Kornimate/medical-research-clean huggingface dataset:
effect of varying testosterone levels on insulin sensitivity in normal and ihh men

Conditions: Hypogonadism

Summary: type 2 diabetes is one of the most common metabolic disorders in the u.s, estimated to affect 16 million americans. established risk factors for this disease include obesity, increased waist/hip ratio, high insulin levels in the blood, and insulin resistance. testosterone may play a role in developing or preventing diabetes, but we do not yet know for sure. the purpose of this research study is to determine if changing testosterone levels in men will result in changes in insulin sensitivity. information learned form this research study may have important public health implications and may point to new strategies for treating or preventing diabetes.

the overall aim of this study is to examine the effect of testosterone on insulin sensitivity using the models of acute and chronic hypogonadism. all subjects will be in good general health and 2 groups of men will be studied in this protocol: 1. thirty healthy normal men aged 18-75 years with normal blood pressure, normal testosterone levels, and not taking any medications known to influence glucose homeostasis or testosterone 2. ten adult men (over the age of 18) with idiopathic hypogonadotropic hypogonadism (ihh)and normal thyroid, adrenal, and growth hormone axes as well as normal prolactin levels and no abnormalities on imaging of the hypothalamic-pituitary region. these men will be on no medications known to influence glucose homeostasis and will have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement.

Eligibility criteria:
inclusion criteria: healthy men: good general health, * normotensive, * normal testosterone levels, * no medications known to influence glucose homeostasis or testosterone levels ihh men: * good general health; * normal thyroid, adrenal, and gh axes; * normal prolactin levels; * no abnormalities on imaging of the hypothalamic-pituitary region; * no medications known to influence glucose homeostasis; * must have been off hormone therapy for a suitable washout period depending on the type of prior androgen replacement

Keywords: ihh kallmann syndrome hypogonadism
prevention of cf exacerbation in childhood: prevec study

Conditions: Cystic Fibrosis; Children; Exhaled Breath Condensate; Non-invasive Inflammatory Markers; Volatile Organic Compounds; Home Monitoring; Quality of Life

Summary: pulmonary exacerbations of cf are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. therefore, prevention of exacerbations in cf is important. the aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with cf. in addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.


Eligibility criteria:
inclusion criteria: * cf disease is defined as the combination of: 1. characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoea); 2. and/or abnormal sweat test (chloride \> 60mm); 3. and/or two cf mutations. exclusion criteria: 1. cardiac abnormalities; 2. mental retardation; 3. no technical satisfactory performance of measurements; 4. on the waiting list for lung transplantation; 5. non-compliance with the home-assessments; 6. patients with burkholderia cepacia; 7. participation in another intervention trial.

Keywords: cystic fibrosis children exhaled breath condensate non-invasive inflammatory markers volatile organic compounds home monitoring quality of life
recombinant human insulin-like growth factor (rhigf-1) treatment of short stature associated with igf-1 deficiency

Conditions: Insulin-Like Growth Factor-1 Deficiency; Growth Disorders

Summary: this study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhigf-1) in increasing height velocity.

growth failure associated with primary igf-1 deficiency (igfd). primary igfd is a term that has been used to describe patients with intrinsic cellular defects in growth hormone (gh) action. in this protocol, primary igfd is defined as short stature (\<-2 standard deviations \[sds\] below the mean for age and gender), and abnormal serum igf-1 (\<-2 sds below the mean for age and gender). the trial is an open-label, concentration-controlled trial conducted at up to 20 centers throughout the united states.

Eligibility criteria:
inclusion criteria: * chronological age ≥ 3 * chronological age or bone age ≤ 12 for boys and ≤ 11 for girls * prepubertal at visit 1 * height sd score of \< -2 * igf-1 sd score of \< -2 exclusion criteria: * prior treatment with gh, igf-1, or other growth-influencing medications * growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality) * chronic illness such as diabetes, cystic fibrosis, etc.

Keywords: primary igf-1 deficiency igf-1
prospective study on endoscopic ultrasound (eus) celiac bloc efficacy in chronic pancreatitis

Conditions: Pancreatitis, Chronic

Summary: the purpose of this study is to determine if celiac bloc (with injection of steroid and local anesthetic) is superior to a sham procedure for pain control and quality of life improvement in patient with chronic pancreatitis and abdominal pain.

chronic pancreatitis is a condition that can lead to very disabling pain symptoms that are difficult to control. the use of morphine is often necessary and also induces a series of secondary symptoms. in this context, the injection into the celiac plexus block of a local anesthetic has often been proposed as an alternative. this procedure, by interrupting the afferent pain signal of pancreatic origin, aims to reduce pain and improve quality of life at the cost of fewer side effects. this procedure can be performed transcutaneously using the anatomical landmark or under radiological control. it can also be performed via endosonography (eus) with better control of the injection site under ultrasound control. the results of the literature concerning the efficacy of the celiac block in chronic pancreatitis are rather encouraging with reported figures of partial or complete pain control in 39 to 65% of patients \[1-7\]. however, the number of prospective studies concerning this technique performed endoscopically remains low to date. in particular, there are no case control studies. data is also poor on the impact on quality of life. the study proposed here will therefore attempt to provide answers to the questions still pending: is the block by eus superior to a diagnostic eus without treatment? ; how long does this treatment last? ; does it have an impact on the quality of life of patients? this study and its draft are inspired by a similar recent study conducted in our department on patients with pancreatic neoplasia. the results of the latter are being submitted for publication.

Eligibility criteria:
inclusion criteria: * abdominal pain compatible with pancreatic ethiology since at least 3 months * chronic pancreatitis on computed tomography (ct), endoscopic retrograde cholangiopancreatography (ercp) or eus * eus feasible * inform consent exclusion criteria: * pregnant women * allergy to local anesthetic * acute pancreatitis in the last 2 weeks * suspicious lesion on pancreatic eus examination * celiac bloc in the last 3 months

Keywords: pancreatitis, chronic abdominal pain celiac bloc endosonography
oestrogen withdrawal in hypopituitary women

Conditions: Hypopituitarism

Summary: by exploring hormonal status in hypopituitary women during oestrogen treatment and without estrogen substitution the influence on sexhormones and organ function is estimated.

38 hypopituitary women were examinined twice. during oestrogen treatment and after 1 month estrogen withdrawal. a control group of healthy women were examined once.antropometric data and hormonal parameters were collected.

Eligibility criteria:
inclusion criteria: * hypopituitarism
insulin therapy for postreperfusion hyperglycemia

Conditions: Hyperglycaemia (Diabetic); Liver Transplantation

Summary: glycemic control during liver transplantation is challenging especially after reperfusion of the liver graft. insulin dose to treat postreperfusion hyperglycemia is retrospectively analyzed using historical data. the proposed dose then is prospectively applied to the patients to assess the adequacy of the insulin dose.

hyperglycemia is common during liver transplantation ,especially after graft reperfusion. response to insulin is frequently unpredictable during postreperfusion period with no consensus or guidelines on glycemic control. the primary aim of this mixed retrospective/prospective study is to investigate the optimal insulin dose to treat hyperglycemia during the postreperfusion period of liver transplantation. in the retrospective study, adult liver recipients (\>18 years old) who underwent liver transplantation between 2004 and 2016 are reviewed. delta glucose is the primary outcome variable defined as the difference in blood glucose levels before and after insulin administration. the relationship between the insulin dose and delta glucose is analyzed with a linear mixed effects analysis to find the optimal insulin dose to treat postreperfusion hyperglycemia. in the prospective trial, the proposed insulin dose is administered to the patient who showed hyperglycemia after graft reperfusion. the frequency and magnitude of glucose reduction is the primary outcome. the secondary outcome is the incidence and degree of hypoglycemia.

Eligibility criteria:
inclusion criteria: * liver recipients who showed hyperglycemia (blood glucose \>180mg/dl) after reperfusion of liver graft. exclusion criteria: * pediatric patients

Keywords: insulin liver transplantation hyperglycemia
electronic pharmacotherapy risk management

Conditions: Asthma; Mental Health; Pain

Summary: the purpose of the utah eprm (electronic pharmacotherapy risk management) project is to improve quality and safety of medication use while simultaneously controlling costs and detecting fraud and abuse.

the eprm project has two objectives: 1. refine and implement a computerized surveillance and trigger tool to support medication therapy and risk management services. the eprm tool will be used to (1) identify potential drug-therapy problems, which include quality, safety and cost-related problems; (2) select patients and providers for in-depth clinical reviews and possibly direct intervention (i.e., letter, phone call, medication therapy management services (mtms), or academic detailing); (3) identify potential fraud and diversion of controlled substances; and (4) track patterns of medication use and evaluate eprm performance, identify improvements, and direct policy change. 2. conduct innovative multi-pronged interventions that are guided by the eprm trigger tool. clinical areas chosen for review include diabetes therapy, hypertension, asthma, antipsychotic therapy, pain management (opioid narcotics and anticonvulsants) and anticoagulation/antiplatelet drugs. interventions in these areas will address potential under and overuse, or patient safety concerns. clinical pharmacists and physicians will implement five types of inter-related interventions: a) provider level reviews, which includes prescribers' profiling and feedback for outlier prescribers; b) patient level reviews and letters to prescribers for high-risk patients; c) phone consultation and academic detailing with outlier prescribers; d) mtms; and e) detecting and pursuing suspected fraud and abuse cases.

Eligibility criteria:
inclusion criteria: * all medicaid recipients and providers with in the salt lake area exclusion criteria: * each participant much be a medicaid recipient

Keywords: fraud and abuse opioids
efficiency assessment of breform. a multicentric stepped-wedge randomized control trial.

Conditions: Schizophrenia

Summary: in psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. it is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. for single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. for caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care. currently, the organization of the french care system does not allow these recommendations to be met. in order to increase the use of psychoeducation in france, early interventions for caregivers must be offered systematically. the effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in france.

the breform project proposes to train health professionals in an early psychoeducation program, the bref program, in order to implement it in their structure, and to evaluate its impact on the burden of caregivers of users living with a first psychotic episode or a schizophrenic disorder. regarding caregivers' outcomes: outcome measures will be assessed at baseline (visit 1, v1), 6 weeks (visit 2, v2), 6 months (visit 3, v3), 12 months (visit 4, v4) after baseline in the active group and in the treatment as usual group regarding patients' outcomes: outcome measures will be assessed at baseline and 12 months after baseline in the active group and in the treatment as usual group regarding mental health professionals' outcomes: outcome measures will be assessed before, after and 16 months after the training course regarding the psychiatric departments' outcomes: outcome measures will be assessed at baseline and 36 months after baseline

Eligibility criteria:
inclusion criteria: * people over 18yo * first-degree relatives (parents, siblings, children) or spouse of the patient * primary caregiver of a patient with schizophrenic disorders or first psychotic episode (dsm5) * consenting to participate to the study exclusion criteria: * mental disorder on axis i * having already benefited from a family intervention such as psychoeducation * caring for several people with severe psychiatric disorders * receiving income for the caring activities * being legally responsible of the patient * having difficulty understanding fluent french * illiterate
study comparing veliparib plus carboplatin and paclitaxel versus investigator's choice of standard chemotherapy in adults receiving first cytotoxic chemotherapy for metastatic or advanced non-squamous non-small cell lung cancer (nsclc) and who are current or former smokers

Conditions: Non-squamous Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * subject must be ≥ 18 years of age with life expectancy \> 12 weeks. * subject must have cytologically or histologically confirmed advanced or metastatic non-squamous nsclc and are current or former smokers. * subject must have nsclc that is not amenable to surgical resection or radiation with curative intent at time of screening. * subject must have at least 1 unidimensional measurable nsclc lesion on a computed tomography (ct) scan as defined by response evaluation criteria in solid tumors (recist) version 1.1. exclusion criteria: * subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (cremophor). * subject has a known hypersensitivity to platinum compounds. * subject has peripheral neuropathy ≥ grade 2. * subject has squamous nsclc, or an untreated known epidermal growth factor receptor (egfr) mutation of exon 19 deletion or l858r mutation in exon 21, or a known anaplastic lymphoma kinase (alk) gene rearrangement. * subject has received prior cytotoxic chemotherapy or chemoradiotherapy for nsclc.

Keywords: veliparib carboplatin paclitaxel cisplatin pemetrexed poly adenosine diphosphate (adp)-ribose polymerase (parp) metastatic non-squamous non-small cell lung cancer
empower rural extension weight management pilot study

Conditions: Obesity; Overweight; Weight Loss

Summary: this research is to expand a virtual weight loss and weight maintenance program to rural counties of illinois. the program uses dietary and lifestyle modifications for adults with obesity. the empower weight loss program has proven to be effective in 3 previous trials. in this research, we target a rural participant population. individuals in rural locations are more likely to be affected by obesity and have unique barriers to weight loss related to geographic isolation including access to health care, preventative care, grocery stores, social networks, internet, and cell service.

empower is a remote weight management program that uses an online textbook platform, e-text, and mobile web application, mealplot. this pilot study will test for feasibility of the empower program in a rural population prior to launching a full-scale study. acceptability measurements will be collected at 3 months to evaluate for needed changes; participants of the pilot study will be permitted to continue on with the full program. empower is a 1-year intervention. data is collected via 24-hour record and daily weighing using a wi-fi-enabled scale. 24-hour records and daily weights are collected within the program's proprietary mealplot website. empower consists of 17 online sessions (45 minutes/each) and 12 individual advising sessions with a nutrition coach.

Eligibility criteria:
inclusion criteria: * age 18-75 years; * bmi in overweight to above range; * not currently pregnant or lactating; * willing to access wi-fi via home or free public wi-fi location at least once a week for 45 minutes * access to a working email * willing to weigh daily and provide data either via bluetooth, wi-fi, or manual input * willing to lose 20 lb. or more and maintain a healthy weight for one year thereafter; * continue daily-weighing for 12-months after the year-long intervention (daily weigh for a total of 2 years); * fluent in reading and writing english. * live within one of the counties of the covered extension education offices: eastern (clark, crawford, edgar), northern (jo daviess, stephenson, winnebago), western (macoupin, christian, jersey, montgomery) exclusion criteria: * age \ 75 years; * severe chronic diseases; * underweight to normal bmi; * currently pregnant; * currently lactating; * failed to commit to daily weighing; * failed to submit 3, 24 hour records; * underwent bariatric surgery or planning on having bariatric surgery within the next year including: roux-en-y gastric bypass, sleeve gastrectomy, duodenal jejunal bypass with sleeve gastrectomy, duodenal switch, laparoscopic adjustable gastric banding.

Keywords: obesity overweight weight loss rural nonmetropolitan protein fiber
the effect of entecavir consolidation on post-tdf treatment durability

Conditions: Chronic Hepatitis B

Summary: clinical relapse occurred much earlier and tended to be more severe after cessation of tdf than etv. the follow-up interval and intensity would be different between etv and tdf after discontinuation of therapy. whether switch therapy from tdf to etv can modify the pattern of relapse is interesting but unclear. our hypothesis is that entecavir consolidation on post-tdf treatment patients reduce and delay the clinical relapse effectively. hence in this proof of concept study we would like to evaluate the effect of 6 months and 12 months of entecavir consolidation on post-tdf treatment durability.

long term nucleoside/nucleotide analogues (nas) treatment is required in the treatment of chronic hepatitis b (chb). according to current treatment guidelines from apasl 2015, nas treatment can be stopped if, after hbsag loss following either anti-hbs seroconversion or at least 12 months of a post-hbsag clearance consolidation period or after treatment for at least 2 years with undetectable hbv dna documented on three separate occasions, 6 months apart. in taiwan, the national health insurance system only reimburse 3 years nas for chb patients. previous study from jeng et al. suggested that the 1-year rate of clinical relapse (hbv dna\>2,000 iu/ml plus alt\>2x uln) after cessation of entecavir(etv) therapy by apasl stopping rule (treatment \>2 years, hbv dna undetectable \>1 year) in hbeag-negative chronic hepatitis b(chb) patients was 45%, of which 25.6% occurred within 6 months. recently, another study from jeng et al showed that 34 hbeag(-) patients who stopped tdf therapy by apasl stopping rule were followed-up every 1-3 months for \>6 months. of these 34 patients, mean age was 51.8 years, 82.4% were males and 14(41.2%) were cirrhotic. the 1-year cumulative clinical relapse rate was 46%, of which 93.3% occurred within 6 months, and 13.3% developed decompensation. clinical relapse occurred much earlier and tended to be more severe after cessation of tdf than etv. the follow-up interval and intensity would be different between etv and tdf after discontinuation of therapy. whether switch therapy from tdf to etv can modify the pattern of relapse is interesting but unclear. our hypothesis is that entecavir consolidation on post-tdf treatment patients reduce and delay the clinical relapse effectively. hence in this proof of concept study we would like to evaluate the effect of 6 months and 12 months of entecavir consolidation on post-tdf treatment durability.

Eligibility criteria:
inclusion criteria: * \>20 yrs old. * no history of lamivudine or telbivudine resistance. * hbsag positive for more than 6 months. * hbeag (-). * hbeag-negative chb under tdf treatment for mora than 2 years and fulfilled apasl 2012 guideline's stopping rule: hbeag (-): undetectable hbv dna on 3 separate occasions at least 6 months apart. exclusion criteria: * lamivudine/telbivudine resistance. * hbeag (+). * hiv, hcv co-infection. * under immunosuppressant treatment (including steroid and biologics).
reverse medical barrel™ device for adjunctive treatment for wide-neck, intracranial, bifurcating/branching aneurysms

Conditions: Intracranial Bifurcating Aneurysms

Summary: single arm study to evaluate the outcomes of treatment with the barrel vrd device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.


Eligibility criteria:
inclusion criteria: 1. male or female between 18 and 85 years old. 2. a wide-neck de novo or non-de novo aneurysm. 3. appropriate informed consent obtainable as determined by local irb. 4. life expectancy \> 24 months. exclusion criteria: 1. aneurysm rupture within 30 days of enrollment. 2. bifurcating aneurysms not treatable with coiling. 3. subject has platelet count of \<70,000. 4. subject has known allergies to nickel-titanium metal. 5. subject has known allergies to aspirin or heparin. 6. subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated). 7. subject is currently participating in another clinical research study. 8. subject is pregnant or breastfeeding. 9. subject has participated in a drug study within the last 30 days. 10. subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.