cyrilzakka/clinical-trials huggingface dataset:
Equol Supplementation on Blood Pressure and Vascular Function

We propose to perform a 24-week randomized, double-blind a placebo-controlled trial among 207 non-equol producing postmenopausal women with prehypertension to examine the effectiveness of equol (10mg and 20mg/d) on 24h ambulatory blood pressure, vascular function and other cardiovascular risks (lipid profile, glycemic control and inflammatory biomarkers) and explore the optimal dosage of equol.

Inclusion criteria

1. Hong Kong Chinese women aged 45-65 y with 2\~8 years menopausal;
2. Mean SBP above 130 mmHg or DBP above 80 mmHg or both based on an average of 6 BP readings on two different occasions measured by sphygmomanometer.
3. Equol non-producer is defined as 24-hour urinary log10 S-equol:daidzein ratio less than -1.75 after daidzein challenge (60mg daidzein daily for 7 consecutive days).

Exclusion criteria

1. Subjects on anti-hypertensive medication or with average SBP≥160 or DBP≥100 or both;
2. Use of medications known to affect BP within past 6 months;
3. Medical history or presence of certain chronic diseases that could affect BP or limit the individual's ability to participate in the study;
4. Present or history of certain cancers;
5. Regular smoker or alcohol consumption more than 30 g/day;
6. Known soy allergy.

Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong Chinese women aged 45-65 y with 2\~8 years menopausal;
2. mean SBP above 130 mmHg or DBP above 80 mmHg or both based on an average of 6 BP readings on two different occasions measured by sphygmomanometer.
3. Equol non-producer is defined as 24-hour urinary log10 S-equol:daidzein ratio less than -1.75 after daidzein challenge (60mg daidzein daily for 7 consecutive days).
4. Written informed consent will be obtained from all the participants prior to enrolment.

Exclusion Criteria:

1. Subjects on anti-hypertensive medication or with average SBP≥160 or DBP≥100 or both;
2. use of medications known to affect BP within past 6 months (hormone therapy, hypoglycemic or weight reduction agents);
3. medical history or presence of certain chronic diseases (stroke, cardiac infarction, severe liver and renal disease etc.) that could affect BP or limit the individual's ability to participate in the study;
4. present or history of breast cancer, endometrial cancer, ovarian cancer, thyroid disorder, abnormal uterine bleeding after menopause;
5. regular smoker or alcohol consumption more than 30 g/day;
6. known soy allergy.
A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors

This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug.

The study was designed to detect a 50% improvement in median PFS\[Progression Free Survival\] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred.

Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC \[Data Monitoring Committee\]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.

The study was terminated on 11 March 2009 because the independent Data Monitoring Committee determined that the study had met its primary endpoint in demonstrating improvement in progression-free survival. The decision to terminate the trial was not based on safety concerns related to sunitinib administration.

Eligibility Criteria:
Inclusion Criteria:

* Well-differentiated advanced/metastatic pancreatic islet cell tumor
* Tumor has shown progression within the past year.

Exclusion Criteria:

* Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues
* Prior treatment with any tyrosine kinase inhibitors or anti-VEGF\[Vascular endothelial growth factor\] angiogenic inhibitors.
* Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted
Effects of Mindfulness Training on Emotional Care

Teachers in Hong Kong are susceptible to professional stress and its associated psychosomatic illnesses. To enhance teachers' well-being, mindfulness training is conducted in local schools. The present study is a randomized controlled trial to investigate 1) the effects of mindfulness training on teachers' well-being (i.e. general health, positive affect, life satisfaction, stress, negative affect), and 2) the mechanisms underlying the effectiveness of mindfulness (i.e. emotional care strategies including anchoring, decentering, and acceptance). Participants will be randomized to either intervention (8-week .b Foundations/ .begin course) or waiting-list control condition. They will complete survey before (baseline), after (post-intervention), and two-months (follow-up) after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or above
* Working in local schools or education institutions
* Willing to participate in mindfulness training voluntarily

Exclusion Criteria:

* Experiencing severe or unstable mental health condition currently
* Completed 8-week mindfulness training previously
* Unwilling to go by random assignment
The SCRIPPS DES REAL WORLD Registry

This study is a prospective, non-randomized, open-label registry of consecutive patients with CAD treated by stent-assisted PCI using at least one CypherTM stent. Up to 1000 pts will be included in the registry. The registry is conducted for the evaluation of the impact of CypherTM Sirolimus-eluting stent implantation in the "real world" of interventional cardiology. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study specific procedures. Consecutive patients treated with the use of the CypherTM stent will be included in the registry. Baseline and post-procedure blood samples will be used to perform platelet function analysis using the Accumetrics Ultegra RPFA (Rapid Platelet Function Assay).

All patients will be followed from enrollment through the hospital discharge for any clinically significant event (death, myocardial infarction, TLR, TVR, major or minor bleeding). A follow-up telephone assessment of death, myocardial infarction, revascularization, and medical treatment will be conducted by experienced research personnel at 30 days, 6 months, 1 year and at least 2 years. All site reported deaths, myocardial infarctions and revascularizations will be adjudicated by an independent Clinical Events Committee for all 1000 patients enrolled in the trial. An interim analysis of the first 750 patients will be conducted and data forwarded to FDA.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Eligible for percutaneous coronary intervention
3. Patient has at least one lesion ≥50% diameter stenosis requiring PCI with stenting
4. Reference vessel diameter 2.25-4.0 mm
5. Percutaneous intervention with use of one or more of the FDA approved CypherTM stents, planned not to exceed 108 mm of stent length.
6. Target lesion is located within a native coronary artery or bypass graft
7. De novo and restenotic lesions, including ISR, radiation failure
8. Be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up
9. Able to understand and grant informed consent

Exclusion Criteria:

1. Confirmed pregnancy at the time of index PCI
2. Has known allergies to aspirin, and to both clopidogrel (PlavixTM) and ticlopidine (TiclidTM)
3. Has known allergies or contraindication to heparin and Bivalirudin (AngiomaxTM)
4. Known allergy or sensitivity to any component of a Sirolimus-eluting stent
5. Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
6. Any serious disease condition with life expectancy of less than 1 year.
Techniques and Pitfalls of Multi-Slice CT Coronary Angiography

The goal of this study is to describe the techniques for coronary multi-slice CT angiography and to illustrate the spectrum of artifacts that can simulate coronary artery stenosis and lead to non-assessable segments using 128- and 160 multi-detector row CT scanners and discuss post-processing pitfalls with each. In addition, to review the normal anatomy and anatomic variants of the coronary arteries and discuss effective strategies for improving the diagnostic accuracy of coronary CT angiography.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of at least 18 years of age, with suspected symptomatic CAD.

Exclusion Criteria:

* Un cooperative patients.
* Those who have allergy to iodinated contrast material or contrast-induced nephropathy,
* Elevated serum creatinine level (1.5 mg/dl) or creatinine clearance \>60 ml/min.
* Atrial fibrillation.
* Aortic stenosis.
* Percutaneous coronary intervention within the past 6 months.
* Intolerance to beta-blockers.
* Body mass index \> 40
* Patients with Agatston calcium scores of \>400
Betaine Effect in Speed-strength Athletes

The study is aimed at assessing the influence of two betaine doses (2.5 g∙d-1 and 5 g∙d-1) supplemented for three weeks in a group of speed-strength trained athletes on anaerobic capacity in Wingate test, performance in CrossFit-like exercise test - Fight Gone Bad, alterations in body compositions and total body water.

The main aim of the project is the assessment of the effects of 3 weeks supplementation with two doses of betaine (2.5 g∙d-1 and 5 g∙d-1) on anaerobic capacity, CrossFit performance, body composition, and betaine metabolism in a group of male speed-strength trained athletes.

The study is designed as a double-blind, randomized, placebo-controlled crossover trial. 80 male participants will be divided randomly into two parallel groups: one receiving 2.5 g·d-1 betaine and the second receiving 5 g·d-1 betaine. In both experimental groups participants will receive both betaine supplement or placebo in a random order. The supplementation periods (betaine and placebo) will last for three weeks each and will be separated by a 3-week washout. The participants will attend four study meetings at the Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences, Poland. Food intake before and during the intervention will be assessed with the use of food diary and intakes of macro- and micronutrients will be calculated with the use of Dieta 5.0 software. On each visit Wingate ergocycling test will be performed, body composition will be measured and blood samples will be taken. The same day in the afternoon/evening hours the Fight Gone Bad (FGB) test will be performed. Body composition will be assessed based on air displacement plethysmography technology using the Bod Pod®. Moreover, total body water content will be analyzed by bioelectric impedance with the use of a BIA 101S analyzer. Anaerobic capacity will be assessed using the classical Wingate test on a cycloergometer. In order to assess CrossFit performance the FGB test will be performed. In blood samples the investigators plan to analyze concentrations of: lipoproteins and triglycerides (biochemical analyzer), betaine (LC-MS method), amino acid profile (LC-MS method), and testosterone (ELISA). MTHFR genotype will be analyzed with using a PCR-RFLP method. Data will be analyzed using the STATISTICA 12 software program.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent from all participants before the study
* a current medical clearance to practice sports,
* training experience: at least 1 year (of CrossFit ttraining),
* minimum of 2 workout sessions (combat sport) a week,

Exclusion Criteria:

* current injury,
* any health-related contraindication,
* declared general feeling of being unwell,
* unwilling to follow the study protocol,
* serious disease or metabolic problems,
* intake of betaine, choline or creatine supplements 4 weeks before the beginning of the study.
Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan RCT

The aim of this study is to clarify the efficacy of the endovascular treatment for acute ischemic stroke patients with large vessel occlusion and are not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke patients who were treated with intravenous rt-PA therapy within 4.5 hours from onset and have persistent occlusion of IC and M1 proximal portion\* confirmed by cerebral angiography.

  \*: M1 proximal portion means the segment of MCA within 5mm from the internal carotid bifurcation.
* Patients who can receive endovascular treatment within 8 hours after the onset.
* Patients whose DWI-ASPECTS was 5 points and more, or CT-ASPECT was 6 points and more just before cerebral angiography.
* Patients whose NIHSS is between 8 and 29 points.
* Patients who are between 20 and 85 years.
* Gender does not matter.
* Consent of this study participants must be obtained from patients or legal representative in writing.

Exclusion Criteria:

* Patients whose neurological symptoms improved and NIHSS is eight points and less after intravenous rt-PA therapy.
* Patients whose mRS was 3 points and more before the onset. 3)Patients with past history of lumbar puncture or arterial puncture that were difficult of hemostasis.
* Patients with intracranial tumor
* Patients with hypersensitivity to contrast agent.
* Patients with serious renal disease.
* Patients with malignant tumor.
* Patients with pregnancy or suspect of pregnancy, or during lactation.
* Patients with findings of acute myocardial infarction or pericarditis after myocardial infarction.
* Patients who cannot be followed for 3 months.
* Patients with past history of cerebral aneurysm, cerebral arteriovenous malformation, cerebral venous thrombosis, or moyamoya disease.
* Patients with other occlusions besides ICA or M1 proximal portion.
* Patients with aortic dissection complicating endovascular treatment.
* Patients with tortuous arteries that prevent the navigation of the device to the target vessel.
* Patients considered inappropriate to participate in the study.
A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions

This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. Half the participants will receive the intervention, and half the participants will receive usual care with education. Intervention subjects are hypothesized to have significantly less pain-related disability versus usual care subjects after 24 weeks.

This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. The investigators propose that emotion regulation is the mechanism of change through which PATH-Pain improves pain and pain-related disability (outcomes). This pilot study will provide initial evidence of the: a) feasibility and acceptability of PATH-Pain; b) effects of PATH-Pain on emotion regulation (mechanism of change) and outcomes (pain and pain-related disability); and c) mediating effect of emotion regulation (mechanism of change) on outcomes (pain and pain-related disability). The investigators will randomize 120 older adults (60 years or older) with chronic non-cancer related pain and negative emotions to PATH-Pain vs. Usual Care with Education (UCE). PATH-Pain will be administered by licensed mental health clinicians. Research assessments will be conducted at the Wright Center at study entry (baseline), and at 5, 10 (end of treatment), and 24 weeks.

Additionally, 20 providers of patients will be interviewed for feedback regarding the intervention.

Edits were made in November 2024 to better align with the study protocol regarding timing and measures.

Eligibility Criteria:
Inclusion Criteria

Patient Participants:

* 60 and older
* chronic pain (pain on most days in past 2 months)
* negative emotions
* MoCA score 16 or higher

Provider Participants:

* providers 18 or over that took care of patient participant

Exclusion Criteria - Patient Participants:

* MoCA score \<16
* cancer related pain
* can not provide capacity to consent
Cumulative Stress and Mental Health in Young Adults

The goal of this observational study is to learn about the needs of young adults - "policrisis generation", exposed to cumulative stress during 2020-2023, in terms of quality of mental health, the psychosocial resources, protective factors for cumulative stress effect, and the standards for effective prevention. The main questions to be answered are:

* How does cumulative stress affect young adults?
* Is there a specific cumulative stress syndrome that can be described?
* What are the risk and the protective factors for cumulative stress?
* How does the "policrisis generation" deal with the cumulative stress they have been exposed to? Participants will complete psychological questionnaires

Background: Epidemiological data are not sufficient to determine the mental health outcomes of exposure to cumulative stress of 2020-2023. Holistic knowledge of risk and protective factors, pathways leading to symptoms (not yet observed), and stress management strategies for the generation living under cumulative stress conditions (pandemic, war, refugee migration, economic crisis) is needed.

Participants: 400 young adults, recruited among university students.

Research methodology: Analysis of data collected by screening questionnaires, psychological scales, and questionnaires, related to mental health conditions.

Eligibility Criteria:
Inclusion Criteria:

* Age between 19 and 25 years
* Standard educational opportunities
* Attending the university course cycle

Exclusion Criteria:

* Age below 19
* Intellectual disability
* Inability to self-complete the research questionnaires
Vestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement

immediate implant placement with VST technique versus early implant placement with contour augmentation in fresh extraction sockets in the esthetic zone.

comparing VST technique with immediate implant placement that end up with final crown after 2 months with contour augmentation with early implant placement after 4- 8 weeks of soft tissue healing , then after 3 months final crown delivery both in fresh extraction sockets in the esthetic zone .

Eligibility Criteria:
Inclusion Criteria:

Non-restorable maxillary teeth in the esthetic zone

Intact adjacent teeth

Adequate palatal and apical bone that allows achieving implant primary stability.

Compromised sockets type II defect (Nicolas Elian 2007)

≥18 years

Systemically healthy patients

Exclusion Criteria:

Extraction sockets with acute or chronic infection or with adjacent infected teeth

Heavy Smokers \> than 10 cigarettes daily

Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.

Unmotivated patients to maintain adequate oral hygiene to follow up.

Patients with physical disabilities that could affect follow up.
18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery

The aim of the study is to compare the endocrine function of pancreas between pre and post metabolic surgery in patients with type 2 diabetes or prediabetes. The study will examine the endocrine function of pancreas using 18F-FDOPA PET/CT imaging and various biochemical laboratory tests


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes or prediabetes
* Body mass index \>25.0 kg/m2
* Written informed consent

Exclusion Criteria:

* Diabetes induced by chronic pancreatitis or pancreas cancer
* Chronic glucocorticoid usage
* Significant coronary artery disease or cerebrovascular disease within the previous 3 months
* Uncompensated congestive heart failure
* Severe pulmonary disease defined as FEV1 \< 50% of predicted value
* End stage renal disease on dialysis
* Acute infectious disease within the previous 3 months
* Pulmonary thromboembolism or thrombophlebitis within the previous 3 months
* History of cancer (except for basal cell skin cancer or cancer in situ)
* Prior gastrointestinal surgery (except for appendectomy or hemorrhoidectomy)
* Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
* History of chronic liver disease (except for NAFLD/NASH)
* Psychiatric disorders including dementia, active psychosis, severe depression requiring \> 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 5 years