Kornimate/medical-research-clean huggingface dataset:
phase ii study of long-term dehydroepiandrosterone for systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: objectives: i. evaluate the long-term safety and tolerance of a synthetic formulation of dehydroepiandrosterone, gl701, in patients with systemic lupus erythematosus who have completed a prior gl701 protocol.

protocol outline: patients receive daily oral dehydroepiandrosterone for 12 months. the dose is adjusted based on disease activity and tolerance of treatment. patients are followed every 3 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- systemic lupus erythematosus by american college of rheumatology criteria mild to moderate disease characterized as follows: prednisone dose (or equivalent) 10 to 30 mg/day no daily dose 1 mg/kg or greater no alternate-day regimen failed prednisone taper in last 12 months and dose stable for at least 6 weeks prior to entry or no attempt to taper in last 12 months and dose stable for at least 3 months prior to entry prior completion of dehydroepiandrosterone (dhea) study required no prior participation in double-blind dhea study at stanford university --prior/concurrent therapy-- no concurrent immunosuppressants no concurrent participation in other clinical studies no investigational agents within the longer of 30 days or 10 half-lives of the agent at least 3 months since immunosuppressants, including: adrenocorticotropin hormone androgens cyclophosphamide azathioprine intravenous immune globulin at least 1 month since change in dose of nonsteroidal anti-inflammatory drugs or hydroxychloroquine --patient characteristics-- age: 18 and over sex: female only performance status: not specified other: no hypersensitivity to dhea or inactive ingredient in gl701 formulation, i.e., cornstarch, lactose, or magnesium stearate no condition that would prevent adequate compliance with study no history of breast cancer or reproductive tract malignancy negative pregnancy test required within 2 weeks prior to entry reliable contraception required of fertile women no estrogen-containing oral contraceptive

Keywords: arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus
metabolic causes of thrombosis in type 2 diabetes - question 1

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel. the proposed protocol will study the separate and combined effects of hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in type 2 dm. our hypothesis is that hyperglycemia, rather than hyperinsulinemia, is responsible for the dysregulation of fibrinolytic balance in diabetics.

this study will test the hypothesis that hyperglycemia will impair, while hyperinsulinemia will improve endothelial function and vascular fibrinolytic balance in type 2 dm. as discussed above, their roles in the increased prevalence of thrombotic events occurring in diabetics have not been defined. more recent data supports insulin as profibrinolytic and hyperglycemia to cause endothelial dysfunction. conclusive studies are lacking in diabetic subjects. furthermore, preliminary data from this lab indicates that in non-diabetic controls, hyperglycemia results in a prothrombotic state by increasing plasma pai-1 and reducing tpa levels. the proposed protocol will study the separate and combined effects of hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in type 2 dm.

Eligibility criteria:
inclusion criteria: * 16 ( 8 female/ 8 male) type 2 diabetic patients age 18-60 yrs * 16 ( 8 female/ 8 male) non-diabetic controls age and weight matched * body mass index 25-52 kgm2 * female volunteers of childbearing potential: negative hcg pregnancy test * volunteers over 40 years old: normal baseline ecg * for those with type 2 diabetes: hba1c 6.5-10% exclusion criteria: * prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease * uncontrolled hypertension * history of cerebrovascular incidents * pregnancy * subjects unable to give voluntary informed consent * subjects with a recent medical illness * subjects with known liver or kidney disease * subjects on anticoagulant drugs, anemic, or with known bleeding diseases * tobacco use

Keywords: type 2 diabetes endothelial function fibrinolytic balance
evaluation of the impact of lung ultrasound on mortality and rehospitalization in patients admitted to the emergency department with dyspnea

Conditions: Dyspnea

Summary: dyspnea is a frequent reason for referral to emergency departments, leading to a 30-day mortality rate of up to 10% and a 3-month rehospitalization rate of over 30%. multiple etiologies, as well as poor performance of clinical examination and chest radiography, lead to a diagnostic error rate of nearly 30% at the end of emergency department care. these diagnostic errors lead to rehospitalization and an excess mortality rate of more than 50% compared to patients with a correct initial diagnosis, which is explained in particular by the use of inappropriate therapies. lung ultrasound is a rapid, non-irradiating, non-invasive, inexpensive, reproducible imaging test that can be used at the bedside. it has a better diagnostic performance than chest radiography, commonly performed in emergency departments.the immediate benefit of lung ultrasound for the most common diagnoses in emergency medicine has already been demonstrated. from an organizational point of view, a few studies have shown a benefit of lung ultrasound in reducing the time spent in emergency departments and the number of additional examinations necessary for the final diagnosis. however, there is no data in the literature on the longer term impact of its use in the emergency department. the primary objective is to evaluate the impact of performing lung ultrasound in terms of 3-month mortality and rehospitalization as part of the diagnostic process for patients admitted to the emergency department with dyspnea.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * admission to the emergency department with dyspnea defined by: the functional sign of dyspnea experienced by the patient; or a clinical sign of respiratory distress. - non-opposition of the patient or patient's family if the patient isn't able exclusion criteria: * trauma-induced dyspnea; * patient being on palliative care; * patient with criteria for initial resuscitation with admission to a critical care unit; * pregnant women, women in labour or nursing mothers; * persons deprived of liberty by judicial or administrative decision; * persons under psychiatric care; * persons admitted to a health or social institution for purposes other than research; * persons of full age subject to a legal protection measure (guardianship, curatorship);

Keywords: lung ultrasonography emergency department mortality rehospitalization
a study to evaluate the efficacy of seasonique for the treatment of cyclic pelvic pain

Conditions: Dysmenorrhea

Summary: this study is being conducted to evaluate the effects of treatment with seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. patients will receive 26 weeks of treatment. the overall study duration will be approximately 9 months. patients will be required to record menstrual pain in a daily diary.


Eligibility criteria:
inclusion criteria: * moderate to severe menstrual-related pain * regular spontaneous menstrual cycles exclusion criteria: * any contraindication to the use of oral contraceptives * treatment with an oral contraceptive in the last 3 months * previous treatment failure with an extended oral contraceptive regimen

Keywords: cyclic pelvic pain dysmenorrhea
corevitas international adolescent atopic dermatitis (ad) drug safety and effectiveness registry

Conditions: Atopic Dermatitis

Summary: prospective observational registry for an adolescent cohort with ad under the care of a dermatology provider. approximately 1500 subjects and 75 clinical sites in north america and select european countries will be recruited to participate with no defined upper limit for either target.

the objective of the registry is to create a cohort of adolescent subjects with ad to evaluate the long-term safety and effectiveness of ad treatments. data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of ad to support ongoing risk-benefit evaluation by drug manufacturers and regulators. further, data collected will inform clinical decision making by patients and treating providers. this will be done through standardized data collection including validated instruments for patient-reported outcomes (pros) and clinician-reported outcomes (clinros), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. this provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

Eligibility criteria:
inclusion criteria: * to be eligible to participate in this registry, an individual must meet all the following criteria: 1. has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified dermatology practitioner. 2. is 12 - 15 years of age at the time of enrollment. 3. meets one of the following conditions at the time of enrollment: 1. has started taking a new enrollment eligible medication within 6 months prior to the enrollment visit. a new medication is a medication that the subject has never taken before. or 2. is prescribed a new enrollment eligible medication at the enrollment visit. a new medication is a medication that the subject has never taken before. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in the registry: 1. is participating or planning to participate in a blinded clinical trial for an ad drug.
chronic obstructive pulmonary disease as a predictor of mortality in cardiac surgery

Conditions: Chronic Obstructive Pulmonary Disease; Cardiac Surgery

Summary: to estimate prevalence of chronic obstructive pulmonary disease (copd) in cardiac surgery population and establish links between copd status, as assessed through pulmonary functional tests, and 2-year mortality


Eligibility criteria:
inclusion criteria: * written informed consent, planned elective coronary artery bypass graft surgery exclusion criteria: * contraindications to pulmonary functional tests, emergency surgery, recent or ongoing myocardial infarction, angina
covid vaccination in liver transplantation

Conditions: COVID-19

Summary: the goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mrna anti-sars-cov2 vaccination in a cohort of high risk liver transplanted patients. seroprevalence is a secondary objective in order to identify seronegative patients with a history of covid-19 (ie who lost antibodies) and seropositive patients with no history of covid-19. the hypothesis is that the degree of immunosuppression is determinant on the seroconversion rate and therefore, although at higher risk of severe forms of covid-19, liver transplanted patients have a lower chance of being protected after vaccination. seroconversion rate in previously seronegative and with no history of covid-19 liver transplanted patients is the main evaluation criteria. the factors associated with the absence of seroconversion will be identified as a potential tool to better adapt the vaccination strategy in this population. the rate of seroconversion after the 1st dose will also be evaluated. safety of the 1st and 2nd injection will be reported as well as their value to predict seroconversion. a control group of patients listed for transplantation will also be included both in the seroprevalence and the seroconversion analysis. persistance of the antibodies in long-term after transplantation and after transplantation for the patients who have been vaccinated before transplantation will also be reported.


Eligibility criteria:
inclusion criteria: * liver transplanted patients for \> 6 months after transplantation * listed cirrhotic patients * age \>18 years-old * consent for vaccination with mrna vaccine exclusion criteria: * vaccination with non mrna anti-sars-cov-2 vaccine * expressed opposition to participation to the study

Keywords: covid-19 sars-cov-2 coronavirus vaccine covid-19 pandemic covid-19 virus disease sars-cov-2 infection solid organ transplant mrna vaccine moderna liver transplant serological testing serological response sars-cov-2 mrna vaccine anti-sars-cov-2 igg antibodies
activity at pulse pressure above an individual threshold in patients with lvad

Conditions: Heart Failure

Summary: pilot study in patients with continuous flow left ventricular assist device (cflvad) to proof the feasibility of a specific individual training at home aimed to increase pulse pressure above a predefined threshold which might attenuate the loss of arterial wall thickness. hypothesis: increasing daily physical activity near to normal (\> 10.000 steps per day) with a pre-defined level of pulse pressure (intensity) is a realizable and feasible approach to investigate changes in arterial wall thickness and cardio-respiratory capacity in cflvad patients.

the investigators will study 3 cflvad patients with low pulse pressure during work package 1 using two different exercises, treadmill and bicycle. walking and cycling present the most commonly used physical activities which are applicable to most individuals on a daily basis. the investigators aim to demonstrate that individual changes of pulse pressure during these types of exercise can be assessed in cflvad patients. in a feasibility study (work package 2) the investigator will enroll 6 cflvad patients to perform home-based physical activity programs including walking a defined number of steps per day with a predefined speed and cycling with a predefined power \[watt\] on a bicycle ergometer. the performance of the patients will be monitored over seven days using a wearable activity device.

Eligibility criteria:
inclusion criteria: * age 45 to 65 * men * time since cflvad implantation \> 3 months and \< 6 months * low pulse pressure at rest, (no pulsatility) exclusion criteria: * musculoskeletal comorbidities restricting exercise * known diabetes mellitus type 1 and 2 * acute or chronic infections * coronary heart disease before cflvad implantation * no pulsatility with increasing exercise

Keywords: lvad
effects on dihydrotestosterone regulated gene expression in benign prostatic hyperplasia or prostate cancer

Conditions: Benign Prostatic Hyperplasia; Prostate Cancer

Summary: dutasteride is used in the treatment of benign prostate enlargement (bph).it inhibits conversion of testosterone (t) into the more potent dihydrotestosterone (dht) to stop prostate (and possibly prostate cancer) growth. dht regulates the expression of certain genes in the prostate. the pharmacodynamics of dht reduction in the prostate were never investigated until now, as every measurement would require prostate tissue retrieval, which is medically and ethically unacceptable. a recently developed test is able to quantitatively measure gene expression in prostate-borne cells, in urine sediments after prostate massage. by measuring this gene expression in patients using dutasteride, it has become possible to assess the pharmacodynamics of gene expression reduction, which is representative for the pharmacodynamics of dht reduction. repeated prostate tissue sampling has therefore become unnecessary. this newly gained knowledge will lead to a better understanding of the action of dutasteride and will possibly help improve treatment of symptomatic bph (benign prostatic hyperplasia) and prca (prostate cancer)in the future.

a randomized, open-label, parallel-group pilot study, to assess the pharmacodynamic effect on dihydrotestosterone regulated gene expression, longitudinally and in a dose dependent manner, of 0.5mg or 3.5mg dutasteride administered orally once daily, for three months in men with symptomatic benign prostatic hyperplasia or during the period between baseline and radical prostatectomy in men with biopsy-proven, clinically localized prostate cancer.

Eligibility criteria:
inclusion criteria: * symptomatic bph, or: biopsy proven, localised (ct1 or ct2) prostate cancer scheduled for radical operation * able to swallow oral medication exclusion criteria: * inability to void spontaneously (eg. dependence on catheter etc.) * history of (prior) prostate cancer previous prostatic surgery

Keywords: dutasteride bph prostate cancer gene expression psa
effectiveness of vitamin b12 versus kenalog on traumatic ulcer associated with orthodontic treatment

Conditions: Mouth Ulcer

Summary: the study is a randomized controlled trial. the participants will be equally divided into two groups to compare the clinical effectiveness of vitamin b12 versus kenalog in treatment of traumatic ulcers associated with orthodontic treatment during

recurrent aphthous stomatitis (ras), commonly called "canker sores," is a perplexing oral condition characterized by the recurrent development of painful aphthous ulcers on non-keratinized oral mucous membranes. recurrent aphthous stomatitis is a relatively common condition, affecting up to 25% of the worldwide population. certain factors predispose to ras, including local trauma, stress, smoking cessation, anemia, and hematinic deficiency. in the patient who undergoes orthodontic management, there is improvement in the dental and facial aesthetics and development of self-confidence. data also supports the prevalence of traumatic ulcers in the oral cavity and periodontal diseases. ulcerations can happen due to brackets, bands, arch wires and long unsupported stretches of wire resting against the lips. vitamin b12, also known as cobalamin, is a water-soluble vitamin primarily found in animal products; plays a vital role in the formation of hematopoietic stem cells and vitaminb12 deficiency may play a role in the pathogenesis of recurring aphthous (ras). triamcinolone (kenalog in orabase) treats and relieves discomfort caused by mouth sores. it works by decreasing inflammation in the mouth. it belongs to a group of medications called topical steroids.

Eligibility criteria:
inclusion criteria: * orthodontic adult patients older than 18 years. * ulcer due to trauma not more than 10 mm in size. exclusion criteria: * patients who had known systemic diseases. * concurrent with lesions in the mouth (bechet's disease, rheumatoid. arthritis, lupus, and acquired immune deficiency syndrome). * a patient who had received other concurrent treatment for aphthous ulcers. * patients with chronic diseases such as liver diseases, rheumatoid arthritis, diabetes, cancer, and renal diseases. * pregnant or nursing women. * patient who had a known vitamin b12 deficiency.
validity and reliability of the turkish version of the comprehensive coordination scale in parkinson's patients

Conditions: Parkinson Disease

Summary: the aim of this study is to investigate the turkish adaptation of the comprehensive coordination scale and its validity and reliability in parkinson's patients.

a turkish version of the comprehensive coordination scale will be made. then, comprehensive coordination scale, 9-hole peg test, timed up and go test, berg balance scale, functional reaching test and modified hoehn and yahr scale will be applied to patients with parkinson's, respectively. in order to determine the reliability of the scale, only the "comprehensive coordination scale" will be video recorded during the first evaluation and inter-rater reliability will be performed by another physiotherapist. for test-retest reliability, patients will be evaluated seven days later by the first physiotherapist who made the evaluation by watching the video again.

Eligibility criteria:
inclusion criteria: * diagnosed with parkinson's, * mini mental test score over 24, * those who have not experienced any serious neurological or orthopedic problems in the last 6 months, * i̇ndividuals who agreed to participate in the study exclusion criteria: * mini mental test score \<24,

Keywords: comprehensive coordination scale validity reliability
cross over convenience and preference study of new mark vii compared to genotropin pen in pediatric and adult subjects

Conditions: Growth Hormone Deficiency

Summary: convenience and preference for the new mark vii pen compared to the current genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 8 years. * subjects who are starting treatment with growth hormone (genotropin) for the first time. exclusion criteria: * subjects with prader-willi syndrome or chronic renal insufficiency. * subjects and caregivers who, in the opinion of the investigator are not able to adequately participate in the study. * subjects with chronic systemic disorders, such as diabetes and heart disease.

Keywords: growth hormone deficiency somatropin injection pen medical device cross over study preference convenience children dyads adults
subjective effects of nitrous oxide in dental patients - 17

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study was to characterize mood changes during nitrous oxide inhalation in patients with different levels of preoperative dental anxiety.


Eligibility criteria:
please contact site for information.

Keywords: nitrous oxide anxiety subjective effects dental patients
caregivers' knowledge of emergency department discharge instructions improves with the use of video

Conditions: Evaluation of Video Discharge Instructions in Improving Understanding

Summary: previous studies demonstrate that patients often have difficulty understanding their discharge instructions. video discharge instructions have the potential to mitigate factors such as illiteracy and limited physician time, which may affect comprehension. our goal is to determine if adding video discharge instructions affects caregivers' understanding of their child's emergency department (ed) visit, plan and follow-up.

caregivers of patients, age 29 days to 18 years, with a diagnosis of fever, vomiting or diarrhea, and wheezing or asthma were randomized into written or video discharge instruction groups. in the ed, caregivers read standard written discharge instructions or watched a 3-minute video based on their child's diagnosis. they were then asked questions regarding information covered in these instructions. after completing the 20-point questionnaire, standard discharge procedure was followed. caregivers were contacted by phone 2-5 days after discharge for a follow-up questionnaire. usefulness of the discharge instructions was also assessed.

Eligibility criteria:
inclusion criteria: * caregivers of pediatric patients age 29 days to 18 years old diagnosed with wheezing or asthma exacerbation, fever, or vomiting and/or diarrhea. exclusion criteria: * caregivers of patients who were critical in the ed, * admitted to the hospital, or given an alternate diagnosis prior to discharge were excluded from the study. * also, non-english speaking caregivers were excluded.

Keywords: discharge instructions video discharge instructions video emergency department discharge instructions ed discharge