Kornimate/medical-research-clean huggingface dataset:
single and multiple dose pharmacokinetics of bms-986165 in a randomized, double-blind, placebo-controlled study in healthy chinese subjects

Conditions: Autoimmune Diseases

Summary: main objective of this study is to assess bms-986165 plasma pk following single and multiple oral doses of bms-986165 in healthy chinese subjects.


Eligibility criteria:
inclusion criteria: * signed informed consent. * healthy participants, as determined by physical examination, ecgs, and clinical laboratory and procedure determinations. * body mass index (bmi) of 18 to 24 kg/m2, inclusive, and total body weight \>= 50 kg. exclusion criteria: * history of allergy to drug class or related compounds. * history or evidence of active infection within 7 days of study day 1. * drug or alcohol abuse within 6 months of study treatment administration. other protocol defined inclusion/exclusion criteria could apply
comparative evaluation of eggshell powder in primary teeth pulpotomy

Conditions: Pulpitis Reversible; Pulp Exposure, Dental

Summary: to assess \& compare clinical \& radiographic effects of eggshell powder, biodentine and mta as pulpotomy agents in primary teeth.

pulpotomy is the most widely accepted technique for treating primary teeth with deep carious lesion, pulp exposure during the operatory process or after a traumatic pulp exposure. mineral trioxide aggregate (mta) is one such material that has shown tremendous potential for regeneration. biodentine™ (hydraulic silicate cement) is a novel dental material with high mechanical characteristics as well as superior biocompatibility and bioactive behaviour. nowadays, chicken eggshell powder (cesp) (a natural calcium-rich source) is achieving wide acceptance in the medical and dental fields. to date, there is insufficient evidence to properly evaluate eggshell powder as a pulpotomy agent in primary teeth; thus, the current study aimed to assess and compare clinical and radiographical success of eggshell powder, biodentine and mta as pulpotomy agents in primary teeth.

Eligibility criteria:
inclusion criteria: * restorable primary molars with deep carious lesions. * absence of gingival swelling or sinus tract. * absence of spontaneous pain * absence of pain on percussion. * absence of discontinuity of lamina dura * absence of internal root resorption. * absence of external root resorption. * absence of inter-radicular or periapical bone destruction (radiolucency). exclusion criteria: * presence of spontaneous pain * presence of gingival swelling or sinus tract * presence of internal or external root resorption * pain on percussion.

Keywords: cone-beam computed tomography egg shell powder biodentine
chronotropic incompetence during exercise testing in obese adolescents

Conditions: Obesity, Childhood; Cardiac Disease; Cardiovascular Risk Factor

Summary: in adolescents with obesity cardiopulmonary exercise testing (cpet) has become an important clinical examination providing valuable information with regard to the integrative exercise responses, including the pulmonary, cardiovascular and muscular systems. during cpet, mechanical constraints in ventilation, an elevated risk for hypoxia and chronotropic incompetence (ci) (defined as the inability of the heart to increase its rate with increased activity), or compromised cardiac function (e.g. lowered heart rate (hr) recovery, chronotropic index and stroke volume) are often observed in obese adults. moreover, several studies regarding exercise capacity and cardiopulmonary responses to maximal endurance exercise testing have been performed in obese adolescents. despite these previous investigations in obese adolescents it remains controversial whether cardiopulmonary disturbances can be observed consistently during cpet. however, a number of studies have reported a suboptimal response to exercise, in particular a reduced peak heart rate (hrpeak) and peak cycling power output (wpeak). adult obesity modifies cardiac behavior, including resting hr and ci, which has a marked effect on exercise capacity. therefore, chronotropic variables are the most important factors that affect exercise performance. it has been shown that both peak and resting hr account for over forty percent of variability of exercise capacity. interestingly, resting hr and hr response to exercise, including a blunted hr increase, low chronotropic index and hr recovery, are important predictors of all-cause mortality and cardiovascular death, at least in adults. these changes in hr during and recovery from cpet are mediated by the balance between sympathetic and vagal activity of the autonomic nervous system. adverse cardiovascular outcomes associated with the metabolic syndrome may be mediated by autonomic dysfunction, whereby obesity is characterized by sympathetic predominance and a decrease in vagal activity in the basal state, where reduced sympathetic responsiveness has been observed during exercise. therefore, these multiple exercise risk markers could provide valuable clinical information regarding cardiometabolic health. nonetheless hr behavior during cpet has not been described in obese adolescents. the goal of this study is to examine the hr behavior of obese adolescents during cpet to clarify whether this population suffer from ci.


Eligibility criteria:
inclusion criteria: * obese or lean (based on extended international (iotf) body mass index cut-offs for thinness, overweight and obesity) * parental permission exclusion criteria: * chronic cardiovascular, renal, pulmonary or orthopaedic disease * medication use that could possibly influence the heart rate
does acetylsalicylic acid reduce the mortality of patients admitted to an intensive care unit

Conditions: Critical Illness

Summary: platelets play a central part not just in homeostasis and thrombosis as the primary effector cells, but they are also key cells in the regulation of the immunological response to various stressors. after activation, platelets release their granules which store different inflammatory mediators that induce coagulation, recruit further platelets, activate complement, attract neutrophils and leukocytes and regulate the vascular tone. platelets activated by systemic inflammation and infection, may also contribute to the development of multiple organ failure. thus, inhibition of platelet activation may have beneficial effects on critically ill patients. the investigators hypothesize that acetylsalicylic acid reduces the mortality of medical intensive care unit patients. in a retrospective study acetylsalicylic acid use was associated with a substantial reduction in a medical intensive care unit population (winning et al., 2010). the investigators will conduct a randomized, double-blind study including 460 patients (2x230), who will be randomized to receive 100mg acetylsalicylic acid(daily, intravenous) or a placebo (0,9% sodium-choride solution) to assess whether acetylsalicylic acid reduces the mortality of medical intensive care unit patients. main outcome criteria will be 28/90day-mortality. furthermore the investigators will assess whether acetylsalicylic acid reduces the risk of suffering thromboembolic complications. post-mortem examinations will be conducted in all patients who die in the course of the study. furthermore we will assess bleeding rates, intensive care unit mortality and pharmacokinetic and pharmacodynamic properties of acetylsalicylic acid in the intensive care unit population.


Eligibility criteria:
inclusion criteria: * patients admitted to an intensive care unit * \>18 years of age exclusion criteria: * known allergy of intolerance to acetylsalicylic acid * recent surgery or planned surgery * active bleeding * known coagulation disorders * discretion of the physician * terminal illness (anticipated life expectancy \<3months; e.g. due to cancer) * platelet count \<20 000 * recent ulcera * recent gastrointestinal bleeding * pregnancy

Keywords: acetylsalicylic acid intensive care unit mortality post mortem examination bleeding
a study of 68ga-aby-025 pet for non-invasive quantification of her2-expression in advanced breast cancer

Conditions: HER2-positive Breast Cancer

Summary: a large multi- center phase ii/iii study with 68ga-aby-025 pet and biopsies in patients with advanced her2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the her2 expression measured by 68ga-aby-025 pet and standard histopathology from relevant tumor biopsies.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. age ≥18 years. 3. histologically or cytologically confirmed her2-positive or borderline positive (for definition see below) adenocarcinoma of the breast. her2-positive defined as: 1. 3+ by immunohistochemistry \[ihc\] in \>10% of cell areas. 2. 2+ by ihc in \>10% of cell areas and her2/cep17 ratio ≥2.0 or her2 copy number ≥ 6.0 by in situ hybridization \[ish\]). her2-borderline positive defines as: 3. 2+ by ihc and her2/cep17 ratio \<2.0 and/or her2 copy number 4.0 - 6.0 by in situ hybridization \[ish\]) ("equivocal"). 4. 2+ by ihc and her2/cep17 ratio \<2.0 and/or her2 copy number \<4.0 by in situ hybridization \[ish\]) ("2+ ish negative"). 5. known inhomogeneous her2-expression in the primary tumor with her2-positive areas \<10% ("inhomogeneous"). 4. primary breast cancer planned for neoadjuvant therapy (stage ii-iii, t2-4n0-3) or metastatic (m1; at least 80 pts). 5. at least one tumor lesion ≥ 10 mm. 6. at least one tumor lesion available for biopsy. 7. newly diagnosed or confirmed progression and planned for therapy with trastuzumab emtansine or anti-her2 targeted therapy(-ies) concomitant with chemotherapy (her2-positive cohort) or chemotherapy (her2-negative patients). 8. who performance status ≤ 2. 9. predicted survival \> 12 weeks. 10. negative pregnancy test in women of childbearing potential (premenopausal or \<12 months of amenorrhea post-menopause and who have not undergone surgical sterilization). women of childbearing potential must use highly effective method of contraception, i.e combined hormonal contraception, or progestogen-only hormonal contraception, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion, or vasectomized partner, or sexual abstinence exclusion criteria: 1. histologically or cytologically confirmed her2-negative breast cancer defined as ihc 0 or 1+. 2. other manifest malignancy. 3. serious uncontrolled concomitant disease including congestive heart failure that would contraindicate the use of any anti-her2 therapy. 4. inadequate organ function, suggested by the following laboratory results: * absolute neutrophil count \<1,500 cells/mm3 * total bilirubin ≥1.5 x uln (unless the patient has documented gilbert's syndrome) * ast (sgot) or alt (sgpt) \>5.0 × uln * serum creatinine clearance \<30 ml/min 5. patients of childbearing potential and sexually active and not willing to use highly effective contraceptive. 6. assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
the effect of selective serotonin reuptake inhibitor (ssri) treatment on affective symptoms and fertility treatment outcome in women undergoing in vitro fertilization (ivf)

Conditions: Depression; Anxiety; In Vitro Fertilization

Summary: women undergoing ivf show a high prevalence of depressive and anxiety symptoms. furthermore, stress has harmful consequences on ivf and pregnancy outcomes. an immunological cascade was suggested to be involved in the process. treatment in this setting is usually psychotherapy rather than pharmacotherapy, despite reasonable biological evidence suggesting beneficial influence of antidepressant therapy on pregnancy and well-being. moreover, pharmacotherapy is more available and affordable than psychotherapy in the public health system. the investigators suggest to study the efficacy of antidepressant treatment in women undergoing ivf treatment, presenting with mild mood symptoms. the investigators hypothesize that treatment will result in a greater attenuation of affective symptoms, as well as in higher pregnancy success rates. furthermore, certain immunological stress-reactive factors, may prove to be the biological mechanism underlying these effects.


Eligibility criteria:
inclusion criteria: 1. women 18 - 45 y.o. 2. a score higher then 45 on the zung self-rating anxiety scale or a score higher then 16 on the center for epidemiologic studies depression scale 3. understanding of hebrew 4. willing to sign the informed consent exclusion criteria: 1. an axis i dsm ivtr diagnosis other then a depressive, adjustment or anxiety disorder 2. suicidal ideation 3. current treatment with antidepressant medication 4. physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.) 5. alcoholism or drug abuse and dependence 6. past severe side effects to ssris 7. failed ivf (4 trials of good quality embryo reinstatement without achieving pregnancy)

Keywords: depression anxiety stress antidepressant therapy ssri infertility in vitro fertilization (ivf) immunological factors depressive and anxiety symptoms in women undergoing ivf treatment
study of chemotherapy-induced hair changes and alopecia, skin aging and nail changes in women with non-metastatic breast cancer

Conditions: Non-Metastatic Breast Cancer

Summary: the purpose of this study is to see how many patients develop hair, skin and nail changes due to cancer treatments. the investigators would like to study the clinical factors, genetic markers, and impact on patients' health-related quality of life to learn more about who is at greater risk. we trust that the study will improve our understanding of how cancer patients feel about their skin, hair, and nail conditions. this information will help us determine the burden on breast cancer patients and survivors. it will also help us learn how to prevent these conditions and it may improve the way we treat them and counsel patients.


Eligibility criteria:
inclusion criteria: * women newly diagnosed with non-metastatic breast cancer (stage 0-iii, any receptor type) at the time of starting chemotherapy (dd-ac-t, cmf, newer combination regimens) or endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane) * women ≥ 18 years at the time of enrollment into the study * able to communicate in english and participate in the informed consent process * able to comply with the follow-up visits, assessments, answering questionnaires exclusion criteria: * metastatic breast cancer * follow-up care/visits not scheduled at mskcc * any current alopecia especially due to an active scalp and/or hair disorder (e.g. alopecia areata), or a pre-existing condition with sequelae (e.g. scarring alopecia) * currently active or uncontrolled medical condition \[e.g. thyroid disorder, auto-immune connective tissue disease (e.g. sle), bmt complications (gvhd)\] or medication intake (e.g. hrt), affecting scalp hair * prior systemic treatment for any malignancy * active secondary cancer requiring cytotoxic chemotherapy * planned (or a history of) radiation therapy to the head * vulnerable populations \[e.g. decisionally impaired (cognitive, psychiatric), terminally ill, prisoners\], or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent * men volunteer inclusion criteria: * post menopausal women, with menopausal status defined as (per self report): * bilateral salpingo-oophorectomy independent of age * if natural menopause, age ≥ 50 with cessation of menses for at least 12 months * or premenopausal women with premenopausal status defined as \<53 years of age with no cessation of menses * able to communicate in english and participate in the informed consent process * able to comply with the baseline assessments and answering questionnaires * women \>/= 18 years at the time of enrollment into the study

Keywords: alopecia skin aging nail changes hair changes 15-198
hispanic and white women's cardiovascular health

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to elucidate the influence of ethnicity and socioeconomic status (ses) on women's cardiovascular health, using recently completed risk factor and mortality data from the stanford five-city project.

design narrative: two data sets were used to evaluate the specific aims: (1) survey risk factor data (e.g., blood pressure, cholesterol, blood lipids, smoking, etc.) on over 4500 girls and women; and (2) surveillance mortality data on over 1800 women.

Eligibility criteria:
no eligibility criteria
rapidly absorbing polyglactin 910 versus poliglecaprone 25 for laceration repair

Conditions: Dyspareunia; Perineal Tear; Sutured Laceration

Summary: to evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to poliglecaprone 25 using a validated sexual function questionnaire. to assess maternal satisfaction with the laceration repair and suture material. to assess overall perineal pain using a visual analog scale. to assess the rate of wound breakdown and the need for suture removal.

this randomized controlled trial will be conducted and vcu medical center comparing 2 types of suture: rapidly absorbing polyglactin 910 (vicryl rapide) and poliglecaprone 25 (monocryl) for first and second-degree lacerations requiring suture repair. patients will be enrolled in the study immediately after vaginal delivery if a laceration occurs spontaneously. patients will be randomized to one of the 2 sutures after enrollment. randomization will be obtained via computer generation in consecutively numbered, opaque sealed envelopes with the name of one of the suture materials. the envelope will be opened at the time of repair of perineal laceration once inclusion criteria have been met by the physician or midwife performing the laceration repair. repair with the chosen suture will be performed using the continuous suture technique using a 3-0 suture, which is current standard practice. patients will not be informed of the type of suture used, although the type of suture will be recorded in the patient's electronic medical record. various maternal and fetal characteristics will be recorded including maternal age, gravity and parity, gestational age at delivery, birth weight, mode of vaginal delivery (spontaneous or operative). pain will be evaluated using a numeric pain scale at their 6 week postpartum visit and at 3 months postpartum via a telephone interview. at 3 months postpartum they will also be asked the following questions - have you resumed sexual intercourse(yes/no)? how long after delivery was it before you resumed intercourse? did you have pain the first time after delivery (yes/no)? do you have continued dyspareunia (1-10)? do you have residual perineal pain unrelated to intercourse? how satisfied are you with your laceration repair (very unsatisfied -1, neutral-3, very satisfied- 5). they will also be administered a 6 question validated female sexual function index.

Eligibility criteria:
inclusion criteria: * english speaking, patients with first and second degree spontaneous lacerations or those with midline or mediolateral epsiotomies that were uncomplicated, and hemodynamically stable paitents exclusion criteria: * non-english speaking, women without laceration or with more extensive third or fourth degree lacerations, and inmates

Keywords: postpartum dyspareunia obestric laceration
bioavailability study of ondansetron orally disintegrating tablets under fasting conditions

Conditions: Healthy

Summary: to compare the single-dose bioavailability of ondansetron 8 mg odt and zofran 8 mg odt

to compare the single-dose bioavailability of kali's ondansetron 8 mg odt with that of glaxosmithkine's zofran 8 mg odt under fasting conditions

Eligibility criteria:
inclusion criteria: * subjects meeting all of the following criteria may be included in the study. * availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject. * males and females aged from 18 to 50 years ol with a body mass index (bmi)within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report. * clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the crf (laboratory tests are presented in section 7.1.3. * healthy according to the laboratory results and physical examination. * normal cardiovascular function according to ecg. * non or ex-smokers. exclusion criteria: * significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs. * presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects. * presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease. * females who are pregnant, lactating or are likely to become pregnant during the study phases. * females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the body. * positive pregnancy test before and during the study. * maintenance therapy with any drug, or significant history or drug dependancy, alcohol abuse (\>3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease. * any clinically significant illness in the previous 28 days before day 1 of this study. * use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.). * participation in another clinical trial in the previous 28 days before day 1 of this study. * donation of 500 ml of blood (canadian blood services, hema-quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study. * positive urine screening of drugs of abuse (drug names are presented in section 7.1.4). * positive results to hiv, hbsag or anti-hcv tests. * history of fainting upon blood sampling.

Keywords: bioequivalence ondansetron odt fasting to determine bioequivalence under fasting conditions
lymphatic magnetic resonance imaging abnormalities in children with tetralogy of fallot: a case-control study

Conditions: Tetralogy of Fallot; Lymphatic

Summary: this study examines subclinical lymphatic abnormalities in tetralogy of fallot patients, utilizing lymphatic magnetic resonance and near-infrared fluorescence imaging.


Eligibility criteria:
inclusion criteria: * tof exclusion criteria: -