Kornimate/medical-research-clean huggingface dataset:
outcomes of autologous bone marrow mononuclear cell administration in the treatment of neurologic sequelea in children with spina bifida

Conditions: Stem Cell Infusion

Summary: the aim of this study was to evaluate the safety and efficacy of autologous bone marrow mononuclear cell infusion in the management of neurological sequelae in children with spina bifida

the aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear cells in 11 patients with spina bifida at vinmec research institute of stem cell and gene technology in hanoi, vietnam from 2016 to 2020

Eligibility criteria:
inclusion criteria: * the patient who was diagnosed with lumbar spina bifida underwent spinal cord close-up surgery. * both genders. * aged between 6 months and 15 years old. * exhibited bowel disorders (constipation, fecal incontinence) and urinary dysfunction (urinary retention or leakage). exclusion criteria: * vertebrae clefts in the chest, neck, and other spinal locations. * coagulopathy. * acute and chronic infection. * kidney function disorder, liver failure * patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome). * distress

Keywords: spina bifida mononuclear cell neurologic sequelea
traditional medicine syndromes in internal hemorrhoids: a cross-sectional study

Conditions: Hemorrhoids Second Degree; Traditional Chinese Medicine (TCM)

Summary: this study aims to investigate the characteristics of traditional medicine (tm) syndromes in patients diagnosed with internal hemorrhoids at le van thinh hospital. internal hemorrhoids are a common anorectal disorder, and their classification in traditional medicine remains inconsistent. the study will examine the prevalence of tm syndromes in patients with internal hemorrhoids and assess the correlation between goligher's classification and tm diagnoses. the study will follow a cross-sectional observational design with an estimated 178 participants. eligible patients are 18 years or older, diagnosed with internal hemorrhoids, and willing to participate. the primary outcomes include the prevalence of tm syndromes in internal hemorrhoids, severity classification according to goligher's scale, and correlation analysis between tm syndromes and clinical severity. the study has received approval from the institutional review board (irb) of the university of medicine and pharmacy at ho chi minh city and will be conducted from december 2024 to april 2025 at le van thinh hospital, vietnam.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older. * diagnosed with internal hemorrhoids at le van thinh hospital using goligher's classification. * willing to participate and provide informed consent exclusion criteria: * patients with colorectal cancer or other serious gastrointestinal diseases. * patients with acute inflammatory bowel disease that may interfere with the diagnosis. * patients with severe chronic illnesses affecting overall health. * patients unable to complete the study questionnaire due to cognitive or language barriers.
interstitial lung disease (ild). diagnostic yield of surgical lung biopsy versus cryobiopsy in the same surgical stage.

Conditions: Lung Diseases, Interstitial

Summary: in patients with interstitial lung disease (ild) with inconsistent clinical and radiological features, establishing a reliable diagnosis of ild requires a surgical lung biopsy transbronchial cryobiopsy is a minimally invasive, rapid, safe technique, and with histologic diagnostic yields, for ild, typically exceeding 70 -80% . the aim of this study is to compare and analyze the diagnostic yield, for ild, and complications following slb and tc methods. the investigators designed a descriptive, comparative and cross-sectional study in patients with ild, in which slb and ct will be performed in the same surgical stage, as diagnostic tests. this study will be conducted from january 2018 to january 2019. surgical lung biopsy and tc will be performed in the same surgical stage in all patients, under general anesthesia and mechanical ventilation. first tc will be performed by a pulmonologist, sequentially a thoracic surgeon will carry out a slb. the samples obtained will be analyzed by different pathologist to compare both techniques in terms of histologic features. diagnostic yield, postoperative complications, comorbidities and lenght of stay will be analyzed and compared following these procedures.


Eligibility criteria:
inclusion criteria: * patients for suspected ild eligible for lung biopsy reviewed during multidisciplinary approach. * subject provides informed consent. * a negative pregnancy test in women of child-bearing potential. * subject is mentally capable of understanding study procedures. * 18 years and older. exclusion criteria: * study subject has any disease or condition that interferes with safe completion of the study including: * platelet count \ 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure. * severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (fev1) \< 0.8, or radiographically as diffuse bullous disease * hemodynamic instability with systolic blood pressure \ 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians * hypoxemia with pulse oximetry values \<88% or partial pressure of oxygen in arterial blood (pao2) \< 60 on baseline oxygen requirements * concurrent participation in another study involving investigational drugs or investigational medical devices * inability to read and understand the necessary study documents

Keywords: interstitial lung disease, cryobiopsy, surgical biopsy
medical and physiological benefits of reduced sitting

Conditions: Metabolic Syndrome; Physical Activity; Insulin Resistance; Cardiovascular Diseases

Summary: the most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. it is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.


Eligibility criteria:
inclusion criteria: * physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in) * sitting time ≥ 10 h /day (measured by the activity monitor during run-in) * bmi 25-40 * blood pressure \< 160/100 mmhg * fasting plasma glucose \< 7.0 mmol/l * fulfills the criteria of the metabolic syndrome according to alberti et al 2009 exclusion criteria: * history of a cardiac event * insulin or medically treated diabetes * any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results * presence of ferromagnetic objects that would make mr imaging contraindicated * abundant use of alcohol * use of narcotics * smoking of tobacco or consuming snuff tobacco * diagnosed depressive or bipolar disorder * previous pet imaging or considerable exposure to radiation

Keywords: physical activity metabolic syndrome insulin sensitivity cardiovascular risk factor sedentary lifestyle accelerometry
an innovative virtually supervised exercise for dialysis patients

Conditions: Diabetes; Chronic Kidney Failure; Hemodialysis Complication

Summary: among patients with diabetes 35% suffer from chronic renal disease and may require dialysis or kidney replacement over time. furthermore, in diabetics with end stage renal disease (esrd) that require dialysis, the risk of foot complications and amputation is even more common, expensive, and devastating. interestingly, even though incidence of foot ulcers in patients with dialysis has been reported to be same as with patients with history of foot ulcers; dialysis patients have significantly higher rate of foot amputation. the goal of this research is to incorporate an innovative virtually supervised non-weight bearing exercise in patients undergoing dialysis to reduce risk of fall and foot ulceration by enhancing lower extremity blood flow, joint perception and joint mobility. diabetic patients on hemodialysis at hamad medical company will be recruited and will be randomized to either intervention (ig) or control (cg) group and followed for 6 months. the intervention group will take part in a 4-week non-weight bearing exercise program twice per week at the hemodialysis clinic under the supervision of a qualified research staff member. this intervention includes interactive game-based exercises including repetitive ankle and foot movements. wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. the control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. changes in balance, gait, and physical activity, incidence of foot problems will be compared pre- and post-intervention. in addition, the incident of falls, foot ulcers, and limb amputation up to 6 months post intervention will be documented. investigators hypothesize that patients receiving sensor-based exercises will benefit more compared to group receiving conventional non-technology training in terms of improving functional performance and reducing incidence of foot problems, falls, and limb amputation.


Eligibility criteria:
inclusion criteria: * adults of 50 years or older, who are undergoing hemodialysis process * patients in diabetes * ability to provide consent exclusion criteria: * non-ambulatory patients (unable to walk independently a distance of 20m with or without existence) * active foot ulcer * major foot amputation * charcot neuroarthropathy * major hearing/vision impaired * any patient with changes in psychotropic or sleep medications in the last 6 weeks * patients concurrently participating in another exercise training * patients with any clinically significant medical or psychiatric condition, or laboratory abnormality

Keywords: exercise exergame hemodialysis balance
intravenous heparin as an adjunct for the treatment of anaphylactic reactions in an emergency department

Conditions: Anaphylaxis

Summary: to determine if intravenous unfractionated heparin (with standard therapy) for treatment of anaphylaxis results in faster time to recovery.

anaphylaxis is a potentially life-threatening entity that requires both immediate recognition and aggressive treatment. although anaphylaxis is infrequent, comprising only 1% of approximately 1.03 million visits to the ed each year that are related to allergic reactions, it is none the less a generally under-recognized and under-treated disease, that is worthy of study due to the potential for a fatal outcome. recently, there has been renewed interest in a commonly used and inexpensive drug (heparin) as a novel component of therapy for anaphylactic/anaphylactoid reactions. heflin eft al. induced anaphylactoid reactions in pigs and compared intravenous unfractionated heparin in one treatment arm to standard therapy (intravenous epinephrine and diphenhydramine) versus placebo. the study revealed that heparin rapidly reversed the shock similar to that of standard emergency treatment. of course this single study done in pigs will not change practice, but it does warrant further investigation into the role that heparin plays in anaphylaxis in humans.

Eligibility criteria:
inclusion criteria: * 18 years and older * english speaking * meets one of the above definitions of anaphylaxis * signs/symptoms onset \<12 hours will get epinephrine or will not get epinephrine because of contraindication to epinephrine administration. exclusion criteria: * history of intracranial hemorrhage at anytime * known cerebral vascular lesion (i.e. aneurysm, arteriovenous malformation) * ischemic cva within the last 3 months * suspected aortic dissection * active bleeding * known bleeding/clotting disorder * closed head trauma within the past 3 months * major surgery (abdominal/thoracic) within the last 3 weeks * active gi bleeding * currently taking warfarin * allergy to heparins * history of heparin-induced thrombocytopenia (aha contraindications to fibrinolytic therapy 2005, micromedix 2007)

Keywords: anaphylaxis anaphylactoid reactions
reduction of inappropriate implantable cardioverter defibrillator (icd) therapies in primary prevention patients

Conditions: Cardiac Death

Summary: the purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (icd) therapies in patient with primary prevention icd indication.

inappropriate icd therapies still remains a major issue with respect to patient's quality of life and proarrhythmic risk. it's the aim of this study to determine efficacy of a dedicated programming concept for avoidance of inappropriate icd therapy in patients who received the icd for primary prevention of sudden cardiac death.

Eligibility criteria:
inclusion criteria: * approved indication for new icd implantation for primary prevention of sudden cardiac death * age \>=18 years * written informed consent exclusion criteria: * icd indication for secondary prevention reasons * icd indication for "electrical" disorders (i.e. long/short qt syndrome, brugada syndrome etc...) * icd change or upgrade * pregnancy * nonage * patient is already participating to another study with active therapy arm * patient will most likely not be able to participate to the routine follow ups in the study center.

Keywords: icd crtd sudden cardiac death device settings patients who received icd/crtd for primary prevention of sudden cardiac death
a study of olomorasib (ly3537982) in participants with hepatic impairment and healthy participants

Conditions: Hepatic Insufficiency; Healthy

Summary: the main purpose of this study is to assess how olomorasib gets into the blood stream and how long it takes the body to remove it when administered to participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. the safety and tolerability of olomorasib will also be evaluated. the study may last up to 6 weeks for each participant including the screening period.


Eligibility criteria:
inclusion criteria: * males and females of non-childbearing potential. * men or women with a body mass index of 18.0 to 40.0 kilograms per meter squared (kg/m²). * able to comply with all study procedures, including the 5- to 6-night stays at the cru and the follow-up phone call. * healthy participants: in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ecg, vital sign measurements, or clinical laboratory evaluations at screening and/or admission as assessed by the investigator (or designee). * participants with hepatic impairment: diagnosis of cirrhosis due to parenchymal liver disease, which is confirmed and documented by at least one of the following: medical history, physical examination, hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy. exclusion criteria: * females who are lactating or of childbearing potential. * history or presence of any of the following, deemed clinically significant by the investigator (or designee), and/or sponsor: 1. metabolic disease 2. gastrointestinal disease 3. hematological disease 4. neurological disease 5. history or presence of clinically significant cardiovascular disease. * abnormal laboratory values determined to be clinically significant by the investigator (or designee). * clinically significant abnormality, as determined by the investigator (or designee), from physical examination. * participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (day 1). * use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (day 1) and through end of trial, unless deemed acceptable by the investigator (or designee) and medical monitor. * history or presence, upon clinical evaluation, of any illness that, in the opinion of the investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.

Keywords: olomorasib hepatic impairment
impacts of superselective infarct-related artery (ira) infusion of tirofiban on myocardial reperfusion and bleeding complications in acute myocardial infarction (ami) patients

Conditions: Myocardial Infarction

Summary: superselective ira infusion of tirofiban may improve myocardial reperfusion and reduce bleeding complications in ami patients.


Eligibility criteria:
inclusion criteria: * stemi patients * chest pain for less than 12hr * plan to pci exclusion criteria: * lm lesion * stent thrombosis * cardiac shock * thrombocytopenia * allergy to asprin
safety and efficacy of saxagliptin plus insulin with or without metformin

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening * if taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening * insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component). * inadequate glycemic control (a1c of 7.5% to 11.0%, inclusive) * body mass index of 45 kg/m² or lower * fasting c-peptide level of 0.8 ng/ml or higher exclusion criteria: * symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms * history of diabetic ketoacidosis or hyperosmolar nonketotic coma * women of childbearing potential unable or unwilling to use acceptable birth control * women who are pregnant or breastfeeding * active liver disease * anemia * chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled) * use of short- or rapid-acting insulin * significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident * congestive heart failure * unstable or rapidly progressing renal disease * history of alcohol or drug abuse within the previous year * history of hemoglobinopathies * unstable major psychiatric disorders * immunocompromised status
outbreak of hemolytic uremic syndrome linked to escherichia coli of serotype o104:h4

Conditions: Hemolytic-uremic Syndrome; Escherichia Coli Infections

Summary: the hemolytic uremic syndrome (hus) in its typical form occurs after a food born infection with a shiga-toxin secreting bacteria, usually escherichia coli of the o157h7 serotype. an outbreak of bloody diarrhea followed by hus begun after a collective meal with 120 persons on june 8th, 2011 in bègles, a city of bordeaux urban area (cub). at least 9 patients, 8 adults and 1 child have been involved in this hus outbreak, e. coli of the o104:h4 serotype being demonstrated in most patients. this outbreak is remarkable by its preponderance in adults and women, its aggressiveness with multiorgan involvement , i.e. the kidneys, brain, liver, pancreas, and skin. pathophysiology, prognosis, and treatment of typical hus are poorly defined, particularly in adults who are usually not involved in typical e. coli o157h7 hus. the aim of the present study is to gain knowledge on these different aspects of the hus, including response to therapy.


Eligibility criteria:
inclusion criteria: * all patients with hus concomitant to the outbreak linked to e. coli o104:h4 exclusion criteria: * patient not willing to participate or to sign informed consent

Keywords: hemolytic-uremic syndrome shiga-toxin-producing e. coli
assessing radio-hybrid prostate specific membrane antigen (rhpsma-7.3) (18f) in healthy volunteers and subjects with prostate cancer

Conditions: Prostate Cancer

Summary: a phase 1, open-label study to assess safety, biodistribution, and internal radiation dosimetry of rhpsma-7.3 (18f) injection in healthy volunteers, and to assess safety and investigate the imaging characteristics in subjects with prostate cancer.


Eligibility criteria:
key inclusion criteria: healthy volunteers 1. male and females 21-65 years. 2. clinically acceptable medical history key exclusion criteria: healthy volunteers 1. received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months. 2. suffers from claustrophobia. 3. bilateral hip prostheses. key inclusion criteria: patients 1. male 18-80 years. 2. histologically confirmed adenocarcinoma of the prostate 3. clinically acceptable medical history 4. eastern cooperative oncology group (ecog) performance status 0-2 key exclusion criteria: patients 1. biopsy 28 days prior to enrollment. 2. extensive metastatic disease. 3. underlying disease which might confound interpretation. 4. bilateral hip prostheses. 5. high energy (\>300 kiloelectron volt (kev)) gamma-emitting radioisotope administered within five physical half-lives, or any intravenous iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug administration. 6. x-ray contrast agent (\<24 hr for intravenous agents and \<5 days for oral agents). 7. history of claustrophobia.
description of the uterine cavity in patients with recurrent miscarriages

Conditions: Recurrent Miscarriages; Habitual Abortions

Summary: to be diagnosed with recurrent miscarriages, a couple might have a child, however experiences three or more miscarriages, primarily this happens during the first trimester. these miscarriages often needs medical evacuation or a d \& c. surgery or retained tissue increases the risk of complications as infection and/or adhesions, known as asherman syndrome, which may result in subfertility. recently chronic infection in the endometrium has been proposed to contribute to the condition, as protocols including treatment with antibiotics have led to birth at term for some of these women. using the very minimal invasive office hysteroscopy, the investigators aim to describe the uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities in the endometrium and chromic infection.

the unit for recurrent pregnancy-loss at rigshospitalet treats about 300 of couples with recurrent miscarriages a year. together with the current examination program, the investigators plan to describe the uterine cavity according to abnormalities as septa, adhesions and further the condition for the endometrium regarding infection and hormone receptors. this description will include descriptive office hysteroscopy with biopsies for histologic - and immunohistochemically examinations.

Eligibility criteria:
inclusion criteria: * correctly diagnosed with recurrent miscarriages exclusion criteria: * known course of the condition

Keywords: miscarriage uterine abnormalities chronic infection