Kornimate/medical-research-clean huggingface dataset:
long-term evaluation of tailored vs anatomical ablation strategy for persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the tailored-lt study is conducted as an extension follow-up until 5 years of the initial tailored-af study (nct04702451), in order to demonstrate the long-term superiority in terms of freedom of atrial fibrillation (af) of a tailored ablation strategy targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary veins isolation (pvi) over an anatomical ablation strategy targeting pvi alone for the initial ablation procedure of persistent af.

the tailored-af study demonstrated at one year's follow-up that a tailored ablation strategy guided by volta medical ai-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (pvi) ablation is more effective to an anatomical ablation strategy targeting pvi alone (current standard of care) for the treatment of persistent atrial fibrillation (af). vx1 legacy device renamed volta af-xplorer was used in the tailored-af study in the treatment arm. no additional treatments are specifically required in the scope of this ancillary tailored-lt study which aims to follow the patients previously treated in the initial tailored-af study over the long-term. however, in the event of repeat procedures during the tailored-lt study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the tailored-af study. the annual follow-up will be performed as in routine clinical practice post af ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post tailored-af study index procedure. it is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the tailored-af study and the date of enrollment in the extension tailored-lt study. in this case, available data (among those expected by the study protocol) will be collected retrospectively. the additional procedures related to this clinical investigation are limited to annual 24-hour holters and to the administration of quality of life questionnaires (sf-36 and afeqt) to the patients during follow-up visits.

Eligibility criteria:
inclusion criteria: * patient who participated in the tailored af study * patient not withdrawn during the 12-month follow-up period post-index procedure in the tailored af study * patient able and willing to provide written informed consent to participate in this extension tailored-lt study exclusion criteria: * person deprived of liberty or under guardianship * person unable to undergo a medical monitoring for geographical, social or psychological reasons

Keywords: artificial intelligence vx1 volta af-xplorer medical device cardiac dispersion volta medical software
reobtain coronary ostia cannulation beyond transcatheter aortic valve stent (re-access)

Conditions: Aortic Stenosis; Coronary Artery Disease

Summary: with the upcoming expansion of transcatheter aortic valve replacement (tavr) indications to younger patients, the feasibility of coronary ostia cannulation beyond different bioprosthesis stent is currently a matter of debate. purpose of this study is: 1) to assess the feasibility to re-engage coronary ostia after tavr; 2) to discover potential native anatomical or prosthesis-related features that may preclude proper coronary cannulation after tavr.

single-center, prospective, pilot study. aim of this study is to assess the feasibility of coronary ostia re-engagement beyond transcatheter aortic valve (tav) stent through a transfemoral access in 300 consecutive patients undergoing transfemoral tavr with pre-procedural computed tomography assessment available. the possibility to selectively cannulate each coronary, the amount of time and contrast will be evaluated in each patient before and after implantation of either balloon-(sapien 3) or self-expanding (evolut r/pro, acurate neo or portico) tavs, thus generating an internal comparator.

Eligibility criteria:
inclusion criteria: * consecutive patients with severe aortic stenosis undergoing tavr with all commercially available devices * availability of preprocedural aortic root evaluation by computed tomography angiography scans exclusion criteria: * tavr in degenerated bioprostheses * known ostial chronic total occlusion * transcatheter valve not deployed in its anatomical position * patients with hemodynamic instability during the procedure

Keywords: tavr coronary cannulation transcatheter aortic prosthesis
zolpidem or exercise for insomnia?

Conditions: Chronic Insomnia

Summary: introduction: the prevalence of chronic insomnia in the general population is between 10 and 15%. the therapy commonly prescribed for its treatment is pharmacological, however, there are several non-pharmacological alternatives being studied, among them physical exercise. although some studies have described the effect of exercise on sleep in insomnia, there are no studies comparing exercise and drugs in the treatment of chronic insomnia, or its effect as coadjuvant therapy. objective: to compare the acute and chronic effects of aerobic exercise and zolpidem on sleep quality, mood and quality of life in patients with chronic insomnia. material and methods: 30 patients with chronic insomnia will be randomly assigned into two groups: exercise (n=15) or zolpidem (n=15). the patients of exercise group will be included in an aerobic exercise program, performed in 50% of reserve heart rate, on a treadmill (50 minutes, 3 times/week), during 6 weeks. the zolpidem group will be treated with zolpidem (10mg/night) during 6 weeks. polysomnography, actigraphy, sleep diary and questionnaires will be used the evaluate sleep pattern. mood and quality of life will be investigated by poms and sf-36 questionnaires. hypothesis: considering previous studies have demonstrated positive effects of aerobic exercise in the insomnia symptoms, the hypothesis of this study is that aerobic exercise, performed at moderate intensity, can control the symptoms of chronic insomnia similarly to pharmacological therapy.


Eligibility criteria:
inclusion criteria: * age 30 -60 years; * clinical diagnosis of chronic insomnia according to the dsm-v; * insomnia complaint at least 3 times a week for at least 3 months; * be physically inactive (exercise less than 2 times a week). exclusion criteria: * evidence that insomnia is directly related to medical conditions or side effects of medications; * obstructive sleep apnea syndrome; * ecg abnormalities that prevent physical exercise or use of beta-blockers; * uncontrolled clinical diseases (diabetes, hypertension, cardiovascular, neurological or renal diseases); * use or history of abuse of alcohol or psychoactive substances); * use of sleeping pills\> 2 times a week; * shift workers.

Keywords: exercise zolpidem sleep
impact evaluation of large-scale sanitation and hygiene interventions

Conditions: Infant Diarrhea

Summary: this study consists of an impact evaluation (ie) of the scaling up handwashing with soap (hwws) and total sanitation and sanitation marketing (tssm) projects of the water and sanitation program (wsp) of the world bank. the objective of this study is to estimate the causal impact of the hwws and tssm interventions on the health and welfare of the rural poor in six developing countries: peru, tanzania, senegal, vietnam, indonesia, and india. the ie will assess the impact of exposure to the hwws and tssm promotion on individual-level hygiene and sanitation practices, and on the health and welfare of children 0-5 years old. by introducing exogenous variation in handwashing and sanitation practices (through exposure to the hwws and tssm promotion), the ie will also answer a number of important questions related to the effect of the intended behavioral change (handwashing and improved sanitation) on health and welfare, thus providing information on the extent to which these behaviors alter intended development outcomes. this study uses a cluster-randomized experimental design, whereby the geographic units called clusters (e.g. village, commune, ward, depending on administrative structure of country) are randomly assigned to receive certain components of the handwashing and sanitation interventions in the case of treatment arms, and no handwashing or sanitation intervention in the case of control arms. . the final sample for the evaluation will consist of approximately 14,000 households, randomly selected, with at least one child between 0 and 24 months of age at baseline. data will be collected from these 14,000 households (approximately 54,781 subjects) through household surveys, anthropometric measurements, blood and stool samples, direct observations of behaviors, and community surveys. the data collected will be analyzed using a differences in differences approach, where possible, and the results will be disseminated to country officials and others stakeholders.


Eligibility criteria:
inclusion criteria: * at least one child 0-24 months (at baseline) lives in the household * adult family member (mother of primary caregiver of the selected children for the study) consents to participate in the study and provides consent for the child's participation exclusion criteria: * none

Keywords: behavior change hygiene & sanitation marketing
predictive value of the mnutric score and survival analysis in critically ill patients hospitalised in the intensive care unit

Conditions: Intensive Care Medicine

Summary: our study is an observational study and the follow-up hematological tests of patients in the intensive care unit will be recorded during their first admission. in this study, routinely checked blood parameters in patients will be interpreted and mnutric scores created together with their clinical features will be recorded. routine blood tests will be performed during these records and no intervention will be made. only an observational study will be conducted.

written informed consent was obtained from all participants or participants whose signature could not be obtained and included in the study. between 1 december 2024 and 1 april 2025, 85 critically ill patients admitted to the anaesthesia intensive care unit of our hospital were included in the study. patients aged 18 years and older who were admitted to the icu and followed for more than 24 hours were included in the study. patients younger than 18 years, pregnant women and patients with gastrointestinal motility disorders were excluded from the study. patients' demographic characteristics, including age, sex, and comorbidities, were recorded at the time of initial admission. haemoglobin (hb), white blood cell (wbc), lymphocyte, platelet, aspartate aminotransferase (ast), alanine aminotransferase (alt), c-reactive protein (crp) and albumin levels were recorded during the first hospitalisation. sequential organ failure assessment score 2 (sofa 2) and apache 2 score values were recorded. the 28-day follow-up of these patients was recorded. patients who died within 28 days and patients who survived were grouped as survivors. the use of vasoactive drugs, renal replacement therapy, the need for mechanical ventilation and the length of stay in the intensive care unit of the groups were recorded during the follow-up period. the nutrition team placed a nasogastric catheter in all patients and started enteral nutrition at 25-30 kcal/kg in patients without contraindications.

Eligibility criteria:
inclusion criteria: * over 18 years old , patients who have been hospitalized for more than 24 hours exclusion criteria: * under 18 years old, pregnancy patients, patients hospitalized for less than 24 hours

Keywords: mturtic score intensiva care mortality
a real-world study of effectiveness and safety in hr+/her2- breast cancer patients treated with ribociclib or alpelisib

Conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer

Summary: this study was a multinational and multicenter cohort study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (hr+/her2-) advanced or metastatic breast cancer (abc/mbc) treated with ribociclib or alpelisib between the period of 01 january 2018 and 30 september 2021. patients who were receiving active treatment for malignancies other than bc or participating in a clinical trial were excluded. this study was conducted retrospectively with secondary use of data.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of locally advanced/metastatic not amenable to surgery hr+/her2- bc (progressed following prior therapy or de novo) for whom the treating physician took the decision to initiate treatment with ribociclib or alpelisib. * patients with at least one prescription for ribociclib or alpelisib during the index period (01 january 2018 to 30 september 2021). exclusion criteria: * patients who were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and other); patients who were participating in other investigator-initiated research or non-interventional study (nis) could be included as long as their standard of care was not altered by the study. * patients on active treatment for malignancies other than hr+/her2- abc/mbc at the time of index. * ipo-porto cohort only: * patients who had participated or were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and others). * patients who underwent part of the treatment for locally advanced/metastatic not amenable to surgery hr+/her2- bc outside the center.
study to evaluate methods that assess the effect of azd4017 in adipose tissue

Conditions: Obesity

Summary: the primary purpose of this study is to investigate different methods to evaluate the effect of azd4017 in adipose tissue after single and multiple doses of azd4017 in abdominally obese but otherwise healthy subjects.


Eligibility criteria:
inclusion criteria: * provision of signed written and dated informed consent * have a body mass index (bmi) between 27 and 35 kg/m2 * waist circumference of \>102 cm exclusion criteria: * history of any clinical significant disease * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product * any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Keywords: pharmacodynamic method evaluation
efficacy and safety of allogeneic mesenchymal precursor cells (rexlemestrocel-l) for the treatment of heart failure.

Conditions: Chronic Heart Failure

Summary: the primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived mesenchymal precursor cells (mpcs \[rexlemestrocel-l\]) is effective in the treatment of chronic heart failure (hf) due to left ventricular (lv) systolic dysfunction.

the purpose of this study is to evaluate the efficacy and safety of a single transendocardial delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic mpcs (rexlemestrocel-l) for improvement in clinical outcomes (heart failure major adverse cardiac events \[hf-mace\]), preventing further adverse cardiac remodeling (left ventricular end systolic volume \[lvesv\] and left ventricular end-diastolic volume \[lvedv\]), and increasing exercise capacity (six-minute walking test \[6mwt\]) in patients with chronic hf due to lv systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.

Eligibility criteria:
inclusion criteria: * the patient is 18 to 80 years of age, inclusive; both men and women will be enrolled. * the patient has a diagnosis of chronic hf of ischemic or nonischemic etiology for at least 6 months * the patient is on stable, optimally tolerated dosages of hf therapies including beta-blockers (approved for country-specific usage), angiotensin-converting enzyme (ace) inhibitors or angiotensin-receptor blockers (arbs), and/or aldosterone antagonists, without change in dose for at least 1 month before study intervention * the patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during screening. * other criteria apply, please contact the investigator exclusion criteria: * the patient has nyha functional class i or functional class iv symptoms. * other criteria apply, please contact the investigator

Keywords: chronic heart failure chf left ventricular systolic dysfunction ischemic heart failure nonischemic heart failure stem cells allogeneic mesenchymal precursor cells
reversal of neuromuscular blockade with sugammadex or usual care in hip fracture surgery or joint (hip/knee) replacement (p07038)

Conditions: Neuromuscular Blockade; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Blood Coagulation; Antithrombotic Agents

Summary: this study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on coagulation parameters in participants undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular blockage induced by rocuronium or vecuronium.

participants will be randomized to sugammadex or usual care in a 1:1 ratio.

Eligibility criteria:
inclusion criteria: * must be american society of anesthesiologists (asa) class 1, 2, or 3 * must be scheduled for a hip fracture surgery or joint (hip or knee) replacement surgery under general anesthesia including the use of rocuronium or vecuronium for neuromuscular blockade * must be: * currently receiving thromboprophylactic (anti-clotting) therapy with low molecular weight heparin (lmwh) or unfractionated heparin (ufh), or * planned to initiate thromboprophylactic therapy with lmwh or ufh prior to or during surgery, or * currently receiving ongoing thromboprophylactic therapy with a vitamin k antagonist that has been temporarily substituted with peri-operative lmwh or ufh, and/or * currently receiving ongoing thromboprophylactic therapy with low-dose aspirin or other antiplatelet therapy * platelet count above the lower limit of normal range * appropriate candidate for rapid reversal of neuromuscular blockade * sexually active females must agree to use a medically accepted method of contraception through seven days after receiving protocol-specified medication exclusion criteria: * anatomical malformations that may lead to difficult intubation * neuromuscular disorder that may affect neuromuscular blockade * history of a coagulation disorder, bleeding diathesis, systemic lupus erythematosus or antiphospholipid syndrome * history or evidence of active abnormal bleeding or blood clotting within 30 days prior to screening * significant hepatic dysfunction * severe renal insufficiency * history or family history of malignant hyperthermia * hypersensitivity or hypersensitivity-like reaction to sugammadex, muscle relaxants, or other medications used during general anesthesia * planned intravenous administration of toremifene and/or fusidic acid within 24 hours before or within 24 hours after study medication * recent, severe trauma * body mass index (bmi) \> 35 * any contraindication to administration of sugammadex or neostigmine/glycopyrrolate (or neostigmine/atropine) * pregnant or intends to become pregnant between randomization and the day 30 follow-up visit * breast-feeding * previously treated with sugammadex or participated in a sugammadex clinical trial * has an active hip/knee infection and is scheduled for revision surgery
a study to evaluate the efficacy and safety of gc3110a in healthy subjects aged 65 years and older

Conditions: Influenza, Human

Summary: the purpose of this study is to evaluate immunological efficacy and safety of gc3110a among healthy adults over 65 years of age.

adults over 65 years of age will be once administered gc3110a(quadrivalent influenza vaccine).

Eligibility criteria:
inclusion criteria: * healthy adults aged 65 years and older * informed consent form has been signed and dated * able to comply with the requirements of the study exclusion criteria: * known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components * personal history of guillain-barre syndrome(gbs) * subjects with severe chronic disease who are considered by investigator to be ineligible for the study * subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study * immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy

Keywords: quadrivalent influenza vaccines
study the safety and efficacy of probiotics use in premature infants

Conditions: Infant, Premature, Diseases

Summary: prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing nec and associated morbidity.


Eligibility criteria:
inclusion criteria: * born with weight\<1500 g * hospitalized within 48 hours after birth exclusion criteria: * present with evidence or suspicion of congenital intestinal obstruction * perforation * gastroschisis * large omphalocele * congenital diaphragmatic hernia * major congenital heart defects
peripheral blood stem cell transplantation from family haploidentical donors in patients with myelodysplastic syndrome and acute leukemia under primary prophylaxis with posaconazole

Conditions: Transplant-Related Hematologic Malignancy; Leukemia, Acute; Myelodysplastic Syndromes; Graft Vs Host Disease; Fungal Infection

Summary: sir-posa is a phase ii trial of peripheral blood stem cell (pbsc) transplantation from a partially compatible family (haplo) donor in patients with a blood tumor (myelodysplastic syndrome (mds) and acute leukemia) treated for the prevention of primary fungal infections with posaconazole. the aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free survival (grfs) in these patients and evaluate the feasibility and efficacy of posaconazole oral tablets as primary antifungal prophylaxis.


Eligibility criteria:
inclusion criteria: * diagnosis of myelodysplastic syndromes or acute leukemia * activation of an alternative donor search by the italian bone marrow donor registry (ibmdr) with absence of a 10/10 human leukocyte antigens (hla) matched unrelated donor * age \>18 * unavailability of a hla-matched related donor (mrd) * performance status : eastern cooperative oncology group (ecog) \<3 * written and signed informed consent * life expectancy not severely limited by concomitant illness. exclusion criteria: * women of child-bearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, intrauterine devices (iuds), vasectomised partner on treatment and for at least 6 months thereafter. * pregnant or nursing (lactating) women. * known allergies, hypersensitivity, or intolerance to any experimental drugs. * any active, uncontrolled infection.