cyrilzakka/clinical-trials huggingface dataset:
Investigation of Genomic Alteration in Patients With Luminal A or Luminal B Subtypes

This is a translational study in patients with operated early breast cancer of Luminal A or Luminal B sub types.The Hellenic Cooperative Oncology Group (HeCOG) has designed an observational biomarker-driven study in patients with Luminal A or Luminal B breast cancer, with the aim to collect valuable biological material from these patients and investigate biomarkers with potential prognostic value.

The HE10A/13 study is an observational study of the Hellenic Cooperative Oncology Group (HeCOG). Its main purpose is the collection of biological material from patients in search of prognostic / predictive biomarkers. Each patient signed an informed consent for the provision of biologic material for future research purposes. The study was conducted in accordance with the Declaration of Helsinki. The clinical and translational protocol has been approved by the Hellenic Cooperative Oncology Group Scientific Committee and is under review by the Institutional Review Board of Metropolitan Hospital. Patients exclusively with Luminal A or Luminal B (Estrogen Receptors (ER)-positive with or without Progesterone Receptors (PgR) positive, HER-negative) breast cancer who received adjuvant chemotherapy with positive lymph nodes or node-negative with tumor stage or pathological features according to Saint Gallen guidelines suggesting high-risk or when genomic testing determined in favor of adjuvant chemotherapy are eligible for registration in the study.

Before registration to the study, each patient signed an informed consent for the provision of biologic material for research purposes.

Potential biomarkers will be examined using in situ or molecular methods in Formalin fixed paraffin embedded (FFPE) tumor sections. For tumor subtyping immunohistochemistry for ER, PgR, HER2, Ki67 and Fluorescence in Situ Hybridization (FISH) will be performed where needed for the assessment of HER2 status; for Epidermal Growth Factor Receptor (EGFR) and CK5 for the classification of basal-like tumors; and, the expression of CD8, CD3 and FOXP3 on (Tumor- infiltrating Lymphocytes (TILs) will also be evaluated. Moreover, will be evaluated the mutational profile, including actionable genomic alterations, and the immune response -related profile of Greek women with breast cancer, via the application of DNA/RNA Next Generation Sequencing (NGS) technologies, relative also to patient outcome.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Luminal A breast cancer sub type
* Luminal B breast cancer sub type
* Positive lymph nodes
* Node- negative with tumor stage or pathological features according to Saint Gallen guidelines.

Exclusion Criteria:

-
PRIME - PRostate Imaging for Margin Evaluation

This study will evaluate the feasibility of using intra-operative Cerenkov Luminescence Imaging (CLI) of prostatectomy specimens to determine tumour margin status. The samples will be imaged using the LightPathTM Imaging System which consists of a light-tight box containing an ultra-sensitive lens and radiation-shielded camera. This study will measure the correlation between margin status of the WLE specimen and the metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM system in clinical practice.

This study is a prospective, single-centre feasibility study to evaluate the use of intra-operative Cerenkov Luminescence Imaging (CLI) of prostatectomy specimens to determine margin status.

Subjects will receive an intravenous injection of 370 Mega Becquerel (MBq) of 18F-choline prior to routine, elective radical prostatectomy. The surgery will be performed according to standard-of-care. The resected prostatectomy specimens will be imaged using the LightPathTM Imaging System, consisting of a light-tight box containing an ultra-sensitive lens and Electron Multiplying Charged-Coupled Device (EMCCD) camera.

This study will measure the agreement between margin status of the prostatectomy specimen as determined by CLI and by histopathology (reference method). This study will assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Men ≥18 years of age diagnosed with high risk prostate cancer, defined as clinical stage ≥T2c, or PSA\>20 ng/ml, or Gleason Score 8-10.
* Patients undergoing radical prostatectomy

Exclusion Criteria:

* Known hypersensitivity to 18F-choline
* Patients currently taking colchicine
* Prior therapy for prostate cancer (e.g. focal therapy)
Human Follicular Fluid Markers and Reproductive Outcomes in IVF

The goal of this observational study is to understand the processes in the growing follicles development in more detail and to improve In Vitro Fertilisation (IVF) treatments. This involves measuring laboratory values in the blood, in the follicular fluid of the woman and in the sperm of the man as well as questionnaires concerning lifestyle factors. These values are then linked to the success of the fertility treatment to find out which of these values increase the success of the IVF treatment.

Furthermore, the investigators want to investigate if there are differences between IVF treatments with or without hormonal stimulation of the ovaries.

This is a one-site prospective exploratory study at the University Clinic for Gynaecological Endocrinology and Reproductive Medicine in Bern. Data of influencing factors on IVF success in women and men will be collected in two types of IVF treatment, i.e. with or without hormonal stimulation of the ovaries.

The investigators want to

* compare the follicular fluid values between the two IVF treatment groups.
* assess the associations and predictive power of follicular fluid / blood and sperm parameters for success of the IVF treatment.
* compare the IVF success in the two treatment groups. The study aims to enrol approximately 200 couples. The data will be collected by the physicians and added to the REDcap study registry. Access to the total data set is only permitted for the principal investigator.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Written consent
* Couples undergoing In Vitro Fertilisation (natural cycle or conventional IVF)

Exclusion Criteria:

* Not willing to participate
* Missing consent
* Female of the couple does not want to participate or missing consent
* Language barrier
* Medical freezing
* Social freezing
* Thawed cycles
* Genetic disorders
* Preimplantation genetic testing (PGT)
* Medication for chronic condition
* Surgery in the last 4 weeks
* Significant trauma in the last 90 days
* Severe reduced sperm quality
* Kryosperm
* Poor responder or expected poor response
Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation

Simulation-based training has been widely implemented in medical education. According to educational theories, simulation-based medical education (SBME) is associated with significant advantages, which has been investigated and proved by many studies. However, the value of SBME in comparison to other instructional methodologies remains largely unknown. Therefore, the aim of this study is to directly compare two instructional methods for neonatal resuscitation training.


Eligibility Criteria:
Inclusion Criteria:

* Fifth-year medical students prior to their mandatory OSCE
* Signing of informed consent

Exclusion Criteria:

* Refusal to participate in the study

The first two OSCEs in July and August will be part of a pilot study. The combined results of both examinations will be used for a sample size calculation.
Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity

A Phase 1 Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity

This study is designed to look at the effect of two doses of PF 06882961 (120 milligram (mg) twice a day (BID) and 200 mg BID) on the levels of one dose of rosuvastatin 10 mg and one dose of midazolam 2 mg, in otherwise healthy, adult participants with obesity. Total duration of study from screening to the telephone visit will be approximately 17 weeks, of which up to 63 days will be inpatient. All subjects take (i) Rosuvastatin alone, Midazolam alone, PF 06882961 alone (120 mg BID), PF 06882961 (120 mg BID) + Rosuvastatin, PF 06882961 (120 mg BID) + Midazolam, PF 06882961 (200 mg BID) alone, PF 06882961 (200 mg BID) + Rosuvastatin, PF 06882961 (200 mg BID)+ Midazolam in the study.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 30.0 kg/m2 and not more than 45.4 kg/m2 at Screening.
* Stable body weight, defined as \<5 kg change (per participant report) for 90 days before Screening

Exclusion Criteria:

* Known prior participation in a trial involving PF-06882961.
* Known intolerance or hypersensitivity to GLP-1R agonists.
* Known hypersensitivity to rosuvastatin or midazolam.
* Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at screening. Note: prior diagnoses of gestational diabetes during pregnancy only are eligible if they meet the other eligibility criteria
* Any lifetime history of a suicide attempt.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
* Participation in a formal weight reduction program (eg, Weight Watchers) within 90 days prior to Screening.
Plant Sterols Effect on Previous Statin Therapy

The purpose of this study is to determine the effect of plant sterols associated with ezetimibe in LDL-cholesterol levels in coronary patients previously on statin therapy

Background: Consumption of food products enriched with plant sterols and treatment with ezetimibe both reduce cholesterol absorption in the intestine by different mechanisms and effectively reduce LDL cholesterol (LDL-c) plasma levels. Although, the associated usage of ezetimibe to plants sterols in coronary patients not reaching recommended lipid levels despite the use of statins has not yet been demonstrated. Objectives: Evaluate if ezetimibe 10mg associated to plant sterols spread enriched with 2g of plant sterols in coronary patients not reaching recommended lipid levels despite the use of statins is able to reduce cholesterol levels after 6 week treatment. Methods: Prospective, open-label study with both male and female patients with stable coronary disease and LDL \> 70mg/dL. Patients will be randomized for the following 6 week treatment: control group (CT) no additional statin therapy, ezetimibe group (EZ) 10 mg/day ezetimibe, plant sterol group (PS) spread enriched with 2g of plant sterols or ezetimibe+plant sterols group (EZ+PS) 10mg/day EZ + 2g PS. Anthropometric evaluations and laboratory exams (blood glucose test, total cholesterol, LDL-c, HDL-c, triglycerides, and C-Reactive Protein) will be performed in all groups at baseline and after the sixth week intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with previous myocardial infarction, stroke or coronary angiography demonstrating significant coronary disease.
* Subjects under statin treatment with a fixed dosage for the previous three months before randomization, and did not reached LDL less than 70mg/dl.

Exclusion Criteria:

* Subjects already taking ezetimibe and/or plant sterols
* Younger than 18 years
* Presence of any contraindication to statin
* Pregnant women or breast-feeding women or
* Patients with previous history of statin hypersensibility
The PortionSize Smartphone App Pilot (PS Pilot)

The objective is to examine the preliminary validity, reliability and perceived participant satisfaction of the PortionSize app.

Overweight and obesity are a burgeoning public health concern, yet only a small minority of smartphone apps that claim to facilitate healthy eating and weight loss incorporate evidence-based principles. Such innovations are important as humans fundamentally cannot accurately estimate portion size. Indeed, portion size estimation errors account for \~50% of the error in self-reported food intake, and data from our laboratory has demonstrated that extensive training results in only modest improvements in portion size estimation accuracy and that portion size estimates remain inaccurate. Our long-term goal is to create simple and accessible interventions that assist individuals with weight control. In particular, we aim to provide easy-to-use phone apps that allow participants to monitor the portion sizes of the foods they consume. These apps guide participants on appropriate portion sizes and provide recommendations of food groups that should be consumed. To that end, we have developed the PortionSize app. We propose to improve the accuracy of portion size measurement, as it is poorly determined by self-report measures. This will occur via the development of the PortionSize smartphone app and this pilot study will test the usability as well as preliminary validity and reliability of the app functionality.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-45 kg/m2 based upon self-reported height and weight
* Have an iPhone and an operable Apple ID, password, and email address and is willing to use these to collect data during the study, acknowledging that data usage, and associated charges, are a result of study participation

Exclusion Criteria:

* For females, pregnancy or breast feeding
* Currently diagnosed with an eating disorder
* Disease that severely affects metabolism, including diabetes, hypercholesterolemia, or dyslipidemia
* Has gained or lost more than 10 lbs in the last 3 months
* PBRC faculty/staff member
* Has suffered serious mental illness that has resulted in serious functional impairment and has substantially interfered with one's life activities within the last 5 years
* Any other medical, psychiatric, or behavioral factors in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol
A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool

This study examines the impact of an online decision tool for patients with early stage invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas. Participants will be randomized to receive either a basic version of a decision tool (similar to existing website with breast cancer information) or an enhanced version (featuring a knowledge building component, a values clarification exercise, and a patient activation module). Our hypothesis is that patients who use the enhanced version of the tool will have greater knowledge of their test and treatment options, have a higher rate of high quality (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the decision-making process.

Patients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. Currently many of these decisions do not meet the definition of a high quality decision, defined as one that is both informed (i.e., based on an accurate understanding of the treatment risks and benefits) and preference-concordant (i.e., consistent with the patients' underlying preferences). Moreover, the introduction of evaluative tests has made these decisions more complicated for many patients. There is a need to improve the quality of locoregional and systemic treatment decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. Ensuring patients can deliberate effectively about these decisions, assert their views and communicate with their clinicians is likely to improve their overall decision preparedness and satisfaction. This study will focus on the third pillar of individualized care by evaluating the impact of an innovative decision tool on locoregional and systemic therapy decision making for newly diagnosed breast cancer patients. The innovative online decision tool has been developed and tested over the past two years by the CanSORT team (R21 CA129859). Pilot data suggests that this tool has a positive impact on patient knowledge and decision outcomes. The goal of this study is to evaluate the impact of this tool, after it is enhanced in collaboration with our Communication and Dissemination Core, on the quality of decision making for locoregional and systemic breast cancer treatment decision making.

Eligibility Criteria:
Inclusion Criteria:

* Stage 1-2 invasive breast cancer diagnosis,
* DCIS
* Ability to read English

Exclusion Criteria:

* Male
Safe Renal Function In Long Term Heart Transplanted Patients

The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy


Eligibility Criteria:
Inclusion Criteria:

* Heart Transplant patients with more than 1 year of follow-up
* Creatinine lower than 3.5 mg/dl
* GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula)
* Cyclosporine in maintenance immunosuppressive therapy
* Patient must be able to sign an approve informed consent
* Prior History of acute rejection within the last 3 months
* Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used

Exclusion Criteria:

* Patients who are recipients of multiple organ transplants
* Prior or current use of sirolimus or everolimus
* History of acute rejection within the last 6 months
* Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months
* Patient not able to attend all follow-up evaluations
EPA Supplementation on Vascular Inflammation, and Gene Expression of PON2 in Patients With Type II Diabetes Mellitus

The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum levels of some indicators of vascular inflammation, and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.

The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase and several indicators of vascular inflammation and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus. In this randomized, double-blind clinical trial, placebo-controlled, single-center, 36 men and women aged 35-50 years with type 2 diabetes are enrolled in the study from the Iranian Diabetes Association. After signing informed consent, all individuals complete a general information form. a 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. Two groups will be classified (blocked) based on sex. The supplement group, will receive 2 g/day EPA for 8 weeks and the placebo group will also receive placebo (containing 2 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropocentric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured.

Eligibility Criteria:
Inclusion criteria:

* Willingness to collaborate in the study
* aged 35-50 years
* having a history of at least 1 year of type 2 diabetes mellitus before the participation in the study based on FBS ≥126 mg/dl or 2hPG ≥200 mg/dl (2-hour plasma glucose),
* 25≤BMI\<30 kg/m2

Exclusion criteria:

* pregnant and breastfeeding women
* using insulin, alcohol consumption, smoking and other drugs
* taking drugs (lipid-lowering, β-blockers, diuretics, estrogens, progesterones, vitamin supplements and ω-3 fatty acid supplements
* followers of the special diet
* history of diabetic retinopathy or diabetic nephropathy
* type 1 diabetes mellitus and other disorders
* any need to take insulin, change in the dose (s) and type of medication or physical activity
The Effect of Cardiopulmonary and Muscular Fitness on Healthy Aging Among Community-Dwelling Older Adults

To compare the different cardiopulmonary and muscular fitness of community-dwelling older adults on healthy aging, and to identify the optimal cutoff points of their cardiopulmonary fitness and muscular fitness on targeting healthy aging.

At the end of the 20th century, the WHO began to promote the issue of healthy aging. From then on, the Taiwan government gradually attached importance to long-term care and devoted to developing community-based health promotion programs for the elderly. Currently, the programs commonly plan to proceed through the group exercise intervention, increasing physical activity to improve their physical fitness and also to prevent their functional disability. This study aims to compare the different cardiorespiratory fitness and muscular fitness of community-dwelling older adults on healthy aging, and figure out to what extent of cardiorespiratory fitness level and muscular fitness level may achieve healthy aging. The present healthy status of participants will be investigated by interviewing if having any disability or frail. Based on multidimensional model, the definition and measurement of healthy aging status include physiological, psychological and social function aspect. In this study, the health aging status is defined as non-frailty, independence in basic and instrumental activities of daily living, normal cognitive function, absent of depression status, good social relations and good environmental support.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 55 years old
* Had contact information from project
* Had attended both pre-test or post-test during program
* Volunteer to participant

Exclusion Criteria:

* Incomplete physical fitness data
* Participant with frailty after screening during the class
* Not available to respond
* Not accept the informed consent
Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

The present study aims to investigate the chronic effect of treatment with doxorubicin and cyclophosphamide on neurovascular control and blood pressure in women undergoing adjuvant treatment for breast cancer.

The development of new drugs and different adjuvant therapeutic regimens, based on the combination of anthracycline (A) and cyclophosphamide (C), have contributed greatly to improve survival rate in breast cancer patients. Despite the clinical benefits of this therapy, AC treatment can cause cardiovascular acute and chronic changes. In a recent investigation, we observed that an acute AC chemotherapy session increases sympathetic nervous activity and blood pressure in patients with breast cancer.

The present study aims to investigate the chronic effects of AC regimen on sympathetic nervous activity, peripheral vasoconstriction, endothelial microparticles and blood pressure, in women with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stage II-III breast cancer
* starting adjuvant chemotherapy

Exclusion Criteria:

* metastatic disease,
* hypercholesterolemia, diabetes,
* hypertension,
* severe lymphedema,
* organic disorders (renal failure, heart failure and chronic liver disease),
* obesity (BMI\> 30) and,
* who are under pharmacological treatment with statins, angiotensin-converting enzyme inhibitors, losartan potassium, beta blockers or antioxidants