Kornimate/medical-research-clean huggingface dataset:
an open label study of chronic polyethyleneglycol3350 use in constipated patients

Conditions: Constipation

Summary: to evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.


Eligibility criteria:
inclusion criteria: * inclusion criteria: * male or female outpatients at least 18 years of age * constipated according to rome i criteria * if female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study * are otherwise in good health, as judged by a physical examination * in the investigator's judgment, patient is mentally competent to sign an instrument of informed consent exclusion criteria: * patients with heme positive stool at screening. patients with heme positive stool that can be attributed to hemorrhoids or anal fissures are eligible for inclusion. * patients with hypo- or hyperthyroidism as determined by history, or screening tsh results. * patients with known or suspected perforation or obstruction. * history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy. * patients with a known history of organic cause for their constipation. * patients meeting the rome definition of irritable bowel syndrome * patients currently taking any of the following medications that are known to effect bowel habits: * antidiarrheals * antacids containing magnesium or aluminum salts * anticholinergics * antispasmodic agents * erythromycin and other macrolides * octreotide * lotronex, zofran, or other 5-ht3 antagonists * zelnorm, or other 5-ht4 agonists * opiods/narcotic analgesics * prokinetics * serotonin re-uptake inhibitors or tricyclic antidepressants * calcium antagonists * patients who are breastfeeding, pregnant, or intend to become pregnant during the study. * female patients of childbearing potential who refuse a pregnancy test. * patients with a known allergy to polyethyleneglycol. * patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures. * patients who, within the past 30 days have participated in an investigational clinical study
to evaluate the performance of hepasphere transarterial chemoembolization combined with hepatic arterial infusion chemotherapy on unresectable colorectal liver metastases

Conditions: Colorectal Liver Metastases (CRCLM)

Summary: both drug-eluting bead transarterial chemoembolization (deb-tace) and hepatic arterial infusion chemotherapy (haic) are recommended for unresectable colorectal liver metastases (crlm) treatment. however, the combined application of deb-tace and haic is not widely accepted. the aim of this single-center retrospective study was to evaluate the efficacy and safety of irinotecan-eluting hepasphere chemoembolization combined with haic for unresectable crlm


Eligibility criteria:
inclusion criteria: * age: ≥18 years old * gender: no limitation * histologically or cytologically documented advanced colorectal carcinoma with unresectable liver metastasis (existence of extrahepatic metastasis is acceptable) * subjects must have at least one measurable lesion per recist v1.1 * patients only received treatment with hepasphere combined with hepatocellular arterial infusion chemotherapy (haic) as interventional therapy during the observation period * child-pugh: a-b * ecog: 0-2. exclusion criteria: * other malignant tumors in the past 5 years * drug-eluting beads from other manufacturers were used during deb-tace * deb-tace combined with haic was used as postoperative adjuvant therapy * pre- or post-surgery relevant examination results were unavailable * imaging information for effectiveness evaluation was unavailable * follow-up failure due to patient information errors, loss, refusal, etc
pre- versus post-operative srs for resectable brain metastases

Conditions: Brain Metastases

Summary: the purpose of this study is to determine if performing radiotherapy (srs) prior to surgery results in better treatment outcomes than performing surgery before radiotherapy for patients with brain metastases. brain metastases occur when cancer cells from a primary cancer (e.g. lung, breast, colon) travel through the bloodstream and spread (metastasize) to the brain. as these new tumors grow they apply pressure and change how healthy brain tissue works. this can lead to a loss of brain function and worsening quality of life. treatments for patients whose cancer has spread to the brain is often surgery, radiation therapy (radiotherapy) or a combination of both. surgery is one the main treatments for brain tumors. to remove the tumor, a neurosurgeon makes an opening in the skull and attempts to the remove the entire tumor. if the tumor is too close to important brain tissue, the surgeon may attempt to remove part of the tumor. removal of the tumor from the brain tissue is called resection. the complete or partial removal of tumor helps to relieve symptoms by reducing pressure on healthy tissues and reduces the amount of tumor that needs to be treated by radiotherapy. one type of radiotherapy used to treat brain metastases is stereotactic radiosurgery (srs). srs uses many focused radiation beams to treat tumors within the brain. unlike surgery, there is no incision or cut being made. instead, srs uses an accurate map of your brain to deliver a precise beam of radiation to the tumors. the radiation damages the tumor cells forcing them to shrink and die off. the focused radiation beams also limit damage to healthy brain tissue minimizing side effects. surgery followed by radiotherapy is a standard treatment for brain metastases. however, there are still risks associated with the combination of treatments. this study plans to investigate whether performing surgery prior to srs results in improved quality of life and decreased side effects.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * pathologically-proven primary malignancy * ecog 0-2 * ability to complete neurocognitive testing without assistance from family or friends. * previous srs to lesions other than the one being resected is allowed * patients of childbearing / reproductive potential must have a negative urine or serum pregnancy test ≤7 days before enrollment * participants capable of giving informed consent, or if appropriate participants having an acceptable individual capable of giving consent exclusion criteria: * patients who have received prior wbrt, or srs to the lesion being resected at time of study accrual * patients unable to undergo mri scan (e.g. pacemaker) * leptomeningeal disease * germ cell tumor, small cell lung cancer or hematological primary malignancy

Keywords: neurosurgery stereotactic radiosurgery
one-visit multi-site intradermal rabies vaccination - dose finding

Conditions: Rabies Pre-exposure Prophylaxis

Summary: to determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * good health according to the investigator * willingness and ability to adhere to the study regimen * able to give informed consent exclusion criteria: * known or suspected previous vaccination against rabies * known or suspected allergy against any of the vaccine components * history of unusual or severe reactions to any previous vaccination * immunocompromized state due to illness or medication * administration of plasma or blood products three months prior to inclusion in the study * (hydroxy)chloroquine or mefloquine use * history of any neurological disorder including epilepsy or febrile seizures * pregnancy or breastfeeding * any current infectious disease other than seasonal cold * bleeding disorders or use of anticoagulants
efficacy and safety for cimicifuga/hypericum product

Conditions: Perimenopausal Disorder

Summary: climacteric complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time.

2 herbal extracts used in general alone will be running together for the best climacteric women on quality of life. the investigators will test the mixture already in the market as gynoplus and remifeminplus, but as each extract has its own particularities the investigators will try cim/hip as a unique formulation versus clifemin® as control and aplause® as comparator. this protocol was performed for the best of our volunteers.

Eligibility criteria:
inclusion criteria: * climacteric women 45-60 years old - pre and postmenopausal * climacteric complains for at least 3 months * no treatments for at least 2 months * mrs score 0.4 or more for at least 3 items * hamilton's scale score from 15-23 exclusion criteria: * hormon therapy or any other for the last 3 months * antidepressive and hypnotic medication for the last 3 months * sever illness (cardiac, hepatic, renal, digestive or metabolic) or tsh alteration * history for allergies and hipersensitivity to any component of the drugs formulations * no knowledge for reading or writing * suicide risk

Keywords: climacteric depression herbal treatment
efficacy and safety of qge031 compared with placebo in patients aged 18-75 years with asthma

Conditions: Asthma

Summary: this study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of qge031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. however, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the phase ii study cqge031b2201 (nct01716754). planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).


Eligibility criteria:
key inclusion criteria: * a diagnosis of allergic asthma, uncontrolled on current medication. * history of at least 2 asthma exacerbations during the last 1 year * forced expiratory volume in one second (fev1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator. key exclusion criteria: * use of tobacco products within the previous 6 months (social occasional smokers may be included). * recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Keywords: asthma
transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy

Conditions: Apical Hypertrophic Cardiomyopathy

Summary: the primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart myectomy for the treatment of apical hypertrophic cardiomyopathy. this is a prospective, single-arm, single-center study.


Eligibility criteria:
inclusion criteria: 1. patients who were diagnosed as apical hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm. 2. patients with heart function of new york heart association ≥ class ii. 3. patients with drug-refractory symptoms or intolerable to pharmaceutical therapies. 4. patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form. exclusion criteria: 1. patients who were pregnant. 2. patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-chamber cardiac surgery. 3. patients who had severe heart failure with left ventricle ejection fraction \< 40%. 4. patients whose estimated life expectancy \< 12 months. 5. patient who were non-compliant. 6. patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.

Keywords: apical hypertrophic cardiomyopathy septal myectomy transapical beating-heart septal myectomy minimally invasive midventricular obstruction and cavity obliteration
endostapler hemostasis study

Conditions: Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale

Summary: the goal of this prospective, multi-center, post-market study is to measure aeon™ endostapler performance with the easy/thick mode feature for laparoscopic bariatric surgery against the echelon flex™ powered stapler system from ethicon. stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. the study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (lsg). the lsg procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. relevant data will be collected using the data collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.


Eligibility criteria:
inclusion criteria: * patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form * informed consent for study obtained and signed from each subject exclusion criteria: * planned open surgical approach * prior bariatric operation (i.e. revisional bariatric surgery) * use of staple line reinforcement material (buttress) * patients taking anticoagulants * patients under the age of 18 on the date of the surgery
cryoapplication versus anti-vegf before diabetic vitrectomy

Conditions: Proliferative Diabetic Retinopathy; Vitreous Hemorrhage; Tractional Retinal Detachment

Summary: pars-plana vitrectomy (ppv) is the cornerstone of surgical treatment for eyes with complicated proliferative diabetic retinopathy. anti-vegf intravitreal injection before ppv has shown a good effect on surgical outcomes. however, many patients present with co-morbidities that contraindicate the usage of anti-vegf in the pre-operative period. thus, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy may be a good alternative. the investigators present herein a comparative study between peripheral retinal cryoapplication and anti-vegf before vitrectomy for complicated proliferative diabetic retinopathy.

pars-plana vitrectomy (ppv) is the cornerstone of surgical treatment of complicated proliferative diabetic retinopathy allowing the removal of vitreous opacity and releasing tractions from the retina. surgical outcomes, however, are variable depending on a large array of pre, per, and post-operative conditions. the preoperative anti-vegf intravitreal injection has shown a good effect on surgical outcomes in patients with vitreous hemorrhage or tractional retinal detachment. however, a great number of patients present with co-morbidities that contraindicate the usage of anti-vegf in the pre-operative period. thus, an alternative to this adjunctive therapy is worth investigating. in another hand, cryoapplication, an old therapeutic tool for proliferative diabetic retinopathy had been used in patients with non-clear ocular media with vitreous hemorrhage. the investigators present herein a comparative study between peripheral retinal cryoapplication and anti-vegf before vitrectomy for complicated proliferative diabetic retinopathy.

Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes mellitus * vitreous or retro-hyaloidal hemorrhage and/or tractional retinal detachment threatening or involving the macula * no or less than 1000 impacts of preoperative retinal photocoagulation and/or iris rubeosis * only one eye per participant exclusion criteria: * negative light perception * previous vitrectomy * contraindication to anti-vegf therapy or retinal cryoapplication * associated rhegmatogenous retinal detachment

Keywords: retinal cryoapplication anti-vegf vitrectomy
prasugrel and ticagrelor in st-segment elevation myocardial infarction

Conditions: ST-Segment Elevation Myocardial Infarction

Summary: to compare efficacy and safety of prasugrel and ticagrelor in patients with st-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

prasugrel and ticagrelor are recommended in patients with st-segment elevation myocardial infarction (stemi) undergoing primary percutaneous coronary intervention (pci). both prasugrel and ticagrelor show more rapid and potent antiplatelet effect compared with clopidogrel. however, previous report comparing the efficacy and safety of prasugrel and ticagrelor in patients with stemi of east asian ethnicity is lacking. therefore, the aim of this study is to compare the antiplatelet efficacy and safety using laboratory platelet function tests and clinical outcomes in patients with stemi treated with either prasugrel or ticagrelor.

Eligibility criteria:
inclusion criteria: * patients with st-segment elevation myocardial infarction * undergoing primary percutaneous coronary intervention * aged between 20 and 80 years exclusion criteria: * previous administration of any antagonist of the platelet adenosine diphosphate (adp) p2y12 receptor (clopidogrel, prasugrel or ticagrelor) * history of stroke or transient ischemic attack * previous gastrointestinal bleeding within 6 months, bleeding diathesis, platelet count \< 100,000/mm3 or hemoglobin \< 10 g/dl * chronic oral anticoagulation treatment * contraindication to the antiplatelet treatment * severe renal insufficiency (serum creatine\>2.5 mg/dl) * severe hepatic dysfunction (serum liver enzyme or bilirubin\>3 times normal limit) * sever chronic obstructive pulmonary disease (copd) or bradycardia * body weight \< 50 kg

Keywords: korea platelet inhibition prasugrel ticagrelor st-segment elevation myocardial infarction
the effect of flexible thoracolumbar brace on scoliosis in cerebral palsy

Conditions: Cerebral Palsy

Summary: the effect of flexible thoracolumbar brace on scoliosis in cerebral palsy, prospective, randomized, open-label trial


Eligibility criteria:
inclusion criteria: * gmfcs level iii, iv, v of the cerebral palsy * 20-45 degree of cobb's angle exclusion criteria: * less than 20 degree or more than 45 degree of cobb's angle * neuromuscular disease including congenital myopathy, spinal muscular atrophy, muscular dystrophy and poliomyelitis * acute lumbar pain * fixed scoliosis

Keywords: cerebral palsy brace scoliosis
escitalopram trial for irritable bowel syndrome (ibs) patients with panic disorder

Conditions: Irritable Bowel Syndrome; Panic Disorder

Summary: this study will be executed according to a randomized double-blind placebo-controlled trial with two parallel groups, treated over the period of 6 months with escitalopram or placebo. hypotheses: escitalopram is more effective than placebo in the control of gastrointestinal symptoms, in irritable bowel syndrome (ibs) patients with panic disorder. escitalopram is more effective than placebo in the control of psychiatric symptoms, in ibs patients with panic disorder.


Eligibility criteria:
inclusion criteria: 1. ibs will be diagnosed according to the rome iii criteria by a gastroenterologist. 2. subtyping of ibs patients will be performed using the following classification according to the rome iii criteria: ibs with constipation (ibs-c), ibs with diarrhea (ibs-d), mixed ibs (ibs-m) or not subtyped ibs (ibs-u). 3. based on the medical history and previous examination, no other causes for the abdominal complaints can be defined. 4. a panic disorder will be diagnosed based on dsm iv criteria by a psychiatrist. 5. age above 18 years and under 70 years. 6. given written informed consent. exclusion criteria: 1. inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, duspatalin, metoclopramide, domperidon, erytromycin), serotonin metabolism (like carbidopa, food supplementation), or epigenetics (like valproic acid), or containing perforated st. john's wort (hypericum perforatum). in general this medication can be stopped without problems. however, this can increase symptoms. when the increase in symptoms will be to high, this medication will be restarted and the patient excluded form the study. 2. administration of investigational drugs in the 180 days prior to the study. 3. major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator), epilepsy or (hypo)manic episodes. 4. pregnancy and lactation. 5. excessive alcohol consumption (\> 20 alcoholic consumptions per week) or drug abuse. 6. co-intervention or other treatment for ibs or anxiety, with the exception of initial co-intervention with benzodiazepines (alprazolam) contrasting side effects due to ssri's during the first two weeks of dose elevation. 7. known prolongation of qt-interval or long-qt-syndrome, other cardiac disease, or use of medication with known prolongation of qt-interval.

Keywords: randomized controlled trial escitalopram irritable bowel syndrome panic disorder
is the amh intrafollicular level a predictor of the ploidy status of the blastocyst?

Conditions: Infertility, Female; Infertility

Summary: to investigate, whether on the day of egg retrieval, after ovarian stimulation for icsi (intracytoplasmic sperm injection), there is a correlation between the intrafollicular amh (anti-müllerian hormone) levels and the ploidy status of the blastocyst.

in clinical practice, amh is used as a diagnostic and/or prognostic marker in women in association with ovulation induction and in various pathophysiological conditions. this study looks to investigate if the hormonal environment that surrounds an oocyte has an impact on the ploidy status of the blastocyst. nowadays, using ngs (next generation sequencing) platform for analysis of 23 pairs of chromosomes for preimplantation genetic testing on blastocysts, the ploidy status of the embryo is more adequately assessed. furthermore, embryo culture to blastocyst will provide further information about embryo quality and possibilities of implantation. to have complete information between the serum hormones, follicular hormones, embryo development and ploidy will provide to clinicians, embryologist and patients further information on embryo selection and adequate ovarian stimulation protocols. the database will be exported from the clinical information manager, vrepro, to a table in excel format through a database-based query system. the exported data will be duly codified to protect the clinical and personal information of the participants. prior to the statistical study, an exploratory data analysis will be carried out to review the quality of the information extracted.

Eligibility criteria:
inclusion criteria: * at least one follicle from each ovary at day of trigger * age from 18 to 40 years old * normal menstrual cycle of 25-35 days * poor, normal and high response will be included * first follicle punctured from each ovary will be consider for inclusion: if the coc (cumulus oocyte complex) is present in clear ff (follicular fluid), the ff will be collected separately for further analysis and the oocyte included in the study exclusion criteria: * very hematic follicular fluid * if the coc is not found in the follicular fluid * azoospermia * known chromosomal abnormalities * severe oat (oligoasthenoteratozoospermia)

Keywords: estradiol fsh lh amh ploidy chromosomes infertility progesterone inhibin b