Kornimate/medical-research-clean huggingface dataset:
buprenorphine for the treatment of neonatal abstinence syndrome

Conditions: Neonatal Abstinence Syndrome

Summary: neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. commonly used treatments at present include morphine or tincture of opium. buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for neonatal abstinence syndrome. this trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").


Eligibility criteria:
inclusion criteria: * ≥ 37 weeks gestation * exposure to opiates in utero * demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment exclusion criteria: * major congenital malformations and/or intrauterine growth retardation * medical illness requiring intensification of medical therapy * concomitant benzodiazepine or severe alcohol abuse, self-report of regular use of alcohol or of benzodiazepines use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother during pregnancy, * concomitant use of cyp 3a inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, hiv protease inhibitors) or inducers (rifampin, carbamazepine, phenobarbital) prior to initiation of nas treatment * seizure activity or other neurologic abnormality * breast feeding * inability of mother to give informed consent due to co-morbid psychiatric diagnosis * hypoglycemia requiring treatment with intravenous glucose

Keywords: neonatal abstinence syndrome buprenorphine neonatal opioid withdrawal
quantifying gait alteration in multiple sclerosis using a wearable device

Conditions: Multiple Sclerosis

Summary: gait alteration is frequent in ms and limitation in walking ability is a major concern in ms patients. the development of wearable device offers the opportunity to collect data during daily activity including walking.

umanit and lmj (nantes university) has developed a device call emsgait to assess walking ability in ms patients individuals (eg ms patients). this device consists in a commercialized imu sensor (metamotionr sensor, mbientilab) worn at the right hip, a smartphone app and dedicated algorithm/mathematical model to extract raw sensor data and calculate individual gait pattern (igp). this igp consists of a curve, based on quaternion and representing the rotation recorded by the imu during an average gait cycle. pursue first pilot work assessing information from igp on gait alteration in ms.

Eligibility criteria:
inclusion criteria: * age 18 - 64 years * diagnosis of ms based on mcdonald criteria (including relapsing-remitting and progressive ms) * no relapse within the last 5 weeks before recruitment * able to walk with or without assistance/help/aid (one or 2 canes) * edss \[0-6\] exclusion criteria: * women who are pregnant * patient having expressed their opposition * patient under guardianship or security measure

Keywords: wearable sensor gait
a study to evaluate efficacy and safety of giredestrant compared with fulvestrant (plus a cdk4/6 inhibitor), in participants with er-positive, her2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionera breast cancer)

Conditions: Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

Summary: this is a phase iii, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a cdk4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (er+), human epidermal growth factor receptor 2-negative (her2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent * documented estrogen receptor-positive (er+), her2-negative (her2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing) * confirmed esr1 mutation status (esr1m versus esr1nmd) in baseline circulating tumor dna (ctdna) through central laboratory testing * resistance to prior adjuvant endocrine therapy (et), which is defined as having relapsed with prior standard adjuvant et, on-treatment after \>/=12 months or off-treatment within 12 months of completion. prior use of adjuvant cdk4/6i is allowed (if relapse occurred \>/=12 months since completion). * no prior systemic anti-cancer therapy for advanced disease * measurable disease as defined per recist v.1.1 or non-measurable (including bone-only) disease * eastern cooperative oncology group performance status (ecog ps) 0-1 * for pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved lhrh agonist therapy (as per local guidelines) for the duration of study treatment exclusion criteria: * prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer * prior treatment with another serd (e.g., fulvestrant, oral serds) or novel er-targeting agents * advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term * active cardiac disease or history of cardiac dysfunction * clinically significant history of liver disease

Keywords: oral selective estrogen receptor degrader (serd) cdk4/6 inhibitor (cdk4/6i) esr1 mutation
short-term atorvastatin's effect on acute kidney injury following cardiac surgery

Conditions: Acute Kidney Injury; Post-Operative Delirium; Icu Delirium; Acute Renal Failure; Delirium

Summary: aim1a: statin naive patient's scheduled for cardiac surgery will be randomized to 80mg atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until hospital discharge to test the hypothesis that short-term atorvastatin use decreases: 1. acute kidney injury following cardiac surgery. 2. postoperative delirium following cardiac surgery. aim1b: patients using statins preoperatively will be randomized to atorvastatin 80mg or placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use decreases: 1. acute kidney injury following cardiac surgery. 2. postoperative delirium following cardiac surgery. endpoints include glomerular filtration, urine and plasma markers of renal dysfunction, markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium, dialysis, stroke, myocardial infarction, time to extubation, icu length of stay, and death.


Eligibility criteria:
inclusion criteria: * open heart surgery exclusion criteria: * acute coronary syndrome with troponin leak or unrelenting angina * liver dysfunction (transaminases 2x normal) * history of myopathy or liver dysfunction on prior statin therapy * use of potent cyp3a4 inhibitors such as antifungal azoles, macrolide antibiotics, hiv protease inhibitors, and nefazodone. * pregnancy or breast feeding * cyclosporine use * dialysis * history of kidney transplant * fibrate users who cannot stop fibrate use.

Keywords: aki delirium statin short-term cardiac
bevacizumab and bkm-120 in patients with metastatic renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: bkm-120 is a drug that may slow the growth of cancer cells. this drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. in this research study, the investigators are testing the safety to bkm-120 at different dose levels. the investigators will also be studying how well tolerated bkm-120 is, and how effective bkm-120 can be in the treatment of kidney cancer.

subjects will receive an intravenous infusion of avastin on day 1 and day 15 of each month (cycle). subjects will take a daily oral dose of bkm-120 at the dose level assigned. subjects will have a clinic visit weekly during cycle 1 and then on day 1 and day 15 of each cycle for blood tests and physical exam.

Eligibility criteria:
inclusion criteria: * metastatic rcc with clear cell component or papillary rcc * life expectancy \> 12 weeks * must have failed at least 1 prior anti-vegf systemic therapy for metastatic rcc exclusion criteria: * prior treatment with a p13k inhibitor or bevacizumab * untreated brain metastases * acute or chronic liver or pancreatic disease * major mood disorder * concurrent severe and/or uncontrolled medical condition * diabetes mellitus * gi disease * currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant * pregnant or breastfeeding * hiv positive * history of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix * uncontrolled hypertension

Keywords: kidney cancer avastin
bli850-302: bli850 vs an approved active control bowel preparation in adult subjects undergoing colonoscopy

Conditions: Colon Cancer

Summary: this is a randomized, parallel, multi-center, single-blind study, comparing bli850 to an fda approved bowel preparation in adult subjects undergoing colonoscopy.


Eligibility criteria:
inclusion criteria: 1. male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including: * evaluation of barium enema results * gi bleeding * anemia of unknown etiology * neoplastic disease surveillance * abnormal endosonography * inflammatory bowel disease * unknown diarrhea or constipation etiology * polypectomy * laser therapy * routine screening 2. at least 18 years of age. 3. otherwise in good health, as determined by physical exam and medical history. 4. if female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, intra-uterine device, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse). 5. negative urine pregnancy test at screening, if applicable. 6. in the investigator's judgment, subject is mentally competent to provide informed consent to participate in the study. exclusion criteria: 1. subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon. 2. subjects with impaired consciousness that predisposes them to pulmonary aspiration. 3. subjects who are undergoing colonoscopy for foreign body removal or decompression. 4. subjects with clinically significant electrolyte abnormalities based on visit 1 laboratory results. 5. subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass). 6. subjects who are pregnant or lactating, or intending to become pregnant during the study. 7. subjects of childbearing potential who refuse a pregnancy test. 8. subjects who are allergic to any preparation components 9. subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures. 10. subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Keywords: colonoscopy screening
chronic postoperative pain after the lichtenstein groin hernioplasty

Conditions: Hernia, Inguinal; Hernia, Femoral; Postoperative Pain; Chronic Pain; PROM; Suture Related Complication

Summary: the study attempts to quantify the relative risks for chronic postoperative inguinal pain (cpip) after lichtenstein repair of groin hernia, depending on mesh type and fixation suture material. for this purpose the investigators will analyze data from the swedish hernia registry (shr).

this is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in shr, which covers \> 95% of all groin hernia repairs in sweden. the large database enables assessment of the relative risks for cpip depending on in particular mesh and mesh fixation, adjusted for other plausible risk factors. each participant was entered at the date of surgery, when demographic and intraoperative data were registered. one year postop, each patient was sent a questionnaire focusing on present pain.

Eligibility criteria:
inclusion criteria: all lichtenstein and similar open mesh repairs that have been registered in the shr from september 1, 2012, until december 31, 2018. exclusion criteria: * laparoscopic repairs. * preperitoneal open repairs. * pure suture repairs * patients not having a 10-digit state-assigned patient identification number.

Keywords: swedish hernia registry lichtenstein surgical mesh surgical sutures
registry of patients with takotsubo syndrome

Conditions: Takotsubo Cardiomyopathy; Broken Heart Syndrome; Tako-tsubo Cardiomyopathy

Summary: takotsubo syndrome is a condition which mimics acute myocardial infarction, and is diagnosed in 1.5% to 2.2% of patients referred to hospital with suspected acute coronary syndrome. it is also known as broken heart syndrome, takotsubo cardiomyopathy, stress cardiomyopathy and apical ballooning cardiomyopathy, among other names. the pathogenesis of this disorder is not well understood. possible mechanisms include catecholamine excess, coronary artery spasm, microvascular dysfunction, among others. this is a multicenter, nation-wide, observational study of patients who were previously diagnosed with takotsubo syndrome. the investigators aim to use this registry to help plan and carry out further studies and to improve understanding of the pathophysiologic mechanisms of this syndrome. in addition participants will be followed for events, and to monitor quality of life and stress.

patients are eligible to participate if they are aged 18 years or older and carry a physician confirmed diagnosis of takotsubo syndrome. patients with a history of takotsubo syndrome will be identified via physician referral, epic search and patient self-referral. patients may register directly through our registry website at www.nyulmc.org/brokenheartstudy or via direct contact with the study team via e-mail or telephone. following completion of a research authorization form and collection of medical records, study team will confirm the diagnosis of takotsubo syndrome. data will be collected including contact information, medical history, data on the takotsubo event(s) including physician records and all relevant imaging. participants will also be asked quality of life questionnaires and will be followed every 4 months for events.

Eligibility criteria:
inclusion criteria: * physician diagnosis of takotsubo syndrome * age\>18 years exclusion criteria: - lack of capacity to provide informed consent
mitochondrial oxidative stress and vascular health in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to examine the effect of mitochondria derived oxidative stress on vascular function in patients with moderate to severe chronic kidney disease.

chronic kidney disease (ckd) patients are at increased risk of cardiovascular disease. endothelial dysfunction, characterized by a reduced bioavailability in nitric oxide, is an independent predictor of cardiovascular disease in ckd. increased oxidative stress is a potential cause of endothelial dysfunction in this patient cohort. this study investigates the role that mitochondrial derived oxidative stress plays in ckd related vascular dysfunction. in a controlled, double blinded trial, stage 3-5 ckd patients will be randomly assigned to receive a 4 week daily dose of a mitochondria targeted antioxidant (mitoq) or a placebo.

Eligibility criteria:
inclusion criteria: * stage 3 - 5 chronic kidney disease exclusion criteria: * history of cardiovascular disease; * current pregnancy; * uncontrolled hypertension; * uncontrolled hyperlipidemia; * current hormone replacement therapy; * current use of tobacco products; * elevated liver enzymes; * current autoimmune disease; * daily use of of antioxidants \>300mg

Keywords: endothelium, vascular mitoq mitochondria oxidative stress chronic renal insufficiency cardiovascular disease
sorafenib in elderly mrcc

Conditions: Carcinoma, Renal Cell

Summary: this prospective, single arm, multi-center pilot study includes 120 mrcc patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. the treatment with sorafenib should comply with the recommendations written in the local product information. the primary endpoint is overall survival. the secondary endpoints including other effectiveness points, safety and patients characteristics. with 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.


Eligibility criteria:
inclusion criteria: * patients with histologically/cytologically diagnosed metastasis rcc who are candidates for systemic therapy and have decided to accept sorafenib treatment. * \>=65 years of age * patients who have signed the informed consent * patients with a life expectancy of ≥12 weeks * no prior systemic treatment exclusion criteria: * the approved local product label must be followed for the exclusion criteria

Keywords: sorafenib renal cell carcinoma(rcc) elderly effectiveness safety
observational study of keratoconus and post-keratoplasty eyes

Conditions: Keratoconus and Post-keratoplasty

Summary: a prospective observational study on keratoconus and post-keratoplasty will be conducted. we will enroll 50 subjects in each of 3 groups: keratoconus, post-pk, and post-dsaek. the optovue anterior segment oct prototype will be used to perform 3-d corneal scans. these scans will be used to measure corneal thickness (pachymetry), corneal topography (anterior and posterior) and epithelial thickness maps. the ultrahigh-speed mit oct prototypes will also be used when they become available. a comprehensive eye examination, placido-ring corneal topography, ultrasound pachymetry, and scheimpflug camera imagery, will be performed for comparison. in some post-pk and post-dsaek cases, vision will be primarily affected by regular astigmatism, myopia, or hyperopia, rather than hoa. these cases can be corrected by standard prk (not oct guided) with adjunctive mitomycin c treatment to prevent haze formation.107, 108 in these cases prk will be performed according to the standard of care and will not be a part of the study protocol. the postoperative results will be observed at the 3-4 month visit with ucva, manifest refraction, bscva, oct scanning, placido topography, ultrasound pachymetry, and scheimpflug camera imagery


Eligibility criteria:
inclusion criteria: • adults (18 \& older) with keratoconus, keratoplasty, dsaek procedures exclusion criteria: * inability to give informed consent. * inability to maintain stable fixation for oct imaging. * inability to commit to required visits to complete the study.

Keywords: keratoconus post-keratoplasty
real-world study of china ozempic clinical practice in patients with type 2 diabetes (scholar)

Conditions: Diabetes Mellitus, Type 2

Summary: this study is to describe the real-world use and impact of semaglutide once-weekly (ow) among participants with type 2 diabetes mellitus (t2dm) in china. participants diagnosed with t2dm who initiated semaglutide ow for the first time between 1 jan 2022 (the date when semaglutide ow was listed in the national reimbursement drug list \[nrdl\] in china\] and 28 feb 2023 (9 months prior to the data extraction cut-off date of 30 nov 2023) will be included in this study. the study period will be 36 months prior to the first date of participants identification period.


Eligibility criteria:
inclusion criteria: * male or female participants aged greater than or equal to (≥) 18 years on index date * participants with diagnosis of t2dm prior to or on index date * participants with initiation of semaglutide ow for the first time within the identification period exclusion criteria: * participants with diagnosis of type 1 diabetes prior to or on index date * participants who were pregnant within 36 months prior to or on index date * participants who participated in any clinical trials within 36 months prior to or on index date which could be identified from medical records
maternal psychological implications of covid-19 pandemic and possible effect on anaesthetic management.

Conditions: Covid-19; Maternal Psychological Distress; Anesthesia

Summary: the aim of this study is to assess the maternal psychological implication of the novel coronavirus covid-19 pandemic. at the same time it will be evaluated whether there is an impact of these implications on the anaesthetic practice.


Eligibility criteria:
inclusion criteria: * all pregnant women over the age of 18 that present in labour (vaginal delivery or caesarean section) exclusion criteria: * psychiatric disorders * drug abuse * not eligible to read and write in greek

Keywords: covid-19 psychological distress maternal anaesthesia
ultrasonography of optic nerve sheath diameter for noninvasive detection of raised intracranial pressure: orient study

Conditions: Ultrasonography

Summary: this study aims to adopt a multi-center large sample size study to define (1) the normal range of chinese onsd; (2) onsd diagnosis for patients with high intracranial pressure; (3) to analyze the correlation between onsd and intracranial pressure.

the onsd, transcranial doppler parameters and baseline data of the normal intracranial pressure group and the enhanced intracranial pressure group (more than 200 mmh2o) .

Eligibility criteria:
inclusion criteria: 1. people requiring lumbar puncture testing due to brain trauma, intracranial infection, intracranial vascular disease, intracranial tumors, peripheral neuropathy for the raised intracranial pressure group. 2. healthy people for the normal intracranial pressure group. exclusion criteria: 1. eye diseases, such as eye trauma, eye tumors, optic neuritis, and glaucoma 2. people with poor temporal window penetration. 3. patients who refuse to sign informed consent.

Keywords: optic nerve sheath diameter intracranial pressure