Kornimate/medical-research-clean huggingface dataset:
offspring born to mothers with polycystic ovary syndrome in guangzhou cohort study

Conditions: PCOS; Offspring, Adult; Hyperandrogenism; Epigenetics; Insulin Resistance; Endocrine Disorder; Metabolic Disturbance

Summary: the offspring born to mothers with polycystic ovary syndrome in guangzhou cohort study (pcos-big) was established to investigate the short- and long-term effects of intrauterine exposure to maternal pcos on the health of offspring in guangzhou, china. data are collected regarding maternal pcos subtypes, nursing, diet and education as well as health outcomes in their later life. biological samples including blood and tissue samples are also collected from participants.

according to preliminary survey, the prevalence of polycystic ovary syndrome (pcos) among chinese women reached 7.5%. hyperandrogenism and insulin resistance were considered as the main pathogenesis of pcos. as reported, the secretion of androgen is higher among women with pcos than the healthy reference population throughout their fertile lives. worth of concern, offspring of pcos patients presented with glucolipid metabolism disorders as early as during their childhood, while whose pathogenesis remains unclear. prenatal exposure of rhesus monkey in pregnant to androgens produces glucolipid metabolic alterations in offspring resembling those in pcos, suggesting that the exposure of the fetus to hyperandrogenism during gestation could affect the glucolipid metabolism of pcos offspring. growing evidence shows that different exposures during pregnancy will affect the dna methylation of offspring and disturb their endocrine and metabolism. a birth cohort would provide an opportunity to examine the short- and long-term effects of pcos exposure, such as hyperandrogenism, on health consequences of the offspring.

Eligibility criteria:
inclusion criteria: * offspring born to women diagnosed with pcos * offspring born to women with \<20 weeks of gestation, intended to eventually deliver in guangzhou women and children's medical center * permanent residents or families intended to remain in guangzhou for ≥3 years exclusion criteria: * none

Keywords: pcos hyperandrogenism epigenetics glucolipid metabolism disorder
hemodynamic optimization of cerebral perfusion after endovascular therapy in patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: mechanical thrombectomy is a very effective treatment in patients who have suffered an acute ischemic stroke associated with intracranial large vessel occlusion. however, less than half of the patients achieve functional independence despite treatment. the optimization of blood pressure after mechanical thrombectomy based on the degree of recanalization achieved at the end of the procedure could improve the perfusion of the ischemic brain tissue thanks to the improvement of blood circulation provided by collateral circulation. for this, authorized hypotensive or hypertensive drugs will be used. moreover, this individualized treatment would allow to decrease reperfusion injury and therefore decrease the risk of intracerebral bleeding complications and cerebral edema. therefore, we designed a clinical trial in which the standard management of blood pressure after mechanical thrombectomy will be compared with a specific protocol in which blood pressure targets are applied according to the degree of recanalization obtained during the thrombectomy procedure. the beneficial effect and risk reduction of this treatment will translate into a better short and long-term outcome


Eligibility criteria:
inclusion criteria: * patients with acute ischemic stroke and large intracranial vessel occlusion within 24 hours after the onset of symptoms in whom mechanical thrombectomy has been performed. * successful recanalization, defined as a tici score of 2b, 2c, or 3. * previous score on the modified rankin scale (mrs) of 0, 1, or 2. * the patient or her legal representative gives informed written or verbal consent exclusion criteria: * aspects score \<6 * vertebral, basilar, a2, p2 and m3-4 occlusion * history of intracerebral hemorrhage * pregnant or breastfeeding patient * patient with congestive heart failure or recent/unstable coronary artery disease (\<3 months) * dissection of aorta, cervical or cerebral or unruptured aortic / cerebral aneurysm or known arteriovenous malformation * any bleeding visible on baseline ct * history of ventricular arrhythmias * use of mao inhibitors * inclusion in other clinical trials.
tak-438 - safety, blood levels & effects of repeated doses

Conditions: Erosive Esophagitis(EE); Gastroesophageal Reflux Disease (GERD)

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of tak-438 in healthy, non-japanese men male subjects following a randomized, double blind, placebo controlled, sequential panel, multiple-dose schedule.

the drug being tested in this study is called tak-438. tak-438 is being tested to find a safe and well-tolerated dose. this study looked at pharmacokinetic (effect of the body on the drug) and pharmacodynamic properties (effect of the drug on the body) as well as look at lab results and side effects in people who took tak-438. this study was designed as a randomized, sequential-panel, multiple repeat dose study. the study population consisted of 4 cohorts with 12 participants in each cohort; with 9 participants randomized to receive a single dose of tak-438, and 3 participants to receive placebo. participants in each cohort received a single dose of study drug once daily after a 10-hour fast. the starting dose was 10 mg followed by administrations of 20, 40, and 30 mg. this single-centre trial was conducted in the united kingdom. the overall time to participate in this study was up to 37 days. participants made 2 visits to the clinic for screening, one 11-day period of confinement to the clinic, and 2 further visits after the confinement period. all participants were contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Eligibility criteria:
inclusion criteria: * male subjects aged 18 to 45, inclusive, who are in good health, as determined by medical history, physical examination, clinical laboratory evaluations and urine drug screen. * the subject has the ability to tolerate the ph probe for 24 hours prior to randomization (day 1). exclusion criteria: * clinically significant history of hypersensitivity to any drug or food or any excipients of tak-438 * history of gastroesophageal reflux disease (gerd), symptomatic gerd, erosive esophagitis, duodenal ulcer,gastric ulcer, dyspepsia, barrett's esophagus, or zollinger-ellison syndrome * the subject has a positive test result for helicobacter pylori at the initial screening visit * any clinically significant results from physical examinations or clinical laboratory results as deemed by the investigator.

Keywords: drug therapy
the neuroprotective effect of remote ischemic conditioning in ruptured aneurysm coiling therapy

Conditions: Aneurysm, Ruptured; Coiling Therapy

Summary: the overall incidence of dwi positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on dwi after endovascular treatment of intracranial aneurysms is still unclear. the investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.


Eligibility criteria:
inclusion criteria: * age 18 years or older * ruptured brain aneurysm deemed suitable for neuroendovascular repair * normal baseline brain mri * female subjects of childbearing potential have a negative pregnancy test. * signed informed consent prior to entering study exclusion criteria: * dissecting or mycotic brain aneurysm. * planned endovascular vessel sacrifice as the primary modality for aneurysm treatment * renal insufficiency with creatinine ≥ 265 umol/l * severe, sustained hypertension (sbp \> 185 mmhg or dbp \> 110 mmhg) * contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs * pre-morbid modified rankin scale score of greater than 1 * patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations patients who are unable to have an mri scan for any reason. * currently participating or previously participated in any investigational drug or device study within 6 months.
brown rice intervention on metabolic syndrome (brims)

Conditions: Metabolic Syndrome X

Summary: the specific aim of this study is to determine the effects of substituting brown for white rice on the treatment of metabolic syndrome (mets).

metabolic syndrome (mets), a constellation of metabolic abnormalities including central obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the development of type 2 diabetes and cvd. it has become one of the major public health challenges in china due to rapidly nutrition transition and the nature of obesity epidemic. treatment of mets in china is very important for the prevention of the epidemic of its consequences (such as cvd and type 2 diabetes). compelling evidence from recent human studies has demonstrated that diet modifications are effective means in mets management. consumption of carbohydrate-rich foods such as rice affects blood glucose and influences diabetes risk. specifically, eating polished white rice may increase diabetes risk, whereas eating brown rice, a whole grain product, may decrease risk. this is likely related to the different ability of white and brown rice to raise blood glucose levels, as measured by their glycemic index (gi) and glycemic load (gl), and to the higher levels of dietary fiber, vitamin b complex, magnesium and other micronutrients in brown rice. a total of 200 participants with mets (defined by atp-iii criteria) will be randomly assigned to a brown rice diet or an isocaloric white rice diet for 16 weeks. effects of substituting brown for white rice will be evaluated by measuring metabolic profile (bmi, blood pressure, total cholesterol, triglyceride, ldl-c and hdl-c, fasting glucose and insulin, hba1c).

Eligibility criteria:
inclusion criteria: * the updated national cholesterol education program adult treatment panel iii (ncep atp iii) criteria for the diagnosis of the mets will be used. mets will be defined with at least three of the following abnormalities: * central obesity (defined as waist circumference ≥ 80 cm for women or ≥ 90 cm for men) * raised triglycerides level: ≥ 150 mg/dl (1.7 mmol/l), or specific treatment for this lipid abnormality; * reduced hdl cholesterol: \< 40 mg/dl (1.0 mmol/l) in males and \< 50 mg/dl (1.3 mmol/l) in females, or specific treatment for this lipid abnormality; * elevated blood pressure (bp): systolic bp ≥ 130 or diastolic bp ≥ 85 mm hg, or treatment of previously diagnosed hypertension; * increased fasting plasma glucose (fpg): ≥ 100 mg/dl (5.6 mmol/l), or previously diagnosed type 2 diabetes. * being able to comply with the specified feeding conditions * being able to eat brown rice * being between the ages of 35 and 60 years exclusion criteria: * pregnancy or lactation * use of insulin * severe kidney disease * cardiovascular diseases, stroke, cancer and psychological disorders * brown rice allergies * drug or alcohol abuse

Keywords: brown rice white rice diabetes risk
investigating the effect of telmisartan (micardis®) on the average 24h blood pressure of therapy-naive and therapy-experienced patients

Conditions: Hypertension

Summary: practical experience report (per) investigating the effect of micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients


Eligibility criteria:
inclusion criteria: 1. patients who have recently been diagnosed with hypertension 2. patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion. exclusion criteria: none (according to investigator)
hybrid high-intensity interval training for persons with spinal cord injury. a feasibility study

Conditions: Spinal Cord Injuries

Summary: this study examines safety and feasibility of a study protocol using a combination of functional electrical legcycling with voluntary armwork (hybrid training) as either skiergometer or armcycling in high intensity intervals for persons with spinal cord injury paraplegia.

cardiovascular disease is one of the most common causes of early death in people with spinal cord injury. physical activity at high intensity is known to reduce the risk of cardiovascular disease in other patient groups. during aerobic training, combining functional electrical stimulation (fes) with voluntary arm-work induces a higher oxygen uptake than fes cycling alone and high intensity interval training induces higher oxygen uptake than training at continuous intensity. the hypothesis is that combining hybrid training with high-intensity induces even higher oxygen uptake thereby reducing the risk of cardiovascular disease. this training modality has not been tested before, so before conducting a randomized controlled trial testing the effect of this training modality on oxygen uptake, the aim was to asses safety and feasibility of this protocol.

Eligibility criteria:
inclusion criteria: * spinal cord injury paraplegia, * complete and incomplete lesions, * ability to be electrically stimulated, * willing to train 3 times a week at high intensity exclusion criteria: * heart pacemaker or other heart problems contradicting high intensity aerobic training, * pregnancy, * unstable fractures, * cancer, * heterotopic ossification, * myositis ossificans, * severe osteoporosis, * pressure ulcers, * newly implanted metal, * newly surgery, * frequent episodes of autonomic hyperreflexia, * very high or low blood pressure, * dislocation or subluxation of joints * high level of shoulder pain at study start.
lumbar transforaminal anterior epidural steroid injections in discogenic low back pain

Conditions: Degenerative Disc Disease; Low Back Pain

Summary: modic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. modic type 1 change is considered an inflammatory process. the aim of this study is to determine the effectiveness of lumbar transforaminal epidural steroid injections in modic type-1 changes.

modic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. however, in degenerative disc disease, whether the pain could be attributed to modic changes or not is still a matter of debate. there are different options in the treatment of low back pain due to degenerative disc disease (ddd) and modic changes. conservative treatments and surgical approaches are some of them. other interventional procedures include intradiscal and epidural steroid injections which have relatively less risk of complications than surgery. the only study in the literature investigating the effectiveness of epidural steroid injections in patients with low back pain associated with modic changes belongs to butterman et al. they reported that patients with modic changes (type 1) responded better to epidural steroid injections than those without endplate irregularities. however, they did not report the details of the procedure, such as the steroid and local anesthetic they used, the amount of them and the level of the procedure. moreover, they used different approaches including interlaminar and transforaminal, which may be misleading while interpreting the results. based on these results, the aim of this study is to determine the effectiveness of lumbar transforaminal epidural steroid injections in modic type-1 changes.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * non-radicular, axial back pain * lack of response to conservative treatments * detection of modic type 1 changes in contrast-enhanced lumbar mri or intervertebral disc findings that may be associated with discogenic pain (nuclear signal intensity change in the disc \[black disc\], height loss, or high-intensity zone) exclusion criteria: * patients younger than 18 and older than 65 * describing pain radiating to the lower extremity (those with radicular pain) * nerve root compression due to disc herniation or other reasons * modic changes in more than one level * positive facet loading test * spinal stenosis or spondylolisthesis * diagnosed with spondylodiscitis * pregnancy * patients with inflammatory rheumatic diseases * patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.) * patients with exercise intolerance

Keywords: transforaminal epidural injection degenerative disc disease modic changes
monitoring of multiple sclerosis (ms) participants with the use of digital technology (smartphones and smartwatches) - a feasibility study

Conditions: Multiple Sclerosis

Summary: this prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with ms and healthy controls. at the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. the configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. active tests will include hand motor function test (hmft), gait test, static balance test, electronic version of the symbol digit modalities test (esdmt), mood scale question (msq), ms impact scale (29-item scale) (msis-29) questionnaire, ms symptom tracking (msst). passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.


Eligibility criteria:
inclusion criteria: for ms participants: * definite diagnosis of ms, confirmed as per the revised mcdonald 2010 criteria * expanded disability status scale (edss) of 0.0 to 5.5, inclusive for all participants: * weight: 45 to 110 kilograms (kg) exclusion criteria: for ms participants: * severely ill and unstable participants as per investigator's discretion * change in dosing regimen or switch of disease modifying therapy (dmt) in the last 12 weeks prior to enrollment for all participants: * pregnant or lactating, or intending to become pregnant during the study
the effect of nasal hair on nasal obstruction

Conditions: Nasal Obstruction

Summary: nasal obstruction is a common complaint prompting presentation to an otolaryngologist. many studies have been performed quantifying and describing the impact of a number of factors on symptoms of nasal obstruction, including anatomical, neoplastic, infectious, and inflammatory causes. despite this scrutiny, no attention has been paid to the nasal vibrissae as a potential anatomical contributor to nasal obstruction. the proposed study intends to elucidate that contribution, if any exists.


Eligibility criteria:
inclusion criteria: * presence of nasal vibrissae * able to tolerate rhinomanometry exclusion criteria: * anatomical or other obvious cause of obstruction * claustrophobia with rhinomanometry mask

Keywords: nasal obstruction vibrissae nasal hair
therapeutic effects of class ii elastics on aligners in different vertical skeletal patterns

Conditions: Malocclusion, Angle Class II

Summary: the objective is to compare the dento-alveolar therapeutic effects of wearing class ii inter-arch traction elastics on aligners versus multi-brackets in an adult population. the principal hypothesis is no significant difference in therapeutic effects of using inter-arch elastics on aligners versus multi-brackets.

it is a non-interventional research involving the human person, research on existing data and / samples in the field of dentofacial orthopedics. this study analyzes the effects of rubber bands when combined with aligners in adult patients. this is a comparative retrospective study of radiographs and casts before and after orthodontic treatment. the patients studied are in angle class ii and adults. two groups are analysed: patients treated with fixed (vestibular multi-attachment) and removable (invisalign-type aligners) appliances.

Eligibility criteria:
inclusion criteria: * cvm stage 5 on lateral teleradiography (end of growth) * angle class ii * treatments with rubber bands for inter-arch traction * end of treatment in class i exclusion criteria: * incomplete data * treatment with extractions, mini-screws, mini-plate or ortho-surgical treatment * dental agenesis (excluding wisdom teeth) * cranial-facial syndromes

Keywords: aligner inter-arch elastic orthodontic class ii malocclusion adult clear aligner orthodontic appliance invisalign class ii elastics angle class ii malocclusion
tivantinib as maintenance treatment in extended small-cell lung cancer (times)

Conditions: Carcinoma, Small Cell

Summary: this study aims to assess the role of met inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed extensive-stage sclc * disease control after the first line platinum/etoposide treatment * ecog performance status of 0 or 1 * measurable disease according to recist version 1.1 criteria * adequate bone marrow, liver, and renal function. * formalin fixed paraffin embedded (ffpe) or frozen tumor tissue material must be available. * resolution of any toxic effects of prior therapy according to nci ctcae, v 4.0 * full recovery from significant complications of the surgery * if childbearing age, use of double-barrier contraceptive measures, oral or abstaining from sexual intercourse during the study and up to 90 days after the last dose of chemotherapy * negative pregnancy test within 72 hours prior to the initiation of study treatment, if of childbearing potential * signed informed consent prior to beginning protocol specific procedures * patients must be available for treatment and follow-up exclusion criteria: * previous therapies with tivantinib or other known c-met inhibitor * radiotherapy for target lesions and major surgical procedure within 4 weeks, prior to the inclusion in the study * palliative radiotherapy within 2 weeks prior to the inclusion in the study * history of malignancy in the past five years, excluding basal cell the cervix, prostate cancer with a value of prostate-specific antigen \<0.2 ng / ml * history of cardiac disease * known human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv) infections * pregnant or lactating women or childbearing/reproductive potential not using adequate contraception * need for breastfeeding during or within 12 weeks of completion of the study * gastrointestinal disorders that may interfere with the absorption of tivantinib * inability or unwillingness to swallow the complete doses of tivantinib * any known contraindication to treatment and other significant comorbid conditions which could jeopardize participation in the study