Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of left bundle branch pacing in patients with cardiac dysfunction and av block

Conditions: Atrioventricular Block, Second and Third Degree; Heart Failure; Left Bundle Branch Pacing

Summary: this study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with lvef \ 40% with lbbp have the non-inferior safety and efficacy than crt on patients' cardiac function and prognosis

patients who meet the inclusion and exclusion criteria will be enrolled into the study. in the study, patients with cardiac dysfunction who met the enrollment criteria and will agree to participate in this trial will be 1:1 randomized to the lbbp group and the crt group. patients who were successfully implanted were enrolled for evaluation and follow-up. the primary end points of the study is the change of lvef within 12 months post-implant in both lbbp treatment group and crt treatment group

Eligibility criteria:
inclusion criteria: * above 18 years old * agree to participate in trial and sign informed consent * nyha cardiac function class i-iii * lvef\<50% * second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage \>40% * patients who are willing to take the de-novo implant or device replacement or upgrade. exclusion criteria: * life expectancy \<1 year * patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery * acute myocardial infarction within 1 month * women of childbearing age who are pregnant or becoming pregnant during the study period * severe liver and kidney dysfunction2 * have been enrolled in another clinical studies that may interferes with the current trial objectives * evidence of severe pulmonary hypertension (pasp\>70mmhg) * evidence of hypertrophic cardiomyopathy which shall affect the prognosis of patients. * the investigator believes that subject's physical condition is not suitable for participation in the trial

Keywords: pacing induced cardiomyopathy heart failure pacing lbbp bvp rvp conduction system pacing cardiac resynchronization therapy bradycardiac arrhythmia
gamma delta t-cell infusion for aml at high risk of relapse after allo hct

Conditions: Acute Myeloid Leukemia

Summary: the purposes of the study are to determine the maximum tolerated dose (mtd) and effectiveness of artificial antigen presenting cell (aapc)-expanded donor t-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (allohct) to treat patients with acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: * male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (allohct) or the treatment eln 2017 adverse risk aml * have \< 5% blasts in bone marrow by morphology at the time of transplantation. patients with pre-allohct or post-allohct flow cytometric or molecular evidence of mrd are allowed * karnofsky performance status (kps) ≥ 70% during the study screening. * free of symptomatic congestive heart failure or uncontrolled arrhythmia * adequate organ function as defined per protocol * negative serum pregnancy test * note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for at least 30 days following study treatment (t-cell infusion); should a woman subject or female partner of a male subject become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study. * agreement to adhere to lifestyle considerations throughout study duration exclusion criteria: * current use of concomitant systemic glucocorticoid at the time of γδ t-cell infusion for any reason will not be allowed in order to avoid their immunosuppressive effects on γδ t-cell function. * active grade ii-iv acute gvhd (patients with prior gvhd should be off prednisone for at least 14 days prior to infusion of the study cell product). * uncontrolled serious infection. * morphologic relapse of leukemia at any timepoint after hct. * active central nervous system malignancy. * pregnancy or lactation. * treatment with another investigational drug or other intervention within 14 days of t-cell infusion

Keywords: aml
effect of rt3d-tee-guided mitral valve repair on outcomes in patients with degenerative mitral valve disease

Conditions: Degenerative Mitral Valve Disease

Summary: the aim of this randomized controlled trial to investigate the effects of real-time 3d transesophageal echocardiography (rt3d-tee)-guided mitral valve repair on surgical failure and 1-year reoccurrence of mitral valve regurgitation in patients with degenerative mitral value disease.


Eligibility criteria:
inclusion criteria: * diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram. * informed consent was obtained exclusion criteria: * re-operation of mitral regurgitation * concurrent surgical plan for congenital heart disease, coronary artery bypass grafting, aortic valve surgery, radiofrequency ablation of atrial fibrillation and other cardiac surgeries. * mitral valve replacement * unable to undergo tee
pregabalin in adolescent patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (a0081180) and who wish to recieve open-label pregabalin


Eligibility criteria:
inclusion criteria: * patients must have met the inclusion criteria for the preceding fibromyalgia study a0081180, and have received pregabalin/placebo under double-blind conditions. exclusion criteria: * patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study a0081180 which was determined to be related to the study medication by the investigator or sponsor.
time-restricted feeding intervention in metabolically-unhealthy postmenopausal women

Conditions: Metabolic Syndrome; Postmenopausal Symptoms

Summary: this is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. it is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.

this is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (trf) on metabolic risk in postmenopausal women. data will be collected for 18 weeks. baseline food timing, activity/sleep, and metabolic parameter (ogtt, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). subjects will then be randomized to the trf intervention or no trf for 16 weeks. subjects in the trf group will be educated about the health benefits of trf. then each subject in the trf group will self-select a 10-h window and consume all daily calories during this time frame. subjects in both the trf and no trf groups will text the time of their first and last daily meals for the duration of the study. at the end of the 16-week trf intervention or no trf, metabolic and anthropometric measurements will be collected.

Eligibility criteria:
inclusion criteria: * postmenopausal women * age 45-65 years * prediabetic or have at least 2 features of metabolic syndrome exclusion criteria: * on hormone therapy * diabetes * heart disease * alcohol consumption of \>2 drinks per day * significant circadian disruption * having care-taking responsibilities that significantly affect sleep * shift work or irregular lifestyle * uncontrolled sleep apnea or other uncontrolled sleep disorder * extreme early or late chronotypes * significant psychiatric disorders * taking adhd medications * diagnosed dysregulated eating behaviors * smoking \>5 cigarettes/day or 30 pack-year history * participating in formal weight loss program * not weight stable

Keywords: postmenopause weight metabolic risk glucose body composition lipid sleep prediabetes fasting circadian inflammation
observational open study of polyoxidonium in hospitalized patients with covid-19

Conditions: Infections, Coronavirus

Summary: the study is designed as an open observational non-comparative study of polyoxidonium®, lyophilizate for solution for injections and topical application, 12 mg in hospitalized patients with coronavirus disease (covid-19).

the study was planned as an observation of polyoxidonium® administered in addition to russian ministry of healthcare (moh) guidance for standard covid-19 treatment. regimens have no limitations to the use of concomitant therapy. the aim of the study is to observe the safety and efficacy of polyoxidonium®, lyophilizate for solution for injections, 12 mg in addition to complex treatment of hospitalized patients with covid-19.

Eligibility criteria:
inclusion criteria: 1. the hospitalized patient was administered polyoxidonium, according to the instruction for medical usage in complex with russian moh guidance for treatment of covid-19. 2. verified coronavirus disease covid-19, and at least one of the following: * severe disease: mechanical ventilation or oxygen supply required with blood oxygen saturation (spo2) ≤ 94% on room air or tachypnea, respiratory rate ≥ 24 breaths per minute, * mild-moderate disease: spo2 \> 94% on room air or respiratory rate \< 24 breaths per minute. 3. the patient signed an informed consent form for participation in this study. 4. the patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol. 5. male and female patients from 18 years of age. 6. confirmed diagnosis of coronavirus disease (covid-19): laboratory-confirmed severe acute respiratory syndrome-related coronavirus 2 (sars-cov-2) infection as determined by polymerase chain reaction (pcr), or other commercial or public health assay in any specimen prior to inclusion. exclusion criteria: 1. pregnancy or breastfeeding. 2. pathological condition that the study doctor considers significant enough to prevent enrolment of this patient. 3. participation in any clinical study within 30 days before the informed consent form provided. 4. hypersensitivity and/or intolerability to any ingredient of the investigational product. 5. acute or chronic renal failure.
immunogenicity of the recombinant zoster vaccine in multiple sclerosis patients

Conditions: Shingles; Zoster

Summary: the purpose of this study is to provide evidence as to whether rzv is immunogenic with an acceptable safety profile in multiple sclerosis patients on anti-cd20 treatment.

in this monocentric study, we will assess the immunogenicity and safety of two doses of the adjuvanted recombinant zoster vaccine (rzv, or shingrix®) in multiple sclerosis patients treated with anti-cd20 (ocrelizumab, group 1) compared to healthy controls (group 2). participants will receive shingrix® on day0 and day60; immunological response will be assessed on day 0, 1, day 60, 61, day90 and day360. unsolicited adverse events of special interest (aesi) will be collected throughout the study period; patients reported outcomes (pros) will be declared for one week after each vaccination. safety of ms patients will be monitored through edss scoring and mri before and 1 month after vaccination (d90) and at day 180 and 360 (edss scoring only)

Eligibility criteria:
inclusion criteria: for ms patients: * 18 years and above * diagnosed with relapsing ms according to mcdonald criteria (2017) * not already vaccinated by rzv and willing to be vaccinated with rzv. * at least 1 year on anti-cd20 treatment: 2 initial infusions of ocrelizumab 300 mg (2 weeks apart), one infusion of ocrelizumab 600 mg 6 months apart, one infusion of ocrelizumab 600 mg 12 months after initial infusions * informed consent as documented by signature for healthy controls * aged 50 to 59 * not already vaccinated by rzv and willing to be vaccinated with rzv * informed consent as documented by signature exclusion criteria: * recent ms relapse in the 6 weeks preceding planned vaccination * ongoing signs of febrile or non-febrile infection at the time of vaccination * recent pregnancy with delivery in the six months preceding vaccination and/or planned pregnancy in the six months following rzv vaccination * immunosuppression from the following: hiv infection, current active systemic auto-immune disease (other than ms), current malignant neoplasm; primary immunodeficiency; recent solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy; conditions requiring medication with immunosuppressive drugs * having received a vaccine in the last month * having received a shingles vaccine within one year * presented with herpes zoster in the previous year * contra-indication to rzv * unable to provide informed consent or inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia. * participation in another study with investigational drug within the 30 days preceding and during the present study.

Keywords: rzv vaccine multiple sclerosis immune response safety
different algorithm models to predict postoperative pneumonia in elderly patients

Conditions: Postoperative Pulmonary Complications

Summary: the researchers aim to compare different algorithms to predict postoperative pneumonia in elderly patients and to assess the risk of pneumonia in elderly patients.

postoperative pneumonia is a common complication that increases the mortality and length of older patients. in order to better assess the risk of postoperative pneumonia in elderly patients, we plan to use database information and different algorithms, such as logistic regression, random forest, and other algorithms respectively to build models and evaluate the effects of the models.

Eligibility criteria:
inclusion criteria: 1. age 65 years or older 2. receiving invasive ventilation during general anesthesia for surgery exclusion criteria: 1. preoperative mechanical ventilation 2. procedures related to a previous surgical complication 3. a second operation after surgery 4. organ transplantation 5. discharged within 24 hours after surgery 6. cardiac and thoracic surgery
effects of active tissue release techniques on groin pain in 2nd trimester of pregnancy

Conditions: Groin Strain

Summary: the study will focus on the effects of active tissue release techniques on groin pain, hip range of motion, and functional disability in 2nd trimester of pregnancy. this will be a randomized controlled trial conducted on 30 participants from prime care hospital. pregnant women in the second trimester aged between 25 to 35 years, who have groin or round ligament pain will be included in this study. a sample of 30 will be divided into 2 groups. group a will undergo treatment of active release techniques for 10 minutes thrice a week with no home plan of home relaxation exercises. in contrast, group b will combine treatment of active release technology with home relaxation exercises. treatment will be given for 4 weeks and pain will be assessed before and after the treatment through (nprs) scale. functional disability will be measured before and after the treatment through quebec scale and force disability scale questionnaire in both groups.

groin pain mostly occurs in the first and second trimesters of pregnancy due to round ligament pain because the womb expands and causes stretching of ligaments making it more likely to become strained. the study will be focused on the effects of active tissue release techniques on groin pain, hip range of motion, and functional disability in 2nd trimester of pregnancy. a baseline treatment of ice therapy will be given for 10 minutes to all participants of this study. a sample of 30 will be divided into 2 groups. group a will undergo treatment of active release techniques for 10 minutes thrice a week with no home plan of home relaxation exercises. in contrast, group b will combine treatment of active release technology with home relaxation exercises. treatment will be given for 4 weeks and pain will be assessed before and after the treatment through (nprs) scale. functional disability will be measured before and after the treatment through the quebec scale and force disability scale questionnaire in both groups. recorded values will be analyzed for any change using spss

Eligibility criteria:
inclusion criteria: * pain in the groin area/ round ligament pain * nprs scores between 4 to 10 * functional activities scoring between 50 to 90 at quebec score exclusion criteria: * any diagnosed pathology like infection , malignancy ,inflammation * any structural deformity of lumbar and pelvic girdle, * any inguinal or lumbar surgery * high risk pregnancy

Keywords: backache pregnancy
effects of vitamin b1 in type 1 diabetic patients

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to determine whether benfotiamine supplementation can reduce markers of microvascular complications in type 1 diabetic patients.

despite intensive strategies designed to achieve good metabolic control, diabetic patients are still at a markedly increased risk of eye and kidney disease, nerve damage, limb amputation, stroke and myocardial infarction as a result of long-term hyperglycemia. it has recently been shown that supplementation with lipid soluble vitamin b1 (benfotiamine) in diabetic rats could effectively block three major biochemical pathways of hyperglycemic damage. it has also been shown that supplementation prevented the development of experimental diabetic retinopathy and nephropathy, without changes in glycemic control. however, the applicability of the above findings to humans is unknown, and the diabetic late complications in experimental animals do not in every aspect mirror the human diabetic complications. this project will allow us to evaluate the potential of benfotiamine to reduce or prevent the further development of microvascular disease in type 1 diabetics.

Eligibility criteria:
inclusion criteria: * type 1 diabetes (of at least 15 years duration) as assessed by medical history. exclusion criteria: * macroalbuminuria * symptomatic gastroparesis. diabetic nephropathy with a creatinine clearance less than 60 cc/min. * evidence of chronic infection. * history of any malignancy. * any chronic medical condition that unduly increases the risk for the potential enrollee as judged by study investigators. * pregnancy, breastfeeding or planned pregnancy within two years. * supplementation with thiamine \> 2mg per day and/or alpha-lipoic acid * chronic alcoholism/alcohol abuse.

Keywords: diabetes complications benfotiamine type 1 diabetes elevated urinary albumin excretion nerve function advanced glycation end products
drug interaction study with a potential alzheimer's disease compound

Conditions: Alzheimer Disease

Summary: the purpose of this study is to determine whether bms-708163 will effect the pharmacokinetics of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and dextromethorphan


Eligibility criteria:
inclusion criteria: * healthy male subjects * 18-45 yrs old inclusive exclusion criteria: * women
efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis

Conditions: Chronic Sinusitis

Summary: the propose of this study to determine efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis

chronic rhinosinusitis (crs) is characterized by symptoms \> 12 weeks two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip): * facial pain/pressure * reduction or loss of smell) mainstay of treatment are medical and surgical treatment ( atb, adenoidectomy, ess) adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect nasal lavage with mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis in pediatrics allergy clinic at siriraj hospital since 2006 use gentamicin nasal irrigation for chronic rhinosinusitis.there have been no studies in gentamicin irrigation in chronic rhinosinusitis. the aims of this study are to evaluate: 1. efficacy of gentamicin nasal irrigation in chronic rhinosinusitis (outcomes: frequency of sinusitis, frequency of antibiotic usage) 2. complication of gentamicin nasal irrigation usage

Eligibility criteria:
inclusion criteria: * chronic rhinosinusitis patients who were followed in pediatrics allergy clinic at siriraj hospital between january 1, 2005, and february 28, 2011 * gentamicin nasal irrigation usage for longer than 3 months exclusion criteria: * patients who used azithromycin prophylaxis within 1 year before and 6 months after started gentamicin nasal irrigation * patients received ivig within 1 year before and 6 months after started gentamicin nasal irrigation * patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation * patients received it within 1 year before and 6 months after started gentamicin nasal irrigation

Keywords: chronic sinusitis gentamicin nasal irrigation
a clinical trial comparing efficacy and safety of dabigatran etexilate with warfarin in patients with cerebral venous and dural sinus thrombosis (re-spect cvt)

Conditions: Thromboembolism

Summary: this is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. this phase iii study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (isth criteria) and new venous thrombotic event (vte) (primary endpoint) with blinded endpoint adjudication.


Eligibility criteria:
inclusion criteria: * written informed consent in accordance with international conference on harmonization (ich) good clinical practice (gcp) guidelines and local legislation and/or regulations * confirmed diagnosis of cerebral venous or dural sinus thrombosis (cvt), with or without intracranial haemorrhage * completion of anticoagulation therapy for 5-15 days which has been administered until randomisation; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin * eligibility for treatment with an oral anticoagulant * further inclusion criteria apply exclusion criteria: * cerebral venous or dural sinus thrombosis (cvt) associated with central nervous system infection or due to head trauma * planned surgical treatment for cvt * conditions associated with increased risk of bleeding * history of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence according to investigator judgment * treatment with an antithrombotic regimen for an indication other than cvt and requiring continuation of that treatment for the original diagnosis without change in the regimen * severe renal impairment * active liver disease * pregnancy, nursing or planning to become pregnant while in the trial * further exclusion criteria apply