Kornimate/medical-research-clean huggingface dataset:
treatment of resistant hypertension by prevention of t-cell co-stimulation

Conditions: Hypertension

Summary: the purpose of this study is to test whether abatacept, a drug approved by the food and drug administration to treat rheumatoid arthritis, may help blood pressure medications to work better. this will be studied in people with high blood pressure that is not well controlled on three or more blood pressure medications, the condition also known as resistant hypertension. we expect to show that adding abatacept therapy to standardized treatment of resistant hypertension will result in a greater decrease in blood pressure at 24 weeks compared to treatment with placebo and conventional blood pressure treatment.


Eligibility criteria:
inclusion criteria: * men and women 18 to 65 years of age with hypertension, treated with three or more anti-hypertensive drugs, one being a diuretic, and * having a systolic blood pressure \>150 mmhg in the clinic and daytime average \>150 mmhg on ambulatory blood pressure monitoring exclusion criteria: * medical history of secondary cause of hypertension, severe obesity (bmi \>35), severe psychiatric disorders, cancer in the last 5 years other than nonmelanoma skin cell cancers, herpes zoster or cytomegalovirus that resolved less than 2 months before * inability to return for abatacept treatment and follow-up for 24 weeks. * inability to understand or complete study-related assessments. * current abuse of drugs or alcohol. * receipt of any live vaccines within 3 months of the anticipated first dose of study medication. * evidence of active or latent bacterial or viral infections at the time of potential enrollment, including human immunodeficiency virus (hiv) * risk for tuberculosis * abnormal laboratory values including positive hepatitis b surface antigen, hemoglobin \ 2.5 times the upper limit of normal (uln), alanine aminotransferase or aspartate aminotransferase \> 2 times the uln.

Keywords: hypertension inflammation
safety study of bms-986015 (anti-kir) in combination with ipilimumab in subjects with selected advanced tumor

Conditions: CANCER, NOS

Summary: to assess the safety and tolerability, characterize the dose-limiting toxicities (dlts), and identify the maximally tolerated dose (mtd) of bms-986015 given in combination with ipilimumab in subjects with select advanced (metastatic and/or unresectable) solid tumors.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * histologic confirmation of one of the following solid tumors that is advanced (unresectable or metastatic) for dose escalation or cohort expansion:non-small cell lung cancer (nsclc), castrate resistant prostate cancer (crpc), melanoma (mel) * at least one measurable lesion at baseline by computed tomography (ct) or magnetic resonance imaging (mri) as per response evaluation criteria in solid tumors (recist) 1.1 criteria * biopsies: subjects in the melanoma cohort must have at least 1 tumor site that can be biopsied at acceptable clinical risk * eastern cooperative oncology group (ecog) status of 0 or 1 * estimated life expectancy of ≥ 12 weeks * white blood cell (wbc) ≥2000/μl, neutrophils ≥1500/μl, platelets ≥ 100x1000/μl, hemoglobin ≥ 8.5 g/dl, creatinine ≤ 1.5 x upper limit of normal (uln) ml/min, alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3x uln * normal thyroid function or be on stable hormone supplementation exclusion criteria: * participation in any prior clinical study with bms-936558 or ipilimumab that has overall survival listed as a primary/co-primary endpoint * subjects with known or suspected brain metastasis * subjects with active autoimmune disease, uncontrolled or significant cardiovascular disease * prior therapy with anti- cytotoxic t-lymphocyte antigen 4 (ctla4) antibody or anti- killer cell immunoglobulin-like receptor (kir) antibody * grade 2 neuropathy
feasibility and acceptability of using weighted blankets to prevent and /or mitigate delirium

Conditions: Delirium

Summary: the use of weighted blankets to avert or alleviate delirium in adult icu patients.

to examine the feasibility and acceptability of weighted blankets as a single component, nonpharmacologic strategy to prevent and/or mitigate delirium in an adult medicine critical care patient population. to examine the feasibility and acceptability of videoconferencing (vcu health zoom), ehr screening, and vcu and vcu health infrastructure (redcap, oncore) for rural participant recruitment and research participation, remote healthcare provider protocol training and research engagement, and remote research monitoring and support for rural patient population. to collect preliminary descriptive data and examine trends related to the use of weighted blankets to prevent and/or mitigate delirium to inform future efficacy trials in an adult medicine critical care patient population (e.g., agitation, delirium, icu length of stay, number ventilator days, sedation/opioid medication usage).

Eligibility criteria:
inclusion criteria: * 18 years of age or older. * requiring icu level of care. * have a primary medical diagnosis. * proficient in english. exclusion criteria: * bmi less than 18.5. * significant deficit in cognitive functioning that is not expected to improve due to an end---stage disease stage or permanent injury (e.g., end-stage encephalopathy, traumatic or anoxic brain injury, dementia). * known pregnancy. * prisoners. * presence of skin injury (e.g., surgical wound, pressure injury, moisture injury) in an anatomical location where additional weight/pressure of blanket could prevent healing and /or lead to an expansion of the injury. * patients with skin injuries to areas easily left uncovered by the blanket (e.g., hands, feet) can be enrolled with additional communication to clinical team to leave areas uncovered to prevent additional injury. * paralysis effecting an area the weighted blanket will cover. * current neuromuscular blocking agent. * presence of recent/unhealed fractures on an area the blanket will cover (e.g., lower limb long bone, rib, pelvis, spine). * history of claustrophobia reported by patient and/or their legally authorized representative (lar). * fever of 37.5°c (99.5°f). * limited english proficiency.
optimizing the obstetrician's movement during a simulated forceps operative vaginal delivery (performac)

Conditions: Obstetric Trauma

Summary: operative vaginal delivery is the main risk factor for pelvic floor trauma occurrence and especially for obstetric anal sphincter injuries. these complications are strongly and negatively impact women's health: fecal incontinence, perineal pain, sexual dysfunction. the risk appears higher in case of operative vaginal delivery assisted by forceps compared to a vacuum delivery. this considered it is likely that optimizing the performance of the operator that perform the operative vaginal delivery will reduce the morbidity associated with this intervention. there are data bout how to optimize the placement of the forceps on the fetal head before performing the delivery but there are no data about the movement of the obstetrician during this intervention. the objective is to analyse the posture and the movement of the obstetrician during a simulated forceps operative vaginal delivery using a 3d cinematic analysis. secondary objectives are to analyse the traction force applied on the forceps during the delivery, to describe the different postures in terms of stability and last to compare the self-declared practice to the objectively observed. this is a prospective study including 40 volunteers (medical doctors and registrars). each volunteer will perform a simulated operative vaginal delivery using a suzor's forceps on a high fidelity mannequin. postures and movement will be assessed using optometric analysis. the force of traction will be assessed during the operative delivery thank to a force sensor on the forceps. the self declared practice collected thanks to individual questionnaires will be compared to the observed practice during the simulation. the prospects are to identify the best posture and movement for performing an operative vaginal delivery and to promote tools for simulation of medical students.


Eligibility criteria:
inclusion criteria: * medical doctor or registrar that have an experience of operative vaginal delivery using forceps in their clinical activity exclusion criteria: * no practice of the forceps at all
personalized circulating dna follow-up in melanoma (percimel)

Conditions: Melanoma

Summary: percimel is an open multicentric study. the purpose of this study is to assess the interest of molecular analysis on circulating tumor dna in the follow-up of the disease.


Eligibility criteria:
inclusion criteria: * locally advanced, operable melanoma * treated by immunotherapy or anti-braf and anti-mek targeted therapies (stage iiib, iiic) or exclusive immunotherapy (stage iv) in an adjuvant situation. exclusion criteria: * second cancer * woman who is pregnant, likely to be pregnant or breastfeeding

Keywords: circulating tumour dna immunotherapy targeted therapy
target controlled infusion of etomidate or propofol for anesthesia of thoracoscopic mitral valve replacement surgery

Conditions: Delirium; Hemodynamic Instability

Summary: for patients requiring the heart valve replacement surgery, heart function is injured in different degree.thus, minimizing the impact of the anesthesia drug on the cardiovascular system has important clinical meanings. etomidate has slight effect on the cardiovascular system, often used in the induction of anesthesia, however target controlled infusion etomidate in maintenance of anesthesia is less used. so, the trial is designed to observe the application value of tci etomidate in thoracoscopic mitral valve replacement surgery.


Eligibility criteria:
inclusion criteria: 1. age 18\~75 years old 2. selective cardiopulmonary bypass thoracoscopic mitral vales replacement surgery 3. received heart surgery for the first time 4. new york heart association(nyha) ii\~iii 5. written informed consent - exclusion criteria: 1. emergency surgery 2. anticipated survival time \<1 yrs 3. serious heart, brain, liver,kidney,lung,endocrine diseases or serious infection 4. prolonged use of hormone or history of adrenal suppression disease 5. severe mediastinal fiber thickening or fibrous adhesions 6. allergy to experimental drug or other contraindications 7. occurred or expected occurring of difficulty airway 8. sure or suspected narcotic analgesics abuse 9. history of neuro-muscular disease 10. mental instability or metal disease 11. pregnancy or brest-feeding 12. participated other clinical trial past 30 days 13. malignant hyperthermia

Keywords: target controlled infusion
assessment of volume-targeted ventilation in patients with neuromuscular disease

Conditions: Neuromuscular Diseases

Summary: assessment of safety and efficacy of volume-targeted ventilation in patients with neuromuscular disease.

patients with neuromuscular diseases (nmd) can suffer from breathing difficulties requiring treatment with a breathing device known as non-invasive ventilation (niv). niv aims to support the lungs in removing the waste gas, carbon dioxide (co2). this is important because patients with high co2 levels tend to have worse clinical outcomes. niv delivers different pressures to the airway when the patient breathes in and when they breathe out. usually, the pressures it delivers are fixed; i.e. they do not change breath-to-breath. newer technology allows the machine to independently change the pressures, depending on various patient factors it can measure. there are a small number of studies that suggested that these 'auto-titrating' machines may improve control of carbon dioxide but further work is needed. one of these modes allows us to set a target volume that should be delivered to the patient each breath, and the machine changes settings to deliver this target volume, in response to changing patient parameters. we aim to investigate the safety and efficacy of this volume-targeted niv (vt-niv), in order to generate data to design a randomised controlled trial to compare vt-niv with fixed-niv. patients with nmd who use fixed-niv will be admitted for a two-night stay to our centre. on the first night, their co2 control will be assessed on their current ventilator. on the second night, they will be switched to the vt-niv mode. they will be discharged and asked to use the new mode for three months. individuals with well-controlled co2 with their usual mode will allow us to assess the safety of vt-niv, and individuals with poorly-controlled co2 will allow us to assess its efficacy. at three months, they will attend an outpatient visit, where use of the new mode will be assessed through data download from the machine and completion of questionnaires.

Eligibility criteria:
inclusion criteria: * slowly progressive neuromuscular disease * established on fixed bi-level ventilation * documented clinical respiratory stability by supervising clinician (no hospitalizations, respiratory infections or change to ventilator settings in preceding 6 weeks) exclusion criteria: * rapidly progressive neuromuscular disease * decompensated respiratory failure (ph \< 7.35) * pregnancy * aged \ 80 * poor adherence to niv (\<4hrs per night) * significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
using behavioral economics to achieve improved healthy behavior outcomes in breast cancer survivors

Conditions: Breast Cancer Female

Summary: preventing or reducing obesity is one factor that has been hailed as a way to improve quality of life, reduce recurrence, and increase survival rates among breast cancer survivors. an experienced team of multi-disciplinary researchers has developed an innovative and unique approach to encourage enhanced nutrition and exercise behaviors in this population using principles of behavioral economics. in particular, the use of social norms or exemplars has been shown in other applications to be effective, and if successful in this population could be inexpensively scaled up for widespread adoption. the proposed pilot study develops a system of text messages for social/mobile media that will provide ongoing reinforcement of desired behavior in breast cancer survivors. these messages would focus on achieving compliance with the expert-developed nutrition and exercise recommendations of the american cancer society. in the main study, 310 breast cancer survivors will be randomly placed in intervention and control groups for the 12 week study. behavior change will be measured using established measures of self-reported behavior. in a sub-study, 60 of the breast cancer survivor participants will also provide blood and urine samples so changes in biomarkers can be assessed. the impact of the study will be measured by biomarkers and self-reported survey responses.


Eligibility criteria:
inclusion criteria: * female * age: 20-75 years old * no current pregnancy or lactation * was diagnosed with stage 0-iiib disease and completed all local and systemic therapy (including herceptin) at least 3 months prior to entry. women can be on or off anti-hormone therapy. * ambulatory * willing to be randomized exclusion criteria: * current participation in other treatment (chemo/radiotherapy) clinical trials * instructed by doctor not to exercise * cannot read english * not able to receive text messages

Keywords: behavioral economics breast cancer survivors nutrition physical activity
primary prevention of depression in offspring of depressed parents

Conditions: Depression

Summary: the purpose of this randomised controlled trial is to see whether a group-based psychological intervention for families can reduce the inflated risk of depression in children and adolescents who have at least one parent who suffers from depression (or who has suffered from depressed in the child's lifetime).


Eligibility criteria:
inclusion criteria: * at least one parent who meets diagnostic criteria for a current (or past, during the child's lifetime) diagnosis of depression * the participating child is aged 8-17 * the participating child has an iq of at least 85 * both child and parent(s) have adequate german-language skills * both child and parents consent to intervention sessions being video-recorded exclusion criteria: * the participating parent(s) has current symptoms of bipolar disorder, psychotic symptoms, personality disorder, substance addiction, or is suicidal * the participating child meets criteria for a current, or previous, episode of any psychiatric disorder * the participating child is undergoing or has undergone treatment for depression * the participating child or parent have serious symptoms of a disorder (or are in crisis) that may hamper their ability to take part in the study

Keywords: depression prevention adolescent child randomised controlled trial risk cognitive behavioural therapy group-based therapy
thymoglobulin in calcineurin inhibitor and steroid minimization protocol

Conditions: Diabetes; Graft Rejection

Summary: this study has been designed to test whether using thymoglobulin with low dose cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant.

all patients will receive methyl prednisone intravenously pre-operatively, as per institutional practice. thymoglobulin will be initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation in all patients and a total dose of 6-7.5mg/kg will be given over 3-5 doses. steroids will be initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days and then patients will be placed on 5mg daily for the remainder of the study. all patients will receive mycophenolic acid at a dose of 2gm/day (cellcept) or 1440mg/day (myfortic) post-transplantation with dose adjustment as needed. cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a c2 target of 600-800 nanograms/ml.

Eligibility criteria:
inclusion criteria: * de novo, single kidney recipient * at least 1 hla mismatch exclusion criteria: * recipient of multiple organs * prior transplant recipient * subjects who have diabetes prior to transplant, as indicated by pre-transplant ogtt * pra \>10% * hepatitis b surface antigen positive * hepatitis c antibody positive * hiv positive
a study to compare the pharmacokinetic profiles of etravil® tablet 10mg and etravil® tablet 25mg

Conditions: Depression; Depressive State; Enuresis

Summary: to evaluate the pharmacokinetics of single oral dose of amitriptyline hydrochloride film-coated tablet 10mg \& 25mg

randomized, single dose, 2-way crossover, open study to compare the pharmacokinetics profile of etravil®(amitriptyline hydrochloride) tablet 10mg and etravil®(amitriptyline hydrochloride) tablet 25mg after a single oral administration in healthy male volunteers

Eligibility criteria:
inclusion criteria: * a healthy adult male within the range of 19 to 50 years old at the time of screening * one with weight of more than 55kg, in the range of ibw 20% * ideal body weight(ibw)(kg)={height(cm)-100}\*0.9 * one who understood completely about this study after the detailed explanation is given, decided to volunteer and gave written informed consent to participate in study in compliance with the requirement of the entire protocol. exclusion criteria: * one with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history * one with glaucoma * one with disorders of micturition include benign prostatic hyperplasia * one with gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug. * one who is allergic or has clinically significant allergic history to the study drug, components or tricyclic antidepressants(tca) * one who shows the following result in vital sign: hypotension(systolic pressure ≤ 100mmhg or diastolic pressure ≤ 65mmhg) or hypertension(systolic pressure ≥ 150mmhg or diastolic pressure ≥ 95mmhg) * one who has drug abuse history * one who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (otc) drugs or vitamins (investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.) * one who has participated in other clinical study within 2 months before study drug administration * one who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment * one who drank over 21 units/week of alcohol(1 unit = 10g of pure alcohol) or subjects who would not be able to stop drinking alcohol during the hospitalization * one who are heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization * one who had a beverage containing caffeine, drank alcohol, or smoked within 48hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization * one with clinically significant observations considered as unsuitable based on medical judgment by investigators

Keywords: depression
cervical cancer screening by self-sampling in a cohort of younger women in ethiopia

Conditions: Cervical Cancer; STI; Human Papilloma Virus; Microbiota

Summary: the overall purpose of the project is to evaluate an algorithm for an hpv self-sampling based cervical cancer screening algorithm in a mid-size town in ethiopia that could be applicable for nationwide implementation in low and middle-income countries (lmic). specific aims are the following: * to evaluate the algorithm using visual inspection with acetic acid (via) and via together with lugol's iodine (vili) as triage and to use hpv self-sample to follow up those treated and those with persisting hpv. * to evaluate the prevalence of chlamydia trachomatis, neisseria gonorrhoeae and other stis in the cohort. * to determine immune response profiles in high-risk hpv-positive women who cleared, persisted, or developed cervical intraepithelial neoplasia 2/3 (cin). * to assess how specific cervicovaginal microbiota compositions are associated with hpv infection, cervical dysplasia, and cancer


Eligibility criteria:
inclusion criteria: * can give consent, age above 18 exclusion criteria: * women who have undergone hysterectomy

Keywords: lmic lowe middle income country screening vaginal microbiota