Kornimate/medical-research-clean huggingface dataset:
evaluation of re-entry values and mindfulness program (revamp) with jail inmates

Conditions: Impulsive Behavior; Substance Abuse; HIV Risk Behavior; Anxiety; Depression; Criminogenic Thinking

Summary: this is a pilot study to examine the acceptability and effectiveness of the re-entry values and mindfulness program (revamp), a group intervention for jail inmates. it is hypothesized that revamp will reduce post-release recidivism, substance abuse, and hiv risk behavior.


Eligibility criteria:
inclusion criteria: * must be 18 years or older * must be male * must be currently incarcerated jail inmate * must be sentenced * sentence must be short enough to serve out sentence at the adult detention center * release date must follow projected final session of treatment * must speak, read, and write in english with sufficient proficiency to use workbook and participate in group sessions * must be assigned to the jail's "general population" exclusion criteria: * actively psychotic * assigned "keep separate" from other group members

Keywords: mindfulness values jail inmates impulsivity substance abuse hiv risk behavior anxiety depression criminogenic thinking
possible protective effect of rosuvastatin in chemotherapy-induced cardiotoxicity in her2 positive breast cancer patients

Conditions: Chemotherapy-induced Cardiotoxicity; Breast Cancer

Summary: this study aims to investigate the possible role of rosuvastatin in protection against cardiotoxicity in her2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab.


Eligibility criteria:
inclusion criteria: * age: 25-75 years old. * gender: female * newly diagnosed her2 positive breast cancer patients who are scheduled to receive doxorubicin followed by trastuzumab adjuvant therapy. * eastern cooperative oncology group (ecog) performance status (ps) ≤ 2 * preserved lv systolic function in which the left ventricular ejection fraction (lvef)≥50%. * patients with normal renal and hematological functions. * alanine amino transferase (alt ≤ 3 times uln). exclusion criteria: * pregnant or lactating females. * eastern cooperative oncology group (ecog) performance status (ps) \> 2 * patients with impaired lv systolic function in which the left ventricular ejection fraction (lvef)\<50%. * patients with significant valvular heart disease, documented coronary artery disease, history of congestive heart failure or cardiomyopathy. * alanine amino transferase (alt \> 3 times uln). * patients already taking statins or other lipid lowering therapy. * patients with a known hypersensitivity to any of the used drugs.
improving access to breast cancer screening and treatment in nigeria: the triple mobile assessment and patient navigation model

Conditions: Breast Cancer

Summary: the goal of this study is to establish a novel community-based breast cancer program to address delayed presentation and lack of access to diagnostic and treatment facilities in south-west nigeria. it is aimed at evaluating the impact of a novel breast cancer early detection program using triple mobile assessment (innovative handheld ibreast exam \[ibe\] device, mobile ultrasound, and mobile mammography) and patient navigation program in a nigerian community.

this study aims to provide screening to asymptomatic women 40-70 years and to provide diagnostic evaluation to women 30-70 years presenting with breast symptoms in a community in south-west nigeria. the project will use a cluster randomized design with 1 community serving as the intervention arm and another community serving as the control arm. both communities will receive breast cancer awareness and education but only the intervention community will receive screening, mobile imaging and navigation. screening with targeted clinical history, clinical breast exam (cbe), and ibe will be performed by trained community health nurses in the intervention community. women with positive cbe or ibe findings will undergo breast imaging with mobile mammography and portable ultrasound, as well as biopsy when indicated by the radiologist who visits the community once a month, and receive navigation by the nurses to the point of care. the control population will receive breast cancer awareness without an organized screening, imaging or navigation program. women presenting to the primary health care centers in the control community will be referred to the teaching hospital as per current standard of care. record of all breast cancer cases seen in the 2 communities during the study period will be obtained.

Eligibility criteria:
inclusion criteria: * asymptomatic women 40 - 70 years * symptomatic women (with breast-related symptoms) 30 - 70 years exclusion criteria: * male subjects * women living outside the study locations (ife east and ife north districts)

Keywords: screening treatment navigation triple mobile assessment
the effect of vitamin d administration to premature infants on vitamin d status and respiratory morbidity

Conditions: Other Preterm Infants; Vitamin D Deficiency; Bronchiolitis; Asthma; Pneumonia

Summary: this trial objective is to assess whether doubling the daily intake of vitamin d improves serum vitamin d levels and serves as primary prevention of respiratory infections and asthma in premature infants. this is a prospective randomized (1:1) double-blinded trial. the study population will be randomized into two groups (1:1): * intervention group - 800 iu of vitamin d once daily * control group - 400 iu of vitamin d once daily patients will be followed up for one year after randomization for serum vitamin d levels and respiratory morbidity.

the rational of this trial is that a daily supplementation of a double dose of vitamin d (800 iu instead of 400 iu) to late premature infants during the first year of life will result in elevated vitamin d serum levels and in an improvement in respiratory morbidity. this randomized trial of vitamin d supplementation is planned to determine the optimal dose of daily vitamin d supplementation required to achieve sufficient vitamin d levels in preterm infants and to assess whether doubling the daily intake of vitamin d may serve as primary prevention of respiratory infections and asthma in premature infants.

Eligibility criteria:
inclusion criteria: 1. preterm infant born at 32+6 to 36+6 weeks of gestational age 2. born at soroka university medical center 3. signed informed consent 4. participants in the trial will be insured by "clalit" hmo exclusion criteria: 1. chromosomal abnormality 2. neurological or muscular congenital anomalies 3. congenital cardiac defect 4. congenital respiratory anomalies 5. congenital git/ liver/ renal anomalies that effect the absorption and/or metabolism of vitamin d and/or other substances. 6. admission after birth to nicu persists more than 5 days

Keywords: vitamin d respiratory morbidity prematurity
preemptive zepatier treatment in donor hcv positive to recipient hcv negative cardiac transplant

Conditions: Cardiac Transplant Disorder; Hepatitis C

Summary: this is a proof of concept, single center study for the donation of hcv-positive hearts to hcv negative recipient patients, with preemptive, interventional treatment with 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent hcv transmission upon transplantation.

phase 1 of this study will be a single case study with only one subject enrolled. once safety has been demonstrated and hcv infection transmission shown to be prevented by the protocol, the study will expand to 10 additional patients. patients will be selected based on their diminished likelihood of receiving a heart from the waitlist within a period during which they would be likely to succumb to severe comorbidities. this will be determined in part through use of a patient's listing status (1a, 1b, 2) and clinical judgment, and the seattle heart failure model.

Eligibility criteria:
inclusion criteria: * recipient is age ≥ 18 years * serum alt within normal limits with no history of liver disease * lack of sensitization (i.e. pra \< 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection exclusion criteria: * sensitization (i.e. pra \>20%) * any liver disease in recipient * albumin \< 3g/dl or platelet count \< 75 x 103/ml * need for dual organ transplant

Keywords: heart transplant cardiac transplant hepatitis c zepatier
dialysis catheter comparative clinical trial

Conditions: End Stage Renal Disease

Summary: the purpose of this clinical trial is to compare the longevity of two dialysis catheters.

this study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.

Eligibility criteria:
inclusion criteria: * subject must be 18 years of age or older. * subject must meet labeled indication for hemodialysis. * subject must have end stage renal disease (esrd). * subject must have a patent right or left internal jugular vein. * subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks. * subject must give written informed consent. exclusion criteria: * subjects who are concurrently enrolled in any randomized clinical trial (rct) or those that may enroll in a rct during the course of the study, or subjects who have been previously randomized into this clinical study. * subjects with active infection at the time of study enrollment. * subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia. * subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding. * subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period. * subjects for whom performing dialysis at flow rates up to 450 ml/min would be contraindicated for any reason. * subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study. * subjects who, in the opinion of the investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.

Keywords: dialysis dialysis catheter kidney disease dialysis clinic chronic catheter catheter kidney
a single-center study to characterize the safety and efficacy of ublituximab in older adults with relapsing forms of multiple sclerosis (rms)

Conditions: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis

Summary: the purpose of this study is to evaluate the safety of ublituximab use in the older ms adult population, as measured by incidence of infection rate

this study is being done to see how safe and effective ublituximab is when given to older adult patients for their rms. since rms patients over age 55 were excluded from previous clinical studies that studied the safety and efficacy of ublituximab, this study is designed to better understand how well this drug is tolerated in rms patients between the ages of 55-80 years. primary endpoints include: * incidence of infection rate from baseline to month 24/eos (including uti and other active acute, opportunistic and/or chronic infection) * incidence of teas/saes from baseline to month 24 with consideration to nature, severity, and occurrence rate of aes approximately 20 participants are expected to be enrolled. participation in this study will last approximately 24 months and will include approximately 6 study visits to the study center.

Eligibility criteria:
inclusion criteria: * signed informed consent * aged 55-80 years old * diagnosis of rms according to the 2017 revised mcdonald criteria * anticipated to begin treatment with or newly treated with ublituximab (within 6 months prior to study entry) according to the local label exclusion criteria: * active participation in an interventional clinical trial for ms * received initial dose of ublituximab more than 6 months prior to study entry * history of life-threatening infusion reaction on any anti-cd20 therapy * evidence of clinically significant chronic or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment, or any history of recurrent infection within 6-12 months prior to initiation of ublituximab
evaluation of patients with vena cava inferior thrombosis

Conditions: Inferior Vena Cava Thrombosis; Venous Thromboembolism

Summary: the purpose of the study is to evaluate patients with inferior vena cava (ivc)thrombosis in terms of etiology, clinical course and prognosis during long-term follow-up. patients with isolated lower extremity dvt, matched for age and gender, serve as controls.

all patients are assessed using a standardized questionnaire and details concerning vte risk factors, concomitant disease, medical conditions, diagnosis and therapy of ivc thrombosis were registered. a blood sample is taken to test for inherited and acquired thrombophilia. in addition, duplex ultrasound examination and digital photoplethysmograph are performed to assess postthrombotic syndrome.

Eligibility criteria:
inclusion criteria: * age 18-90 years exclusion criteria: * none
prospective analysis into development of hypernatremia in critically ill patients

Conditions: Hypernatremia; Critical Illness

Summary: hypernatremia is frequently encountered in patients admitted to the intensive care unit (icu) and associated with increased mortality and length of stay. previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. however, data of larger populations or data on infusion rates, fluid and sodium balance or renal replacement therapy is lacking. the predecessor of this study was the hypnic trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis. this study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the hypnic trial.


Eligibility criteria:
inclusion criteria: * admitted to intensive care unit * age 18 years or older exclusion criteria: * age 17 years or younger
lesser poland cracovian heart failure registry

Conditions: Heart Failure; Heart Failure Acute

Summary: the goal of lesser poland cracovian heart failure registry (lecra-hf) is to expand the knowledge about acute heart failure (ahf) and its long-term prognosis. the main questions are: * assessment of long-term prognosis of ahf and its determinants * determination of the optimal ahf treatment methods * assessment of indications for invasive coronary arteries diagnostics and revascularization and their long-term effects * analysis of the particular hf subtypes (hfimpef, hfpef, hfsnef, hfref, hfmref)

lecra-hf is a registry of patients with acute heart failure (ahf) hospitalized in the department of coronary disease and heart failure, john paul ii hospital in krakow, jagiellonian university medical college. so far, a small population of patients has been included in similar registries conducted in the polish population. this did not allow to draw reliable conclusions about this diverse group of patients. as part of the lecra-hf registry, a comprehensive analysis of the clinical characteristics of patients is planned, taking into account their medical history, anthropometric measurements, results of electrocardiographic, imaging and laboratory tests, as well as the treatment used during the index hospitalization and after discharge. their long-term prognosis will also be analyzed. lecra-hf is a continuous registry, updated annually until 2026. the data collected in the lecra-hf will be used to distinguish and describe relatively new subtypes of hf (hfimpef, hfsnef) as well as to properly characterize that difficult and very diverse population with a serious long-term prognosis.

Eligibility criteria:
inclusion criteria: * hospitalization due to acute heart failure * \> 18 years of age exclusion criteria: * inability to give informed consent to participate in the registry

Keywords: heart failure acute heart failure decompensation revascularization long-term prognosis
postoperative cognitive dysfunction after propofol anesthesia for noncardiac surgery

Conditions: Patients ASA I, II, III

Summary: background: postoperative cognitive dysfunction (pocd) in elderly patients after noncardiac surgery is a common problem. therefore,this study was designed to assess pocd after closed-loop coadministration of propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia in elderly patients undergoing major noncardiac surgery. methods: after approval of the local ethical committee was obtained, 204 patients (american society of anesthesiologists physical status i-iii; age, \> 55 yr) undergoing surgery (duration, \> 1 h) were enrolled into this pospective randomized monocenter study. patients received anesthesia 3 days after using a neuropsychological test battery.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i-iii; * undergoing surgery (duration, \> 1 h) exclusion criteria: -

Keywords: physical status i-iii; age > 55 yr) undergoing surgery (duration, > 1 h)
drug interaction study of sar302503 in patients with solid tumor

Conditions: Solid Tumor

Summary: primary objective: * to assess the effect of 15-day repeated oral doses of 500 mg sar302503 on the cytochrome p450 activity using a cyp probe cocktail (2c19, 2d6 and 3a4). * to document pharmacokinetics of sar302503 after repeated 500 mg oral daily doses. secondary objectives: * to assess the safety profile of 15-day repeated oral doses of 500 mg sar302503 in segment 1 * to characterize the safety and tolerability of 28-day consecutive doses of 500 mg sar302503 in segment 2 * to determine antitumor activity in segment 2

the duration of the study for an individual patient will include a period to assess eligibility (screening period 21 days), followed by a treatment period of at least 15 days of study treatment, and an end-of-treatment visit at least 30 days following the last administration of study drug. however, treatment may continue if patients are receiving benefit and do not have unacceptable toxicity or meet study withdrawal criteria.

Eligibility criteria:
inclusion criteria : * histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist * signed informed consent exclusion criteria: * less than 18 years of age. * limited physical functioning (as evaluated by the eastern cooperative oncology group (ecog) scale) * inability to follow study requirements and schedule * treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other anti-cancer therapy * serious medical illness at same time of study and/or significantly abnormal lab reports * lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding. * men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug * continued toxic effects of prior chemotherapy * evidence of other concurrent active malignancy * other concurrent serious illness or medical condition * cardiac abnormalities include bradycardia, av block or other conduction defect on ecg, and patients taking a beta blocker. * patients with insulin-dependent diabetes mellitus. * patients with known active (acute or chronic) hepatitis a, b, c, and hepatitis b and c carries. prior history of chronic liver disease (e.g., chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis \[nash\]). * inadequate organ function * history of partial or total gastrectomy, or, if in the opinion of the investigator, have any other disorder that would inhibit absorption of oral medications. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study of mabthera (rituximab) in patients with idiopathic thrombocytopenic purpura.

Conditions: Idiopathic Thrombocytopenic Purpura

Summary: this single arm study will evaluate the efficacy and safety of mabthera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (itp). patients will receive infusions of mabthera 1000mg i.v. on days 1 and 15. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * refractory, relapsing or chronic idiopathic thrombocytopenic purpura; * stable therapy during 3 weeks prior to study entry. exclusion criteria: * newly diagnosed itp (\<6 weeks); * prior treatment with mabthera; * active bleeding requiring platelet transfusion within 7 days prior to entry into study.
preconception and pregnancy obesity treatment and prevention among women with a history of depression

Conditions: Depression

Summary: the purpose of the preconception and pregnancy obesity treatment and prevention among women with a history of depression preliminary study is to provide a lifestyle intervention for women with a history of depression who are trying to conceive or are pregnant in order to prevent excessive pre-pregnancy weights, avoid excessive gestational weight gain, and to improve other markers of metabolic health. the treatment program consists of 10 private sessions with a trained clinician at no cost to participants.

the investigators are evaluating a new lifestyle intervention to help women with a history of depression who are pregnant or trying to conceive to learn to exercise, eat well, and live a healthy lifestyle. they are interested in examining if this therapy-based program can positively impact eating and exercising habits and see if the treatment is enjoyable. all participants will receive this intervention.

Eligibility criteria:
inclusion criteria: * history of depression * pregnant in first trimester or planning to become pregnant within next year * ability to give informed consent * age \> or = 18 and \< 45 years * overweight or obese (body mass index \> 25 kg/m\^2) exclusion criteria: * unwilling/unable to comply with study procedures * endorsed item on the physical activity readiness questionnaire (par-q) * diagnosis of anorexia nervosa or bulimia nervosa in the past month * diagnosis of substance dependence in the past month * active suicidality (montgomery asberg depression rating scale (madrs) item 10 score \> 4) * exercising regularly (i.e., 5 days per week for 30 min) * neurologic disorder or history of head trauma * contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries, contraindications to exercise for pregnant women)

Keywords: preconception pregnancy lifestyle