Kornimate/medical-research-clean huggingface dataset:
retarded surgery following neoadjuvant chemotherapy in advanced ovarian cancer

Conditions: Ovarian Cancer Stage IV; Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IIIb

Summary: the aim of chrono trial is to compare the dfs when surgery is performed after 3 courses of nact, or after 6 courses of nact, in a prospective multi institutional randomized setting,considering only patients initially unsuitable for primary surgery.


Eligibility criteria:
inclusion criteria: 1. female patients ≥18 years. 2. histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma, high grade serous or endometrioïd, with the exception of mucinous, clear cell and carcinosarcoma histologies. 3. performance status \< 2 (see appendix 2). 4. documented international federation of gynecologic oncology (figo 2014, appendix 1) stage iiib-iiic-iva unsuitable for complete primary cytoreductive surgery (confirmed by open laparoscopy or by laparotomy \[not mandatory for stage iva\]). 5. patient must be judged resectable after 3 courses of neoadjuvant chemotherapy 6. adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery: * white blood cells (wbc) \>3x109/l, absolute neutrophil count (anc) ≥1,5x109/l, platelets (plt) ≥100x109/l, hemoglobin (hb) ≥9 g/dl, * serum creatinine \<1.25 x upper normal limit (unl) or creatinine clearance ≥ 30 ml/min according to cockroft-gault formula or to local lab measurement, serum bilirubin \<1.25 x unl, ast(sgot) and alt(sgpt) \<2.5 x unl. 7. signed informed consent obtained prior to any study-specific procedures. 8. patient affiliated to, or a beneficiary of, a social security category exclusion criteria: 1. mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies. 2. synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites). 3. patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (cva, stroke) or transient ischemic attack (tia) or subarachnoid hemorrhage before 6 months from the enrollment on this study. 4. any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol (including but not limited to impaired cardiac function or clinically significant cardiac diseases, active or uncontrolled infections, hiv-positive patients on antiretroviral therapy, uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impaired respiratory function requiring oxygen-dependence, serious psychiatric disorders). 5. pregnant or breastfeeding women.

Keywords: ovarian cancer retarded surgery neoadjuvant chemotherapy
noradrenergic manipulation and virtual reality exposure therapy in phobic participants

Conditions: Phobic Disorders

Summary: recent advances in animal research have identified pharmacological agents that appear to both accelerate and consolidate extinction learning. one cognitive enhancers is yohimbine hydrochloride (yoh). a finding in animal literature is that the administration of yoh during extinction trials accelerates fear reduction and may convert ineffective exposures in to successful ones. it is thought that the mechanism of enhanced emotional memory is through elevated norepinephrine. however, recent findings demonstrate mixed results. in a randomized controlled trial claustrophobic participants underwent exposure in combination with yoh or placebo. the yoh group showed significantly better results on anxiety improvement than the placebo group. in a more recent study with participants with fear of flying no additional benefits of yoh were demonstrated. therefore, we intend to replicate and extend these studies by enhancing the dose of yoh in combination with vret and by extending our experimental design with another group which receives propranolol in combination with vret. propranolol is β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation in healthy humans. in this randomized controlled trial a between groups design is chosen to further characterize the differential within and between trial extinction and to enhance possible between groups effects. sixty participants with fear of flying or fear of heights will be randomly assigned to one of the following three conditions 1) vret plus yoh, 2) vret plus propranolol, or 3) vret plus placebo. participants in all conditions will be offered three sessions of vret over a period of two weeks.


Eligibility criteria:
inclusion criteria: * marked fear of flying or acrophobia, indicated by a subjective fear rating of moderate or higher on anxiety specific measures. being older than 18 years and younger than 75 years. exclusion criteria: -

Keywords: phobic disorders (fear of flying and acrophobia) virtual reality exposure therapy fear extinction propranolol yohimbine
investigating temporal improvements in survival following st-elevation myocardial infarction.

Conditions: Acute Myocardial Infarction

Summary: the aim of the study was to use data from the myocardial ischaemia national audit project (minap) to investigate whether temporal improvements in survival were associated with changes in patients' baseline clinical risk or use of guideline-indicated treatments for the management of stemi, and to determine the extent to which associations explained the temporal improvements in survival.


Eligibility criteria:
inclusion criteria: * aged 18 years or more * patients hospitalised with st-elevation myocardial infarction exclusion criteria: * patients hospitalised with phenotypes other than st-elevation myocardial infarction

Keywords: acute myocardial infarction mortality evidence-based care myocardial ischaemia national audit project st-elevation myocardial infarction
a study of ly3475766 in healthy participants

Conditions: Dyslipidemias

Summary: this study will evaluate the safety and tolerability of ly3475766 when given to participants with high levels of blood fat called triglycerides. it will also investigate how the body processes the study drug and the effect of the study drug on the body. information about any side effects will be documented. this study will last up to 16 weeks for each participant.


Eligibility criteria:
inclusion criteria: * are overtly healthy males or females, apart from dyslipidemia * male participants must agree to adhere to contraception restrictions * female participants must be of nonchildbearing potential and include those who are infertile due to surgical sterilization or those who are postmenopausal * have a body mass index (bmi) \>18.5 and \<40 kilograms per meter squared (kg/m²) * have clinical laboratory test results within normal reference range, or acceptable deviations per investigator discretion * have a fasting triglyceride (tg) level that is 135 to 499 milligrams per deciliter (mg/dl), inclusive, at both screening and day -1 * have a fasting low density lipoprotein cholesterol (ldl-c) level greater than or equal to (≥) 70 mg/dl, inclusive, at screening and day -1 * have had a stable body weight for the 3 months prior to randomization (\<5% body weight change) * have not modified diet or adopted any nutritional lifestyle modification within 3 months prior to randomization exclusion criteria: * are taking or have started taking proprotein convertase subtilisin/kexin type 9 (pcsk9) inhibitors within 3 months prior to randomization; or statins, fibrates, or niacin ≤1000 mg/day within 8 weeks prior to randomization; or niacin \>1000 milligrams per day (mg/day) within 16 weeks prior to randomization; or any other lipid-lowering agents within 1 month prior to randomization * are taking or have started taking a beta-blocker, antiarrhythmic, non-dihydropyridine calcium channel blocker, ivabradine, or any other heart rate lowering agent within 1 month or 5 half-lives prior to randomization, whichever is longer * have a diagnosis of diabetes mellitus (type 1 diabetes mellitus or type 2 diabetes mellitus) or have 1 of the following at screening: fasting plasma glucose concentration ≥126 mg/dl (7.0 millimoles per liter \[mmol/l\]) or a glycated hemoglobin level ≥6.5% (48 millimoles per mole \[mmol/mol\]) * have previously completed or withdrawn from this study or any other study investigating ly3475766, and have previously received the investigational product * have known allergies to ly3475766, related compounds, or any components of the formulation, or history of significant atopy * have a seated heart rate ≤50 beats per minute * have clinically significant abnormal electrocardiogram (ecg) results constituting a risk while taking the investigational product, as determined by the investigator * have an abnormal blood pressure (bp) as determined by the investigator
a study comparing the efficacy and safety of chf 1535 (bdp +ff) inhalation powder, administered via the next inhaler, versus chf 1535 (bdp +ff), administered via a pmdi, in moderate to severe asthma

Conditions: Asthma

Summary: to demonstrate that chf 1535 via next dpi (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of chf 1535 via hfa-134a "extrafine" pmdi in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids


Eligibility criteria:
inclusion criteria: * written informed consent * outpatients of both sexes, aged \> 12 years * moderate to severe symptomatic asthma * forced expiratory volume in the first second (fev1) \> 40% and \< 80% of the predicted normal values * reversibility test * "partly controlled" asthma (gina revised 2006) * patients free of long-acting beta2-agonists (labas) treatment * under inhaled corticosteroids (ics) treatment * a minimum inspiratory flow ≥ 40 l/min 10. * non-smokers or ex smokers * asthma control questionnaire acq score ≥ 1.5 exclusion criteria: * pregnant or nursing (lactating) women * women of child-bearing potential, unless they are menopausal or have acceptable methods of contraception * significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer * history of near fatal asthma * occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit * diagnosis copd * history of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency * diagnosis of restrictive lung disease * patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids) * intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids * allergy to any component of the study treatments * any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit * significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ; * patients with abnormal qtc
a study to determine the feasibility of wireless electrocardiography

Conditions: Atrial Fibrillation; Premature Atrial and Ventricular Beats; Conduction Defects; Normal Sinus Rhythm

Summary: the investigators are conducting a prospective, observational study to examine the ecg waveforms captured by the new medical device as compared to a traditional holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by qualified clinicians. the hypothesis is that this new medical device prototype is non-inferior to traditional holter monitoring for capturing ecg waveforms that can be visually assessed for atrial and ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.


Eligibility criteria:
inclusion criteria: * patients must be at least 18 years of age * patients must have a medical indication to wear a holter monitor * patients must not be pregnant * patients must be able to comply with the study procedures * patients must be willing to participate and able to provide informed consent * patients must be willing to wear both devices (holter and the wireless device prototype) simultaneously and continuously for a 2 to 3 hr period exclusion criteria: * patients who are not able or willing to comply with study procedures * patients with an existing implanted cardioverter-defibrillator and/or pacemaker * patients with a known life threatening arrhythmia * patients who manifest low voltage on their electrocardiogram * patients affected by inflammatory and/or infectious skin disorders
a single center study to evaluate the efficacy and safety of etc 1002 in subjects with type 2 diabetes

Conditions: Hyperlipidemia; Type 2 Diabetes

Summary: this phase 2 study will asses the ldl-c lowering efficacy of etc-1002 versus placebo in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes meeting all of the following: * minimum 6 month history of diabetes prior to screening visit; * fasting c-peptide ≥ 0.8 ng/ml at screening visit; * hba1c at screening visit 7-10%; * fasting glucose from 140-270 mg/dl on day -7 following washout of all glucose regulating drugs and supplements. * bmi at screening visit from 25-35 kg/m2; * ldl-c at screening ≥ 100 mg/dl
effect of liraglutide vs cpap on cardiometabolic outcomes in obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: this is an explorative, proof-of-concept study exploring the potential therapeutic role of a liraglutide-based weight loss regimen versus standard cpap or the combination of both on metabolic parameters, blood pressure, endothelial function, coronary artery calcification, vascular inflammation and apnea/hypopnea index in non-diabetic patients with moderate to severe obstructive sleep apnea


Eligibility criteria:
inclusion criteria: * newly diagnosed moderate-severe osa (by standard psg) * body mass index between 30 - 40 * age 18 - 60 years * able to provide written, informed consent exclusion criteria: * pregnancy * requirement for supplemental oxygen * previous diagnosis of osa or previous cpap treatment * diagnosis of diabetes * previous treatment with glp-1 analogue * previous surgical treatment for obesity * active treatment for malignancy or severe psychiatric disorder * acute coronary syndrome or stroke within 3 months prior to study * history of decompensated heart failure * professional drivers or drivers with a history of road-traffic accident due to sleepiness * severe excessive daytime sleepiness defined as epworth sleepiness scale \>15

Keywords: liraglutide continuous positive airway pressure insulin resistance vascular inflammation
french hiv-hbv cohort

Conditions: Hepatitis B; HIV; Liver Cirrhosis; End Stage Liver Disease

Summary: the overarching purpose of this study is to further understand the reasons for and clinical implications of persistent hbv infection in patients co-infected with hiv and hbv in the era of highly effective antiviral treatment against both viruses.

the french hiv-hbv cohort is an observational, non-interventional study including 308 hiv-infected patients with chronic hbv infection (hbsag-positive serology \>6 months) in seven clinical centers. patients were recruited in 2002-2003 and followed prospectively every three to twelve months, during two phases, until 2010-2011. extensive information on a variety of hiv- and hbv-related parameters were collected during these study visits. this particular study aims to extend follow-up of the french hiv-hbv cohort using a different type of design. patients who completed at least one study phase of the french hiv-hbv cohort are selected for participation. patients continuing follow-up at a participating clinical center are asked to undergo their routine clinical visit, during which time medical data from the years since last cohort visit until their routine visit are extracted. for those who died, information from the years since last cohort visit until death will be collected. the primary objective for this cohort extension is to further understand the reasons for and clinical implications of persistent hbv infection in patients co-infected with hiv and hbv in the era of highly effective antiviral treatment against both viruses. the following secondary objectives are as follows: * to establish the extent of persistent viremia (pv) of hbv, quantified either in serum or within the hepatocyte * to understand whether this persistence effects clinically-relevant serological outcomes (i.e. hbeag and hbsag seroclearance and seroconversion along with hbsag quantification) after prolonged follow-up * to quantify the evolution of liver fibrosis using non-invasive methods and, in a small subset of patients, liver biopsies, while investigating the virological and immunological factors associated with its progression and regression * to describe the causes of liver-related and non-liver-related morbidity and mortality and the direct effect of persistent hbv dna replication on these outcomes

Eligibility criteria:
inclusion criteria: * hbsag seropositivity for \>6 months (at initial cohort inclusion) * hiv-positive serology confirmed with western blot (at initial cohort inclusion) * karnofsky score \>70 (at initial cohort inclusion) * age ≥18 years old (at initial cohort inclusion) * completed follow-up in at least one previous study phase of the french hiv-hbv cohort * obtained signed written informed consent exclusion criteria: * refusal to participate * any severe physical, clinical or mental condition preventing participation
impact of nmes and hpro on recovery after sah- pilot study

Conditions: Subarachnoid Hemorrhage; Muscle Atrophy; Inflammation; Nutritional and Metabolic Disease

Summary: the study purpose is to investigate the hypothesis that in adults with sah, early neuromuscular electrical stimulation (nmes) and high protein supplementation (hpro) will improve muscle mass, metabolic and inflammatory biomarker profiles, compared to sah controls receiving standard of care interventions for nutrition and mobilization. the investigators will accomplish this by studying the effects of a high protein (hpro) nutritional treatment as well as nmes intervention have upon muscle wasting and motor strength acutely after sah. this will be addressed in a prospective trial of sah patients receiving hrpo with nmes as compared to age and severity-matched sah patients undergoing standard of care interventions for nutrition and mobilization. additionally, the study will investigate the impact hpro and nmes interventions have upon inflammatory cytokines and markers of energy balance. results of this study will establish evidence for precision nutrition plus early exercise to mitigate the catabolic and inflammatory state produced by sah to improve muscle, metabolic, and health recovery outcomes.


Eligibility criteria:
inclusion criteria: 1. . being diagnosed with aneurysmal sah 2. . aneurysmal repair within 48 hours of ictus. 3. . age between 25 and 80 years old. (\>=25 years old and \<=80 years old) 4. . expected stay in the nccu \> 72 hours. 5. . admission hunt hess grade \>=2. 6. modified fisher score \>1. exclusion criteria: 1. . subjects diagnosed with sah from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes; 2. . unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care; 3. . unlikely to remain in the icu for more than 7 days; 4. . body mass index \ 40 kg/m2; 5. . allergy to whey protein; 6. . evidence of lower extremity paresis or spasticity within 48 hours of injury 7. . pre-morbid modified rankin score \>1. 8. . known pregnancy 9. . presence of active malignancy 10. . diagnosis of an inflammatory disorder 11. . presence of a neuromuscular disorder 12. . diagnosis of chronic renal insufficiency or acute kidney injury (gfr \< 30 ml/min/1.73m2) 13. . hepatic insufficiency defined as ast/alt levels \>2.5 above normal upper limits. 14. . on-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (ceeg) at time of enrollment 15. . prisoner.
family networks (fans) for children with developmental disorders and delays

Conditions: Neurodevelopmental Disorders; Developmental Disabilities

Summary: over 6% of children in pakistan suffer from a developmental disorder (intellectual disability or autistic spectrum disorder) and most receive no intervention.in an earlier proof of concept study, the investigators integrated social, technological and business innovations to develop and successfully pilot a sustainable service for such children in one rural population of 30,000. affected families were identified through a mobile phone-based interactive voice response system, and organised into family networks. 'champion' family volunteers were trained in evidence-based interventions. a tablet-based android application was developed for training, monitoring and supervision of the champions, based on the world health organization's guidelines. the champions delivered the intervention to other families in the network. the project was sustainable and demonstrated significant improvements in the lives of children and their families in the first 6 months of its operation. the investigators are scaling-up this intervention to a population of 1 million. the investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up programme using cluster randomized control trial nested within the scale-up study.


Eligibility criteria:
inclusion criteria: * children aged between 2-12 years, * screen positive on any of the ten questions screen questionnaire items # 1,4,5,7,8,9,10 for developmental disorders and delays. * developmental disorder and delay present according to clinical assessment (history \& clinical examination for developmental delay in motor, communication, social, cognitive, daily living skills domains according to mhgap developmental disorders guidelines for clinical assessment exclusion criteria: * co-morbid physical or mental conditions in the child requiring inpatient hospitalization * deafness or blindness in the child * primary caregiver not available or unwilling to participate in the intervention program for 6 months * physical or mental conditions in the primary caregiver needing inpatient hospitalization or frequent outpatient visits (more than two times a month) * written consent not obtained for participation in the trial by the primary caregiver

Keywords: cluster randomized trial developmental delays neurodevelopmental disorders autism intellectual disability low resource settings family volunteers