Kornimate/medical-research-clean huggingface dataset:
allogeneic hmsc injection in patients with hypoplastic left heart syndrome

Conditions: Hypoplastic Left Heart Syndrome

Summary: this study is intended to evaluate the safety and feasibility of intramyocardial injection of allogeneic mesenchymal cells during the bi-directional cavopulmonary anastomosis (bdcpa) surgery for hypoplastic left heart syndrome (hlhs) pediatric patients.

this is an open label study, intended as a safety and efficacy assessment prior to a full comparator study. in this phase i study, cells administered will be delivered in 6-10 intramyocardial injections that will be tested in 20 patients and 10 patients will be controls with a total of 30 hlhs patients. a total of 30 patients with hlhs will be enrolled in a staged enrollment process. in this open-labeled study, a maximum of 20 patients will eventually receive intramyocardial injection of the allogeneic mesenchymal stem cells and 10 control patients with no cell injection. the enrollment of the patients will occur in two stages groups: group a and group b. in group a, 10 consecutive hlhs patients will be initially enrolled in the allogenic mscs treatment arm to determine feasibility and safety. after 6 months of the last enrolled patient in group a, all group a patients will be assessed in order to determine whether it is feasible and safe, including the harvesting, processing, and administering of the allogeneic mscs. thereafter, group b will start enrolling a total of 20 hlhs patients which will be randomized to the treatment and control arms in a 1:1 ratio, respectively, in order to have 10 allogeneic mscs-treated patient and 10 control patients. at the completion of this phase i clinical study, the total enrolled cohort will be 20 patients treated with allogeneic mscs and 10 patients in the control arm.

Eligibility criteria:
inclusion criteria: * subjects with hypoplastic left heart syndrome (all types) requiring bdcpa surgery. exclusion criteria: * have hlhs and restrictive or intact atrial septum. * be undergoing the norwood procedure that do not have hlhs. * have significant coronary artery sinusoids. * require mechanical circulatory support prior to surgery. * have an underlying evidence of arrhythmia requiring anti-arrhythmia therapy. * parent or guardian unwilling or unable to comply with necessary follow-up(s) * be serum positive for hiv, hepatitis bsag (b surface antigen) or viremic hepatitis c. * be unsuitable for inclusion in the study, in the opinion of the investigator. * need for concomitant surgery for aortic coarctation or tricuspid valve repair.

Keywords: pediatrics hlhs
study to assess the efficacy and safety of the beta-3 agonist mirabegron (ym178) in patients with symptoms of overactive bladder

Conditions: Urinary Bladder, Overactive

Summary: the study is intended to test efficacy, safety and tolerability of two doses of mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.


Eligibility criteria:
inclusion criteria: * subject is willing and able to complete the micturition diary and questionnaires correctly * subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months * subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period * subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period exclusion criteria: * subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control * subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor * subject has an indwelling catheter or practices intermittent self-catheterization * subject has diabetic neuropathy * subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs * subject receives non-drug treatment including electro-stimulation therapy * subject has severe hypertension * subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, ym178, other beta-adrenoreceptor (ß-ar) agonists, or lactose or any of the other inactive ingredients * subject has been treated with any investigational drug or device within 30 days (90 days in the uk) * subject had an average total daily urine volume \> 3000 ml as recorded in the 3-day micturition diary period * subject has serum creatinine \>150 umol/l, aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \> 2x upper limit of normal range (uln), or gamma glutamyl transferase (γ-gt) \> 3x uln * subject has a clinically significant abnormal electrocardiogram (ecg)

Keywords: micturition urinary incontinence urinary urge incontinence overactive bladder (oab) urgency ym178 frequency
pioglitazone protects diabetes mellitus (dm) patients against re-infarction (ppar study)

Conditions: Diabetes Mellitus; Myocardial Infarction

Summary: to evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (mi) in patients with dm and old myocardial infarction

type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in coronary artery. so we designed a prospective randomized multi-center trial named the pioglitazone could reduce the recurrence of myocardial infarction in patients with dm and myocardial infarction(ppar study) to evaluate whether pioglitazone could reduce the recurrence of myocardial infarction in patients with dm(hba1c\<6.5%) and myocardial infarction. more than 100 hospitals will participate in the ppar study. patients with dm who have history of prior myocardial infarction are randomly allocated to receive pioglitazone or (1)instructs weight reduction, appropriate diet, regular exercise and/or (2)prescribes sulfonylurea agents. the number of patients to be recruited is 720 and this study will continue at least 2 years until 7 year or the end of the study. the primary end-points are (1) cardiovascular mortality and (2) hospitalization for cardiovascular events. effects in suppression of new diabetes development also will be evaluated. we should recognize dm as important therapeutic target to decrease recurrence of cardiovascular events. ppar study, a large scale multi-center trial in japan, will provide us new evidence how to treat dm patients with prior myocardial infarction.

Eligibility criteria:
inclusion criteria: 1. diabetes mellitus (fasting plasma glucose levels of\>126 mg/dl, or 2-hour 75g oral glucose tolerance test (ogtt) value of \>200 mg/dl, and hba1c levels of\<6.5% (47.5 ifcc)) 2. history of myocardial infarction 3. age between 20-79 years old exclusion criteria: 1. acute mi occurring within the last 7 days 2. new york heart association (nyha) symptoms of no fewer ii or with left ventricular ejection fraction of not more than 40% 3. suspected type i dm 4. scheduled coronary angioplasty or history of coronary artery bypass graft surgery 5. serious liver or kidney damage 6. history of allergy or drug hypersensitivity 7. arteriosclerosis obliterans with fontaine stage iii or worse 8. inability to understand and/or comply with study medications, procedures and/or follow-up or any conditions that may render the patient unable to complete the study in the opinion of the investigator.

Keywords: diabetes mellitus myocardial infarction pioglitazone
endometrial carcinoma: comparison of surgical approaches (laparoscopy vs laparotomy)

Conditions: Endometrial Carcinoma

Summary: since the publication of the lap2 study, a prospective randomized trial, laparoscopy has been considered the gold standard for treating patients with early-stage endometrial cancer (ec). however, no prospective randomized trials have been published reporting comparable data in patients with ec at high risk of recurrence (advanced stages or non-endometrioid histology). nonetheless, some retrospective studies and a systematic review of the literature have demonstrated that minimally invasive surgery achieves better perioperative outcomes than laparotomy without compromising survival in patients with ec at high risk of recurrence. the aim of this multicenter retrospective observational study is to evaluate the safety of minimally invasive surgery in treating ec at low, intermediate, and high risk of recurrence according to the esmo-esgo classification, based on cases treated in hospitals within the emilia romagna region. specifically, we aim to assess the effects of a minimally invasive surgical approach compared to laparotomy in terms of: 1. perioperative and postoperative complications: including the need for transfusions during and/or after surgery, duration of surgery, fever exceeding 38°c for more than 48 hours, and length of hospitalization. 2. long-term oncological outcomes: including overall survival, disease-free survival, recurrence rates, recurrence sites, and time to recurrence. this comparison will include patients treated for both endometrioid and non-endometrioid ec to provide a comprehensive evaluation of minimally invasive surgery versus laparotomy. by delineating the safety and efficacy of laparoscopic techniques, particularly for higher-risk patients, this research could refine surgical standards and guide clinical decision-making, emphasizing evidence-based practices for tailored patient care. the study also aligns with broader efforts to optimize cancer management in regional and national healthcare settings.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of endometrial cancer who underwent surgical treatment between 2000 and 2020 exclusion criteria: * patients with other types of tumors (e.g., cervical or ovarian cancer). * patients for whom surgical and/or post-operative data are unavailable. * patients with a follow-up period of less than 6 months. * patients who refuse to provide informed consent.

Keywords: endometrial cancer laparoscopy laparotomy minimally invasive surgery risk of recurrence surgical complications
acupuncture for functional dyspepsia: a functional magnetic resonance imaging (fmri) study

Conditions: Functional Dyspepsia

Summary: he-mu-point combination（st36 and cv12） is one of the most commonly used acupoints combination with synergistic effect for functional dyspepsia(fd). the investigators design the trial to identify the efficacy and explore the central integrated mechanism of puncturing at he-mu-point combination on fd with functional magnetic resonance imaging (fmri).

105 participants with functional dyspepsia will be allocated into three groups: low-he point group, mu point group and he-mu-point combination group.every participant will receive 20 sessions of manual acupuncture treatment during 4 weeks. clinical evaluations will be assessed three times, as measured after randomization, 10 and 20 sessions of treatment.the fmri scans will be conducted twice, after randomization and treatment completion.

Eligibility criteria:
inclusion criteria: 1. right handed，age between 18 and 45 years old, college degree or above; 2. match the rome iii criteria on fd; 3. no local organic disease by gastroscope examination; 4. before entering the study, without taking any prokinetic agents at least 15days and participating in other clinical study; 5. signing an informed consent in writing by the participant or the immediate family member. exclusion criteria: 1. consciousness, cannot express subjective symptoms and psychiatric participants; 2. participants with advanced cancer or other serious wasting diseases, easy to be infected and bleeding; 3. complicating with severe cardiovascular, hepatic,nephritic,digestive, hematopoietic system diseases; 4. impregnate or lactation female; 5. severe depression and anxiety symptoms; 6. female with serious dysmenorrhea; 7. obvious headache, migraine, history of head injury.

Keywords: acupuncture functional dyspepsia functional magnetic resonance imaging (fmri)
laparoscopic totally extraperitoneal inguinal hernia repair with fibrin glue versus tack mesh fixation

Conditions: Inguinal Hernia

Summary: the quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. as many as 10% of the patients report increased pain following surgery. therefore, the current study aimed to assess the quality-of-life for patients with post-inguinal hernia repair by mesh fixation versus fibrin glue.

a wide variety of mesh fixation techniques are available for laparoscopic hernia repair. these can be broadly divided into mechanical and nonmechanical methods. mechanical methods include sutures and tissue penetrating fixation devices like tackers. nonmechanical techniques include self-gripping meshes and tissue adhesives (glues). mechanical methods are hypothesized to cause more postoperative pain and increased risk of seroma formation, hematoma formation, and osteitis pubis due to tissue trauma and also have increased risk of chronic pain due to nerve entrapment. on the other hand, nonmechanical methods do not have these disadvantages. furthermore, the quality of life after hernia surgery like chronic pain and discomfort has frequently been reported with a frequency varying from 0 to 53%. as many as 10% of the patients report increased pain following surgery. such a chronic pain is often developed due to the use of open inguinal technique along with heavy weight mesh with mechanical fixation techniques, presence of severe pain before surgery and young age. to the best of our knowledge, there are lacking evidence assessing the impact of mesh fixation using fibrin glue upon the quality of life of patients. therefore, the current study aimed to assess the quality-of-life for patients who had post inguinal hernia repair by mesh fixation versus fibrin glue.

Eligibility criteria:
inclusion criteria: 1. age group of 18-60 years. 2. all types of inguinal hernias. 3. didn't undergo pervious hernia repair surgery. exclusion criteria: 1. patients who are unfit for general anesthesia or with american society of anesthesiologists (asa) grade 3 and above. 2. presence of other groin or abdominal hernias. 3. patients with complicated hernias such as irreducibility, obstruction, and incarceration. 4. patients with obesity or morbid obesity bmi \>= 35.
a study of mabthera/rituxan (rituximab) in combination with fludarabine and cyclophosphamide as primary therapy in elderly patients with chronic lymphocytic leukemia

Conditions: Lymphocytic Leukemia, Chronic

Summary: this single arm, open-label study will assess the safety and efficacy of low dose fludarabine and cyclophosphamide in combination with standard dose mabthera/rituxan (rituximab) as primary therapy in elderly patients (\>/= 65 years) with chronic lymphocytic leukemia. patients will receive six 28-day cycles of treatment with mabthera/rituxan (375 mg/m2 intravenously \[iv\] day 0 of cycle 1, 500 mg/m2 iv day 1 of cycles 2-6), fludarabine (12.5 mg/m2/d iv days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv days 1-3, cycles 1-6). anticipated time on study treatment is 6 months, with a 30-month follow-up period.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 65 years of age * previously untreated b-cell chronic lymphocytic leukemia (cll) * binet stage c or active binet stage a and b disease exclusion criteria: * prior treatment for cll * cll with transformation (richter's syndrome) * suspected or known central nervous system (cns) involvement of cll * impaired renal or hepatic function * human immunodeficiency virus (hiv) positivity, active hepatitis b/c or hepatitis b virus (hbv) surface antigen positive, or any active or uncontrolled infections * patients with anti-hbv core antibodies (past infection with hbv) but who are negative for hepatitis b virus surface antigen (hbvsag) (either anti-hbs ab positive or negative) and are positive for hbv- deoxyribonucleic acid (dna) by polymerase chain reaction (pcr) analysis * concomitant diseases requiring chronic steroid administration * active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast or prostate carcinoma) * eastern cooperative oncology group (ecog) performance status \>/= 3
safety and biomarker response to (+)-epicatechin in becker muscular dystrophy

Conditions: Becker Muscular Dystrophy

Summary: this is a phase 1, open-label, dose escalation study aimed at evaluating the safety, early efficacy and potential biomarkers of (+)-epicatechin in patients with becker or becker-like muscular dystrophy (bmd).

the safety and tolerability of three escalating doses of (+)-epicatechin will be assessed and early effectiveness measured by changes in plasma biomarkers, tissue biomarkers from muscle biopsies, cardiac imaging, and on clinical function assessments of participants' muscle strength. all patients will receive oral (+)-epicatechin for a total duration of approximately 52 weeks. three doses of (+)-epicatechin will be tested in sequential 2 month periods with total daily doses of 75, 150, and 225 mg/day (+)-epicatechin. doses will be escalated every 2 months, if tolerated, for the first 6 months of the study. participants will then continue to receive the highest does they tolerated for an additional 6 months.

Eligibility criteria:
inclusion criteria: 1. participant must be ≥16 to \<60 years of age. 2. genotype confirmation showing a mutation of the dystrophin gene. 3. ambulation - participants must show a history of ambulation past the age of 16 years, with continued ambulation thereafter. 4. if on glucocorticoid treatment in the last 12 months, participants must be on a stable dose at screening. participants cannot start steroids during the study. exclusion criteria: 1. a diagnosis of other neurological diseases or presence of relevant somatic disorders that are not related to becker muscular dystrophy. 2. participants with a history of migraine headaches requiring medical attention and active treatment within the past 6 months. 3. participants with allergies to chocolate or cocoa. 4. surgery or orthopedic injury that might affect muscle strength or function within 3 months before study entry or planned surgery at any time during the study. 5. presence of a concomitant neurologic disease (e.g., parkinson's disease) that could negatively impact mobility or balance. 6. symptomatic heart failure (new york heart association class iii or iv) or known left ventricular ejection fraction \<40% by echocardiogram. 7. presence of documented intrinsic lung disease (e.g., chronic obstructive pulmonary disease, pulmonary fibrosis). 8. evidence of current liver disease or impairment. 9. inadequate renal function. 10. platelet count, wbc count, and hemoglobin at screening \<lower limit of normal (lln). 11. surgery or orthopedic injury that might affect muscle strength or function within 3 months before study entry or planned surgery at any time during the study
paricalcitol compared to maxacalcitol in chronic kidney disease patients with secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism; Hemodialysis

Summary: this study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.


Eligibility criteria:
inclusion criteria: * chronic kidney disease (ckd) patients with ipth \>=300 pg/ml, adjusted calcium \>=8.4 to \<10.2 mg/dl, and phosphorus \<=6.5 mg/dl * patients receiving dialysis 3 times weekly for at least 3 months before informed consent was obtained and scheduled to receive the same hemodialysis during the study period * patients using dialysate with constant concentration of calcium for 4 weeks before informed consent was obtained and receiving phosphate binder with constant dose regimen for 2 weeks before informed consent was obtained exclusion criteria: * patients taking drugs that affect ipth, calcium, or bone metabolism * patients with a history of allergic reaction or significant sensitivity to vitamin d * patients who received parathyroidectomy or ethanol infusion within 1 year before informed consent was obtained * patients with malignancy or with clinically significant hepatic disease (liver function tests more than 3 times the upper limit of normal) or with refractory hepatic disease * patients with cardiovascular disease designated as new york heart association class iii or iv or with any of the following cardiovascular or cerebrovascular diseases within 6 months before informed consent was obtained: * acute coronary syndrome (myocardial infarction or unstable angina) or acute cerebral vascular disease (cerebral infarction or cerebral hemorrhage) * coronary arterial revascularization (such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty) * cerebral arterial revascularization (such as cerebral aneurysm clipping, cerebral aneurysm embolization, carotid artery endarterectomy) * arteriosclerosis obliterans with rest pain (fontaine classification iii or more severe) * patients with severe hypertension (defined as mean resting blood pressure taken with the patient in a supine position before dialysis and at 6 dialyses sessions before informed consent was obtained: systolic \>= 180 mmhg and diastolic \>= 110 mmhg) * patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin \>=8% for 3 months before informed consent was obtained) * patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained * patients who require chronic use of cytochrome p450 (cyp3a) inhibitors or inducers * patients who are taking products that contain aluminum 2 weeks before informed consent was obtained * patients who have taken paricalcitol in the past

Keywords: secondary hyperparathyroidism hemodialysis paricalcitol maxacalcitol