Kornimate/medical-research-clean huggingface dataset:
study with a topical gel containing triac and dhea in subjects with skin atrophy due to glucocorticoids

Conditions: Skin Atrophy

Summary: an open, uncontrolled pharmacokinetic study with a new topical combination gel containing triiodothyroacetic acid (triac) and dehydroepiandrosterone (dhea) in subjects with skin atrophy due to topical treatment with glucocorticoids.

at the baseline visit (day 1) and after completion of all evaluations, each subject who qualifies for entry will will receive a dose of 0.5 g imp on the back of a hand affected with skin atrophy. pk-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.

Eligibility criteria:
inclusion criteria: 1. written informed consent has been obtained prior to initiating any study specific procedures 2. men and women of at least 18 years old 3. subjects with hand eczema and confirmed skin atrophy on the back of a hand caused by treatment with topical glucocorticoids for at least 6 months 4. atrophic skin area of approximately 100 cm2 (back of a hand) 5. females of childbearing potential must have a negative urine pregnancy test result upon entry into the study 6. females of child-bearing potential may participate only if using reliable means of contraception exclusion criteria: 1. skin atrophy with open ulcer(s) involved 2. participation in any other study involving investigational drug(s) within 30 days prior to study entry 3. use of systemic or topical glucocorticoids, thyroid hormones, vitamin a analogues, dhea, and testosterone within 3 weeks before entry into the study 4. known thyroid disease of any type 5. women with polycystic ovary syndrome (pco), congenital adrenal hyperplasia or other androgen excess syndromes 6. subjects who have previously participated in this study
a phase i study of sim0388 in participants with malignant ascites.

Conditions: Malignant Ascites

Summary: malignant ascites is a common complication of malignant tumor. the objective of this study is to evaluate the safety, efficacy, and pharmacokinetic characteristics of intraperitoneal perfusion with docetaxel polymeric micelles (sim0388) for injection in patients with malignant ascites

the study starts with a dose escalation part followed by a dose expansion part. the primary objective of the dose escalation part is to evaluate the safety and tolerability of sim0388 peritoneal perfusion, and determine the maximum tolerated dose (mtd) and/or the recommended dose(s) (rd) of sim0388 peritoneal perfusion. the primary objective of the dose expansion part is to evaluate the efficacy of sim0388 intraperitoneal perfusion in the treatment of malignant ascites.

Eligibility criteria:
inclusion criteria: * voluntary participation and signature of informed consent form;. * ≥ 18 years of age, male or female. * participants with histologically and/or cytologically confirmed advanced/metastatic solid tumors;. * failure of at least one line of standard systemic anti-tumor therapy, unsuitability for standard systemic therapy, or absence of standard systemic therapy options. * moderate or greater ascites confirmed by ultrasonography * ecog performance status of 0, 1or 2. * life expectancy ≥ 3 months. * adequate hematologic and organ function. * women of childbearing potential (wocbp) must have a negative serum pregnancy test. wocbp and male subjects agree to use adequate contraception. exclusion criteria: * participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment * prior history of intraperitoneal paclitaxel-based therapy. * use of strong cyp3a4 inhibitors or inducers within 7 days before the first dose or anticipated use during the study. * failure to recover from adverse events caused by prior interventions to ≤grade 1 * complete intestinal obstruction within 30 days prior to the first dose. * myocardial infarction within 6 months, current unstable angina, primary cardiomyopathy, cerebrovascular events, congestive heart failure, symptomatic coronary artery disease requiring medication, arrhythmia requiring medication, qtcf interval \>470 ms, or uncontrolled hypertension. * uncontrolled primary brain tumors or cns metastases. * active infection. * known history of hiv infection. * active hepatitis b or hepatitis c infection. * hypersensitivity to any active or inactive ingredient of sim0388. * pregnant or lactating women. * any condition (medical history, disease, treatment, or lab abnormality) that may interfere with study results, impede full participation, or deemed by the investigator to contradict the subject's best interests.

Keywords: malignant ascites solid tumor
high intensity focused ultrasound in patients with varicose veins in singapore

Conditions: Varicose Veins; Venous Reflux; Chronic Venous Insufficiency

Summary: the aim of the study is to evaluate the efficacy of non-invasive echotherapy for the treatment of varicose veins, within local population, using the sonovein® device. the quality of life scores at baseline, 2 weeks, 3 months, 6 months and 12 months will be assessed using the eq-50d, avvq and civiq scores. patient satisfaction at these time points will also be assessed.

sonovein® is a unique echotherapy solution, combining therapeutic ultrasound and ultrasound for monitoring. the high-intensity ultrasound beam is focused on the vein through a magnifying glass. as thermal energy is delivered, the thermocoagulation property of ultrasound energy affects the vein wall, causing shrinking and collapsing of the target vein. thus creating a fibrotic seal and occluding the vessel. the treated vein is immediately closed after the procedure, and its diameter will continuously reduce over time, becoming a fibrotic chord. the treatment along the vein is steered automatically via a touch screen monitor. in-beam linear ultrasound probe allows visualisation of the vein in real-time and insures optimal accuracy. the study involves prospective data collection of 30 patients that will be undergoing hifu as choice of treatment for their varicose veins / cvi. questionnaires will be conducted at 5 timepoints - baseline before procedure, 2 weeks, 3 months, 6 months and 12 months. subjects will be seen at outpatient clinic post-procedure. besides questionnaires, physical examination and duplex ultrasound scan will be conducted at 2 weeks, 3 months, 6 months and 12 months to ensure occlusion of treated vein.

Eligibility criteria:
inclusion criteria: 1. age \>21 years, able to understand the requirements of the study and provide informed consent. 2. c2 - c5 varicose veins / cvi 3. symptomatic primary gsv, ssv or aasv incompetence, with reflux \>0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling. 4. patients who has gsv, ssv or aasv diameters of 3mm to 12mm in the standing position. exclusion criteria: 1. current dvt or history of dvt 2. recurrent varicose veins 3. pregnant patients 4. arterial disease (abpi\<0.8) 5. sepsis 6. patients who are unwilling to participate 7. inability or unwillingness to complete questionnaires 8. adverse reaction to sclerosant or cyanoacrylate 9. gsv, ssv or aasv severely tortuous 10. life expectancy \< 1 year 11. active treatment for malignancy other than non-melanoma skin cancer 12. current, regular use of systemic anticoagulation (e.g. warfarin, heparin) 13. daily use of narcotic analgesia or nsaids to control pain associated with venous disease

Keywords: endovenous ablation
telma - observational study in daily medical practice of the effectiveness of telmisartan for treatment of hypertension in patients with and without confirmed albuminuria in belgium

Conditions: Hypertension

Summary: this study was carried out in the context of daily medical practice to compare the effectiveness of telmisartan in the treatment of hypertension complicated or not with the presence of protein in the urine, which is called albuminuria. hypertension is a chronic, treatable but not curable disease and is defined as a combination of a systolic blood pressure of 140 mmhg or more and a diastolic pressure of 90 mmhg or more. the kidneys are often the first organs damaged by hypertension; renal damage could easily be diagnosed using a urine dipstick and should be part of a routine examination in hypertensive patient. the aim of the study is to see if the decrease of blood pressure (both systolic and diastolic) after approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same or different to that in patients without albuminuria. every patient participating should have two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few questions about is concomitant disease and drugs were asked.


Eligibility criteria:
inclusion criteria: age above or equal to 18, no upper limit patient has been treated and followed up for more than 6 months by the same general practitioner (gp) hypertension treated for at least 3 months and not under control at the time of inclusion in the study \[systolic blood pressure (sbp) above or equal to 140 mmhg and diastolic blood pressure (dbp) above or equal to 90 mmhg, or sbp above or equal to 130 mmhg and dbp above or equal to 80 mmhg if patient has chronic renal insufficiency or diabetes\] results available from at least two tests of albuminuria antihypertensive treatment remained unchanged during the month prior data collection decision by the gp to introduce telmisartan (either in combination with hydrochlorthiazide \[hctz\] or not) in the antihypertensive treatment (normal prescription) written informed consent of the patient to collect his/her data exclusion criteria: blood pressure under control \[sbp below 140 mmhg and dbp below 90 mmhg or sbp below 130 mmhg and dbp below 80 mmhg if patient has chronic renal insufficiency or diabetes\] the patient refuse to allow his/her data to be collected women of childbearing potential not using an effective contraception method, as well as women who are breastfeeding patients with proteinuria above or equal to 1g/l or with glomerular filtration rate (gfr) below 15 ml/min/1.73 m² current or prior use of telmisartan within the last 12 months change in the antihypertensive treatment during the month prior to collection of the data
directional deep brain stimulation with patients with advanced parkinson's disease

Conditions: Parkinson Disease

Summary: the aim of the study is to assess the clinical outcome in patients with parkinson's disease treated with directional deep brain stimulation (ddbs). the patients have been selected for the ddbs treatment by their treating neurologist. the study is a registry-based follow-up study.

the study group consists of patients with advanced parkinson's disease treated with directional deep brain stimulation in helsinki university hospital between 2017 - 2020. the study is a registry-based follow-up study. the aim of the study is to assess the clinical outcome and possible adverse effects of the ddbs treatment. the data will be collected from the patient records. the observed time points are 6-month's, 12-month's and 18-month's postoperative visits. the following data will collected: the scores of unified parkinson's disease questionnaire part iii (updrs-iii), non-motor symptoms questionnaire (nms-quest), beck depression inventory (bdi), mini-mental state examination (mmse), abnormal involuntary movement scale (aims) evaluated in the screening phase for ddbs treatment and at 6-months' follow-up. possible levodopa equivalent dose changes, ledds, will also be assessed at these time points.

Eligibility criteria:
inclusion criteria: * patients with advanced parkinson's disease and treated with directional deep brain stimulation exclusion criteria: * patients with advanced parkinson's disease and not treated with directional deeb brain stimulation

Keywords: deep brain stimulation advanced parkinson's disease dbs ddbs
barrett's esophagus - 315 - 3 way cross over

Conditions: Barrett's Esophagus

Summary: this study evaluates pge2 production, cox-2 enzyme activity and pcna expression in barrett's metaplastic tissue. all patients will have a baseline endoscopy with multiple biopsies. the patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin, esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing period, whilst undergoing further follow up endoscopies and multiple biopsies.


Eligibility criteria:
inclusion criteria: * a biopsy-proven diagnosis of barrett's esophagus segment length greater than 2cm with no dysplasia or adenocarcinoma. * clinically normal laboratory results and physical findings at screening. exclusion criteria: * a history of esophageal, gastric or duodenal surgery, including antireflux surgery or endoscopic antireflux procedures, except for simple closure of an ulcer. * evidence of the following diseases or conditions: * barrett's esophagus less than or greater than 2cm that is positive for high grade dysplasia or adenocarcinoma * signs and symptoms of gastric outlet obstruction * active peptic ulcer disease * severe liver disease * pancreatitis * malabsorption * active inflammatory bowel disease * severe pulmonary, cardiovascular or renal disease * impaired renal function or abnormal urine sediment on repeated examinations * esophageal stricture or active, severe esophagitis.

Keywords: barrett's esophagus nexium
testing a digital intervention for adolescents

Conditions: Rumination; Stress, Psychological

Summary: teen participants (ages 13-17) will be randomly assigned to either an experimental (the happify teens digital platform), or a waitlist control group. the study includes an 8-week intervention period and a 1-month follow up period.

teen participants (ages 13-17) will be randomly assigned to either the experimental group in which participants receive access to happify teens, a digital platform rooted in several therapeutic traditions that aims to improve wellbeing, or a waitlist control group. both group conditions last 8 weeks. participants assigned to the happify teens platform will have full access to the intervention, with featured tracks that focus on dealing with stress, worries and building skills for greater happiness. participants assigned to the waitlist (control) condition will not have access to the happify teens platform for the full study period (12 weeks total). participants in the waitlist control will receive access to happify teens after the full study period is complete (12 weeks). perceived stress, rumination, and optimism will be assessed via self-report at baseline, end of the 8-week intervention, and at 1 month post intervention.

Eligibility criteria:
inclusion criteria: * 13-17 years of age * us resident * perceived stress scale score ≥ 10 * ruminative responses scale score ≥ 14 * ability and willingness to complete study activities * willingness and access to using a digital intervention via mobile application or web browser exclusion criteria: * current or past user of any happify platform * non-us resident * perceived stress scale score \< 10 * ruminative responses scale score \< 14
mechanism of endothelial dysfunction in obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: the investigators hypothesized that patients with obstructive sleep apnea (osa) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to osa, and therefore would resolve with treatment of osa.

impaired vascular regulation of the microcirculation is a consequence of obstructive sleep apnea (osa). nitric oxide (no) related endothelial dysfunction occurs in osa as the earliest vascular abnormality prior to the manifestation of vascular disease and it results in impaired vasodilatory response to hypoxia. these abnormalities have already been described in osa patients. the role of oxidative stress in endothelial dysfunction is present in vascular disorders. the presence of oxidative stress in osa patients is also well established. the effect of increased superoxide on endothelial function has also been described in the literature. the mechanism of this effect is unknown and is the focus of this research. we hypothesized that patients with obstructive sleep apnea (osa) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to osa, and therefore would resolve with treatment of osa.

Eligibility criteria:
inclusion criteria: 1. apnea-hypopnea index (ahi) \> 15 events per hours. exclusion criteria: 1. hypertension defined by existing treatment with antihypertensives or any measurement of systolic pressure above 130 mmhg, or diastolic pressure above 85 mmhg; 2. dyslipidemia defined by fasting cholesterol above 200; or fasting ldl over 150 mg/dl; 3. diabetes defined as existing diagnosis, hemoglobin a1c \>7 or fasting glucose \>110 on two separate measurements (standard fasting glucose or hba1c criteria); 4. cad defined by history of angina, coronary event or abnormal stress test; 5. peripheral vascular disease (pvd) defined by history of stroke, claudication or abnormal ankle brachial index; 6. concurrent smoking; 7. pregnancy; 8. use of erectile dysfunction drugs, or any medications for chronic conditions; 9)chronic liver or renal disease. fasting blood test for glucose, cholesterol, on all participants who have not had these tests in the 6 month prior to enrollment, will be obtained at the time of screening. the remaining criteria will be evaluated by reviewing the medical records and history taking on the day of first visit.
creating healthier communities through meaningful partnerships: a model from the national african american male wellness initiative - osu partnership

Conditions: Hypertension; Diabetes; Sedentary Behavior; High Cholesterol; Diet, Healthy; Smoking Reduction; Weight Loss

Summary: primary objective: test feasibility and acceptability of a 24-week community-based lifestyle intervention to improve cardiovascular health among african american males. secondary objectives: 1) navigate participants to establish primary care and address social and patient activation needs that present barriers to wellness; 2) examine changes in cardiovascular health as per american heart association life's simple 7 metrics including blood pressure, cholesterol, glucose, smoking, body mass index, physical activity and dietary intake (1); and 3) increase african american male participation in clinical trials.

chronic diseases, particularly diabetes (dm), cardiovascular disease (cvd), and cancer, pose a tremendous burden for ohio residents, health systems, and employers. this burden is not equally distributed and mortality from these diseases is greatest among african american (aa) men. the national african american male wellness initiative (aamwi) was established in columbus, ohio in 2004. through numerous events including an annual walk with health fair, the aamwi aims to reduce premature mortality among aa males. it has become the largest health initiative in central ohio for aa's, spanning 5 cities in ohio and total of 16 nationally. the ohio state university (osu) partners with the aamwi to advance health equity in dm, cvd, and cancer. through our partnership, community health workers (chws) and health coaches (hcs) aim to activate at-risk aa men to embrace wellness by: 1) facilitating engagement with a primary care provider and addressing social determinants of health that present barriers to wellness; 2) improving participants' "life's simple 7" (ls7) american heart association (aha) metrics (blood pressure, cholesterol, glucose, smoking, body mass index, physical activity and dietary intake) through a community team-based intervention (lloyd-jones, 2010); and 3) increasing participation in clinical trials.

Eligibility criteria:
inclusion criteria: * african american men (self-report) * adult age 18 years or older * poor or average cardiovascular health (\< 4 ls7 metrics in the ideal range) from the american heart association 2020 guidelines * participant is appropriate for group setting. exclusion criteria: * non-english speaking * living outside of the metro columbus area * unable to perform physical activity
replication of an early evaluation of 30-day readmissions among nonvalvular atrial fibrillation patients treated with dabigatran, rivaroxaban, apixaban, or warfarin in the u.s

Conditions: Atrial Fibrillation

Summary: the overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (nvaf) patients in the u.s.


Eligibility criteria:
inclusion criteria: * have a primary or secondary diagnosis of af identified by international classification of diseases, ninth revision, clinical modification (icd-9-cm) codes from the cerner health facts hospital database between january 1, 2012 and august 31, 2014 * age 18 years or older as of initial hospitalization with af diagnosis exclusion criteria: * have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. this exclusion criterion is consistent with that used in other previous bms health economics and outcomes research (heor) studies and is used to ensure that the study populations are nvaf patients * received multiple types of noacs during the index hospitalization. preliminary analysis showed that very few patients receive multiple types of noacs during the same hospitalization. this exclusion criterion will allow to cleanly group patients into the different new oral anticoagulant (noac) usage groups

Keywords: anticoagulation