Kornimate/medical-research-clean huggingface dataset:
treatment of the anemia of myelodysplastic syndromes by the association of epoetin beta and all trans retinoic acid

Conditions: Anemia in Myelodysplastic Syndromes

Summary: the purpose of this study is * to evaluate the efficacy of association of erythropoetin (neorecormon) and atra in patients with low risk myelodysplastic syndromes * to evaluate the tolerance of this treatment


Eligibility criteria:
inclusion criteria: * patients ≥18 years with ra, rars, raeb (blasts \<10%) * hb\ of 2 months or transfused since less 2 months * hb\ of 2 months and thrombocytopenia defined by platelets \< 50 000/mm3, or neutropenia\<10 000mm3 * for women of child bearing age, necessity of contraception during all the duration of the study exclusion criteria: * patient with lung disease, cardiac, neurological, gastro-intestinal or genito - urinary disorders not connected to genito -urinary not connected to myelodysplasia * patient having received intensive chemotherapy in the 3 months before inclusion in the protocol * raebt * raeb \>10% blasts * treatment with rhu-epo, darbepoetin ou rhu-gcsf , 2 months before inclusion * patient presenting an iron , b12 vitamin or folic acid uncorrected deficit * cmml * uncontrolled systemic hypertension * creatinine clearance \< 300 µm/l * pregnant patient or in period of lactation * life expectancy \< 6 months

Keywords: anemia myelodysplastic syndromes low risk bone marrow diseases
effect of food on the pharmacokinetics of lpm3770164 sustained-release tablets

Conditions: Huntington Disease; Tardive Dyskinesia

Summary: this is a a single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the pharmacokinetic characteristics and safety of oral administration of lpm3770164 sustained-release tablets 30 mg in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. subject who voluntarily participate and sign the informed consent form; 2. healthy male/female volunteers aged 18 to 45 years; 3. body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (bmi) 18.5 \~ 26.0 kg/m2, inclusive; 4. able to comply with the lifestyle restrictions. exclusion criteria: 1. subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution; 2. subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results; 3. any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;. 4. subject has a history of self-mutilation; or at risk of suicide; 5. subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial; 6. subject has abnormal vital signs, laboratory abnormalities, and ecgs; 7. subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing; 8. subject positive for hepatitis b surface antigen (hbsag), hepatitis c antibody (hcv-ab), hiv antibody (hiv-ab), or syphilis seroreactivity (trust); 9. subject has a history of alcohol abuse within 1 year or positive alcohol breath test results; 10. subject has a history of substance abuse within 1 year or a positive urine drug screen; 11. subject who has daily smoking of ≥ 5 cigarettes within 3 months; 12. subject who has special requirements for food, cannot comply with the unified diet or have dysphagia 13. subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration; 14. subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration; 15. subject who has participated in other clinical trials and were enrolled/randomized within 3 months before administration; 16. subject has used blood products or being blood donor or blood loss within 3 months; 17. pregnant, lactating women, or positive pregnancy test; 18. subject who refusal to contraception, or plan to donate sperm or ovums; 19. other conditions which would make participation in the study unsuitable
validation of a new prognostic score for adult patients with ras wild-type mcrc treated with vectibix® and folfiri or folfox in first line (validate)

Conditions: Metastatic Colorectal Cancer; RAS Wild-type

Summary: a safety and efficacy study of first line therapy with vectibix® in combination with folfiri or folfox to validate a prognostic score in adult patients with ras wild-type metastatic colorectal cancer in a real world setting (validate)

this is a non-interventional, prospective, open-label, single-arm, 3-cohort, multicenter study in germany and austria. in total, 606 patients will be enrolled in approx. 120 oncological sites (office-based medical oncologists, oncology outpatient-centers, and university hospitals) in a time period of 48 months. of these, 202 patients with high risk, 202 patients with intermediate risk, and 202 patients with low risk, as a priori assessed by the metastatic colorectal cancer prognostic score (mccs), will be included. overall survival of the pre-defined prognostic groups will be analyzed as primary endpoint to validate the mccs. patients have been scheduled to receive first line combination therapy with panitumumab and folfiri or folfox according to the current smpc valid for germany and austria, respectively. data on efficacy in terms of tumor response evaluation / survival and safety (adrs) will be collected during first line therapy. a subset of patients participating in the 'validate-pro' project (n=303) will be assessed for general and health-related quality of life with patient questionnaires. biomarker status beyond ras will be collected at baseline. the documentation of defined patient data including survival will continue until the end of the individual study participation which is latest 36 months after last patient in. the end of study will be at latest at 36 months after last patient in (lpi).

Eligibility criteria:
inclusion criteria: * eligibility according to current smpc * signed written informed consent * diagnosis of ras-wt mcrc * no prior systemic therapy in the palliative setting * aged 18 years or older exclusion criteria: * any contraindication according to current smpc * participation in other clinical trials

Keywords: mcrc first line panitumumab mccs prognostic score prognosis ras wild type
value of routine hysteroscopy prior to ivf/icsi cycles

Conditions: Infertility

Summary: in the current study the investigators hypothesize that routine hysteroscopy prior to ivf/icsi cycle increases the clinical pregnancy rate.

a randomized controlled study involving 300 patients with recurrent implantation failure

Eligibility criteria:
inclusion criteria: 1. patient's age ranged from 20-40 years. 2. normal appearance of the uterine cavity on hysterosalpingography. 3. patients prepared for ivf/icsi cycle. exclusion criteria: 1. patients who have any contraindications for hysteroscopy. (menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of pelvic inflammatory diseases). 2. patients with uterine cavity pathology previously known to the examiner. 3. patients with previous uterine surgery such as myomectomy. 4. patients with abnormal hsg.

Keywords: hysteroscopy - recurrent implantation failure
the third epidemiological research of refractory wounds in china

Conditions: Wound of Skin

Summary: this study is a cross-sectional survey in patients who underwent treatment of chronic cutaneous wounds from a nationally representative sample in our hospital from january 2018 to december 2018．

chronic cutaneous wounds represent a major health care burden in china however, limited information exists regarding the epidemiologic changes associated with recent social and economic devdopment．we designed a cross-sectional survey in patients who underwent treatment of chronic cutaneous wounds from a nationally representative sample in our hospital from january 2018 to december 2018．

Eligibility criteria:
inclusion criteria: - patients who underwent treatment of chronic cutaneous wounds in our hospital from 1/2018-12/2018． exclusion criteria: - no

Keywords: cutaneous wounds epidemiology china
patent foramen ovale (pfo) closure at the time of endovascular cardiac electronic device implantation

Conditions: Foramen Ovale, Patent

Summary: participants enrolled in this study will have been diagnosed with patent foramen ovale (pfo) and have been scheduled to have a cardiovascular implantable electronic device (cied) such as a pacemaker, implantable cardioverter-defibrillator (icd), or cardiac resynchronization therapy (crt) device implanted. a pfo is a condition when there is a hole in the septum (the wall separating the right and left sides) of the heart. the purpose of this study is to determine whether closing the pfo with the gore® cardioform septal occluder in people with an endocardial device leads reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (tia) compared to not closing the pfo.


Eligibility criteria:
inclusion criteria: * a clinical indication for a transvenous pacemaker or defibrillator implantation, * must have a documented pfo determined from transthoracic echocardiogram (tte) echocardiographic agitated saline contrast study that is determined to be feasible for transcatheter closure. * the gore® cardioform septal occluder should only be used in subjects whose vasculature is adequate to accommodate a 10 fr delivery sheath (or 12 fr delivery sheath when a guidewire is used). * all subjects must be able to undergo standardized neurocognitive testing, and dementia/mental status examination screening. exclusion criteria: * subjects with a survival expectancy of less than one year. * subjects with an atrial septal defect or shunt that clinically requires closure for hemodynamic or other purposes. * absence of a clinical indication for a transvenous cied system. * subjects with any clinical indication mandating anticoagulation. * subjects with previously placed cied devices will be excluded. * unable to take anti-platelet medications such as aspirin or clopidogrel (plavix). * with anatomy where the gore® cardioform septal occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins. * with active endocarditis, or other infections producing bacteremia, or with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement. * with known intracardiac thrombi. * known pregnancy at the time of automated implantable cardioverter-defibrillator (aicd) implant
intravenous magnesium sulphate in acute ischemic stroke

Conditions: Stroke; Ischemic Stroke

Summary: magnesium has a neuroprotective role so the investigators aim to evaluate the role of intravenous magnesium sulphate in improving the clinical outcomes as assessed by the nih stroke scale (nihss) in patients with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * adults with a confirmed diagnosis of ischemic stroke on neurological examination and ct scan findings aged between 45 -95 years of age of either gender. * adults presenting within a stroke onset of 24 hours. exclusion criteria: * patients with confirmed diagnosis other than ischemic stroke (evidence of intracranial bleed or space occupying lesion) * subjects with systolic blood pressure less than 90mmhg * presence of bundle branch block or atrioventricular block. * serum creatinine \> 3mg/dl * respiratory failure (o2 saturation \ 24 or \<12) * pregnancy.
effectiveness of distraction techniques on pain intensity during immunization among infants

Conditions: Pain

Summary: a study to assess and compare the effectiveness of distraction techniques on pain intensity during immunization among infants in selected hospital of ambala, haryana.

immunization is an important part of public health intervention and cost effective strategy to control the infectious diseases especially in children and it is one of the most common painful procedure in infants. pain during immunization leads to distressing experience for the infant, parents and health care worker. distraction is non pharmacological method which is used for diverting attention from noxious stimulus by passively redirecting the attention or by actively performed by the subject in the performance of diversion technique. aim and objectives:the aim of present study was to compare the effectiveness of distraction techniques on pain intensity during immunization among infants. the objectives of the study were to assess and compare the mean pain scores among infants receiving immunization in electronic toy group, key toy group, simple toy group and control group and to find out the association of pain scores among infants receiving immunization with their selected variables. material and methods: a true experimental multiple intervention post test control design was used. there were 100 infants selected using simple random sampling technique and were randomly allocated in various groups such as electronic toy group, key toy group, simple toy group and control group using lottery method. during immunization, distraction techniques were shown to experimental groups and routine care was given to control group. research tool was submitted to 7 experts from various specialists for validity. reliability was calculated by kappa method and it was 0.83 of flacc pain scale to assess pain intensity during immunization among infants. data collection was done in january 2017. the obtained data was analyzed and interpreted in terms of objectives and research hypotheses. analysis was done by using descriptive and inferential statistics.

Eligibility criteria:
inclusion criteria: * • infants who were-visiting immunization clinics of civil hospital for immunization. having 10 and 14 weeks of age. receiving pentavalent vaccine. parents and caregivers who were willing to give consent exclusion criteria: the study excluded infants who: had undergone any painful procedure 2 hour prior to immunization, were visually or hearing disabled. had history of seizures, use of topical anesthetics at immunization site, use of sedatives, analgesics or opioids in the preceding 24 hours.
study of coffee mannooligosaccharides for weight management

Conditions: Obesity

Summary: the goal of this study is to establish the role of coffee mannooligosaccharides (mos), provided in a beverage format, on body weight regulation. overweight and obese men and women will be randomized to one of 2 groups: placebo or mos beverage. they will be required to consume 2 beverages/day for the duration of the 2 phases of the study. the mos beverage will provide 2 g of mos (total of 4 g/d). this dose level has been found to be well tolerated and safe. in the first phase, subjects will be counseled once monthly on a nutrition-related topic on an individual basis. they will be asked to maintain their regular eating and exercise habits for the duration of the 12 week period. an 8-week washout period will follow during which time they will not be required to consume the beverages. the second phase of the study will be a weight loss phase. for this phase, subjects will be re-randomized and may consume the alternate or the same beverage as the first phase, depending on the outcome of randomization. during this phase, they will undergo group counseling on a weekly basis. counseling sessions will focus on weight loss and ways to achieve moderate weight loss of approximately 1-2 lbs/week. measurements will be taken at the beginning and end of each phase. this study will allow us to determine whether mos helps maintain body weight and prevent weight gain (first phase) and whether it helps to stimulate weight loss (second phase). the results will allow us to find ways in which overweight and obese individuals can incorporate beverages in their diets that will help promote weight loss.


Eligibility criteria:
inclusion criteria: * body mass index 27-33 kg/m2 * stable body weight exclusion criteria: * body width \> 46 cm * medications known to affect body weight, lipids, blood pressure * pregnant or lactating women * less than 1 y post-partum

Keywords: body composition weight loss weight management beverages diet
comparison of a conventional and a realistic self-modified model

Conditions: Cricothyroidotomy; Difficult Airway; Obesity

Summary: according to the recently published german guidelines for the prehospital airway management regular training for cricothyroidotomy is recommended. even though participants prefer animal or cadaver trainingmodels, it is not possible to perform this comprehensive for a large number of participants due to organizational requirements like food hygiene, limited shelf-life and preparation time and expense. therefore the investigators modified an available for purchase cricothyroidotomy trainer (the airsim combo x) with everyday suitable and cost-effective utensils. as a control group the investigators used a conventional simple plastic model.

obesity is an important risk factor for a cannot intubate cannot ventilate situation. obese patients are more likely to require a cricothyroidotomy, due to failure rates of routine airway management. relevant landmarks can be difficult to palpate. and the greater depth of the soft tissues overlying the larynx. due to this reasons the investigators modified the adult intubation manikin airsim combo x with a drunk baby diaper to simulate the neck of an obese patient. as a further modification the investigators prepared freezer bags filled with faked blood to simulate a possible bleeding. 35 medial doctors of the department of anesthesiology and 35 paramedics are going to perform two cricothyroidotomies in each model. for the one time participants use the scalpelcric set and for the other time participants use the scalpelcric set plus a speculum. primary endpoint is the evaluation of reality of the two different manikins.

Eligibility criteria:
inclusion criteria: * written informed consent * german language in speaking and writing * capability of giving consent exclusion criteria: * participants unwilling or unable to give informed consent
reduction of cancer related fatigue in patients during tki therapy

Conditions: All Tumor Entities Treated With TKI Therapy

Summary: the purpose of this pilot study is to determine the effects of a 12-week resistance training program on cancer related fatigue in cancer patients receiving tyrosine kinase inhibitor (tki) therapy. it is hypothesized that incidence and severity of cancer related fatigue can be reduced by exercise training in this population which leads to an improved treatment completion rate.


Eligibility criteria:
inclusion criteria: * male and female cancer patients * prior to tyrosine kinase inhibitor therapy (any substance, any line) * age: at least 18 yrs * body mass index (bmi): at least 18 kg/m2 * ecog performance status: at most 2 * must be able to meet the requirements of the study protocol exclusion criteria: * acute infectious diseases * no ambulatory ability * severe neurological disorders * severe cardiovascular diseases * severe pulmonary insufficiency * severe renal insufficiency * other current tumor diseases * conditions rendering compliance impossible * participation in regular strength training

Keywords: physical activity exercise training fatigue cancer tki tyrosine kinase inhibitor
a prospective randomized controlled multicenter trial of delayed gastric emptying (dge) after pancreaticoduodenectomy evaluating by gastrointestinal reconstruction

Conditions: Postprocedural Delayed Gastric Emptying

Summary: the purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.

the purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction. delayed gastric emptying after pancreaticoduodenectomy is important to affect the postoperative course and qol. we conducted a prospective randomized trial on 240 patients who underwent pancreaticoduodenectomy for comparing between antecolic and retrocolic gastrointestinal reconstruction. the primary endpoint was defined as incidence of delayed gastric emptying by isgps criteria. the secondary endpoint was defined as incidence of other postoperative morbidity. patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated for pancreatic head and periampullary disease, and an appropriate informed consent was obtained. exclusion criteria was 1) patients who have the history of gastrectomy, 2) patients who have severe cardiorespiratory dysfunction, 3) patients who have liver cirrhosis or are receiving dialysis, and 4) patients who were diagnosed inadequate for this study by a physician.

Eligibility criteria:
inclusion criteria: * patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy exclusion criteria: * patients who have the history of gastrectomy * patients who have severe cardiorespiratory dysfunction * patients who have liver cirrhosis or are receiving dialysis * patients who were diagnosed inadequacy for this study by a physician

Keywords: delayed gastric emptying(dge) pancreaticoduodenectomy(pd) randomized controlled trial(rct) gastro- or duodeno- jejunostomy reconstruction morbidity
ensite real-time cardiac performance measurements (rt cpm) study

Conditions: Heart Failure

Summary: the ensite real-time cardiac performance measurements study (ensite rt cpm) is a multicenter, international, acute, non-significant risk study, designed to enroll a maximum of 40 patient. the goal of the study is to collect 3-d systolic/diastolic data with the ensite navx mapping system during a crt implant. patients enrolled in this study will undergo navx cpm recording of the heart using the ensite navx mapping system during the implantation of a cardiac resynchronization therapy device.


Eligibility criteria:
inclusion criteria: * be undergoing a new st. jude medical crt-d or crt-p device implantation * have the ability to provide informed consent for study participation and be willing to comply with the prescribed perioperative evaluations exclusion criteria: * have a recent myocardial infarction within 40 days prior to enrollment * have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures * be less than 18 years of age * be pregnant women * be currently participating in a clinical study that includes an active treatment arm