Kornimate/medical-research-clean huggingface dataset:
local adaptation of cost effectiveness model for apixaban atrial fibrillation indication - venezuela

Conditions: Non-Valvular Atrial Fibrillation

Summary: to characterize treatment patterns and healthcare resource utilization among adults diagnosed with non-valvular atrial fibrillation (nvaf) from the private setting in venezuela.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of af (incident and prevalent cases) * patient with at least 18 years * patients enrolment before and during the study period * patients treated in venezuela exclusion criteria: * women who were pregnant at any moment during the study period
carvedilol + vsl#3 versus endoscopic variceal ligation for primary prophylaxis of esophageal variceal bleeding in cirrhotic patients non responder to carvedilol.

Conditions: Cirrhosis

Summary: patients of cirrhosis will be enrolled who have large esophageal varices, which have never bled. after successful screening baseline hepatic venous pressure gradient (hvpg) will be measured. tablet carvedilol 3.125 mg bd for 1 week will be started. it will be increased to 6.25 mg bd and continued for next 7 weeks. after completion of 8 weeks the hepatic venous pressure gradient (hvpg) will again be measured to find out responders (hepatic venous pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure gradient \<12 mm hg) and non responders (hepatic venous pressure gradient \<20% reduction).the responders will be excluded from the study while the non responders will be randomize into carvedilol+vsl#3 versus endoscopic variceal ligation.


Eligibility criteria:
inclusion criteria: * patients of cirrhosis with portal hypertension aged 18 to 75 years who have large esophageal varices with or without red color signs and have not bled previously. exclusion criteria: * any contra-indication to beta-blockers * coagulopathy with inr \>1.8 at the time of enrollment * any endoscopic variceal ligation or sclerotherapy within last 3 months * any past history of surgery for portal hypertension * significant cardio or pulmonary co-morbidity * any malignancy * refusal to participate in the study
vitamin d levels in patients with central retinal vein occlusion- a prospective controlled study

Conditions: Vitamin d Deficiency; Central Retinal Vein Occlusion

Summary: retinal vein occlusion (rvo) is a common vascular disease of the eye. studies have shown that the risk of venous thrombosis is higher in winter so even concerning rvo. studies have shown a possible link between sun exposure and venous thrombosis. vitamin d levels have been shown to have a similar seasonal variation, with a peak occurring in the summer. the primary source of vitamin d is from sunlight when ultraviolet b (uvb) radiation penetrates the skin and converts 7-dehydrocholesterol to 25-hydroxycholecalciferol vitamin d3 (25-ohvitd) via previtamin d. in stockholm situated at latitude 59˚ 20΄ north, it is not possible to synthesize vitamin d at sufficient levels in winter and the exposure time required to reach a standard dose is impractical from at least october through march. the aim of the study is to evaluate vitamin d levels in central retinal vein occlusion (crvo) patients and compare them with the vitamin d levels in randomly selected control patients matched for age and month of disease onset. this is to evaluate whether vitamin d deficiency may be a risk factor in the onset of crvo. the hypothesis of the study is that patients with crvo have lower levels of vitamin d than matched controls.

the study will last one year and is expected to include 120 patients with rvo and 120 control patients. the first 10 rvo patients visiting st. erik's eye hospital with disease duration of maximum 3 months will be included in the study each month. the control patients will be chosen randomly by the central bureau of statistics and matched for age and gender according to disease distribution known from previous studies. the control group will receive a letter with information of the study, informed consent form and details about the blood sampling procedure. every month 50 patients in the control group will be invited to participate in the study. only the first 10 control subjects will be included in the study. each month a blood sample will be taken from 10 patients with rvo and 10 subjects in the control group. all the subjects will only have one blood sample taken during the study. blood will be analyzed to measure the vitamin d level. vitamin d levels will be compared at the end of the study between groups and evaluated according to the time of year for sampling. all the blood sampling will be done by the laboratory at karolinska university hospital. participation in the study is completely voluntary. the details of the study has been reviewed and approved by the ethics committee.

Eligibility criteria:
inclusion criteria: newly diagnosed central retinal vein occlusion (3 months) exclusion criteria: -

Keywords: vitamin d deficiency central retinal vein occlusion
sensitivity of pdl-1-analysis from pleural effusion in non-small cell lung cancer

Conditions: Lung Neoplasms

Summary: this is a prospective diagnostic pilot study to create hypotheses regarding immunocytochemistry (icc) pd-l1 analysis of pleural effusions in nsclc patients as compared to the reference standard of pd-l1 immunohistochemistry (ihc). this comparison will be done to assess sensitivity and specificity of pd-l1 detection by icc in pleural effusions.


Eligibility criteria:
inclusion criteria: * presence of malignant pleural effusion with indication for pleural puncture and thoracoscopy * confirmed diagnosis of non-small cell lung cancer according to ers guidelines * written informed consent exclusion criteria: * pregnancy and/or lactation * acute and life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, etc.) * any contraindication to undergo thoracoscopy (e.g. anticoagulation therapy which cannot be discontinued for the procedure) * any medical, psychological or other condition impairing the patient's ability to provide informed consent
real world effectiveness of natalizumab extended interval dosing in a french cohort

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: natalizumab (ntz) use in multiple sclerosis (ms) in highly active patients has been largely established during the last rationale 10 years in both clinical trials and real-world practice. along with its efficacy, ntz use has been limited by potential risk of progressive multifocal leukoencephalopathy (pml). thus, several studies have tried to assess how to minimize this risk. one suggested approach is to move from the standard interval dose (sid) of 4 weeks to an extended interval dose (eid) of 5 weeks or longer. extending the dosing interval of ntz has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (pml) while maintaining efficacy. we propose to retrospectively analyze data from clinical records coming from rrms patients treated in france at 5 different centers; caen, nice, bobigny and toulouse hospitals as well as percy military hospital, to evaluate the effectiveness of natalizumab eid in subjects who have previously been treated with natalizumab sid for 12 months, in relation to continued sid treatment. in the clinical practice of these centers, patients are shifted after minimum 12 months under sid to an eid of 6 weeks regardless antibody jc serum status. clinical, magnetic resonance imaging (mri) and serum anti-jcv antibody status data are collected when available. the objective of this study is to assess the efficacy in term of arr and safety.


Eligibility criteria:
inclusion criteria: * patients receiving at least 11 infusions of natalizumab as disease-modifying monotherapy for rrms that is consistent with the approved dosing exclusion criteria: * patients for whom the ntz infusion history and/or mri and clinical history is not available. * patients with dosing gap defined as \>=12 weeks between any two doses. * patients with over dose defined as \<3 weeks between any two doses. * pregnancy during the follow-up period

Keywords: natalizumab extended interval dosing
e3 breast cancer taxotere combination

Conditions: Advanced Breast Cancer

Summary: to assess the efficacy of zd6474 in combination with docetaxel in the treatment of abc using the progression event count methodology


Eligibility criteria:
inclusion criteria: * females with histological/cytological confirmation of breast cancer. * subjects with a measurable lesion or bone lesions exclusion criteria: * previous radiotherapy within 6 weeks * significant cardiac events, arrhythmias or other cardiac conditions

Keywords: zactima
a study to improve cardiovascular outcomes in high risk patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: coronary artery disease and heart attacks are the leading cause of death in the uk. our population is ageing. the number of older patients suffering heart attacks and having angioplasty procedures to open up blocked heart arteries is increasing. after angioplasty, older patients (80 years of age or over) are at 5 times increased risk of death at one year compared to their predicted normal life expectancy. in addition, many patients present with further heart attacks, stroke and undergo repeat heart catheter test and angioplasty procedures. at present it is not clear who will or will not experience further problems in the future. the ability to predict who will and will not suffer future problems at the time of initial presentation can be helpful in providing additional treatment and close monitoring to those that are at risk of further problems. the icon 1 study is set out to study just that. in this study, older patients will undergo a comprehensive evaluation of the cardiovascular disease burden by undergoing additional investigations. these results from each patient will be used to develop a risk score that will inform physicians of the patient's future risk of developing adverse events and provide a better understanding of how to manage older patients with coronary artery disease and also help plan future studies looking at treatment strategies that might be beneficial in improving outcomes.


Eligibility criteria:
inclusion criteria: older patients (65+) presenting with acs for coronary angiography will be recruited into this study. exclusion criteria: those presenting with cardiogenic shock, those with co-existing malignancy with life expectancy less than one year and those with evidence of active infection such as urinary tract infection, pneumonia, sepsis and any wound infection will also be excluded from the study.
impacts of different pressure pneumoperitoneum on myocardial and pulmonary injuries after robot-assisted surgery

Conditions: Prostatic Neoplasms; Urinary Bladder Neoplasms

Summary: this study is aimed to determine whether low- and standard-pressure pneumoperitoneum have different impacts on troponin t（tnt) level as well as pulmonary complications after prolonged robot-assisted surgeries in the trendelenburg position.

the hypothesis of this study is based on several studies reported that increased postoperative troponin t(tnt) level was significantly associated with 30-day mortality, and some other reports showed that low-pressure pneumoperitoneum had better haemodynamic outcome than that of standard-pressure pneumoperitoneum. hence, we hypothesize that different pneumoperitoneal pressure may lead to different levels of tnt after prolonged robot-assisted surgeries. this clinical trial will be conducted in huadong hospital affiliated to fudan university and ruijin hospital shanghai jiao tong university school of medicine,both are tertiary hospitals in shanghai, china. after signing the informed consent, subjects who meet the eligibility criteria will be randomly assigned to low- or standard-pressure pneumoperitoneum group.the randomization plans will be implemented using statistical software r, and will be stored in an online database.these subjects will be recruited from january 1st 2016 to december 31st 2017. tnt is set as the primary endpoint for this trial to evaluate the myocardial injuries, and will be measured for each patient who will undergo in-patient robot-assisted urological surgery within 24 hours postoperatively using the fourth-generation high-sensitivity tnt assay. the total sample size will be 280.with 140 patients in each of the two treatment groups, the power will be at least 0.70 to detect an increment of tnt level among 80% of subjects.chest ct scan is used to diagnose the pulmonary complications on the third day postoperatively. data will be collected to analysize whether prolonged different intraperitoneal pressure has different impacts on cardiopulmonary injuries.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo robot-assisted radical prostatectomy or other robot-assisted urological surgeries last longer than 3 hours * patients who are classified as american society of anesthesiologists（asa）i and ii * patient's preoperative troponin t(tnt) level is normal exclusion criteria: * patients with preoperative cardiopulmonary dysfunction who can not understand prolonged surgeries in the trendelenburg position：severe pulmonary dysfunction or new york heart association(nyha) classification is ⅲ-ⅳ. * body mass index\>30. * any intraoperative situation as follows：1. any cause to cancel operation or change robot-assisted surgery to open surgery 2. intraoperative cardiovascular accidents.

Keywords: standard-pressure pneumoperitoneum prolonged pneumoperitoneum myocardial injuries troponin t(tnt) trendelenburg position chest ct scan low-pressure pneumoperitoneum robot-assisted surgery
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cell intravenous infusion for osteoporosis

Conditions: Osteoporosis

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of osteoporosis

this patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of osteoporosis. patients will receive a single intravenous infusion of uc-mscs. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of osteoporosis * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: osteoporosis stem cell treatment
a platform study to evaluate investigational therapies in chronic hepatitis b infection

Conditions: Hepatitis B, Chronic

Summary: this is a phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis b virus infection.

vir-shb1-v201 (strive) sub-protocol a is a phase 2 study under the prevail platform trial. this is a multi-center, open-label study designed to evaluate the safety and efficacy of regimens containing vir-3434, vir-2218, pegasys (peg-ifnα), and nucleotide reverse transcriptase inhibitors (nrti) in noncirrhotic adult participants with chronic hbv infection that have not received prior nrti or pegasys treatment. vir-shb1-v202 (thrive) sub-protocol b is a phase 2 study under the prevail platform trial. this is a multi-center open-label study designed to evaluate the safety and efficacy of regimens containing vir-3434 and nrti with or without vir-2218 in noncirrhotic adult participants with low viral burden of chronic hbv infection.

Eligibility criteria:
inclusion criteria: * male or female ages 18 or older * chronic hbv infection for \>/= 6 months * chronic hbv infection defined as a positive serum hbsag, hbv dna, or hbeag on 2 occasions at least 6 months apart based on previous or current laboratory documentation * strive: hbeag positive or negative, hbv dna \> 2,000 iu/ml, alt \> uln and ≤ 5x uln * thrive: must be/have the following, within the 1-year period prior to screening: hbeag negative, hbv dna ≤ 2,000 iu/ml, alt ≤ uln exclusion criteria: * any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation * history of clinically significant liver disease from non-hbv etiology * history or current evidence of hepatic decompensation * co-infection with human immunodeficiency virus (hiv), hepatitis a virus (hav), hepatitis c virus (hcv), hepatitis d virus (hdv) or hepatitis e virus (hev). * history or clinical evidence of alcohol or drug abuse * strive and thrive: significant fibrosis or cirrhosis * strive and thrive: history of immune complex disease * strive and thrive: history of autoimmune disorder * strive and thrive: history of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of vir-3434 * strive: prior nrti or peg-ifn therapy * strive: history of known contraindication to any interferon product * thrive: prior nrti therapy \< 24 weeks of study or any prior peg-ifn therapy

Keywords: hepatitis b virus chronic hepatitis b hbv hepatitis
clinical study on the impact of covid-19 vaccine on allogeneic hematopoietic stem cell transplantation

Conditions: Hematologic Diseases

Summary: aim of this study will evaluate the impact of covid-19 vaccine on safety and efficacy of hematological patients received allogeneic hematopoietic stem cell transplantation.

since the first detection of a corona virus disease 2019 (covid-19) infection in late 2019, the syndrome coronavirus-2 (sars-cov-2) has spread rapidly across the globe, threatening the health and safety of an increasing number of people. the development of the sars-cov-2 vaccine has been shown to be effective in reducing the chance of covid-19 infection and the severity of the disease. to control the covid-19 pandemic, an increasing number of studies are calling for people to receive the sars-cov-2 vaccine, and the chinese government is also advocating universal vaccination. however, the investigators have found in our work that as vaccination has become more widespread, clinicians have become somewhat confused about whether they can choose someone who has been vaccinated against sars-cov-2 as a donor for a bone marrow transplant, and what is the optimal time for allogeneic hematopoietic stem cell transplantation (allo-hsct) in vaccined hematological patients. this study will evaluate the impact of covid-19 vaccine on safety and efficacy of hematological patients received allo-hsct.

Eligibility criteria:
inclusion criteria: 1. allogeneic hematopoietic stem cell transplantation is expected to start in the short term. 2. able and willing to provide written informed consent and comply with all requirements for study participation (including all study procedures). exclusion criteria: 1. patients or donors with a history of previous infection with sars-cov-2. 2. patients or donors are currently infected with sars-cov-2. 3. patients have a history of other malignancies, disease progression, or is currently on systemic therapy.

Keywords: allo-hsct covid-19 vaccine
remote vinyasa yoga program for heart health

Conditions: Hypertension; Cardiovascular Diseases

Summary: the purpose of this study is to test a 12-week vinyasa yoga (flow yoga) intervention via zoom. this program will be for 30 individuals with high blood pressure. 15 will receive the intervention and 15 will follow their usual routine. the investigators will determine if this vinyasa yoga program is feasible and acceptable in this population. investigators will measure and compare blood pressure and other health responses such as physical health and well-being before and after participants complete the intervention or usual care period. the investigators hope to demonstrate that vinyasa yoga is a good option to improve heart health in people with high blood pressure. primary objective - examine the feasibility, acceptability, and preliminary efficacy of a 12-wk remotely-delivered vinyasa yoga intervention (3 x per week) on cardiovascular (cv) health in adults with hypertension (htn).


Eligibility criteria:
inclusion criteria: * individuals with a resting systolic bp \>130 mmhg exclusion criteria: * report currently meeting aerobic activity guidelines (150 min/wk) * practice yoga regularly (1 or more day/wk in the past month) * have physical limitations or a major medical condition contraindicating yoga or assessments * have uncontrolled htn (systolic bp 160 mmhg or diastolic bp 100 mmhg) * are currently pregnant or planning to become pregnant within 6 months * are not on a stable dose of medications that could affect study outcomes * are concurrently enrolled in another lifestyle program * no vulnerable populations will be included

Keywords: yoga vinyasa yoga
adaptive training exercise programs for improving cardiorespiratory fitness after breast cancer treatment, the activate trial

Conditions: Breast Cancer; Invasive Breast Carcinoma

Summary: this clinical trial studies the feasibility of implementing various adaptive training exercise programs to improve cardiorespiratory fitness in patients after receiving breast cancer treatment. information from this study may help researchers better understand how to implement adaptive training interventions to improve cardiorespiratory fitness in patients after receiving breast cancer treatment.

outline: patients are randomized to the interventional groups or control group. intervention groups: patients are randomized to 1 of 2 interventional arms. arm i: patients participate in aerobic exercise (ae) sessions 3 times per week for 12 weeks. after 12-weeks, non-responders participate in combined ae and resistance exercise (re) sessions for an additional 12 weeks, while responders continue participating in the ae sessions alone for an additional 12 weeks. arm ii: patients participate in re sessions 3 times per week for 12 weeks. after 12-weeks, non-responders may participate in a further 12-weeks of combined ae and re sessions, while responders continue participating in the re sessions alone for an additional 12 weeks. control group: after 24 weeks, patients receive a digital copy of the 12-week ae sessions and 12-week re sessions and an outline of sessions for 24 weeks.

Eligibility criteria:
inclusion criteria: 1. age 18 - 75 years, inclusive 2. female gender 3. prior diagnosis of invasive breast cancer 4. completion of chemotherapy or receipt of trastuzumab (herceptin) therapy within the past 6 - 60 months (0.5 - 5 years) 5. reduced cardiorespiratory functional capacity, defined as below the median estimated crf for age/sex-matched controls exclusion criteria: 1. actively receiving radiation treatment 2. medical history of heart failure, coronary artery disease or arrhythmia 3. contraindications to cardiopulmonary exercise testing (cpet) 4. contraindications to magnetic resonance imaging (mri) (e.g ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices, non-compatible mri tissue expanders or breast implants, or other implanted non-compatible mri devices), weight over 550 lbs, or symptomatic claustrophobia 5. contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably 6. unwilling to complete intervention procedures or outcome measures

Keywords: breast cancer exercise fatigue fitness aerobic survivor