Kornimate/medical-research-clean huggingface dataset:
study evaluating effectiveness and safety of zimberelimab and domvanalimab in lung cancer

Conditions: Non Small Cell Lung Cancer; Nonsquamous Non Small Cell Lung Cancer; Squamous Non Small Cell Lung Cancer; Lung Cancer

Summary: this is a phase 2 study to evaluate zimberelimab (ab122) combined with domvanalimab (ab154) in front-line, pd-l1-high, locally advanced or metastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
key inclusion criteria: * histologically confirmed, treatment naïve, locally advanced or metastatic (stage iiib iv per ajcc version 8), squamous or non-squamous nsclc with documented high pd l1 expression (tc ≥ 50%) as determined by the ventana sp263 ihc assay, as assessed by central laboratories). * eastern cooperative oncology group (ecog) performance status score of 0 or 1 * must have at least 1 measurable lesion per recist v1.1 * adequate organ and marrow function * if a participant has brain or meningeal metastases, the participant must meet the following criteria: 1. have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose. 2. participants with previously treated brain metastases may participate provided they have stable central nervous system (cns) disease for at least 4 weeks prior to enrollment. stable cns disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for cns disease for at least 14 days prior to the start of study treatment. participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted. 3. carcinomatous meningitis is excluded regardless of clinical stability. key exclusion criteria: * presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available * use of any live vaccines against infectious diseases within 28 days of first dose * any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy. * prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer * prior treatment with any anti-pd-1, anti-pd-l1 or any other antibody targeting an immune checkpoint. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: domvanalimab zimberelimab non small cell lung cancer lung cancer nsclc
chocolate and cvd risk in postmenopausal women

Conditions: Cardiovascular Disease; Heart Disease; Stroke

Summary: the investigators will conduct an epidemiological analysis of data from the women's health initiative to investigate the prospective association between chocolate intake and the risk of heart disease and stroke.

background: three recent meta-analyses found significant prospective inverse associations between chocolate intake and cardiovascular disease risk. evidence from these meta-analyses suggests that such inverse associations may only apply to elderly individuals or those with preexisting major chronic disease. objective: the investigators will assess the association between habitual chocolate intake and subsequent incident coronary heart disease (chd) and stroke, and the potential effect of modification by age. design: the investigators will conduct multivariable cox regression analyses using data from 83,310 postmenopausal women free of baseline preexisting major chronic disease in the prospective women's health initiative cohort. chocolate intake was assessed using a food frequency questionnaire. physician adjudicated events or deaths were ascertained up to september 30, 2013.

Eligibility criteria:
inclusion criteria: 1. postmenopausal women 2. age between 50 and 79 years 3. enrolled in the women's health initiative (whi) observational study, or in the control arm of one or more overlapping whi clinical trials. exclusion criteria: 1. implausible energy intakes, defined as \ 5,000 kcal/d; 2. implausible body mass indices (bmi) (\ 50 kg/m2) 3. implausible height\<122 cm (4 ft.) 4. self-reported preexisting serious chronic disease at baseline, including diabetes, angina, myocardial infarction (mi), stroke, heart failure, coronary artery bypass graft, percutaneous coronary intervention or cancer. 5. missing data on preexisting major chronic disease or any exposure, outcome or confounder variables.

Keywords: coronary heart disease stroke chocolate consumption postmenopausal women nutrition dietary intake epidemiology
wake therapy in the treatment of depression

Conditions: Major Depressive Disorder; Bipolar Disorder

Summary: this pilot study seeks to replicate previous findings that sleep deprivation results in marked improvement in depression symptoms, as well as to test whether concurrent treatment with light therapy and lithium are successful in locking in and maintaining therapeutic effects in both bipolar and unipolar depressed subjects.

both refractory depression and bipolar depression are difficult to treat. a night of complete sleep deprivation has been shown to result in marked improvement in 60% of depressed patients, although maintenance of therapeutic effects have not been sustained with wake therapy alone. this pilot study will assess the effectiveness of wake therapy in treating both bipolar depression (5 participants)and major depression (5 participants), as well as the effectiveness of concomitant light therapy and lithium in maintaining the therapeutic effects. participants will undergo direct observation in the hospital for one week during initial treatment with alternating nights of sleep deprivation, light therapy and lithium treatment, and then will be seen weekly as outpatients for 6 weeks.

Eligibility criteria:
inclusion criteria: 1. current major depressive episode (mdd, bp-i or bp-ii) 2. if not bp-i or bp-ii, treatment refractory to ≥ 2 adequately used antidepressants having different mechanisms 3. if bp-i or bp-ii, treatment refractory to ≥ 1 standard treatment, such as lithium or valproate 4. physically healthy 5. age 18-75 6. not taking current antidepressants(antidepressants deemed effective will not be discontinued exclusion criteria: 1. medically unstable condition 2. past intolerance of lithium (bipolar only) 3. history of (or current) psychosis or epilepsy 4. current (past six months) drug or alcohol abuse/dependence 5. pregnancy 6. contraindication to lithium (bipolar only) 7. significant retinal pathology (e.g., retinitis pigmentosa, macular degeneration) 8. currently taking effective antidepressant 9. cognitive dysfunction 10. parkinson's disease 11. thyroid stimulating hormone \> 5 milli international units/liter 12. left ventricular hypertrophy 13. symptomatic mitral valve prolapse 14. abnormal creatinine

Keywords: depression
an open-label phase i study of orally available novel small-molecule fibroblast growth factor receptors (fgfr) 1,2,3 and 4 inhibitor, asp5878 at single and multiple doses in patients with solid tumors

Conditions: Solid Tumors

Summary: the objectives of this study are to determine the tolerability, safety, pharmacokinetics (pk), pharmacodynamics (pd), and efficacy of oral asp5878 in participants with solid tumors.

this study consists of two parts. in the dose-escalation part, asp5878 (orally available novel small-molecule fgfr 1,2,3 and 4 inhibitor, multiple dosing once-a-day (q.d.), multiple dosing twice-a-day (b.i.d.) or 5-day on/2-day off dosing twice-a-day (5on-2off)) is administered to participants with solid tumors in an increasing dose manner, and the tolerability, safety, pharmacokinetics (pk), pharmacodynamics (pd) and efficacy of asp5878 are evaluated in these participants. cycle 0 consists of 3 days and cycle 1 and subsequent cycles consist of 28 days each in the dose-escalation part. in the expansion part, 16mg twice-a-day 5-day on/2-day off dose of asp5878 (5on-2off) is administered to participants with solid tumors and safety, pk, pd and efficacy of asp5878 are evaluated. the expansion part starts from cycle 1 and each cycle consists of 28 days.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed solid tumor. * participant must meet at least one of the following criteria in the judgment of the investigator or sub-investigator: * disease progression despite standard therapies * progressive disease without any standard therapies established * standard therapies are considered intolerable * eastern cooperative oncology group performance status 0 or 1. * predicted life expectancy ≥ 12 weeks in the judgment of the investigator or sub-investigator. exclusion criteria: * participant with ≥ grade 2 (ctcae v 4.0-jcog) persistent symptoms and objective findings due to the toxicity attributable to prior treatment with antitumor effect (except alopecia). * participant who received a prior treatment intended for antitumor effect (medication, surgery, radiotherapy, etc.) within 4 weeks prior to the planned first day of study drug dosing (or participant who received mitomycin c or nitrosourea within 6 weeks prior to the planned first day of study drug dosing). * a major surgical procedure within 4 weeks prior to the planned first day of study drug dosing or a surgical procedure is planned during the course of the study. * participant who were treated with other investigational drug or medical device within 4 weeks prior to the planned first day of study drug dosing. * participant who has a history of organ transplantation. * participant with a brain metastasis with symptoms or requiring treatment.

Keywords: asp5878 fgfr 1,2,3 and 4 inhibitor
safety, tolerability and efficacy study of stx209 in subjects with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: the study objective is to explore the efficacy, safety and tolerability of stx209 for treatment of irritability in subjects with fsx. we hypothesize that stx209 will improve irritability and other typical problem behaviors associated with fragile x syndrome. we also hypothesize that stx209 will be safe and well tolerated.


Eligibility criteria:
inclusion criteria: * male or female subjects 12 to 40 years of age eventually expanding to 6 years of age * molecular documentation of the fragile x mutation. * clinical global impression - severity (cgi-s) rating for problem behavior of moderate or higher at screening and at visit 1 * an aberrant behavior checklist (abc-c) irritability subscale score \>12 and at least 3 items on the irritability subscale rated at least moderate or above. * current treatment with no more than three psychoactive medications, including anti-epileptics. * current pharmacological treatment regimen has been stable for at least 4 weeks. exclusion criteria: * subjects with a history of seizure disorder who are not currently receiving treatment with antiepileptics. * subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. this includes, but is not limited to impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease. * subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. * subjects who are currently receiving treatment with racemic baclofen. * subjects currently treated with vigabatrin or tiagabine. * subjects taking another investigational drug currently or within the last 30 days.

Keywords: fragile x syndrome irritability behavior problems
salivary testosterone in men: diurnal variation and post-prandial responses

Conditions: Hypogonadism, Male

Summary: the purpose is to evaluate sal-t against standard biomarkers of male gonadal status based on serum t, calculated free t and bat. the optimal salivary sampling in terms of fasting and time of day will also be defined. the ultimate aim is to add sal-t into the trust's repertoire of tests in investigating suspected hypogonadism in men.

to investigate whether salivary (free) testosterone is subject to similar prandial variations reported for serum total testosterone. study 1: assessment of diurnal variation in salivary testosterone adjusted for prandial state in 20 healthy men. study 2: measurement of salivary and serum testosterone and related biomarkers before and after a standard 75g oral glucose load in 40 men.

Eligibility criteria:
for 1st part of study -volunteers: inclusion criteria: * aged 20-60 years * male exclusion criteria: * subjects with learning disability or those lacking mental capacity to give consent. * on (prescribed and over-the-counter) medication and herbal remedies known to affect androgen metabolism. * known hypogonadism. * conditions known to affect androgen metabolism, including chronic inflammatory diseases, chronic liver disease, chronic kidney disease and thyroid dysfunction. * any co-morbidity. * periodontal disease. * dental work 48 hours prior to the test. * exercise on the day, prior to and during sampling periods. * brushed teeth within 1hr prior to sample collection. * obesity defined as a body mass index (bmi) of greater than 29.9 kg/m2as 2nd part of study for glucose load - oral glucose tolerance test (ogtt): inclusion criteria: * aged over 40-60 years. * attending for routine 75 g ogtt exclusion criteria: * subjects with learning disability or lacking mental capacity to give consent. * on (prescribed and over-the-counter) medication and herbal remedies known to affect androgen metabolism. * known hypogonadism. * conditions known to affect androgen metabolism, including chronic inflammatory diseases, chronic liver disease, chronic kidney disease and thyroid dysfunction. * subjects with difficult venous access. * periodontal disease. * dental work 48 hours prior to the test. * brushed teeth within 1hour prior to sample collection. * exercise on day prior to and during the ogtt.
dose response study of lasofoxifene in postmenopausal women with osteoporosis - japanese asian dose evaluation

Conditions: Osteoporosis

Summary: to establish the optimal dose of lasofoxifene that is fully effective in increasing the bmd in postmenopausal asian women.


Eligibility criteria:
inclusion criteria: * postmenopausal asian women with osteoporosis defined by low bmd exclusion criteria: * metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism
oral tramadol versus oral celecoxib for post-perineal repair analgesia

Conditions: Perineal Pain

Summary: this trial will be performed to compare the effectiveness of oral tramadol versus oral celecoxib for the management of perineal pain following episiotomy or perineal tear repair after spontaneous vaginal birth in obese women

pain after episiotomy or tear of perineal tissues during childbirth is often inadequately treated and may be severe. not only did perineal pain negatively affect the physical and mental functioning of the woman, but also it might decrease the success of breastfeeding and reduced her ability to care for her child. the methods of relieving perineal pain included medication and non-medication. when the perineal pain was mild, the most common analgesic used was acetaminophen. whereas the perineal pain was more severe, other drugs had been chosen such as opioid, non-opioid, and a combination of both opioid and non-opioid analgesics

Eligibility criteria:
inclusion criteria: * age:18-35 years * obese women with bmi ≥ 30. * completed full 37-weeks gestation. * spontaneous vaginal delivery with medio-lateral episiotomy or perineal tear requiring repair. * singleton alive fetus. exclusion criteria: * known allergy to investigated drugs(tramadol or celecoxib). * regular use of analgesic drugs before or during pregnancy. * any medical condition known to be potentially exacerbated by opioids, including alimentary canal disorders, hepatic and renal disease. * instrumental vaginal delivery. * 3rd or 4th degree perineal tear. * severe postpartum haemorrhage (\>1,500 ml). * complicating maternal diseases (pregestational/gestational diabetes mellitus; bleeding disorders; pre-eclampsia and other hypertensive disorders of pregnancy). * epidural nor combined spinal-epidural analgesia in labour * a history of peptic ulcer,asthma,thrombocytopaenia.
vaginal progesterone versus progesterone in oil in donor egg recipient in vitro fertilization cycles utilizing vitrified donor eggs

Conditions: Infertility

Summary: the aim of this study is to evaluate both pharmaceutical therapy and advanced treatment techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.

the primary objective of this study is to evaluate the clinical pregnancy rate of micronized progesterone (endometrin, ferring pharmaceuticals) compared to progesterone in oil injections in in-vitro fertilization (ivf) donor egg recipients. the secondary objective is to evaluate the effectiveness of freezing/vitrification of donor eggs. effectiveness of vitrification will be evaluated by egg thaw/survival, fertilization, and implantation rates.

Eligibility criteria:
inclusion criteria: oocyte donors: * age 21-34 years of age * bmi 18-34 * normal ovarian reserve, defined as fsh \ 10 * medical evaluation consistent with fda criteria for donor inclusion donor oocyte recipients * documented history of infertility requiring donor oocyte for optimal fertility potential * documentation of a normal uterine cavity by hysteroscopy, hysterosonogram, or hsg within 1 year of study screening * fresh or frozen sperm exclusion criteria: oocyte donors: * abnormal ovarian reserve, defined as fsh \ 10, prior poor response to controlled ovarian hyper-stimulation(cohs) * failure to meet fda criteria for donor approval (risk factor and medical evaluation) * previous history of poor response to cohs donor oocyte recipients: * uncontrolled hypothyroidism, hyperprolactinemia, or systemic disease that may interfere with study treatment * active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders * surgically aspirated sperm (tese) * 2 or more clinical pregnancy losses (excluding aneuploidy for previous autologous cycles) * clinically significant gynecologic pathology or uterine abnormality, such as submucosal fibroids \> 5 cm, communicating hydrosalpinx, uncorrected uterine septum, undiagnosed vaginal bleeding, endometrial atypia, or any other condition that could adversely affect pregnancy outcomes * history of 2 or more failed ivf donor cycles

Keywords: in-vitro fertilization donor egg ivf
leveraging exercise stress echocardiography for heart failure with preserved ejection fraction

Conditions: Chest Pain; Shortness of Breath

Summary: the purpose of this study is to find out if additional images taken during a stress echocardiogram study and risk score calculation will help the doctor determine if shortness of breath or chest pain are caused by stiff heart (heart failure with preserved ejection fraction or hfpef).


Eligibility criteria:
inclusion criteria: * clinically indicated exercise stress echo for the evaluation of exertional dyspnea or chest pain * age ≥50 years exclusion criteria: * known history of hfpef * lvef \<50% on baseline echo study * history of hypertrophic cardiomyopathy, amyloidosis, or pulmonary arterial hypertension, severe right ventricular dysfunction and severe valvular disease based on chart review or baseline echo study * history of organ transplant (heart, kidney, liver, lungs) * severe pulmonary disease requiring ambulatory oxygen therapy * end-stage renal disease requiring long-term renal replacement therapy * decompensated liver disease * conditions that prevent accurate assessment of e/e' ratio (mitral prosthetic valve, severe mitral annular calcification) * plan to use echo contrast agent during stress study (i.e. contrast agent needed for baseline study) * patients from outside duke health system with no plan for long-term care at duke

Keywords: stress echocardiogram
a concordance study comparing insulin treatments in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: a study to compare insulin use and its effect on glucose control and other outcomes in patients with type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * insulin-naive * non-smoker exclusion criteria: * significant pulmonary, hepatic or renal disease * severe congestive heart failure * active malignancy or malignancy within the last 5 years * systemic glucocorticoid therapy
concentrated growth factors applied in maxillary sinus floor elevation via a lateral window approach

Conditions: Maxillary Sinus Disease

Summary: to investigate the effects of concentrated growth factors applied in maxillary sinus floor elevation via a lateral window approach with simultaneous implant placement on repair of bone defects and new bone formation.

maxillary sinus floor elevation via a lateral window approach is the most effective method of overcoming the shortage of bone mass deficiency in atrophic maxillary posterior region. bone transplantation is considered to be a prerequisite for the success of maxillary sinus floor elevation. platelet-rich plasma and platelet-rich fibrin have been used to accelerate bone formation, regeneration, and repair. however, few in-depth studies are reported on the effects of concentrated growth factors on new bone formation.

Eligibility criteria:
inclusion criteria: * loss of one or more maxillary molars in the posterior maxillary region * occlusogingival distance of \> 4 mm * residual bone height of 2-5 mm in the posterior maxillary region, no obvious maxillary sinus separation * no problems with the lungs, heart, or brain * normal liver and kidney function * normal coagulation function * adequate prosthetic space * no history of bruxism or temporomandibular joint disorders * no tumors, cysts and polyps in maxillary sinus * no acute or chronic maxillary sinusitis * no acute periodontitis * no oral mucosal disease * age 20-45 years * able to tolerate the stress of anesthesia and surgery exclusion criteria: * residual bone height of \< 1 mm in the posterior maxillary region or presence of maxillary sinus mucosa rupture * poor control of complex periodontal disease * local inflammation or poor oral hygiene * poorly treated maxillary disease * with severe bruxism * with temporomandibular joint disorders * alcohol consumption and cigarette smoking (20 cigarettes/d) * have a history of chemotherapy and radiation therapy in face and neck * pregnant * with coagulation disorders * with autoimmune disease * with severe osteoporosis * with acute maxillary sinusitis * unable to tolerate simple surgery because of systemic diseases including severe diabetes mellitus and heart disease * unable to provide informed consent