Kornimate/medical-research-clean huggingface dataset:
radial versus femoral access for superselective embolization of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Hepatocellular Carcinoma Non-resectable

Summary: the aim of this prospective, randomized study is to compare tra vs tfa for superselective embolization of hcc using bland microparticles performed by multiple operators. in particular, main objectives are to compare: 1. the success rates of tra and tfa including crossing over events between techniques 2. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization 3. access-related adverse events 4. patient preference and reported discomfort

hepatic arterial chemoembolization is a safe, proven, and effective technique for the treatment of a number of malignancies, including primary and secondary tumors \[1, 2\]. this endovascular treatment is performed via femoral artery access in most cases. in the last decades, the transradial approach (tra) has emerged as a valid alternative to the transfemoral approach (tfa), and it is commonly used in coronary angioplasty as well as stent placement. in particular, shorter monitoring time after the procedure, earlier ambulation, shorter hospital stay and less discomfort associated with potentially reduced bleeding risks make tra an attractive alternative to tfa. to date, only one study exists comparing tra vs tfa in liver embolizations \[3\]. however, it is non-randomized and reports only the outcomes of one operator performing lobar embolization for multiple liver malignancies. the aim of this prospective, randomized study is to compare tra vs tfa for superselective embolization of hcc using bland microparticles performed by multiple operators. in particular, main objectives are to compare: 1. the success rates of tra and tfa including crossing over events between techniques 2. the inter-operator outcomes in terms of time to complete the vascular access and the vessel catheterization 3. access-related adverse events 4. patient preference and reported discomfort

Eligibility criteria:
inclusion criteria: * patients affected by hcc with indication to tae from a multidisciplinary team discussion. exclusion criteria * tae for other malignancies or bleedings; * pregnancy.

Keywords: embolisation, therapeutic embolization, therapeutic hepatocellular carcinoma hcc tae
administration of hyperthermic intraperitoneal chemotherapy in the general ward

Conditions: Epithelial Ovarian Cancer

Summary: ovarian cancer is the most lethal gynecologic malignancy. the majority of patients get diagnosed with advanced disease with peritoneal dissemination.it has been demonstrated that the addition of hyperthermic intraperitoneal chemotherapy (hipec) to interval debulking surgery can improve the prognosis. the national comprehensive cancer network (nccn) treatment guideline has recommended hipec as a first-line treatment for patients with advanced ovarian cancer. however, the guideline recommended the "dutch model" of hipec, which is limited for routinely being performed in china. so we propose a hipec treatment modality, the bedside closed hipec in the general ward (c-hipec), which is suitable for the clinical characteristics of china. the aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion.

the dutch model is limited for the following reasons: 1) the hipec treatment requires to be done in the operating room, which means the operation time would be lengthened. 2) high rate of exposure to chemotherapeutic drugs among healthcare workers. 3) it has significant safety concerns because it does not take into account racial differences in drug toxicity. this study is an investigator-initiated prospective multicenter feasibility study with a non-inferiority design, so as to provide evidence-based medical evidence for the use of the c-hipec model as an alternative to the "dutch model" in clinical practice in china.

Eligibility criteria:
inclusion criteria:（the following conditions must be met at the same time） 1. pathologically confirmed primary epithelial ovarian, fallopian tube, and primary peritoneal cancers in figo stages iii-iv. 2. previous neoadjuvant chemotherapy with platinum + vincristine and ≤ 4 courses of neoadjuvant chemotherapy. 3. the residual tumor diameter is ≤1 cm after interval debulking surgery, and the reason for receiving ids is that the patient cannot tolerate pds due to the poor condition or the pds cannot achieve optimal cytoreduction due to high tumor burden. 4. age from 18 to 70 years. 5. bone marrow reserve was well functioning. leukocytosis ≥ 3.0×10\^9/l, neutrophilic granulocyte ≥ 1.5 × 10\^9/l, platelet count ≥ 100 × 10\^9/l, and hemoglobin ≥ 80 g/l. 6. organs work well. ast ≤ 2.5 × uln, alt ≤ 2.5 × upper limit of normal(uln), total serum bilirubin ≤ 1.5 × uln, and creatinine ≤ 1.5 × uln. 7. ecog score 0-1. 8. patients voluntarily sign an informed consent form exclusion criteria: (none of which was eligible) 1. patients diagnosed with other malignant tumors within 5 years (excluding skin and thyroid cancers). 2. patient is allergic to erythroxylanes. 3. patients treated with anticancer drugs in other clinical trials. 4. high risk of anastomotic fistula or intestinal obstruction assessed during interval debulking surgery. 5. any situation of disease instability or potentially impact safety and adherence of patient.

Keywords: epithelial ovarian cancer hyperthermic intraperitoneal chemotherapy
tolerance and compliance of a high caloric, high protein oral nutritional supplement - scheduled intake

Conditions: Malnutrition

Summary: the aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ons) in elderly people


Eligibility criteria:
inclusion criteria: 1. sex: male/female 2. age: 65 years or older 3. body-mass index (bmi): ≥ 16.0 kg/m² and ≤ 30.0 kg/m² 4. subjects with an indication for ons of approx. 400 kcal per day for at least 7 days 5. written informed consent exclusion criteria: 1. existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition 2. subjects with galactosaemia or similar metabolic disorders 3. subjects with severely impaired gastrointestinal function or complete failure 4. subjects with insulin-requiring diabetes 5. subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day) 6. subjects reporting frequent occurrence of migraine attacks 7. subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia) 8. existing mouth abnormalities, which cause impaired gustatory sense 9. subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication) 10. subjects passing through chemotherapy (last cycle \< 2 months ago) 11. known allergic reactions or intolerance to any ingredient used or to constituents of the ons 12. subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator 13. consumption of any additional ons, enteral nutrition via tube or parenteral nutrition 14. subjects with need of a special diet contradicting the intake of the ons 15. history of relevant central nervous system (cns) and/or psychiatric disorders and/or currently treated cns and/or psychiatric disorders 16. subjects with dysphagia or with high aspiration risk 17. enrolment in another clinical study 18. administration of any investigational medicinal product during the last month prior to individual enrolment of the subject 19. subjects who are not able to self-report gi-problems and compliance 20. subjects who report a general dislike of the ons flavour 21. subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned 22. subjects suspected or known not to follow instructions 23. subjects unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical study

Keywords: malnutrition geriatric subjects nursing home
amiodarone, lidocaine or neither for out-of-hospital cardiac arrest due to ventricular fibrillation or tachycardia

Conditions: Cardiac Arrest

Summary: the primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new captisol-enabled formulation of iv amiodarone (nexterone-pm101) compared to placebo.

the primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new captisol-enabled formulation of iv amiodarone (pm101) compared to placebo. the corresponding null hypothesis is that survival to hospital discharge is identically distributed when out-of-hospital vf/vt arrest is treated with pm101 or placebo. the secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of: 1. lidocaine compared to placebo 2. pm101 compared to lidocaine the corresponding null hypotheses are that survival to hospital admission is identically distributed when out-of-hospital vf/vt arrest is treated with lidocaine as compared with placebo, and with pm101 as compared with lidocaine.

Eligibility criteria:
inclusion criteria: * age at least 18 years or local age of consent * non-traumatic out-of-hospital cardiac arrest treated by resuscitation outcomes consortium (roc) emergency medical services (ems) with advanced life support capability * vf or pulseless vt presenting as the initial arrest arrhythmia or results from conversion of another arrhythmia (such as transient asystole or pulseless electrical activity) * incessant or recurrent vf/vt after receipt of ≥ 1 shocks * established vascular access exclusion criteria: * asystole or pulseless electrical activity (pea) as the initial arrest rhythm who never transition to vf or pulseless vt * written advance directive to not attempt resuscitation (dnar) * blunt, penetrating, or burn-related injury * exsanguination * protected populations (prisoners, pregnancy, children under local age of consent) * treated exclusively by non-roc ems agency/provider, or by basic life support-only capable roc ems providers * prior receipt of open label lidocaine or amiodarone during resuscitation

Keywords: cardiac arrest cardiopulmonary resuscitation ventricular fibrillation pulseless ventricular tachycardia non-traumatic out of hospital cardiac arrest (oohca)
cold water and decision-making

Conditions: Behavior; Stress; Quality of Life; Psychological Wellbeing

Summary: the behavioral within-subject cross-over design study "cova" aims to investigate the effect of a short-term full-body cold-water immersion vs. warm-water immersion control on value-based choice, psychological well-being, and peripheral physiology.

this randomized within-subject cross-over design behavioral study in cognitive neuroscience will employ an acute peripheral physiological intervention, i.e., a 10-minute full-body cold-water (10-16°c) immersion vs. a control condition (10 min @ 30- 36°c water) on two visits separated by approx. 30 days. forty eligible female and male participants will be subject to a head-out full-body cold-water immersion or a warm-water condition (control) on two visits. participants will perform resting-state and task-based non-invasive electrophysiological recordings of the heart, pulse, respiration, skin conductance, and pupil, will undergo thermographic imaging, pre- and post-immersion blood sampling (4 time points), engage in two computer-based decision-making tasks (reinforcement learning task, risk decision-making task), a brief food choice task, and receive a battery of psychometric questionnaires. the visits are separated by approximately 30 days and do not differ in their timeline except for the primary intervention, i.e., cold vs warm-water immersion, and the medical screening on visit 1.

Eligibility criteria:
inclusion criteria: * 18-40 years of age * consent to participate * fluency in german * physically and mentally healthy * bmi 18-30 kg/m2 * normal day-night rhythm exclusion criteria: * raynaud syndrome * cold urticaria * high resting heart rate (\>160 beats per minute) * acute infection * diagnosed current or former illnesses of * brain and mind * heart and blood circulation * gastrointestinal system * endocrine system * other serious past or present medical conditions * wearing of medical devices (e.g., pacemaker) * fear of blood, needles, or phlebotomy * allergies to plasters, gels, and other medical equipment * allergies to commercially available liquid meals (e.g., shakes, yfood labs gmbh) * recurrent intake of medication which affect metabolism * regular nicotine consumption (e.g., vaping, cigarettes) * excessive alcohol consumption (\>14 servings/week) * recent illegal drug consumption (within 2 weeks prior) * strong mental or physical stress * excessive exercise (\>2 h high-intensity exercise/day) * pregnancy or breastfeeding * inability to wear skin-exposing swimwear, e.g., for religious reasons * affinity for winter swimming, cryotherapy, breathwork (\>3 times/year)

Keywords: decision-making psychology stress cold-exposure cold-water immersion
safety and effectiveness of zemplar injection in decreasing ipth levels in pediatric esrd subjects on hemodialysis

Conditions: Secondary Hyperparathyroidism; End Stage Renal Disease

Summary: the purpose of this study is to see if zemplar, a vitamin d medication, safely and effectively decreases parathyroid hormone in children ages 2-20 with end stage renal disease.


Eligibility criteria:
subjects ages 2-20 with esrd on hemodialysis with secondary hyperparathyroidism
brain health together: development and pilot test

Conditions: Cognitive Impairment; Subjective Cognitive Decline; Mild Cognitive Impairment (MCI)

Summary: the objectives of this study were to develop and pilot-test brain health together (bht), a 12-week, virtual-group program that combines our evidence-based, mind-body, group movement program with brain health education and coaching to reduce dementia risk through targeting modifiable risk factors among older adults with cognitive impairment.

our study design for developing, pilot-testing, and refining the bht program was conducted in 2 phases. in phase 1, the investigators used a human-centered design approach to deeply understand and respond to the needs, challenges, and motivations of potential users when developing the bht program. in phase 2, the investigators performed a pilot study to refine bht program content and assess acceptability and potential feasibility.

Eligibility criteria:
inclusion criteria: * mild cognitive impairment or subjective cognitive decline * english language proficiency * active participants in moving together (intervention arm) exclusion criteria: * wheelchair user * medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually-delivered multicomponent intervention * moderate/severe dementia severity
copeptin in aortic valve replacement

Conditions: Copeptin in Patients Undergoing Aortic Valve Replacement

Summary: copeptin is accepted as a marker of stress. we want to evaluate the preoperative and early postoperative copeptin leavens in patients undergoing different aortic valve procedures


Eligibility criteria:
inclusion criteria: * patients undergoing surgical aortic valve replacment * patients undergoing transcatheter aortic valve replacment exclusion criteria: * denial by patient
recombinant human c1 inhibitor for the treatment of acute attacks in patients with hereditary angioedema

Conditions: Hereditary Angioedema; Angioneurotic Edema

Summary: hereditary angioedema ("hae") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). these attacks are often painful and disabling, and, in some cases, life-threatening. "hae" is caused by mutations in the "c1inh" gene that lead to a decrease in the blood level of functional "c1inh". this multi-center study was designed to assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of recombinant human c1 inhibitor ("rhc1inh") in the treatment of acute hereditary angioedema attacks. funding source - fda oopd

a prospectively planned interim analysis will be performed on the double-blind data.

Eligibility criteria:
main inclusion criteria: * clear clinical and laboratory diagnosis of hae * plasma level of functional c1inh of less than 50% of normal * acute abdominal, urogenital, peripheral, and/or oro-facial/pharyngeal/laryngeal hae attack main exclusion criteria: * acquired angioedema * pregnancy or breastfeeding * treatment with any investigational drug within prior 30 days * body weight \>120 kg
behavioral economic intervention to improve hiv behaviors in sexual minority individuals

Conditions: HIV Prevention

Summary: this research study is testing a new behavioral therapy called episodic future thinking or eft can help people reduce drug use and risky sexual behaviors while helping them adhere to their hiv prevention medication (prep). participants will be randomly assigned to one of two groups. one group will receive standard care, which includes counseling on hiv prevention, drug use reduction, and sexual health. the other group will receive standard care plus a new program called episodic future thinking (eft), where participants will think about and plan for their future goals using a mobile app and counseling sessions. study procedures that are not part of regular care include filling out surveys, providing blood, urine, and swab samples for testing, and using the eft app.

phase 1 of the study will involve a formative evaluation of the episodic future thinking (eft) intervention among (n=10) sexual minority individuals (smis) utilizing qualitative interviews. (this phase of the study data will not be reported on clinicaltrials.gov, since it is not part of the randomized controlled trial). phase 2 of the study will utilize a two-arm pilot randomized controlled trial of episodic future thinking plus standard of care (intervention) vs. standard of care only (control) condition to improved hiv-related behaviors (prep adherence, sexual risk behaviors and methamphetamine use) among sexual minority individuals.

Eligibility criteria:
inclusion criteria: * adults 18 - 34 years of age * hiv negative (assessed via rapid hiv antibody test) * identify as gay, bisexual or transgender * recent (past 3 months) methamphetamine use * currently prescribed and taking hiv prep medication * self-reported hiv prep nonadherence in the past three months * urine screen test for prep nonadherence * self-reported condomless anal sex or a sti in the past three months * able to attend all study visits * fluent in english exclusion criteria: * currently receiving treatment for any substance use disorder, * hiv positive * having a medical or psychiatric illness that in the opinion of the pi would interfere with study participation * unable to provide informed consent * unable to attend protocol directed study visits * any plans that would preclude study completion (e.g. surgery, major medical treatments such as chemotherapy, incarceration, travel/moving out of san antonio, texas)

Keywords: hiv negative methamphetamine use hiv prep medication
a study of the safety and effectiveness of lyophilized certolizumab pegol in the treatment of signs and symptoms of rheumatoid arthritis and in prevention of joint damage in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: an open ended study in which patients who completed the double-blind study cdp870-027 \[nct00152386\] are given certolizumab pegol (czp) and assessed for signs and symptoms of rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: patients must have either failed to achieve american college of rheumatology 20 % response criteria (acr20) at weeks 12 and 14 in c87027 \[nct00152386\], or must have completed the entire week 52 assessment of c87027 \[nct00152386\] trial. exclusion criteria: * a diagnosis of any other inflammatory arthritis (e.g. psoriatic arthritis or ankylosing spondylitis) * a secondary, non-inflammatory type of arthritis (e.g. osteoarthritis or fibromyalgia) that in the investigator's opinion is symptomatic enough to interfere with evaluation of the effect of cdp870 on the patient's primary diagnosis of rheumatoid arthritis * any concomitant biological therapy * any experimental therapy, within or outside a clinical trial

Keywords: rheumatoid arthritis cdp870 certolizumab pegol cimzia
a study in patients with moderate to severe active rheumatoid arthritis comparing different infusion durations of roactemra/actemra (tocilizumab) treatment

Conditions: Rheumatoid Arthritis

Summary: this multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened roactemra/actemra (tocilizumab) infusion time compared to the normal infusion time. patients will be randomized to 8 mg/kg roactemra/actemra infusion of 31 minutes every 4 weeks or to roactemra/actemra 8 mg/kg infusion of 60 minutes every 4 weeks. the anticipated time on study treatment is 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, at least 18 years of age, inclusive * diagnosis of rheumatoid arthritis of at least 6 months duration * moderate to severe active rheumatoid arthritis (das28 \>/=3.2) * patients received at least 1 disease-modifying anti-rheumatic drug (dmard) and/or 1 or more tnfalfa-inhibitors over a period of at least 8 weeks exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization * rheumatic autoimmune disease other than rheumatoid arthritis * prior history of or current inflammatory joint disease other than rheumatoid arthritis * functional class iv (acr criteria) * history of severe allergic reaction to human, humanized or murine monoclonal antibodies * known active current or history of recurrent infection (including tuberculosis) * primary or secondary immunodeficiency (history of or currently active) * body weight \>150 kg * previous treatment with any cell-depleting therapies * previous treatment with tocilizumab