Kornimate/medical-research-clean huggingface dataset:
azilect® (rasagiline) in levodopa-treated parkinson's patients with motor fluctuations in china

Conditions: Parkinson's Disease

Summary: the rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated parkinson's disease (pd) chinese patients with motor fluctuations. azilect® (rasagiline) is indicated for the treatment of idiopathic pd as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.


Eligibility criteria:
inclusion criteria: * patients with idiopathic pd. * patients with motor fluctuations averaging at least 1 hour daily in the "off" state during the waking hours. * patients with a modified hoehn and yahr stage ≤3 in the "on" state. * patients taking optimised levodopa or dopa decarboxylase inhibitor (ddi) therapy; they must be stable for at least 14 days prior to baseline. * patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses of levodopa. * patients who have demonstrated the ability to keep accurate "24-hour" diaries prior to randomisation. exclusion criteria: * patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation. * patients with a clinically significant or unstable vascular disease. * patients who have undergone a neurosurgical intervention of pd. * patients with severe disabling dyskinesias. * patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study. * patients with a mini mental state examination (mmse) score ≤24. * patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion. other inclusion and exclusion criteria may apply.

Keywords: rasagiline azilect parkinson´s disease motor fluctuations
comparing pain relief between exparel® injection vs. on-q catheter as the postsurgical analgesia following total knee arthroplasty (tka)

Conditions: Osteoarthritis: Joint Replacement Surgery

Summary: the goal of this research project is to evaluate the effectiveness of a novel treatment to control pain after total knee arthroplasty (tka). the proposed approach to manage pain and eliminate risks associated with catheters is the use of exparel injection into the joint at the time of surgery.


Eligibility criteria:
inclusion criteria: 1. adults scheduled to undergo primary total knee replacement 2. willing and able to provide informed consent
renal denervation in patients with heart failure with normal lv ejection fraction

Conditions: Heart Failure, Diastolic; Hypertension

Summary: it is a randomized prospective controlled study of transcatheter renal denervation in patients with heart failure with normal lv ejection fraction. the purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with heart failure with normal lv ejection fraction, due to reduction in renal and systemic sympathetic activity.


Eligibility criteria:
inclusion criteria: * hypertension treated with at least 2 antihypertensive drugs; * heart failure with a normal lv ejection fraction; * left ventricular hypertrophy (lv mass index \> 96 g/m2 in women and \> 116 g/m2 in men); * ≥ 18 years of age; exclusion criteria: * known secondary cause of hypertension * uncontrolled blood pressure (≥ 180x110mmhg) * unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent * advanced renal insufficiency (estimated glomerular filtration rate (gfr) \< 30 ml/min/1.73 square meters) * diabetes mellitus type 1 * acute coronary syndrome or a cerebrovascular accident in the last 6 months * known other cause of respiratory dysfunction * previous lv systolic dysfunction (lvef \< 50%) * restrictive cardiomyopathy or hypertrophic cardiomyopathy * significant valvar dysfunction * atrial flutter or atrial fibrillation * use of the oral anticoagulants * drug and alcohol dependence

Keywords: heart failure heart failure, diastolic hypertension renal denervation irrigated radiofrequency catheter
multi-site evaluation of an evidence-based positive youth development program

Conditions: Unintended Pregnancy; Adolescent Problem Behavior

Summary: investigators are carrying out a study to assess the immediate and long-term effects of a positive youth development program (the teen outreach program) on high school youth in florida. this study will answer the following questions: what is the impact of the teen outreach program on sexual activity and positive youth development at the end of the program and 10 months after the program?

schools were randomly allocated to either the intervention or the control group. at treatment (intervention) schools, youth participated in top in addition to their health, hope, critical thinking, career research, or leadership class. at control (non-intervention) schools, youth simply participated in their business-as-usual health, hope, critical thinking, career research, or leadership class. two cohorts of students were recruited for this study, the first cohort joined the study in august 2012 and the second cohort joined the study in august 2013. a survey was given to youth at both treatment and control schools. the paper-and-pencil survey took approximately 30 minutes and asked questions about youth school, grades, peers, health behaviors, and behaviors related to teen pregnancy, including what the participant believes and does in regards to sexual health. the survey was completely confidential and participant names were not linked to survey responses. all survey materials were pre-approved by school administration and the school district office. participants will be asked to complete the a survey at pre-intervention, post-intervention, and 10-months post-intervention (cohort 1 only)

Eligibility criteria:
inclusion criteria: * enrolled in a class selected for evaluation * had parental consent * proficient in english * capable of independently taking a paper and pencil survey exclusion criteria: * not enrolled in a class randomly selected for the evaluation * they joined a participating class after the completion of the parental consent process * not sufficiently proficient in english * could not independently take a paper and pencil survey

Keywords: positive youth development teen outreach teen pregnancy prevention
the effect of duodenal, ileal or combined infusion of tastants on food intake

Conditions: Obesity

Summary: rationale: the appearance of tastants in the small intestine can result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. these processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. the effects of intraduodenal and/or intraileal infusion of a combination of tastants (sweet (rebaudioside a), bitter (quinine) en umami (monosodium glutamate(msg))) and placebo on ad libitum food intake, satiation and gastrointestinal symptoms will be investigated. objective: to investigate the effect of intraduodenal, intraileal and combined infusion of a combination of tastants versus infusion of placebo on food intake. secondary objectives: 1. to compare the effect of intraduodenal versus intraileal versus combined intraduodenal and intraileal delivery of a combination of tastants on satiation. 2. to assess the effect of intraduodenal and/or intraileal delivery of a combination of tastants on gastrointestinal symptoms/complaints.


Eligibility criteria:
inclusion criteria: * based on medical history and previous examination, no gastrointestinal complaints can be defined. * age between 18 and 65 years. this study will include healthy adult subjects (male and female). women must be taking contraceptives. * bmi between 18 and 25 kg/m2) * weight stable over at least the last 6 months exclusion criteria: * history of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, heent (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. the severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator. * use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing * administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study * major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator) * dieting (medically prescribed, vegetarian, diabetic, microbiological, biological dynamic) * pregnancy, lactation * excessive alcohol consumption (\>20 alcoholic consumptions per week) * smoking * weight \<60kg * non-tasters of sweet, bitter or umami * evidence of msg-hypersensitivity or chinese restaurant syndrome
alfaurus : a db randomized parallel group study of alfuzosin 10mg od vs placebo in the management of aur in patients with a 1st episode due to bph

Conditions: Prostatic Hyperplasia; Acute Urinary Retention

Summary: to assess the efficacy of alfuzosin 10mg od in the management of acute urinary retention associated with bph. to assess the safety of alfuzosin in this population and health care consumption.

double-blind, placebo controlled, randomized multicenter, phase iii study comparing 2 parallel groups (alfuzosin 10mg od or placebo) in patients with a first episode of acute urinary retention related to bph.the acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal. those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. for all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Eligibility criteria:
inclusion criteria: * male aged over 50 years * having given his written consent * presenting with a first episode of painful acute urinary retention related to bph * with a catheterized urine volume between ml and ml at the time of retention exclusion criteria: * associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin * iatrogenic causes of urinary retention

Keywords: acute urinary retention international prostate symptom score (ipss)
tissue sodium in patients with psoriasis

Conditions: Psoriasis Vulgaris; Healthy

Summary: sodium can be buffered in the skin, which mechanism is altered during aging and in certain diseases such as hypertension. high salt environment can promote autoimmunity by expanding pathogenic il-17 producing t helper (th17) cells. psoriasis is a relapsing and remitting inflammatory autoimmune disease affecting the skin and joints and involves proinflammatory th17 cells. here we tested the hypothesis if psoriatic skin has a higher sodium content in humans.

the cytokine interleukin-17a (il-17a) is a crucial player in the pathogenesis of the autoimmune disease of psoriasis. this neutrophil recruiting cytokine is produced by il-17a producing cd4+ t cells (th17) and gamma/delta t cells of the skin and evokes an inflammation circuit finally leading to the classical clinical picture of psoriasis with hyper- and parakeratosis, erythema, scaling and neutrophil abscess formation. besides genetic factors, lifestyle factors are relevant and decide if an autoimmune disease becomes manifest. it was shown previously that increased salt (sodium chloride, nacl) concentrations boost the induction of murine and human th17 cells. however, more - and also clinical - studies are needed to understand the correlation between salt content and il-17a in autoimmune diseases. this study investigates the hypothesis if skin sodium content in human psoriasis is increased in order to get further insight into the il-17a-salt-interplay.

Eligibility criteria:
inclusion criteria: * age: 18-80 * body mass index (bmi) 18.5- 40 kg/m2 * glomerular filtration rate \>60 ml/min/1.73m2 exclusion criteria: * diagnosed or treated hypertension and/or blood pressure above 140/90 at screening * palpable peripheral oedema during phyisical examination at screening * any type of diabetes mellitus and/or hgba1c\>6.5% at screening * subjects with a thyroid-stimulating hormone \>4.2 mu/l at screening * psoriasis patients treated with systemic corticosteroids, chemotherapy agent (methothrexate) or with any kind of biologics/biosimilars * subjects with acute disease * pregnant or lactating women * metal or medical device implant in the body * tattoo on the lower extremities * subjects with a history of drug or alcohol abuse * subjects who are legal incapacitated or their circumstances do not enable the patient to fully understand the nature, significance and scope of this study.

Keywords: psoriasis sodium skin
the effect of bariatric surgery on thyroid function and morphology

Conditions: Thyroid Function; Obesity

Summary: the aim is to evaluate the effect of dramatic weight loss after bariatric surgery on thyroid function (thyroid hormone levels and particulary morphological changes) in the short and long-term setting of a cross-sectional study. a particular focus will be made with regard to putting into correlation preoperative thyroid function abnormalities and postoperative changes over time with respect to the type of bariatric intervention carried out.

background: over the last decades, there has been an increase in obesity in virtually all population groups with approximately 1.6 billion adults worldwide estimated to be overweight in 2005 and 400 million of these people qualifying as being obese. although hormonal disturbances may play a certain role in the development of obesity, more important are the possible consequences of obesity and the influence of surgically-induced rapid weight loss on overall endocrine function of these patients. studies evaluating the effect of weight loss on thyroid function show inconsistent results. whilst some authors have shown that weight loss after bariatric surgery may have a positive effect on thyroid dysfunction, especially in individuals with preoperative subclinical hypothyroidism 1 resulting in normalisation of tsh levels, others fail to show any significant postoperative changes. objective: to evaluate the effect of dramatic weight loss after bariatric surgery on thyroid function (thyroid hormone levels and particularly morphological changes) in the short and long-term in the setting of a cross-sectional study. a particular focus will be made with regard to putting into correlation preoperative thyroid function abnormalities and postoperative changes over time with respect to the type of bariatric intervention carried out. methods: bmi, thyroid hormones (tsh, ft3, ft4 levels), need for thyroxin substitution (or equivalent medication) as well as pre- and postoperative morphological changes in the thyroid gland (usually via sonography)and leptin values will be assessed retrospectively.

Eligibility criteria:
inclusion criteria: * patients who underwent bariatric surgery between 1998 and 2007 exclusion criteria * age \>18 years

Keywords: thyroid gland bariatric surgery weight loss thyroid hormones adult morbid obesity cohort
the effect of intracapsular injection of terlipressin versus carbitocin on hemoglobin and blood loss during laparoscopic myomectomy operations

Conditions: Myoma

Summary: our study aims to evaluate the efficacy of intracapsular injection of terlipressin versus carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic myomectomy. moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. this clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

this study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at wael elbanna clinic and the nrc site. the study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. data will be pooled and presented in aggregate, without the identification of individual subjects. the study materials that will be used will include blood tests and ultrasound. the study will involve three study arms: * arm 1: intramyometrial injection of terlipressin in women undergoing laparoscopic myomectomy procedure * arm 2: intramyometrial injection of carbetocin in women undergoing laparoscopic myomectomy procedure * arm 3: intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation.

Eligibility criteria:
inclusion criteria 1. women aged 16-45 years 2. appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm) 3. baseline hemoglobin ≥9 g/dl 4. no contra-indications to the use of glyopressin or carbitocin 5. myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility 6. not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks) exclusion criteria: 1. previous myomectomy 2. history of bleeding disorders 3. concurrent anticoagulation therapy 4. history of uncontrolled ischaemic heart disease 5. any pelvic abnormalities requiring concomitant surgery 6. treatment with a gnrh agonist or ulipristal acetate within three months preceding surgery 7. inability to understand and provide written informed consent
characteristic and survival outcomes in hepatocellular carcinoma patients: on top of viral hepatitis versus combined viral and metabolic-associated steatotic liver disease

Conditions: Hepatocellular Carcinoma (HCC)

Summary: hepatocellular carcinoma (hcc) is one of the most prevalent cancers globally and ranks as the third leading cause of cancer-related deaths . it primarily arises in patients with chronic liver disease and liver cirrhosis, which can result from various etiologies, including viral hepatitis and metabolic disorders. viral hepatitis, especially hepatitis b virus (hbv) and hepatitis c virus (hcv), is well-established as a major risk factor for hcc. chronic hbv infection is associated with a higher risk of hcc, particularly in areas with high endemicity . similarly, hcv is linked to significant liver-related morbidity and mortality, with hcc being a leading complication . in recent years, the increasing prevalence of metabolic-associated steatotic liver disease (masld) has emerged as a significant contributor to liver disease and hcc, particularly in the context of the obesity epidemic. masld is characterized by fatty liver disease associated with metabolic risk factors such as obesity, insulin resistance, and type 2 diabetes . the combination of chronic viral hepatitis and masld may exacerbate liver damage and contribute to the development of hcc, although the specific mechanisms remain to be fully elucidated despite the known associations between these risk factors and hcc, there remains a shortage of comprehensive studies comparing the clinical characteristics and survival outcomes of patients with hcc due to viral hepatitis alone versus those with combined viral and masld. understanding these differences is crucial for optimizing surveillance, treatment strategies, and prognostic assessment for patients at risk of hcc. the aim of the study compare the clinical characteristics of hcc patients with viral hepatitis versus those with combined viral and masld. - analyze survival outcomes in both groups and correlate these outcomes with patients' characteristics.


Eligibility criteria:
inclusion criteria: * adults (≥18 years old) diagnosed with hcc based on radiological, histological (if needed), or biomarker criteria (e.g., elevated afp). . documented history of: * chronic hepatitis b virus (hbv) infection or hepatitis c virus (hcv) infection. * masld defined as hepatic steatosis (≥5%) confirmed by fibroscan or abdominal ultrasound along with at least one metabolic risk factor (e.g., obesity, type 2 diabetes, hypertension). ability to provide informed consent exclusion criteria: * . other causes of chronic liver disease (e.g., autoimmune hepatitis, hemochromatosis, wilson's disease). * patients with incomplete clinical or diagnostic data. * presence of other malignancies. * patients refuse to participate
study to evaluate the efficacy and safety of 90y-smt487 in subjects with symptomatic malignant carcinoid tumors

Conditions: Malignant Carcinoid Tumor

Summary: subjects will be screened to determine octreoscan® uptake. and upon meeting the eligibility criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the study at specific time points. actual treatment will consist of three six-week cycles of a fixed total dose of 13.3 gbq (360 mci) of 90y-smt487. the total dose will be divided into three equal doses and administered as a single activity of 4.4 gbq (120 mci) of 90y-smt487 once every six weeks for three cycles. an amino acid infusion will be administered along with each dose. long-term follow up will occur at 6 and 12 months after day 1/ cycle 1. survival will be assessed every six months.


Eligibility criteria:
inclusion criteria: 1. life expectancy \> 6 months. 2. subjects must have distant metastases. 3. subjects must be able to discontinue sandostatin lar treatment for at least 1 month prior to day 1/cycle 1; last dose of sandostatin lar must be 60 days or more prior to the first octreother™ dose. for subcutaneous sandostatin discontinuation should be 12 hours. subjects taking other long acting somatostatin analogues must discontinue the analogue at least 2 times the dosing interval. 4. upon baseline disease assessment, all subjects must have at least 1 measurable site of disease that either has never been irradiated or if the measurable lesion has been previously irradiated; this same lesion has since demonstrated progression base don the swog response criteria. 5. subjects must state or agree with the statement that "i have symptoms from my cancer that bother me." subjects must have failed to gain complete symptom control despite an optimal attempt at somatostatin therapy in the judgement of their physician. exclusion criteria: 1. chemotherapy, biologic therapy or other investigational therapy within 4 weeks of day 1. 2. surgery, hormonal therapy (not including somatostatin analogues) or radiation, within 2 weeks of day 1. 3. subjects with know brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start. 4. subjects who received high dose octreoscan therapy or other radiolabelled somatostatin therapy or other systemic radiolabelled therapy (e.g. mibg) for treatment of metastatic carcinoid.

Keywords: malignant carcinoid tumors