium plays a central role in the control of blood vessel function. When healthy, the endothelium prevents vasospasm, blood clot formation, and the development of atherosclerosis. Endothelial function is abnormal in patients with diabetes mellitus and this abnormality contributes to the development of cardiovascular disease.

The present pilot study is designed to test the hypothesis that resveratrol (90 mg/day and 270 mg/day for one week each) will have favorable effects on endothelial function in patients with diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Male and Female subjects.
2. Age over 21 years old.
3. Body mass index greater than or equal to 25 and less than 35 kg/m2
4. Clinically stable Type 2 diabetes mellitus.
5. Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.
6. Willing to refrain from consumption of red wine, grape juice, and grape products beginning two weeks before and continuing throughout the entire study period.

Exclusion Criteria:

1. Women who lactating or pregnant. All women with childbearing potential will undergo a urine pregnancy test at each visit to exclude pregnancy.
2. Treatment with an investigational product within the last 30 days.
3. Clinically evident major illness of other organ systems, including end-stage cancer, renal failure, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
4. Liver transaminase levels greater than 3X the upper limit of normal.
5. History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
6. Vitamin supplements exceeding two times the recommending daily allowance (RDA) within the last 30 days prior to screening.
7. Resveratrol, green tea and isoflavone supplements within the last 30 days prior to screening.
8. Subjects who practice a vegetarian or vegan diet
9. Subjects taking budesonide, buspirone, eplerenone, eletriptan, felodipine, midazolam, saquinavir, sildenafil, triazolam, vardenafil, alfentanil, astemizole, cisapride, cyclosporine, diergotamine, ergotamine, fentanyl, irinotecan, pimozide, quinidine, sirolimus, tacrolimus, terfenadine, or warfarin.
Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction

This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.

Postoperative cognitive dysfunction is related with the use of opioids in the postoperative period, lack of physical activity, fatigue, postoperative pain and quality of life. The use of corticosteroids preoperatively reduces postoperative pain, fatigue, nausea and vomiting in the postoperative period and is frequently used as an adjuvant in anesthesia. This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patients over 60 years,
* underwent surgery for inguinal hernia repair, Nissen procedure, cholecystectomy or other surgeries midsize under general anesthesia and hospital stay expected within 72 hours.

Exclusion Criteria:

* age less than 60 years,
* history of brain disease or dementia, other psychiatric disorders that affect cognition,
* lack of proficiency in Portuguese,
* use of corticosteroids or opioid preoperatively.
N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation

The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation.

Secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.

Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive radical chemoradiation treatment.

The major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm the hypothesis generated by the INT 0139.

Eligibility Criteria:
Inclusion Criteria:

* Stage IIIA (N2) disease
* Potentially resectable disease
* Stage Lung Cancer with CT scan or PET-CT.
* N2 involvement: it is not necessary pathological proof.
* No progression after induction treatment.

Exclusion Criteria:

* T4 or N3 stage.
* Bulky disease or not resectable.
Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery

The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.

Subjects who can not be randomized due to any reason will be enrolled at observational group.

Eligibility Criteria:
Inclusion Criteria:

* Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent
* Low or intermediate risk level surgery
* Written informed consent

Exclusion Criteria:

* Acute coronary syndrome within 1 month
* Heart failure NYHA III to IV
* Contraindication to Aspirin
* On anticoagulant therapy
* Emergent surgery
* Cardiac surgery
* High bleeding risk surgeries, e.g., Intra-cranial surgery, Intra-spinal surgery, Retinal surgery
* Pregnancy or breast-feeding
* Life expectancy less than 1year
Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates

The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT) responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead placement compared to traditional LV lead placement.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be implanted with an FDA approved St. Jude Medical CRT-D device (i.e. PROMOTE® or newer devices with similar functionality)
* Patients will have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D
* Patients will receive a new implant or an upgrade from an existing pacemaker or Implantable Cardiovertor Defibrillator with no prior Left Ventricular lead placement
* Patients must be in sinus rhythm at the time of enrollment visit and baseline measurements

Exclusion Criteria:

* Persistent or permanent atrial fibrillation
* Heart transplantation
* Recent myocardial infarction (\< 90 days)
* Contra-indication to contrast agent
* Are less than 18 years of age
* Are pregnant
* Are currently participating in a clinical investigation that includes an active treatment arm
* Have a life expectancy of less than 6 months
Clinical Presentations and Surgical Outcome of Obstructive Müllerian Anomalies

The present study aims at:

A. The main outcome is to compare preoperative and postoperative visual analog scale VAS from 0 to 10 of maximum perceived pain in ladies with OMAs.

1. description of clinical presentation and percentage of OMAs in relation to other Mullerian anomalies
2. description of different subtypes and its percentage.
3. description of the corrective procedures and their short-term outcomes.

Obstructive Mullerian anomalies (OMAs) represent a real challenge in diagnosis and treatment, its incidence is not yet recognized. Care givers and gynecologist should be aware with its clinical presentation to avoid its delayed diagnosis and misdiagnosis. In addition, delayed diagnoses may result in retrograde menstruation, recurrent cyclic pains, chronic pelvic pains, poor quality of life and threats to future fertility.

Cases with complete obstructive Müllerian anomalies (C-OMAs) classically present with recurrent cyclic pains at puberty and their diagnosis is usually established easily. However, cases with Hemi obstructive anomalies (H-OMA) usually present with progressive dysmenorrhea and delayed diagnosis may result in pelvic adhesions, progressive hematosalpinx and endometriosis which directly threats natural future fertility. H-OMAs may results from obstructing uterine septa or unilateral cervical obstruction in a double uterus. Also, it may result from obstructing longitudinal vaginal septa in cases with double uterus, septate uterus or hybrid septate uterus .

A hybrid uterine anomaly is relatively a recent term that described the coexistence of septate and bicornuate uterus together. Pure septate uterus has a convex or flat fundus, when there is any fundal depression, it is termed hybrid septate uterus.

Pain with or without amenorrhoea is the main presentation of OMAs. Surgical correction should improve these symptoms. To the best of our knowledge there is no published prospective trials compared visual analog scale VAS in ladies with OMAs before and after surgical correction.

Eligibility Criteria:
Inclusion Criteria:

* All cases with OMAs or H-OMAs

Exclusion Criteria:

* Cases who refuse to participate in the study. 2.Cases who underwent previous surgical repair for their OMA or H-OMA.