cyrilzakka/clinical-trials huggingface dataset:
Cerebral Excitability and Cognitive Performance

This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions.


Eligibility Criteria:
Inclusion Criteria:

- Between ages of 18-65.

Exclusion Criteria:

* History of adverse reaction to tDCS (trans-cranial direct current stimulation).
* History of seizure activity.
* History of head injury (including neurosurgery).
* History of illness causing brain injury.
* History of other brain-related condition (such as traumatic brain injury).
* History of diagnosis with a neurological or psychiatric disorder.
* History of metal in head (outside of mouth), such as shrapnel, surgical clips, or fragments from welding or metalwork.
* History of sensitive scalp.
Clinical Utility of ClarityDX Prostate

ClarityDX Prostate builds upon the utility of total and free PSA as well as simple clinical features in a decision support model to determine a patient's risk of having clinically significant prostate cancer. The highly accurate ClarityDX Prostate risk score enables clinicians and patients to collectively make more informed decisions regarding the appropriateness of subsequent imaging or biopsy procedures. The clinical pathway aligns with the Canadian Urological Association (CUA) to use adjunctive strategies to better stratify risk of clinically significant prostate cancer.

ClarityDX Prostate consists of four separate models that can be used depending on the information available:

1. ClarityDX Prostate. This model incorporates the patient's total PSA and free PSA levels as well as the age of the patient and whether they have had a previous negative biopsy.
2. ClarityDX Prostate + DRE. This model incorporates ClarityDX Prostate + DRE (normal or abnormal DRE findings).
3. ClarityDX Prostate + MRI. This model incorporates ClarityDX Prostate + MRI (PI-RADS score and prostate volume as determined from an mpMRI scan).
4. ClarityDX Prostate + MRI + DRE. This model incorporates ClarityDX Prostate + MRI + DRE.

PRIMARY OBJECTIVE The purpose of this study is to investigate the clinical utility of ClarityDX Prostate on in reducing further healthcare utilization for men identified to be at risk of prostate cancer.

SECONDARY OBJECTIVES

* Assess the effect of ClarityDX Prostate on the proportion of negative biopsies and biopsies diagnosing Gleason Grade (GG)\<2.
* Measure the difference in MRI numbers between the test and control groups.
* Evaluate the effect of ClarityDX Prostate on the prioritization of healthcare services to participants with high-risk of having clinically significant prostate cancer.
* Infer the potential to use ClarityDX Prostate for prostate cancer screening to inform urology referral.
* Perform a health economics assessment and cost-benefit analysis for the use of ClarityDX Prostate.

This is a prospective, randomized, two-armed clinical utility study that will enroll participants referred to urology clinics for suspicion of prostate cancer. The arms of the study are ClarityDX Prostate and Standard of Care (SOC).

When stratifying patients for prostate cancer, it is ideal to avoid delay in treating high-risk participants that do require a biopsy, while avoiding unnecessary procedures in low-risk patients. The purpose of this study is to investigate in a real-world setting whether the use of ClarityDX Prostate would further reduce potentially unnecessary healthcare utilization of men referred to urology clinics with suspicion of prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Males ≥ 18 years of age
2. Referred to urology for suspicion of prostate cancer
3. No prior prostate cancer diagnosis
4. Willing to participate in the study
5. Availability for cancer care in the jurisdiction of recruitment

Exclusion Criteria:

1. Unwilling to participate in the study
2. Unable to consent
The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women

This pilot study plans to learn more about the aging of blood vessels and arteries in women. As women age and go through menopause, their risk for cardiovascular disease increases. Also with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone replacement therapy to restore estradiol levels does not protect women from cardiovascular disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease risk. However, there are differences between men and women in their response to exercise. In older men, exercise improves the health of their arteries, but in postmenopausal women, exercise does not provide this benefit. The purpose of this pilot study is to determine whether low estradiol levels in postmenopausal women are responsible for the poor vascular response to exercise. In this study the investigators will also test whether treatment with resveratrol, a plant compound found in red wine, improves postmenopausal women's response to exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol will improve vascular responses to an acute bout of exercise.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 50-70 and at least 1 year beyond menopause;
* resting blood pressure \<140/90 mmHg;
* plasma glucose concentrations \<110 mg/dL under fasting conditions;
* BMI \< 35;
* LDL cholesterol \< 160 mg/dL;
* sedentary or recreationally active (\<3 days of vigorous aerobic exercise);
* no use of OCs, HT, or other medications that might influence cardiovascular function;
* nonsmokers;
* no use of vitamin supplements, blood thinners or NSAIDS, or willing to stop use one month prior to and for the duration of the study;
* not taking any other medications that would interact with E2 patch or resveratrol to confound interpretation of results.

Exclusion Criteria:

* history of or active E2-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia (≥ 150 mg/dL), and CVD;
* known allergy to transdermal patch, or resveratrol;
* history of stomach ulcer or bleeding;
* other contraindications to HT or resveratrol.
* other conditions for which individuals will be excluded from the study include: diabetes, active infection, history of seizures or disease that affects the nervous system or an abnormal resting ECG.
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery

Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery. Cohort study investigating the efficacy of THRIVE pre-oxygenation using pre-determined number of vital capacity breaths and comparing the efficacy to face mask pre-oxygenation. Aimed to recruit ASA 1-2 term pregnant women having elective caesarean section.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo elective caesarean delivery
* singleton pregnancy
* American Society of Anaesthesiologists (ASA) Physical Status Grade II
* gestational age between 37 - 42 weeks

Exclusion Criteria:

* multiple pregnancy
* pre-eclampsia
* known fetal abnormality
* maternal cardio-respiratory comorbidity
* Body Mass Index (BMI) \> 35 kg/m2.
Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese ACS Patients

Prasugrel has a faster onset of action and greater platelet inhibition with less inter-individual response variability than clopidogrel. Japan and Taiwan are the only two nations where adjusted/Asian dose of prasugrel (loading dose (LD)/maintenance (MD): 20/3.75 mg) was approved for clinical use. However, there is no data regarding the effectiveness of adjusted dose of prasugrel on platelet reactivity in Taiwanese patients with acute coronary syndrome (ACS). This study aim to evaluate the pharmacodynamic of the Asian dose prasugrel on the platelet reactivity after percutaneous coronary intervention (PCI) for patients with ACS.

Rationale and Background Prasugrel provides more potent and rapid platelet inhibition compared to Clopidogrel.

Rapid and effective inhibition of the platelet P2Y12 receptor is of pivotal importance in patients with AMI who undergo PCI.

Prasugrel (60 mg loading and 10 mg/day maintenance dose) is a new generation P2Y12 inhibitor that achieves greater and faster platelet inhibition comparing with clopidogrel in patients undergoing PCI.

As revealed by 2 head-to-head studies, reducing Prasugrel dosages to 20/3.75 LD/MD (mg) was still efficacious but led to less bleeding events than the original 60/10 LD/MD (mg).

In TRITON-TIMI 38 trial, prasugrel was associated with not only significantly less ischemic events but also more non-CABG TIMI major bleeding, as compared to Clopidogrel.

In the PRASFIT-ACS study from Japan (20 mg loading and 3.75 mg/day maintenance dose), prasugrel was associated with a 23% reduction of MACE and the incidence of non-CABG major bleeding was similar to clopidogrel.

There is NO data regarding the effectiveness of Japanese loading dose of prasugrel on platelet reactivity in Taiwanese patients with AMI.

This study use PRU for efficacy and ISTH major bleeding for safety evaluations; the anticipated results are prompt and effective platelet inhibition as well as comparably low bleeding rate.

Eligibility Criteria:
Inclusion Criteria:

* Age\>=20
* Mentally competent to provide an informed consent.
* A person being diagnosed with acute coronary syndrome and arranged for a percutaneous coronary intervention.

Exclusion Criteria:

* A history of hemorrhagic stroke at any time in the past.
* Active internal bleeding or has a history of a bleeding disorder (i.e. hemophilia).
* Severe liver disease; for example, cirrhosis.
Abnormalities of the Eye's Anterior Chamber, Iris, Cornea and Lens

This study will investigate congenital or developmental eye abnormalities that affect the iris, cornea and lens, and are usually accompanied by elevated pressure within the eye. These disorders can cause vision loss, and the increased eye pressure can lead to glaucoma, a condition that may also cause loss of eyesight.

Patients with eye anterior chamber eye disease, such as Axenfeld's syndrome, Rieger's anomaly, Peter's anomaly, iridocorneal endothelial syndrome, megalocornea, ocular hypertension, and others, are eligible for this study. Participants will have a medical examination, family history, and comprehensive eye examination. Tests and procedures may include photographs of the cornea, iris, and the structure through which fluid that normally circulates behind the cornea drains out of the eye. Some patients may undergo indentation tonography to measure how easily this fluid drains. In this procedure, the patient lies on an examination table and both eyes are numbed with eye drops. A small instrument (tonometer) is placed on the surface of one eye, and with the other eye, the patient looks at an overhead light. Other tests may include photographs of the back of the eye and ultrasound imaging of the structures of the eye. A blood sample may be drawn to study the genetic disorder responsible for the disease. Patients will have follow-up examinations every 6 months for the duration of the study.

Medical or surgical therapy will be recommended, as appropriate, for patients who develop elevated eye pressure or vision loss.

This study will concentrate on abnormalities of the anterior chamber with or without elevated intraocular pressure. The purpose of the study will be to determine if there is a common pathogenesis shared by these conditions. A natural history study of 40 individuals with these diseases will utilize clinical measurements and photographs for documentation of this hypothesis. In addition, surgical specimens, when available, will be studied.

Eligibility Criteria:
The eye conditions to be studied include Axenfeld's syndrome, Rieger's anomaly, Peter's anomaly, (all with or without glaucoma), Iridocorneal Endothelial syndrome, Aniridia, Pigment Dispersion syndrome, Megalocornea and other conditions with clinical abnormalities of the anterior chamber.

Patients will not be included in the study if they do not fit the morphologic characteristics of the disease in question or if the patient's general medical condition or other related factors make it impossible for him or her to continue participation in the study.
COhort of antithrOmbotic Use and cLinical Outcomes in Patients With Atrial Fibrillation (COOL-AF) Phase 2

Atrial fibrillation (AF) is a leading cause of cardiovascular mortality and morbidity. Asian patients with AF have a higher rate of major bleeding including intracranial hemorrhage (ICH) compared to non-Asians. Non-vitamin K antagonist oral anticoagulants (NOACs) are the safer drugs compared to warfarin due to a lower rate of ICH, but the rate of NOACs use in many Asian AF is much lower than non-Asian countries due to economic concerns. The purpose of the COhort of antithrOmbotic use and cLinical outcomes in patients with Atrial Fibrillation (COOL-AF) Phase 2 registry is to determine the changes in antithrombotic patterns and the impact on clinical outcomes.

The COOL-AF Phase 2 study is a prospective observational multicenter study of patients with known or newly diagnosed non-valvular AF in Thailand. The aim is a sample size is 3680 patients from 33 centers within a 2-years enrollment timeline. Patients will be follow-up every 6 months until 3 years. The study outcomes were death, ischemic stroke/systemic embolism, major bleeding, myocardial infarction, heart failure, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ECG or ECG tracing from ambulatory ECG monitoring.

Exclusion Criteria:

1. Patients who have experienced an ischemic stroke within the past 3 months before enrollment.
2. Patients with a platelet count less than 100,000/mm3 or who have myeloproliferative disorders (essential thrombocythemia, chronic myeloid leukemia, polycythemia vera, agnogenic myeloid metaplasia), hyperviscosity syndrome, chronic disseminated intravascular coagulation (DIC), or antiphospholipid syndrome.
3. Patients with a mechanical prosthetic heart valve.
4. Patients with rheumatic mitral stenosis.
5. Patients participating in research projects with concealed treatments.
6. Patients expected to have a life expectancy of less than 3 years due to other diseases, such as cancer or AIDS, as determined from medical records.
7. Pregnancy.
8. Patients unable to follow the treatment plan.
9. Patients who do not consent to participate in the study.
10. Patients who are hospitalized or discharged from the hospital within the past 1 month.Contact/Locations
the Effect of ABCC2 Genetic Polymorphism on Neurotoxicity in Gastrointestinal Cancer Patients Receiving Oxaliplatin

Study the effect of genetic polymorphism (rs1885301, rs4148396 and rs3740066) in the membrane of Multidrug resistance protein 2 (MRP2) encoded by ATP-binding cassette C2 (ABCC2) gene and its genetic expression levels on neurotoxicity in gasrtointestinal cancer patients reciving Oxaliplatin-based chemotherapy.

Several solutes carriers and ATP-binding cassette transporters have been implicated in the influx or efflux of platinum-based chemotherapeutic agents such as cisplatin, carboplatin, and oxaliplatin. The ATP-binding cassette (ABC-) transporter superfamily contains several family members that may confer intrinsic or acquired multidrug resistance (MDR) by extruding anticancer agents or their metabolites from cells and suppression of such transporters may lead to sensitisation to cytostatic agents. Multidrug resistance protein 2 (MRP2), encoded by the ATP-binding cassette C2 (ABCC2) gene , is an efflux pump located on the apical membrane of many polarized cells, which transports conjugate compounds by an ATP-dependent mechanism like oxaliplatin. Single nucleotide polymorphisms (SNPs) in genes involved in drug transport like ABCC2 gene may lead to higher intracellular oxaliplatin accumulation in the dorsal root ganglia and thus increased risk of Oxaliplatin-induced peripheral neurotoxicity (OXPN). Enhanced ABCC2 expression can lead to decreased cellular glutathione content. Glutathione is needed for oxaliplatin detoxification via conjugation, and it was reported that low glutathione intra- cellular levels can cause increased oxaliplatin cytotoxicity. Moreover, ABCC2 mediates the export of the oxaliplatin-glutathione conjugated form, and ABCC2 overexpressing cells were resistant to platinum derivatives.

Eligibility Criteria:
Inclusion Criteria:

1. gastrointestinal cancer Patients ( ≥ stages II ) who receive Oxaliplatin based chemotherapy ( FOLFOX6 ) for adjuvant and metastatic setting.
2. Eastern Cooperative Oncology Group ( ECOG ) performance ≤ 2.
3. Adequate bone marrow functions ,liver functions and renal functions.

Exclusion Criteria:

1. Patients who have any clinical neuropathy.
2. Pateints with Diabetes mellitus.
3. Serious comorbid systemic disorder incompatible with study.
4. Pregnancy.
5. Other primary tumors.
S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000

RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment.

PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.

OBJECTIVES:

Primary

* To assess the effect of selenium on colorectal adenoma (CRA) occurrence.
* To assess the effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA.
* To assess the effect of selenium on colorectal cancer (CRC) incidence.

Secondary

* To assess the effect of vitamin E on CRA occurrence.
* To assess the effect of vitamin E on CRC incidence.

Tertiary

* To explore the effect modification of selenium and vitamin E by aspirin on CRA occurrence.
* To explore the effect modification of selenium and vitamin E by body mass index.

OUTLINE: This is a multicenter study.

Endoscopically obtained tissue samples are reviewed by study pathologists to confirm the presence (or absence) of a colorectal adenoma (CRA). If a CRA is present, the number, location, size, histology, and degree of dysplasia are documented. The CRA is also reviewed to exclude a diagnosis of colorectal cancer.

Additional data, including aspirin use, height and weight, date of birth, and other demographic and baseline characteristics, is also obtained. Participants' medical records are reviewed periodically.

Participants are followed annually.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Enrolled on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000
* Screened by lower endoscopy (i.e., sigmoidoscopy and/or colonoscopy) after randomization on SELECT trial

PATIENT CHARACTERISTICS:

* Willing to sign an applicable medical records release form
* Willing to allow the release of tissue for central pathology review of resected polyps and endoscopic biopsies

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia

The main objective of project is to compare validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents is performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.

The main objective of project will be comparing validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Obtained results of different methods will enable to determine if the bronchial secretion sample, stomach content sample or oropharyngeal smear are comparable to precise but technically difficult protected brush. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP will be other priorities of the project. The role of atypical and fungal pathogens in HAP initiation will be discovered as well. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents will be performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.

Project fulfills program objectives of molecular-biologic approaches and research support in infectious diseases domain. It will make contribution to faster and more precise HAP diagnosis and adequate antibiotic therapy.

Eligibility Criteria:
Inclusion Criteria:

* clinical signs of HAP
* need for intubation and mechanical ventilation

Exclusion Criteria:

* inability to obtain samples in 24 hours after clinical diagnosis of HAP
Diced Cartilage in Breast Reconstruction

Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment, which can lead to contour deformity in the craniomedial breast pole. This study evaluated the use of diced cartilage (DC) to counteract substance loss in the microvascular anastomosis area, and investigated safety and suitability of the procedure to avoid postoperative deformities.

This retrospective, single-center cohort study included all breast reconstructions in which DC was used from October 2021 to June 2023. Reconstructions using DC were subdivided based on previous exposure to breast radiotherapy (DC vs. DCR). The control group consisted of an equal number of consecutive reconstructions performed prior to the use of DC. The effect of DC on breast contour preservation was investigated using breast magnetic resonance imaging (MRI; \> 6 months post-op) and photographic documentation (6-month follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Autologous free flap breast reconstruction using the internal mammary vessels as recipient vessels from October 2021 to June 2023
* MRI subcohort: Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively

Exclusion Criteria:

* Autologous free flap breast reconstruction using a perforator of the internal mammary vessels as recipient vessels from October 2021 to June 2023
* Autologous free flap breast reconstruction using the thoracodorsal vessels as recipient vessels from October 2021 to June 2023