Kornimate/medical-research-clean huggingface dataset:
enhancing quality of life for older adults with and without mild cognitive impairment (mci) through social engagement over video technology

Conditions: Aging; Mild Cognitive Impairment; Aging Well

Summary: the goal of this randomized controlled trial is to rigorously assess the efficacy of an 8-week social engagement oneclick intervention. a total of 120 older adults with and without mild cognitive impairment (60 per group) will be randomized after a baseline assessment to the social engagement oneclick intervention group or the waitlist control group. participants assigned to the intervention group will receive the social engagement oneclick intervention for 8 weeks, and will complete a mid-assessment at week 4, and a post-assessment at week 8. participants assigned to the waitlist control group will receive no intervention for the first 8 weeks and will complete assessments at week 4 and week 8. subsequently, as an extension to this study, participants assigned to the waitlist control group will have an opportunity to participate in 8 weeks of social engagement oneclick intervention, with intervention effects assessed at week 4 and week 8.


Eligibility criteria:
inclusion criteria: * age 65+ * fluent in english * adequate visual and auditory acuity * passing score on telephone interview for cognitive status - modified (tics-m) of 22 and above included * passing score on montreal cognitive assessment (moca) of 20 and above included * geriatric depression scale (gds) score of less than 9 * stated willingness to comply with all study procedures and availability for the duration of the study * access to and ability to use necessary resources for participating in technology-based intervention exclusion criteria: * diagnosis of dementia * live in assisted living facility or skilled nursing facility

Keywords: videoconferencing social engagement loneliness social isolation quality of life
vitamin d and immune mechanisms of hypertension in type 2 diabetics

Conditions: Diabetes Mellitus, Type 2; Hypertension; Vitamin D Deficiency

Summary: this trial will evaluate whether a particular type of circulating white blood cell, monocytes, from type 2 diabetics with high blood pressure and vitamin d deficiency vs. sufficiency will induce hormones that increase blood pressure.

more than half of patients with type 2 diabetes mellitus develop hypertension, which doubles their risk for cardiovascular disease. inflammation plays a role in the development of these diseases, and monocytes, a type of white blood cell, may be critical. this study will isolate monocytes from blood samples of patients with type 2 diabetes and high blood pressure who have either high levels of vitamin d or low levels of vitamin d, and determine what their effects are on stimulating production in kidney cells of a hormone that increases blood pressure.

Eligibility criteria:
inclusion criteria: * type 2 diabetes (t2dm) * age: 25-80 years old * vitamin 25(oh)d3 levels \ 30 ng/ml. * hba1c: 5.5%-9.5% * blood pressure: \<160/100 mm hg on bp lowering medications and * blood pressure: \>120/80 to 160/100 mmhg without bp lowering medications exclusion criteria: * recent weight loss of more than 5% within 3 months prior to screening * current pregnancy * hypercalcemia * previous heart attack and stroke * heart failure * atrial fibrillation * heavy alcohol consumption * extreme diets (atkins, south beach) * chronic renal failure: stage 4 or worse * \>2 + proteinuria on urine sample * chronic diseases known to affect immunity
safety and efficacy of immune therapy for condyloma

Conditions: Condylomata Acuminata

Summary: cytokine-induced killer (cik) cells will be co-cultured with hpv induced dendritic cells (dcs); hpv specific dc-cik will be induced to condylomata acuminata patients using interferon, whose recurrence rate and total cost will be compared to condylomata acuminata patients only use interferon.


Eligibility criteria:
inclusion criteria:all patients have typical clinical characters of condyloma, positive for hpv-dna test; all patients have been treated for cryotherapy or laser plus interferon for over half a year without completely recovery. all patients or their family will sign informed consent and approved by ethics committee of shenzhen second people's hospital - exclusion criteria:pregnant, blood disease, contraindication for immune therapy, allergic to interferon -

Keywords: dc-cik interferon
a study of response-guided duration of combination therapy with gs-9190, gs-9256, pegasys® and copegus® in previously untreated subjects with genotype 1 chronic hepatitis c

Conditions: Chronic Hepatitis C Infection

Summary: this phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with gs-9190 and gs-9256 in combination with peginterferon alfa-2a (pegasys®) and ribavirin (copegus®). additionally, the efficacy and safety of 24 weeks of gs-9256 in combination with peginterferon alfa-2a (pegasys®) and ribavirin (copegus®) will be evaluated.


Eligibility criteria:
inclusion criteria: * adult subjects 18 to 70 years of age * chronic hcv infection for at least 6 months prior to baseline (day 1) * liver biopsy results (performed no more than 2 years prior to screening) indicating the absence of cirrhosis * monoinfection with hcv genotype 1a or 1b * hcv treatment-naïve * body mass index (bmi) between 18 and 36 kg/m2 * creatinine clearance \>/= 50 ml/min * subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male. * screening laboratory values within defined thresholds for alt, ast, leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (tsh), potassium, magnesium exclusion criteria: * autoimmune disease * decompensated liver disease or cirrhosis * poorly controlled diabetes mellitus * severe psychiatric illness * severe chronic obstructive pulmonary disease (copd) * serological evidence of co-infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or another hcv genotype * suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers) * history of hemoglobinopathy * known retinal disease * subjects who are immunosuppressed * subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse * subjects who are on or are expected to be on a potent cytochrome p450 (cyp) 3a4 or pgp inhibitor, or a qt prolonging medication within 2 weeks of baseline (day 1) or during the study * subjects must have no history of clinically significant cardiac disease, including a family history of long qt syndrome, and no relevant electrocardiogram (ecg) abnormalities at screening

Keywords: hepatitis c hcv rapid virologic response sustained virologic response direct acting antiviral combination therapy hcv rna polymerase inhibitor protease inhibitor treatment naïve gs-9190 gs-9256
blood transfusions in thalassemia patients, complications and adverse effects

Conditions: Thalassemia; Sickle Cell Anemia

Summary: patients suffering from thalassemia or another hemoglobinopathies required regular blood transfusions. the complications and adverse effects of blood transfusions can be classified as immediate and late. among the immediate effects the most common are allergic reactions and fever, besides congestive heart failure in patients with cardiomyopathy. the late effects are mostly related to blood transmitted infections like hiv or hepatitis c infections. the purpose of this study is to summarize the data of those complications in a cohort of 100 patients receiving regular blood transfusion.

about 100 patients aged several months to 50 years are treated in the pediatric hematology unit, most of those patients receive blood transfusions monthly. the adverse reactions were routinely recorded during each transfusion. all the patients were also screened annually for the incidence of blood transmitted infections principally hiv and hepatitis c. all those records will be systematically screened and all the immediate or late adverse reactions and complications related to blood transfusions will be summarized. a second goal of this study will be to control the staff strictness related to the ministry of health protocol dealing to blood transfusions.

Eligibility criteria:
inclusion criteria: * patients receiving blood transfusions due to chronic hematologic disorders exclusion criteria: * not applicable

Keywords: blood transfusions adverse events hepatitis c hiv
latissimus dorsi tendon transfer or partial arthroscopic repair of massive rotator cuff tears

Conditions: Full Thickness Rotator Cuff Tear

Summary: a massive tear of the rotator cuff is a debilitating condition that causes pain, significant impairments in strength, and resultant loss of activity of the affected arm. to our knowledge, there is no level 1 evidence comparing surgical procedures to treat massive rotator cuff tears. adding the first randomized controlled trial to will be a substantial contribution to the current body of evidence available in the subject of massive rotator cuff tears. most studies found in the literature following patients with massive rotator cuff tears are retrospective, have small numbers of patients, offer no control group and do not adequately compare treatment methods.moreover, there is no consensus from experts regarding which treatment is superior. our multicentre orthopaedic study group proposes a multicentre randomized clinical trial prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the treatment of massive rotator cuff tears. this study will include the use of comprehensive functional, motor and radiographic outcome assessments.


Eligibility criteria:
inclusion criteria: * men or women aged 40 to 65 years of age * massive rotator cuff tear, identified by mri as being greater than 4cm in greatest diameter. * provision of informed consent exclusion criteria: * absence of functioning latissimus dorsi muscle (assessed by "cough test" * absence of subscapularis muscle insertion (assessed by mri) * glenohumeral arthritis of grade 2 or higher, including evidence of acromio-humeral arthritis * acute tears (identifiable injury which precluded symptoms in past 6 months) * neurologic injury causing paralysis of affected shoulder girdle/arm * limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (asa grade iv or higher) * anticipated problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Keywords: shoulder rotator cuff tendon transfer arthroscopic repair
autonomous artificial intelligence versus ai assisted human optical diagnosis

Conditions: Colonic Polyp; Artificial Intelligence

Summary: computer-aided image-enhanced endoscopy can predict the nature of colorectal polyps with over 90% accuracy. this technology uses artificial intelligence (ai) to analyze video recordings of polyps, learning to make diagnoses in real-time. this means that doctors can get immediate predictions about small polyps during the procedure, reducing the need for separate pathology exams and saving costs, ultimately improving patient care. human and ai interactions are complex and a framework to reap synergistic effects cadx systems when used by humans to harness optimal performance needs to be established. ai solutions in medicine are usually developed to be used as assistive devices, however, then they rely on humans to correct ai errors. optical polyp diagnosis is a complex task. non experts usually achieve diagnostic accuracy in 70-80%. cadx systems have a similar diagnostic accuracy when used autonomously. clinical evaluation of cadx systems showed that cadx assisted od performs equally to the operator performance when using non cadx assisted od. to harness a benefit of clinical cadx implementation we would have to find a way that synergies between human and cadx come into play to eliminate cases in which cadx assisted and/ or human od results in low diagnostic accuracy and also addresses the problem of serrated polyp recognition.

our study hypothesis is that for cadx implementation, instead of using the high/low confidence framework, identifying cases with suboptimal diagnostic accuracy could be facilitated through identifying cases in which cadx and endoscopist disagreed in their diagnosis. eliminating such cases might separate out cases with low accuracy when using cadx assisted od. since endoscopists have a high sensitivity but low specificity for serrated polyp od, this framework will also allow us to implement a strategy to adequately manage serrated polyps found in the cohort.

Eligibility criteria:
inclusion criteria: * indication for full colonoscopy. exclusion criteria: * known inflammatory bowel disease * active colitis * coagulopathy * familial polyposis syndrome * poor general health, defined as an american society of anesthesiologists class \>3 * emergency colonoscopy

Keywords: optical diagnosis, artificial intelligence
results of sleeve gastrectomy surgery in relation with eating habits (after one year)

Conditions: Other Habit and Impulse Disorders; Obesity

Summary: sleeve gastrectomy is one of the most common surgical procedures performed today for patients that undergo bariatric surgery. one of the primary reasons for morbid obesity is unhealthy eating habits and the belief that changes in those habits can ensure the success. objectives: the investigators aimed to explore the effect of different eating habits prior to the bariatric surgery on the surgery success and on different aspect of quality of life. design: the investigators conducted this study on patients that underwent sleeve gastrectomy as the first bariatric operation.

the investigators conducted this study on patients that underwent sleeve gastrectomy as the first bariatric operation. the investigators divided the patients into groups according to their pre-operation eating habits: binge, sweet, snack and high volume and compared different aspects of the surgery such as weight loss, bmi and distance from ideal weight. the investigators also examined the effect of the surgery on the quality of life, sexual life, physical activity, eating habits and satisfaction from the surgery by a telephonic survey that was conducted up to one year after the surgery.

Eligibility criteria:
inclusion criteria: * morbid obesity * approved for bariatric surgery by the hospital's committee * patients that underwent primary surgery exclusion criteria: * recurrent surgery
timing of coronary artery bypass surgery among patients with acute coronary syndromes initially on ticagrelor

Conditions: Acute Coronary Syndrome

Summary: ticagrelor, a more potent p2y12 inhibitor, has been shown to reduce major adverse cardiac events (mace) in acute coronary syndromes (acs). it is increasingly used as a first line therapy in acs. however, more potent p2y12 inhibition has been associated with increased bleeding. this may be of particular concern for patients with acs who require coronary artery bypass surgery (cabg). in particular, the timing for cessation of ticagrelor before proceeding to cabg is unclear. rapid titrate cabg is a randomized vanguard study to evaluate the feasibility and preliminary safety of a strategy of early versus delayed cabg in acs patients initially treated with ticagrelor and to identify potential mechanisms underlying benefits or complications of early bypass surgery.


Eligibility criteria:
inclusion criteria: * acs patient referred for cabg and have received \>= 1 dose of ticagrelor before decision for cabg made exclusion criteria: patients are excluded if they: * refuse consent for enrollment * are deemed to require immediate cabg (day 0 or day 1) * have a st-elevation myocardial infarction (stemi )initially treated with primary pci * are undergoing concurrent valve surgery * are intolerant or allergic to aspirin * have been on an oral anticoagulant (including a vitamin k antagonist or a noac) * received adjuvant therapy with a glycoprotein iibiiia inhibitor * have a co-morbidity with life-expectancy of \< 1 year * have active bleeding

Keywords: acute coronary syndrome coronary artery bypass surgery ticagrelor antiplatelet therapy platelet function testing
exercise in juvenile takayasu disease

Conditions: Takayasu's Arteritis

Summary: juvenile takayasu disease is characterized by chronic inflammation that leads to vascular disease. exercise may render anti-inflammatory effects and protect against cardiovascular events. this trial aims to investigate the therapeutic role of exercise in juvenile takayasu disease.

takayasu's arteritis (ta) is a chronic inflammatory disease that affects large and medium-sized arteries. the number of cases describe in children and adolescents has growing, and the hypertension is one of the symptoms most common, followed by other manifestations that affects cardiovascular systems. all clinical manifestations may aggravate by physical inactivity and can creating a vicious cycle of inflammation, whereas the risks of morbidity and mortality increase significantly in the pediatric population, impairing function and physical capacity, quality of life and evolution to adult life. thereby, physical exercise it is show to be an efficient strategy to reduce all these risk factors, however, no one study, until now, was conducted to available the effects of exercise in children with ta. objective: investigated the effects of 12-week home-based exercise program, where the patients receive a guideline from a physical education professional, teaching how to do the exercise at home. the beneficial effects of the programs expect is to be associated with improved cardiovascular risk factors, function and physical capacity, and body composition. methods: this is a prospective, longitudinal and randomized clinical trial. all patients will be recruited at the clinical hospital of the university of sao paulo medical school (hc-fmusp), in the laboratory of evaluation and conditioning in rheumatology, pediatric rheumatology outpatient clinics of the department of pediatrics, federal university of são paulo and the children's institute of the university of são paulo and the vasculitis unit of the hc-fmusp rheumatology service. in order to evaluate the therapeutic effects of exercise program act on ta, the following pre and post intervention evaluations will be performed: physical activity level; global clinical evaluation; anthropometry and body composition; hematological and inflammatory blood parameters; cardiovascular risk factors; aerobic capacity; functional capacity and fatigue; quality of life; and 18 fdg pet with magnetic resonance angiography.

Eligibility criteria:
inclusion criteria: * diagnosis of juvenile takayasu disease exclusion criteria: * cardiac and renal insufficiency * physical limitation hampering exercise training * non-controlled metabolic disorders * associated chronic diseases (last 6 months)
blood pressure variability in acute ischemic stroke

Conditions: Ischemic Stroke

Summary: the purpose of this study is the evaluation and comparison of blood pressure variability indices and ambulatory arterial stiffness index obtained by ambulatory blood pressure monitoring as prognostic indicators in the functional outcome of acute ischemic stroke.

all consecutive patients admitted with acute (within 24 hours after stroke onset) ischemic stroke in three university hospital of northern and central greece will be included. blood pressure measurements are being obtained with ambulatory 24-hour bp monitoring (abpm) every 20 minutes within 24 hours of admission using automated oscillometric device (tm2430, a\&d company ltd) during day-time (7:00-22:59) and night-time (23:00-6:59). several clinical, laboratory and imaging parameters are prospectively registered. also, patients' medical history, previous medical treatment and cardiovascular risk factors are registered. functional outcome is assessed by the modified rankin scale score at 3 months. also, stroke recurrence and cardiovascular and all-cause mortality will be assessed.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke * admission within 24 after the onset of symptoms exclusion criteria: * transient ischemic attack * intracerebral hemorrhage * subarachnoid hemorrhage * cerebral sinus venous thrombosis * stroke mimics * late admission (\>24 hours after stroke onset)

Keywords: acute ischemic stroke blood pressure variability ambulatory arterial stiffness index ambulatory blood pressure monitoring outcome
bioequivalence between two tablet formulations of doxycycline carragenate

Conditions: Bacterial Infection

Summary: the purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 55 years. * body mass index (bmi) of 18 to 30 kg/m2. exclusion criteria: * evidence or history of clinically significant abnormality. * any condition possibly affecting drug absorption. * a positive urine drug screen.

Keywords: bioequivalence
safety and efficacy of annual or biannual doses of moxidectin or ivermectin for onchocerciasis

Conditions: Onchocerciasis

Summary: the primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of o. volvulus microfilaria in skin, the parasite that causes river blindness. secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.


Eligibility criteria:
inclusion criteria: * provision of written informed consent, or assent with parental or guardian written consent. * mean ≥ 10 o. volvulus microfilariae/mg skin, determined by four skin snips * living in a village selected for the study. * age ≥ 12 years. * all female participants of childbearing potential must commit to the use of a reliable method of birth control for the duration of treatment and until 3 months after completion of dosing with investigational product. exclusion criteria: * pregnant or breast-feeding. * any concurrent condition that, in the opinion of the investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health. * has received ivermectin, oral diethylcarbamazine (dec) or doxycycline (for \> 2 weeks) within 6 months of baseline. * has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to baseline. * known or suspected allergy to ivermectin or moxidectin or their excipients. * self-reported planned or ongoing activities within the study period that would make it unlikely that a participant will be available for all planned treatment rounds and follow-up examinations. * weight \> 88 kg. * infection with loa loa.