Kornimate/medical-research-clean huggingface dataset:
safety, pharmacokinetics, and pharmacodynamics of oral azacitidine in subjects with myelodysplastic syndromes, chronic myelomonocytic leukemia and acute myelogenous leukemia

Conditions: Myelodysplastic Syndromes (MDS); Chronic Myelomonocytic Leukemia (CMML); Acute Myelogenous Leukemia (AML)

Summary: the purpose of this study is to determine whether a tablet form of azacitidine that taken by mouth is safe. this phase i study will also look at different doses and different treatment schedules in order to better understand the effects (positive and negative) of oral azacitidine on the body and on the disease mds, aml and cmml.

optional extension phase (oep) to the aza ph us 2007 cl 005 study which allows subjects who continue to receive oral azacitidine and have stable disease or are demonstrating clinical benefit as assessed by the investigator, and have consented to participate, may enter the oep of this study (at their current doses) at the start of their next cycle. subjects who are entering the oep should be discontinued from part 1 or part 2 protocol prescribed therapy in the aza ph us 2007 cl 005 study. subjects may continue to receive oral azacitidine in the oep until they meet the criteria for study discontinuation or oral azacitidine becomes commercially available. subjects discontinuing from the oep will have an oep discontinuation visit 28 days after the last dose of study drug or at study withdrawal. primary objective of oep is to evaluate long term safety of oral azacitidine.

Eligibility criteria:
inclusion criteria: * 18 years or older. * diagnosis of low or int-1 risk mds * low platelet count, and/or low hemoglobin, and/or rbc transfusion-dependent and/or platelet transfusion-dependent * ecog performance status 0-2 * standard safety inclusion for serum creatinine, ast, alt, bilirubin. * serum bicarbonate greater than or equal to 20 meq/l. * use of acceptable birth control. * signed, written informed consent. exclusion criteria: * diagnosis of acute pml. * previous or concurrent malignancy. * prior treatment with azacitidine or other demethylating agents. * treatment with any anticancer therapy or investigational drugs within 21 days. * hypersensitivity to azacitidine or mannitol. * presence of gi disease. * active, uncontrolled infection. * known human immunodeficiency virus (hiv) or hepatitis c, or known active viral hepatitis b. * breastfeeding or pregnant females; * presence of serious illness, medical condition, or other medical history which would be likely to interfere with a subject's participation in the study or with the interpretation of the results. * current congestive heart failure (ny heart association class iii-iv), unstable angina or angina requiring surgical or medical intervention within 6 months, myocardial infarct within 6 months, or uncontrolled cardiac arrhythmia.

Keywords: myelodysplastic syndromes mds acute myelogenous leukemia aml chronic myelomonocytic leukemia cmml
a descriptive exploration of flourishing through kink

Conditions: Impact on Psychological Well-being of Involvement in Kink Behaviors

Summary: the study examines the experiences of people who have engaged in alternative sexual behaviors, like kink or bdsm, and whether there have been any positive effects on well-being

the study design is an observational, cross-sectional mixed methods study with data collected anonymously online via a computer-assisted survey through qualtrics. subjects will be recruited through nonprobability snowball sampling

Eligibility criteria:
inclusion criteria: - 1. age of majority in the legal jurisdiction (geographic location) where the survey is taken (usually age 18) 2. self-reported involvement in kink behaviors 3. self-reported english-language proficiency sufficient to understand the study instrument. 4. answer correctly a series of questions to screen for bots and fraudulent responses exclusion criteria: * 1. report no involvement in kink activities or behaviors 2. answer incorrectly three or more questions for bot detection and fraudulent responses, 3+ out of 4 bot detection questions. 3. clearly fraudulent use of the internet survey, such as: evidence of non-human data entry via an internet "bot", duplicative or prank data entry that entails contradictory or clearly fraudulent data. 4. any condition that, in the professional judgment of the principal investigator, should exclude an individual from participation in the study.

Keywords: kink, bdsm, flourishing, trauma recovery
a study of the effectiveness of additional risk minimization measures related to arava® (leflunomide) in saudi arabia

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

Summary: the main objective of this post-authorization safety study is to assess healthcare professionals' awareness, knowledge, and behavior related to receipt and reading of the direct healthcare professional communication and educational materials for arava® (leflunomide) and of the additional risk minimization measures.


Eligibility criteria:
inclusion criteria: * healthcare professionals working only in saudi arabia * for prescribers: orthopedics, internists, family physicians, general practitioners, dermatologists, obstetricians/gynecologists, immunologists, and rheumatologists who prescribed leflunomide to women of childbearing potential in the six months preceding the time of the inclusion * for prescribers: physicians or pharmacists who have prescribed or dispensed leflunomide in a pre-specified period of the 6 months leading up to survey completion * for pharmacists: pharmacists (including clinical pharmacists) who have dispensed leflunomide to women of childbearing potential in the six months preceding the time of the inclusion exclusion criteria: * healthcare professionals who may have conflicts of interest with the survey (i.e., employed by regulatory bodies or pharmaceutical companies) * healthcare professionals (with a relative) involved in leflunomide -related lawsuits or associations for victims of leflunomide syndrome * healthcare professionals who are not prescribing leflunomide * healthcare professionals who have prescribed or dispensed leflunomide earlier than 6 months before the survey completion the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
ayurvedic nutritional counseling for patients with ibs in comparison to conventional nutritional counseling

Conditions: IBS - Irritable Bowel Syndrome

Summary: the main goal of this randomized controlled clinical study is to evaluate the efficacy of an individual ayurvedic nutritional counseling (according to tradition) compared to an individual conventional dietary advice (according to the german nutrition society - dge) in patients with irritable bowel syndrome. it is to be investigated whether nutritional therapy elements, which patients can self-implement independently in the home environment, can achieve sustainable therapy effects.


Eligibility criteria:
inclusion criteria: * diagnosis "irritable bowel syndrome" according to the rom-iii criteria and the german s3 guideline (layer 2011) * female and male patients between 18 and 70 years of age * declaration of consent exclusion criteria: * bad general condition * serious acute or chronic comorbidity * pregnancy and breast feeding period * eating disorder * in recognition procedures for early retirement or disability * simultaneous participation in another clinical trial * participation in a clinical trial within the last 3 months before enrollment

Keywords: ayurveda ibs complementary medicine nutritional counseling
oxn pr vs placebo in opioid-naive subjects suffering from severe pain due to bladder pain syndrome (bps)

Conditions: Interstitial Cystitis; Painful Bladder Syndrome; Pain

Summary: the study compares the analgesic efficacy of oxn pr vs placebo in opioid-naive subjects suffering from severe pain due to bladder pain syndrome.

the study consists of a screening period followed by randomisation of the patients in a 1:1 ratio to oxn pr treatment or placebo treatment in a double blind fashion. the double blind phase will last for 8 weeks.

Eligibility criteria:
inclusion criteria: * history of severe pain due to bladder pain syndrome (bps) for at least 6 months * subject's treatment of pain due to bps is insufficient * subjects must not have received opioid containing medication in the last 6 months exclusion criteria: * females who are pregnant or lactating * subjects with any contraindication/history of hypersensitivity to oxycodone, naloxone, paracetamol, related products or other ingredients * subjects with any situation in which opioids are contraindicated like severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma or paralytic ileus * evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease, as determined by medical history, clinical laboratory tests, ecg results, and physical examination that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results * abnormal aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatise levels (\> 3 times the upper limit of normal), gamma glutamyl transpeptidase \> 3 times the upper limit of normal * abnormal total bilirubin and/or creatinine level(s)

Keywords: severe pain bladder pain syndrome interstitial cystitis painful bladder syndrome severe pain due to bladder pain syndrome/interstitial cystitis/painful bladder syndrome
cohort study on a following-up system of native arteriovenous fistulae

Conditions: Arteriovenous Fistulae

Summary: a cohort including more than 100 maintenance hemodialysis patients will be followed up according to a certain following-up system of native arteriovenous fistulae (avf) prospectively. the assessment results of the following-up system of avf help the physicians make decisions of avf surgery and puncture methods. the results of this study would identify the effect of the system on survival of avf. other 100 hemodialysis patients from other centers will be treated by routine protocol and compared to the experiment goup.

the following-up system of avf includes 3 stages. in the 1st stage, before avf surgery operation, the contents of following-up system of avf include history, physical exam, ultrasonography detection. the assesment results will guide the methods of the avf surgery operation. in the 2nd stage, before avf puncture firstly and 3 months after avf operation, the contents of following-up system of avf include physical exam and ultrasonography detection. the results will help the nurses and doctors make a decision of the method of avf puncture. in the 3rd stage, during the following 2 years after avf puncture successfully, the contents include physical exam and ultrasonography detection regularly. the adequacy of hemodialysis by using avf will be assessed by urea clearance index (kt/v). the data of patients in other hemodialysis centers will be recorded and compared to the patients in experiment group.

Eligibility criteria:
inclusion criteria: * maintenance hemodialysis patients using avf; * ages 18-70 years old; * agreement with frequent following-up. exclusion criteria: * younger than 18 years or elder than 70 years; * cachexia; * acute renal failure; * exceptive life time less than 6 months; * pregnant or planning pregnant; * waiting for renal transplantation or transferring to peritoneal dialysis.

Keywords: hemodialysis chronic renal failure arteriovenous fistulae
elias: early loop-recorder in suspected arrhythmogenic syncope

Conditions: Syncope

Summary: this is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.


Eligibility criteria:
inclusion criteria: * two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes exclusion criteria: * indication for the implantation of a pacemaker * indication for the implantation of an implantable cardioverter defibrillator * cardiac diseases which need intervention (khk, aortic stenosis, mitral stenosis, left ventricular \[lv\] outflow stenosis, decompensated heart failure) * contraindication for a diagnostic procedure requested by the study protocol * enrollment in another study * circumstances or comorbidities which do not allow enrollment

Keywords: syncope of uncertain etiology repeated presyncopes
differential effectiveness of robotic assisted therapy on upper extremity function in patients with chronic stroke

Conditions: Chronic Stroke

Summary: the objectives of this study are to: determine the effects of exoskeleton vs. end effector training systems on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in patients with chronic stroke.

according to the theory and literature review, there are two hypotheses in this study. one is that exoskeleton training system has better benefits than end-effector training system in motion control techniques, joint mobility and muscle tone control. second, end-effector training system has better benefits than exoskeleton training system in the functional activity level and daily life participation.

Eligibility criteria:
inclusion criteria: * chronic stroke more than 3 months. * fma score 29\~59. * modified ashworth scale proximal part ≤ 3, modified ashworth scale distal part ≤ 2, and no serious muscle spasms. * mini mental state examination ≥ 24 and no serious cognitive impairment. * learn more about the research content and can provide informed consent. exclusion criteria: * other neurological disease * inability to understand instructions * current participation in any other research * botulinum toxin injection within 3 months

Keywords: robotic-assisted therapy rehabilitation
effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) frequently occurs after cardiac surgery using cardiopulmonary bypass (cpb). recombinant human erythropoietin (rhuepo) is known to provide organ protection against ischemia-reperfusion injury through its anti-inflammatory properties. the aim of the present study was to investigate the effect of a single preoperative bolus of epo on the incidence of aki following complex valvular heart surgery in a randomized, controlled and double-blind trial.


Eligibility criteria:
inclusion criteria: * preoperative risk factors for aki and scheduled for complex valvular heart operations * enrolled criteria for high risk of aki were patients with more than 2 of bellows: female, serum creatinine \>1.2 mg/dl, preoperative a-fib, gfr \ 65 years, peripheral vascular disease. * complex valvular heart operations were defined as double-valve surgery, combined valve and coronary artery bypass grafting procedures, bentall operation, combined mitral valve surgery and tricuspid annuloplasty or reoperation. exclusion criteria: * patients with preexisting uncontrolled hypertension (diastolic blood pressure \> 100 mmhg), immunosuppression, history of thromboembolism, malignant disease, seizure, liver dysfunction, renal impairment (serum creatinine \> 2 mg/dl), and drug or alcohol abuse were excluded.

Keywords: erythropoietin acute kidney injury valvular heart surgery
study of the regulation of parathyroid hormone secretion in pseudohypoparathyroidism

Conditions: Pseudohypoparathyroidism

Summary: objectives: determine the relationship between serum calcium concentrations and parathyroid hormone secretion in patients with pseudohypoparathyroidism.

protocol outline: patients are tested for parathyroid hormone response following sequential graded intravenous infusions of sodium citrate and calcium gluconate. assays include ionized calcium and intact parathyroid hormone.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- pseudohypoparathyroidism, i.e.: renal resistance to parathyroid hormone or albright hereditary osteodystrophy no other illness unless related to pseudohypoparathyroidism no pregnant women

Keywords: endocrine disorders pseudohypoparathyroidism rare disease
cardiac index, svr/svri during weaning from ecc- data obtained from femoral and radial artery transducer

Conditions: Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease

Summary: swan ganz catheter-edwards lifesciences obtains values of cardiac output/index and systemic vascular resistance/index using the mean artery pressure of either radial or femoral artery. during weaning from extracorporeal circulation, arterial waveform-derived cardiac output measurements from radial cannulation site is not reliable as compared with measurements obtained from femoral cannulation site.

50 consecutive cardiac surgical patients undergoing on-pump primary coronary artery bypass, valve replacement or combined surgery are included in the study. cardiac output is measured sequentially by the arterial pressure waveform analysis method from radial and femoral arterial sites

Eligibility criteria:
inclusion criteria: coronary artery disease , aortic valve stenosis, aortic valve regurgitation, mitral valve stenosis, mitral valve regurgitation, exclusion criteria: none

Keywords: cardiac output cardiac index systemic vascular resistance
efficacy and safety of ozenoxacin 1% cream versus placebo in the treatment of patients with impetigo

Conditions: Impetigo

Summary: this is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of bullous or non bullous impetigo. the patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. in case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. additionally for patients \< 12 years the total area will not exceed a maximum of 2% of the body surface area. * total skin infection rating scale (sirs) score of at least 8, including pus/exudate score of at least 1 exclusion criteria: * has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic. * has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °c (99.0 °f)
clinical outcome of laparoscopic versus open nissen fundoplication in children: 3-year follow-up study of randomized controlled trial.

Conditions: Gastro -Oesophagal Reflux

Summary: long-term results following laparoscopic and open nissen fundoplication for gastro-oesophageal reflux will be objectively assessed in a selected population of patients already included in a randomized controlled trial comparing the two different techniques. the presence of postoperative symptoms will be evaluated by an independent clinician using an objective questionnaire. the recurrence of gastro-oesophageal reflux will be studied by 24-hours ph study. furthermore the presence of gastric motility disorders will be studied by electrogastrography and 13c-octanoic acid breath test.


Eligibility criteria:
inclusion criteria: all patients with gastro - oesophagal reflux - exclusion criteria: -
pre-operative steroids in crssp

Conditions: Chronic Sinus Disease; Chronic Sinusitis, Ethmoidal; Chronic Sinusitis, Sphenoidal; Chronic Sinusitis - Maxillary Bilateral; Chronic Sinusitis - Frontoethmoidal

Summary: randomized controlled trial to determine the effectiveness of a five-day course of pre-operative oral steroids on decreasing intra-operative blood loss during endoscopic sinus surgery.

the study will be a randomized cohort study, and patients will be recruited before surgery. following randomization, patients will be given either a course of prednisone (30 milligrams per day for 5 days, to be started five days prior to surgery) or no additional pre-operative prescriptions besides what is clinically determined by their treating physician. patients will be scheduled for surgery and undergo functional endoscopic sinus surgery with timing as clinically indicated. during endoscopic sinus surgery, surgical video will be recorded and stored on encrypted, flash drives with unique, non phi, indicators to identify drives. subsequently, each video will be graded by two, blinded surgeons for field visualization and thoroughness of dissection. intra-operative blood loss will also be recorded. post-operative data through 30 days post-operatively will be collected including: post-operative complications, resolution of symptoms, and nasal crusting during post-operative follow up. following completion of data collection, these data will be analyzed by a separate, blinded investigator.

Eligibility criteria:
inclusion criteria: * adult patients between the ages of 18 and 99 years of age with a diagnosis of chronic rhinosinusitis without polyps who are being scheduled for functional endoscopic sinus surgery exclusion criteria: * patients under 18 years old, patients with a condition in which the use of systemic corticosteroids is contraindicated (poorly controlled diabetes mellitus, poorly controlled hypertension, active or untreated tuberculosis, active viral or fungal infection, acute angle glaucoma, osteoporosis, or acute congestive heart failure) patients allergic to corticosteroids, or, patients unwilling or unable to take the prescribed course of pre-operative steroids.