Kornimate/medical-research-clean huggingface dataset:
effects of hormonal infertility treatment on cognition in pre-menopausal women

Conditions: Infertility

Summary: the purpose of this study is to examine the effects of marked alterations in ovarian steroid hormones on cognitive functions in women. sex hormones and stress hormones of women awaiting or undergoing in-vitro fertilization (ivf) will be compared with levels of women adopting children and women on oral contraceptives.

much of our understanding of the effects of ovarian steroid hormones on cognitive functioning comes from studies of changes in cognitive function associated with hormone replacement therapy (hrt) in post-menopausal women and changes in menstrual cycle phase in premenopausal women. if fluctuations in ovarian sex steroid hormone levels across the normal physiological range affect cognitive functions in women, then marked alterations in hormone levels should have a notable effect on cognitive function. hormonal in-vitro fertilization (ivf) treatments for female infertility result in dramatic fluctuations in estrogen levels. women awaiting infertility treatment report negative emotions, depressed mood, declines in memory and concentration, and higher levels of reported stress compared to women who have never experienced infertility. four groups of twenty women each will be recruited for this observational study: * group 1 - ivf treatment with gnrh-a alone * group 2 - ivf treatment with gnrh-a plus sex steroid stimulating hormones * group 3 - adpt control (women in the process of adopting children) * group 4 - oc (oral contraceptives) control all groups will receive a cognitive/affect assessment twice, with a 3-week interval between assessments. blood and salivary samples will be taken on the two test days to measure ovarian sex steroid hormone levels and stress hormone levels. salivary samples will also be taken on a third day in between the two test days. heart period variability (hpv), a measure of cardiac functioning, will be measured using electrocardiogram (ecg).

Eligibility criteria:
inclusion criteria: * women 25 years and older, who are still ovulating * residing in maryland or the washington dc metropolitan area * healthy women in one of the following groups: * 1) beginning or currently undergoing ivf infertility treatments with gnrh-a alone, * 2) beginning or currently undergoing ivf infertility treatments with gnrh-a plus sex steroid stimulating hormones, * 3) going through the adoption process, or * 4) taking monophasic oral contraceptives for at least six months exclusion criteria: * english not the primary language * women who are peri- or post-menopausal * women who are currently taking anti-depressants or have a history of head injury or neurological/psychiatric condition * groups 1 \& 2 (ivf) - women who are undergoing inter-uterine insemination as an infertility treatment * group 3 (adpt) - women who underwent hormonal infertility treatments within the previous 6 months * group 4 (oc) - women on progesterone only (mini-pill) oral contraceptives

Keywords: ivf in vitro fertilization hormones stress memory cognitive function adoption
analysis of sleep study data to assess depressive burden

Conditions: Sleep Disorder; Depressive; Behavioral Disorder; Mood Disorders

Summary: this study evaluates the effectiveness of the meb-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener. this study uses objective physiological markers from meb-001 to estimate the clinically significant depressive burden as subjectively reported by the subject with the beck depression inventory - ii (bdi-ii).

this study evaluates the effectiveness of the meb-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener. this study uses objective physiological markers from meb-001 to estimate the clinically significant depressive burden as subjectively reported by the subject with the bdi-ii. this is a two (2)-phase, non-significant risk, cross-sectional, naturalistic, single-arm, multi-center study conducted under a common protocol and designed to: phase 1: meb-001 algorithm development (software medical device). phase 2: evaluate the effectiveness of the meb-001 device in assessing physiological parameters that provide clinically significant depressive burden screener.

Eligibility criteria:
inclusion criteria: * subject is age ≥18 years and ≤75 years. * subject is willing and able to provide consent. * subject has the ability to read and understand the instructions for the study. * subject is willing to adhere to study procedures. * subject is willing to undergo full night psg study, as prescribed. exclusion criteria: * subject has a pacemaker. * subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).
pediatric bipolar registry

Conditions: Bipolar Disorder; Depression; Mania; Psychosis

Summary: the goal of the pediatric bipolar registry (pbr) is to provide a comprehensive assessment regarding the diagnosis and treatment of pediatric bipolar disorder to children and adolescents with any current mood state and/or children/adolescents who are offspring of a parent with bipolar disorder (bd) type i or ii and their families.

data collected will be utilized to perform a retrospective chart review to include measure outcomes and de-identified demographic information detailed in the attached case report forms. in each case where a diagnosis of bipolar disorder i, bipolar disorder ii, or bipolar disorder nos is determined, the child/adolescent will be added to the pbr and provided with information about local providers that are qualified to treat their diagnosis. each subject can elect to be notified about future research studies s/he may qualify for. furthermore, the investigators will provide ongoing newsletters with useful information that addresses the latest research underway in the field with the families. if requested, the investigators will provide a written report to their current provider detailing our evaluation. the potential for a breach in confidentiality always exists; however, information that is obtained will be stored in password a protected database and locked file drawers in locked offices; data will have identifying information sheered from it to prevent loss of confidentiality, and all staff must sign confidentiality certificates. if child abuse is detected, the research team is obligated to follow mandatory state reporting laws. to the investigators' knowledge, there is no registry for pediatric bipolar disorder in the city of houston or the state of texas that provides the comprehensive evaluation that we are proposing for these children and adolescents and their families. therefore, this will be a novel service within this division that will provide research to families and potential clients for providers managing these families across the state of texas.

Eligibility criteria:
inclusion criteria 1. age 6-17 years old at time of initial visit. 2. any current mood state diagnosis of a dsm- iv bipolar disorder, type i, type ii and nos. 3. offsprings of a parent diagnosed with bipolar disorder type i or type ii. exclusion criteria 1. pervasive developmental disorder (pdd) (and/or pdd nos) 2. mental retardation/intellectual disability 3. severe neurological disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis). 4. schizophrenia 5. uncontrolled or severe medical problem

Keywords: bipolar disorder pediatric offspring depression mania children of parents who suffer from bipolar disorder
effectiveness of neck isometric exercises and cervical mobilization on cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: effectiveness of neck isometric exercises and cervical mobilization will be compared to observe the efficacy of these techniques on cervical radiculopathy

two groups will be formed to observe the efficacy of neck isometric exercises and cervical mobilization on cervical radiculopathy by using nprs, rom and qol tools.

Eligibility criteria:
inclusion criteria: * males and females with age between 25-50 years * patients referred from neuro and orthopedic departments with diagnosed cervical radiculopathy. * complaint of neck pain on neck bending with positive spurling's test. * complaint of neck pain, numbness and tingling in arm with positive spurling's test. exclusion criteria: * cervical trauma * any other orthopedic and neurological conditions of cervical spine. * fracture * malignancy
preoperative cognitive impairment predicts postoperative delirium

Conditions: Delirium in Old Age; Neurocognitive Disorders; Cognitive Impairment

Summary: preoperative cognitive impairment (pci) may increase the incidence of postoperative delirium (pod), yet screening for cognitive impairment is rarely performed. this study hypothesized that mini-cog for preoperative cognitive impairment screening predicts postoperative delirium. elderly patients (65 years or older) attending henan provincial people's hospital during the trial period who required elective thoracic surgery were recruited into the study.

we collected data points on demographics and hospital episodes through the electronic medical record the day before surgery. cognitive function screening (mini-cog; the mini-mental state examination, mmse), depression screening (patient health questionnaire-9, phq-9), sleep quality assessment (pittsburgh sleep quality index, psqi), and pain assessment (numeric rating scale, nrs) were performed, and the time spent on mini-cog test and mmse assessment was recorded. the short confusion assessment method (cam) was administered once per day on postoperative days 1 to 5 to evaluate delirium.

Eligibility criteria:
inclusion criteria: 1. 65 years of age or older, 2. elective thoracic surgery, 3. under general anesthesia. exclusion criteria: 1. history of psychiatric disorders, 2. use of any antipsychotic drugs, 3. asa score \>3 4. severe visual, hearing, or physical dysfunction unable to complete the scale 5. advanced malignant tumors of the chest with distant metastases to bone, liver, etc., 6. history of general anesthesia surgery in the last six months.
study of an oral tyrosine kinase inhibitor of vegfr-2 to treat small-volume ovarian, peritoneal, fallopian tube cancer

Conditions: Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms

Summary: the purpose of this study is to determine whether cp-547,632, an oral vegfr-2 tyrosine kinase inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer for patients who have failed first line platinum-based therapy and have a persistent rising ca-125.


Eligibility criteria:
inclusion criteria: * histologically proven epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancerrecurrent or persistent elevated ca-125. * for the purpose of this study, elevated ca-125 is defined as a value of â‰¥40 u/ml on two separate consecutive determinations made â‰¥1 week apart. * ca-125 values obtained within 4 weeks of abdominal surgery should not be taken into account. * no definitive disease or clinical and findings of small volume disease (\&#163;1cm by spiral ct or \&#163;2cm by conventional ct or clinical exam). exclusion criteria: * no prior exposure to mouse antibodies or prior vegf or vegf receptor targeted treatment or other anti-angiogenic-directed, anti-cancer treatment including thalidomide. * no prior consolidation therapy with cytotoxic agents for ovarian cancer. * continuation of hormone replacement therapy is permitted. * no requirement for concomitant anticoagulant therapy. * administration of low dose anticoagulants for maintenance of central venous access is permitted.no chronic oral or intravenous steroid use.
perfusion imaging with myocardial contrast echocardiography in hcm

Conditions: Hypertrophic Cardiomyopathy

Summary: the objective of this study is to determine whether myocardial contrast echocardiography in patients with cardiomyopathy (hcm) can detect resting hypo-perfusion due to fibrosis or stress induced perfusion defects due to associated abnormalities in intramyocardial arteries and the microcirculation. a secondary aim will be to determine whether abnormalities in perfusion are associated with either severity of symptoms (chest pain and dyspnea), presence of arrhythmias, and regional function of the septum.


Eligibility criteria:
inclusion criteria: * age 18-80 years * established diagnosis of hcm exclusion criteria: * known history of coronary or peripheral artery disease * history of myocardial infarction * pregnant or lactating females * hypersensitivity to any ultrasound contrast agent * evidence right-to-left or bi-directional intracardiac shunt * moderate or greater valve disease other than from hcm (systolic anterior motion of the mitral valve) * history of septal ablation or myectomy * hemodynamic instability * pacemaker dependent heart rhythm
to compare the pharmacokinetics of a single oral dose of tc-5214 in subjects with renal impairment and with subjects with normal renal function

Conditions: Healthy Volunteers; Patients; Pharmacokinetics; Renal Impairment

Summary: the purpose of this study is to compare the absorption and distribution of a single oral dose of tc-5214 in subjects with renal impairment and with subjects with normal renal function.


Eligibility criteria:
inclusion criteria: * males and non-pregnant, non-lactating females 18 to 80 years old inclusive with suitable veins for cannulation or repeated venipuncture with a weight of at least 50 kg. * regarding renal function, subjects will be classified as either normal or as suffering from mild, moderate or severe renal impairment. classification of renal impairment will be based using an abbreviated 4 variable modified diet in renal disease (mdrd) equations. to ensure the assessment of consistent estimated glomerular filtration rate (egfr) using the mdrd, a single equation will be used (see section 6.2) * negative screen for human immunodeficiency virus and negative results for serum hepatitis b surface antigen * regarding renal function, subjects will be classified as either normal or as suffering from mild, moderate or severe renal impairment. classification of renal impairment will be based using an abbreviated 4 variable mdrd equation. to ensure the assessment of consistent estimated glomerular filtration rate (egfr) using the mdrd, a single equation will be used. exclusion criteria: * history of any clinically significant medical, neurologic or psychiatric disease or disorder (other than those previously defined as acceptable for these population) which, in the opinion of the investigator and sponsor, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study: this includes seizure activity and repeated episodes of major depression. * subjects with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study * subjects with an active renal transplant (subjects who have previously received a renal transplant and are currently undergoing dialysis due to transplant failure may be enrolled) * any clinically significant acute illness or medical/surgical procedure within 4 weeks of the first administration of investigational product (ip) (other than those previously defined as acceptable for these population) as judged by the investigator. * positive test in drugs of abuse screens (except for prescription medications, which are verified by the investigator), or alcohol on admission to the clinic prior to the administration of the ip

Keywords: phase 1 healthy volunteers volunteers with renal impairment pharmacokinetics tc-5214
functional outcomes of the bobath approach on patients with brain tumors: comparison with stroke patients

Conditions: Brain Neoplasms; Stroke, Acute

Summary: the aim of this study is to examine the functional recovery results of the bobath (ndt) approach in patients with primary brain tumors and compare the results with those of stroke patients.


Eligibility criteria:
inclusion criteria: * acute phase patients with brain tumor and stroke in after surgery exclusion criteria: * modified rankin scale \<2 * high grade tumor * infratentorial tumor * gcs\<14 * rehabilitation session time\<3 * second or more tumor surgery * second or more stroke * bilateral stroke

Keywords: brain neoplasms stroke rehabilitation
feasibility study to evaluate safety and device performance of the hospital glucose management system (hgms)

Conditions: Hyperglycemia

Summary: the purpose of this study is to assess safety and device performance of the medtronic hospital glucose management system (hgms) for up to 72-hours.

assess safety and device performance of the medtronic hgms in the critically-ill setting and analyze the following: 1. device performance: * functionality of hgms * alerts/alarms specificity and sensitivity * system workflow 2. safety: * descriptive statistics will be used to characterize safety events * moderate and severe anticipated device and procedure related adverse events * all serious adverse events and unanticipated adverse device effects related events

Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old 2. subject is admitted to the icu 3. subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl 4. subject has a treatment regimen that includes an intended continuous intravenous insulin for at least 24 hours a. including patients with no previous diagnosis of diabetes mellitus 5. subject has anticipated life expectancy greater than 96 hours 6. subject has recent platelet count greater than 30,000 per micro-liter exclusion criteria: 1. subject currently has a suspected or diagnosed medical condition that, in the opinion of the investigator, warrants exclusion from the study or prevents the subject from completing the study 2. subject is currently participating in another investigational drug or device study 3. subject is pregnant, as determined by hospital admission 4. subject is receiving treatment that includes hydroxyurea.

Keywords: medtronic diabetes hospital continuous glucose monitor intensive care unit
evaluation of the effect of an app in improving treatment adherence in hypertensive patients in hypertension ambulatory

Conditions: Blood Pressure; Adhesion

Summary: brief summary: through the app, the user will have the opportunity to connect directly with the health professional, clarify doubts and manage the treatment of their hypertension.

to evaluate treatment adherence and blood pressure reduction, through the hipercross app, between two groups of hypertensive patients in a hypertension public ambulatory in porto alegre. the investigators hope to identify better adherence to treatment, as well as a significant reduction in blood pressure, all of these results will be better evaluated using the hipercross application.

Eligibility criteria:
inclusion criteria: * hypertensive patients admitted to the hypertension clinic at instituto de cardiologia * older 18 years exclusion criteria: * patients without a mobile phone compatible with the app

Keywords: software hypertension technology
a dose escalation study of the safety and pharmacokinetics of gsk1363089 (formerly xl880) administered orally daily to subjects with solid tumors

Conditions: Solid Tumours

Summary: this clinical study is being conducted at two sites to determine the optimum dose, safety, and tolerability of oral daily gsk1363089 treatment in adults with solid tumors. this study is no longer recruiting subjects.


Eligibility criteria:
inclusion criteria: * histologically confirmed solid tumor which is metastatic or unresectable with no known effective treatment measures, * ecog performance status of \</= 2. * adequate bone marrow reserve, hepatic, renal, and cardiovascular function, * negative pregnancy test. exclusion criteria: * anticancer therapy within 30 days of the start of treatment, * received radiation to =25% of bone marrow within 30 days of treatment. * known brain metastasis, * uncontrolled intercurrent illness, * hiv positive, * pregnant or breastfeeding women.

Keywords: xl880 met inhibitor gsk1363089 solid tumors c-met
a study to assess adverse events and change in disease activity of risankizumab subcutaneous induction treatment for moderately to severely active crohn's disease.

Conditions: Crohn's Disease

Summary: crohn's disease (cd) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. it can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. this study will assess how safe and effective risankizumab subcutaneous (sc) induction treatment is in treating moderately to severely active cd in adult participants. risankizumab is an approved drug for adults with cd. this study comprises of a period a, a period b, and a period c. in period a, participants are placed in 1 of 2 groups to receive either risankizumab sc dose a or placebo. in period b, based on response, participants will receive risankizumab sc dose b or placebo. participants who do not have improvement in cd symptoms at week 12 will receive risankizumab sc dose c and participants with worsening cd symptoms in period b will receive risankizumab sc. in period c, eligible participants will receive open-label risankizumab sc dose d. approximately 276 adult participants with a diagnosis of moderately to severely active cd will be enrolled in approximately 250 sites globally. participants will receive sc induction treatment of risankizumab or matching placebo for up to 24 weeks in period a and b followed by an open-label risankizumab extension in period c for 52 weeks. the duration of the study will be approximately 93 weeks.


Eligibility criteria:
inclusion criteria: * biopsy-confirmed diagnosis of cd for at least 3 months prior to baseline. * participant meets the following disease activity criteria: 1. moderate to severe cd as assessed by cdai 2. endoscopic evidence of mucosal inflammation as documented by a ses-cd * participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for cd. exclusion criteria: * participants with a current diagnosis of ulcerative colitis or indeterminate colitis. * participants with unstable doses of concomitant crohn's disease therapy. * participants with prior exposure to p19 inhibitors. * participants with complications of crohn's disease. * participants having an ostomy or ileoanal pouch.

Keywords: risankizumab, skyrizi, crohn's disease, abbv-066