cyrilzakka/clinical-trials huggingface dataset:
Pharmacogenomics of Antiplatelet Response - II (PARes-II)

This clinical trial is examining the effect of 4-week aspirin therapy on platelet transcriptome in persons at high-risk for myocardial infarction or stroke due to family history of early-onset coronary artery disease.

Platelet aggregation can initiate thrombosis on ulcerated arterial plaques resulting in acute coronary syndrome (ACS). There is large variation in platelet aggregation between individuals. As the genetic message to the cell machinery is conveyed through its transcriptome, we hypothesize that much of the variability in platelet function can be explained by transcriptome changes including differences in gene or isoform expression, altered splicing events, or allele-specific expression. Moreover, aspirin modifies gene expression in several cells, but whether it also affects platelet transcriptome has not yet been studied. Our goal is to characterize the platelet transcriptome and identify genes that are up- or down-regulated after 4-week aspirin therapy. A major strength of our study is that it enrolls individuals from European Americans and African Americans and thus will have the ability to study similarities and differences between the two. The study will produce innovative comparative genomic/platelet phenotype data and will provide a potential pharmacogenomic and diagnostic template for the future discovery of novel antiplatelet regimens to prevent thrombosis-related cardiovascular disease events.

Eligibility Criteria:
Inclusion Criteria:

* Participants from the GeneSTAR cohort
* Unaffected with no overt coronary artery disease or serious vascular event (stroke or peripheral vascular disease diagnosis
* Women who are postmenopausal.
* Women who use a reliable contraceptive method; a reliable contraceptive method will be defined as personal history of tubal ligation, ongoing use of intra-uterine device, or ongoing use of oral contraceptive pills.

Exclusion Criteria:

* Presence of any CAD or stroke, transient ischemic attacks, peripheral arterial disease
* Persons taking aspirin, NSAIDS, or any anti-coagulants who are medically unable to stop them for a two week pre-trial
* A history of allergy to aspirin or clopidogrel
* Weight \< 60kg
* Age \< 45 and \> 75 years of age
* A history of recent or any active bleeding
* Serious or current co-morbidity (AIDS, cancer)
* Pregnant women as determined by urine dipstick pregnancy test
* Any aneurysms on cranial magnetic resonance imaging/magnetic resonance angiography (obtained recently in the GeneSTAR participants)
* Blood pressure above \>=159/95mmHg
* History of a gastric or duodenal ulcer, or significant gastrointestinal disease, like regional enteritis
* Mental incompetence to make a decision to participate (developmentally disabled, and persons with diagnosed psychiatric disorders-documented in primary care records).
Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration

Comparing the result of of iliac vein stenting and compression therapy in management of recurrent venous ulceration.

Venous ulceration is the most common etiology of lower extremity ulceration, approximately affecting almost 1% of the world's population. although its overall prevalence is relatively low, the refractory nature of venous ulceration increases morbidity, mortality , the patient's quality of life, and have a significant financial burden on the global budget. the primary risk factors are: old age, obesity deep venous thrombosis, phlebitis and previous leg injuries.

Iliac vein compression is a prevalent finding in patients with venous system pathology. It has a variety of causes, including May-Turner syndrome, endometriosis, bladder distension, common iliac artery aneurysm or internal iliac artery aneurysm.

venous compression becomes clinically significant when there's an increase in venous pressure, which in turn causes venous insufficiency. This contributes to the development of a state of chronic venous stasis, which sequentially causes pooling of blood, triggers further capillary damage and activates inflammatory mediators with the end result of venous ulcer development and impaired wound healing.

Located on bony prominences, venous ulcers are typically shallow, irregular with granulation tissue and fibrin present in their bases. A careful physical examination is required for a proper diagnosis, but he clinical challenge remains in its management, which includes prevention or the treatment of the clinical implications.

Treatment modalities should always be directed to the cause of the ulcer; they can be divided into:

* non invasive management, such as medical therapy, bandaging and dressings.
* invasive, such as endovascular and surgical techniques.

Eligibility Criteria:
Inclusion Criteria:

* iliac vein compression.
* competent superficial venous system.
* isolated iliac vein lesion.
* patent femoropopliteal segment.
* ulcers located in the gaiter area.
* age \> 12 years
* patients with ulcers located in the gaiter area, along with the following associated symptoms: leg heaviness, pain, varicose veins, edema, hemosedrin staining, pruritus, venous dermatitis, lipodermatoscelrosis, telangiectasias, corona phlebectatica, atrophie blanche and deformity of the leg.

Exclusion Criteria:

* patients with arterial disease in the same limb.
* patients with history of phlebitis.
* patients with congenital venous malformation
* patients with malignancy.
* patients with raised renal chemistry.
* patients with skin allergy.
* diabetic neuropathic ulcer.
* atypical site of venous ulcer.
* acute onset DVT.
* age \< 12 years.
Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer

Investigators plan to carry out a study to investigate two different pills, Vitamin D and melatonin, and whether they can reduce the spread of cancer cells in the tumors of women with breast cancer. These pills are inexpensive and have very few side effects. A large number of studies using cell cultures and animals have shown that both vitamin D and melatonin can help destroy breast cancer cells. However thoughtful and well-designed studies are necessary on humans to see if they can decrease the spread of breast cancer, and possibly even prevent breast cancer. The proposed study aims to understand the anti-cancer activity of vitamin D and melatonin. This knowledge will assist in creating efficient cancer prevention strategies for Canadians. This study will include women with breast cancer who are being planned for surgery, and will assess whether treatment with vitamin D (dose of 2000 IU per day) in a group of 36 women, or melatonin (dose of 20mg per day) in another group of 36 women, or both pills together in yet another group of 36 women, reduces the spread of cancer cells when compared to a fourth group of 36 women who are treated with sugar pills. To do this we will measure a substance in the blood called Ki67, which provides information about the spread of cancer. Investigators will compare the Ki67 levels in the 4 groups, and all women will receive identical appearing pills so they will not know which treatment they received.


Eligibility Criteria:
Inclusion Criteria:

* Woman with histologically confirmed invasive breast cancer (ductal, lobular, or mixed)
* Planned to undergo definitive surgery, either lumpectomy or mastectomy in 3 or more weeks

Exclusion Criteria:

* Less than 18 years of age
* Stage IIIB or IV disease
* Inoperable locally advanced or metastatic breast cancer
* Neoadjuvant chemotherapy is intended
* Currently taking vitamin D supplements
* Currently taking melatonin supplements
* Previously taking vitamin D or melatonin supplements within the last 3 months
* Currently taking a multivitamin and not willing to discontinue for the duration of the study
* Hyperparathyroid disease or other calcium disturbance in the past five years
* Active renal stones in the last six months
* Renal failure (creatinine \> 190 mmol/L)
* Hypercalcemia (serum calcium \> 2.6 mmol/L)
* Known pregnancy
* Participation in another clinical trial where the patient receives any other investigational product
* Unwilling or unable to provide informed consent
Prospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital

Coronary heart disease (CHD) has a serious health threaten to population. PCI is a well-proved measure in CHD management. However, the knowledge about the real-life PCI use and how evidence-based therapies in routine clinical practice is limited. By consecutively recruiting PCI patients in a large-scale hospital in in Northeast China,this study will examine various real-life factors, that may affect patients recovery after the procedure. Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be established based on the findings, to improve patients outcomes in future finally.

Cardiovascular disease (CVD) is a major concern in public health in China. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. Practical and applied knowledge from large unselected population is needed to guide practice for quality improvement.

This study will enroll patients undergoing PCI in a large-scale hospital in in Northeast China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. CAG imaging will be reviewed by 2 cardiologists through PACS. Other Procedural data, including stent type, total stent length and so on, came from operation records of PCI cases finished by operators. At 1 month, 6 month, 12 month, 3 year and 5 year after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. If participants can not return to the clinic for follow up visits,a telephone interview will be conducted to get the related information. Before discharge,, blood sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect patients recovery after PCI, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients undergoing a percutaneous coronary intervention (PCI) for coronary lesions.

Exclusion Criteria:

* Previously enrolled in the R-PUSH study
Discharge Training Given to Primiparous Mothers Who Had a Cesarean Delivery

This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.

The research is a pre-test-post-test, randomized controlled experimental study.

The research is a pre-test-post-test, randomized controlled experimental study. To prevent selection bias, participants were included in the training and control groups by applying the randomization method. The sample consisted of a total of 70 women (experimental group: 35 women and control group: 35 women). The study was carried out with women who lying to Obstetrics Clinic of Aydın Gynecology and Children's Diseases Hospital and met the study criteria.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak and understand Turkish,
* At least primary school graduate,
* 18 years and over,
* Those who gave birth by cesarean section,
* Primiparous mothers will be included in the research.

Exclusion Criteria:

* Those who have a physical disability (vision, hearing, etc.) that prevents them from taking care of themselves,
* In a risky postpartum period,
* Having a history of chronic disease,
* Those who were hospitalized during pregnancy,
* Those who do not have their baby with them after birth,
* Foreign nationals,
* Mothers with psychiatric diagnoses will not be included in the study.
Prevention of Ocular Graft-Versus-Host Disease With Topical Cyclosporine in Recipients of Allogeneic HSCT

Ocular Graft Versus Host Disease (OGVHD) is a serious potential complication of allogeneic bone marrow transplants. The usual treatment is topical cyclosporine but when the treatment is initiated the damage to the lacrimal glands has already taken place.

The present study aims to prevent OGVHD in reduced-intensity allogeneic hematopoietic transplants by using topical cyclosporine immediately after the engraftment has been achieved

The patient will start using topical cyclosporine immediately after engraftment has taken place (around day 14-18 after the cell infusion) and will continue to receive it for one year.

All \>18 year old patients receiving allogeneic stem cell transplants performed with a reduced intensity conditioning regimen at our center are potential candidates for the study.

The purpose of the study is to evaluate the efficacy of topical cyclosporine in prevention of ocular versus graft disease when its use is indicated immediately after the engraftment has occured.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have written consent wishing to participate in the study
* Patients who have received an allogeneic stem cell hematopoietic transplants performed with a reduced intensity conditioning regimen
* \>18 year old

Exclusion Criteria:

* \<18 year old
* Patients not wishing to participate in the study or have
* Patients who have received autologous stem cell hematopoietic transplants
* Patients with history of rheumatologic diseases
* Patients with a previous diagnosis of dry eye síndrome
* Patients with previous eye surgery that disrupts corenal integrity
The Role of the Gut Microbiota in Estrogen Metabolism and Dietary Flax as a Potential Modulator.

The purpose of this pilot study is to determine if suppressing estrogen in premenopausal women results in changes in gut microbiota and if dietary flaxseed modulates these changes.

This pilot study will begin to address whether gut microbiota change with estrogen suppression. Specifically, the investigators will test whether gut microbial diversity and abundance change in response to estrogen suppression and consumption of dietary flaxseed. To test this possibility the investigators will recruit premenopausal women (age 20-40 years old)and collect fecal samples before and after 1 month of estrogen suppression with GnRH agonist. The investigators will analyze the gut microbiota in response to estrogen loss and whether this differs with the consumption of flaxseed.

Eligibility Criteria:
Inclusion Criteria:

* healthy premenopausal women (20-40 years)
* normal to overweight (22-29.9 kg/m2)
* normally menstruating (25-35 day cycles)
* not have used estrogen-based contraception for \>6 months.
* sedentary to moderately active (exercise ≤120 min week-1)
* must not be taking phytoestrogenic dietary supplements, or lipid- or glucose- lowering medications.

Exclusion Criteria:

* smoking
* pregnancy or breastfeeding
* Hormonal contraceptive use (past 6 mo.)
* Women with contraindications to GnRHAG:
* History of fragility fracture
* Low BMD (i.e., proximal femur or lumbar spine z scores \< -2.0)
* Abnormal vaginal bleeding
* History of breast cancer or other estrogen-dependent neoplasms
* History of venous thromboembolic events
* Hypersensitivity to leuprolide acetate or benzyl alcohol (the vehicle for injection of leuprolide acetate)
* Evidence for depressive symptoms (Score ≥ 18 on the Beck Depression Inventory, BDI)
* Moderate or severe renal impairment defined as a calculated creatinine clearance \<50 mL/min based on the equation of Cockcroft and Gault91
* Chronic hepatobiliary disease, conservatively defined as liver function tests (AST, ALT, alkaline phosphatase, Total Bilirubin) \>1.5 times the upper limit of normal (if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed)
* antibiotic or probiotic use within 2 months of sample collection
Bariatric Surgery on the West Coast of Norway (Vestlandet)

Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is now an established treatment at several other hospitals in the health region (Voss Hospital (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from different surgical methods.

This project is part of the regional strategic research initiative in the Helse Vest

Primary endpoints for the study are weight loss and self-reported quality of life (QoL) evaluated by Short Form (SF)-36 and Impact of Weight Wed Quality of Life-Lite (IWQOL-Lite)) Our hypothesis is that patients operated with RYGBP (Roux A-Y Gastric Bypass) and BPD / DS (biliopancreatic diversion with duodenal switch) have the same weight and same QoL after 5 years of follow-up as patients treated with gastric sleeve (laparoscopic gastric sleeve (LSG)) We will also compare the groups with respect to a number of secondary endpoints

400 patients (approximately 100 patients / institution) will be included in the main study. Some of the programs that run on secondary endpoints will be conducted separately under study at each hospital. These studies will be reported in separate articles.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes 18-60 years old
* Patients with morbid obesity that is applied to the bariatric surgery.
* Signed informed consent

Exclusion Criteria:

* Patients who become pregnant in the follow-up period will not continue in the study but the data will be treated as lost too follow up.
Risk Stratification of COVID-19 Using Urine Biomarkers

Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and in infected patients, it produces symptoms which range from completely asymptomatic to those expressing severe illness. Early recognition of those developing severe manifestations allows for rapid and appropriate intervention, including admission to intensive care unit and intensive care therapy, such as mechanical ventilation. A current problem is that only limited data exist predicting the clinical course of COVID-19. This study will determine whether non-invasive urinalysis is useful in assessing and predicting the severity or clinical course of patients with COVID-19.

This study will conduct to elucidate the following clinical question;

1. if the single urinary biomarker or the combination of urinary biomarkers will clarify the risk of COVID-19 confirmed mild cases. These biomarkers must be warranted to clinical use based on the evaluation by either CE or PMDA or FDA. Examination should be done within 72 h after the start of COVID-19.
2. if above addressed biomarker can classify the effectiveness of therapy directed to COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 confirmed cases by qPCR exam or equivalent.
* Those who agreed to join this study
* Those who received treatment at NCGM, affiliated hospital and institute including accommodation facilities for observational purposes.

Exclusion Criteria:

* Age less than 20
* Those who do not have smart phone (no personal contract)
* eGFR less than 30
* Any pre-existing illness with fever, weakness, or respiratory difficulties, Pregnancy or breastfeeding.
* Doctors' judgements to inappropriate for inclusion
Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell

This is a Phase I/II multicenter study which aims to assess the toxicity profile of Romiplostim in patients with transfusion-dependent thrombocytopenia after allogeneic HSCT.

A total of 24 patients with transfusion-dependent thrombocytopenia after allogeneic HSCT will be included.

The main endpoint is the incidence and severity of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be ≥ 18 years, willing and able to sign informed consent
* Patients could have been transplanted for hematological disorder (malignant or non-malignant) excepted myelodysplastic syndromes patients and had received either a myeloablative or a reduced intensity conditioning. All sources of allogeneic stem cells are allowed.
* Prolonged (\> 2 months) transfusion-dependent thrombocytopenia
* Screenings mean platelet count≤ 20 x giga/L or screenings mean platelet count ≤ 50 x giga/L with a history of bleeding.
* (ECOG) performance status of 0-2
* Adequate liver function
* Serum creatinine ≤ 176.8 μmol/L
* Bone marrow aspirate with cytogenetics within 6 days of the first dose of romiplostim
* Written informed consent

Exclusion Criteria:

* Relapse/progression of hematological malignancy (marrow examination required)
* Non-controlled acute and/or chronic graft versus host disease (GvHD)
* Active or uncontrolled infections
* Cardiac pathology - Thrombosis
* Pregnancy or breast feeding
* Received interleukin-11 (IL-11) within 4 weeks of screening or previously received any thrombopoietic growth factor
* Patients on anticoagulant therapy
* Receipt or planned receipt of Pegylated Granulocyte Colony Stimulating Factor (PEG-G-CSF), or Granulocyte macrophage-colony stimulating factor (GM-CSF) within 4 weeks of the first dose of investigational product
* Subject not using adequate contraceptive precautions, in the judgment of the investigator
* Sensitivity to any Escherichia coli-derived product
* Inability to comply with study procedures.
* Subject currently is enrolled in or has not yet completed 30 days since ending other investigational device or drug study
* No medical insurance in the French Health system
Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis: Peer Mentoring Program

Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a solution to the common problem of delayed treatment. Early peer support may result in improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the first two years post-diagnosis. The whole intervention study comprises of two parts: The first part involves the development and testing of a peer mentor training initiative, which is called "Peer to Peer Mentoring: Facilitating Individuals with Early Inflammatory Arthritis to Manage their Arthritis - Peer Mentor Training". The second part, which is the focus of this study, involves the delivery of a one-on-one peer support intervention from a trained peer mentor to an individual newly diagnosed with EIA. The feasibility and acceptability of the program will be determined, as well as the health outcomes following the participation of the program.


Eligibility Criteria:
Inclusion Criteria:

1. Have EIA disease duration within 6-52 weeks
2. At least 3 swollen joints, assessed by the treating rheumatologist, OR positive compression test for the metacarpophalangeal joints OR positive compression test for the metatarsophalangeal joints OR at least 30 minutes of morning stiffness
3. Prescription of a DMARD/biologic by the treating rheumatologist
4. Ability to speak and understand English without the aid of a secondary support person; AND
5. Capability to provide informed consent.

Exclusion Criteria:

1. IA disease duration less than 6 weeks or greater than 1 year
2. Previous or ongoing DMARD or biologic treatment
3. Inability to speak or read grade 6 English; AND
4. Inability to provide informed consent