Kornimate/medical-research-clean huggingface dataset:
fabry outcome survey (fos)

Conditions: Fabry Disease

Summary: the purpose of this study is to collect data that will increase understanding of fabry disease history and progression, in treated and untreated patients with fabry disease. the data from fos may provide guidance to healthcare professionals about disease treatment options.


Eligibility criteria:
inclusion criteria: 1. participants must have a documented diagnosis of fabry disease * this may include a genetic mutation analysis. the collection of the genetic mutation analysis result is optional and dependent on the participant providing their consent for this data to be used in the fos registry. * participants can be untreated, currently or previously treated with replagal, or any other approved treatment for fabry disease. 2. signed and dated written informed consent from the participant * for participants aged less than (\<) 18 years (or as per local regulation), parent and/or participant's legally authorized representative (lar), and assent of the minor, where applicable, is necessary. * if a participant is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the informed consent discussion and should sign and personally date the informed consent. * informed consent must be obtained from lars for cognitively impaired participants when applicable. exclusion criteria: 1. participants currently enrolled in ongoing blinded clinical trials (drugs or devices; includes all blinded trials) will be excluded from the registry.

Keywords: genetic fabry disease glycolipid lysosomal
fluid responsiveness tested by the effective pulmonary blood flow during a positive end-expiratory trial

Conditions: Cardiovascular Diseases

Summary: fluid responsiveness is difficult to assess at the bedside. the accuracy of published techniques to detect preload-dependent patients have many pitfalls and limitations. the present study test the role of noninvasive effective pulmonary blood flow measured by expired carbon dioxide to detect fluid responsivess in mechanically ventilated patients.

this is a prospective and observational study designed to test the accuracy of the non-invasive effective pulmonary blood flow measured by the capnodynamic methodology for detect preload-dependent patients. fourty patients undergoing mechanical ventilation during surgery will be studied. preload-depency (fluid responsiveness) will be tested during an increase in end-expiratory pressure (peep) from 5 to 10 cmh2o during one minute. pulse pressure variation will be use as the reference method to detect preload-dependency. the effective pulmonary blood flow will be continuously recorded during the peep maneuver. receiver operator curves will be used to detect fluid responsiveness taking a pulse pressure variation higher than 13%.the corresponding cut off value for the effective pulmonary blood flow signal will be determined..

Eligibility criteria:
inclusion criteria: * written informed consent * programmed cardiac and noncardiac surgeries * need of invasive arterial blood pressure monitoring. exclusion criteria: * emergency surgeries. * acute pulmonary diseases * arrhytmias * congestive cardiac failure

Keywords: carbon dioxide pulmonary blood flow ventilation
toremifene in treating patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: estrogen can stimulate the growth of ovarian cancer cells. hormone therapy using toremifene may fight ovarian cancer by reducing the production of estrogen. purpose: randomized phase ii trial to study the effectiveness of toremifene in treating patients who have recurrent or refractory ovarian cancer.

objectives: * determine the effects of toremifene in terms of response rate, duration of response, duration of survival, and toxicity in patients with chemotherapy resistant papillary carcinoma of the ovary. * assess whether a dose response effect is likely for this regimen in these patients. * assess quality of life of these patients. outline: this is a randomized study. patients receive one of two doses of oral toremifene daily for 4 weeks. treatment continues in the absence of disease progression or unacceptable toxicity. quality of life is assessed before therapy and then every 4 weeks during therapy. patients are followed every 12 weeks until death. projected accrual: the study was closed before any patient accrual.

Eligibility criteria:
disease characteristics: * histologically confirmed serous papillary carcinoma of the ovary * recurrent or refractory disease following at least one regimen including paclitaxel, cisplatin, or carboplatin * measurable disease outside of irradiated field * no cns metastases patient characteristics: age: * 18 and over performance status: * zubrod 0-2 life expectancy: * at least 16 weeks hematopoietic: * absolute neutrophil count at least 1,800/mm\^3 * platelet count at least 125,000/mm\^3 * no history of thrombosis or thromboembolic events hepatic: * bilirubin no greater than 2.0 mg/dl renal: * creatinine no greater than 2.0 mg/dl other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 2 months after study * no other concurrent second malignancy or prior malignancy within past 5 years, except basal or squamous cell skin cancer or curatively treated stage i carcinoma of the cervix * no concurrent infection * at least 3 days since prior fever (unless due to tumor) * no other concurrent severe medical illness * no hiv positivity prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * no concurrent chemotherapy endocrine therapy: * no prior tamoxifen or antiestrogen therapy radiotherapy: * see disease characteristics * at least 6 months since prior radiotherapy * no concurrent radiotherapy except to symptomatic or potentially disabling bone lesion accompanied by other measurable disease surgery: * not specified other: * no concurrent anticoagulants * no other concurrent therapeutic trials

Keywords: recurrent ovarian epithelial cancer ovarian serous cystadenocarcinoma
life without diabetes

Conditions: Prevention of Developing Type 2 Diabetes

Summary: the aim of the study 'live - without diabetes' is to investigate the effects of increased physical activity on a daily basis with or without (high intense interval training) hiit (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes

a total of 125 individuals with pre-diabetes will be included and randomized into four different groups (n=25, each group): 1) increased daily activity detected by the pedometer, 2) increased daily activity detected by the pedometer + hiit, 3) hiit, and 4) increased daily activity detected by the pedometer + group intervention 5) a control group (maintain unchanged activity and life-style during the duration of the study).

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 25 kg/m2 * prediabetes: 6.1 % ≤ glycated hemoglobin a1c (hba1c) ≤ 6.4 % and / or increased fasting plasma glucose (fpg): 6.1 mm ≤ fpg ≤ 6.9 mm and / or abnormal glucose tolerance (7.8 mm ≤ 2 hour plasma glucose (pg) ≤ 11.0 mmol) * weekly training status \<150 minutes exclusion criteria: * bmi \<25 kg/m2 * diabetes * pregnancy and breastfeeding * treatment with medicine, there influence glucose metabolism * decreased liver function (liver transaminases \> 3 times of limit of normal)
blood pressure during esd is related with the postoperative bleeding

Conditions: Gastrointestinal Disease; Gastrointestinal Bleeding

Summary: endoscopic submucosal dissection(esd) is a prominent minimally invasive operation technique for treating early gastrointestinal tumor. but promoting esd is uneasy because of its complications such as postoperative bleeding, perforation and so on. so if we decrease the rate of postoperative bleeding, esd might be better popularized. some study indicated that hypertension was the independent risk factor of postoperative bleeding. endoscopic center of fudan university zhongshan hospital is a rich experienced medical unit in doing esd operation in china. referring to our experience, if we can use some special methods to find the potential bleeding spot which is not obvious during esd operation and we coagulate it precisely, then we may control the risk of postoperative bleeding. based on the above hypothesis, our team designed this study to examine whether increasing blood pressure during gastric esd could help to control the risk of postoperative bleeding.


Eligibility criteria:
inclusion criteria: * a. the indications for esd for gastric neoplasms, such as intramucosal gastric cancer and adenoma, include intramucosal differentiated tubular adenocarcinoma of any size without ulceration or signs of submucosal invasion and intramucosal differentiated-type adenocarcinoma of less than 3 cm with an ulcer scar. the histology, tumor location, and depth of invasion fulfilled the criteria of the japanese research society for gastric cancer. b. the eligible patients' blood coagulation function should be normal without any associated medicine influenced. exclusion criteria: * a. previously treated by radical gastrectomy. b. pregnant or on breast feeding. c. patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism. d. coagulopathy: liver cirrhosis, thrombocytopenia. e. anti-platelet agents. allergic to ppi or norepinephrine. f. patients with sever hypertension(systolic pressure\>180mmhg), or the hypotensor cann't control blood pressure suitably. g. patients with cardiovascular and cerebrovascular events within 6 months.

Keywords: endoscopic submucosal dissection postoperation bleeding
perceived lactose intolerance

Conditions: Lactose Intolerance

Summary: the goal of this study was to examine the effects of self-perceived lactose intolerance (spli) as it relates to calcium intake and specific health problems that have been attributed to reduced intake of calcium and foods from the dairy group in a nationally representative multi-ethnic sample of adults.


Eligibility criteria:
inclusion criteria: * adults between 18 and 50 years old exclusion criteria: * pregnant women

Keywords: perceived lactose intolerance calcium/dairy consumption specific health outcomes
safety and efficacy study of doxycycline/ursodeoxycholicacid on disease progression in attr amyloidosis

Conditions: Transthyretin Amyloidosis; Cardiomyopathy

Summary: the primary objective for this study is to evaluate the efficacy of doxycycline + ursodeoxycholic acid (udca) on disease progression in transthyretin amyloidosis (attr) subjects with cardiomyopathy with or without neuropathy.


Eligibility criteria:
inclusion criteria: * cardiomyopathy with septal thickness \> 15 mm and/or s-nt-probnp \> 300 ng/ * age \>50 years * male and females after menopause. menopause is defined as 6 to 12 months of amenorrhea in a woman over 45 years of age. * written informed consent to be obtained prior to any study procedure * histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green birefringent material in congo red-stained tissue specimens, and typing of amyloid deposits as ttr and identification of amyloid fibril type. * molecular definition of the ttr mutation or immunohistochemical staining of amyloid fibrils with anti ttr antibody * new york heart association (nyha) class \<iii * systolic blood pressure \>100 mmhg (standing) * must have symptomatic organ involvement with amyloid to justify therapy exclusion criteria: * liver transplantation in the previous 6 months or liver transplantation anticipated in less than 6 months; * alt and/or ast \> 2 x upper normal limit (unl); * creatinine clearance \< 30 ml/min (cockcroft -gault formula) * any other lab values, illness or condition that in the opinion of the investigator might place the subject at unacceptable risk for participation in the study; * history of hypersensitivity to any of the ingredients of the study therapies; * use of any investigational drug, device (or biologic) within 4 weeks prior to study entry or during the study.

Keywords: transthyretin amyloidosis cardiomyopathy attr neuropathy
effect of cycle ergometer in the rehabilitation of elderly patients with total hip arthroplasty

Conditions: Osteoarthritis, Hip; Osteonecrosis

Summary: the aim of this study is to evaluate the effects of an exercise program with a cycle ergometer in functional outcome and related-health quality of life (rhql) in elderly patients with total hip arthroplasty.

behavioral: ergometer cycling ergometer cycling under the guidance of a physical therapist after the second postoperative week. these training sessions were scheduled to be performed two times a week for a time period of at least eith weeks. behavioral: no ergometer cycling patients of the no ergometer cycling group did not receive any ergometer cycling after surgery, only conventional exercises.

Eligibility criteria:
inclusion criteria: * aged patients (60 years or more) of both sexes * being submitted to the total hip arthroplasty, primary and unilateral, for hip osteoarthritis or hip osteonecrosis * no history of physical therapy two months before surgery exclusion criteria: * arthroplasty of hip fracture or other condition; * neurological disease that compromises motor function; * postoperative complications (dislocation, infection, cardiovascular events); * revision of the prosthesis; * patients who are unable to attend the sessions of physical therapy or refused to participate in the study

Keywords: hip arthroplasty aged rehabilitation exercise therapy
continuous v bolus infusion of cefazolin during ventral hernia repair

Conditions: Surgical Site Infections

Summary: patients undergoing an elective ventral hernia repair will be randomly assigned to receive either bolus infusion or continuous infusion of the cefazolin as the prophylactic antibiotic. the blood concentrations of unbound cefazolin would be measured in their blood samples and the levels compared within the two groups with respect to their minimal inhibitory concentration (mic) value.

patients who will be undergoing elective ventral hernia repair will be potential candidates for this study. once identified, the surgical team will approach the participant for consent and inclusion in the study. on the day of surgery, the subjects will be assigned to either the bolus group (cb) or continuous infusion group (ci) according to a randomly generated assignment procedure. during the procedure, the dose of prophylactic cefazolin will be given an hour before surgery and will be administered in accordance to group assignment. subjects in the cb will receive bolus infusions of cefazolin every 4 hours till the end of surgery. subjects in the ci group will receive an initial bolus injection of cefazolin followed by a continuous infusion till the closure of skin incision. blood samples will be taken during surgery at t=0, 15, 30 and 60 minutes and every hour following till the end of surgery or 6 hours (whichever comes sooner)

Eligibility criteria:
inclusion criteria: * age \>18 years * elective open ventral hernia repair in cdc class one (clean) cases * planned operative time greater than 4 hours * planned routine administration of cefazolin for pre-op prophylaxis * no history of mrsa exclusion criteria: * patients unable to give informed consent * allergy to cephalosporins * pre-existing documented infection or ostomy (class ii-iv wounds) * received cefazolin within 24 hours before surgery * creatinine clearance \< 30 ml/min * upstaging of wound class intra-op that results in the administration of additional antibiotics

Keywords: anesthesia surgical antimicrobial prophylaxis surgical site infections
dexmedetomidine and laparoscopic surgery

Conditions: Anesthesia Complication

Summary: conventionally general anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . the main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. the main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. in this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia. the pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered


Eligibility criteria:
inclusion criteria: * elective gynaecological laparoscopic surgery * age 20-45 yrs * suspected surgery time 30 minutes * inflation pressure \<13 cm h20 exclusion criteria: * contraindications to regional block (infection at the needle insertion site) * altered conscious level. * pregnancy * body mass index \>35 * height \<155 cm * patients who have difficulty understanding the study protocol
lower silesia sinus reducer registry

Conditions: Safety Issues; Efficacy, Self

Summary: lower silesia sinus reducer registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (canadian cardiovascular society \[ccs\] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent coronary sinus reducer implantation .

lower silesia sinus reducer registry is a single-center, single-arm registry including all consecutive patients who were referred to the cardiac department of copper health center due to chronic disabling refractory angina pectoris (canadian cardiovascular society \[ccs\] classes 2-4) despite maximally tolerated anti-angina medical therapy and underwent coronary sinus reducer implantation. all patients were evaluated by the local heart team and considered not amenable to percutaneous or surgical revascularization procedures. after the heart team evaluation patients were qualified for the procedure or coronary sinus reducer implantation unless they met one of the exclusion criteria. initial patient evaluation (prior to device implantation) consisted of past medical history, actual clinical assessment with an evaluation of ccs class, seattle angina questionnaire - 7 items (saq-7) scores, 6-min walk distance (6-mwt) test, and echocardiography. first, a follow-up visit was scheduled 1 month after the implantation procedure.the study will include clinical assessments every six months during an observation period. the primary outcomes will be gathered one year after the implantation of the cs. nevertheless, clinical follow-up will continue for up to five years after the procedure.

Eligibility criteria:
inclusion criteria: 1. present of chronic disabling refractory angina pectoris (canadian cardiovascular society \[ccs\] classes 2-4) despite maximally tolerated anti-angina medical therapy 2. heart team evaluation with consideration of ineligibility for percutaneous or surgical revascularization procedures. exclusion criteria: 1. recent acute coronary syndrome (\<3 months), 2. recent coronary revascularization (\<3 months) 3. a mean right atrial pressure higher than 15 mm hg 4. coronary sinus proximal diameter \ 14mm 5. life expectancy under 12 months, 6. advanced heart failure (new york heart association \[nyha\] classification - classes 3-4), 7. potential implantable cardiac resynchronization therapy defibrillator (crt-d) implantation candidate.

Keywords: coronary sinus reducer refractory angina chronic coronary artery diseases (cad) non-obstructive coronary artery diseases (cad) coronary microvascular dysfunction
objective structured assessment of technical skills (osats) evaluation of shoulder dystocia management

Conditions: Shoulder Dystocia

Summary: this trial tests whether hands-on training is superior to expert demonstration regarding the management of shoulder dystocia (stuck shoulder) during delivery on a training model.

we prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized sd algorithm scheme on a pelvic training model. probands are tested with a 22 item objective structured assessment of technical skills (osats) scoring system after training and 72 hours thereafter. osats scores are the primary outcome. performance time (pt), self assessment (sa), confidence (con), and global rating scale (grs) are the secondary outcomes. statistics will beperformed using mann-whitney u-test, chi-square test, and multivariable logistic regression analysis.

Eligibility criteria:
inclusion criteria: * informed consent exclusion criteria: * none

Keywords: shoulder dystocia training to assess the effectiveness of hands-on training versus expert demonstration
effect of spacer in extrafine formoterol-beclomethasone treatment to asthma

Conditions: Asthma

Summary: combined inhaled treatment with long acting adrenergics and steroids in an unique inhaler plays an important role in the management of non-mild asthma. some studies have demonstrated that the use of spacers achieve better lung deposition and decrease the number of side effects. recently a new combined treatment for asthma has been developed (extrafine formoterol plus beclomethasone dipropionate). the small size of the extrafine particles of this new combination get the small airway and theorically improve their positive effect. some authors have stated that the use of a spacer with extrafine particle could decrease the effectiveness of this treatment due to the adhesion of particles on the walls of the spacer because of the electrostatic characteristics of plastic spacers. however, there are no clinical or functional studies demonstrating the role of this phenomena in the control of asthmatic patients. the investigators' hypothesis is that the benefit of using spacers with this new treatment is at least equal in magnitude than the loss of efficacy because of the adhesion of particles on the wall of the spacer and then the investigators hypothesized that the use of spacer with extrafine formoterol-beclomethasone do not suppose a decrease in clinical or functional control in stable moderate-severe asthma patients.


Eligibility criteria:
inclusion criteria: * moderate-severe asthma * stable asthma * 18-75 years old exclusion criteria: * exacerbation of asthma * instability with the study treatment * other cardiopulmonary disease

Keywords: asthma formoterol beclomethasone extrafine formulation spacer moderate severe stable