Kornimate/medical-research-clean huggingface dataset:
teaching academic success skills to students with autism spectrum disorders in clinical setting

Conditions: Autism Spectrum Disorder

Summary: the goal of the study is to develop an academic ef intervention, teaching academic skills to kids (task), for high functioning (i.e., iq score ≥80) middle-school youth with asd and ef deficits. aim 1: use focus group methodology and advice from expert consultants to develop the task intervention targeting academic ef skills for middle school youth with asd that is tailored to the unique needs of these individuals (e.g., content specific to asd ef deficits, incorporate evidence-based teaching principles and methods for asd). aim 2: examine the feasibility and acceptability of task in 3 open trials to assess initial feasibility and efficacy.

the goal of the study is to develop an academic ef intervention, teaching academic skills to kids (task), for high functioning (i.e., iq score ≥80) middle-school youth with asd and ef deficits. aim 1: develop the task intervention targeting academic ef skills for middle school youth with asd that is tailored to the unique needs of these individuals (e.g., content specific to asd ef deficits, incorporate evidence-based teaching principles and methods for asd). a methodologically rigorous, well-integrated iterative and collaborative design process with input from multiple stakeholders, including school mental health professionals, teachers, parents, and youth with asd, will be utilized. aim 2: examine the feasibility and acceptability of task in 3 open trials including the feasibility of: 1) implementing the measurement protocol, 2) operationalizing intervention delivery, 3) assessing both trained and untrained areas of functioning, 4) assessing whether improvements in academic ef skills (proposed mechanism of treatment) are related to functional educational outcomes (e.g., homework behaviors, grades), and 5) exploring the data for potential treatment moderators (e.g., gender, severity). it is hypothesized that task will be feasible, acceptable (attendance, satisfaction), and will result in improved academic ef skills associated with reduced academic impairment and homework problems.

Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder * iq \>80 * 7th grade at time of intervention * mainstreamed classroom * executive functioning problems identified on parent or teacher brief-2 exclusion criteria: * danger to self or others
quadripolar leads for the management of heart failure patients in the middle east

Conditions: Heart Failure

Summary: heart failure is the most rapidly growing cardiovascular condition in developed countries. despite advances in medical therapy, patients with heart failure are at high risk for death and hospitalization. cardiac resynchronization therapy - defibrillators (crt-d) are an effective treatment for heart failure. despite the high success rate of a crt-d implant, there is a possibility of 10% that the lv lead cannot be implanted in patients undergoing a trans-venous system implantation. in this case, the patients may undergo multiple procedures before a lead is successfully implanted. these implant failures are not due to patient selection but rather to patients heart anatomy leading to lead stability problems, phrenic nerve stimulation (also called diaphragmatic stimulation) and poor electrical measurements. the phrenic nerve is not part of the heart but runs near to this area on the way to a large muscle, called diaphragm, which separates the lung space from the space containing stomach, liver, kidneys and other internal organs in the abdomen. if the lead electrode is close to this nerve, it can cause a small part of it to contract giving you an uncomfortable hiccupping sensation. in many patients, phrenic nerve stimulation is not identified until after the implant procedure when movement and postural changes bring the lv lead into closer contact with the phrenic nerve. the investigation is performed to demonstrate the equality of performance of two different modalities of optimization of the implanted device and quartet lead, empirical (anatomical) optimization and right ventricle left ventricle (rvlv) conduction delay optimization.


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years of age * patient met standard crt-d device indications (left ventricular ejection fraction (lvef) ≤ 35%, qrs ≥ 120 ms, new york heart association (nyha) class ii, iii or ambulatory class iv heart failure (hf) symptoms with optimal recommended medical therapy) and will be implanted with an st jude medical crt-d * patient is willing to provide written informed consent. exclusion criteria: * patient with non left bundle branch block (rbbb, intraventricular delay (ivcd) block) * patient has an epicardial ventricular lead system. * patient has limited intrinsic atrial activity (≤ 40 bpm). * patient has persistent or permanent atrial fibrillation. * patient's life expectancy is less than 1 year * patient is pregnant. * patient is dependent on iv inotropic agents.

Keywords: crt-d heart failure middle east quadripolar
the china pulmonary thromboembolism registry study

Conditions: Pulmonary Embolism; Deep Venous Thrombosis; Venous Thromboembolism

Summary: epidemiological data on pulmonary embolism (pe) in china needs to be updated and reported. the china pulmonary thromboembolism registry study (cures) is designed to provide the cross-sectional spectrum and chronological trends of pe in china, as well as to reveal the intrinsic etiology and pathogenesis of the disease. the cures is an ongoing large prospective multicenter registry, which was originally initiated in january 2009 via enrolling suspected or confirmed pe or pe with dvt (deep venous thrombosis) patients and assessed their in-hospital outcomes from 100 medical centers in the china pe-dvt network. as of july 2011, in order to determine the pe-relevant short-term outcomes, enrolled participants were followed-up for at least three months in a longitudinal manner. since august 2016, with the launch and development of precision medicine research scheme in china, the main principle investigators of cures decided to collect enrolled patients' blood samples with regular follow-ups every three or six months for at least two years (for long-term outcomes). the study protocol has been approved by the china-japan friendship hospital ethics committee, and all collaborating centers received approvals from their local ethics committee. all patients provided written or verbal informed consent to their participation.


Eligibility criteria:
patients aged 18 years or above who are admitted to the 100 participating medical centers with suspected pe or pe with dvt are potentially eligible participants and consecutively enrolled in this registry. inclusion criteria: * objectively confirmed symptomatic pe or pe with dvt patients aged 18 years or above; * be able to provide written or verbal informed consent to participation. exclusion criteria: * younger than 18 years; * participation in a therapeutic clinical trial with an unknown drug; * inability for at least three-month follow-up since july 2011; * suspected pe or pe with dvt patients admitted to the hospital whereas without confirmed medical evidence; * patients with a history of pe or dvt readmitted to the hospital for examination or treatment however with no evidence of acute episode or recurrence; * withdrawal or lack of informed consent.

Keywords: pulmonary embolism deep venous thrombosis venous thromboembolism registry real-world study
computed tomography laser mammography breast imaging device

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the sensitivity and specificity of the ctlm system when used adjunctively with mammography compared to mammography alone in the heterogeneously and extremely dense breast population.


Eligibility criteria:
inclusion criteria: * female * 21 and over * heterogeneously or extremely dense breast * schedule for biopsy * gave informed consent exclusion criteria: * mammogram not performed within the last 60 days * open lesions on the breast * previous breast biopsy within 60 days of the ctlm scan * surgical deformity of breasts * commercial tattoos * protoporphyria * lactating
effectiveness of zinc supplementation with topical retinoids in acne vulgaris patients

Conditions: Acne Vulgaris

Summary: the study was 8 weeks, randomized, double-blind, placebo-controlled trial to assess the effect of zinc sulphate on symptoms of mild and moderate acne vulgaris in 122 patients. participants was assessed at baseline, and 8 weeks. subjects was randomized to receive either 20 mg elemental zinc daily or 20 mg placebo tablet daily for 8 weeks. the primary outcome was the measure of the gags score and the secondary measure includes serum zinc level and evaluate adverse effects.

acne vulgaris (av) is the eighth most prevalent disease worldwide. acne is a self-limiting condition, it may cause significant psychological and social problems, depression, disfigurement, and scarring that can persist for a lifetime. multiple factors contribute to acne pathogenesis including increased sebum production, aberrant keratinization of the pilosebaceous duct, bacteria such as propionibacterium acnes, hormonal influences, the skin microbiome, and chronic inflammation. relapse rates in patients with acne after treatment with standard of care vary between 10% and 60%. recent trials attempted to assess the effect of zinc in reducing the severity of symptoms of acne vulgaris patients. this study evaluates whether there is any role of zinc in reducing acne symptoms between those who did and did not receive zinc in an 8 weeks period. this includes 122 acne vulgaris patients who were recruited from dermatology and venereology opd of bsmmu. participants took either 20 mg elemental zinc daily in the form of zinc sulphate tablet or 20 mg placebo tablet daily for 8 weeks. initially, baseline serum zinc level was measured and repeated again after 8 weeks of intervention. a baseline acne symptoms survey was done by gags score and also repeated at 8 weeks.

Eligibility criteria:
inclusion criteria: * newly diagnosed mild and moderate av patients diagnosed by a dermatologist at the outpatient department of dermatology and venereology, * age: 11-35 years, * gender: both male and female exclusion criteria: * pregnancy and lactation, * history of oral contraceptive pills, zinc, and iron intake, * suffering from any cosmetic induced acne

Keywords: av zinc gags serum zinc level
phase 1 study of fg-3019 in subjects with type 1 or type 2 diabetes mellitus and diabetic nephropathy

Conditions: Diabetes Mellitus; Diabetic Nephropathy

Summary: the purpose of this study is to evaluate the safety and tolerability of two dosing regimens of fg-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (acei) and/or angiotensin ii receptor antagonist (arb) therapy.


Eligibility criteria:
inclusion criteria: 1. age 18-80 years, inclusive 2. diagnosis of type 1 or type 2 diabetes according to american diabetes association (ada) criteria 3. first morning urinary acr \>0.200 g/g 4. receiving stable doses of acei and/or arb therapy prior to screening 5. estimated glomerular filtration rate of ≥20 and \<90 ml/min/1.73 m2 6. willingness to maintain acei and/or arb therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose 7. maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization exclusion criteria: 1. female subjects who are pregnant or breastfeeding 2. organ transplant recipient, previous dialysis, or non-diabetic renal disease other than benign cysts or anatomical variants 3. any history of new york heart association (nyha) class iii/iv heart failure (hf) 4. screening electrocardiogram showing acute, clinically significant findings including but not limited to st depression 5. recent history of serious heart problems (e.g. coronary artery bypass graft, cerebrovascular accident, or myocardial infarction) 6. history of cancer in the past 5 years, possibly excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer. 7. history of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies 8. participation in other studies of investigational drugs at the time of screening and receipt of an investigational drug within 42 days prior to screening 9. aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>2.5 times the upper limit of normal 10. hemoglobin \<10 g/dl 11. positive for hiv (igg) antibody

Keywords: type 1 or type 2 diabetes proteinuria
factor xia inhibition for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty

Conditions: Knee Arthroplasty, Total

Summary: this study was to compare the study drug bay1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (tka). the study was open-label, but observer-blinded for the different doses of bay1213790. this means that it was known which treatment was given, but it was not known which dose of bay1213790 was administered.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years and undergoing elective primary, unilateral total knee arthroplasty (tka) * women of non-childbearing potential exclusion criteria: * high risk for clinically significant bleeding * prior deep vein thrombosis * body weight above 135 kg * creatinine clearance below 60 ml/min * recent (\<6 months) myocardial infarction or ischemic stroke * contraindication listed in the local label of the comparator treatments * requirement for full dose anticoagulation or dual antiplatelet therapy

Keywords: orthopedic surgery venous thromboembolism deep vein thrombosis (dvt) anticoagulation
vitamin d in armenia: vitamin d repletion strategies with dibase, and vitamin d and vitamin d binding protein and covid

Conditions: Vitamin D Deficiency

Summary: this is a three-arm unblinded prospective interventional study of vitamin d supplementation in participants with insufficient vitamin d at three different induction and maintenance dosing regimens (high dose, low frequency; medium dose, medium frequency, and low dose, high frequency). measurements of serum vitamin d will take place at 4, 8, 12, 24, and 36 weeks, and will be compared to determine which regimen was most effective at achieving and maintaining ideal serum vitamin d levels.

data obtained from many epidemiological studies suggest that vitamin d deficiency is widespread throughout the world, despite increasing attention to the relationships between vitamin d deficiency and skeletal health as well as many other organ systems. this proposal is designed to optimally replace vitamin d deficient subjects with oral vitamin d solution (dibase) among a well-characterized population whose mean vitamin d level have been established. in a recent nationwide study, this research team established that the country of armenia has marginal levels of 25-hydoxyvitamin d among a free-living population of pre- and postmenopausal women: the average level was 19.76 ng/ml with 54% of subjects showing levels that are clearly insufficient. equally impressive is the finding that fully 20% of women over 65 years of age, have levels that are below 12 ng/ml (\< 30 nmol/l). following consent, all participants will receive a unique participant identification number, and will then complete a brief questionnaire regarding demographics, selected medical history, and contact information. all participants will then be directed to the ecosense laboratory, where they will provide blood sample via venipuncture for vitamin d. for those participants with a 25-hydroxyvitamin d level of less than 30 ng/ml, they will be called back to ecosense laboratory where they will provide blood sample via venipuncture for calcium, and then brought to the osteoporosis center, where they will be randomly allocated into one of three treatment groups. participants will be instructed on how to dose the supplement as appropriate for their assigned arm, and then receive 4 weeks of the vitamin d supplement. participants will return to the osteoporosis center at the end of week 4 to obtain an interval history, be assessed for any adverse reactions, compliance, or symptoms of infection or illness. blood samples will be obtained at weeks 4, 8, 12, 24, and 36 for measurement of 25-hydroxyvitamin d and calcium at the collaborating laboratory as described above, and all participants will be informed of their lab test results as they become available.

Eligibility criteria:
inclusion criteria: * age 18 to 75 * willing to participate in the study * no vitamin d supplements for at least 1 year exclusion criteria: * not meeting inclusion criteria

Keywords: vitamin d repletion
sunbit uv measuring device to track sun behavior

Conditions: Immunosuppression; Skin Neoplasms

Summary: sunbit is a new wearable uv dosimeter to measure solar radiation in real time. the purpose of this study is to track sun behavior of patients at high risk for skin cancer, to investigate the feasibility of this prototype in daily life and to investigate the technical accuracy of the sunbit.

a total of 20 patients will be included to wear the sunbit system during the time of 4 weeks. after this 4 weeks sunbit will be recollected and data in the form of uv indices will be extracted and analyzed. patients will be recruited in the department of dermatology of the university hospital zürich. the target population comprises patients with a high risk of melanoma and non-melanoma skin cancer, thus especially patients with an immunosuppressive therapy due to organ transplantation.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * history of skin cancer (melanoma or nmsc) or patients with high risk of skin cancer (e.g. immunosuppressive therapy) * oral and written informed consent exclusion criteria: * any medical condition that renders the patient bedridden for the duration of 2 weeks

Keywords: sun behavior immunosuppression skin neoplasms sunbit uv sensor uv dosimeter solar radiation uv exposition uv index
peripheral bypass trial for completion control

Conditions: Chronic Limb-Threatening Ischemia

Summary: the goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle


Eligibility criteria:
inclusion criteria: * chronic limb-threatening ischemia as defined by presence of peripheral artery disease (pad) in combination with rest pain, gangrene, or a lower limb ulceration\>2 weeks duration (ref global guidelines) * atherosclerotic infra-popliteal pad * adequate distal anastomotic target (crural, tibial or popliteal below the knee with one single run-off) between knee and ankle distal to the stenotic/occluded segment. * available autogenous vein conduit based on preoperative vein mapping. * understand the nature of the procedure and willingness to comply with protocol. attend follow-up appointments and provide written informed consent. exclusion criteria: * bypass with artificial conduit or cryopreserved allografts * bypass for non-atherosclerotic lesions * life-expectancy less than 2 years * any psychological, developmental, physical or emotional disorder that the investigator believes would interfere with surgery or follow-up. * any condition that the investigator believes should exclude participation. * excessive risk for adverse events during open surgery as judged by the investigator.

Keywords: clti
comparison of novofine® needles (4 mm vs. 6 mm)

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this trial is conducted in europe. the aim of this investigation is to explore the safety of a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with diabetes.


Eligibility criteria:
inclusion criteria: * children * type 1 diabetes * insulin treatment for more than ½ year * bmi lesser than or equal to 19 kg/m2 * last hba1c taken within the last year lesser than 10.5% * girls: only prepubertal * boys: both pre pubertal and pubertal. adults * type 1 and 2 diabetes * insulin treatment for more than ½ year * bmi lesser than or equal to 23 kg/m2 * last hba1c taken within the last year lesser than 10.5% exclusion criteria: * known or suspected allergy to trial product(s) or related products. * pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any). * skin disease at abdomen and/or thigh
alisporivir with rbv in chronic hepatitis c genotype 2 and 3 participants for whom interferon is not an option

Conditions: Hepatitis C; Liver Disease

Summary: the primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis c virus (hcv) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of deb025 in combination with ribavirin (rbv) during the first 12 weeks treatment in chronic hepatitis c genotype (gt)-2 and gt-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.


Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained before any assessment is performed 2. participants with hcv genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon 3. males or females aged ≥18 years 4. diagnosed chronic hepatitis c virus infection exclusion criteria: 1. use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment 2. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 3. hepatitis b surface antigen (hbsag) positive 4. human immunodeficiency virus (hiv) positive other protocol-defined inclusion/exclusion criteria apply.

Keywords: chronic hepatitis c genotype 2 chronic hepatitis c genotype 3 cyclophilin inhibitor interferon intolerant
isometric handgrip exercise for blood pressure management

Conditions: Hypertension

Summary: recent meta-analyses suggest isometric resistance training (irt) may be superior to aerobic exercise for lowering blood pressure. the investigators intend to conduct the largest, longest, prospective, double-blind randomized controlled trial using isometric resistance training to reduce blood pressure to reduce hypertension.

we are looking to assess the effect of isometric exercise on ambulatory blood pressure in participants aged 40-70 years who are either pre- or mild hypertensive; either un-medicated or taking medication to control their blood pressure. our secondary aims are to examine whether the size of blood pressure change is different in those people taking or not taking anti-hypertensive medication, to determine the anti-hypertensive mechanism to irt, and to establish rate of de-training effects after participants have ceased irt.

Eligibility criteria:
inclusion criteria: * blood pressure above 120/80 currently not taking anti-hypertensive medications whose doctor has suggested would benefit from exercise; and * people currently taking beta blockers for blood pressure management. exclusion criteria: * younger than 30yrs and older than 70 yrs; * unable to voluntary participate; * unable to participate under doctor's recommendation; * smokers; * arthritis or carpal tunnel which may be aggravated with handgrip exercise; * known cardiovascular disease (angina) and the following co-morbid conditions: * obesity, * insulin resistance, * depression, * mobility impairment, * sleep apnoea, * fatty liver disease or * renal disease