Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate the safety and effectiveness of mer® stents in carotid revascularisation.

Conditions: Carotid Artery Stenosis

Summary: the aim of the study is to confirm, whether the mer® stent can be used, without limitations, for the endovascular carotid stenosis treatment in daily clinical practice. eligible patients will undergo the procedure of the common or internal carotid artery stenting using mer® with proximal or distal neuroprotection.

mer® stent will be implanted in eligible patients with common and internal carotid stenosis after an informed consent. potential benefit of the mer® stent implantation will be evaluated based on angiography and duplex doppler ultrasound examination. follow ups are scheduled at 30 days, 6 and 12 months after index procedure. except for clinical follow up patients will undergo carotid vessels ultrasound examination after 6 and 12 months. in case of an emergency visit, caused by the serious adverse event, patient will undergo: neurological and cardiac evaluation as well as carotid vessels usg examination and extended ct or mri scans. in general, all procedures in the study will follow the local standard of care. the type of devices used during the angioplasty (including the mer® stents) will not differ from the devices used in the usual clinical practice in the hospital. dapt and other medical therapy will be consistent with the rules of the polish and european society of cardiology.

Eligibility criteria:
inclusion criteria: * de novo lesion located in the internal carotid artery or common carotid artery * ds ≥50% (nonsymptomatic patients) and ≤99% based on qca * ds ≥75% (symptomatic patients) and ≤99% based on qca * target lesion available for 20-60mm lenght and 4-10mm diameter scaffold * patient eligible for cas * age ≥ 18 * life expentancy ≥ 12 months * the patient's written informed consent has been obtained prior to the procedure. exclusion criteria: * lack of neurological cas qualification * the patient has experienced an acute myocardial infarction within 72 hours of the procedure * the patient has known paroxysmal, persistent or permanent atrial fibrillation or flutter * the patient has known gastrointestinal bleeding * pregnancy * dapt contraindications * surgery planned within 1 month after the procedure * a platelet count \ 600,000/mm³ * the patient has known nickel, titanium or contrast allergy * the target vessel is totally occluded * the patient has stent(s) in the target lesion * statin therapy contraindications * the target lesion has massive calcifications * hyperthyroidism * post-radiotherapy side effects * no pulse in femoral artery * chronic kidney disease (creatinine level \>2,0 mg/dl or egfr\<30 ml/min/1.73 m2 or dialysotherapy)

Keywords: carotid artery stroke stent
simplified monitoring myanmar sm2 study

Conditions: Hepatitis C; Liver Cirrhoses; Liver Inflammation; HIV Infections

Summary: the study will evaluate the proportion of patients with undetectable hcv rna at 12 weeks post-treatment (svr12) following a course of daa therapy delivered using a simplified schedule of safety and virological monitoring.

a total of 200 hiv/hcv co-infected patients who plan to commence daa therapy at specialist hospital waibargi and mingaladon, will be enrolled by simple random sampling. in addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard hcv rna testing. they will also have a finger-stick capillary blood sample collected for a hcv point of care test, using the the xpert hcv assay performed in the genexpert point of care machine. dried blood spot collection (dbs) for hcv core antigen and hcv rna testing will be collected as a research sample. concordance between standard of care method and new dbs method will be evaluated. the proportion of patients reaching svr will be calculated.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to participate in this study. 1. have voluntarily signed the consent form. 2. 18 years of age or older. 3. hcv antibody positive. 4. hiv antibody positive. exclusion criteria: subjects who meet any of the exclusion criteria are not to be enrolled in this study. 1. clinically significant illness (other than hcv) or any other major medical disorder that may interfere with the subject treatment, assessment or compliance with the protocol. 2. creatinine clearance (clcr) \< 30ml/min at screening. 3. pregnant or nursing female. 4. use of prohibited concomitant medications. 5. inability or unwillingness to provide informed consent or abide by the study requirements.
cognitive impairment and affective mood disorders in patients with ibd

Conditions: Inflammatory Bowel Diseases; Mild Cognitive Impairment; Depression; Anxiety; Stress; Quality of Life

Summary: the aim is to evaluate the presence of mild cognitive impairment (mci) in patients with inflammatory bowel disease (ibd). this will be done by cognitive tests. along them, screening for depression, anxiety and stress will be done. a blood sample for determining serum values of homocysteine, protein s100-b, amyloid and bdnf will be stored. patients will be followed-up for 2 years.

the aim is to evaluate the presence of mild cognitive impairment (mci) in patients with inflammatory bowel disease (ibd). this will be done by cognitive tests. along them, screening for depression, anxiety and stress will be done. a blood sample for determining serum values of homocysteine, protein s100-b, amyloid and bdnf will be stored. patients will be followed-up for 2 years. study has 3 phases: inclusion, 1 year visit and 2 year visit. inclusion: consent signing, checking exclusion and inclusion criteria, cognitive testing, blood sample storing, questionnaires for screening. 1. year visit: cognitive testing. 2. year visit: cognitive testing.

Eligibility criteria:
inclusion criteria: 1. diagnosis of ibd for ibd group. 2. no diagnosis of ibd for healthy controls group. 3. obtainment of signed informed consent. exclusion criteria: 1. no consent form signed. 2. pregnancy. 3. severe organ insufficiency (cardiac, renal, respiratory, liver). 4. prior severe head trauma. 5. neoplasia. 6. prior neurodegenerative disease. 7. prior diagnosis of cognitive impairment or dementia. 8. prior cardiac arrest. 9. use of b9 and b12 vitamin supplements. 10. involvement in other clinical trials. 11. unclear diagnosis. 12. prior psychiatric disorders. 13. prior use of neuroleptics. 14. proven history of familiar alzheimer disease. 15. alcohol and drugs abuse. 16. prior stroke. 17. prior myocardial infarction.

Keywords: inflammatory bowel disease mild cognitive impairment depression quality of life mild cognitive impairment serum biomarkers
a safety study of sgn-cd33a in aml patients

Conditions: Acute Myelogenous Leukemia; Acute Myeloid Leukemia; Acute Promyelocytic Leukemia

Summary: this study will examine the safety profile of vadastuximab talirine (sgn-cd33a) administered as a single agent and in combination with a hypomethylating agent (hma). the main purpose of the study is to find the maximum tolerated dose (mtd, which is the highest dose that does not cause unacceptable side effects) of sgn-cd33a in patients with acute myeloid leukemia (aml). the mtd will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of sgn-cd33a. in addition, the pharmacokinetic profile and anti-leukemia activity of sgn-cd33a will be assessed.

this study will explore sgn-cd33a as a monotherapy and in combination with a hypomethylating agent (hma; i.e., azacitidine or decitabine). initial study treatment with sgn-cd33a includes a maximum of 2 cycles of treatment for monotherapy and 4 cycles for combination cohorts. patients who achieve documented cr or cri (monotherapy) or clinical benefit (combination) during the first part of the study are eligible to continue treatment. additional monotherapy cohorts may include patients with relapsed acute promyelocytic leukemia, relapsed patients with nucleophosmin-1 gene mutation (absence of fms-like tyrosine kinase 3 mutation) (npm1-mutated, flt-3 wild type), alternate dosing schedules (fractionated dosing on days 1 and 4), treatment naive patients with aml who declined intensive therapy, and patients who have relapsed after post-allogeneic stem cell transplant. patients in the combination cohort will be treated with azacitidine or decitabine per institutional practice prior to sgn-cd33a dosing. expansion cohorts may be added for further evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumor activity.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia, positive for cd33 * eastern cooperative oncology group status of 0 or 1 * adequate baseline renal and hepatic function * central venous access * either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation * bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients exclusion criteria: * inadequate lung function * prior allogeneic stem cell transplant, except for a specific cohort * high-dose chemotherapy within 4 weeks of study drug * antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)

Keywords: acute myeloid leukemia antibody-drug conjugate cd33 antigen immunotherapy drug therapy acute myelogenous leukemia acute promyelocytic leukemia apl
effects of whole body vibration on lower extremity with diplegic spastic cerebral palsy

Conditions: Spastic Diplegia

Summary: this study will help to determine the beneficial effects of high frequency vibration on children with diplegic cerebral palsy in improving balance ,spasticity, strength of lower limb and quality of life and a comparison between the effect of simple conventional treatment and conventional management with the usage of vibrational therapy in cp patients.

a study "effect of whole body vibration training on mobility in children with cerebral palsy "states whole body vibrational therapy induce an improvement in independent ambulation and mobility of lower limb by strengthening of muscles along with the refinement of walking pattern ,gait speed and stride length in children with cerebral palsy. on the basis of our study a better treatment protocol can be designed for future in diplegic spastic cerebral palsy children.

Eligibility criteria:
inclusion criteria: * gross motor function classification level ii-iii * modified ashworth scale of 1-2 exclusion criteria: * auditory/ visually impaired * other neurological conditions e.g. spina bifida etc. * lower limb contractures * children with history of lower limb surgery in last 6 months
effect of psychotherapy on quality of life and recurrence of events in patients with recurrent vasovagal syncope: a randomized pilot study

Conditions: Syncope

Summary: recurrent vasovagal syncope although presenting a benign prognosis in terms of survival, is associated with significant impairment of quality of life. the impaired emotional status is also related to the recurrence of the events, closing a negative cycle for the evolution of the disease. this study aims to evaluate the effect of psychotherapy on the quality of life and in the number of syncope and pre-syncope events during one year of follow-up of patients with recurrent vasovagal syncope.


Eligibility criteria:
inclusion criteria: * diagnosis of vasovagal syncope with positive tilt test and recurrent episodes (≥2 episode within 6 months) * signed free and informed consent form exclusion criteria: * severe comorbidity with life expectancy \<1 year * age \<18 years * current psychotherapeutic follow-up * cardiac or neurological syncope * pregnancy

Keywords: psychotherapy syncope quality of life psychoanalytic psychosomatics
development the potentiality of β-1,3/1,6-d-glucan (polysaccharide peptide) from mycelia extract of indonesia's ganoderma lucidum as adjuvant therapy in patients with cardiometabolic syndrome

Conditions: Cardiometabolic Syndrome

Summary: the aim of this study is to determine the role and efficacy of β-1,3/1,6-d-glucan (polysaccharide peptide) from mycelia extract of indonesia's ganoderma lucidum as an antioxidant and anti-inflammatory agent on cardiometabolic syndrome

this study is held at saiful anwar general hospital and general hospital of brawijaya university by enrolled 70 participants and using a double-blinded true experimental using a randomized control perspective method with pre-test and post-test design, to determine the effect of giving β-1,3/1,6-d-glucan (polysaccharide peptide) from mycelia extract of indonesia's ganoderma lucidum on cardiometabolic syndrome population. the intended target or experimental variables that will be studied in this study are blood pressure, body mass index, blood glucose profile (fasting glucose, hba1c), lipid profile (total cholesterol, high-density lipoprotein, low-density lipoprotein, and triglyceride), renal function profile (urea and creatinine), heart function from echocardiography examination, inflammation parameter (interleukin 6, tumor necrosis factor-alpha, and high sensitivity c-reactive protein), stress oxidative parameter (superoxide dismutase and malondialdehyde), endothelial function parameter (nitric oxide), and quality of life that conducted by completion of the sf-36 questionnaire. hypothesis of this study is β-1,3/1,6-d-glucan (polysaccharide peptide) from mycelia extract of indonesia's ganoderma lucidum can acts as a chronic anti-inflammatory and antioxidant agent in cardiometabolic syndrome patients by contributing in blood pressure control, body mass index control, blood glucose improvement, lipid profile improvement, renal function profile improvement, heart function improvement, and better quality of life. beside that, the investigators hope that there will be a change of inflammation, stress oxidative, and endothelial function parameter in which shift to the good level.

Eligibility criteria:
inclusion criteria: * age more or same than 18 years old * defined as metabolic syndrome patients based on ncep-atp iii criteria with modified of obesity classification (waist measurement) for asian population * agreed to participate in this study exclusion criteria: * allergic to ganoderma lucidum * pregnant woman * participate in another drug or medical device study * waiting for an organ transplantation or have undergone a transplant * cancer patients who undergoing a chemotherapy or radiotherapy * people with organ failure * could not be randomized and participate in this study by clinical judgement

Keywords: β-1,3/1,6-d-glucan polysaccharide peptide ganoderma lucidum cardiometabolic syndrome
the effect of rock inhibitors on corneas of patients with glaucoma and pseudophakic bullous keratopathy (pbk)

Conditions: Pseudophakic Bullous Keratopathy; Glaucoma

Summary: the goal of this clinical trial is to learn if topical netarsudil/latanoprost works to treat pseudophakic bullous keratopathy in patients with glaucoma. the main questions it aims to answer are: does topical netarsudil/latanoprost improves visual function in patients with glaucoma and pseudophakic bullous keratopathy? does topical netarsudil/latanoprost affects the central corneal thickness (cct) in patients with glaucoma and pseudophakic bullous keratopathy? researchers will compare topical netarsudil/latanoprost to a placebo (a look-alike substance that contains no drug) to see if topical netarsudil/latanoprost works to treat pseudophakic bullous keratopathy (pbk). participants will take topical netarsudil/latanoprost or a placebo every day for 3 months and visit the clinic once every two weeks for checkups and tests.

patients with glaucoma and pseudophakic bullous keratopathy will be randomly divided in two groups. group 1 will take topical netarsudil/latanoprost 1x daily for 3 months and group 2 will take topical placebo (artificial tear substitute) 1x daily for 3 months. visual acuity (va) will be evaluated using snellen chart and converted to logarithm of the minimum angle of resolution (logmar). central corneal thickness (cct) measurements will be performed using ultrasound pacymetry (micro medical devices, inc, ca). information about adverse effects will be recorded during the study. patients will visit every two weeks for checkups and measurements for 3 months.

Eligibility criteria:
inclusion criteria: * both sex, * age between 40 and 90 years * pseudophakic bullous keratopathy * glaucoma exclusion criteria: * other anterior segment pathology (corneal opacities); * ocular surface inflammation * retinal diseases affecting visual acuity

Keywords: glaucoma topical rock inhibitors netarsudil/latanoprost corneal edema pseudophakic bullous keratopathy (pbk)
study about acting of adaptive sport in musculoskeletal, cardiovascular system and the quality of life of individuals with spinal cord injury through biomedical instrumentation

Conditions: Adaptive Sport in Spinal Cord Injury

Summary: the hypothesis is to the fulfillment of canoeing, handbike and conventional physiotherapy activities the groups could show improvement in muscle strength of the arms, decreased resistance of the lower limbs (spasticity), improved trunk balance and movements of the upper limbs, improves cardiovascular function, bone health, and consequently improve the quality of life.


Eligibility criteria:
inclusion criteria: * aged 15-40 years * of both sexes * with injury time over 8 months, who present spasticity in the lower limbs up to grade 2 according to the scale of ashwoth modified patient with paraplegia or paraparesis in thoracolumbar level (lower than t2) levels. exclusion criteria: * age over 40 years * lesion less than 8 months * above t2 lesions * musculoskeletal disorders such as deformity * severe contracture * previously diagnosed cardiovascular abnormalities or risk factors such as hypertension * diabetes and obesity, use of medications and cardiopressant cardioestimuladoras, smoking and alcoholics. * for individuals who participate in the group canoeing and by adapting the pool will still include the following exclusion criteria: * decubitus ulcers * fungal infections * urinary incontinence * inflammatory processes and neoplasms.

Keywords: spinal cord injury, adaptive sport, dynamometry, electromyography, force platform.
the effectiveness of dynamic taping in preventing muscle fatigue

Conditions: Fatigue; Muscle, Heart; Shoulder Pain; Sport Injury

Summary: the purpose of this study is to assess the efficacy of dynamic tape in prevent shoulder muscle fatigue.

after being informed about the study and the potential of risk, all participants will undergo a screening to determine eligibility for study entry and giving written informed consent. we will include 20 participants who have pitch 100 times with dynamic taping or shame taping in randomized sequence. there must be more than 2 weeks resting between 2 test. we will test maximal force in shoulder flexion, extension, abduction and adduction before and after test. we also record spins and speed of baseball for performance outcome. to our hypothesis, we suggest dynamic taping could decrease the arm fatigue after long-term pitching.

Eligibility criteria:
inclusion criteria: * more than 20 years old * amateur baseball player * could tolerate pitching 100 times exclusion criteria: * shoulder pain who could not tolerate 100 pitching * upper limb surgery history * allergy to topical agent
a study of mdl 28,574a in hiv-infected patients

Conditions: HIV Infections

Summary: to characterize the safety profile of mdl 28574a following both acute and subchronic dosing in hiv-positive patients. to determine the mtd of both acute and subchronic doses of this drug when administered as oral solution. to determine the pharmacokinetic profile of mdl 28574a and castanospermine (from which mdl 28574a is derived) following both acute and subchronic dosing.

in part a of the study, patients receive a single oral dose of mdl 28574a on day 1 and are followed through day 7. in part b, patients receive single daily doses of the drug on days 1 through 14 and are followed through day 21.

Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * cd4 count \>= 500 cells/mm3. * no evidence of aids. * no antiretroviral therapy within 30 days prior to study entry. note: * presence of lymphadenopathy in two or more extrainguinal sites, at least 1 cm in diameter for 3 or more months, is permitted. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * clinically significant abnormalities on routine hematology (other than cd4 count and western blot), serum chemistry, and urinalysis. * abnormal ekg. * positive stool guaiac. * abnormal medical history or physical exam including temperature, heart rate, and blood pressure. * clinically significant organ abnormality or disease. * positive urine drug screen for illicit drugs. * inability to comply with study procedures. concurrent medication: excluded: * routine treatment with nonprescription medications. * treatment with other medications except with approval of the investigator. patients with the following prior conditions are excluded: * prior participation in this trial. * serious physical or mental illness within 1 year prior to study entry that would confound interpretation of data. prior medication: excluded: * antiretroviral therapy within 30 days prior to study entry. * known medications that alter renal, hepatic, or hematologic/immunologic function (such as barbiturates, phenothiazines, cimetidine, and immunomodulators) within 14 days prior to study entry. * routine treatment with nonprescription medications within 3 days prior to study entry. history of alcohol or drug abuse within the past year.

Keywords: mdl 28574