Kornimate/medical-research-clean huggingface dataset:
sulpiride versus placebo for reducting hot flushes during climacteric

Conditions: Menopausal Syndrome; Hot Flashes

Summary: * introduction: estrogen hormonal therapy associated or not with progestagen is the standard therapy for the treatment of hot flushes. however some women are not candidates for hormone replacement therapy for medical reasons or for choice. * main goal: reducing the number of hot flushes per week * materials and methods: a double-blind sulpiride versus placebo that includes selected randomized patients which show symptoms of menopause. the study will be conducted at hc porto alegre (brazil) for 8 weeks of intervention. the expected result is a significant reduction in the number of hot flushes/day evaluated by daily questionnaires

it will be held 4 visits. the v0 (first one) to implement the consent form, review the inclusion and exclusion criteria and laboratory exams and deliver the diary book of hot flushes. the v1 (second visit) randomization and provide medication for the first 30 days. the v2 (third visit) to make the record diary of hot flushes already filled, to deliver new specifications and to provide medication for the last 30 days. the v3 (fourth visit) to evaluate the record diary of hot flushes already completed and to make a final evaluation of the study.

Eligibility criteria:
inclusion criteria: * healthy women in postmenopausal women with at least five moderate to intense hot flushes per day exclusion criteria: * use of hormone replacement therapy or psychiatric drugs for at least 3 months * hypersensitivity to sulpiride * current or history of prolactin dependent tumor * treating breast cancer or treated * diagnosed or suspected pheochromocytoma * current use of levodopa * abnormal heart rhythm (qt prolongation, bradycardia low 55 beats per minute) * hypokalemia and other serious electrolyte disturbances * current or treated stroke * pregnancy or breastfeeding

Keywords: menopause nonhormonal treatment sulpiride
effect of virtual reality on functional fitness and quality of life of older population

Conditions: Aging; Happiness; Quality of Life

Summary: the purpose of this study is to assess the influence of virtual reality (vr) on the different parameters, happiness, quality of life and functional fitness, among older population. the study aims to conduct a randomized controlled trial, where the participants in intervention group will use vr and those in control group do not use vr.

this study aims to conduct a randomized control trial, on 60 older age group participants, and perform the functional fitness test based on the protocol developed by rikli and jones, before and after the vr intervention. the functional fitness tests include evaluation of upper body strength, lower body strength, cardiorespiratory endurance, upper body flexibility test, lower body flexibility test, balance, agility test. they will be randomly assigned to the intervention group, receiving the vr program, and the control group who will not receive the vr program. the participants in the intervention group will be asked to use the vr device for 15 minutes, twice a week for 6 weeks, along with their daily routine activities. control group will carry out the daily routine activities, without the intervention. the change in the quality of life (qol) and happiness, for both control and intervention groups, will be assessed through euroqol 5 dimensions 3 level questionnaire (eq-5d-3l), mini version of chinese happiness inventory questionnaire, respectively, to filled at recruitment and follow-up after 6 weeks. the effect of the vr programs will be determined by the comparison of performance, for the functional fitness tests before and after the intervention and also, for the differences between the control and intervention groups

Eligibility criteria:
inclusion criteria: * participants aged 60 years or older and approach tmu aging center. * able to understand mandarin chinese. * gives informed consent to participate * no past or current history of serious medical disease * ability to perform activities of daily living * understands the intent of the study exclusion criteria: * participants aged below 60 years of age. * not able to understand mandarin chinese. * does not gives informed consent to participate * past or current history of serious medical disease * inability to perform activities of daily living * does not understand the intent of the study

Keywords: virtual reality older population functional fitness quality of life happiness
response of korean medicine hospital to covid-19

Conditions: Covid19

Summary: the objectives of this study are to report the response strategy to prevent covid-19 spread implemented at a korean medicine hospital, and the satisfaction survey results regarding its preventive measures.

the objectives of this study are (1) to report the response strategy to prevent covid-19 spread implemented at a korean medicine hospital situated in seoul, korea, (2) to describe patient visit trends compared to the number of confirmed covid-19 cases during the covid-19 peak in february - april 2020, and (3) to provide results of a satisfaction survey regarding its preventive measures.

Eligibility criteria:
inclusion criteria: * inpatients hospitalized at jaseng hospital of korean medicine during march 23-25, 2020 * outpatients visiting jaseng hospital of korean medicine during march 23-25, 2020 exclusion criteria: * visitors visiting jaseng hospital of korean medicine during march 23-25, 2020 for purposes other than treatment
pilot study of atorvastatin and anakinra in children with coronary artery abnormalities secondary to kawasaki disease

Conditions: Kawasaki Disease

Summary: kawasaki disease (kd) is the leading cause of acquired heart disease in children in the developed world. despite available treatment, 25% of children in san diego county appropriately treated for kd develop coronary artery abnormalities that could lead to complications later in life, including heart attack. although we can identify children with kd that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. anakinra, a therapy that blocks the high levels of interleukin 1 (il1) that leads to inflammation during acute kd, has been shown in the kd mouse model to prevent the development of coronary artery damage. both of these therapies have been demonstrated to be safe and well-tolerated in kd patients. therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute kd and early coronary artery abnormalities.


Eligibility criteria:
inclusion criteria: * acute kawasaki disease with a z score of 3 or larger of the lad or rca exclusion criteria: * taking a cyp3a4 metabolized drug (such as cyclosporine)
renal sympathetic modification in patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using thermocool® catheter in patients with metabolic syndrome, and evaluate safety and efficacy of the intervention.

metabolic syndrome is combination risk factors of serial cardiovascular and metabolic disease, included central obesity, insulin resistance, dyslipidemia, and hypertension. basic studies suggested that sympathetic nerves over activity played an important role in the development and perpetuation of metabolic syndrome. clinical therapies occurred by complication treatment and therapeutic life-style changes. present study of renal ablation for sympathetic modification shows a new method to decrease sympathetic nerves activity. we assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of metabolic syndrome. this trial is going to recruit 200 patients (ablation group vs control group = 1:1) with a follow-up duration of 3 years. patients in ablation group will receive additional necessary medications besides expectant intervention, and patients in control group will receive appropriate medications only. we aim to observe the incident of composite cardiovascular events after renal sympathetic modification using thermocool® catheter in patients with hypertension, and evaluate safety and efficacy of the intervention.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old, and ≤ 75 years old of age * abnormal metabolism: 1) body mass index (bmi) of ≥ 25 kg/m2; 2) total triglyceride (tg) of ≥ 1.70mmol/l (150mg/dl); 3) high density lipoprotein- cholesterol (hdl-c) of male \<0.91mmol/l (35mg/dl), and of female \<1.01mmol/l (39mg/dl); 4)fasting blood glucose 6.1mmol/l (110mg/dl), or glucose tolerance test of 2 hours ≥ 7.8 mmol/l (140mg/dl); 5), or history of diabetes mellitus * estimated glomerular filtration rate (egfr) of ≥ 45ml/min * is competent and willing to provide written, informed consent to participate in this clinical study exclusion criteria: * secondary hypertension * type 1 diabetes mellitus * estimated glomerular filtration rate (egfr) of \< 45ml/min * has the history of renal restenosis or renal stents implantation * has experienced ami (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months * patients with sick sinus syndrome * pregnant women * mental disorders * patients that have allergy to contrast agent * patients that do not go with follow-up * others such as researcher considers it is not appropriate to be included into the study

Keywords: renal artery sympathetic nerves modification metabolic syndrome
the effect of cholecalciferol in pre-frail elderly

Conditions: Pre-frail Elderly

Summary: vitamin d plays important role in musculoskeletal health and has been known to influence immune system. inflammaging is one of risk factors that may contribute to development of frailty in elderly. the purpose of this study is to determine the effects of cholecalciferol in pre-frail elderly receiving calcium supplementation on handgrip strength, gait speed, vitamin d receptor, igf-1 and il-6. fall incidence and improvement of frailty status will also be assessed.

this is a randomized double-blind placebo-controlled study in pre-frail elderly. measurement of frailty status based on fried frailty phenotype criteria (weight loss, weakness, exhaustion, slowness, low physical activity level) . subjects who fulfill eligibility criteria will be randomized into 2 groups, one group will received cholecalciferol 4000 iu once daily and the other group will received placebo once daily. each subjects in both groups will received calcium lactate 500 mg once daily. intervention will be held for 12 weeks. handgrip strength and gait speed will be assessed at baseline, every 4 weeks, and at week 12. other outcome measures will be assessed at baseline and at week 12.

Eligibility criteria:
inclusion criteria: 1. pre-frail elderly 2. capable to understand and carry-out the instruction exclusion criteria: 1. allergic to cholecalciferol, calcium, or its components 2. hypercalcemia (total serum calcium \> 10,5 mg/dl) 3. unwilling to stop using drug contain vitamin d or vitamin d analog or calcium 4. using steroid or nsaid routinely 5. acute illness during inclusion period, eg. pneumonia, stroke attack, acute exacerbation of chronic obstructive pulmonary disease, asthma attack, hypertensive urgency/emergency, acute decompensated heart failure 6. having condition that can affect measurement of handgrip strength and gait speed, eg. hemiparesis, severe pain in extremities 7. hepatic cirrhosis, malignancy, autoimmune disease, nephrolithiasis, malabsorption syndrome (eg. chronic diarrhea) , diabetes mellitus with hba1c \> = 8% in the last 3 months, diabetes mellitus with obvious sign and symptoms of catabolic decompensation (polyphagia, polydipsia, polyuria), chronic kidney disease stage iv-v or decreased renal function with estimated glomerular filtration rate \< 30 ml/minute/1,73 m2 8. using drug that can affect vitamin d absorption, eg. bile acid sequestrants 9. cognitive impairment (abbreviated mental test score \< 8) 10. depression (geriatric depression scale score \> = 10) 11. unwilling to join the study

Keywords: frailty pre-frail elderly cholecalciferol handgrip strength gait speed vitamin d receptor insulin growth factor-1 interleukin-6
study evaluating sirolimus in kidney transplant recipients.

Conditions: Kidney Failure; Graft vs Host Disease

Summary: renal function at 12 months assessed by calculated creatinine clearance.


Eligibility criteria:
inclusion criteria: * age is older than 18 years. * end-stage renal disease, with subjects scheduled for kidney transplant. * women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment. other inclusion applies. exclusion criteria: * evidence of active systemic or localized major infection. * use of any investigational drug or treatment up to 4 weeks prior to study entry. * known hypersensitivity to srl or its derivatives, macrolide antibiotics, corticosteroids, basiliximab. * multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant). * immunosuppression therapies other than those allowed in the protocol. * treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (all known to interact with srl) that is not discontinued prior to study entry. other exclusion applies.

Keywords: kidney transplant
the neurological pupil index (npi) on intensive care unit (icu) trial

Conditions: Hypoxic Encephalopathy

Summary: the trial will evaluate the use of the "neurological pupil index" npi, measured with the digital pupillometer (neuroptics) compared to clinical examination for better reliability. the investigators hypothesize that digital evaluation will offer a higher sensitivity/ specificity compared to clinical examination.

absent pupillary reaction after cardiac arrest might indicate a severe hypoxic encephalopathy. because the examination of the pupillary reaction is easy it is part of the clinical routine but due to the different medication and the dynamic process of reperfusion injury to the brain a clinical evaluation might be not precise enough. the npi has been shown to be superior to clinical evaluation in different settings but without regard towards cardiac arrest survivors. the pupillometer is a hand-held, cordless, and simple to use device which removes subjectivity in the measurement of pupil size and the pupillary light reflex.

Eligibility criteria:
inclusion criteria: * all survivors after cardiac arrest exclusion criteria: * underlying disease limiting the pupillary reflex

Keywords: hypoxic encephalopathy cardiac arrest outcome pupillary reflex
study of ins37217 inhalation solution in mild to moderate cystic fibrosis lung disease

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to assess the safety and effectiveness of multiple dosages of ins37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (cf) lung disease. study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).

the purpose of this study is to: * assess the safety and efficacy of multiple dose levels of ins37217 compared to placebo over 28 days in subjects with mild to moderate cf lung disease; * explore evidence of activity of ins37217 and placebo administered via pari lc star nebulizer; * identify dose(s) that will be studied in subsequent trials.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * fev1 greater than or equal to 75% of predicted normal for age, gender, and height * oxyhemoglobin saturation greater than or equal to 90% * clinically stable exclusion criteria: * abnormal renal or liver function * clinically significant findings atypical for moderate cystic fibrosis

Keywords: cystic fibrosis
evaluation of psma-pet and mpmri in high-risk prostate cancer - using histopathologic validation

Conditions: Prostate Cancer

Summary: in this trial the connection between image properties (mpmri and psma-pet) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.

open, non-randomized, prospective multi-center trial, with consecutive recruiting, between skåne university hospital and umeå university hospital. high-risk prostate cancer patients referred for radical prostatectomy.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed prostate cancer planned to be treated with radical prostatectomy 2. psma-pet/ct conducted as part of the clinical management for the existing prostate cancer. 3. ≥4 weeks since last biopsy of the prostate 4. one or more of the following criteria 1. ct3, or high suspicion of extra prostatic growth on mpmri 2. gleason score ≥8 3. psa 20-49 ng/ml 5. \>18 years 6. given a written consent to participate in the trial exclusion criteria: 1. non-mr-safe implants or another contraindication to mri or pet 2. claustrophobia 3. unfit for mri or pet/mri examination for any other reason, e.g., back pain 4. who ps \>1 5. patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens) 6. tur-p within 6 months 7. metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis. 8. patients with previous diagnosis of other malignant disease. exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour. 9. creatinine clearance \< 30ml/min (acc. to http://www.fass.se/lif/produktfakta-/kreatinin.jsp) 10. tinnitus or severe hearing loss
an evaluation of dupilumab in patients with moderate to severe uncontrolled asthma

Conditions: Asthma

Summary: primary objective: to evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma. secondary objective: to evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to: * safety and tolerability * dupilumab systemic exposure and anti-drug antibodies

total duration per participant of approximately 43 weeks including a screening period (14-21 days), a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).

Eligibility criteria:
inclusion criteria: participants with a physician diagnosis of moderate to severe, uncontrolled asthma for \>=12 months, based on the global initiative for asthma (gina) 2009 guidelines and: * existing treatment with moderate or high-dose inhaled corticosteroid / long-acting beta-2 agonist * forced expiratory volume (fev1) 40 to 80% of predicted normal * asthma control questionnaire, 5-question version (acq-5) score \>=1.5 * reversibility of at least 12% and 200 ml in forced expiratory volume (fev1) * had experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma exclusion criteria: * participants \<18 years * chronic obstructive pulmonary disease (copd) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, churg-strauss syndrome, allergic bronchopulmonary aspergillosis) which impaired pulmonary function tests * chest x-ray within 12 months of screening visit or at screening visit with clinically significant findings of lung disease(s) other than asthma * current smoker or cessation of smoking within 6 months prior to visit 1 * previous smoker with a smoking history \>10 pack-years the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
combination of intravitreal ranibizumab with or without micropulse laser for the treatment of dme

Conditions: Diabetic Macular Edema

Summary: the objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.

to investigate the efficacy of intravitreal ranibizumab injections compared to combination with micropulse laser in chinese patients with visual impairment in dme. the result of the study will be used to support new therapy in dme patients in china.

Eligibility criteria:
inclusion criteria: * informed consent form must be signed before any tests or procedures are done * male or female of 30 to 80 years of age (inclusive) at the first screening visit * diagnosis of type 2 diabetes, with fasting blood glucose≤10mmol/l, hba1c≤10.0% * diabetic medication must be stable for at least 3 months before first screening visit and remain stable during study * diagnosis of non-proliferative diabetic retinopathy with diabetic macular edema resulting in visual acuity reduction * study eye's bcva between 24 to 78 etdrs letters at screening and baseline of the study * macular edema of the study eye and central retinal thickness ≥300 µm determined by sd-oct * study eye had not had grid pattern photocoagulation, intraocular surgery, intravitreal corticosteroid injections and intravitreal anti-vegf injections for at least 3 months before baseline * non-study eye's bcva ≥ 24 etdrs letters at screening and baseline of the study * non-study eye had not had intravitreal anti-vegf injections for at least 3 months before baseline * if both eyes qualify, then investigators will choose an eye with worse bcva as study eye. only study eye will receive intravitreal ranibizumab and/or micropulse laser treatment exclusion criteria: * failure to follow study or follow-up procedures * pregnant or breast-feeding woman and woman without adequate method of contraception * history of stroke or myocardial infarction within 3 months before screening * renal failure or creatinine \> 2.0 mg/dl * uncontrolled systemic diseases or systemic treatment that may affect results of the study * active ocular or intraocular infections of either eye * neovascularization of the iris or neovascular glaucoma of either eye * a history of uveitis or vitreous macular traction in study eye * glaucoma or iop≥24 mmhg of study eye