Kornimate/medical-research-clean huggingface dataset:
long term metformin in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the investigators analyzed collection data of 10 years for the efficacy of metformin on body mass, menstrual frequencies, metabolic and hormonal outcomes in women with polycystic ovary syndrome (pcos) and bmi ≥ 25kg/m2. each patient's age and height were recorded at baseline. in addition each patient weight, waist circumference, menstrual regularity, fasting glucose, glucose after 120 minute oral glucose tolerance test, luteinizing hormone, follicle stimulating hormone , free and direct testosterone, androstenedione, sex hormone binding globulin, dehydroepiandrosterone sulfate were identified at baseline and at the every follow up visit where available.


Eligibility criteria:
inclusion criteria: * pcos phenotype a * bmi≥ 25kg/m2 * metformin 1000mg twice a day for at least one year exclusion criteria: * pcos phenotype b, c, d * bmi \<25kg/m2 * had been treated with spironolactone or oral contraceptives alone or in combination with metformin * had history of bariatric surgery * became pregnant during the observation period * had inability to tolerate metformin, leading to the cessation of drug therapy within first follow up year
first-in-human study of ccw702 in patients with metastatic castration resistant prostate cancer

Conditions: Metastatic Castration-Resistant Prostate Adenocarcinoma

Summary: ccw702 is an investigational immunotherapy for prostate cancer. this is a two-part, first-in-human study to assess the safety and tolerability of ccw702 administered subcutaneously to patients with metastatic, castration resistant prostate cancer. part i is divided in to two subparts, in both subparts patients will receive ascending dosages of ccw702 with the goal to determine the maximum tolerated dose (mtd) of ccw702 and efficacious regimen. part ia will explore every other other day dosing (qod); part ib will explore weekly dosing (q7d). in part ii of the study, patients will be given the recommended part/phase 2 dose (rp2d) q7d. the study will also assess the pharmacokinetics and pharmacodynamics of ccw702.


Eligibility criteria:
inclusion criteria: * men ≥ 18 years of age at time of informed consent * for part 1 and part 2: men with metastatic castration resistant prostate cancer (mcrpc) with histologically or cytologically confirmed adenocarcinoma of the prostate as defined by one or more of the prostate cancer clinical trials working group 3 (pcwg3) criteria * patients with treated brain metastasis or lmd are eligible if brain imaging shows no evidence of progression * must have prostate-specific antigen (psa) and/or radiographic progression on at least one novel androgen receptor (ar)-targeted therapy (abiraterone acetate, enzalutamide). * eastern cooperative oncology group performance status of 0-1 * adequate liver function * adequate hematopoietic function * testosterone level ≤ 50 ng/ml (or 1.73 nmol/l) * patient has a life expectancy of greater than 12 weeks exclusion criteria: * patients whose tumors solely exhibit neuroendocrine differentiation or small cell features by histopathology * patients with new or progressive brain metastasis or leptomeningeal disease (lmd) * patients with a history of clinically significant cardiovascular disease such as symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of stroke or myocardial infarction within 6 months of enrollment * patients with peripheral neuropathy ctcae grade \>/= 2 * patients with a known history of hypersensitivity, allergy or intolerance to ccw702 or its excipients * patients with untreated or imminent spinal cord compression
transverse facial cleft repair using precise location of commissure

Conditions: Transverse Facial Cleft

Summary: to compare the effect of redesigned transverse facial cleft treatment and traditional transverse facial cleft treatment.

nine patients with transverse facial cleft were treated with redesigned repair using precise location of commissure. the main outcome measurement included scar, symmetry of the commissure. they were graded in five scores by five resident physicians who had never seen the patients. the results were compared with healthy controls.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of transverse facial cleft disease; * must not received any lip surgeries before; * such disease can be accompanied by external ear abnormalities, hypoplastic mandible, cleft lip and palate. exclusion criteria: * severe general diseases; * patients who had been treated with lip surgery; * patients and/or his/her family didn't want to continue the clinical trial.
ready for change: enhancing motivational engagement prior to iipt

Conditions: Chronic Pain

Summary: this is a randomized, motivational-interviewing-based intervention to improve readiness-to-change, or willingness to engage in a self-management approach to chronic pain, for patients referred to our intensive interdisciplinary pain rehabilitation day program.

readiness to change, or willingness to engage in a self-management approach to chronic pain and disability, is the most powerful predictor of children's success in intensive pediatric pain rehabilitation. motivational enhancement therapy (met) is an approach that has been effective in increasing readiness to change and treatment engagement for other behaviorally-oriented health interventions. however, met has never been systemically employed in the context of treating pediatric chronic pain and disability. this demonstration project seeks to test the effects of a novel telehealth intervention using motivation enhancement therapy to improve patient and parent engagement in, and outcomes of, an intensive interdisciplinary day hospital program for children with complex chronic pain conditions and associated disability, the pediatric pain rehabilitation center (pprc). the intervention, pprc-prep, is a 4 week met-based telehealth intervention that will be offered to families of children with refractory chronic pain conditions awaiting admission to the pprc at boston children's hospital at waltham. families approved for and awaiting pprc admission will be randomized to receive pprc-prep along with usual care or to a comparison group receiving treatment as usual. study aims include assessing the feasibility and acceptability of the intervention along with measuring its potential to increase readiness to engage in a self-management approach assessed at time of admission to the pprc using established measures of readiness to change, pain acceptance, and committed action. investigators will also evaluate the effects of pprc-prep on program length of stay and on reductions of disability and pain at pprc discharge and short-term (8-week) follow up through comparison of families who undergo pprc-prep with families who do not undergo pprc-prep. demonstrating the feasibility and preliminary effectiveness of pprc-prep will enable the study team to establish this as a routine component of our approach to care for children with complex, refractory chronic pain and disability.

Eligibility criteria:
inclusion criteria: * patient age 8-18 at enrollment * presence of chronic pain condition for \> 3 months with moderate or severe disability * accepts referral to pprc and awaiting admission exclusion criteria: * non-english speaking * no access to device with telehealth capability

Keywords: chronic pain pediatric
effect of systemic hypoxia and hyperoxia on retinal oxygen saturation

Conditions: Retinal Oxygenation; Retinal Blood Flow

Summary: adequate perfusion and oxygenation is essential for the function of the inner retina. although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. the development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. the current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 35 years * nonsmokers * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropy \< 3 dpt. exclusion criteria: * regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive) * symptoms of a clinically relevant illness in the 3 weeks before the first study day * presence of any form of anemia * blood donation during the previous 3 weeks * pregnancy

Keywords: retinal oxygen saturation retinal blood flow hyperoxia hypoxia
effectiveness of double-layer compression therapy in the healing of chronic venous ulcers in primary health care

Conditions: Venous Ulcers

Summary: the purpose of this study is to evaluate the effectiveness of a multilayer compression bandage (two layers), compared with the crepe bandage, on healing of venous leg ulcers, in patients attended in nursing primary care health centres, at 12 weeks follow-up.

this study also compares the effectiveness of the multilayer and the crepe bandage, on healing of venous leg ulcers measured by the resvech 2.0 scale and evaluates improvement in quality of life, measured by the charing cross venous ulcer questionnaire (ccvuq-e) and analyze the sociodemographic, clinical, and treatment factors associated with complete healing of venous ulcers. design: multicentre, controlled, parallel group, randomized clinical trial, with blind evaluation of the response variable. setting: primary care health centres (madrid). subjects: patients with venous leg ulcers, treated by nurses at the participating centres. intervention: experimental group: multilayer compression bandage (two layers). control group: crepe bandage. sample size: 216 patients (108 in each group) variables:main: complete healing after 12 weeks follow-up. secondary: degree of healing (resvech 2.0). quality of life (ccvuq-e). adverse reactions. related to the healing process: comorbidities, topical and systematic treatments, exercise, bmi. prognostic factors: location, number and duration of ulcer. sociodemographic factors data analysis: by intention to treat. comparative analysis of the two groups (chi-squared or t-test). effectiveness analysis sing kaplan-meier, log rank test and cox regression analysis

Eligibility criteria:
inclusion criteria: * people with a diagnosis of chronic venous ulcer over six weeks duration. * presence of a larger ankle arm index (abi) of 0.8 and less than 1.3. * people able to follow the trial own demands, able to understand the questionnaires, with no intention of moving and localizable for the duration of the study. * that give written informed consent to participate exclusion criteria: * patients diagnosed with poorly controlled diabetes mellitus (last hba1c greater than 7). * in antineoplastic therapy. * decompensated heart -insufficience . * dermatitis acute phase, at the time of the study. * rheumatoid-arthritis. * thrombosis venosa (dvt) in acute phase. * patients with mixed ulcers * patients who participate simultaneously in another clinical trial.

Keywords: venous ulcer wound healing compression bandages
analysis of oncogenes in intrahepatic cholangiocarcinoma or mixed hepatocellular-cholangiocarcinoma in tumor tissue samples

Conditions: Intrahepatic Cholangiocarcinoma; Mixed Hepatocellular Cholangiocarcinoma; Cholangiocarcinoma

Summary: the primary objective of this study is to estimate the frequency of fgfr2 fusions in archived intrahepatic cholangiocarcinoma (icca) or mixed hepatocellular-cholangiocarcinoma (hcc-cca) tumor samples

this is a non-interventional, observational study of archived human tissue samples; no surgical procedures will be required and no treatment will be provided as part of this study. approximately 150 archived tissue samples obtained from patients with icca or mixed hcc-cca will be analyzed for somatic alteration status and will include cholangiocarcinoma-specific fgfr2 fusion isoforms.

Eligibility criteria:
inclusion criteria: * if required by law or local regulations (i.e., the sample is from an identifiable subject), signed written informed consent should be granted prior to use of the sample in the study * ≥ 18 years of age * histologically or cytologically confirmed icca or mixed hcc-cca, who are/were eligible for systemic therapy (samples collected prior to initiation of the systemic therapy may be submitted for testing) * have one or more formalin fixed and paraffin embedded blocks available. if blocks are not evaluable, 7-10 unstained, non-baked slides with 5-micron thick sections with at least 20% tumor tissue should be available. (potential participants who are scheduled to undergo surgical treatment may agree to provide surplus of tissues not required for diagnosis and have to provide informed consent prior to the surgery.) exclusion criteria: * not applicable: patients must meet all of the inclusion criteria.

Keywords: fgfr2 fusion icca mixed hcc-cca intrahepatic cholangiocarcinoma mixed hepatocellular cholangiocarcinoma cholangiocarcinoma arqule
coronary artery plaque burden in stable angina and non-obstructive coronary artery disease

Conditions: Coronary Artery Disease; Plaque, Atherosclerotic

Summary: non-obstructive coronary artery disease (cad), particularly common in women, has been associated with impaired quality of life and risk of recurrent hospitalizations. several studies have also demonstrated increased risk of incident acute coronary events and mortality. the main objective of the project is to assess the association between coronary artery plaque features by coronary ct angiography and long term prognosis in a large unselected population undergoing ct coronary angiography due to stable angina and suspected myocardial ischemia from the norwegian registry for invasive cardiology (noric) diagnosed with non-obstructive cad by coronary ct angiography.

patients with stable angina and non-obstructive coronary artery disease by ct coronary angiography will be selected from the norwegian registry of invasive cardiology (noric). this is a national quality control registry run and controlled by the norwegian institute of public health (www.fhi.no). all ct coronary angiograms will be reanalyzed using advanced post-processing analysis software to assess coronary artery plaque burden, distribution and composition. through linking with the norwegian cardiovascular disease registry and the cause of death registry (www.fhi.no) we will be able to assess the association between long-term prognosis (5 years) and coronary artery plaque features.

Eligibility criteria:
inclusion criteria: * stable angina * non-obstructive coronary artery disease by ct coronary angiography defined as \<50% stenosis (lumen diameter reduction) exclusion criteria: * obstructive coronary artery disease * unstable angina * previous myocardial infarction, heart surgery or percutaneous coronary interventions

Keywords: coronary artery disease plaque burden prognosis
pharmacokinetic variability of daptomycin during prolonged therapy for bone and joint infections

Conditions: Bone and Joint Infection; Patient Treated by Daptomycin

Summary: daptomycin is a cyclic lipopeptide that has been proposed as an alternative therapeutic option in patients with prosthetic joint infection caused by staphylococcus or enterococcus species in the latest infectious diseases society of america (idsa) guidelines. the population pharmacokinetics (pk) of daptomycin have been described in various groups of patients in previous publications. however, little information exists on the pk of daptomycin in patients with bone and joint infections (bji). also, previous population studies did not investigate daptomycin pk over prolonged therapy, and, to our knowledge, no study has reported the intraindividual pk variability of this drug. the aim of this study is to describe the inter- and intraindividual pk variability of this drug.


Eligibility criteria:
inclusion criteria: * patients treated with daptomycin for bji in lyon center in 2012 and 2013 exclusion criteria: -

Keywords: bone and joint infection daptomycin
impact of cerebral ventricular dilatations and cerebrospinal fluid pulsations on periventricular white matter in hydrocephalic patients

Conditions: Hydrocephalus; Cerebral Ventricle; Cerebrospinal Fluid; White Matter Fiber

Summary: hydrocephalus is characterized by excessive accumulation of cerebrospinal fluid (csf) in the ventricles of the brain. one of the forms of hydrocephalus is called "normal pressure", although one of the main signs is precisely an alteration of the intracranial pressure (icp), it is here called active hydrocephalus (ha). although mri is the reference radiological modality for the characterization of ha. the evan's and desh index are radiological diagnostic criteria based on the dilation and morphology of the csf compartments. these morphological indices remain insensitive and specific. in recent years, advances in phase contrast (mri-pc) and diffusion (mri-dti) mri have generated new biomarkers of brain viability. the aim of this study is to characterize by mri the impact of hydrocephalus on brain fluids and tissues.


Eligibility criteria:
inclusion criteria: * for patients with hydrocephalus: * age \> 55, * ventricular dilation: evans index \> 0.3; * patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms; * absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition. * for controls: * age ≥ 55; * no ventricular dilation: evans index \< 0.3; * individuals who have no neurological or psychiatric disease; * no neurological deficit. * no history of neurosurgery or head trauma; * signed informed consent; * affiliation to a social security scheme. exclusion criteria: * all patients who have a neurological disease other than active hydrocephalus will be excluded; * individuals unable to sign or understand consent; * individuals with psychiatric, neurological or medical development; * individuals under treatment with psychoactive drugs; * individuals who cannot tolerate an mri examination; * any individual with implant, pacemaker, prosthesis and ferromagnetic object

Keywords: hydrocephalus cerebral ventricles cerebrospinal fluid white matter fibers functional biomarkers
sugammadex on remifentanil ce for preventing emergence cough in male

Conditions: Gallbladder Diseases

Summary: the primary purpose of this study is to investigate the optimal ce of remifentanil for preventing emergence cough following extubation during general anesthesia in male patients who are reversed with sugammadex or neostigmine.

remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. it allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. in addition, cough suppression of remifentanil enables smooth extubation with reduced complications. however, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. reduced ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Eligibility criteria:
inclusion criteria: * laparoscopic cholecystectomy under general anesthesia exclusion criteria: * bmi \> 30 kg/m2, respiratory infection, uncontrolled hypertension
a comparison of the effectiveness of seroquel xr and seroquel xr plus lithium in patients with acute bipolar mania: an open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative,study

Conditions: Acute Bipolar Mania

Summary: the primary objective of this study is to compare the efficacy of seroquel xr monotherapy compared with seroquel xr plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in young mania ratings scale (ymrs) total score to day 29 using the last observation carried forward method.

a comparison of the effectiveness of seroquel xr and seroquel xr plus lithium in patients with acute bipolar mania: an open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative, phase 4 study.

Eligibility criteria:
inclusion criteria: * female and/or male inpatients or outpatients, aged over 18 years and under 65 years * documented clinical diagnosis meeting the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria * ymrs total score =20 at enrollment and randomization (day 1) patients had a history of at least one manic episode that required hospitalization and/or treatment with a mood stabilizer or antipsychotic. * female patients must have a negative urine human chorionic gonadotropin (hcg) test at enrolment and must be using a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive exclusion criteria: * pregnancy or lactation meeting the criteria for any other (than bipolar disorder) dsm-iv axis i diagnosis, concomitant organic mental disorder or mental retardation * patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others * administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization/baseline * known intolerance or hypersensitivity to, or lack of response to previous treatment with quetiapine fumarate or lithium

Keywords: acute bipolar mania seroquel xr seroquel xr plus lithium quetiapine fumarate
18f-fdg uptake heterogeneity predicts pyrotinib response

Conditions: HER2-positive Breast Cancer

Summary: heterogeneity of 18f-fluorodeoxyglucose (fdg) uptake is a promising marker for predicting response to treatment. this study aimed to evaluate the ability of pretreatment positron emission tomography/computed tomography (pet/ct) 18f-fdg-based heterogeneity to predict the response to pyrotinib in patients with human epidermal growth factor receptor 2 (her2)-positive metastatic breast cancer (mbc).


Eligibility criteria:
inclusion criteria: * pathologically confirmed her2 positive breast cancer * treated with pyrotinib in the metastatic settings * underwent whole-body fdg pet/ct within 4 weeks before the initiation of pyrotinib and capecitabine were included in this study exclusion criteria: * incomplete medical history * loss of follow up
efficacy of mitraclip vs. pascal for the treatment of mitral regurgitation in an all-comer population

Conditions: Mitral Regurgitation; Valvular Heart Disease; Heart Failure

Summary: to investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.

in the context of m-teer, two different systems (mitraclip vs. pascal) are ce certified and clinically available. in the case of non-complex anatomy, both systems are comparable in terms of effectiveness. whether this holds true in cases of complex or highly complex anatomy in an "allcomer patient population" is currently unclear.

Eligibility criteria:
inclusion criteria: * age equal or above 18 years * written consent * heart team recommends m-teer exclusion criteria: * mitral stenosis (mv mean pg \> 5 mmhg) * cardiogenic shock or hemodynamic instability at the time of intervention * active endocarditis * participant in another interventional cardiology study

Keywords: mitral regurgitation teer mitraclip pascal