Kornimate/medical-research-clean huggingface dataset:
genetic substudy of the alternans before cardioverter defibrillator (abcd) trial

Conditions: Ventricular Tachycardia; Cardiovascular Diseases; Arrythmia; CVD

Summary: the abcd clinical study (clinicaltrials.gov identifier nct00187291) was designed to determine if a t-wave alternans (twa) test is equivalent to an electrophysiology study (eps) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained tachycardia. the purpose of the abcd genetic sub-study is to identify genetic markers that predict twa status and arrhythmia risk in this same population.

the primary objective of this study is to test the hypothesis that therapy directed primarily by a t wave alternans (twa) test, measured non-invasively during exercise, is equivalent to therapy directed by an electrophysiological study (eps) in predicting spontaneous ventricular tachyarrhythmic events (vtes) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia (nsvt). in the absence of any previous life-threatening ventricular arrhythmia (i.e., for primary prevention), icd implantation is currently indicated in patients with ischemic heart disease, left ventricular dysfunction, asymptomatic non-sustained ventricular tachycardia, and a positive eps. the objective of this study is to demonstrate that a twa test directed therapy is equivalent to eps directed therapy in guiding icd implantation for the purpose of primary prevention of sudden cardiac death (scd) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia.

Eligibility criteria:
inclusion criteria: subjects previously enrolled in the abcd trial sponsored by st. jude medical (clinicaltrials.gov identifier nct00187291) * patients with ischemic heart disease * left ventricular ejection fraction (lvef) \< 40% * non-sustained ventricular tachycardia exclusion criteria: individuals who were not previously enrolled in the abcd trial are not eligible for this genetic sub-study.

Keywords: arrhythmia heart failure t-wave alternans implanted cardioverter defibrillator biological markers molecular genetics corus cad asges age/sex/gene expression score gene expression ges cvd precision medicine sudden cardiac death electrophysiology study cardiovascular disease icd eps scd twa
phase iv study: vunakizumab efficacy and safety in moderate-to-severe plaque psoriasis

Conditions: Moderate to Severe Plaque Psoriasis

Summary: this is a prospective, single-arm, multicenter, phase iv study of 1564 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis who have converted from other biologics. to explore the efficacy of difficult-to-treat area, patient satisfaction and patient-reported outcomes (pro).


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old at the time of signing the informed consent, regardless of gender; 2. diagnosed with moderate to severe plaque psoriasis; 3. the subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study; 4. patients who have been treated with biologics for ≥12 weeks prior to screening and are in line with the biologics conversion recommendations of the chinese guidelines for the treatment of psoriasis biologics and small molecule drugs (2024 edition), and who have been screened and evaluated by researchers as eligible for biologics therapy. exclusion criteria: 1. patients previously treated with il-17a inhibitors (il-17ai) had primary failure; 2. patients who had previously used il-17a inhibitors (il-17ai) and experienced drug-related adverse events leading to drug withdrawal; 3. patients with severe hypersensitivity to the active ingredient or any excipients of vunakizumab; 4. fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after the last receipt of the study drug; 5. patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors; 6. any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.
micro-dose, macro-impact: leveraging psychedelics in frontline healthcare workers during the covid-19 pandemic

Conditions: Acute Stress Disorder

Summary: a retrospective chart review of an open-label trial of low-dose ketamine administered to front-line healthcare workers who were identified as experiencing acute stress disorder due to the covid-19 pandemic.

an investigation of a novel, off-label use of an fda approved drug (ketamine) in a low(micro) dose sublingual formulation of ketamine provided to front-line healthcare workers who were identified as suffering from acute stress disorder. the study was conducted completely virtually via real-time telemedicine for physician visits and via asynchronous interaction for outcomes data collection. patients self-referred to the study via email outreach, and diagnosis was confirmed by medically validated screening assessments and study physician confirmation. once treatment was initiated, patients were seen via live telemedicine every 40 days while treatment response/outcomes data was collected weekly and monthly. patients were treated up to 120 days.

Eligibility criteria:
inclusion criteria: 1. greater than 18 years of age 2. demonstrate capacity to consent to the study 3. a frontline health care worker-defined as any ems personnel (firefighter, emt, flight nurse, etc.), or any hospital-based worker (particularly in the ed, icu, or or) such as an rn, md/do, or non-clinical support staff (evs, etc.) 4. experiencing acute stress disorder as determined by clinically validated screening tools - exclusion criteria: 1. currently on prescription medications for psychiatric issues 2. currently pregnant or breastfeeding or actively trying to get pregnant 3. history of seizure disorder, liver disease, or psychosis/mania 4. uncontrolled hypertension 5. physician discretion: any condition deemed inappropriate that will increase the risk -
pregabalin in partial seizures (preps): an open-label, multicenter add on therapy trial

Conditions: Partial Seizures

Summary: the purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin bid (75 to 300mg day titration, bid) to existing standard aed (antiepileptic drugs).

this study was terminated on 17 march 2009 due to delayed enrollment. the decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.

Eligibility criteria:
inclusion criteria: * male or female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure. exclusion criteria: * patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.

Keywords: lyrica epilepsies - partial
effect of rosiglitazone on adma in critical illness

Conditions: Critical Illness; Multiple Organ Failure

Summary: the purpose of this study is to determine whether rosiglitazone,decreases the adma concentration and thereby increases the arginine/adma ratio of critically ill patients.

endothelial vasodilatation dysfunction precedes the development of arteriosclerosis. the endothelium plays a pivotal role in the control of the vascular tone by releasing nitric oxide (no). the amino acid arginine is the sole substrate for the enzyme no synthase (nos). asymmetric dimethylarginine (adma) is an endogenous derivative of arginine that inhibits nos. thus the arginine/adma ratio an important determinant of no production by nos. adma is an independent risk factor for cardiovascular disease, but elevated levels of adma have also been shown to be a strong independent predictor of icu mortality. the central mechanism by which adma may cause deterioration in critically ill patients is by impairing organ blood flow and reducing cardiac function, especially during stress. accumulation of adma could thereby be a causative factor in the development multi organ failure (mof). thus inhibition of no production by adma may become especially important when cardiac demand is increased.

Eligibility criteria:
inclusion criteria: * critically ill patients * age between 18 and 75 years * sofa score \> 7 exclusion criteria: * history of diabetes mellitus * history of hypercholesterolemia * history of hyperhomocysteinemia * impaired hepatic function

Keywords: adma mof critical illness
a study to test how a new long-acting insulin (insulin icodec) works in the body of people with liver disease

Conditions: Diabetes Mellitus, Type 2

Summary: participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing. the study will last for about 8 weeks. participants will have 8 visits with the study doctor in the clinical research unit. insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 ml (about a spoonful). participants must not participate if they meet certain conditions called exclusion criteria, such as an age of below 18 years or above 70 years, if participants are over- or underweight, using certain medicines, or have serious health conditions (other than impaired liver function ). women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female * aged 18-70 years (both inclusive) at the time of signing informed consent * body mass index between 18.5 and 39.9 kg/m\^2 (both inclusive) specific inclusion criterion only for subjects with hepatic impairment * subjects with stable hepatic impairment classified as child-pugh grade a, b or c as assessed by the investigator. stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator. exclusion criteria: * known or suspected hypersensitivity to trial product or related products * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) * diagnosis of diabetes mellitus
accessibility of the world health organization's etb catalogue of recommendations

Conditions: Tuberculosis

Summary: the world health organization's global tuberculosis programme (who-gtb) issues evidence-informed guideline recommendations on tuberculosis (tb). these recommendations are used by decision-makers, guideline developers and other stakeholders. in an effort to improve the accessibility and usability of these recommendations, a new etb catalogue of recommendations has been developed. this study aims to compare the accessibility of the new etb catalogue to the earlier method of accessing recommendations directed through the general who website.

this is a two-arm superiority randomized controlled trial. the primary objective is to compare the accessibility of information between the etb catalogue (intervention) and who tb (comparison). secondary outcomes include understanding of the information, satisfaction of catalogue presentation, and preference toward the catalogue. current and potential users of tb recommendations will be recruited. data will be collected using a survey with demographic questions and subsequent 1:1 randomization to the intervention. superiority will be declared if the mean difference in accessibility is 0.5 or greater for the intervention arm on the seven-point likert scale.

Eligibility criteria:
inclusion criteria: * stakeholders who consider themselves to be users or potential users of tuberculosis (tb) recommendations will be eligible for participation. for the purposes of this trial, a user is defined as someone who has previously accessed tb guidelines, recommendations or policy advice, and a potential user is someone who plans to access tb guidelines, recommendations, or policy advice in the future. * participants may be part of any group that has a stake in tb, including the public, healthcare providers, policymakers, or researchers. participants may be from either low- and middle-income countries (lmic) or high-income countries (hic). * they may also vary in levels of education and previous tb work experience. exclusion criteria: * individuals involved in etb catalogue development.

Keywords: grade guidelines recommendations recommendation mapping evidence mapping
finding barriers and designing solutions to promote women s cancer screening in south africa

Conditions: Cervical Cancer

Summary: the primary aim of the study explore drivers of cervical cancer screening and barriers contributing to low screening coverage among women in south africa. secondary aims are determining preferences for cervical cancer prevention services using a discrete choice experiment and developing a multi-level package of interventions that will address barriers to cervical cancer screening and improve engagement in care among women.

cervical cancer is a leading cause of cancer death among south african women. despite a comprehensive national cancer control policy, cervical screening coverage is low and attrition during on-ward referrals for diagnostic confirmation and treatment remains common. this study uses a sequential mixed-methods design: phase 1) a qualitative exploratory phase using focus groups and in-depth interviews with women, men, other stakeholders will inform our design and interpretation of quantitative findings from a multi-cohort dce. phase 2) women will be recruited to participate in the dce and determine their preferences for cancer screening services. phase 3) design thinking to co-create an intervention package for cervical cancer screening and enhanced linkage between screening, diagnosis, and treatment will be created.

Eligibility criteria:
inclusion criteria focus groups with hiv-positive women 1. hiv-positive 2. women 18 years and older 3. participants should be willing and able to provide written informed consent focus groups with hiv-negative women 1. hiv-negative 2. women 18 years and older 3. participants should be willing and able to provide written informed consent focus groups with men 1. male partners who are 18 years and older 2. participants should be willing and able to provide written informed consent in-depth interviews with key stakeholders 1. healthcare providers working within the public health system and other key stakeholders 2. individuals 18 years and older 3. participants should be willing and able to provide written informed consent exclusion criteria: focus groups with hiv-positive women 1. women younger than 18 years 2. unwilling or unable to provide written informed consent focus groups with hiv-negative women 1. women younger than 18 years 2. unwilling or unable to provide written informed consent focus groups with men 1. male partners younger than 18 years 2. participants unwilling or unable to provide written informed consent in-depth interviews with key stakeholders 1. providers who do not work in the public health system 2. individuals younger than 18 years 3. participants unwilling or unable to provide written informed consent

Keywords: sequential mixed-methods hiv screening
genicular artery embolization for the treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis; Degenerative Joint Disease of Knee

Summary: the purpose of this clinical research study is to examine whether embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. embozene is a medical device made by boston scientific approved in the united states for the treatment of hypervascular tumors and arteriovenous malformations. it consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. one of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. the goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. this is done by infusing embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.

this is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (gae) for treatment of symptomatic knee osteoarthritis (oa). subjects will be treated with a genicular artery embolization (gae) procedure performed with embozene microspheres. the microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. the primary objective of this investigation is to assess safety of genicular artery embolization (gae) for knee osteoarthritis (oa) using embozene particles.

Eligibility criteria:
inclusion criteria: * provided informed consent * age ≥ 40 years and ≤ 80 years * life expectancy greater than 12 months * ineligibility for or refusal of surgical management * moderate-severe knee pain as determined by visual analog scale \> 4 * osteoarthritis based on xray * local knee tenderness * resistant/failed conservative treatment (e.g. nsaids/physical therapy/steroid joint injection) exclusion criteria:• mild knee pain as determined by visual analog scale \< 4 * chronic renal insufficiency (serum creatinine \>2 mg/dl) * uncorrectable bleeding diathesis: international normalized ratio (inr) \>1.6, platelets \<50,000 * significant arterial atherosclerosis that would limit selective angiography * allergy to iodinated contrast agents that is not responsive to steroid management * active infection or malignancy * appropriate candidate for knee replacement surgery determined by clinical and physical examination * recent (within 3 months) or active cigarette use

Keywords: microspheres artery embolization knee osteoarthritis chronic pain embozene
randomized double-blind parallel trial to evaluate equivalence in efficacy and safety of hd203 and enbrel in ra patients

Conditions: Rheumatoid Arthritis

Summary: the objective is to prove the equivalence in efficacy and safety of hd203 and enbrel® in combination with methotrexate in patients with rheumatoid arthritis.

primary objective: to prove the equivalence between two groups by comparing the acr20 of w24 with the baseline after injecting hd203 25mg and (enbrel®) 25mg into the patients with rheumatoid arthritis for 24 weeks. secondary objective: to compare the efficacy of acr20, acr50 and acr70, etc along with safety in adverse event, vital signs, laboratory test, physical examination and immunogenicity, etc between two groups with baseline after injecting hd203 25mg and (enbrel®) 25mg into patients with rheumatoid arthritis for 48 weeks.

Eligibility criteria:
inclusion criteria: * males and females who are 20 or over * patients who satisfy the classification criteria of rheumatoid arthritis according to american colleague of rheumatology (acr 1987) * patients who are applicable to functional status i - iii of american colleague of rheumatology exclusion criteria: * patients who have autoimmune diseases other than rheumatoid arthritis or have significant secondary systematic disease caused by rheumatoid arthritis * patients who are currently participating in other clinical studies or receiving treatment for drugs not sold in the market or for experiment * patients who have significant other diseases that may affect the clinical trial when judged by the clinical trial investigator * in the opinion of the investigator, may put the patient at risk because of participation on the study or may influence the patients' ability to participate in the study
prospective multicenter observational study of atezolizumab combination therapy in lung cancer (j-tail-2)

Conditions: Non-small Cell Lung Cancer; Extensive Disease Small Cell Lung Cancer

Summary: this is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(nsclc) or extensive disease small cell lung cancer(ed-sclc). 800 patients in nsclc cohort and 400 patients in ed-sclc cohort will be enrolled in this trial to assess the efficacy and safety of this combination.

primary endpoint: 12 months os, secondary endpoints: overall survival(os), 6 months survival rate(6mo os), 12 months survival rate(12mo os), progression-free survival(pfs), time to treatment failure (ttf), objective response rate(orr), disease control rate(dcr), duration of response(dor) ,safety and comprehensive geriatric assessment(g8)

Eligibility criteria:
inclusion criteria: \ 1. patients 20 years of age or older at the time of signed consent. 2. patients with unresectable, advanced and recurrent non-small cell lung cancer. 3. patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the optimal use promotion guideline. 4. patients who signed informed consent form before enrolling the study. the consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. \ 1. patients 20 years of age or older at the time of signed consent. 2. patients with extensive disease small cell lung cancer. 3. patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the optimal use promotion guideline. 4. patients who signed informed consent form before enrolling the study. the consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. exclusion criteria: \ (1) patients who are unsuitable for enrolment into the study by the investigator's judgment. \ (1) patients who are unsuitable for enrolment into the study by the investigator's judgment.

Keywords: atezolizumab
teleassisted surgery for gynecological disease in obese patients - ob-alfx

Conditions: Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis

Summary: phase ii prospective single-institutional study.

the aim of this phase ii prospective single-institutional study is to assess feasibility and early complications rate of telelap alf-x surgical treatment in obese patients affected by gynecological disease.

Eligibility criteria:
inclusion criteria: * informed consent * 30 ≤ bmi \< 40 * asa \< iii * ovarian cyst * prophylactic bilateral salpingo-oophorectomy * ectopic pregnancy * pelvic inflammatory disease * sterility/infertility * benign uterine disease (fibromatosis, adenomyosis) * endometrial hiperplasia * early-stage endometrial cancer * preneoplastic lesions of the cervix * ia1 cervical cancer * pelvic endometriosis exclusion criteria: * pregnancy * liver disease * coagulopathies * clinical conditions contraindicating laparoscopy

Keywords: robotic surgery telelap-alfx gynecological disease