Kornimate/medical-research-clean huggingface dataset:
effects of blood letting in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome (ms) has an increasing prevalence worldwide and there is an urgent need for improvement of medical treatment. in traditional medicine phlebotomy (blood letting) is a recommended treatment for subjects with obesity and vascular disease. recent studies showed that blood letting with iron depletion may improve insulin sensitivity in patients with diabetes mellitus. the investigators aimed to test if traditional blood letting has beneficial effects in patients with ms. a randomized trial with a sample size of 64 self-referred ms patients was conducted. patients in the blood letting group were allocated to blood letting intervention and the control group was offered a later treatment (waiting list). in the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks. primary outcomes were the change of systolic blood pressure and of insulin sensitivity as measured by homa-index.


Eligibility criteria:
inclusion criteria: * 25-70 years of age * given diagnosis of metabolic syndrome exclusion criteria: * clinically significant hepatic, neurological, endocrinologic, or other major systemic or inflammatory disease, including malignancy * known history of hemochromatosis, or presence of the cys282tyr mutation * history of drug or alcohol abuse * manifest cardiac disease * history of disturbances in iron balance (e.g., hemosiderosis from any cause, atransferrinemia) * preexisting anemia

Keywords: metabolic syndrome phlebotomy blood letting hypertension insulin sensitivity
observational study of the decision making towards clinical trials in cancer patients

Conditions: Lung Cancer; Liver Cancer

Summary: this is a cross-sectional, observational and correlational survey study.this study is aim to survey the the knowledge, attitudes, and decision making towards clinical trials in cancer patients in taiwan (r.o.c.), which attempts to invite some cancer patients who have been experienced the treatment clinical trials' informed consent process. the research tool is a questionnaire which includes some scale: (1)clinical trial knowledge scale, (2) attitude toward randomized clinical trials scale, (3) shared decision making(sdm-q-9),(4) satisfaction with decision (swd-scale), and (5) decision regret scale(drs). the investigators expect the research outcome can provide some instructions to improve patients' autonomy, satisfaction of the decision making and communication process between patients and medical professors whenever cancer patients participating in clinical trials.

this study is been conduct in national taiwan university hospital , taiwan. the main measurement tool is a self-report questionnaire, which is designed to answer some outcome measures for the following aspect: 1. to find out the knowledge, attitudes, shared decision making level, subjective norm, and behavior intentions towards clinical trials in cancer patients. 2. to find out the main influencing factors of behavior intentions towards participating in clinical trials

Eligibility criteria:
inclusion criteria: 1. cancer patients who have been approved lung cancer or liver cancer. 2. patients who have been experienced the informed consent process about clinical trial, which duration is in 6 months before they enter this study. exclusion criteria: 1. patients who have conscious disorientation that can not answer questionnaire 2. patients only participate in some gene clinical trials without treatment or drugs.

Keywords: patients satisfaction decision making informed consent
ds-8201a versus t-dm1 for human epidermal growth factor receptor 2 (her2)-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and taxane [destiny-breast03]

Conditions: Breast Cancer

Summary: this study is designed to compare the anti-tumor activity as well as the safety and efficacy of ds-8201a versus t-dm1 in her2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.


Eligibility criteria:
inclusion criteria: * is the age of majority in their country * has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has confirmed her2-positive expression as determined according to american society of clinical oncology - college of american pathologists guidelines evaluated at a central laboratory 3. was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane * has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy) * is her2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. if archived tissue is not available, agrees to provide a fresh biopsy. * if of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for 7 months after the last dose of ds-8201a (females); 4.5 months after last dose of ds-8201a (males) or 7 months after the last dose of t-dm1 * has adequate renal and hepatic function exclusion criteria: * has previously been treated with an anti-her2 antibody drug conjugate (adc) in the metastatic setting. prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy * has uncontrolled or significant cardiovascular disease * has a history of (noninfectious) interstitial lung disease (ild)/pneumonitis that required steroids, has current ild/pneumonitis, or where suspected ild/pneumonitis cannot be ruled out by imaging at screening * has spinal cord compression or clinically active central nervous system (cns) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. 1. participants with clinically inactive brain metastases may be included in the study. 2. participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. a minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.

Keywords: breast cancer metastatic breast cancer ds-8201a destiny - breast 03
a study to evaluate the efficacy and safety of seletracetam in adult patients with refractory partial onset seizures

Conditions: Epilepsies, Partial

Summary: this study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. it will also help to determine the best dose to use.


Eligibility criteria:
inclusion criteria: * subjects from 16 to 70 years old * confirmed diagnosis of focal epilepsy * partial seizures uncontrolled while taking 1 or 2 aeds * at least 8 partial seizures during the 8-week baseline period exclusion criteria: * seizures occurring only in clusters * status epilepticus within 1 year * progressive cns disorder * other serious or uncontrolled diseases

Keywords: seletracetam epilepsies partial epilepsy focal
effect of immunocal® with exercise versus casein with exercise on aging processes in elderly persons

Conditions: Aging; Sarcopenia

Summary: aging is typically associated with a decrease in skeletal muscle mass and muscle function, which contributes decisively to disability in old age and to the loss of quality of life.resistance exercise can increase muscle strength, function and mass in older adults. the primary aim of this study is to determine whether the combination of resistance training with a supplementation of a cysteine- rich whey protein isolate (immunocal) compared to combination of resistance training with casein used as control (casein contains little cysteine) could have the potential to provide a synergic beneficial impact on muscle mass and function which could translate to an improved quality of life in elderly persons.


Eligibility criteria:
inclusion criteria: * age 65 or older * estimated gfr above 45ml/min * total bilirubin in the normal range (0.2 to 1.2 mg/dl) ast (10-35 u/l for women and 10-50 u/l for men). alt equal to or less than 2.5 times the upper limit of normal * bmi between 18.5-29.9 (kg)/m2 * sedentary (\< 2 hours of structured exercise)in the last 2 or 3 months * based on investigator judgment according to current canadian guidelines, medical conditions such as hypertension, diabetes and hyperlipidemia have to be stable and optimally controlled before the subject starts the study. exclusion criteria: * history of angioedema or allergic reactions to any compound used in this study. * milk protein intolerance * subjects currently using n-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements. * major surgery in the year prior to testing * acute coronary or vascular event within the last year or progressive angina * stroke within the past 2 years * neurologist and/or orthopedic limitations * uncontrolled thyroid or pituitary disease * medication which has a major affect on cognitive function * signs of early dementia as assessed by mini-mental state examination * weight loss of more than 4kg(or more than 5% body weight) over last 6 months * alcohol abuse * medication which interferes with muscle mass i.e. (corticosteroids) * any life threatening conditions based on investigator judgment. * subjects with allergies/intolerance to soya. * subjects currently undergoing immunosuppressive therapy.

Keywords: elderly persons muscle function and strength body composition inflammatory cytokine levels cognitive functions cysteine-rich whey protein isolate immunocal resistance training improved muscle function improved quality of life aging processes quality of life
study comparing spp100 (aliskiren) 150mg to placebo and to losartan 50mg in patients with mild to moderate essential hypertension

Conditions: Hypertension

Summary: assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension


Eligibility criteria:
inclusion criteria: * age: 20 - 75 years old * gender: male or female * status: outpatients * mild to moderate essential hypertension exclusion criteria: * pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant * patients with mssbp \>==180 mmhg and/or msdbp \>=110 mmhg at visit 1, 2 or 3 * patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.) * patients suspected of having malignant hypertension other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, aliskiren, blood pressure, renin
evaluation of early standardized task-specific training (estt)

Conditions: Acute Stroke

Summary: a. specific aims: 1. there is one specific aim of this study. the aim is to evaluate the effectiveness of early standardized task-specific training (estt) in persons with acute stroke. b. hypothesis: 1. it is our hypothesis that subjects who receive estt will walk faster and more symmetrically than published reports of gait outcomes in persons with stroke.

it is our contention that gait recovery after stroke is impacted by the interventions that are acutely utilized during training. there is not a consensus about how to most effectively train individuals after stroke. it is clear, however, that most persons are left with significant and often debilitating gait dysfunction after stroke so there is an urgent need to find more effective therapeutic methods.

Eligibility criteria:
inclusion criteria: * recent stroke (less than 6 weeks) * able to give conformed consent or have family member who can give consent * first time stroke or complete recovery from prior stroke exclusion criteria: * non-ambulatory before onset of stroke * bilateral stroke * presence of severe cardiac problems * other co-morbidities which would affect gait training (i.e. amputation, spinal cord injury, traumatic brain injury, etc.) * recent myocardial infarct (within 4 weeks) * any uncontrolled health condition for which exercise is contraindicated * severe lower extremity joint disease/pathology that would interfere with gait training * subjects with bmi greater than 40 * significant cognitive impairment * age greater than 80 years or less than 16 years * able to complete 5 or more full heel raises with the affected ankle in standing with the knee extended with no more than one or two fingers on support surface for balance

Keywords: stroke gait acute
serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery

Conditions: Anesthesia, Local; Pain, Postoperative

Summary: acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery. to date, several procedures have been described but the best modality of locoregional analgesia for thoracoscopic surgery has not been assessed yet. the main objective of this study is to evaluate efficiency of several validated approaches for preoperative locoregional analgesia, comparing serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery. to this end, the investigators will conduct an interventional prospective monocentric, double blind, compared and randomized study. previously to thoracoscopic surgery, patients will be randomized in one of the three following arms: serratus plain block, paravertebral block or serratus plain block and paravertebral block combined.


Eligibility criteria:
inclusion criteria: * adult patient over18 years old * without guardianship * video-assisted thoracoscopic surgery with 3 trocars * no cons-indications to loco-regional anesthesia (allergy, skin condition) exclusion criteria: * patient under 18 years old * patient under guardianship * pregnant * rejection of consent * rejection of loco-regional anesthesia * chronic pain antecedents under morphine medication * pain assessment impossible

Keywords: anesthesia, local pain, postoperative
a study of the long-term safety of abt-089 for subjects with mild-to-moderate alzheimer's disease who participated in the m06-876 study

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of abt-089 in adults with mild-to-moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * the subject was randomized into study m06-876 and completed the study. * the subject must remain on the same dose of achei that was used during the m06-876 study. * the subject is in general good health, as judged by the investigator exclusion criteria: * the subject is currently, or plans to participate in another experimental study during the course of this trial. * the subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.
cord blood transplantation in patients with advanced lymphoid malignancies

Conditions: Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor

Summary: indication: patients with advanced lymphoid malignancies in the absence of an hla identical or mismatch donor. objectives: overall survival at one year. efficacy \>60%, rejection rate \<20%. inclusion criteria: age: 18-65 years old, no sibling or unrelated donor identified, low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation); hodgkin lymphoma in early relapse (\<1 year), who received at least one autologous transplantation and sensible to chemotherapy and cll with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation. stem cell source: two cord blood units containing both together more than 3x107 frozen nucleated cells/kg with no more than 2 out of 6 hla mismatches between them and with the patients.


Eligibility criteria:
inclusion criteria: * age: 18-65 years old * no sibling or unrelated donor identified (9/10 or 10/10) * with either one of these advanced lymphoid malignancies 1. low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation) 2. hodgkin lymphoma in early relapse (\<1 year)who received at least one autologous transplantation and sensible to chemotherapy 3. cll with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation. exclusion criteria: * no patient signed consent * previous allograft * psychiatric conditions * hiv positive * hvc hepatitis requiring treatment * previous total body irradiation (tbi) * any contraindication to tbi * any contraindication to allograft, such as cardiovascular, respiratory, renla or liver dysfunctions * no health care insurance

Keywords: cord blood transplant advanced lymphoid malignancies
endoscopic ultrasound-guided drainage of pancreatic pseudocysts

Conditions: Pancreatic Pseudocyst

Summary: the purpose of this study is to compare the effect of lumen-apposing metal stent (lams) and traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.

inclusion criteria 1. subject with ages from 18-80 years old 2. subject with pancreatic pseudocysts confirmed by ct 3. subject with a history of msap or sap, the pseudocysts were formed more than 3 months 4. the size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall 5. subject has the symptoms related with the pseudocyst 6. the consent form has been signed exclusion criteria 1. subject is younger than 18 years or older than 80 years 2. pancreatic pseudocyst communicate with the main pancreatic duct 3. subject can't accept the endoscopic procedure 4. pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess 5. the distance between gastric and the wall of the pseudocyst is more than 1 cm 6. subject with 2 or more than 2 cysts 7. subject has blood coagulation dysfunction 8. pregnant or subject has mental disorders

Eligibility criteria:
inclusion criteria: 1. subject with ages from 18-80 years old 2. subject with pancreatic pseudocysts confirmed by ct 3. subject with a history of msap or sap, the pseudocysts were formed more than 3 months 4. the size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall 5. subject has the symptoms related with the pseudocyst 6. the consent form has been signed exclusion criteria: 1. subject is younger than 18 years or older than 80 years 2. pancreatic pseudocyst communicate with the main pancreatic duct 3. subject can't accept the endoscopic procedure 4. pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess 5. the distance between gastric and the wall of the pseudocyst is more than 1 cm 6. subject with 2 or more than 2 cysts 7. subject has blood coagulation dysfunction 8. pregnant or subject has mental disorders
natural course and prognosis of pfic and effect of biliary diversion

Conditions: Progressive Familial Intrahepatic Cholestasis

Summary: the natural course of pfic syndromes and the effect of diversion techniques, have so far not been characterized in a rigorous manner within a larger population of patients. in fact, the clinical or biochemical parameters which most directly define and/or predict the success of reduced enterohepatic circulation (either by surgical diversion or medically) are still unclear. the present project aims to: 1. define the natural course of disease in patients with genetically defined fic1 deficiency (pfic1), bsep deficiency (pfic2), mdr3 deficiency (pfic3) and other subtypes of the pfic disease family (including e.g. myo5b deficiency, tjp2 deficiency, a.o.), with respect to relevant biochemical and clinical parameters (and if available, histological). included will be patients homozygous for a known, disease-causing mutation, patients compound homozygous for two disease-causing mutations or heterozygous for one disease-causing mutation in combination with the corresponding clinical phenotype . 2. define the change in the natural course of disease in response to biliary diversion surgery and or liver transplantation, based on short- and long(er)-term changes in biochemical (if available, histological) and clinical parameters, including outcome measures. follow up after transplantation will be limited, follow up after surgical biliary diversion will be as long as possible. 3. assessment of biochemical variables as possible surrogate endpoints for clinical hard endpoints. if possible this allows for identification of low-risk to high-risk patients early during follow-up. 4. if patient numbers permit, to establish genotype-phenotype relationships for the most common genetic mutations causing the indicated diseases. based on this project it is anticipated that the investigators are able: * to characterize the variation in natural course of disease (whether or not genotype dependent) to allow clinicians to rationally select a target population for assessing the effect of medical intervention, rather than surgical biliary diversion); * to identify and qualify one or more biomarkers that independently predict either improved or poor clinical outcomes of surgical biliary diversion; * to investigate if the identified biomarker(s) can be used as surrogate end point(s) for assessing and predicting outcomes with novel interventional strategies.


Eligibility criteria:
inclusion criteria: clinical suspicion for fic1-, bsep- or mdr3-deficiency or of any other subtype of the pfic family