cyrilzakka/clinical-trials huggingface dataset:
Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study

The aim of this study is to determine the prevalence of myocardial ischaemia in asymptomatic high risk type 2 diabetic patients using stress cardiac MR and how many stress cardiac MR examinations are false positive.

Asymptomatic coronary artery disease (CAD) is highly prevalent (ie. 17-59%) in type 2 diabetic patients. In addition, cardiovascular disease remains the most common cause of death in type 2 diabetics. Previous trials using coronary computed tomography angiograms (CCTA) or nuclear myocardial perfusion imaging (MPI) to screen for asymptomatic coronary artery disease requiring intervention have been unsuccessful at reducing cardiovascular and all cause mortality when compared to optimised medical therapy where cardiovascular risk factors are treated in order to reduce cardiovascular complications. Possible reasons for this include, the choice of imaging modality, the intervention chosen (eg. bare metal stents vs drug eluting stents), patient cohort (eg. all diabetics vs high risk diabetics). Stress cardiac magnetic resonance (CMR) is ideally suited to assess this group of high risk patients as there is no radiation exposure and it allows a more complete analysis of the heart including the assessment of myocardial viability, cardiac systolic and diastolic function. The significance of this envisioned randomised controlled trial is firstly to investigate if stress CMR screening will reduce major adverse cardiovascular events including death. Secondly, a study using stress CMR has never been performed.

Eligibility Criteria:
Inclusion Criteria:

* Onset of type 2 diabetes at ≥30yrs old with no history of ketoacidosis
* 60-80yrs old
* Framingham Risk Score ≥20%

Exclusion Criteria:

* Angina pectoris or chest discomfort
* Stress test or coronary angiography within 2 years
* Previous myocardial infarction (MI)
* Previous coronary artery stenting or coronary artery bypass grafting
* Any clinical indication or contraindication for stress testing
* Any contraindication to stress CMR (eg. non-MRI compatible devices)
* Contraindication to gadolinium based contrast agent (eg. Renal impairment with an estimated glomerular filtration rate (GFR) \<30ml/min/1.73m2)
* Life expectancy \<2 years due to cancer or liver disease
* Contraindication to dual antiplatelet therapy
* Planned need for concomitant cardiac surgery
* Refusal or inability to sign an informed consent.
* Potential for non-compliance towards the requirements in the trial protocol
* Unable to cover the costs of percutaneous coronary intervention (PCI) whether through government subsidies, etc
Blood Brain Flow and Exercise

Cerebral vasodilator responses to CO2 will be measured in young healthy adults, healthy sedentary older adults, and healthy exercise trained older adults. This variable will be examined before and after administering the cyclooxygenase inhibitor indomethacin, which has been shown to blunt cerebral vasodilator responses. In addition, the investigators will examine these counter-regulatory hemodynamic mechanisms to hypoperfusion caused by indomethacin.

Normal aging reduces cerebral blood flow and cognitive function. Aging also appears to alter functional connectivity within the brain, which is associated with cognitive functioning. Observational studies suggest that regular physical activity is associated with higher cerebral blood flow and improved cognitive function. However, the mechanistic links among regular physical activity and cerebral blood flow with advancing age are unknown. In this context, it is unclear if aging or exercise training status alters the neurovascular coupling of blood flow in the brain. Thus, the overall goal of this study is to examine the age-related changes in cerebral vasodilatory capacity, an important homeostatic mechanism and marker for effective regulation of cerebral perfusion, in order to determine how it is mechanistically linked to cognition. Additionally, the investigators will explore the potential beneficial effect of physical activity on the relationships between cerebral vasodilation and cognition in humans.

The research aims are:

1. To determine if cerebral vasodilator responses are affected by age and exercise training status in healthy adults.
2. To compare the effect of cyclooxygenase inhibition on cerebral vasodilator responses in healthy adults.
3. To determine the neurovascular counter-regulatory response to cyclooxygenase inhibition in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Young subjects between 18-35 years old
* Older subjects between 55-75 years old
* Nonsmokers
* Physically active (exercise more than 3 times per week for at least 30 minutes)
* Sedentary (no formal exercise over 1 hour per week).

Exclusion Criteria:

* Outside of the specified age range
* Present with history or evidence of hepatic, renal, or hematological disease; peripheral vascular disease; stroke/neurovascular disease; diabetes; hypertension
* Take medications that indicate hepatic, renal, hematological disease; cardiovascular disease, including hypertension; stroke/neurovascular disease; and diabetes
* Body mass index \>34 kg/m2
* Take physician-prescribed medications that may interact with indomethacin: 1) cardiovascular drugs (e.g. angiotensin-converting-enzyme inhibitor (ACE inhibitors), angiotensin II receptor blockers (ARB's), Diuretics); 2) drugs that would increase bleeding risk (e.g. warfarin, heparin, clopidogrel, rivaroxaban, other NSAIDs); or 3) drugs associated with increased renal toxicity (e.g. cyclosporin, tacrolimus)
* Vulnerable populations (i.e. pregnant women, prisoners, individuals lacking capacity to consent, etc.)
Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates

Despite the significant benefits of herpes zoster vaccine (HZV), vaccination rates remain low. Electronic medical records (EMR) can serve as a practical strategy to better facilitate the application of preventative health care, such as increasing immunization rates. A new care model that can increase the herpes zoster vaccination rate, as well as other preventative health services, is warranted. The objective of this study is to investigate if the functions of an EMR, in combination with a pharmacist as part of the care team, can improve the herpes zoster vaccination rate.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 60 years of age

Exclusion Criteria:

* Documented herpes zoster vaccine in the EMR
Performance Assessment Of The PMD-200 In Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure

Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure

The proposed study is design to further demonstrates the capability of the Nociception Level, (NoL) Index in identify and discriminate between painful event and non-painful period following pain stimulus of Straight Leg Raising (SLR) test in patients with degenerative lumbar spine disease. This feasibility study may provide first indication for a validation method that will be able to evaluate the outcome of a surgical procedure within the degenerative lumbar spine patient. Currently, there is lack of understanding of long-term outcomes after such surgeries.

In this study, the investigators plan to demonstrate that the NoL Index may serve as an indicator to the surgical procedure outcome. It will compare the objective measurement of the NoL to the patient Visual Analogue Scale (VAS) score and disability questionnaire that will characterize the subject pain perception prior and following the surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 and less than 65 (18 \< Age \< 65).
* The subject suffer from unilateral degenerative lumbar spine disease
* The subject suffer from leg pain only in one leg, while no pain in the other leg.
* The subject was hospitalized in the neurosurgery department of the hospital in order to undergoes spinal surgery due to the above disease
* A signed Informed Consent Form (ICF) has been obtain from the subject

Exclusion Criteria:

* The subject has a bi-lateral degenerative lumbar spine disease
* The subject is pregnant
Mannitol Brain Relaxation Effect

Mannitol is widely used in patients with elevated intracranial pressure. In neurosurgical field, especially in large size or with brain edema, it is necessary to decrease brain volume to facilitate surgical approach. In general, 0.25 -1.5g of mannitol per kilogram has been known to decrease ICP effectively. But there are some debates in regard to appropriate dose of mannitol.

Previous meta-analysis reported that mannitol has dose-response relationship with intracranial pressure. Another study of Sorani showed dose-response relationship between mannitol and intracranial pressure (ICP) in traumatic brain injury patients.

In this study, authors would investigate that mannitol increments can provide more brain relaxation in patients undergoing craniotomy for supratentorial brain tumor removal.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent craniotomy for supratentorial brain tumor under general anesthesia

Exclusion Criteria:

* Patient who does not agree to the study
* Patients with or American Society of Anesthesiologists (ASA) physical status class IV or more
* Patients with glasgow coma scale (GCS) under 13 points
* Patients who have hyponatremia or hypernatremia (Na\<130 or \>150mEq/L)
* Patients who have congestive heart failure or moderately decreased renal function (GFR \<60ml/min/1.73m2)
* Patients with extraventricular drainage such as external ventricular drain (EVD) or ventriculoperitoneal (VP) shunt
* Patients who already under mannitolization
Evaluation of Oncoxin-Viusid® in Head and Neck Cancer

Nutritional supplements containing antioxidants seem to decrease toxicity associated with Radiotherapy (RT) and Chemotherapy (CT) in patients with malignant head and neck tumors. Oncoxin-Viusid® (OV) is a nutritional supplement with antioxidant, immunomodulator and antitumor effects.

Objective

To assess the efficacy and safety of OV in patients with head and neck tumors during treatment with radio-chemotherapy.

Materials and Methods

Patients diagnosed with Head and Neck Carcinoma, and indicated to follow a radiotherapy treatment concurrent with Radiosensitizing Chemotherapy, were included in a phase II, randomized, prospective, controlled and double-blind study in two treatment arms: RT + CT + Placebo (n = 30) and RT + CT + OV (n = 30) during one year in a tertiary center (INOR), with the aim of evaluating the reduction of toxicities of RT-CT and improve the quality of life of patients during these oncospecific treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* over 18 years of age
* With histological diagnosis of carcinoma of the head and neck
* Regardless of the variety or degree of histological differentiation and clinical stage
* Tributaries of concomitant treatment with ionizing radiation and radiosensitizing chemotherapy with intercurrent diseases compensated and index of Karnofsky \> 59
* Acceptable hematological parameters
* Women not pregnant or lactating
* Who authorized their inclusion in the investigation, through their informed consent.

Exclusion Criteria:

* Patients with a second concomitant primary tumor and / or contraindication to platinum chemotherapy
* Patients who are under another research protocol or who have decompensated psychiatric disorders.
The GReek AntiPlatElet (GRAPE) Registry: A Multicenter Observational Prospective Investigation of Antiplatelet Treatment in Patients With Acute Coronary Syndrome Subjected to Percutaneous Coronary Intervention

This is a multicenter, prospective, observational investigation, focusing of antiplatelet treatment in patients with moderate to high risk acute coronary syndrome (TIMI risk score ≥3)subjected to percutaneous coronary intervention (PCI), being conducted in 7 PCI capable hospitals in Greece. Data concerning patients' demographic, clinical/procedural characteristics and contraindications/special warnings and precautions to P2Y12 inhibitors are collected during initial hospitalization. Study involves 3 follow-up visits after hospital discharge(Day 30, at 6 months and at 12 months) where data on major adverse cardiac events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG), bleeding events(according to Bleeding Academic Research Consortium criteria)and adherence to antiplatelet treatment are collected.

In patients under ticagrelor or prasugrel treatment, platelet reactivity measurement with VerifyNow assay will be performed at Day 30


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Acute coronary syndrome moderate to high risk (TIMI risk score ≥3) subjected to PCI
* Informed consent

Exclusion Criteria:

* Pregnancy/Breastfeeding
* Inability to give informed consent
* High probability of being unavailable for follow-up visits
Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone

Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production (glucose rate of appearance \[Ra\]), primarily muscle glucose utilization (glucose rate of disappearance \[Rd\]), and adipose tissue related free fatty acid production (glycerol rate of appearance \[Ra\]).

We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in insulin sensitivity.

Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling pathways in antipsychotic naïve healthy young men.

We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in insulin signaling.

See brief description

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-45 years
* BMI approximately ≥ 25 and \< 35
* insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl

Exclusion Criteria:

* Any DSM-IV Axis I diagnosis
* prisoners
* any serious medical disorder (i.e. metabolic diseases, type 1 or 2 diabetes mellitus, endocrine disease, coagulopathy, clinically significant anemia, acute infection)
* taking prescription medications
* non-sedentary lifestyle with \> 3 hours of exercise per week
Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy

The main purpose of this study is to evaluate the safety and tolerability of combination therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin (based on body weight) for 48 weeks in HCV genotype 1 infected subjects, who are non-responders to previous pegylated interferon alfa plus ribavirin therapy.

This is an open-label, multicenter study. All subjects will receive Infergen 24 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body weight) administered by mouth daily for 48 weeks

\* If any 5 of the first 10 subjects can not tolerate the 24 mcg daily dosage of Infergen by week 4, as determined by the principal investigator, then the dosage of Infergen will be changed to 15 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body weight) administered by mouth daily for 48 weeks


Eligibility Criteria:
Inclusion Criteria:

* Must have documented failure to respond to past treatment with a Pegylated IFN + RBV. Failure to respond to past treatment is defined as positive HCV RNA at 12 weeks and less than a 2 log drop from baseline; OR positive HCV RNA and greater than 2 log drop from baseline at week 12 and must have received 24 weeks of therapy and still have a positive HCV RNA
* Must have tolerated previous hepatitis C therapy
* Must be off hepatitis C therapy for 3 months prior to study participation
* Must have had a liver biopsy within the past 5 years

Exclusion Criteria:

* Decompensated liver disease
* Laboratory abnormalities as per protocol
* HIV+
* Autoimmune disease
* Unstable or deteriorating cardiovascular or cerebrovascular disease
* History of seizures in past 5 years
* Alcohol or drug abuse in past year
* Pregnant or lactating women
Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease

The purpose of the study is to determine the response of 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.

The study will also try to determine Streptococcus pneumoniae colonization in patients 50 years or older with end stage renal disease on dialysis.

The purpose of the study is to determine the immunogenicity of 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis. Patients will receive one dose of 0.5ml of Prevnar-13 intra-muscularly. Antibody response to pneumococcal serotypes will be studied ar 2months and 12 months after administration of vaccine.

The study will try to determine Streptococcus pneumoniae colonization in patients 50 years or older with end stage renal disease on dialysis and also investigate if there are any change in Streptococcus pneumoniae colonization after Prevnar-13 vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 50years of age with End stage renal disease on dialysis (both hemodialysis and peritoneal dialysis).
* Scheduled to receive pneumococcal vaccine either after 5years of previous vaccination or starting vaccination as part of standard care during the study period

Exclusion Criteria:

* History of S. pneumoniae infection within the last 5 years
* Vaccinated with an influenza- or diphtheria-containing vaccine within the last 6 months
* History of any severe adverse reaction associated with a vaccine
* Received gamma-globulins within the previous 6 months
* Known or suspected HIV or on immunosuppressive medications.
* Functional or anatomic asplenia
* serious chronic medical condition
Matching Patients With Hematologic Malignancy to Adequate Clinical Trials

A molecular profile of a patient with hematologic malignancy, for whom standard-of-care had failed, is identified using next generation sequencing. Patients are assigned to early clinical trials of targeted agent based on the molecular profiling or physician's choice. The improvement of outcomes in the intention-to-treat population is investigated.

Most of hematologic malignancy patient becomes incurable with standard treatment during their disease course. Although these patients are recommended to participate in an early phase clinical trials, the response rate have reported be only 4 to 6 percent. Over several decades, a lot of cancer driving mutations has been identified, and targeted agents directed at the mutations are continuously developed and studied in many clinical trials. Most of the clinical trials recruited participants regardless of mutational status of them. Recently, however, participants has been recruited in recent clinical trials according to the presence of specific mutations. The response rate of these recent clinical trials is 12-75%.

In this pragmatic clinical trial, cancer driving mutations in hematologic malignancy patients is identified using next generation sequencing, and assign patients to an appropriate clinical trial which is anticipated to exhibit the best response. The improvement of outcome of this biomarker-driven assignment is investigated.

Eligibility Criteria:
Inclusion Criteria:

* adults with \> 18 years old
* incurable hematologic malignancy patients who failed to respond to standard treatment
* patients who agreed to this protocol with informed consent
* Eastern Cooperative Oncology Group performance status ≤ 3
* Tolerable major organ function determined by laboratory examination

Exclusion Criteria:

* Expected survival \< 3 months
* patients with poor compliance
* patients who can not give an informed consent
* patients who are participating another clinical trials
A Non-inferiority Study Comparing Two Heparin Sodium Preparations in Hip Fracture Surgery

The primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.

The primary objective of the study is to assess the efficacy of unfractionated heparin sodium of porcine origin (Eurofarma) in the prophylaxis of VTE relative to unfractionated heparin sodium of porcine origin from APP Pharmaceuticals. The primary endpoint will be the frequency of DVT determined by Doppler ultrasound (DUS).

Eligibility Criteria:
Inclusion Criteria:

In order to be enrolled in this study, eligible patients must meet all criteria below:

* ICF signing;
* Aged 60 to 85 years old;
* Indication of hip orthopedic surgery due to fracture occurred within the last 5 days;
* Normal coagulation profile or with alterations up to 25% of normal values.

Exclusion Criteria:

Patients who meet any of the following criteria will not be eligible for the study:

* Previous hip surgery;
* Fracture secondary to the presence of metastasis;
* Recent traumatic brain, thoracic, or abdominal injury (up to 30 days before study start);
* Recent occurrence (up to 30 days before study start) of cerebrovascular accident;
* Serum concentration of hemoglobin below 9 g/dL;
* Prior occurrence (in the last 5 years) of confirmed or suspected thromboembolic event;
* Occurrence of major bleeding in the last 6 months (any spontaneous gastrointestinal bleeding; central nervous system bleeding; massive epistaxis, or gum bleeding; gross hematuria, or vaginal bleeding);
* Confirmed or suspected blood dyscrasia;
* Diagnosis of neoplasm other than in situ in the last 24 months or any active neoplasm (neoplasms in situ do not prevent patient from participating);
* Liver or kidney failure;
* Clinically significant gastrointestinal cardiovascular, neurological disease, or laboratory abnormalities, which at the investigator's opinion, may interfere with individual's participation in the study or with assessment of individual's response to treatment;
* Hypersensitivity to heparin;
* Previous use (15 days before study start) of oral anticoagulants or expected use during the study (see Appendix B);
* Recent participation (previous 12 months) in a clinical trial.