Kornimate/medical-research-clean huggingface dataset:
substudy 01a: zilovertamab vedotin in pediatric and young adult participants with hematologic malignancies or solid tumors (mk-9999-01a/lightbeam-u01)

Conditions: B-cell Acute Lymphoblastic Leukemia; Diffuse Large B-cell Lymphoma; Burkitt Lymphoma; Neuroblastoma; Ewing Sarcoma

Summary: substudy 01a is part of a platform study. the purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory b-cell acute lymphoblastic leukemia (b-all), diffuse large b-cell lymphoma (dlbcl)/burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with ewing sarcoma.


Eligibility criteria:
the main inclusion and exclusion criteria include but are not limited to the following: inclusion criteria: * for hematological malignancies: confirmed diagnosis of b-precursor b-all or dlbcl/burkitt lymphoma according to world health organization (who) classification of neoplasms of the lymphoid tissues. * for solid tumor malignancies: histologically confirmed diagnosis of neuroblastoma or ewing sarcoma. exclusion criteria: * history of solid organ transplant. * clinically significant (ie, active) cardiovascular disease. * known history of liver cirrhosis. * ongoing grade \>1 peripheral neuropathy. * demyelinating form of charcot-marie-tooth disease. * diagnosed with down syndrome. * ongoing graft-versus-host disease (gvhd) of any grade or receiving systemic gvhd treatment or prophylaxis. * history of human immunodeficiency virus (hiv) infection. * contraindication or hypersensitivity to any of the study intervention components. * received prior radiotherapy within 4 weeks of start of study intervention. participants must have recovered from all radiation-related toxicities. * ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). prednisone equivalent dosing must have been stable for at least 4 weeks before cycle 1 day 1 (c1d1). * received a strong cytochrome p450 3a4 (cyp3a4) inhibitor within 7 days or a strong cyp3a4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong cyp3a4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention * received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and/or cytoreductive therapy with steroids/hydroxyurea. * received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. administration of killed vaccines is allowed. * has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * known additional malignancy that is progressing or has required active treatment within the past 1 year. * active infection requiring systemic therapy. * known history of hepatitis b or known active hepatitis c virus infection. * participants who have not adequately recovered from major surgery or have ongoing surgical complications.
heat killed probiotics in the prevention of necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis; Enterocolitis, Necrotizing

Summary: prophylactic probiotics have been shown to decrease the incidence of necrotizing enterocolitis (nec) in premature neonates. however, there is some resistance to giving live bacteria to small babies. based on animal data, the investigators hypothesized that heat inactivated probiotics would also reduce nec.

preterm neonates, \<1500 gm birth weight will potentially be candidates for study and will be recruited when they begin enteral feeding. the infants will be prospectively and randomly assigned to one of two groups: 1. treatment group - to receive daily inactivated probiotic prophylaxis starting with the initiation of feeds. 1 tsp powder will be diluted in 2 cc of mother's milk when possible or in similac special care formula 24 cal when mother's milk is not available; and 2. control group - to receive 2 cc/day of placebo similarly diluted. supplements will be continued until the infant tolerates enteral feeds of 100 cc/kg/day or reaches 35 weeks post conceptual age (whichever comes last). biotikid, a probiotic mixture, will be heated to 100 degrees c for 10 minutes. babies will be followed clinically for signs of nec, and with urine intestinal fatty acid binding protein (ifabp) and fecal calprotectin levels. the investigators primary aim is to demonstrate that premature neonates who are treated prophylactically with heat inactivated probiotics will have less necrotizing enterocolitis when compared to age matched infants given placebo. the investigators secondary objectives are to demonstrate the following: * that the decrease in nec will coincide with improved intestinal barrier integrity, as reflected by levels of: * i-fabp in urine * fecal calprotectin

Eligibility criteria:
inclusion criteria: * preterm neonates * ≤1500 gm birth weight exclusion criteria: * infants who are not deemed likely to survive more than one week; * infants who are not started on enteral feeds by one week of age; * infants who have significant congenital malformations or other gastrointestinal problem
altering mechanisms of frailty in persons living with hiv aged 50 to 65

Conditions: Hiv; Frailty Syndrome

Summary: people living with hiv are living longer as their disease is controlled with antiretroviral medications. yet they are experiencing frailty more often and more than ten years earlier than those without hiv. in elderly persons without hiv, frailty is associated with decreased muscle strength and chronic inflammation. less is known about what is driving early frailty in hiv or effective prevention measures for aging adults with hiv. it may be that having hiv infection impairs energy production by mitochondria within the cells and contributes to the muscle weakness and inflammation accompanying frailty in people living with hiv . this study will examine the impact of six weeks of moderately paced walking on energy production in the cells, inflammation markers and frailty scores in people living with well-controlled hiv who are aged 50 to 65.


Eligibility criteria:
inclusion criteria: * adults aged 50 to 65 * documentation of hiv infection from medical provider * currently receiving antiretrovirals * hiv viral load less than 50 iu/ml for at least six months * cd4 count at least 350 cell/mm3 for the last six months * willing and able to walk at least 30 minutes 3 times weekly within 30 minutes of umb * speaks english exclusion criteria: * current smokers * weight less than 110 pounds * subjects taking long-term corticosteroids equivalent to 10mg/day or more, or immunomodulators * subjects with conditions known to affect inflammatory or mitochondrial function other than hiv, such as rheumatoid arthritis, gout, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, parkinson's disease, alzheimer's disease, active hepatitis, sleep apnea or autoimmune diseases. * current drug or alcohol use or dependence or unstable mental health conditions that, in the opinion of the investigator, would interfere with adherence to study requirements

Keywords: physical activity mitochondrial respiration inflammation
the effect of vitamin d3 on postoperative pain in patients undergoing craniotomy

Conditions: Brain Neoplasms

Summary: vitamin d is a hormone mainly synthesized in the skin in the presence of sunlight. like other hormones, vitamin d plays a role in a wide range of processes in the body. some studies have shown vitamin d has anti-inflammatory effects in the body by reducing the release of pro-inflammatory cytokines and suppressing t-cell responses. therefore, vitamin d may be effective on reduce pain by such mechanisms. in this trial patients with brain tumor under craniotomy will receive a single high dose vitamin d compared to the control group.

a randomized, double blind, controlled trial will be conducted in intensive care unit (icu) and neurosurgery ward, in shohada-e-tajrish hospital,tehran, iran. first, patients will be carefully checked for inclusion and exclusion criteria. then, the eligible patients will complete the consent form for this study. 60 eligible brain tumor patients diagnosed by surgeon that are ready for craniotomy will be selected.these patients will be divided into two groups. intervention group will be received an intramuscular (im) single dose of vitamin d (300000 iu),while another group will not receive. pain in patients will be checked daily by up to 3 days after surgery. finally, the vas pain score will be compared in both groups.

Eligibility criteria:
inclusion criteria: * written informed consent of patient or legal representative * 25(oh)d level below 20ng/dl exclusion criteria: * other trial participation, including previous participation in the pilot trial * pregnant or lactating women * hypercalcemia * hyperphosphatemia * tuberculosis * sarcoidosis * history of nephrolithiasis * history of hyperparathyroidism * medications that interfere with vitamin d metabolism * renal insufficiency
does tamsulosin facilitate semi-rigid ureteroscopic

Conditions: Ureter Stone

Summary: ureteric calculi are one of the most common reasons for frequent urolithiasis. the estimated prevalence is 8-13% of all calculi. medical expulsive therapy (met) is recommended by the european association of urology (eau) (2013) for 5-10 mm ureteric stones to facilitate stone passage. for met, alpha blockers, mainly tamsulosin, have shown efficacy in several randomized controlled trials. the underlying pathophysiology of this therapy is supported by the presence and distribution of adrenoreceptors in the ureter. blocking the action of alpha-1 receptors by pharmacological agents (alpha blockers), such as alfuzosin, terazosin, doxazosin, and, most typically, tamsulosin, results in the relaxation of the ureteric smooth muscle. ureteroscopy (urs) is the most commonly performed procedure for the treatment of ureteral calculi, with a high (\>90%) stone-free rate after a single treatment. advancing a rigid ureteroscope into a non-dilated ureter may be difficult and cause complications. ureteric dilatation may provide access to stones, but not in all cases, and ureteral mucosal injury up to perforation might occur.

based on the role of alpha blockers, mainly tamsulosin, in met of ureteric calculus, the investigator will attempt to extend the use of alpha blockers prior to urs for procedural ease. the investigator will conduct a prospective, randomized double-blind study to evaluate whether alpha blockers facilitate the negotiation of the ureteroscope if administered preoperatively.

Eligibility criteria:
inclusion criteria: * lower ureteral stone. * age: 18 - 75 years. * normal renal function. * single sided ureteral stone with normal other kideny. * sign the informed consent. * be willing/able to adhere to follow up visits. exclusion criteria: * upper and middle ureteral stones. * renal impairment. * age \< 18 years or 75 \< years. * female who were pregnant * bilateral ureteric stone or solitary kidney. * urinary tract infection need drainage.
defining the serum ferritin concentration in kenyan women at which the body senses iron depletion and begins to upregulate iron absorption

Conditions: Iron-deficiency; Ferritin Threshold; Iron Absorption; Stable Iron Isotopes

Summary: the serum or plasma ferritin concentration (referred to hereafter as ferritin) is the most widely used indicator to detect iron deficiency and a low ferritin indicates depleted iron stores. however, the threshold ferritin that defines iron deficiency remains unclear and diagnostic ferritin cutoffs from expert groups vary widely. our study aim is to define the ferritin in kenyan young women at which the body senses iron depletion and begins to upregulate iron absorption from the diet; this approach could provide a functionally defined threshold of iron deficiency in sub-saharan african women.


Eligibility criteria:
inclusion criteria: * age 18-28 y, not pregnant or lactating * body weight \<75 kg * body mass index (bmi) between 17 and 25 kg/m2 * no acute illness/infection (self-reported) * no metabolic or gastrointestinal disorders (self-reported) * no use of medications affecting iron absorption or metabolism during the study * no intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study
safety and efficacy of cefecin tab. in patients with acute sinusitis

Conditions: Acute Sinusitis

Summary: this is a multi-center, double-blind, randomized, active controlled, parallel group phase 4 clinical trial to re-confirm the efficacy and safety of cefetamet pivoxil formulation in sinusitis patients

patients with acute sinusitis were randomly assigned (1:1) to receive either cefetamet (500 mg twice daily, study group) or cefdinir (100 mg three times a day, control group) and corresponding placebo t.i.d. or b.i.d. for 2 weeks.

Eligibility criteria:
inclusion criteria: * patients diagnosed with sinusitis (accompanied with otitis media) at screening, and whose first symptoms occurred within the past 3 weeks * symptoms or signs of acute sinusitis persist without improvement for 10 days after onset or symptoms or signs of acute sinusitis initially improve and then worsen within 10 days exclusion criteria: * those who have a history of hypersensitivity to cephalosporin, penicillin, or other beta-lactam antibiotics * those with a history of allergic rhinitis or other rhinitis * those who have been diagnosed with sinusitis more than 3 times within a year * have had or scheduled sinus surgery within 1 month * creatinine clearance \< 40 ml/min at screening * those whose ast, alt, and total bilirubin are more than 3 times the upper limit of normal at screening * cystic fibrosis patients
the effect of training given to patients with copd in line with pender's health promotion model

Conditions: Chronic Obstructive Pulmonary Disease; Self Efficacy

Summary: this study was conducted as a randomized controlled experimental study. the study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. the study was terminated with the participation of 140 patients, 70 in each group. data were collected with descriptive information form and copd self-efficacy scale.

this study was conducted as a randomized controlled experimental study. the study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. the study was terminated with the participation of 140 patients, 70 in each group. data were collected with the descriptive information form and copd self-efficacy scale. self-efficacy of all patients was assessed at the beginning of the study. patients in the intervention group were given training prepared in line with the health promotion model. the control group received standard practices of the clinic. after three months, patients' self-efficacy was re-evaluated.

Eligibility criteria:
inclusion criteria: * being 18 years of age or older, * having been diagnosed with copd at least 6 months ago, * volunteering to participate in the study, * being able to speak and understand turkish and communicate effectively, * not having a mental or physical disability that would prevent answering the questions. exclusion criteria: * having a psychiatric illness, * having vision and hearing problems, * having cognitive dysfunction, * not volunteering to participate in the study.
optimizing behavioral healthcare delivery through technology

Conditions: Mood Disorders; Anxiety Disorders

Summary: the goal of this randomized controlled clinical trial is to determine the feasibility, acceptability, and preliminary efficacy of an artificial intelligence platform )שׁ( for behavioral health in facilitating better clinical outcomes for adult patients receiving outpatient therapy. the main question\[s\] it aims to answer are: * whether an ai platform designed for behavioral healthcare would be feasible and acceptable to patients and therapists. * whether the depression and anxiety outcomes of adults receiving outpatient cognitive-behavioral therapy (cbt) in a community-based clinic would be superior among patients whose therapists used an ai-based platform to support clinical decision making and administrative tasks compared to patients receiving treatment-as-usual (tau). participants will receive cbt for depression or anxiety and complete standardized assessments. participants will be followed for the first two months of therapy.

the need for scalable delivery of mental health care services that are efficient and effective is now a major public health priority. artificial intelligence (ai) tools have the potential to improve behavioral healthcare services by helping clinicians collect objective data on patients' progress, streamline their workflow, and automate administrative tasks. the goal of this study is to determine the feasibility, acceptability, and preliminary efficacy of an ai platform for behavioral health in facilitating better clinical outcomes for patients receiving outpatient therapy. this open randomized clinical trial will compare an ai platform provided by eleos health to treatment-as-usual (tau) during the first 2 months of therapy. the study will be conducted at a community-based clinic in the u.s. participants will be adults referred for outpatient, individual cognitive behavioral therapy for a main diagnosis of a depressive or anxiety disorder. patients will be randomized to receive either therapy provided with the support of an ai platform developed by eleos health or tau at the same clinic. data analysis will be carried out based on intention-to-treat principle. the primary outcomes include the feasibility and acceptability of the ai platform. secondary outcomes include changes in depression (patient health questionnaire-9) and anxiety (generalized anxiety disorder-7) scores as well as treatment attendance and satisfaction. findings of this study will inform the optimization of future trials and services offered to individuals seeking mental health support in the u.s.

Eligibility criteria:
inclusion criteria: 1. older than 18 years old. 2. presenting for an outpatient cbt for a depressive or anxiety disorder. exclusion criteria: 1. age \<18. 2. individuals who are medically unstable for outpatient treatment. 3. a severe mental health condition that might interfere with treatment compliance (e.g., psychotic depression, psychosis, active substance dependence).

Keywords: mood disorders anxiety disorders evidence-based practices community-based clinics artificial intelligence
eculizumab to treat thrombotic microangiopathy/atypical hemolytic uremic syndrome -associated multiple organ dysfunction syndrome in hematopoietic stem cell transplant recipients

Conditions: Thrombotic Microangiopathies; Atypical Hemolytic Uremic Syndrome; Multiple Organ Dysfunction Syndrome

Summary: hematopoietic stem cell transplantation (hct)-associated thrombotic microangiopathy (tma) is an understudied complication of hct that significantly affects transplant related morbidity and mortality. the investigators hypothesize that early intervention with complement blocker eculizumab will double survival in hct recipients with high risk tma, as compared to historical untreated controls. an optimal eculizumab dosing schedule can be determined for this population through eculizumab pharmacokinetic/pharmacodynamic (pk/pd) testing.

this clinical trial is a prospective single arm multi-institution study in children and young adults undergoing allogeneic or autologous hematopoietic stem cell transplantation who will receive early therapy with eculizumab to prevent tma-associated mods after transplantation. the purpose of this research study is to examine efficacy of complement blocker eculizumab in hct recipients with high risk tma and to determine optimal eculizumab dosing regimen for hct recipients with tma using pk/pd studies. all patients will receive therapy based on their weight for 24 weeks. survival will be assessed at 6 months from tma diagnosis.

Eligibility criteria:
inclusion criteria: * patients of any age undergoing allogeneic or autologous hct * histologic tma diagnosis or clinical tma diagnosis and presenting with high risk disease features including elevated plasma sc5b-9 above laboratory normal value (≥244ng/ml) and proteinuria measured as ≥30mg/dl of protein on random urinalysis x2 or protein/creatinine ratio ≥1mg/mg or patient receiving renal replacement therapy. * minimum weight of ≥ 5kg. exclusion criteria: * known hypersensitivity to any constituent of the study medication. * subjects with unresolved serious neisseria meningitides infection or progressive severe infection. * patients with diagnosis of ttp as defined by adamst13 activity test \<10%. * patients previously treated with eculizumab or other complement blocker for tma within the 60 days prior to first dose of study treatment.

Keywords: hematopoietic stem cell transplant
prediction and pathogenesis of the immune reconstitution inflammatory syndrome

Conditions: Immune Reconstitution Inflammatory Syndrome; Opportunistic Infections

Summary: the objective of this project is to determine clinical and biological predictors of immune reconstitution inflammatory syndrome (iris) occurrence in hiv infected patients who are started on antiretroviral therapy (art), and to obtain more insight into the pathogenesis of this syndrome. the investigators will prospectively study hiv infected patients in sub saharan africa who will be initiated on art and are at risk to develop iris in all its different appearances. in these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict iris, and the investigators will obtain insight into which inflammatory pathways become activated during iris. this project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in lambaréné, gabon, in the central african rainforest belt. in gabon little research has been done in the field of hiv. the epidemiological pattern of iris in gabon will be described. promising putative plasma biomarkers will be validated for their use in daily practice.


Eligibility criteria:
inclusion criteria: * age \> 18 years * informed consent * art naive exclusion criteria: * no informed consent * history of art use * pregnancy

Keywords: immune reconstitution inflammatory syndrome biomarkers hiv art predictive factors epidemiological pattern gabon