Kornimate/medical-research-clean huggingface dataset:
evaluating the benefits of physiologic insulin delivery

Conditions: Type 1 Diabetes

Summary: in normal physiology insulin is secreted by beta cells into the portal vein. there have been a number of purported benefits among long-term intraperitoneal insulin users. in the present study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under ultrasound guidance and compare it to subcutaneous injection. we will measure glucose, insulin and glucagon following these injections, to assess for benefits in counter-regulatory hormone production and insulin pharmacokinetics.

the eventual goal of this line of work is an implanted insulin pump that delivers insulin automatically into the peritoneum based on continuous glucose data. all prior intraperitoneal pharmacokinetic studies used only concentrated regular insulin, which may be too slow to provide full closed-loop insulin delivery without meal announcement. a description of intraperitoneal ultra-rapid insulin kinetics, as well as counter-regulatory hormonal factors that may counter hypoglycemia is needed. upper versus lower peritoneal delivery may also affect insulin kinetics. a possible benefit of intraperitoneal insulin is restoration of glucagon response in longstanding diabetes and clearance of insulin by the liver, both of which could provide hypoglycemic rescue in automated insulin delivery systems.

Eligibility criteria:
inclusion criteria: 1. 18-60 years of age 2. clinical diagnosis of type 1 diabetes 3. on insulin pump therapy and continuous glucose monitor (cgm) for at least 3 months 4. ability to safely receive intraperitoneal injection 5. for females, not currently known to be pregnant 6. understanding and willingness to follow the protocol and sign informed consent 7. ability to speak, read and write in the language of the investigators exclusion criteria: 1. diabetic ketoacidosis in the past 3 months 2. severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment 3. pregnant or lactating 4. active infection 5. a known medical condition that in the judgment of the investigator might interfere with the completion of the protocol 6. known cardiovascular events in the last 6 months 7. known seizure disorder 8. inpatient psychiatric treatment in the past 6 months 9. lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication. 10. suspected drug or alcohol abuse 11. chronic kidney disease (gfr \< 60 ml/min/1.73m\^2)
daily hand-held vibration therapy

Conditions: Neuropathy; Cancer; Chemotherapeutic Drug - Induced Nephropathy; Chemotherapeutic Toxicity

Summary: the purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of cipn in the hands. the investigators hypothesize that daily vibration therapy can reduce the severity of patient's cipn in their hands and improve cipn-related quality of life. the hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating cipn in the future.


Eligibility criteria:
inclusion criteria: 1. 18 years or older at enrollment 2. able to provide informed consent and health insurance portability and accountability act (hipaa) authorization 3. have completed chemotherapy ≥ 60 days prior to enrollment 4. were exposed to neurotoxic chemotherapy with one or more of the following agents in the following doses: paclitaxel (cumulative dose: ≥ 300 mg/m2) docetaxel (cumulative dose: ≥ 100 mg/m2) nab-paclitaxel (cumulative dose: ≥ 750 mg/m2) oxaliplatin (cumulative dose: ≥ 510 mg/m2) carboplatin (cumulative dose: ≥ 600 mg/m2) cisplatin (cumulative dose: ≥ 200 mg/m2) vincristine (cumulative dose: ≥ 4 mg/m2) bortezomib (cumulative dose: ≥ 16 mg/m) 5. continue to display evidence of sensory cipn in the hands rated at a grade ≥ 2 according the national cancer institute's common toxicity criteria-adverse events (nci-ctc-ae, version 5.0) scale ≥ 60 days post-chemotherapy 6. if solid tumor cancer, must have non-metastatic cancer 7. agree to return to clinic for required study related measurements at specified intervals exclusion criteria: 1. have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.) 2. known diagnosis of diabetes mellitus. 3. known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection. 4. will be receiving concurrent radiation of the upper-extremity

Keywords: neuropathy vibration
orthopulse™ and its effect on the rate of orthodontic tooth alignment: a pilot feasibility study

Conditions: Malocclusion

Summary: the aim of this study is to determine the effect of orthopulse™, an intra-oral led (light emitting diode) photobiomodulation device, on the rate of anterior orthodontic alignment.


Eligibility criteria:
inclusion criteria: * presence of permanent dentition * eligible and scheduled for full mouth fixed orthodontic treatment * class i or class ii malocclusion (no more than ½ cusp in class ii) * non-extraction in all quadrants * non-smoker * good oral hygiene as determined by the investigator * no adjunct treatment such as extra- or intra-oral appliances exclusion criteria: * pregnant females * patient is currently enrolled in another clinical study * non-steroidal anti-inflammatory drug (nsaid) use during study (acetominophen acceptable) * periodontally involved teeth * use of bisphosphonates * unerupted or partially erupted maxillary teeth * teeth blocked out of alignment and unable to engage initial arch wire * spaces present in the maxillary arch

Keywords: alignment phase photobiomodulation orthodontic treatment malocclusion orthopulse™
empagliflozin to prevent post-operative atrial fibrillation

Conditions: Post-operative Atrial Fibrillation; CABG

Summary: this is an interventional, double-blind, placebo controlled, multicenter, randomized clinical trial with allocation sequence concealment and blinded endpoint adjudication. the goal of present study is to investigate if periprocedural administration of 10 mg once daily empagliflozin, a sodium-glucose cotransporter-2 inhibitor (sglt2i), can reduce the incidence of post-operative atrial fibrillation and/or atrial flutter in patients with chronic coronary syndrome scheduled for isolated cabg. this trial will be conducted in two referral teaching cardiology hospitals in tehran. 492 adult patients who are scheduled for elective isolated coronary artery bypass graft (cabg) surgery will be randomly assigned to one of the groups of intervention (empagliflozin 10 mg daily) or placebo starting 3 days before surgery until discharge.

study aim: evaluating the role of empagliflozin on the rate of postoperative atrial fibrillation in comparison with placebo design: two arms, parallel-group, phase 3, randomized, double-blind, placebo-controlled trial on 492 patients settings and conduct: recruitment site: tehran heart center and rajaie cardiovascular medical and research center for blinding, the drug or placebo will be given to the ward based on the patient's code in the randomization system for monitoring, the blood samples for creatinine, sodium, potassium, and fasting blood sugar along with clinical evaluations will be given on day 0 and daily thereafter (max= 30 days) in specific wards and will be compared at the end of any atrial fibrillation lasting longer than 30 seconds based on 24-hour 12-lead ecg monitoring will be accepted as atrial fibrillation after entering the study, the patients are placed in one of two groups, sample and control; in the sample group, they are treated with the usual treatment regimen plus empagliflozin at a dose of 10 mg during the hospitalization period. patients in the control arm will receive a matching placebo.

Eligibility criteria:
inclusion criteria * adult patients (≥18 years) who are candidates for isolated cabg * patients who provided written informed consent and are willing to participate in the study exclusion criteria * history of type ⅰ or ⅱ diabetes mellitus * history of ketoacidosis * history of atrial fibrillation or flutter * history of recurrent uti * sglt2i or any other oral hypoglycemic medications used due to other indications * patients with acute kidney injury (45) * severe hepatic disease (child-pugh score c) * patients with estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 * patients who are candidates for emergent cabg * patients with unstable hemodynamic state * patients with positive urine culture, urinary symptoms (frequency, dysuria, hesitancy), and asymptomatic bacteriuria * patients who are enrolled in other clinical trials * patients with a history of drug-sensitive reactions to sglt2i * pregnancy or lactation

Keywords: atrial fibrillation cabg cardiac surgery empagliflozin post-operative af sglt2 inhibitors
effect of dietary fat type in combination with high protein on plasma homocysteine levels

Conditions: Healthy

Summary: in this study, the investigators address the research question of whether palm olein will have a positive influence on plasma total homocysteine levels in human volunteers provided with high-protein diets formulated from common malaysian foods. hypothesis: there is a significant difference on the effects of the three experimental oils (palm olein, olive and coconut oil) on plasma thy levels and the other markers of coronary heart disease (chd) risk measured.

the experimental are comprise of 30% kcal fat, 20% kcal protein and 50% kcal carbohydrate. each of the test fat \[palm olein (poo), virgin olive oil (oo) and coconut oil (co)\] contributes to two-thirds of total dietary fat will be compared. three meals a day providing 2000 kcal, including breakfast, lunch and dinner will be provided for the 5-weeks period of each fat rotation. 45 volunteers are fed with normal cooking oil for 3 weeks for standardisation purpose. they were then stratified into 3 groups according to gender, homocysteine and cholesterol level. the volunteers will be randomized, blinded and will undergo a 3 arms crossover intervention. each intervention will take 5 wk with 2 wk wash out in between. baseline blood samples will be taken while other blood samples will be collected at week-4 and -5 of the study.

Eligibility criteria:
inclusion criteria: * apparently healthy adult males and females aged 20-60 years, with bmi 23.0 -29.9 kg/m2, and free from any disease (will be decided through history taking, physical examination and biochemical tests). * not on any medication or treatment associated with reduction of chd. * non-smokers and non heavy drinker or having smoking or alcoholic history. * not pregnant or lactating. * willing to adhere to the dietary guidelines to the study. exclusion criteria: * obese \[body mass index (bmi) ≥ 30\] or grossly underweight (bmi \< 18). * suffering from chronic diseases such as diabetes mellitus, chd, cancer or any liver/renal disease. * people with blood clotting problem. * hypertensive persons (systolic pressure \> 140 mmhg, diastolic pressure \> 90 mmhg)

Keywords: palm olein homocsyteine cholesterol lipoproteins interleukins crp blood pressure total homocystein serum lipid profile serum apolipoproteins inflammatory markers
a study of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (d/c/f/taf) evaluated as a fixed dose combination regimen in participants switching from an integrase inhibitor who have experienced rapid weight gain

Conditions: HIV-1

Summary: the purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (d/c/f/taf) fixed-dose combination (fdc) (immediate switch arm) compared to continuing the current integrase (ini) + tenofovir alafenamide/emtricitabine (taf/ftc) antiretroviral (arv) regimen (delayed switch arm) in virologically-suppressed human immunodeficiency virus (hiv)-1 infected participants who have experienced rapid and significant body weight gain.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of greater than or equal to (\>=) 18 kilogram per meter square (kg/m\^2) at time of starting an integrase (ini)-based regimen plus tenofovir alafenamide/emtricitabine (taf/ftc) antiretroviral (arv) regimen * documented human immunodeficiency virus (hiv)-1 infection * currently being treated with a stable arv regimen consisting of an ini combined with taf/ftc for \>=6 consecutive months preceding the screening visit and experienced a \>=10 percent (%) increase in body weight within a 36-month time period prior to screening and while on the current ini + taf/ftc arv regimen * documented evidence of being virologically suppressed while on the current stable ini+taf/ftc arv regimen prior to screening * at least one plasma hiv-1 rna measurement less than (\<) 50 copies/milliliter (ml) occurring between 12 and 2 months prior to the screening visit while on the stable ini+ taf/ftc arv regimen and have hiv-1 rna \<50 copies/ ml at the screening visit exclusion criteria: * known history of malignancy within the past 5 years or ongoing malignancy other than cutaneous kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma * known allergies, hypersensitivity, or intolerance to d/c/f/taf fixed-dose combination (fdc) tablet or its excipients * active hepatitis b (hbv) or hepatitis c virus (hcv) infection * uncontrolled diabetes that will require treatment with insulin during the study period * evidence of child pugh class c based on clinical laboratory testing and clinical evaluation * history of failure on darunavir (drv) treatment or known documented history of \>=1 drv resistance-associated mutations (ram) * screening hepatic transaminases \>5x the upper limit of the normal range * screening creatinine based estimated glomerular filtration rate (egfrcr) \<30 ml/min according to the cockcroft-gault formula for creatinine clearance * participants initiating or discontinuing concomitant medications associated with significant changes in weight within the last 90 days
effects of different warming methods in laparoscopic cholecystectomy surgery

Conditions: Inadvertent Perioperative Hypothermia

Summary: cold gases given during laparoscopic cholecystectomy are the most important cause of hypothermia. however, even surgery alone is an 80% important cause of hypothermia. inadvertent perioperative hypothermia is a common complication of the surgical process that can cause serious complications. in most of the patients, tremors, increase in pain, deterioration in comfort and changes in some physiological parameters can be seen. despite this, there are not enough warming devices that nurses can use practically and are easy to use, affordable and comfortable for the patient. in the literature, it is stated in the evidence-based guidelines for determining the hypothermia risks of patients and taking early precautions.

the parallel group randomized controlled three group study blinded by the evaluator aims to investigate the effectiveness of different warming methods in laparoscopic cholecystectomy patients. this study general surgery at yozgat bozok university hospital in turkey are performed in clinics. all patients are male and female patients who have undergone surgery and met the inclusion criteria.

Eligibility criteria:
inclusion criteria: * patients are qualified to answer research questions, * bmi is between 18.5 kg / m2 and 30 kg / m2, * not using therapeutic hypothermia in the surgery, * not being treated with chronic opioids, * operation time is between 60 minutes and 6 hours, * having received general anesthesia during the operation, * reception of patients with asa classification i or ii, * absence of anemia, coagulation problem and peripheral circulatory disease or metabolic disease. exclusion criteria: * intraoperative and postoperative have complications (bleeding, arrest, nausea, vomiting, etc.), * conversion of surgery from laparoscopy to open surgery.

Keywords: inadvertent perioperative hypothermia laparoscopic cholecystectomy nurse pain physiological parameters shivering thermal comfort
sdoh-homecare intervention focus team (shift) trial to improve stroke outcomes

Conditions: Stroke; Social Determinants of Health

Summary: primary goal: to test the hypothesis that among stroke patients 18-75 years with ≥3 sdoh risk factors, shift will improve: (1) functional outcomes as measured by the sis (primary outcome), (2) physiological outcomes as measured by changes in blood pressure and cognition, (secondary outcomes) and (3) epigenetic allostatic load biomarkers (exploratory outcome) such as dna methylation (dnam) and telomere length, at 6 months and 1-year post-stroke, compared with usual care (uc).

adverse social determinants of health (sdoh) have been shown increase stroke risk in a dose dependent manner. the sdoh-homecare intervention focus team (shift) trial is a phase 3, randomized, blinded outcome trial that tests the hypothesis that a homecare intervention shortly after discharge from an acute stroke unit by a team comprising a community health worker (chw), a community social worker (csw) and a community nurse (cn) can improve health outcomes among stroke patients with three or more sdoh compared with uc.

Eligibility criteria:
inclusion criteria: 1. ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable caa) 2. age 18-75 years old. 3. have at least 3 sdoh barriers from within the 5 sdoh domains (social and community, education, economic, neighborhood/environment, health care). 4. have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after. 5. pre-stroke modified rankin scale score of ≤3 6. residence in new york city.. 7. english or spanish speaking. 8. can provide informed consent and engage in the initial assessment prior to stroke discharge. 9. lives in a household with a telephone, and has a caregiver (family member or home health aide) if not fully independent on discharge. if the patient requires a family member to assist with activities of daily living or decision-making, the family member must state a willingness to be present at home visits where their assistance is needed. exclusion criteria: 1. discharge disposition to a long term care facility. 2. diagnosis of dementia or other neurological neurological diagnosis that affects cognition. 3. diagnosis of active major depression. 4. aphasia severe enough to preclude initial examination. 5. impaired level of consciousness at initial cognitive assessment. 6. subarachnoid hemorrhage. 7. diagnosis of probable cerebral amyloid angiopathy by boston criteria. 8. life expectancy less than 1 year.

Keywords: stroke social determinants of health health disparities community health workers home visits
long-term follow-up study of human stem cells transplanted in subjects with connatal pelizaeus-merzbacher disease (pmd)

Conditions: Pelizaeus-Merzbacher Disease; PMD

Summary: the purpose of this study is to determine the long term safety and preliminary effect of hucns-sc cells transplanted in subjects with connatal pelizaeus-merzbacher disease (pmd).

only subjects who underwent hucns-sc transplantation under protocol cl-n01-pmd will be enrolled in this long term follow-up study. subjects will return to the site six months and one year after completion of the phase i study and then annually for a total study duration of four years. phone calls will also be made by the investigator to the subject's parent/legal guardian bi-annually to conduct a phone visit through the four-year duration of the study.

Eligibility criteria:
inclusion criteria: * subjects who received hucns-sc cells under protocol cl-n01-pmd exclusion criteria: * subjects who received off-protocol immunosuppressive medications. * subjects who are concurrently enrolled in another investigational study.

Keywords: long term follow-up hucns-sc cells human central nervous system stem cells
is the lack of prior exposure to sperm antigens associated with worse neonatal and maternal outcomes?

Conditions: Obstructive Azoospermia; Obstetric Complication

Summary: the objective of this study is to determine if the lack of exposure to sperm antigens is associated with worse maternal and neonatal outcomes in pregnancies obtained after icsi (intracytoplasmic sperm injection)-tese (testicular sperm extraction) for obstructive azoospermia. the primary outcomes that will be investigated include: * maternal outcomes: live birth rate (lbr), abortion rate, and the rate of the main obstetrics complication, such as pre-eclampsia, gestational hypertension and diabetes mellitus. * neonatal outcomes: gestational age, prematurity rate, birth weight, sex ratio, 1- and 5-min apgar, birth defects.

several studies investigated the role of paternal factors in the development of preeclampsia; in particular, they analyzed the correlation between the vaginal exposure to male partner's semen and the incidence of preeclampsia, observing both a reduced risk of preeclampsia after prolonged exposure to the paternal seminal fluid and a higher incidence of preeclampsia in pregnancies conceived with a new father or with sperm donor. this leads to the hypothesis of an immunological role for sperm in inducing a mucosal immune tolerance-like status at the level of the uterus that could be critical in the subsequent implantation. previous studies also examined the neonatal outcomes from pregnancies obtained from surgically retrieved sperm, either epididymal or testicular sperm, and underlined that there is not overall increased risk in neonatal outcomes. our study aims at having a complete view on paternal, maternal and neonatal information and a follow up, that allows to correct possible confounders and to analyze a wider group of outcomes.

Eligibility criteria:
inclusion criteria for case arm: * primary infertility * diagnosis of obstructive azoospermia * icsi-tese cycles inclusion criteria for control arm: * primary infertility * icsi cycles with sperm from ejaculate exclusion criteria: * pre-gestational hypertension * pre-gestational diabetes

Keywords: neonatal outcomes
conséquences of the covid-19 lockdown measures on the chru nancy pediatric emergency services

Conditions: Number of Patients During the Studying Period; Reason for Consultation

Summary: the first period of covid 19 lockdown measures (from 18 march to 11 may 2020) change the french people way of life and their medicine knowledges. a study which evaluates the nancy's pediatric emergencies population utilization during this time could detect pathological changes. the medical impact of home confinement will show an increase (trauma, maltreatment) or decrease (virus disease) of several pathology. the study aims to help clinicians to the children care if another time of home confinement happened. the main objective is to evaluate the behavioural changes and the reason consultation in nancy's pediatric emergencies from 18 march to 30 june 2020 comparate to the same time in 2019. we will continue the search after the end of home confinement until 30 june 2020 to evaluate what happened just after.


Eligibility criteria:
inclusion criteria: * children who are cared during the study period to the nancy's pediatric emergencies exclusion criteria: * be more than 18 years old * not being seen by a doctor