Kornimate/medical-research-clean huggingface dataset:
effects and importance of epinephrine/adrenalin deficiency in cah

Conditions: Congenital Adrenal Hyperplasia

Summary: individuals with cah produce lower levels of epinephrine (adrenalin) than controls. this can be correlated to the cyp21a2 genotype and is most pronounced in the classic forms. individuals with cah have an increased risk of developing hypoglycemia because both cortisol and epinephrine are important counter regulatory hormones. stress dosing is essential in situations of increased physical stress such as infections with fever for example. glucocorticoid treatment and stress dosing cannot compensate fully during physical stress neither for the reaction to psychological stress. this may render various types of difficulties in the individual's life. we aim to investigate if the deficient epinephrine production can be confirmed and if it is related to the increased level of anxiety and vulnerability to stress that we observe in the patients. specific aims of the study: * analyse the epinephrine/adrenalin production in patients with cah using measurements of epinephrine and metanephrine in blood, during an exercise test * assess stress vulnerability and anxiety using validated questionnaires * correlate the results to severity of disease, cyp21a2 genotype * investigate if psychological and somatic stress symptoms are related to the epinephrine production capacity.

after written informed consent study subjects, patients and controls, are invited to fill in a web based survey with the validated questionnaires. a link to the survey, expected to take 30 - 60 minutes to complete, is mailed to to the subjects . a subgroup of study subjects are invited to perform an ergo-spirometri test followed by the exercise test at the hospital. they are asked not to eat for 6 hours or drink any coffe during the day before the test. a venous catheter is used for blood sampling during the exercise. ecg, an orthostatic blood pressure test and a the ergo-spirometry test are performed before the subject is asked to do the exercise test, a cycling maximum test. blood glucose, lactate, are followed every 4 minutes. adrenal androgens, cortisol, insulin and methoxy-catecholamine are measured before and when the subject has reached maximum effort load and the test is ended. the physical capacity, orthostatic blood pressure and the blood test results are related to the severity of cah and to the maximum level of methoxy-cathecholamine produced by each individual. in the larger group of individuals, not taking part in the exercise test but completing the survey the genotype is correlated to the questionnaire results.

Eligibility criteria:
inclusion criteria: * cah due to 21-hydroxylase deficiency, exclusion criteria: * cardiovascular disease
a study to evaluate the efficacy and safety of medi0382 in the treatment of overweight and obese subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is designed to evaluate the dose range for medi0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of medi0382


Eligibility criteria:
inclusion criteria: * provision of informed consent * male and female subjects aged ≥ 18 years at screening * body mass index ≥ 25 kg/m2 at screening * hba1c range of 7.0% to 10.5% (inclusive) at screening * diagnosed with type-2 diabetes mellitus (t2dm) and treated with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening. use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to screening is acceptable * women of childbearing potential (wocbp), not breastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product (ip), with a negative pregnancy test within 72 hours prior to the start of ip exclusion criteria: * history of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the ip, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures * any subject who has received another ip as part of a clinical study or a glp-1 receptor agonist containing preparation within the last 30 days or 5 half lives of the drug (whichever is longer) at the time of screening * severe allergy/hypersensitivity to any of the proposed study treatments or excipients * symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily subcutaneous (sc) insulin for a period longer than 2 weeks within 90 days prior to screening * acute or chronic pancreatitis. subjects with serum triglyceride concentrations above 1000 mg/dl (11 mmol/l) at screening * significant inflammatory bowel disease or other severe disease or surgery affecting the upper gastrointestinal (gi) tract * significant hepatic disease * impaired renal function defined as estimated glomerular filtration rate (egfr) ≤30 ml/minute/1.73m2 at screening * severely uncontrolled hypertension * unstable angina pectoris, myocardial infarction (mi), transient ischaemic attack (tia), or stroke within 3 months prior to screening * severe congestive heart failure
study to investigate the safety and immunogenicity of a tetravalent chimeric dengue vaccine in healthy volunteers between the ages of 1.5 - 45 years

Conditions: Healthy

Summary: the purpose of this study is to assess the safety of takeda's tetravalent dengue vaccine (tdv) (previously denvax) administered subcutaneously in healthy adults and children. in addition the antibody response to the four dengue virus serotypes will be evaluated.

the vaccine tested in this study was tetravalent dengue vaccine (tdv). tdv was tested to assess safety and immunogenicity in healthy adults and children living in dengue endemic countries. the study enrolled 360 healthy participants. the study was conducted in 2 parts, part 1 - age descending and and part 2 - expansion - ages 1.5-11 years. participants were allocated to one of the four age cohorts in part 1 (21 to 45 years, 12 to 20 years, 6 to 11 years, and 1.5 to 5 years) and expansion age cohort 1.5-11 years in part 2. participants were randomized in 2:1 ratio and in 3: 1 ratio in part 1 and 2 respectively to receive: * tdv 0.5 ml sc injection * placebo (inactive solution) - this is a solution that looks like the study drug but has no active ingredient this multi-center trial was conducted worldwide. the overall time to participate in this study was up to 37 months (including screening period). participants made multiple visits to the clinic including a final visit at day 1080.

Eligibility criteria:
inclusion criteria: * in good health as determined by medical history, physical examination including height and weight * normal safety laboratory values at screening * negative for human immunodeficiency virus-1 (hiv-1) antibodies, hepatitis c antibodies \& hepatitis b surface antigen * females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception * weight: within 1.3 times of the upper limit of local normal age-adjusted body mass index (bmi) exclusion criteria: * for participants ≥12 years, clinically significant electrocardiogram (ecg) findings * history of significant dermatologic (skin) disease within last 6 months * history of diabetes mellitus * history of thymic pathology, thymectomy, myasthenia or any immunodeficiency * history of recurring headaches or migraines * hypersensitivity to any vaccine * for participants ≥12 years, positive urine screen for cocaine, amphetamines, opiates, or cannabinoids * history of alcohol abuse * pregnant or lactating female

Keywords: normal healthy adults and children safety and tolerability active vaccine placebo dengue virus vaccine immune response
promoting repeated hiv self-testing among msm in hong kong

Conditions: Behavior, Health

Summary: in this longitudinal study, we will firstly construct a cohort of hiv negative msm, who will be exposed to an online video-based intervention promoting hiv testing in general and real-time hiv self-testing with online counselling service (hivst-online) in particular. participants will receive intervention at baseline, month 6 and month 12.

500 msm will be recruited via venue-based, online outreach, and ngo referrals. at baseline, month 6 and month 12, participants received online intervention promoting hiv testing in general and hiv testing with online real-time counseling service. free hiv self-testing kits will be mailed to participants at baseline, month 6 and month 12. upon appointment, a testing administrator will provide online real-time pre-test and post-test counseling service for hiv self-testing users.

Eligibility criteria:
inclusion criteria: * hong kong chinese speaking men * ≥18 years old * anal intercourse with at least one man in the last six months * access to online face-to-face communication tools (e.g., line, skype, whatsapp) exclusion criteria: * self-reported to be hiv positive

Keywords: hiv testing hiv self-testing
a study of ritonavir-boosted invirase (saquinavir) in treatment-naïve hiv-1 infected patients

Conditions: HIV Infections

Summary: this open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a modified invirase (saquinavir)/ritonavir regimen in treatment-naïve hiv-1 infected patients. patients will receive invirase 500 mg plus ritonavir 100 mg twice daily orally for the first week, followed by invirase 1000 mg plus ritonavir 100 mg twice daily orally for the second week. the study treatment will be given in combination with two nucleoside reverse transcriptase inhibitors (nrtis), in accordance with the current clinical hiv treatment guidelines. anticipated time on study treatment is 14 days.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * hiv-1 infection * currently treatment-naïve and eligible to initiate a ritonavir-boosted protease inhibitor based regimen and willing and able to initiate saquinavir/ritonavir therapy for the first 14 days; the saquinavir/ritonavir regimen will be in combination with two nucleoside reverse transcriptase inhibitors (nrtis), in accordance with the current clinical hiv treatment guidelines * body mass index 18-32 kg/m2, inclusive * female patients of childbearing potential and male patients with female partners of childbearing potential must use 2 methods of contraception as defined by protocol during the study and for at least one month after the last dose of study drug * non-smoker or patients who have stopped smoking more than three months prior to day 1 of the study exclusion criteria: * coinfection with hepatitis b or c (acute or chronic) * anticipated use or need for significant concomitant medical treatment during the study period, other than background antiretroviral therapy * participation in a clinical study with an investigational drug or device within 3 months prior to day 1 of the study * pregnant or lactating women * any clinically relevant history of substance abuse or addiction including alcohol and/or other drugs of abuse * special dietary restrictions that would prohibit consumption of standardized meal (e.g. vegetarian, vegan, gluten-free, lactose-free, kosher) * decompensated liver disease * congenital or documented acquired qt prolongation * electrolyte disturbances, particularly uncorrected hypokalaemia * clinically relevant bradycardia * clinically relevant heart failure with reduced left-ventricular ejection fraction * previous history of symptomatic arrhythmias * history of clinically significant gastro-intestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, , hematological, or allergic disease, metabolic disorder, cancer, or cirrhosis
a study of olezarsen (formerly known as akcea-apociii-lrx) in participants with familial chylomicronemia syndrome (fcs)

Conditions: Familial Chylomicronemia Syndrome

Summary: the purpose of this study is to evaluate the effect of olezarsen (formerly known as akcea-apociii-lrx) on the percent change in fasting triglycerides (tg) from baseline.

this is a multi-center, open-label extension (ole) study of up to 60 participants with fcs rolling-over from study isis 678354-cs3 (nct04568434). participants will receive olezarsen during a 157-week treatment period, followed by a 13-week post-treatment follow-up period. the length of participation in this study is approximately 201 weeks, which includes an up to 31-day qualification period, a 157-week treatment period, and a 13-week post-treatment evaluation period. treatment has been extended to obtain additional safety assessments and efficacy data and to provide patients with continued access to isis 678354 until the drug may be available commercially.

Eligibility criteria:
inclusion criteria: • satisfactory completion of treatment with olezarsen in the index study (isis 678354-cs3, last dose as scheduled at week 49) with an acceptable safety profile, per investigator judgement. exclusion criteria: • have any new condition or worsening of existing condition which in the opinion of the investigator would make the participant unsuitable for enrollment, or could interfere with the patient participating in or completing the study, including need for treatment with medications disallowed in the index study (isis 678354-cs3).

Keywords: fcs
optical coherence tomography (oct) and oct angiography(octa) deep learning in waldenström's macroglobulinemia patients

Conditions: Waldenstrom Macroglobulinemia

Summary: this study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in waldenström's macroglobulinemia patients, using optical coherence tomography angiography.

waldenstrom macroglobulinemia (mak-roe-glob-u-lih-nee-me-uh) is a rare type of cancer that begins in the white blood cells. the optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features. the study evaluates the changes in optical coherence tomography angiography features in waldenstrom macroglobulinemia, elaborating these data with artificial intelligence.

Eligibility criteria:
inclusion criteria: * age older than 18 years * diagnosis of waldenstrom macroglobulinemia * absence of previous ocular surgery and congenital eye diseases. * absence of errors of refraction * absence of lens opacities * absence of low-quality oct and octa images exclusion criteria: * • age younger than 18 years * previous ocular surgery and congenital eye diseases * errors of refraction * lens opacities * low-quality oct and octa images
impact of baduanjin exercise combined with rational emotive behavior therapy on sleep and mood in patients with post-stroke depression

Conditions: Stroke

Summary: patients and their families all agreed .


Eligibility criteria:
inclusion criteria: 1. conformity to the diagnostic criteria for stroke in the \&#34;diagnostic essentials of various cerebrovascular diseases\&#34; revised by the fourth national cerebrovascular academic conference, and confirmed by cranial ct or mri. 2. the course of stroke was 2 weeks to 6 months, with steady conditions and stable vital signs. 3. the age ranged from 30 to 80 years old, with at least a junior high school education. 4. the patients had no serious intellectual, language comprehension and behavioral disorders, and could complete the assessment of scales. 5. achieving a sitting balance of at least reaches level 3, brunnstrom stage iv or above, and being able to complete baduanjin training. 6. the national institutes of health stroke scale (nihss) ≤ 15 points. 7. conforming to the diagnostic criteria for depression in the \&#34;chinese experts consensus on clinical practice of post-stroke depression\&#34;. exclusion criteria: the exclusion criteria: 1. disturbance of consciousness, unable to cooperate with polysomnography (psg) and scale evaluators. 2. pre-existing diagnosis of depression before stroke. 3. severe pre-existing sleep disorders before stroke. 4. patients with mental illness, immune system disorders, severe liver and kidney dysfunction, and severe cardiopulmonary dysfunction
losartan to improve hip microfracture

Conditions: Hip Osteoarthritis; Hip Impingement Syndrome; Cartilage Damage; Fibrosis

Summary: phase i/iia randomized, double-blind, placebo-controlled clinical trial to assess safety and efficacy of oral losartan for improving cartilage repair following microfracture to treat focal cartilage defects during hip arthroscopy.

this is a prospective, double-blind, placebo-controlled, randomized clinical trial that will be conducted at the steadman clinic and steadman philippon research institute. articular cartilage defects that extend full thickness to subchondral bone rarely heal without intervention. some patients may not develop clinically significant problems from acute full-thickness chondral defects, but many eventually suffer from debilitating degenerative changes. microfracture is the most commonly used first-line treatment technique for chondral lesions in the hip, however, this procedure's effectiveness is limited by the repair tissue being a hybrid of hyaline and fibrocartilage. we hypothesize that administration of a transforming growth factor beta 1 (tgf-β1) blocker, losartan (an approved hypertension drug, angiotensin ii receptor antagonist) with microfracture will enhance articular cartilage repair as assessed on quantitative magnetic resonance imaging. we will also measure patient benefit through the recording of patient reported outcomes in the 18 months following surgery. the division of pulmonary, allergy and rheumatology products within the center for drug evaluation and research at the food and drug administration has granted an investigational new drug (ind) exemption to pursue this trial in accordance with 21 cfr 312.2(b).

Eligibility criteria:
inclusion criteria: * underwent primary hip arthroscopy * underwent baseline quantitative mri at the steadman clinic (tsc) * single, localized, grade 3 or 4 cartilage lesion of the acetabulum or femoral head treated with bone marrow stimulation (bms; i.e. microfracture) * aged 18-60 at time of surgery * tonnis grade 1 or less exclusion criteria: * two or more cartilage lesions of grade 3 or 4 * less than 2 mm of minimal hip joint space * osteoarthritis or diffuse change of cartilage * non-english speaking * prior hip surgery on operative hip * pre-existing bony deformity caused by previous fracture(s) * synovial chondromatosis * pigmented villonodular synovitis (pvns) * dysplasia (center edge angle \<20 degrees) * history of avascular necrosis (avn), perthes disease, or slipped capital femoral epiphysis (scfe) * inflammatory arthritis or other arthritis caused by autoimmune disease * patients allergic to any active or inactive ingredient of losartan * patients taking medication with known losartan interaction, including phenobarbital, rifampin, and fluconazole. * subjects that are currently taking losartan

Keywords: cartilage microfracture losartan transforming growth factor beta 1 hip arthroscopy
post-approval observational study of elpida® in the first line therapy for hiv-1 infected patients with background standard art

Conditions: HIV-1-infection

Summary: this post-registration observational study is designed to monitor the safety parameters and efficacy of elpida® in actual practice in the first-line treatment of hiv-1 infected patients on the background of the standard baseline art.

this study is a multicenter, open-label, post-registration observational non-interventional study of the use of elpida® in the first line of therapy for hiv-1 infected patients against a background of standard baseline art (nnrtis + 2 nrtis). the study is scheduled to be conducted approximately in 20 centers for the prevention and control of aids in russia. in total, 2000 hiv-1-infected patients who are prescribed therapy with elpida® (20 mg capsules) against the background of standard baseline art are planned to be included in the study. the observational study will collect data from patients who signed informed consent and meet all inclusion/non-inclusion criteria from the time that precedes the therapy by elpida® up to 96 weeks of treatment or until early elimination. the data will be obtained through routine visits and procedures, including demographics and history, height, body weight, body mass index (bmi), laboratory data (viral load of hiv-1, cd4+-t-lymphocytes, resistance mutations in hiv-1, screening for hepatitis b and c, syphilis, general and biochemical blood analysis, general urine analysis) and instrumental examinations (electrocardiography (ecg), chest x-ray/fluorography). throughout the study, patients will keep observation diaries for recording aes and concomitant therapy. data on the intake of art drugs and ae related to their use will also be collected.

Eligibility criteria:
inclusion criteria: 1. a signed patient information sheet and a form of informed consent to participate in the study. 2. men and women aged 18 and over. 3. document supported hiv-1 infection. 4. patients whom during the previous 24 weeks first line art was prescried comprising the drug elpida®, including patients who are art-naive or were transferred to elpida® from other first line art regimens due to intolerance (transfer from other nnrtis - within the class; transfer from protease inhibitors, including boosted ones, due to lipid metabolism disorders or other adverse reactions (ar) if the virological effectiveness of the previous art regimen - was effective - reaching undetectable levels of viral load). exclusion criteria: 1. current participation in the clinical trial. 2. significant alcohol and/(or) drug dependence, which, according to the researcher, can prevent collection of data. 3. increase of ast/alt levels by more than 2.5 times higher than the upper limit of the reference range at week 0 visit. 4. replication stage of chronic hepatitis c (presence of hcv rna), requiring therapy. 5. use of elpida® in violation of indications officially approved by the ministry of health of the russian federation on the package leaflet. 6. significant secondary diseases requiring treatment.

Keywords: hiv-1
regulation of immunological cytokines by qiliqiangxin capsule in dilated cardiomyopathy patients

Conditions: Congestive Heart Failure

Summary: purpose :research into the impact of qiliqiangxin capsule on ifn-γ，il-4，nt-probnp in dilated cardiomyopathy patients with heart failure. methods :data were collected from the patients with idiopathic dilated cardiomyopathy ( cardiac function nyha ⅱ-ⅳ) in the first affiliated hospital of harbin medical university from may 2012 to april 2014. these 30 cases were treated under the recommendations of normal diagnosis and treatment in cardiomyopathy. this experiment was randomized double-blinded，the experimental interferences were avoided and patients were divided into the experimental group and the placebo group. the patients in experimental group received the relevant tests and inspections before the beginning of experiment，signed the informed consent. then the investigators get the venous blood centrifugalization and cryopreservation. the patients take the medicine qiliqiangxin three times per day，four tablets at a time. afrer a month，the investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and keep blood specimens. three and six month later，electrocardiogram and echocardiography were taken and the determination of the nt - probnp was done. the placebo group was followed up in the same way.


Eligibility criteria:
inclusion criteria: * congetive heart failure exclusion criteria: * valvular heart diseases