cyrilzakka/clinical-trials huggingface dataset:
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort

Patients with active cancer are \~5-fold more likely to develop a venous thromboembolism (VTE) than those without. When VTE occurs, cancer patients carry an up to a 3-fold higher rate of thrombosis recurrence and \~twice the risk of bleeding during anticoagulation. Therefore, it is critical to utilize anticoagulants that optimize efficacy while minimizing bleeding risk when treating cancer-associated thrombosis (CAT).

Guidelines list direct-acting oral anticoagulants (DOACs) as an alternative to low molecular-weight heparin (LMWH) for treatment of CAT. The strength-of-recommendation for DOACs is based on data from multiple randomized controlled trials (RCTs) comparing them to LMWHs to treat CAT, with results suggesting DOACs may reduce thrombosis risk but with potentially more frequent bleeding (particularly in those with certain gastrointestinal and genitourinary cancers).

Observational studies evaluating DOACs for CAT treatment have been published, but these studies have been either single-arm, evaluated cancer subtypes not recommended for DOAC treatment, were of limited sample size and/or employed heterogeneous definitions of active cancer. We seek to evaluate the effectiveness and safety of rivaroxaban versus LMWH for CAT treatment in active cancer patients using a large de-identified electronic health record database.

Retrospective cohort analysis using US Optum® De-Identified EHR data. We will use Optum EHR (electronic health records) data from November January 1, 2012 through latest available data (currently September 2020).


Eligibility Criteria:
Inclusion Criteria:

* Be ≥18 years of age at the time of anticoagulation initiation.
* Have active cancer admitted to the hospital, emergency department or observation unit for acute DVT and/or PE.
* Treated with rivaroxaban (or any DOAC in secondary analysis) or LMWH as their first anticoagulant on day 7 post-acute CAT event diagnosis (index date) o increase the probability of accurately classifying patients' intended outpatient anticoagulant for CAT treatment and that patients are compared at the same point from diagnosis.
* Have been active in the data set for at least 12-months prior to the index event (based on the "First Month Active" field) and had at least one provider visit in the 12-months prior to the acute VTE event (baseline period).

Exclusion Criteria:

* Evidence of atrial fibrillation, recent hip/knee replacement (within 35 days of index VTE), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis, or mitral valve repair/replacement.
* Pregnancy.
* Initiation of rivaroxaban at a dose other than 15 mg twice daily or non-therapeutic doses of other DOAC or LMWH (e.g., enoxaparin at a dose other than 1 mg/kg twice daily or 1.5 mg/kg once daily; dalteparin at a dose other than 200 IU/kg of total body weight)
* Evidence of use of anticoagulation use during the 12-months prior per written prescription or patient self-report
Canola Oil, Fibre and DHA Enhanced Clinical Trial

The purpose of this study is to examine the effects of consumption of a novel food supplement consisting of Canola Oil, Fibre and DHA, containing the most effective food bioactives, including n-3 fatty acid enriched dietary oil high in monounsaturated fatty acids (MUFAs) and soluble dietary fibre, aiming at the management of heart disease risk factors in people with metabolic syndrome and to test its efficacy and safety in humans.

The proposed study is a randomized, single-blind, crossover trial, it will be conducted at the Richardson Centre for Functional Food and Nutraceuticals (RCFFN), University of Manitoba. The study design will consist of 4 phases with 30 days per phase, each phase will be separated by 4-week washout periods. Participants will consume a recommended weight-maintaining diet (35% energy from fat, 50% carbohydrate, 15% protein) supplemented with the following novel Muffin and cookies: (a) control food containing butter, sunflower and safflower oil comprised largely of saturated fat with substantial levels of n-6 linoleic acid, and refined wheat flour common to current North American intakes, (b) food containing high oleic canola oil and docosahexaenoic acid (HOCO-DHA) and refined wheat flour, (c) food containing high molecular weight barley B-glucan and a combination of sunflower, safflower oil and butter, (d) food containing combination of HOCO-DHA and high molecular weight barley β-glucan. Treatments will be isocalorically incorporated into muffin and cookies consumed in equal parts at breakfast and supper.

Eligibility Criteria:
Inclusion Criteria:

* BMI≥25 Kg/m2
* Waist circumference ≥94 cm (males) or ≥80 cm (females)

Meet at least two of the following:

* Triglycerides ≥1.7 mmol/L
* High density lipoprotein (HDL) cholesterol \<1 mmol/L (males) or \<1.3 mmol/L (females)
* Low density lipoprotein (LDL) cholesterol ≥2.7 mmol/L
* Fasting glucose ≥5.6 mmol/L

Exclusion Criteria:

* Consuming lipid lowering medications
* Consuming nutritional supplements
* Disease or disorder that could interfere with absorption
* Smokers
* Hypertension ≥150 mmHg (systolic) and/or ≥100 mmHg (diastolic)
* Planning to become pregnant
* Consume \>1 alcoholic drink/day
* Medication within a month prior to screening
Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3)

Endothelin-1 (ET-1) has been linked to a number of conditions including pulmonary arterial hypertension (PAH). ET-1 acts via 2 receptors, ETA and ETB. The ET-1 receptor blockers bosentan and sitaxsentan have been shown to be beneficial in patients with PAH. Bosentan blocks both ETA and ETB receptors. Sitaxsentan selectively blocks ETA receptors. Theoretically, selective ETA blockade may be associated with greater vasodilation and clearance of ET-1 by leaving the ETB receptor unblocked. This has not been directly studied in humans.

We aim to investigate the endothelial ETB-mediated vascular responses between bosentan and sitaxsentan by using a ETB selective agonist (ET-3). We hypothesise that at clinically relevant doses:

* Bosentan will show evidence of ETB receptor blockade compared to sitaxsentan and placebo.
* These effects will be confirmed by 2 functional markers of ETB receptor antagonism: plasma ET-1 (a very sensitive, but not necessarily clinically relevant marker), and the forearm vasodilator response to ET-3.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and post-menopausal women
* Age 18-70 years
* BMI 18-35 kg/m2

Exclusion Criteria:

* Are mentally or legally incapacitated
* Have donated blood within the last 4 weeks
* Have a history of past or present drug or alcohol abuse
* Have participated in another clinical trial within 1 month
* Are considered to be at a high risk of HIV or Hepatitis B
* Are taking routine medicines
* Are women taking hormone replacement therapy
* Have significant medical or psychiatric illness
Metformin for the Prevention of the Metabolic Side-effects of Zyprexa

We hypothesize that metformin co-administered with olanzapine will be well tolerated and associated with significantly less insulin resistance, weight gain and dyslipidemia as compared to olanzapine plus placebo.

Increased risk of metabolic complications with olanzapine therapy, relative to other antipsychotics, may lead clinicians to avoid its use, despite evidence of greater efficacy. These problems may also pose a therapeutic dilemma for patients who respond well to olanzapine. Metabolic complications negatively impact on morbidity and mortality, impair quality of life and increase illness relapse secondary to medication non-compliance. Thus far, no pharmacologic agent co-administered with olanzapine has proven effective at preventing these untoward effects. The present study proposes to examine the efficacy and safety of metformin to attenuate the metabolic side effects associated with olanzapine.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of: Schizophrenia, Schizoaffective Disorder, Bipolar I or II or major depression with psychotic features who will be started on or who have just started taking Olanzapine (Zyprexa).

Exclusion Criteria:

* Patients with either a history of diabetes mellitus or a baseline FBG\>126 or two random blood sugars of \> 200 or during a OGTT glucose level of \> 200 two hours after a glucose load of 50 grams. (All American Diabetes Association criteria for diabetes mellitus).
* Baseline liver function tests (SGOT, SGPT, AP) greater than 3X normal.
* Chronic alcoholism
* MDRD less than 60 ml/1.73 m2. Modification of Diet in Renal Disease (MDRD) Equation estimates the glomerular filtration rate as a measure of kidney function. This equation takes into account the plasma creatinine, age, race and gender, and is a more accurate estimation of glomerular filtration rate than serum creatinine alone.
* Patients with unstable medical problems, including cardiovascular instability or significant congestive heart failure (as determined by study investigators).
* Prolonged QTc greater than 430 ms on baseline EKG.
* History of lactic acidosis.
* History of hypoglycemia.
* Current treatment with metformin or other antidiabetic agents.
* Treatment with any antihyperlipidemic medication within 3 months of randomization.
* Treatment with olanzapine or clozapine within 3 months of randomization.
* Concurrent treatment with ziprasidone, risperidone, quetiapine or aripiprazole or any other neuroleptic medication.
* Concurrent use of OTC chromium, gymnema or cimetidine will be prohibited. Patient may discontinue these medications up to one day prior to randomization.
* Current treatment with corticosteroids.
Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia

The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.

Eligibility Criteria:
Inclusion Criteria:

Term pregnancy Singleton ASA I and II, BMI \<35, elective C/section

Exclusion Criteria:

patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.
Effects of Feedback on Learning of a Motor Sequence Task

Feedback delivered during motor practice can help promote motor skill learning and promote confidence. However, the optimal way to provide feedback to promote learning and confidence is unknown. This project will study how the feedback that is provided during practice of a movement skill can help people learn and build confidence. The investigators will measure motor skill performance and confidence before and after a session of motor practice.

Feedback may be a useful tool to optimize motor learning during practice. For example, feedback during practice that indicates the learner is performing above average (i.e. positive social comparative feedback) enhances motor skill learning and self-efficacy in healthy adults. While this type of feedback is hypothesized to promote learning in some tasks, no studies have examined whether positive social comparative feedback during practice promotes motor learning in a traditional motor sequence task. Therefore, the aim of the proposed project is to investigate the effect of positive social comparative feedback on the learning of a joystick-based motor sequence task in healthy adults. The study aims to recruit 60 participants who will be randomized into 1 of 3 feedback groups (control group, performance feedback, and performance plus positive feedback). Participants will practice a motor sequence task on a single day and then return for retention performance testing about 24 hours later. Changes in performance (response time to complete a sequence) and self-efficacy will be measured from baseline to 24 hours later at retention.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 40 years
* Right-hand dominant

Exclusion Criteria:

* Medical diagnosis or medication that affects dopamine (e.g. dopamine reuptake inhibitors)
* musculoskeletal issues that limit upper extremity movement
International Pachyonychia Congenita Research Registry

International Pachyonychia Congenita Research Registry (IPCRR) is a patient registry for those suffering from Pachyonychia Congenita (PC). PC is an ultra-rare extremely painful skin disorder that causes painful blisters and callus on feet and sometimes hands, thickened nails, cysts and other features. The IPCRR consists of a questionnaire, patient photos, optional physician notes from telephone consultation to validate questionnaire and free genetic testing.

HOW TO PARTICIPATE IN IPCRR

Step One: The IPCRR forms are available online at http://www.pachyonychia.org/patient-registry/. The Consent Form protects your privacy and the Questionnaire gathers important details that distinguish PC from other conditions and helps to identify specific characteristics of each type of PC. You may stop and start as often as needed before completing the forms. If you are not certain about an answer, you may skip that question.

Step Two: Take photos as shown in the Questionnaire sample photo page. You can upload the images online with the Questionnaire. If you prefer, you may email the photos. Photos of your PC are very important. Note: If you do not have access to a computer and wish to have the IPCRR forms mailed, please contact PC Project.

Step Three: When your Consent Form, Questionnaire, and Photos are received by PC Project, we will have an intake call with you to review your information and to discuss the next steps.

Step Four: If referred for genetic testing, you will then be sent the special saliva test kit (no travel required). Usually, only saliva is needed and from only one family member. The sample is collected by spitting into the vial in the kit and then mailing it in the envelope provided. Genetic testing is complex and time-consuming - it is not like a sugar test or pregnancy test, and can take many months to be completed, but the testing begins as soon as your sample arrives.

When the confirming results are received, a full genetic testing report is provided to you with precise information and suggestions specific to your condition. You may find the report very valuable with physicians or other medical providers as well as for school personnel, employers, disability hearings, or other special needs. All information is held confidentially by PC Project and the research is reported anonymously. There is no cost to you for any of these tests or assistance from PC Project. You may also request additional consultations as needed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Pachyonychia Congenita or similar disorder

Exclusion Criteria:

* N/A
Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)

This research is being conducted to examine the effects of nasal insufflation of warm and humidified air through a small nasal cannula on sleep, breathing pulmonary function, and daytime exercise capability.

Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity including substantial daytime fatigue exertional intolerance and ventilatory impairment, which hits a nadir in the morning. Nocturnal disturbances in sleep and breathing are common in COPD, although the impact of these disturbances on COPD morbidity remains largely unknown. The hypothesis is that COPD induces specific sleep and breathing disturbances that remain a substantial source of morbidity in this disorder.

Current therapy for treating nocturnal disturbances in sleep and breathing in COPD including nocturnal oxygen has failed to improve morning fatigue and pulmonary function. This study promises to significantly alter our approach to the diagnosis and management of sleep disordered breathing in COPD.

Eligibility Criteria:
Inclusion Criteria:

* Consenting adults over the age of 21
* BMI \< 40 kg/m2

Exclusion Criteria:

* Diagnosed with sleep apnea (apnea and hypopneas of \>10 events/hr).
* A sleep efficiency of \<30%, or a prior diagnosis of disorders that impair sleep architecture.
* Unstable cardiovascular disease (decompensated heart failure, myocardial infarction within the past 3 months, revascularization procedure within the past 3 months, unstable arrhythmias, uncontrolled hypertension (BP \> 190/110)).
* Severe renal insufficiency requiring dialysis.
* Liver cirrhosis.
* A recent acute illness in a 6 weeks period prior to the sleep studies.
* We will exclude subjects with severe daytime hypoxemia (Oxyhemoglobin saturation (SaO2) \<80% or partial pressure of oxygen (PaO2) \<55 mmHg at rest).
* Chronic use of sedatives or respiratory depressants that would affect sleep quality (e.g., benzodiazepines or other hypnotics or narcotics).
* Pregnancy.
* Tracheostomy or other significant oropharyngeal or nasopharyngeal surgery, in the last 6 months.
* Narcolepsy and other neurological disorders such as Parkinson's Disease.
* Severe hepatic insufficiency.
* Bleeding disorders or Coumadin use.
* Allergy to lidocaine or benzocaine.
* Language/dementia/psychiatric issues - the participant must be able to provide consent.
A Nutrigenetic Intervention in MASLD

The study is designed as a 12-week randomized controlled dietary intervention in individuals who had been diagnosed with NAFLD in the last 6 months and whose body mass index is above 25 at the time of participation in the pre-screening. The study sample is determined as 150 subjects and randomization will be done by stratification according to PNPLA3 genotype. At baseline, hepatic steatosis and fibrosis will be measured with Fibroscan, body composition will be analyzed, and transaminases and sugar and lipid metabolism indicators will be examined. The study will be conducted in parallel groups, with each group receiving equal amounts and intensity of Mediterranean diet or low-fat diet therapy. At the end of the 12-week intervention, baseline measurements will be repeated and the efficacy of the Mediterranean Diet and Low-fat diet therapies will be compared, as well as the effect of PNPLA3 mutation on intrahepatic response will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign informed consent
* BMI\> 25 kg/m2
* Between 18-80 years
* previous clinical diagnosis of MASLD by abdominal USG, MRI, FibroScan® or liver biopsy

Exclusion Criteria:

* Excessive alcohol use (more than 20 g/day for women and 30g/day for men= \>2 units alcohol/day for women and \>3 units for men)
* Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency
* Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART)
* Celiac disease
* pregnancy and breastfeeding
Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome

The primary objective of this study is to describe the response to treatment with biosimilar EPO alpha in MDS patients who had already been treated with "originator" EPO alpha and were responsive, and in patients who started treatment with biosimilar EPO alpha

To date, therapy with erythropoiesis-stimulating agents (ESAs) has been shown to be effective in the treatment of symptomatic anemia in patients with Myelodysplastic Syndrome ( MDS) at low to intermediate risk, with the percentage of responsive patients ranging from 15 to 63%, depending on the characteristics of the patients treated, and averaging 45%.

Significant improvement in survival and quality of life was observed in treatment-responsive patients compared with non-responsive patients.

Recently, biosimilar ESAs have been introduced into clinical practice, and in patients with renal failure anemia and anemia associated with antineoplastic chemotherapy, their efficacy and safety have been demonstrated.

However, data on the efficacy and safety of biosimilar ESAs in patients with MDS are scarce to date, and efficacy and safety data for the purpose of their approval have been mainly extrapolated from studies conducted in patients with anemia from renal failure and anemia from antineoplastic chemotherapy. In these conditions bone marrow erythropoiesis is reduced but not qualitatively impaired as in MDS.

These considerations may justify a retrospective study examining the efficacy and safety of biosimilar EPO alpha in a real-life setting in anemic MDS patients.

Eligibility Criteria:
Inclusion Criteria:

MDS patients with symptomatic anemia (pre-treatment hemoglobin \< 10g/dL) who started treatment with biosimilar EPO alpha, diagnosed according to the WHO 2016 classification, and characterized by very low, low, or intermediate IPSS-R risk and a pre-treatment serum EPO level \< 500 U/L, who started treatment with biosimilar EPO alpha at the U. O. of Hematology of IRCCS AOUBO during the period from 01/06/2018 to 31/12/2021.

* Age ≥ 18 years at the time of enrollment
* Acquisition of informed consent to study participation and data processing

Exclusion Criteria:

* - Presence of other possible contributory causes of anemia (e.g., anemia from chronic inflammatory disease, hemolysis, hemorrhage)
* Poor compliance with treatment
* Very impaired general clinical condition (ECOG performance status \> 3)
* Concomitant treatment with antineoplastic cytotoxic drugs