Kornimate/medical-research-clean huggingface dataset:
confirmatory study of ik-3001 in japanese subjects with peri-/post-op pulmonary hypertension assoc. with cardiac surgery

Conditions: Hypertension, Pulmonary; Ventricular Dysfunction, Left

Summary: sixteen japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of ik-3001.

this is a multi-center, open-label, clinical study of the safety and efficacy of ik-3001 in 16 subjects with peri- and post-operative pulmonary hypertension associated with cardiac surgery. two primary sub-sets of this patient population will be evaluated in this study: 1. adults with severe congestive heart failure having lvad implant 2. children requiring surgery for congenital heart disease with corresponding ph or having glenn surgery or fontan surgery for single-ventricle physiology. children with severe pulmonary hypertension due to congenital heart disease who require inhaled nitric oxide (ino) pre-operatively may also be enrolled.

Eligibility criteria:
inclusion criteria: 1. subjects must meet one of the following criteria: 1. adults, aged 15 to 80 years, with severe congestive heart failure (chf) and scheduled for left ventricular assist device (lvad) placement; or 2. children, aged \< 15 years, scheduled for surgery for congenital heart disease which may associate pulmonary hypertension (ph)(including children with severe ph due to congenital heart failure and with severe hypoxemia secondary to high pulmonary vascular resistance or either a history or a possibility of developing ph crisis, who are deemed by an investigator or subinvestigator to require ik-3001 pre-operatively); or 3. children, aged \< 15 years, with congenital heart disease and scheduled for glenn surgery; or 4. children, aged \< 15 years, with congenital heart disease and scheduled for fontan surgery. 2. for women of childbearing potential, a negative result for a pregnancy test documented prior to enrollment. 3. subjects must give written informed consent. if the subject is a minor the subject's legally acceptable representative (parent or legal guardian) must give written informed consent. exclusion criteria: 1. lung hypoplasia or other pre-existing severe lung disease; 2. planned bi-ventricular support; 3. participation in another clinical trial of an investigational agent within 28 days from the day of informed consent for this study including subjects who are deemed to carry a residual effect of an investigational product lasting more than 28 days from a previous investigational study; 4. subjects with ph secondary to organic obstructive lesions in pulmonary arteries; 5. subjects not under mechanical ventilation; 6. investigator or subinvestigator decision that the subject is unsuitable for this study.

Keywords: pulmonary hypertension cardiac surgery glenn surgery fontan surgery left ventricular assist device lvad
effects of pericapsular nerve group block on postoperative recovery for total hip arthroplasty

Conditions: Analgesia; Postoperative Pain, Acute

Summary: the hypothesis of this study is that patients who undergo peng block in before total hip artroplasthy (tha) surgery with spinal anesthesia will have reduced postoperative pain scores, less need for opioid analgesics and earlier mobilisation.

this prospective randomised controlled study included a total of 60 patients aged 40-85 years who underwent tha surgery under spinal anaesthesia. patients were divided into two groups as peng block (n:30) and non-peng block (n:30). peng block was placed in the fascial plane between the pseudotendon and pubic ramus with usg in-plane technique, 20 ml of 0.5% bupivacaine was administered and surgery was initiated. the primary outcome of the study was to investigate the effect of preoperative peng block application on postoperative pain, opioid requirement, mobilisation time, hip joint patency and length of hospital stay in patients undergoing tha surgery. the secondary outcome was to investigate the effect of peng block on perioperative haemodynamics and postoperative side effects. for multimodal analgesia, 10 ml 0.5% bupivacaine + 10 ml 2% lidocaine is infiltrated into the surgical wound incision line by the surgical team at the end of surgery. after tramadol 50 mg loading with pca device, a basal rate of 5-10 mg/hour (20 mg bolus dose + 30 minutes lock time) is given with paracetamol 10 mg/kg iv (8 hours interval).

Eligibility criteria:
inclusion criteria: * tha performed by posterior approach * 40-85 age range * asa 1-3 exclusion criteria: under 40 years of age, over 85 years of age, * asa 4 and above, * cognitive impairment (alzheimer's disease, dementia, delirium etc.), * hip fracture, * application site infection, * allergy to local anaesthetic agents, * patients are non-consenting patients.

Keywords: multimodal analgesia pericapsular nerve group block total hip arthroplasty spinal anesthesia
penetration of ertapenem into bone

Conditions: Amputation

Summary: the aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with diabetes mellitus (d.m) or peripheral vascular diseases (p.v.d) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues

twelve patients with d.m or p.v.d who are undergoing bellow knee amputation with or without gangrene. within four weeks prior the amputation a vascular profile will be determined by doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements (tcpo2) on the dorsal side of the mid foot of the affected limb. each patient will receive 1 g of ertapenem in 100 ml of normal saline by iv infusion -during 30 minutes through ivac: * -2 days prior the amputation * -1 day prior the amputation * 1 hour before amputation the infusions will be started approximately at the same time of the 3rd infusion, prior the planned amputation. blood samples (approximately 6ml each) will be collected before ertapenem administration, simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery

Eligibility criteria:
inclusion criteria: * age \> 18 * diabetes mellitus or peripheral vascular disease * undergoing bellow knee amputation with or without gangrene * patients without clinical signs of acute infection * creatinine clearence more than 60 cc/ min exclusion criteria: * known hypersensitivity to any component of ertapenem or to other drugs in the same class. * patients who have demonstrated anaphylactic reactions to beta-lactams. * cns disorders (e.g., brain lesions or history of seizures). * patient treated with other antibiotics at least 72 hours. * pregnant women, nursing women, or fertile women not practicing adequate methods of contraception. * patient or legal representative of the patient is unable to provide written informed consent for any reason. * patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug to the patient. * neutropenia * renal failure * hepatic insufficiency: \> x 2 upper limit. * a need for any additional concomitant systemic antibacterial agent. * life expectancy less than 6 month * patient is undergoing immunosuppressive therapy, including use of high dose corticosteroids (e.g.,20 mg or more prednisone or equivalent per day) * patient is in a situation or has a condition which, in the investigator's opinion, may interfere with optimal participation in the study. * participation in an another clinical trial.

Keywords: ertapenem bone drug level blood drug level tissue drug level
evaluation of the efficacy of omega + phospholipids vs. omega alone in patients with hypertriglyceridemia: randomized clinical trial

Conditions: Hypertriglyceridemia

Summary: hypertriglyceridemia is a significant risk factor for cardiovascular diseases. omega-3 fatty acids have been shown to reduce triglyceride levels, and their combination with phospholipids could offer additional benefits in improving lipid profiles and inflammatory markers. this study aims to evaluate the efficacy of combining omega-3 with phospholipids compared to omega-3 alone in patients with hypertriglyceridemia. the objective of the clinical trial is to provide robust evidence on the benefits of this combination in improving lipid profiles and reducing inflammation, which could have a significant impact on clinical practices and future dietary recommendations.

this study aims to evaluate the efficacy of combining omega-3 with phospholipids compared to omega-3 alone in patients with hypertriglyceridemia. the objective of the clinical trial is to provide robust evidence of the benefits of this combination in improving lipid profiles and reducing inflammation, which could significantly impact clinical practices and future dietary recommendations.

Eligibility criteria:
inclusion criteria: * patients aged ≥18 to 65 years. * triglyceride levels ≥ 150 mg/dl and ≤ 500 mg/dl. * signed informed consent. exclusion criteria: * use of omega-3 supplements in the last 3 months. * use of any lipid-lowering medication. * known allergy to the components of the treatment. * uncontrolled chronic diseases (e.g., renal failure, liver disease). * any type of cancer. * undergoing treatment for hiv. * pregnancy or breastfeeding. * use of substances or prescribed medications that may increase triglyceride levels (e.g., estrogens, atypical antipsychotics, etc.). -

Keywords: hypertriglyceridemia;fatty acids, omega-3;phospholipids, omega-3
expanded access to nanodoce

Conditions: Urogenital Neoplasms

Summary: nanology may consider offering expanded access to nanodoce for patients who do not meet the enrollment criteria of clinical trials in progress.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -
development and pilot testing of the students with autism accessing general education (saage) model

Conditions: Autism Spectrum Disorder

Summary: study personnel will use evidence based behavioral skills training procedures to coach educators to implement modules designed to increase the quality of educational services and access to inclusive settings in elementary school for students with autism spectrum disorder.

this project brings together the expertise of investigators at three centers to develop and conduct a pilot test of a new comprehensive intervention to increase the quality of educational services and access to inclusive settings for students with autism spectrum disorder (asd) in elementary school (kindergarten through 5th grade). the intervention model, students with autism accessing general education (saage), integrates evidence-based strategies to teach skills to students with asd in schools, best practices derived from this literature by the project investigators, a recent guidebook written by the principal investigator, and research on collaboration with community providers such as school teams to implement interventions efficaciously and sustainably. saage begins with strategies to help a school form a cohesive team to oversee implementation of the model in the school. for each student, saage uses a modular approach for identifying goals for a student, selecting appropriate teaching strategies, and systematically monitoring progress and trouble-shooting. the modules center on core and associated features of asd. study personnel will use well established behavioral skills training procedures to coach educators to implement the modules.

Eligibility criteria:
inclusion criteria: children subjects: * are enrolled in school grades kindergarten through 5th * have an iep educational classification of autism, confirmed by the autism diagnostic observation schedule, second edition, and dsm-5 checklist * no planned changes in school placement or core team members during the school year of participation adult subjects (teachers, para educators): * instructional personnel who currently support a participating child with asd at school (e.g., teacher, instructional assistant, speech pathologist, occupational therapist) * letter from instructional personnel's district or school indicating agreement to take part in the research project exclusion criteria: children subjects • diagnosis of (1) genetic disorders such as fragile x, down syndrome, or tuberous sclerosis; 2) profound vision or hearing loss; or (3) motor disabilities such as cerebral palsy (these multiple disabilities would prevent standard implementation of the intervention protocol). adult subjects • instructional personnel whose written consent was not obtained
68ga-fapi pet/ct in liver fibrosis patients

Conditions: Liver Fibrosis; Positron Emission Tomography

Summary: to evaluate the potential value of 68ga-fapi-04 positron emission tomography/computed tomography (pet/ct) for the diagnosis and prognosis in liver fibrosis disease.

subjects with liver fibrosis underwent 68ga-fapi-04 pet/ct scanning. liver fibrosis lesion uptake was quantified by the maximum standard uptake value (suvmax). subjects also received the conventional clinical assessment for liver fibrosis, such as transient elastography (te) and blood biochemical indexes (bbi) testing. the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy of 68ga-fapi-04 pet/ct, te and bbi were calculated and compared to evaluate the diagnostic efficacy.

Eligibility criteria:
inclusion criteria: * adult patients (aged 18 years or order) * patients with suspected or new diagnosed or previously treated liver fibrosis (supporting evidence may include te, bbi, mri, ct and pathology report) * patients who had scheduled 68ga-fapi-04 pet/ct scan * patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the clinical research ethics committee exclusion criteria: * patients without liver fibrosis lesions * patients with pregnancy * the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
study to evaluate smecta® vs placebo on the time to recovery following an acute diarrhoea episode in adults

Conditions: Diarrhea

Summary: the purpose of this study is to evaluate whether smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode.


Eligibility criteria:
inclusion criteria: * acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less * patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day exclusion criteria: * gross blood, pus in the stools * fever \>39ºc * other episode of acute watery diarrhoea within the last 30 days * history of chronic diarrhoea or motor diarrhoea
web-based application to test for long-term cognitive deficits in biocog patients

Conditions: Cognitive Deficits

Summary: in the present study, a long-term cognitive follow-up of participants of the biocog cohort (data collection period 2014 - 2019, ethical vote no: ea2/092/14) from the berlin study center is to be will be performed in order to record long-term cognitive sequelae (7 to 10 years after study inclusion). in addition to a medical telephone/video visit, the follow-up includes the collection of cognitive tests via web applications and questionnaires of acceptance and usability in the home environment. the study data are analysed in cooperation with the university of bonn, university medical center schleswig-holstein and the university of essen.

the primary research objective is the exploratory investigation of changes in cognitive test performance as well as cognitive self-care and functionality in former biocog patients and biocog subjects in the non-surgical comparison cohort in the long-term follow-up (7 - 10 years) compared to the baseline survey (from the biocog main study).the primary question is operationalized in several ways: * according to the international statistical classification of diseases and related health problems(icd-10) classification system * according to the diagnostic and statistical manual of mental disorders-5 (dsm-5) classification system * computer-based, online and independently conducted cognitive testing using cantab web based testing from cambridge cognition * cognitive self-care using geriatric depression scale item 10 * cognitive self-care with multifactorial memory questionnaire * cognitive other-care with the informant questionnaire on cognitive decline in the elderly questionnaire * functionality with activities of daily living (adls) \& instrumental activities of daily living (iadls) questionnaire * additionally: quality of life with 5-level eq-5d version (eq-5d-5l) evaluation by mild cognitive impairment algorithm of the university clinic bonn (research group prof. wagner). evaluation by mild/major neurocognitive disorder (ncd) algorithm of charité - university medicine berlin (research group prof. spies)

Eligibility criteria:
patients inclusion criteria: * patients of berliner biocog cohort with cognitive testing (cantab research suite) at baseline and with plasma samples for baseline that can be contacted. * written informed consent for participation in the biocog-web study. * data and reserve samples from patients in the berlin biocog cohort who can no longer be contacted. exclusion criteria: * none subjects inclusion criterion: -biocog subjects of the non-operated comparison cohort from berlin with cognitive testing (cantab research suite) at baseline who are contactable exclusion criteria: -none
effects of estrogen deficiency on energy expenditure

Conditions: Obesity

Summary: menopause is associated with weight gain, but the reasons why are not clear. in this study, the investigators will determine if reducing estrogen levels causes a decrease in the ability of the body to produce heat. if so, this would suggest this is one way that menopause may cause weight gain.

the purpose of this pilot study is to investigate the role of the female sex hormone estrogen, on metabolism, thermoregulation and energy expenditure. weight and fat gain increase after the menopause, but reasons for this are not clear. loss of estrogen may cause changes in how women regulate metabolism and thermoregulation, possibly leading to weight gain. specifically, this study will determine how loss of estrogen affects facultative thermogenesis. loosely defined, facultative thermogenesis represents heat production that is turned on when needed. for example, when body core temperature falls below a certain threshold, a shivering response is invoked in skeletal muscle to increase heat production and, thus, energy expenditure. however, exposure over several hours to mild cold temperatures that do not trigger shivering (16-20⁰ c) also induces an increase in energy expenditure (cold-induced non-shivering thermogenesis). although several different tissues may contribute to this response, the recent identification of functional brown adipose tissue (bat) in humans has promoted an interest in how bat is activated in humans and its potential role in regulating energy balance and body weight. the investigators will measure bat activity using pet/ct scans pre and post three months of estrogen suppression.

Eligibility criteria:
inclusion criteria: * body mass index \< 30 kg/m2 * normal menstrual cycles * premenopausal exclusion criteria: * irregular menstrual cycles defined as 2 or more missed cycles in the previous year * on hormonal contraceptive or menopausal therapy * positive pregnancy test * intention to become pregnant or start hormonal contraceptive therapy during the period of study * lactation * severe osteopenia or osteoporosis (i.e., proximal femur or lumbar spine t scores \< -2.0) * abnormal vaginal bleeding * thyroid dysfunction * uncontrolled hypertension * exercising at least 30 minutes per day at a moderate to vigorous intensity \>1 d/wk) over the past 6 months
health consequences of the burden of atrial fibrillation

Conditions: Atrial Fibrillation; Burden

Summary: the swiss-af-burden study will be embedded in the follow-up visits of the swiss-af cohort study. the research question of the current atrial fibrillation burden will be answered by using 7-day holter-ecg recordings and continuous implanted loop recorder recording, whereas cardiac mri examination will give results about cardiac dimensions and function. the 7-day holter ecg will be repeated after one year. the cmri will be performed separately or directly after the brain mri to minimize the additional burden for the patients. only a subsample of 100 patients will additionally receive ilr for 2 years.


Eligibility criteria:
inclusion criteria: * swiss-af study patient * paroxysmal or persistent af exclusion criteria: * permanent af * swiss-af patients not willing or able to undergo 7-day holter monitoring * specifically for cmri: pregnant women or women of child-bearing age without a prior negative pregnancy test

Keywords: atrial fibrillation burden
wool clothing for the management of childhood atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis over two consecutive six-week periods.

the study will aim for a sample size of approximately 40 patients between the ages of 0 and 3 years of children referred to the dermatology department at the royal children's hospital for management of mild to moderate atopic dermatitis. they will be sequentially recruited and randomized to the wool-standard clothing arm or standard clothing-wool arm. the study will run for 12 weeks for each participant with two 6-week periods, either of wool followed by standard clothing or standard followed by wool clothing. participants will be assessed by a blinded trained researcher during this time, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks. the primary outcome is change in the severity of atopic eczema at 6 weeks. severity of atopic eczema will be measured using the scoring atopic dermatitis (scorad) index. secondary outcomes include the change in the severity of eczema using the scorad at 3 weeks and the atopic dermatitis severity index (adsi) score at 3 and 6 weeks and quality of life assessment using the dermatology life quality index (dlqi) at 3 and 6 weeks.

Eligibility criteria:
inclusion criteria: * mild to moderate eczema as determined by a scorad of 1-50 at their initial visit * has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf * is capable of returning for review having had education through the royal children's hospital eczema workshop exclusion criteria: * known reactions to wool products * is unable to attend visits * has unstable eczema defined by treatment escalation or increased topical anti-inflammatory use in the preceding 2 months