Kornimate/medical-research-clean huggingface dataset:
a study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk myelodysplastic syndromes (mds)

Conditions: Myelodysplastic Syndromes (MDS)

Summary: this is a phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk mds comprising a dose-escalation portion and a safety expansion portion.


Eligibility criteria:
inclusion criteria: * participant must have documented diagnosis of untreated de novo mds with: * international prognostic scoring system (ipss) risk categories int-2 or high (minimum ipss overall score of 1.5) or revised ipss (ipss-r) categories intermediate, high or very high (score of \> 3) and * presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate. * eastern cooperative oncology group (ecog) performance score of less than or equal to 2. exclusion criteria: * participant has received prior therapy for mds. (prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy). * participant has received prior therapy with a bcl-2 homology 3 (bh3) mimetic. * participant has a diagnosis other than previously untreated de novo mds (as defined in the protocol) including: * mds with ipss risk categories low or int-1 (overall ipss score \< 1.5) * therapy-related mds (t-mds). * mds evolving from a pre-existing myeloproliferative neoplasm (mpn). * mds/mpn including chronic myelomonocytic leukemia (cmml), atypical chronic myeloid leukemia (cml), juvenile myelomonocytic leukemia (jmml) and unclassifiable mds/mpn. * participant has received allogeneic hematopoietic stem cell transplantation (hsct) or solid organ transplantation. * participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.

Keywords: higher-risk (hr) myelodysplastic syndromes (mds) pharmacokinetic venetoclax azacitidine acute myelogenous leukemia myelodysplastic syndromes (mds) treatment-naïve higher-risk
continuous glucose monitoring for women with diabetes mellitus in the intrapartum and postpartum inpatient care

Conditions: Diabetes, Gestational

Summary: diabetes mellitus affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. increasing numbers of women are either entering pregnancy with a continuous glucose monitor (cgm) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those using cgm. since the introduction of cgm in the late 1990s, there has been slow acceptance of their validation and use in the inpatient setting. the investigators propose an observational prospective cohort study to analyze the correlation of cgm data with traditional capillary glucose readings in the intrapartum and postpartum settings.


Eligibility criteria:
inclusion criteria: * age 18-50 years * women with a viable singleton or twin intrauterine pregnancy between 22 5/7 and 41 6/7 weeks gestation based on the best obstetric estimate by acog criteria * diagnosis of insulin-dependent pregestational diabetes mellitus (type 1 or type 2 diabetes) * planning to deliver at osu wexner medical center * able to understand the study, and having understood, provide written informed consent in english exclusion criteria: * gestational diabetes mellitus, maturity onset diabetes of young, and cystic fibrosis related diabetes * abnormal obstetrical ultrasound suspicious for major congenital abnormality * known or suspected fetal aneuploidy (by either cvs, amniocentesis, or cell-free dna) * participation in another trial that may influence the primary outcome, without prior approval * participation in this trial in a prior pregnancy * higher order pregnancy * history of severe skin allergy to adhesive products or cgm within the previous 3 months
atrial fibrillation registry 2017

Conditions: Atrial Fibrillation; Mitral Valve Failure

Summary: monocentric, prospective, randomized trial of cardiac surgical arrhythmia using endocardial radiofrequency atrial ablation compared with a cryo ablation system in the setting of cardiac surgery.

regular, rhythmic monitoring (24-hour holter ecg, 5 and 28 days, 3 and 6 months po) of patients after cardiac surgery on the mitral valve with atrial ablation for paroxysmal, persistent, and permanent atrial fibrillation with regard to the presence or stability of sinus rhythm.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * present, written informed consent from the patient * paroxysmal, persistent, or permanent atrial fibrillation not longer than 10 years according to guidelines (acc, aha, esc) * planned cardiac surgery on the mitral valve * echo parameters : la size a.p. ≤ 55mm exclusion criteria: * permanent atrial fibrillation longer than 10 years * echo parameters : la size a.p. \> 55mm * pregnancy * life expectancy \< 12 months * lack of cognitive or mental capacity to participate in the study * patients who are to be included in another clinical (interventional) study at the same time or who are already participating in such a study

Keywords: sinus rhythm atrial fibrillation
discharge criteria of preterm infants

Conditions: Length of Stay

Summary: this retrospective study aims to compare discharge criteria and their impact on the length of stay using two neonatal intensive care units from two countries. the possible discharge criteria include temperature control, apnea observation, periodic respiration, least weight limit, and parents' readiness. the data were collected retrospectively in each study site.

aims: to compare discharge criteria and their impact on the length of stay among preterm infants in japan and finland. the possible discharge criteria include temperature control, apnea observation, periodic respiration, least weight limit, and parents' readiness. study design and settings: this is a retrospective comparison study in two nicus: a level iv in japan and a level iii in finland. patients: eligible infants are those who were born between 28+0 and 31+6 weeks of gestation and who were discharged home from the study sites between january 2020 and december 2021. infants will be excluded if (1) they have major anomalies at birth, (2) they are not discharged home from the study sites, or (3) they are discharged home with oxygen and/or after tracheostomy. outcome measures: the primary outcomes are the most common last discharge criterion between the two nicus, and the potential shortening effects of each discharge criterion on the length of stay. the secondary outcome is the postmenstrual age (pma) for each discharge criterion. statistics: the comparison between two continuous variables will be carried out by the student t test. ethics: the ethics committee of nagano children's hospital gave ethical approval to this study. the study permission was obtained in both study sites.

Eligibility criteria:
inclusion criteria: * born between 28 and 31 weeks of gestation and * discharged home from the study sites between january 2020 and december 2021 exclusion criteria: * having major anomalies at birth * need for home oxygen therapy, tracheostomy, and/or gastrostomy at discharge

Keywords: early discharge family centered care tube feeding transition to home neonatal home care
hcv + to hcv - kidney transplant

Conditions: Kidney Failure; Hepatitis C

Summary: this is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic daa therapy in kidney transplantation to prevent the transmission of hepatitis c virus infection from an hcv-positive donor kidney to an hcv-negative recipient.

the goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic daa therapy after kidney transplant prevents the transmission of hepatitis c virus (hcv) infection from an hcv-positive donor kidney to an hcv-naive recipient.

Eligibility criteria:
recipient inclusion criteria: * met mgh transplant center criteria and already listed for kidney transplant * must agree to birth control. women must agree to use birth control in accordance with mycophenolate risk evaluation and mitigation strategy and at least one barrier method * no evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team * able to sign informed consent recipient exclusion criteria: * pregnant or nursing (lactating) women * hbv positivity (ag or dna) * any contra-indication to kidney transplantation per center protocol donor inclusion criteria * detectable hcv nat test * kdpi score is less than ≤ 0.850 * traditional donor selection criteria met - acceptable for transplantation per usual evaluation donor exclusion criteria * confirmed hiv * confirmed hbv positive (surface antigen or hbv dna positive) * any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Keywords: kidney transplant kidney failure hcv hepatitis c
a study to evaluate the safety, tolerability, and immunogenicity of motavizumab (medi-524) after dosing for a second season in children

Conditions: Motavizumab Administration for a Second Season for RSV Prophylaxis

Summary: the primary objective of this study was to determine the effect on immune reactivity to motavizumab (medi-524) of monthly intramuscular (im) doses of motavizumab (medi-524) administered for a second season in children.

this was a phase 1/2, randomized, double-blind study in which motavizumab (medi-524) or palivizumab was administered to children who previously participated in mi-cp104. children who received at least 3 doses of motavizumab in mi-cp104 were eligible for enrollment. subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by im injection every 30 days for a total of 4-5 injections during the 2004-05 rsv season subsequent to the season in which they were participants of mi-cp104. all subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.

Eligibility criteria:
inclusion criteria: * previous participation in mi-cp104 and received at least 3 injections of medi-524 in mi-cp104 * the child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday) * the child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months) * written informed consent obtained from the patient's parent(s) or legal guardian exclusion criteria: * currently hospitalized * receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure \[cpap\]) * evidence of infection with hepatitis a, b, or c virus * known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or hiv infection * suspected serious allergic or immune mediated events with prior receipt of medi-524 * acute illness or progressive clinical disorder * active infection, including acute respiratory syncytial virus (rsv) infection at the time of enrollment * previous reaction to igiv, blood products, or other foreign proteins * have ever received palivizumab * received within the past 120 days or currently receiving immunoglobulin products (such as rsv-igiv \[respigam(r)\], ivig), or any investigational agents (except medi-524) * currently participating in any investigational study

Keywords: motavizumab, palivizumab, synagis rezield, medi-524
efficacy of mavacamten in patients with symptomatic latent obstructive hypertrophic cardiomyopathy

Conditions: HCM - Hypertrophic Cardiomyopathy; Mavacamten

Summary: this study aimed to evaluate the efficacy and safety of mavacamten compared to no treatment in patients with symptomatic latent obstructive hypertrophic cardiomyopathy. the trial was randomized into two groups: mavacamten group and non-mavacamten group. over the 30-week treatment period, patients underwent a series of assessments at predefined time points, including transthoracic echocardiography, electrocardiogram (ecg), holter monitoring, nyha functional classification, kansas city cardiomyopathy questionnaire (kccq), and cardiac biomarkers.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. weight greater than 45 kg. 3. adequate acoustic windows to allow for accurate transthoracic echocardiograms (ttes). 4. diagnosis of latent obstructive hypertrophic cardiomyopathy, in accordance with the current guidelines of the american college of cardiology foundation/american heart association, european society of cardiology, and chinese society of cardiology. 5. left ventricular ejection fraction (lvef) ≥55% at rest, confirmed by the echocardiography core laboratory. 6. new york heart association (nyha) class ii or iii symptoms at the time of screening. 7. resting oxygen saturation ≥90% at the time of screening. exclusion criteria: 1. any acute or severe comorbidities (e.g., severe infections or hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction). 2. currently using or having used prohibited medications within 14 days prior to screening, such as cytochrome cyp2c19 inhibitors (e.g., omeprazole or esomeprazole) or strong cyp3a4 inhibitors. 3. life expectancy of less than 1 year. 4. pregnant or breastfeeding women. 5. history of syncope or sustained ventricular tachyarrhythmia during exercise within the past 6 months. 6. atrial fibrillation (af). 7. patients currently receiving or planning to receive treatment with disopyramide, cibenzoline, ranolazine, or a combination of beta-blockers with verapamil or diltiazem.

Keywords: hcm mavacamten
efficacy study of standard ballroom and latin dance program in type 2 diabetes and obesity

Conditions: Diabetes; Obesity

Summary: to test the metabolic and clinical effects of a 6-month program of dancing in subjects with type 2 diabetes and/or obesity, chronically cared for in two diabetes/metabolic units. self-selection of the leisure time activity program was allowed to increase adherence to the physical activity programs.


Eligibility criteria:
inclusion criteria: * type 2 diabetes in fairly good metabolic control (glycosylated hemoglobin (hba1c) \ 94 cm in males, \>80 in females), with/without prediabetes or minor alterations of hba1c. exclusion criteria: * previous cardiovascular events, muscle-skeletal problems reducing physical ability, any general condition limiting systematic adherence

Keywords: dance physical activity physical fitness weight loss
novel stretching versus post isometric relaxation techniques on shoulder disability in athletes

Conditions: Glenohumeral Internal Rotation Deficit

Summary: it was a randomized control trial in which thirty (30) participants having grid, age between 20-40 years were randomly allocated into two groups i-e ns (novel stretching) group (30) and pir (posterior isometric relaxation techniques) group (30), february 2022 to march 2022.pir group received the posterior isometric relaxation techniques (three times a week for one month) and ns group received the novel stretching (three times a week for one month). ir rom was measured with a goniometer while pain was measured with numeric pain rating scale intervention and disability of arm, shoulder and hand was measured with dash score before, immediately, and at week 4 post intervention.


Eligibility criteria:
inclusion criteria: * male and female * between the ages of 18 and 40 * athletes with glenohumeral internal deficit * basketball, tennis, javelin, squash, swimmers, volleyball, and weightlifter * participated in local and regional sporting events * showed a 10° or higher variation in internal rotation range of motion between shoulders (dominant versus non-dominant) exclusion criteria: * footballer, cricketer, and hockey player * recovering from extensive shoulder and elbow surgery that was performed three months ago. * presently undergoing medical intervention for the shoulder * suffer from a life-threatening illness

Keywords: range of motion,pain,shoulder,stretching
a clinical trial of infliximab for uveitis

Conditions: Uveitis

Summary: this project is designed to test the hypothesis that inhibition of binding between tumor necrosis factor alpha (tnf-alpha) and its receptors using remicade (infliximab, chimeric mouse/human igg1k monoclonal antibody directed against human tnf-alpha, centocor, malvern,pa) is clinically useful for patients with uveitis that is refractory to other forms of systemic immunosuppressive therapy.


Eligibility criteria:
inclusion criteria: 1. the study group will include patients suffering from treatment-resistant vision-threatening uveitis who attend the uveitis clinic at casey eye institute. 2. we plan to enroll 32 patients. exclusion criteria: 1. patients with ocular or systemic infection. 2. patients with the subtype of uveitis termed pars planitis who have mri scan evidence of demyelination. there is a theoretical risk of adverse outcome of tnf-alpha inhibition on the clinical course of multiple sclerosis. patients who suffer from pars planitis are at increased risk of developing multiple sclerosis. 3. children under the age of 9. 4. patients with known sensitivity to mouse proteins. remicade is a chimeric protein with human and murine components. 5. patients with history of cancer (exception- skin cancers which are curatively resected), organ transplantation (exception- cornea), recent drug or alcohol addiction, or inability to keep appointments. 6. patients with other serious systemic diseases that could interfere with participation in the study. 7. it is specifically noted that pregnant women and nursing mothers will be excluded from this study.
dep-ru regimen as a salvage therapy for hlh

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: this study aimed to investigate the efficacy and safety of ruxolitinib together with liposomal doxorubicin, etoposide and methylprednisolone (dep-ru) as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis.


Eligibility criteria:
inclusion criteria: 1. meet hlh-04 diagnostic criteria; 2. treated with hlh-94 no less than 2 weeks before enrollment and did not achieve at least pr; or relapsed patients after remission； 3. life expectancy exceeds 1 month; 4. age≥1 year old and ≤70 years old, gender is not limited； 5. before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal； 6. serum hiv antigen or antibody negative； 7. hcv antibody is negative, or hcv antibody is positive, but hcv rna is negative； 8. both hbv surface antigen and hbv core antibody were negative. if any of the above is positive, peripheral blood hepatitis b virus dna titer should be detected, and less than 1×103 copies/ml can enter the group； 9. echocardiographic examination of lvef ≥ 50%; 10. informed consent. exclusion criteria: 1. heart function above grade ii (nyha)； 2. accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2； 3. pregnancy or lactating women； 4. allergic to pegaspargase, doxorubicin or etoposide； 5. active bleeding of the internal organs； 6. uncontrollable infection； 7. serious mental illness; 8. non-melanoma skin cancer history; 9. patients unable to comply during the trial and/or follow-up phase; 10. participate in other clinical research at the same time.
effect of pacap38/vip on migraineurs measured by magnetic resonance

Conditions: Migraine Without Aura

Summary: the purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (pacap38) and vasoactive intestinal polypeptide (vip) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (mri), including mr angiography (mra) and functional mri (fmri). mra will be used to detect changes in intracranial artery circumferences before and after pacap38 and vip. fmri will be used oo detect changes in blood-oxygenation-level-dependent-signal (bold-signal). pacap38 but not vip induces migraine like attacks in migraine patients. the migraine specific drug sumatriptan will be given to relieve pain and the effect will also be registered using mra and fmri.


Eligibility criteria:
inclusion criteria: * healthy migraine patient without aura * age 18-40 * weight 50-100 kg * fertile women must use safe contraceptives exclusion criteria: * tension type headache more than 5 days per month * other primary headaches * daily use of medication except contraceptives * drug taken within 4 times the half life for the specific drug except contraceptives * pregnant or lactating women * exposure to radiation within the last year * hypotension or hypertension * cardiovascular or cerebrovascular disease * mental illness or substance abuse * other significant conditions determined by the examining doctor * contraindications to mri scan * headache within the last 48 hours before start of trial

Keywords: pacap38 mma migraine angiography vip vasodilatation
stress hormones and human cocaine use - 7

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to determine the hpa axis and adrenergic system activation in response to cocaine administration.

the goal of this study was to investigate the role of sympathetic-adrenal medullary (sam) and hy0pothalamo-pituitary-adrenal (hpa) systems in mediating the addictive effects of cocaine. a toal of 6 male subjects were enrolled for this 5 day inpatient study. subjects were assigned to either cocaine (32mg /70kg iv) or placebo (saline iv) treatment during the first experimental sessions and were crossed over to the alternative treatment during the second experimental session. endpoints that were followed during the experimental sessions included neuroendocrine (serum epinephrine, norepinephrine and cortisol levels), physological (heart rate/blood pressure, ekg) and subjective measures (beck depression inventory, craving questionnaire). we hypothesized that cocaine administration would lead to increased blood levels of norpinephrine, epinephrine and cortisol in cocaine dependent subjects.

Eligibility criteria:
inclusion criteria: males between the ages of 20-45. history of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. current history of good health and normal ekg. exclusion criteria: history of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. current problem with major depressive disorder. current use of alcohol or other drugs on a daily basis. history of major medical illnesses. currently on parole, probation or a legal history of violence. treatment for chemical dependency within the past 6 months. history of sensitivity to tricyclic compounds or other prescription drugs. use of any psychotropic drugs including maois in the past 6 months.

Keywords: cocaine dependence
study of the effectiveness and safety of darunavir/cobicistat (drv/c) containing regimens in routine clinical practice

Conditions: HIV Infections

Summary: this is a retrospective observational study of patients who have taken a regimen containing drv / c at least 24 weeks prior to study initiation

the study will include 750 patients and will record data at 24 weeks. the study will also record data at 48 weeks for those patients whom these data are available

Eligibility criteria:
inclusion criteria: * patients with hiv infection * inform consent document. * to have initiated therapy containing drv / c and have a follow-up of at least 24 weeks. exclusion criteria: * not having evaluable clinical data of the patient * patients not routinely followed in the center * patient less than 18 years of age.