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

Conditions: Polycystic Ovary Syndrome

Summary: the investigators wanted to elucidate the effects of metformin in polycystic ovary syndrome (pcos) by performing a randomized, double-blinded, placebo-controlled cross-over study.

eligible women who gave written informed consent were assigned to 6 months of treatment with either 850 mg of metformin or placebo twice daily, followed by a wash-out period of 3 months before cross-over to the alternate treatment for another 6 months. randomization defining treatment sequence was done at inclusion by random number tables. the appearance of the tablets was identical, and patients and investigators were blinded to treatment allocation. the randomization code was stored in a closed envelope until all participants had finished the treatment. participants were seen by one of the investigators before inclusion and every second month during treatment periods, always in the morning after an overnight fast of at least 8 h. they were weighed wearing light clothing. waist circumference was measured at the umbilical level and hip circumference at the trochanter region. systolic and diastolic blood pressure was measured with a semiautomatic blood pressure monitor and a blood sample was drawn for immediate analysis without respect to bleeding periods. all participants registered their bleeding periods in a calendar during both study periods and the 3 months wash-out period. calculation of sample size was based on the assumption that at least 50% of the women would experience at least 30% more menstrual periods on metformin than on placebo. based on a power of 90 (b = 0.10) to detect a significant difference \[two-sided p-value of 0.05\], the minimum sampling size was calculated to 44 subjects. we also assumed a 10% drop-out rate, and thus aimed at including 50 women. as drop-out rate quickly rose higher than expected, we decided to include 60 women. in the intention-to-treat analysis, the values of each participant after 6 months of metformin or placebo were compared with the baseline values. linear regression analysis with the changes in testosterone and homeostasis model assessment (homa) index as dependent variables was performed to examine potential relations between the changes. the per protocol analysis included data from participants completing both study periods, i.e. the difference between the values of each participant after placebo and metformin, respectively, was calculated, and a significance test performed on the differences.

Eligibility criteria:
inclusion criteria: * testosterone value above the upper normal limit and * oligo- or amenorrhea, exclusion criteria: * periclimacteric gonadotrophin values, * hyperprolactinaemia, * diabetes mellitus, * impaired thyroid, * renal or hepatic function, * hormonal treatment, * pregnancy, * lactation or a wish for fertility treatment.

Keywords: pcos metformin obesity randomized controlled trial
episodic memory before and after surgery in drug-resistant partial epilepsies

Conditions: Epilepsy, Unspecified, Pharmacologically Resistant; Memory Impairment

Summary: this study has two purposes: firstly, a better understanding of the neurobiological processes underlying episodic memory and, secondly, the development of useful clinical applications for epileptic patients, in particular the prediction of postoperative memory deficits and the development of cognitive remediation therapies. memory performances during a fmri experiment will be assessed in controls and epileptic patients before and after the surgery.


Eligibility criteria:
inclusion criteria: * patients with drug-resistant epilepsy * age of 18 years or more * follow-up in the epilepsy unit at pitié-salpêtrière hospital * before or after the presurgical evaluation unit including a video-eeg monitoring, a structural brain imaging and a full neuropsychological assessment * covered by a social security system * signing of consent form exclusion criteria: * persons under guardianship, curatorship or any other administrative or judicial deprivation of rights and freedom * refusal to consent form * contraindications to mri * pregnancy * refusal to be informed in the case of detection of an abnormality during the experiment

Keywords: epilepsy surgery functional mri memory outcome
role of abbreviated mri in follow-up of hepatocellular carcinoma .

Conditions: Hepatocellular Carcinoma

Summary: role of adc value and dwi in abbreviated mri compared to post-contrast ct in follow-up of hcc after tace.

hepatocellular carcinoma (hcc) is the 5th most common cancer in the world and the most common in egypt . trans-arterial chemoembolization (tace) is the treatment recommended for unresectable hcc according to barcelona clinic liver cancer staging and is widely used . hcc is nourished only by the hepatic artery, so tace causes ischemia and coagulative necrosis. however; viable neoplastic tissue residual may be seen after tace. assessment of post-tace tumor response is important in determining treatment success and in guiding future therapy . many studies have assessed the diagnostic performance of multiphasic contrast-enhanced computed tomography (ct) and magnetic resonance imaging (mri) in diagnosis of hcc with noted higher sensitivity of mri compared to ct. ct or mri are recommended for assessment of response after treatment as well . diffusion-weighted imaging (dwi) and apparent diffusion coefficient (adc) are functional mri techniques that detect signal changes in tissues due to water proton motion. the intact membranes of viable tumor cells restrict water diffusion, whereas necrotic tumor cells with disrupted cell membranes exhibit increased water diffusion and which differentiate the biological activity of hcc

Eligibility criteria:
inclusion criteria: * patients who underwent tace for unresectable hcc with patent portal vein based on doppler, no ascites, and satisfactory liver function. age between 20-year old and 85-year old exclusion criteria: * estimated gfr less than 60 previous history of severe allergic reaction to the iodinated contrast agent patients with claustrophobia who can't undergo mr examination. patients having cochlear implants or cardiac pacemaker
assessing closed-loop insulin delivery in children with type 1 diabetes.

Conditions: Diabetes Mellitus, Type 1

Summary: the objective of this clinical trial is to assess the safety of our insulin dosing algorithm in children with type 1 diabetes in a free-living study.

this is a preliminary pilot study to generate data to optimize an insulin dosing algorithm to regulate glucose levels in children with type 1 diabetes. there will be up to two 40-hour test in outpatient settings, in which we will assess an insulin dosing algorithm. the two tests will allow us to compare different tunings in the same patient (this allows easier interpretation of the data). for example, if in a specific participant, the dosing algorithm reduced insulin delivery at night to avoid low blood glucose levesl but led to a rebound increase in glucose levels, then a second visit with a slightly different target range will help answer this question. the objective of this clinical trial is to assess the safety of our algorithm in children with type 1 diabetes in a free-living study.

Eligibility criteria:
inclusion criteria: 1. male or female children between 2 and 13 years of age. 2. clinical diagnosis of type 1 diabetes mellitus (the diagnosis of type 1 diabetes is based on the investigator's judgment). 3. using insulin pump therapy for at least 3 months 4. for participants aged 7-13 years: total daily insulin dose ≤ 40 units and 0.5 ≥ units/kg/day. for participants aged 2-6 years: total daily insulin dose \[8, 40\] units and 0.3 ≥ units/kg/day. 5. most recent (in the last 6 months) hba1c ≤ 12%. exclusion criteria: 1. using medtronic 670g automated insulin delivery system (since participant's basal rates and insulin-to-carbohydrate ratios may reflect the use of 670g; generally overestimated by 20%). 2. severe hypoglycaemia or ketoacidosis episode ≤ two months before admission. 3. medical illness or other issues likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Keywords: pediatric artificial pancreas
study of tarlatamab in combination with yl201 with or without anti-programmed death ligand 1 (pd-l1) in participants with extensive stage (es) small cell lung cancer (sclc)

Conditions: Small Cell Lung Cancer

Summary: the primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with yl201 with or without anti-pd-l1.


Eligibility criteria:
inclusion criteria: * participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent. * participants with histologically or cytologically confirmed es-sclc. * for parts 1 and 2, participant must have es-sclc that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy. * for part 3, participants must have es-sclc and no prior systemic treatment for es sclc other than 1 cycle of platinum-based chemotherapy, etoposide, and pd-(l)1 inhibitor in the first-line setting. * at least 1 measurable lesion as defined by recist 1.1. * participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver). exclusion criteria: * prior delta-like ligand 3 (dll3) or b7 homolog 3 (b7-h3) targeted therapy. * prior exposure to topoisomerase i inhibitors or antibody-drug conjugate (adc) with topoisomerase i inhibitor payload. * symptomatic central nervous system (cns) metastases. note: participants with asymptomatic brain metastases are eligible as defined in the protocol. * history of (non-infectious) interstitial lung disease (ild)/pneumonitis that required corticosteroids, current ild/pneumonitis, or suspected ild/pneumonitis that cannot be ruled out by imaging at screening. * baseline requirement of supplemental oxygen.

Keywords: small cell lung cancer sclc tarlatamab yl201 anti-pd-l1 atezolizumab durvalumab
effectiveness of bilateral ptns compared to unilateral ptns for the treatment of overactive bladder/urge incontinence

Conditions: Overactive Bladder Syndrome; Urinary Incontinence, Urge

Summary: this study is designed to evaluate whether bilateral posterior tibial nerve stimulation is more effective than unilateral posterior tibial nerve stimulation at treating overactive bladder and urge urinary incontinence

percutaneous tibial nerve stimulation (ptns) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. it is currently carried out by stimulating one of the posterior tibial nerves unilaterally. the aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. enrolled patients will be randomized into two groups. the control group will receive the traditional unilateral treatment of ptns. the intervention group will receive bilateral ptns treatment. intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary

Eligibility criteria:
inclusion criteria: 1. female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy 2. patients who consent to participate in the study 3. patients on pharmacologic therapy at the time of recruitment can continue their treatment exclusion criteria: 1. pregnant patients 2. patients with pacemakers of implantable defibrillators 3. patients with neurogenic bladder 4. patients who have received botox or have an implant for sacral nerve stimulation 5. patients with uncontrolled bleeding disorder 6. patients with unhealed ulcers or with leg edema surrounding medial malleolus

Keywords: overactive bladder oab urge urinary incontinence ptns
physiological effects of lung recruitment during general anesthesia and low-tidal volume ventilation

Conditions: Anesthesia, General; Surgery

Summary: low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery. a recent large randomized controlled trial failed to detect a significant difference between two different approaches for ensuring adequate lung recruitment (peep=12 cmh2o + scheduled recruiting maneuvers vs. peep 2 cmh2o) during protective ventilation. thus, in patients undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different positive end-expiratory pressure (peep) levels and recruiting maneuvers remain to be established. design: prospective, cross-over, physiological trial. purpose to assess the physiological effects of different peep levels with or without scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal surgery and receiving low-tidal volume ventilation.


Eligibility criteria:
inclusion criteria: * asa physical status i-ii patients * scheduled for open abdominal surgery (major gastrointestinal surgery: duodeno-cephalo-pancreatectomy, gastrectomy, hemi-colectomy; gynecological surgery; oncologic surgery) * expected duration of surgery \>= 150 minutes exclusion criteria: * pregnancy * bmi\>30 kg/m\^2 * hepatic surgery * cardiac failure nyha\>2 * history of chronic respiratory failure
a phase 1/2a study to assess the safety and efficacy of ckd-516 tab. in combination with irinotecan inj.

Conditions: Colorectal Cancer

Summary: the purpose of this open-label, dose-escalation phase i trial is to evaluate the safety, tolerability and pharmacokinetic profiles and to assess the efficacy of ckd-516 tablet in combination with irinotecan inj. in patients with previously treated advanced colorectal cancer

ckd-516 tab. in combination with irinotecan inj.(1cycle=14days)

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 19 years or older 2. patients who failed existing anti-cancer therapies 3. ecog performance status ≤ 1 4. life expectancy of ≥ 12 weeks 5. adequate hematological, hepatic and renal functions: 6. patients who give written informed consent voluntarily exclusion criteria: 1. prior systemic chemo-, radiochemo-, radio-, immuno-, hormonal and/or biological therapy within 2 weeks before study participation (in case of nitrosoureas and/or mitomycin, within 6 weeks before study participation) 2. patients who received major surgery within 4 weeks before study participation (in case of vats and/or onc surgery, within 2 weeks before study participation) 3. symptomatic cns metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.) 4. nyha class iii or iv heart failure, uncontrolled hypertension (sbp/dbp \> 140/90 mm hg), other clinically significant cardiovascular abnormalities at investigator's discretion (e.g., lvef \< 50%, clinically significant cardiac wall abnormalities or cardiac muscle damages) 5. acute coronary syndrome (unstable angina or myocardial infarction) within 6 months 6. uncontrolled arrhythmia 7. significant cerebrovascular diseases including stroke within 6 months 8. significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases 9. patients with known active hepatitis, hiv infection, or other uncontrolled infectious disease 10. patients who cannot receive ip by mouth and have a history of clinically significant gastrointestinal disorders which can impede administration, transit or absorption of the ip 11. a history of severe drug hypersensitivity or hypersensitivity to analogs of the ip 12. pregnancy or breast-feeding 13. women of childbearing potential (wocbp) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 3 months after the end of treatment 14. patients who received other investigational products or used other investigational devices within 3 weeks before participation 15. patients who cannot participate in this trial by investigator's discretion
a 6-month efficacy and safety study of org 50081 in adult patients with chronic primary insomnia (21106/p05701/mk-8265-002)

Conditions: Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorder, Intrinsic

Summary: to investigate the long-term efficacy and safety of treatment with esmirtazapine (org 50081, sch 900265, mk-8265) compared to placebo, in participants with chronic primary insomnia. primary efficacy variable is total sleep time (tst).

insomnia is a common complaint or disorder throughout the world. about one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. the majority of the insomniacs suffer chronically from their complaints. the maleic acid salt of org 4420, code name org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. the first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. all 3 esmirtazapine dose groups showed a statistically significant positive effect on tst (objective and subjective) and wake time after sleep onset (waso), as compared to placebo. the current study is designed to assess the long-term efficacy and safety of esmirtazapine in a double-blind, randomized, placebo-controlled, parallel group outpatient trial in participants suffering from chronic primary insomnia. during the 6-month treatment period, participants are randomly assigned to receive either esmirtazapine or placebo. then, during the 7-day discontinuation period, participants who received esmirtazapine in the 6-month treatment period are randomly assigned to receive either esmirtazapine or placebo, while participants who received placebo in the 6-month treatment period continue to receive placebo.

Eligibility criteria:
inclusion criteria: * are at least 18 and less than 65 years; * sign written informed consent after the scope and nature of the investigation have been explained; * have shown capability to complete the logpad questionnaires; * have difficulty falling asleep, maintaining sleep or have early morning awakening; exclusion criteria: * significant medical or psychiatric illness causing sleep disturbances. * have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide. * have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy. * significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year. * currently diagnosed or meet the criteria for major depressive disorder (mdd) or have been treated for mdd in the last 2 years. * substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year. * are night workers or rotating shift workers or plan to travel through more than 3 time-zones. * routinely nap during the day. * have a body mass index (bmi) of 36 or more.

Keywords: placebo controlled randomized double blind
effects of exoskeleton-assisted gait training on functional rehabilitation outcomes in patients with stroke

Conditions: Stroke; Weakness of Extremities as Sequela of Stroke

Summary: the goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.

abstract objective: the goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility. background: method: the investigators will study 50 patients with stroke consecutively admitted to a designated stroke rehabilitation unit in the oklahoma city va medical center. all patients will receive their daily 3-hours conventional therapy, plus an hour of either exoskeleton or over-ground gait training 3 times per week for 60 minutes. patients were assigned to either the experimental (exoskeleton) or the control (over-ground) groups by computer-generated randomization. this is an open-label pragmatic trial, where neither the patients nor the clinicians could be masked to the intervention. institution review board (irb) approval will be obtained for the protocol. the demographic data to be collected includes: age, gender, race/ethnicity, stroke onset to admission, stroke types (ischemic/hemorrhagic), and stroke severity (on the national institute of health stroke severity \[nihss\] scale. admission and discharge total functional independence measure (fim), spasticity and depression scores, ambulation velocity over 2-minutes (2-mwt) in feet/minute, and discharge disposition. the intervention is indego® exoskeleton. the primary outcome measures were: changes in the fim, depression and spasticity scores. the secondary outcome measure was discharge disposition. continuous variables were analyzed using students t-test, ordinal variables were analyzed using mann-whitney, and the nominal variables were analyzed using chi-square analyses.

Eligibility criteria:
inclusion criteria: 1. all patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging. 2. medically stable from a cardio-respiratory stand point so that they can participate in daily therapies. 3. depressed patients will be included in the study 4. patients able to stand alone 5. patients able to provide a written informed consent, from cognitively intact patients (admission mini mental scale examination \[mmse\] greater than or equal to 21). exclusion criteria: 1. aphasic patients unable to communicate 2. confused patients 3. patients medically unstable 4. patients unable to stand alone 5. refusal to provide written informed consent

Keywords: stroke leg weakness exoskeleton