Kornimate/medical-research-clean huggingface dataset:
comparative assessment of the clinical utility of ovarian stimulation with menotropin versus menotropin plus gnrh antagonist

Conditions: Sterility

Summary: to assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + gnrh antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination. study hypothesis: protocols combining urinary gonadotrophins + gnrh antagonist should be more effective than monotherapy.


Eligibility criteria:
inclusion criteria: * women aged 18-36 years * body mass index (bmi) between 18 and 26 * prolactin within the laboratory normal range * couples affected by sterility able to treat by iui (intrauterine insemination) * patients undergoing menopur® treatment * normal thyroid function * regular menses (21-35 days) * couples willing to participate in the study that have signed the informed consent form * seminal sample rem\>3 million exclusion criteria: * two previous art (assisted reproductive technology) cycles without ongoing pregnancy * policystic ovarian syndrome * evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
g-csf in preventing neutropenia in women receiving chemotherapy for breast cancer

Conditions: Breast Cancer; Chemotherapeutic Agent Toxicity; Neutropenia

Summary: rationale: g-csf may prevent or reduce febrile neutropenia in women receiving chemotherapy for breast cancer. it is not yet known which g-csf regimen is more effective in preventing neutropenia. purpose: this phase ii trial is studying how well g-csf works in preventing neutropenia in women receiving chemotherapy for breast cancer.

objectives: primary * evaluate the efficacy of filgrastim (g-csf) in preventing hematological toxicity in women with breast cancer receiving neoadjuvant or adjuvant chemotherapy. secondary * compare actual vs theoretical dose intensity. outline: this is a multicenter study. patients are stratified according to age (\< 65 years vs ≥ 65 years) and prior chemotherapy (adjuvant vs neoadjuvant). patients are assigned to 1 of 2 groups. * group 1: patients receive filgrastim (g-csf) subcutaneously (sc) once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. chemotherapy courses repeat every three weeks for 3-6 courses. * group 2: patients receive g-csf sc once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. chemotherapy courses repeat every three weeks for 3-6 courses. patients may also receive secondary prophylaxis with g-csf if they experience an episode of neutropenia.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens: * six courses of epirubicin hydrochloride and docetaxel * six courses of fluorouracil, epirubicin hydrochloride, and cyclophosphamide (fec) 100 or 3 courses of fec 100 and 3 courses of docetaxel 100 * must have received at least 2 chemotherapy regimens prior to study therapy * no malignant hematological disease * hormone receptor status not specified patient characteristics: * menopausal status not specified * not pregnant or nursing * fertile patients must use effective contraception * no contraindications to standard neoadjuvant or adjuvant chemotherapy * no known hypersensitivity to g-csf or any of its components * no patients deprived of liberty or under guardianship * no psychological, familial, social, or geographical reasons preventing follow-up prior concurrent therapy: * see disease characteristics * no concurrent participation in another experimental drug study

Keywords: neutropenia chemotherapeutic agent toxicity recurrent breast cancer stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
effects of tyrosine kinase inhibitors on liver enzymes and electrolytes

Conditions: Patients Diagnosed as Chronic Meyloid Leukemia

Summary: determine the effects of tyrosine kinase inhibitors on liver enzymes and electrolytes in relation to hematologic response in patients with chronic phase chronic meyloid leukemia.. assiut university hospital insight..

cml is a myeloproliferative neoplasm with unique biological and clinical features. cml accounts for 15_20% of newly diagnosed cases of leukemias among adults. cml can present in three clinical phases : chronic phase, accelerated phase and blast phase. cml is characterized by prodction of a breakpoint cluster region abelson(bcr-abl) fusion protein with abl kinase activity. this is due to reciprocal translocation between chromosome 9 and 22. imatinib \& nilotinib, an abl kinase inhibitors, which has revolutionized the cml therapy, are a selective tyrosine kinase inhibitors. the aim of the study is to determine the changes of liver enzymes and electrolytes in relation to hematologic response during treatment period.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients with cml * chronic phase cml * normal hepatic and renal functions exclusion criteria: * blastic phase cml * accelerated phase cml * hepatic \& renal impairment
the use of rfviia in trauma patients: a multi-center case registry

Conditions: Traumatic Hemorrhage; Hemorrhagic Shock

Summary: trauma surgeons throughout the us have begun using recombinant activated factor vii (rfviia) to control severe hemorrhage following injury when traditional measures have failed. despite promising results from several small studies, there remain several unanswered questions regarding the use of this relatively expensive product in injured patients including: * the timing of administration * selection of appropriate patients who are most likely to benefit * the effective dose in injured patients * the potential need for repeated dosing * the need for administration of platelets and correction of acidosis prior to administering the first dose * the risks associated with the use of rfviia including venous and/or arterial thrombosis * the potential for rfviia to cause or aggravate post-injury organ failure and/or infectious complications * an analysis of cost versus benefit the purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above. to this end, the western trauma association foundation is sponsoring a multi-center case registry for patients receiving rfviia for treatment of uncontrolled hemorrhage.

this is a prospective, multi-center case registry that seeks to combine the collective experience with the use of rfviia at ucsf/sfgh with other trauma centers. the study is being conducted under the auspices of the western trauma association and the american association of the surgery of trauma. both organizations have a long history of successfully completing multi-center studies. the outcomes to be used in this study are: 1) survival, 2) amount of blood products infused before and after rfviia, 3) coagulation factors (ptt, inr) before and after, and 4) the surgeon's assessment of hemostasis. data will also be analyzed to determine the cost effectiveness of rfviia when compared with other methods of treating severe hemorrhage, primarily administration of blood products. finally, the incidence of complications and thrombotic events after drug administration will be evaluated.

Eligibility criteria:
inclusion criteria: coagulopathy treated with rfviia exclusion criteria: none

Keywords: recombinant factor viia traumatic hemorrhage hemorrhagic shock coagulopathy
effectiveness and implementation of a clinician decision support system to prevent suicidal behaviors

Conditions: Suicide; Suicide, Attempted

Summary: the primary aim of this project are to evaluate a comprehensive, practice-ready, and deployment-focused strategy for improving the prediction and prevention of suicide attempts among a sample of 4,000 patients presenting to an ed with a psychiatric concern. our first aim is to evaluate the effects of providing information about risk of patient suicidal behavior to ed clinicians. we hypothesize that patients randomly assigned to have their clinician receive their risk score will have a lower rate of suicide attempts during 6-month follow-up and that this effect will be mediated by changes in clinician decision-making.


Eligibility criteria:
inclusion criteria: * age 18 years or older * presentation to emergency psychiatry service exclusion criteria: * inability to understand study procedures and provide informed consent, such as those with gross cognitive impairment (including florid psychosis), intellectual disability, dementia, acute intoxication * presence of violent or extremely agitated behavior
implantation of endobronchial valves versus intrabronchial valves in patients with severe heterogeneous emphysema

Conditions: Pulmonary Emphysema

Summary: patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.

patient enrollment and data acquisition is to be carried out on a prospective basis. it is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. after decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral ibv treatment or unilateral ebv treatment in each case. all patients will undergo treatment at one study centre in heidelberg.

Eligibility criteria:
inclusion criteria: * pulmonary function: fev1 \ 150 %, tlc \> 100 % * heterogeneous emphysema exclusion criteria: * homogeneous emphysema * significant bronchiectasis * severe concomitant diseases * pregnancy
effect of 10-day overnight hypoxia treatment on whole body insulin sensitivity (sleep high study)

Conditions: Insulin Resistance

Summary: the purpose of this study is to look at how a reduction in oxygen levels (hypoxia) influences insulin sensitivity and carbohydrate metabolism. it is expected that 10 nights of exposure to moderate hypoxia (\~ 15% o2, similar to conditions at an altitude of \~7500 feet) will improve glucose metabolism.


Eligibility criteria:
inclusion criteria: * aged 20-45 years * male * obese category (bmi \> 30 kg/m2) * healthy as assessed by a self-reported health questionnaire * non-smokers * weight stable over the past 3 months (\<2kg fluctuation) exclusion criteria: * female * diabetes * sleep apnea * hypertension * history of altitude sickness * individuals taking any chronic medications * individuals taking any stimulants * individuals taking beta-blockers * individuals with chronic alcohol consumption (\>3 drinks per day) or drug abuse. * individuals unable to abstain from caffeinated beverage or alcohol the days of study testing * individuals with history disease or history of stroke

Keywords: obesity hypoxia insulin sensitivity altitude
gender in face-voice integration

Conditions: Healthy

Summary: bayesian models of perception represent a promising approach to describe information processing by the brain. predictive coding hypothesizes a process in which top-down expectations are continuously compared across multiple hierarchical levels with bottom-up sensory inputs and the differences or error signals are propagated in a bottom-up direction. the investigators hypothesize that strong expectations, are best investigated in expert processes such as face and voice recognition in humans. individuals in complex social systems need to extract socially relevant information in a fast and efficient manner; hence, the majority of humans constitute face, voice and gender experts. nevertheless, linking such combined abilities to brain activity with regards to the predictive coding hypothesis has not been attempted.our results suggest asymmetric contributions of visual and auditory signals to the gender classification task. this sensitive psychophysical procedure is implemented in a decoding approach using fmri and multi-voxel pattern analysis (mvpa). the investigators plan to test whether cortical areas implicated in processing auditory and visual gender signals show similar asymmetries.


Eligibility criteria:
inclusion criteria: * healthy men and women, right-handed * no neurological antecedent * signed informed consent exclusion criteria: * pregnant women * volunteers with mri contraindications: persons using a pacemaker or insulin pump, persons with a metallic prosthesis or an intracerebral clip, as well as claustrophobic subjects, neurosensory stimulator or implantable defibrillator, cochlear implants, body foreign ferromagnetic ocular or cerebral close to nerve structures, agitation of the subject (non-cooperating or agitated subjects), ventriculoperitoneal neurosurgical bypass valves, dental apparatus. * persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty, as well as persons of legal age protected by law. * participants refusing to be informed of the results of the medical examination (inclusion). * participants refusing to be informed of the possible detection of an anomaly.

Keywords: fmri, perception, face-voice processing
jardiance regulartory post marketing surveillance in korean type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: to monitor the safety profile and effectiveness of empagliflozin in korea patients with type 2 diabetes mellitus in a routine clinical practice setting


Eligibility criteria:
inclusion criteria: 1. patients who have been started on jardiance® in accordance with the approved label in korea 2. age = 19 years at enrolment 3. patients who have signed on the data release consent form exclusion criteria: 1. known hypersensitivity to empagliflozin or any of its excipients 2. patients with type 1 diabetes or for the treatment of diabetic ketoacidosis 3. patients with persistent estimated glomerular filtration rate \<60 ml/min/1.73 m2,end stage renal disease or on dialysis 4. patients with rare hereditary conditions of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption 5. patients for whom empagliflozin is contraindicated according local label of jardiance®
effects of chronic acid-base changes on ventilatory and perceptual responses

Conditions: Healthy

Summary: approximately 30% of people aged 65 years and older experience breathlessness (perceived respiratory difficulty) during daily activity. the main causes of increased breathlessness in the healthy elderly are poorly understood and are the main focus of the proposed study. some possible contributing factors include abnormalities in the control and/or mechanics of breathing. to evaluate these possible contributory factors, the investigators will compare ventilatory and perceptual responses to: 1) exercise, 2) increased levels of inspired carbon dioxide, and 3) reduced levels of inspired oxygen under strictly-controlled experimental conditions where the investigators increase or decrease breathing requirements by altering dietary salt intake in healthy 40-80 year old men and women. exercise and rebreathing tests will be performed at baseline and at the end of each 3 day treatment period. breathlessness intensity will be measured and compared at a standardized work rate, ventilation or end-tidal pco2 during these tests.


Eligibility criteria:
inclusion criteria: * healthy, regularly active adults * non-smoking * bmi 18-30 kg/m2 exclusion criteria: * history of lung and/or heart disease (including cardiac arrhythmias) or other comorbidity which could interfere with proper conduct of the intervention or tests * hypotension or hypertension * hypercholesterolemia * sleep disordered breathing * inability to perform cycle exercise or comply with other testing procedures

Keywords: acid-base balance ventilatory control dyspnea exercise modified rebreathing procedure normal older
impact of lvad implantation on micro- and macrovascular function

Conditions: End Stage Heart Failure

Summary: end stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. heart transplantation (htx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. left ventricular assist devices (lvads) are considered as a vital therapeutic option to temporarily or permanently assist the failing circulation. the hemodynamic vascular consequences of implanting lvads have not been studied in detail. the aim of the study is to investigate the effect of lvad implantation compared to heart transplant (htx) on micro- and macrovascular function in patients with end stage heart failure.


Eligibility criteria:
inclusion criteria: * patients after htx * patients after lvad implantation * patients with stable coronary heart disease and normal systolic left ventricular function * healthy volunteers * written informed consent exclusion criteria: * acute inflammation * cardiac arrhythmia * renal failure * malignant disease

Keywords: left ventricular assist device endothelial function microvascular perfusion microparticles
evaluate efficacy and safety in chinese patients with infantile-onset pompe disease with one year alglucosidase alfa treatment

Conditions: Glycogen Storage Disease Type II

Summary: primary objective: to evaluate effect of 52-week treatment with alglucosidase alfa in the extension of survival and improvement of cardiomyopathy measured by left ventricular mass index in chinese patients with infantile-onset pompe disease. secondary objectives: * to observe the improvement of physical growth, motor and cognitive development of 52-week treatment with alglucosidase alfa in infantile-onset pompe disease from the baseline. * to observe the efficacy on survival free of invasive ventilation, use of any ventilation support of 52- week treatment with alglucosidase alfa in chinese patients with infantile-onset pompe disease. * to evaluate the safety and tolerability of alglucosidase alfa in chinese patients with infantile-onset pompe disease.

total of 56 weeks in the study period, including an up to 28-day screening period and 52-week treatment period, followed by 30-day post-treatment observation period. after the end of 52-week treatment, patients' guardians could choose to participate in a patient assistance program (pap) sponsored by sanofi and launched before first patient out (fpo) or reimbursement from social insurance for continued treatment.

Eligibility criteria:
inclusion criteria: * subject's parents or legal guardians must provide written informed consent prior to any study-related procedures. * documented onset of pompe disease symptoms up to 12 months of age (corrected for gestation if born before 40 weeks); diagnosis of pompe disease confirmed by acid alpha-glucosidase enzyme deficiency from any tissue source and acid alpha-glucosidase gene mutations. * age 0-12 months at enrollment, defined as at the time of providing written informed consent. * cardiomyopathy (abnormal left ventricular mass indices \[lvmis\], measured by echocardiography, abnormal value is defined as ≥65 g/m2 for patients up to 12 months old) confirmed by cardiologist at study site. exclusion criteria: * patient who has previously been treated with acid alpha-glucosidase. * patient who is participating in another clinical study using any investigational therapy. * conditions/situations such as: * clinical signs of cardiac failure with ejection fraction \< 40%. * respiratory insufficiency (oxygen saturation \ 55 mm hg \[venous\] or \> 40 mm hydrargyrum \[arterial\] in room air or any ventilator use). * patients who are dependent on invasive or non-invasive ventilator support. * patients with major congenital anomaly or clinically significant intercurrent organic disease unrelated to pompe disease. * patients not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
comparison of levobupivacaine, ropivacaine and bupivacaine in epidural anaesthesia

Conditions: Pain Insensitivity, Congenital

Summary: this study compares the clinical efficacy of newer local anaesthetic drugs levobupivacaine and ropivacaine with bupivacaine in lumbar epidural anaesthesia for hip surgeries.

some of the most common day care surgeries are hip surgeries, in which local anaesthetic agents can be used via epidural route for both intra-op and post-op analgesia. among the drugs used nowadays are lignocaine, bupivacaine, levobupivacaine and ropivacaine.however bupivacaine usage is not free from side effects. the claimed benefits of both levobupivacaine and ropivacaine are reduced cardiac toxicity on overdose and more specific effects on sensory rather than motor nerve fibres. ropivacaine, an analog of mepivacaine, is one of the long acting amide anaesthetic agent similar to bupivacaine in chemical structure and anaesthetic function. it is a first enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and rapid recovery of motor function. levobupivacaine is the pure s (-)-enantiomer of bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia than its racemic parent.

Eligibility criteria:
inclusion criteria: * asa grade i and ii patients of either sex * age 18-60 years * undergoing various hip surgeries under lumbar epidural anesthesia exclusion criteria: * refusal for epidural * asa-iii\&iv * head injury * psychiatric disease * known allergic to test drugs * major systemic disease * any analgesia with in past 24 hours

Keywords: lumbar epidural anaesthesia