Kornimate/medical-research-clean huggingface dataset:
paclitaxel, ifosfamide, and cisplatin in treating patients with metastatic testicular cancer

Conditions: Testicular Germ Cell Tumor

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining paclitaxel, ifosfamide, and cisplatin in treating patients who have metastatic testicular cancer that has recurred following treatment.

objectives: * determine the feasibility of combining paclitaxel, ifosfamide, and cisplatin induction in patients with metastatic nonseminomatous germ cell tumor of the testis in first relapse following first line treatment with bleomycin, etoposide, and cisplatin. * determine the response rates to this regimen in these patients outline: this is a multicenter study. patients receive paclitaxel iv over 3 hours and ifosfamide iv and cisplatin iv daily for 5 days. patients with stable or responding disease repeat treatment every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a minimum of 25 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * metastatic nonseminomatous germ cell tumor of the testis * in first relapse following first line treatment with bleomycin, etoposide, and cisplatin * biopsy proven germ cell tumor or * rising tumor markers (alpha fetoprotein and/or human chorionic gonadotropin) * no brain metastases patient characteristics: age: * 16 to 64 performance status: * 0-2 life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * glomerular filtration rate greater than 50 ml/min other: * no other prior malignancy except curatively treated nonmelanomatous skin cancer or superficial bladder cancer prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * no prior experimental drugs

Keywords: stage iii malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor testicular embryonal carcinoma testicular choriocarcinoma testicular teratoma testicular yolk sac tumor testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and yolk sac tumor testicular yolk sac tumor and teratoma testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and teratoma
effects of long biliopancreatic limb versus long alimentary limb in superobesity, a randomized study

Conditions: Severe Obesity

Summary: surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. we do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. side effects of bypassing can also be different. study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.

randomisation in the or between long biliopancreatic limb and long alimentary limb. gastric component identical. perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the gastroenteroanastomosis.

Eligibility criteria:
inclusion criteria: * bmi \> 50 exclusion criteria: * psychiatric disease * inflammatory bowel disease * inability to understand swedish
promoting healthy weight across the pregnancy and postpartum period

Conditions: Obesity

Summary: this project evaluates the effectiveness of an evidence-based intervention (health-p2) to prevent excessive weight gain from pregnancy through 12 months postpartum when disseminated and implemented in real-world settings, through parents as teachers. to enhance the impact of health-p2, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when health-p2 is implemented within this national home visiting organization. this partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes.

women are exceptionally vulnerable during childbearing years to gain disproportionally large amounts of weight when compared to men or other life periods. weight gained during pregnancy and retained after the postpartum period contributes to obesity development and progression. evidence based lifestyle interventions addressing the trajectory of weight gain across the childbearing continuum can reverse these alarming trends of excessive weight among young women, but have had limited uptake due to time, expense, and parenting priorities. to address this gap, our research team developed the lifestyle intervention healthy eating, activity living, taught at home during pregnancy and postpartum (health-p2) in partnership with parents as teachers (pat). this study will provide evidence for the dissemination and implementation (d\&i) of health-p2 across pat's network of sites, promoting healthy weight on a national scale. the study builds on our previous work with a pragmatic cluster randomized controlled trial to evaluate d\&i of health-p2 across multiple levels to achieve widespread impact. first, we will determine weight outcomes (12-month postpartum weight; gestational weigh gain) among 336 overweight/obese women (n=168 health-p2; n=168 usual care) when parent educators (\~8/site) from pat sites nationwide receive the health-p2 training through pat national center's existing training infrastructure and conduct health-p2 as part of routine practice. from a d\&i perspective, an evaluation guided by re-aim will measure implementation outcomes (acceptability, appropriateness, feasibility, fidelity, adaptation). further, the conceptual framework for implementation research will guide an assessment of contextual factors that influence external validity at multiple levels (mother, parent educator, pat site).

Eligibility criteria:
for parent educators: inclusion criteria: * deliver pat at a site participating in the study * provide informed consent exclusion criteria: • at least 18 years of age for the participants: inclusion criteria: * 18-45 years of age * pregnant * overweight or obese (bmi over 25 kg/m2) before becoming pregnant * english or spanish speaking * participating or willing to participate in pat at a participating pat site until baby turns 1 * able to give informed consent for participation exclusion criteria: * planning to become pregnant again before their baby turns 1 * unable to engage in a walking program
a study to evaluate the effect of of albuterol sulfate inhalation aerosol, eq 90 mcg base (sun pharmaceuticals industries limited)

Conditions: Asthma

Summary: to evaluate the pharmacodynamic equivalence of albuterol sulfate inhalation aerosol, eq 90 mcg base (sun pharmaceuticals industries limited) to proair® hfa (albuterol sulfate) inhalation aerosol, eq 90 mcg base (teva respiratory, llc) in subjects with stable, mild asthma


Eligibility criteria:
inclusion criteria: 1. men or non-pregnant women 18 to 65 years of age. 2. signed informed consent form that meets all criteria of current food and drug administration (fda) regulations. 3. females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test 4. ability to use inhalation aerosol correctly. exclusion criteria: 1. any clinically significant finding on physical exam in the opinion of the investigator, would compromise subject's safety or data integrity. 2. employees of the investigator or research center or their immediate family members. 3. previous participation in this study. 4. inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
evaluation of remnant cholesterol levels and monocyte-to-hdl-cholesterol ratio as predictors of coronary artery disease severity in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome; ACS (acute Coronary Syndrome); Monocyte to HDL Cholesterol Ratio; STEMI; Non STEMI

Summary: 1. evaluation of serum level of remnant cholesterol and monocyte/hdl ratio as predictors of severity of coronary artery disease in patients with acute coronary syndrome. 2. evaluate predictive value of remnant cholesterol serum level and monocyte/hdl ratio to detect in-hospital worse clinical outcomes and 45 days major adverse cardiac events (mace) after acute coronary syndrome.

acute coronary syndrome (acs) refers to a group of conditions that include st-elevation myocardial infarction (stemi), non-st elevation myocardial infarction (nstemi), and unstable angina. it is a type of coronary heart disease (chd), acs is the most common cause of death in patients with cad and it is estimated that about 661,000 people in the united states suffer from acs in 2016 ,which highlights the importance of risk assessment for acs. elevated remnant cholesterol, including cholesterol carried in vldl and chylomicron remnants, is emerging as a causal risk factor for ascv in addition to elevated ldl-cholesterol ,studies of the general population have shown that risk of myocardial infarction, ischemic stroke and peripheral artery disease is increased in individuals with elevated remnant cholesterol. high-density lipoprotein-cholesterol (hdl-c) exhibits anti-atherosclerotic effects by neutralizing the pro-inflammatory and pro-oxidant effects of monocytes via inhibiting the migration of macrophages and ldl oxidation in addition to the efflux of cholesterol from these cells. furthermore, hdl plays a role in suppressing the activation of monocytes and proliferation-differentiation of monocyte progenitor cells. thus, accumulation of monocytes and reduction of hdl-c may participate in atherosclerosis and cardiovascular diseases (cvd) . global registry of acute coronary events (grace) score is a risk assessment system for acs based on risk factors summarized from clinical cases. the synergy between percutaneous coronary intervention with taxus and cardiac surgery (syntax) score is a scoring system for risk stratification based on the anatomical characteristics of coronary artery lesions to help cardiologists, interventionists and surgeons to grade the complexity of coronary artery lesions .

Eligibility criteria:
inclusion criteria: * patients with acute coronary syndrome presented to er of assiut university hospital scheduled for primary pci and able to provide informed consent. exclusion criteria: * patients on previous statin therapy. * patients with severe renal dysfunction (creatinine clearance \<30 ml/min) or other contraindications to pci. * patients with missed data or who couldn't be followed up

Keywords: acs acute coronary syndrome stemi non stemi monocyte/hdl ratio
molecular epidemiology of essential hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Hypertension

Summary: to localize individual genes, called blood pressure quantitative trait genes \[bpqtgs\], which influence blood pressure levels in the population-at- large, and to determine if these genes are able to predict the occurrence of essential hypertension or coronary artery disease.

background: essential hypertension reaches epidemic proportions among adults and is a significant risk factor for premature coronary artery disease \[cad\] and stroke. the research to localize bpqtgs represents an initial step toward applying dna information to early identification of at-risk individuals and understanding the complex relationships among blood pressure, essential hypertension, and coronary artery disease. design narrative: the study has four aims. aim 1 uses robust sibling pair linkage methods, parental marker data, and office blood pressure levels measured on 1,376 full sibling pairs to localize bpqtgs to regions of the human genome marked by highly polymorphic tandem repeat loci in or very near to 59 genes involved in blood pressure regulation. these genes were selected based on their involvement in the renin/angiotensin system, ion transport, cardiac physiology, biometabolism of neurotransmitters, or carbohydrate and lipid metabolism. at each gene, a highly polymorphic tandem repeat marker locus has already been identified. aim 2 uses methods of association analysis for related individuals and office blood pressure levels measured on 587 full sibships to localize bpqtgs to regions of the human genome marked by the 59 candidate bpqtgs. aim 3 determines if variation in these bpqtgs improves the ability to predict differences in blood pressure levels in a sample of 1,166 unrelated normotensive adults or essential hypertension status in a sample of 1,160 unrelated grandparents beyond that provided by established predictors. aim 4 determines if variation in these bpqtgs improves the ability to predict symptomatic or asymptomatic coronary artery disease status beyond that provided by established predictors including blood pressure and essential hypertension. aims 3 and 4 also ask whether the predictive relationship of the traditional risk factors to blood pressure, essential hypertension, or coronary artery disease is different among genotypes at these bpqtgs. the study was renewed in fy 1999 to continue data analysis.

Eligibility criteria:
no eligibility criteria
adrenal functions in autosomal dominant polycystic kidney disease

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: we aimed to evaluate the hypothalamus-pituitary-adrenal axis in autosomal dominant polycystic kidney disease (adpkd) patients. twenty two adpkd patients and 27 healthy subjects were enrolled.

context: autosomal dominant polycystic kidney disease (adpkd) is the most common hereditary kidney disease and extrarenal manifestations may be observed in many organ systems. hypothalamus-pituitary-adrenal axis in patients with adpkd was not evaluated extensively. objective: we aimed to evaluate the hypothalamus-pituitary-adrenal axis in adpkd patients. methods: twenty two adpkd patients and 27 healthy subjects were enrolled. basal dehydroepiandrosterone-sulfate (dheas) levels and cortisol and dehydroepiandrosterone responses to low dose short adrenocorticotropin stimulation test were assessed. correlation analyses of these parameters with glomerular filtration rates, renal volumes and pain characteristics in patients with adpkd were done.

Eligibility criteria:
inclusion criteria: * healthy subjects * diagnosis of autosomal dominant polycystic kidney disease exclusion criteria: * a glomerular filtration rate below 60 ml/min * history of recent major surgery * systemic infections with fever * significant hirsutism (ferriman gallwey score≥8) * congenital adrenal hyperplasia * late onset congenital adrenal hyperplasia * systemic corticosteroid use (including previous use) * topical corticosteroid use * menstrual irregularity * history of thromboembolism * uncontrolled diabetes or hypertension * history of psychosis * pregnancy * lactation * history of hypersensitivity to tetracosactin

Keywords: autosomal dominant polycystic kidney disease adrenal functions renal volume glomerular filtration rate adrenal cortex function tests
bariatric surgery and pharmacokinetics of venlafaxine

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on venlafaxine are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics venlafaxine hydrochloride
turkapne - the turkish sleep apnea database: a national, multicenter, observational, prospective cohort study

Conditions: Obstructive Sleep Apnea

Summary: primary aim of the turkapne (the turkish sleep apnea database) study is to generate a cross-sectional nationwide database to define clinical and polysomnographic characteristics of the sleep apnea patients in turkey. associations of phenotypes of sleep apnea patients with metabolic and cardiovascular diseases as well as risk for traffic accidents will be explored as secondary aims. impact of treatment of sleep apnea on metabolic and cardiovascular complications as well as compliance with positive airway pressure treatment will be further explored longitudinally.

all subjects undergoing sleep study for suspicion of obstructive sleep apnea will be registered in a web-based national database regarding: * anthropometric data, educational status, driving licence, * smoking and alcohol use * comorbidities, and drug use * questionnaires, excessive daytime sleepiness * polygraphic and polysomnographic findings * blood pressure measurements * if taken, blood glucose, lipids and other biochemical markers * if measured, lung function test results * if measured, echocardiography findings * follow-up data regarding treatment modality and compliance

Eligibility criteria:
inclusion criteria: * consecutive adult patients undergoing sleep study for suspicion of obstructive sleep apnea * ability to read and speak * signed informed consent. exclusion criteria: * subjects who use positive airway pressure * subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies * subjects with alcohol dependency
ovrcome self-guided virtual reality for specific phobias

Conditions: Specific Phobia

Summary: specific phobias: fear of flying, heights, spiders, dogs and needles are the extremely common and exposure therapy (et) is the first line of treatment. using virtual reality (vr), participants will have control in gradual exposure to their fears. ovrcome (https://www.ovrcome.io/ virtual reality app), is a self-help vret for specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video. the investigators hypothesize that ovrcome is effective in reducing specific phobia symptoms.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria: * are between 18-64 years old * have a fear of flying, heights, spiders, dogs, needles and score above 4 on the brief standard self rating scale for phobic patients (marks, i. matthews ,a (1979) behaviour research and therapy) * have access to a smart phone and internet * willing to participate in the research study and providing informed consent exclusion criteria: a potential subject who meets any of the following criteria will be excluded from participation in this study: * present with symptoms of severe depression or suicidality respectively as measured with the phq-9; total score \> 19 * have insufficient knowledge of the english language * are under current treatment for specific phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).
colocare study - colorectal cancer cohort

Conditions: Colorectal Cancer

Summary: colocare is an international prospective cohort study of stage i-iv colorectal cancer patients (icd-10 c18-c20).

the colocare study is a multicenter initiative establishing an international cohort of colorectal cancer (crc) patients for interdisciplinary studies of crc prognosis and outcomes with sites at the fred hutchinson cancer center, seattle (washington, usa), h. lee moffitt cancer center and research institute, tampa (florida, usa), the university hospital heidelberg (germany), the huntsman cancer institute (utah, usa), the cedars-senai medical center (california, usa), university of washington st. louis (missouri, usa), and university of tennessee (tennessee, usa). aims: the colocare study investigates clinical outcomes, including disease-free and overall survival, predictors of cancer recurrence, survival, health-related quality-of-life and treatment toxicities. in addition, cross-sectional analyses of biomarkers and/or health behaviors are undertaken. patients will be recruited if their age range is 18-89 years. for patients recruited after 09/01/2021 the age range is between 18-69 years, except if they participate in specific sub-studies or in studies for older cancer patients. recruitment of patients \>70 years was re-initiated after 06/2024 in anticipation of r01 grant funding. patients are recruited at baseline (time of first diagnosis) and followed for up to 5 years at regular timepoints (3m, 6m, 12m, 24m, 36m, 48m, 60m). the cohort includes a comprehensive collection of specimens and data. for the u01 renewal phase (start september 2021) we specifically focus on the recruitment of minorities (early-onset patients, african american patients, hispanic patients) and patients with rectal cancer. furthermore, we will have an overall focus on questionnaire assessment at baseline, 12, and 60 months and intensive medical chart abstraction 24 months and 60. months after enrollment into the study.

Eligibility criteria:
inclusion criteria: 1. age 18-89 years; for patients recruited after 09/01/2021 the age range is 18-69 years. recruitment of patients 70 years and older was maintained for specific sub-studies and re-initiated for specific r01 grant funding in \~06/2024 2. men and women 3. newly-diagnosed colon or rectal cancer (stages i-iv); crc in treatment (fhcrc and hci) 4. english (fhcrc, moffitt, hci, cedars-sinai, washu st. louis) or german (university hospital heidelberg)-speaking; 5. mentally/physically able to consent and participate. exclusion criteria: * if one of the above in not fulfilled * insufficient language or consent capacity

Keywords: colorectal cancer rectosigmoid rectum colon
safety and efficacy trial of hg004 for leber congenital amaurosis related to rpe65 gene mutations (star)

Conditions: Leber Congenital Amaurosis; Inherited Retinal Diseases Caused by RPE65 Mutations

Summary: the purpose of the study is to determine whether hg004 as gene therapy is safe and effective for the treatment of leber congenital amaurosis caused by mutations in rpe65 gene.


Eligibility criteria:
inclusion criteria: * male or females between 6 and 50 years of age at the time of signing the informed consent form. * willing to adhere to protocol as evidenced by written informed consent or parental permission and subject assent. * clinical confirmed diagnosis of leber congenital amaurosis (lca) and molecular diagnosis of lca due to rpe65 mutations. * ability to perform tests of visual and retinal function. * visual acuity of ≤ 20/80 or visual field less than 20 degrees in the eye to be injected. * acceptable hematology, clinical chemistry, and urine laboratory parameters. exclusion criteria: * pre-existing eye conditions that would preclude the planned surgery or interfere with interpretation of study endpoints or complications of surgery (e.g., glaucoma requiring upcoming surgery, corneal or significant lenticular opacities). * presence of epiretinal membrane by oct. * complicating systemic diseases or clinically significant abnormal baseline laboratory values. * complicating systemic diseases would include those in which the disease itself, or the treatment for the disease, can alter ocular function. * prior ocular surgery within six months. * prior gene therapy or oligonucleotide therapy treatments. * any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation.

Keywords: ird lca lca2