Kornimate/medical-research-clean huggingface dataset:
digital wavefront sensing

Conditions: Wavefront Aberration, Corneal; Refractive Errors

Summary: a holographic optical coherence tomography (h-oct) setup is used to detect the wavefront by means of phase reconstruction.

h-oct will be tested in this study for its suitability for the qualitative investigation of aberrometry. we aim to achieve a digital equivalent for wavefront calculation of the widespread analog procedure commonly used with conventional wavefront-aberrometers. the results will be compared with those from a conventional analog wavefront calculation method. in the course of this pilot study, 20 eyes of phakic and 10 eyes of pseudophakic subjects with suspected higher order aberrations will be examined using h-oct.

Eligibility criteria:
inclusion criteria: 1. informed consent 2. men and women aged between 18 and 85 years 3. normal ophthalmic findings except refractive errors or suspected higher order aberrations 4. normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant exclusion criteria: 1. hyperopia \> +6 dpt. and myopia \< -6 dpt. 2. known ophthalmic diseases such as age related macular degeneration, diabetic retinopathy, glaucoma, retinal detachment or previous ocular trauma and surgeries except cataract extraction 3. participation in a clinical trial in the previous 3 weeks 4. presence of any abnormalities preventing reliable measurements as judged by the investigator 5. pregnancy, planned pregnancy or lactating

Keywords: digital wavefront sensing optical coherence tomography
adherence and health effects of video dance in postmenopausal women

Conditions: Post Menopausal

Summary: this is a 6 month randomized clinical trial comparing video dance, brisk walking and delayed entry controls. the interventions have two phases; a 12 week initiation phase with substantial structure and supervision, followed by a 12 week transition phase, with reduced structure and supervision. participants are 168 overweight or obese, sedentary postmenopausal women aged 50 to 65; 60 in each exercise arm and 48 in the wait list control group. the following research questions will be assessed: 1. is exercise adherence at 6 months better with video dance games compared to brisk walking? 2. does video dance game exercise compared to wait list controls, induce beneficial changes in physical and mental health? 3. does video dance game exercise compared to brisk walking better promote balance, attention and visual spatial skills, without loss of benefit to cardiovascular fitness? 4. is video dance preferred to brisk walking for exercise among postmenopausal women? if so, who and why?


Eligibility criteria:
inclusion criteria: * participants must be female * age 50-65 * not currently exercising at least 20 minutes * three times per week * a bmi of 25 or higher exclusion criteria: * exclusions are largely related to medical safety and include history of osteoporosis, osteoporotic fractures, active cardiovascular disease, uncontrolled hypertension, weight bearing pain that would limit exercise, seizure disorder or any medical condition or medication that would limit the safety of the study.

Keywords: menopause sedentary overweight
efficacy and safety of tamibarotene(am80h) for htlv-1 associated myelopathy/ tropical spastic paraparesis (ham/tsp)

Conditions: HTLV-I-Associated Myelopathy

Summary: an open-label, non-randomised, uncontrolled, proof-of-concept study of patients with htlv-i-associated myelopathy/tropical spastic paraparesis (ham/tsp). participants will receive oral administration of tamibarotene in the amount of 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks. the patients will be followed up for further 8 weeks. efficacy will be monitored by measuring clinical scores including motor and urination function, htlv-1 proviral load, immunological parameters, and markers in the spinal fluid. safety will be evaluated at the same time.


Eligibility criteria:
inclusion criteria: * patients who have been diagnosed as ham according to the who criteria * patients who are positive for htlv-i antibody in the spinal fluid * patients, if female, who are not pregnant or breastfeeding, either agreed to take contraceptive measures during and two years after the treatment, or sterile * patients, if male, who agreed to take contraceptive measures during and six months after the treatment * patients who have been informed and understood the contents of the study and consented to participate in the signed form. exclusion criteria: * patients who has a rapid progress in the symptoms defined as an increase of two or more in osame's motor disability score for ham patients in the past one year. * patients of hyperlipidemia (serum triglyceride higher than 400 mg/dl) * patients who were administered new or increased dose of corticosteroid in the past 8 weeks before the intervention * patients who received steroid pulse therapy in the past 8 weeks before the intervention * patients who were administered new or increased dose of immunosuppressant in the past 8 weeks before the intervention * patients with a history of serious drug allergy * patients with significant complication such as malignancy, severe heart failure, and other serious diseases. * patients who were in the past administered etretinate.

Keywords: tropical spastic paraparesis ham tsp
virtual visits at brigham and women's hospital

Conditions: Heart Failure; Hypertension; Diabetes Mellitus; Stroke; BPH; Hyperlipidemia

Summary: clinicians slated for virtual visit rollout will be randomized (stratified by department) to either receive immediate virtual visit on-boarding (intervention arm) or delayed (3-months later) virtual visit on-boarding (control arm). the investigators plan to enroll no more than 200 clinicians. any clinician in a department selected by the brigham health virtual care team for access to virtual visits is eligible, unless s/he saw less than 20 patients monthly over the last 6 months. the brigham health virtual care team will onboard all clinicians and provide virtual visit support as per their usual protocol. the primary study endpoint is third-available appointment, a well-adopted measure of access. other secondary endpoints revolve around continuity, efficiency, utilization, safety, cost, and patient experience.

if enrolled in the intervention arm, the following steps will occur: * the clinician will receive the intervention arm follow-up email ("follow-up email - intervention" in the appendix). * the brigham health virtual care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process. * the clinician will schedule virtual visits as s/he and/or her/his department see fit. virtual visits occur on an already-in-use partners- and brigham-approved video platform (attached). if enrolled in the control arm, the following steps will occur: * the clinician will receive the control arm follow-up email ("follow-up email - control" in the appendix). * three months from the time of the follow-up email, the brigham health virtual care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process. * the clinician will schedule virtual visits as s/he and/or her/his department see fit. virtual visits occur on an already-in-use partners- and brigham-approved video platform (attached). the investigators plan to follow patients of both clinician cohorts for a total of 6-months. the investigators will perform retrospective review of patient electronic health records and patients will receive a redcap survey (attached), an evaluation mechanism already employed by the virtual care team. again, aside from the initial randomization and retrospective data collection and analysis, all of the above would have occurred irrespective of this research protocol.

Eligibility criteria:
inclusion criteria: * clinician whose department is chosen for virtual visit rollout exclusion criteria: * clinician who saw on average fewer than 20 patients monthly over the past 6 months * clinician who opts out of virtual visits

Keywords: virtual care virtual visit telemedicine
antiarrythmic drugs - long-term follow-up in the modern era

Conditions: Cardiac Dysrhythmia

Summary: antiarrhythmic drugs are associated with significant side effect profiles. amiodarone has primarily class iii action and whilst it has unrivalled efficacy in management of certain arrhythmias, it has a formidable side effect profile. complications of continued therapy include, thyroiditis, hepatitis, cholestasis, increased skin sensitivity and pulmonary fibrosis. current prescribing guidelines recommend frequent blood tests to monitor kidney, liver and thyroid function, in addition to frequent pulmonary function tests. sotalol is a betablocker which possesses class iii action in high doses and may predispose to qt prolongation other class i agents such as flecainide and propafenone can be associated with sudden cardiac death in certain populations, and may predispose to other arrhythmias. this study will examine the incidence of discontinuation of aad therapy and adverse events.


Eligibility criteria:
inclusion criteria: * at least one prescription for antiarrythmic drug

Keywords: cardiac dysrhythmia safety
exercise training and type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess whether 4-months of interval-walking exercise training improves glycemic control in individuals with type 2 diabetes mellitus. the effects of interval-walking training will be compared to continuous-walking exercise in a randomised, controlled trial design. changes in glycemic control will be examined using oral glucose tolerance tests (ogtt) with stable isotope methodology. in addition, insulin sensitivity and secretion will be examined using glucose clamps combined with glucagon-like peptide 1 (glp-1) and glucose-dependent insulinotropic polypeptide (gip).


Eligibility criteria:
inclusion criteria: * age 18 to 80 * normal glucose tolerance, impaired glucose tolerance, or type 2 diabetes (as evidenced by use of oral hypoglycemic medication or 2-hour ogtt glucose \> 11.1 mmol/l) exclusion criteria: * insulin treatment or type 1 diabetes * bmi \ 40 * physically active * undergoing weight-loss/gain * pregnancy * contraindication to exercise (ecg/cpx) * significant cardiovascular disease * history of renal/hepatic/gastrointestinal/pulmonary disease * clotting or bleeding disorders

Keywords: exercise diabetes obesity insulin sensitivity insulin secretion beta-cell function glycemic control gip glp-1
cold heart study: a randomized pilot trial of surfactant therapy

Conditions: Congenital Heart Disease; Hypoplastic Left Heart Syndrome

Summary: this clinical trial is being done to see if giving surfactant (curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days needed in the hospital. the primary hypothesis for this study is that there will be fewer days needed on mechanical ventilation and improved lung compliance and pulmonary gas exchange.

this study will enroll infants undergoing cardiothoracic surgery requiring deep hypothermic circulatory arrest (dhca) at the university of michigan's c.s. mott children's hospital. patients that are eligible will be randomized to receive either one dose surfactant or the sham (air) arm after the surgical procedure. patients will be monitored for an additional 30 days after the breathing tube is removed. it is possible that subjects may be discharged prior to the last assessment, therefore for subjects who have been discharged a member of the study team will contact the parent (s) or legal authorized representative by telephone.

Eligibility criteria:
inclusion criteria: * patients less than or equal to 12 weeks of age with hypoplastic left heart syndrome (hlhs) undergoing cardiothoracic surgical correction (norwood) requiring dhca. * infants weighing 2500 grams or greater at the time of surgery. * written informed consent from parent(s) or legally appointed representative (lar). exclusion criteria: * patients who are less than 36 weeks post menstrual age (pma) at the time of surgical correction. * underlying craniofacial, airway or lung anomalies which could compromise administration of surfactant. * infants weighing less than 2500 grams at the time of the surgical correction. * mechanical ventilation for\> 7 days prior to surgical correction.

Keywords: norwood procedure
long term therapy with imatinib: development of late side effects and compliance to treatment

Conditions: Chronic Myeloid Leukemia; Newly Diagnosed

Summary: imatinib has revolutionised the treatment of chronic myeloid leukaemia (cml). the first clinical trials were conducted in 1998 in patients with advanced disease, and by 2002 imatinib was established as the standard therapy for all patients including those recently diagnosed. in spite of overwhelming evidence about its efficacy we still need to gain more knowledge about issues related to long term treatment with imatinib such as why some patients respond better than others, the development of side effects and the quality of life.

we plan to follow prospectively a cohort of cml patients in order to study their compliance to therapy,pharmacological levels of imatinib and the prevalence of side effects. we expect to be able to correlate the actual dose received, the pharmacological levels of drug in blood, with the change in the level of residual disease (measured by q-pcr) at various time points. we also want to gain insight into the relationship between compliance to therapy and specific side effects and between compliance and duration of treatment. we will also assess the adherence to imatinib therapy after increases in the drug dose that are part of standard treatment.

Eligibility criteria:
inclusion criteria: * patients with cml who have been treated with imatinib (glivec®) within 6 months of diagnosis as first line therapy. initial therapy with hydroxyurea is permitted. exclusion criteria: * unable to give consent. * unable to communicate with the medical and nursing staff

Keywords: chronic myeloid leukemia long term imatinib therapy compliance newly diagnosed late side effects
kazakh version of reflux symptom index

Conditions: Laryngopharyngeal Reflux Symptoms; Laryngopharyngitis Chronic; Gastro Esophageal Reflux Disease

Summary: reflux symptoms index (rsi) were developed to identify a clinical index of suspicion for laryngopharyngeal reflux (lpr) in patients with ear, nose, and throat symptoms. rsi is an efficient diagnostic tool for lpr/ it is easy to use, even for those who know little about lpr. it does not require special equipment or examinations and is inexpensive. thus, it can be considered highly efficient and cost-effective. the study will focus on translating and testing the rsi into kazakh language and comparing its results in healthy people and people with laryngopharyngeal reflux.


Eligibility criteria:
inclusion criteria: * patient's informed consent; * age: 18-74 years old; * no serious somatic diseases; * patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching; * diagnosis: chronic pharyngitis; * chronic laryngitis. exclusion criteria: * disagreement to participate in scientific research; * age: under 18 and over 74; * severe somatic diseases, organic lesions of the gastrointestinal tract and ent organs; * patients with pulmonary pathologies; * patients with allergic manifestations (chronic or allergic rhinosinusitis and nasal polyposis); * with diagnoses: acute respiratory diseases; * patients with general neuralgic disorders; * pregnancy; * benign lesions of the vocal cords; * acid-suppressive therapy within 4 weeks prior to recruitment

Keywords: laryngopharyngeal reflux laryngopharyngeal reflux symptoms laryngitis laryngopharyngitis chronic gastro esophageal reflux
lithium versus anticonvulsants and the risk of physical disorders

Conditions: Bipolar Disorder

Summary: nationwide population-based register linkage study covering the entire 5.9 million inhabitants in denmark systematically investigating the associations between sustained long-term use of lithium versus lamotrigine and valproate, and the risk of a range of physical disorders emulating a randomized trial.

the study includes two cohorts. cohort 1: all 12.607 patients with a diagnosis of bipolar disorder (icd-10 code: df30-31.9) who subsequently were exposed to either lithium, lamotrigine or valproate between 1997 and 2021. cohort 2: as cohort 1, but regardless of prior diagnosis of bipolar disorder (n= 156.678). main analyses considered a patient exposed to a drug 92 days after a prescription and a 10-year follow-up and 4 sensitivity analyses considered a patient exposed to a drug for 60 and 180 days after a prescription, respectively, and with 5- and 15-years follow-up, respectively.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine or valproate exclusion criteria: * none

Keywords: lithium lamotrigerne valproate physical disorders
prevention trial to achieve cardiovascular targets

Conditions: Coronary Artery Disease; Peripheral Arterial Disease; Hyperlipidemia; Hypertension; Diabetes; Prediabetes; Obesity

Summary: the objective of impact (investigation of motivational interviewing and prevention consults to achieve cardiovascular targets) is to determine the best management strategy for patients undergoing cardiovascular intervention. impact is a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. the study will compare different cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult, and (3) cardiovascular prevention consult with a behavioral intervention program over a 6-month period. the trial hypothesis is that for patients undergoing a cardiovascular intervention, a prevention consult and behavioral intervention is superior to usual care in reducing cardiovascular risk. the primary endpoint will be non-hdl cholesterol. secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, medication adherence and quality of life. impact is scheduled to begin enrollment in the june of 2012.

specific aims primary aim: the primary aim is that a targeted cardiovascular prevention consult will reduce non-hdl cholesterol compared to usual care at 6 months post-intervention. secondary aim: the secondary aim is that a targeted cardiovascular prevention consult plus a behavioral intervention will reduce non-hdl cholesterol compared to usual care at 6 months post-intervention.

Eligibility criteria:
inclusion criteria: * at least 21 years of age or older * subjects scheduled to undergo a percutaneous coronary or peripheral vascular intervention * patients must have the ability to understand and the willingness to sign a written informed consent document exclusion criteria: * life expectancy less than 1-year * inability to walk
the onset time of rocuronium in emergency and elective surgery

Conditions: Inguinal Hernia; Acute Appendicitis

Summary: rocuronium, a nondepolarizing neuromuscular blocking agent, is used in general anesthesia to provide conditions for endotracheal intubating. recommended dose is 0,6 mg/kg and 90 seconds after intravenous injection, patients can be intubated. anxiety levels may vary in patients undergoing emergency and elective surgery. patients undergoing emergency surgery may display exaggerated laryngoscopic responses. the purpose of this study is to investigate the effect of patient anxiety levels on the onset time of rocuronium in terms of anxiety scores and train of four (tof) 0.1 times.

after obtaining ethics committee approval, american society of anesthesiologists physiological status 1 (asa 1) patients, undergoing elective inguinal hernia repair and acute appendectomy, will be included to trial. patients will be taken to the operating room without premedication. spielberger's state-trait anxiety inventory (stai) will be administered to patients for determining anxiety level. electrocardiogram, blood pressure and peripheric oxygen saturation (spo2) will be monitored. after opening intravenous access on hand dorsum, ringer lactate solution will be given. neuromuscular monitoring and drug injections will be done as described in "good clinical research practice (gcrp) in pharmacodynamic studies of neuromuscular blocking agents". tof-guard sx acceleromyograph (organon-teknika) will be monitored on corrugator supercilii muscle because of its sensitivity to laryngeal muscles. in induction of anesthesia, propofol 2 mg kg-1 and fentanyl 1 mcg kg-1 will be administered intravenously. after loss of conscious, tof-guard sx will be calibrated and then 0.6 mg kg-1 rocuronium will be administered in 5 seconds. 20 milliampere (ma) current tof stimulation (200 ms, square wave, 2 hz for 1.5 s) will be repeated in every 15 s. patients will be intubated in tof 0.1 time. stai score, heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, spo2, tof 0.1 time and intubation conditions will be compared between two groups.

Eligibility criteria:
inclusion criteria: * bmi 18,5-24,9 * asa 1 exclusion criteria: * allergy to used drugs during anesthesia * neuromuscular disease * liver and kidney failure * heart failure * anticipated difficult airway * using aminoglycosides * bmi\ 25

Keywords: rocuronium onset time anxiety
efficacy and safety of tdf+3tc+efv in adults with hiv/hbv coinfection

Conditions: Hiv

Summary: this is a phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human immunodeficiency virus-1 and hepatitis b virus coinfection.

hiv/hbv co-infections are frequently observed due to shared routes of transmission. tdf and 3tc are nucleotide analogues that can inhibit both hiv and hbv dna polymerases. there is higher risk to cause drug resistance in treating hbv or hiv infection with 3tc or tdf monotherapy than combination trerapy. combination tharapy could decreases drug resistance. china's hiv epidemic remains one of low prevalence overall, but with pockets of high infection among specific sub-populations and in some localities. china has a very high endemicity for hepatitis b too. a substantial proportion of hiv-infected individuals are co-infected with hbv. tdf + 3tc + efv will be a common regimen for hiv/hbv co-infected chinese individuals. the purpose of this study of this study is to determine whether tdf will be safe for patients with hiv and hbv co-infection and the combination of tdf+3tc+efv will suppress hiv and hbv viral load below ldl at week 48 of treatment in patients with hiv and hbv co-infeciton.this study will enroll 100 adult subjects and follow these patients for 48 weekes.there will be one enrollment visit(baseline) and visits at 2,4,8,12,24,36,48 weeks after initiation of the study regimen.

Eligibility criteria:
inclusion criteria: * serologically-confirmed hiv and hbv infection * willingness to participate in a clinical trial * no previous or current use of antiretroviral regimen * clinical conditions stable * blood creatinine less than 3 times the upper limit of normal values. hbv dna\>1000copies/ml, tbil\<34umol/l,alt\<400u/l * with clinical indications for haart exclusion criteria: * patient refuses to sign the consent to participate * unwillingness to adhere to visit schedule or maintain adherence with medications * illnesses so serve as to likely require hospitalization * with other conditions that not suitable to be enrolled will be subject to medical review

Keywords: hbv co-infection art tdf