Kornimate/medical-research-clean huggingface dataset:
migraine prophylaxis with clopidogrel trial

Conditions: Migraine

Summary: the underlying mechanisms of association between the right-to-left shunts (rls) and migraine may concern with platelet aggregation and paradoxical embolization. the aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with rls.

many studies have shown an increased prevalence of right-to-left shunts in migraineurs. the underlying mechanisms of association between the right-to-left shunts (rls) and migraine may concern with platelet aggregation and paradoxical embolization. in the present study, migraineurs without taking prophylactic medicines regularly will be given only clopidogrel 75 mg daily for three months. migraineurs who are unresponsive to at least two commonly applied preventive medications, clopidogrel 75 mg daily will be added to his/her existing prophylactic migraine regimen for three months. patients will be followed up at the third month and the sixth month for headache frequency, attack duration of headache, migraine disability assessment scale（midas）scores, headache impact test（hit-6）scores and visual analogue scale（vas）scores. investigators will evaluate the changes of these measurements between baseline and the follow-up time. the aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with rls.

Eligibility criteria:
inclusion criteria: * migraine with or without aura diagnosed by a neurologist according to the criteria of the international headache society (3nd edition) * experience a minimum of two migraine attacks per month in a 3-month baseline phase * without regular use of prophylactic treatments or unresponsive to two and more commonly applied preventive medications * the presence of rls confirmed by contrast-enhanced transcranial doppler * no positive findings in cranial ct and mri exclusion criteria: * other types of headaches * systemic chronic diseases, cerebrovascular disease, abnormal platelet or liver function * history of head injury * other contraindications to clopidogrel treatment
topical mebo versus lidocane in healing time of traumatic oral ulcer

Conditions: Mebo; Lidocaine; Healing; Traumatic Oral Ulceration

Summary: this study aims to assess topical mebo application on pain relief and wound healing.

one of the conditions that affect the mouth frequently is a traumatic ulcer. between 3 and 24 % of the population are affected, which is a significant prevalence. it is symptomatic to treat traumatized ulcers. oral wound healing is a dynamic process and complicated phenomenon involving secondary concerns, a succession of overlapping stages of rebuilding cell and tissue structure. inflammation, granulation tissue creation, matrix formation, re-epithelialization, and tissue remodeling are some of the cellular and physiological activities that occur during wound healing. oral wound healing is a dynamic process and complex phenomenon involving secondary issues, series overlapping stages of restoring tissue and cellular structures. since 1995, the moist exposed burn ointment (mebo), a chinese burn ointment, has had a recognized us patent. beta-sitosterol, phellodendron amurense, scutellaria baicalensis, coptis chinensis, pheretima aspergillum, beeswax, and sesame oil are all natural ingredients found in mebo, a pure herbal extract.

Eligibility criteria:
inclusion criteria: * age from 20 to 50 years. * both sexes. * systemically healthy patients. * patients with good oral hygiene. exclusion criteria: * patients with any uncontrolled local or systemic disease. * smokers. * pregnancy and lactation. * patients allergic to the used agents.
structure and function of salivary proteins

Conditions: Cystic Fibrosis

Summary: this study seeks to provide point-of-care clinical diagnostic systems for the diagnosis of current disease status using saliva as a sample specimen.

the overall hypothesis of this study is that whole saliva and its components, due to its direct anatomic relation to the airways, provides a window on the composition and nature of the disease-specific response in the bronchial, sinus, and nasal airways. by examining proteins created in saliva, we hope to validate that saliva is an important diagnostic tool for for rapid analysis of respiratory status. we further propose that rapid salivary diagnostics will improve patient care in prevalent respiratory diseases with frequent health care utilization and high morbidity, such as asthma, chronic obstructive pulmonary disease (copd), and cystic fibrosis (cf).

Eligibility criteria:
inclusion criteria: * 6 or more years of age * confirmed cystic fibrosis exclusion criteria: * pregnant
pharmacogenetics of torasemide and spironolactone in hypertension treatment

Conditions: Hypertension; Genetic Predisposition; Drug Effect

Summary: phase iii interventional study to evaluate the different efficacy of torasemide and spironolactone in reducing systolic blood pressure in carriers and non-carriers of the different genotypic combinations for lanosterol and uromodulin

the investigators will enroll 144 naïve hypertensive subjects who will undertake 2-4 weeks of run-in and 4 weeks of treatment (7 day window at each visit). during this period partecipants will follow a low sodium diet (about 5g/day) and will be monitored with blood chemistry tests

Eligibility criteria:
inclusion criteria: * male (25-65 years) and female (45-65 years in menopause defined as "12 consecutive months of amenorrhea for which no other physiological or pathological cause has been identified in woman over 45 years of age") * newly diagnosed hypertensive patients never treated before or on single antihypertensive drug therapy * hypertension grade i or ii (according to 2013 esh guidelines, in the patient untreated or despite therapy), defined as the following: * at visits t-4 and t-2 (week -4 and week -2 ± 7 days, run-in period) the mean of the last 3 consecutive sbp measurements must be \>=140 mmhg and/or diastolic bp\>= 90mmhg * at the t0 visit (week 0 ± 7 days, enrollment), the mean of the last 3 consecutive systolic bp measurements must be \>=140 mmhg and \ =90 mmhg and \<110 mmhg * signing of the informed consent for participation in the study and for genotyping. exclusion criteria: * known causes of secondary hypertension * stage ii hypertension (sbp\>= 180 and sbp\>=110 mmhg * history of renal artery stenosis * significant kidney disease (egfr-ck-epi less than 60 ml/min) * refractory hypokalemia or hyponatremia (napl \< 126 meq/l) * hyperkalemia (k \> 5.5 meq/l) * hypercalcemia * symptomatic hyperuricemia * liver disease (transaminases greater than 3 times the maximum laboratory value) * cardiac pathologies (previous myocardial infarction, atrial fibrillation in progress, etc.) * diabetes (fasting blood sugar \>126mg/dl) -. current statin treatment * obesity (bmi \>30 kg/m2) * ongoing pregnancy * breastfeeding in progress * anuria * hypovolemia and dehydration * known hypersensitivity to the study drugs (spironolactone or torasemide) or to any of the excipients * ongoing therapy with aminoglycosides or cephalosporins * participation in a clinical study in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug * patients unable to express valid consent

Keywords: hypertension genetics torasemide spironolactone pharmacogenetics
safety and efficacy of fluocinolone acetonide intravitreal implant

Conditions: Non-infectious Uveitis

Summary: this is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. an additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.


Eligibility criteria:
inclusion criteria: * males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent, * non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study, * had clinically 'quiet' eyes at surgery. exclusion criteria: * coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.
evaluation of gallium-68-hbed-cc-psma imaging in prostate cancer patients

Conditions: Prostate Cancer

Summary: the investigators are imaging patients with prostate cancer using a new pet imaging agent (ga-68 hbed-cc psma) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.

imaging and staging of prostate cancer is critical for surgical and treatment planning. patients with suspected metastatic prostate cancer will be imaged using gallium-68 labeled hbed-cc psma in order to demonstrate its utility. the investigators plan to utilize this data to obtain further approvals of the hbed-cc psma compound, so that this agent will become available for clinical imaging in prostate cancer patients. this compound has been shown to be superior to choline based pet agents for the staging of prostate cancer, both carbon-11 and fluorine-18 compounds. but this compound was not patented and therefore no company or private entity will make the investment required to bring hbed-cc psma to market. in the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future fda approval. this study focuses on three patients populations that are imaged. in the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis. in the biochemical recurrence population, the primary objective is to determine the sensitivity of recurrence location. in the castrate resistant prostate cancer population the primary objective is to determine if psma pet detects more metastatic lesions than conventional imaging.

Eligibility criteria:
inclusion criteria: 1. known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below: * treatment naïve patients with one of the following risk factors: capra (cancer of the prostate risk assessment) score ≥ 5, prostate-specific antigen (psa) ≥ 15 ng/ml and/or gleason score ≥ 4+4. * patients with biochemical recurrence after prostatectomy or radiation therapy with a psa doubling time less than 12 months. i. these patients may have received androgen deprivation therapy prior to imaging. * patients with castrate resistant prostate cancer with progressive disease as defined by prostate cancer clinical trials working group (pcwg2) criteria (27). i. patients with castrate resistant prostate cancer can be either on treatment or off treatment 2. age \> 18. 3. karnofsky performance status of \> 50 (or eastern cooperative oncology group (ecog)/world health organization (who) equivalent). 4. ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: 1. patients exceeding the weight limitations of the scanner or are not able to enter the bore of the pet scanner due to bmi. 2. inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.). 3. inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
changes in volumetric hemodynamic parameters induced by fluid removal on hemodialysis

Conditions: End Stage Renal Failure on Dialysis; Body Fluid Retention; Impedance; Cardiac Output, Low

Summary: changes in volumetric hemodynamic parameters and fluid overload (cardiac index,stroke volume, thoracic fluid content, systemic vascular resistance) were measured using a impedance cardiography (icg) (cardioscreen 1000 - haemodynamic measurement system, medis. gmbh ilmenau) beginning 15 min prior to midweek dialysis session and continuous measurement thereafter, with a 15-min period after the termination of hemodialysis. fluid overload were measured by bcm monitor fresenius before hemodialysis.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * patients on maintenance hemodialysis at least 3 months * stable dry weight * single-pool kt/v \>1.4 * no clinical cardiovascular disease during the 6 months preceding entry exclusion criteria: * not meet the above criteria * episode of illness (for example: infection) * pregnancy
the impact of the distribution of adipose tissue on the occurrence of metabolic disorders and the level of cardiopulmonary fitness

Conditions: Obesity, Abdominal

Summary: the aim of the research was to assess the impact of the distribution of abdominal fat (subcutaneous sat and visceral vat estimated at the height of the navel) on selected metabolic parameters and on specific parameters of cardiopulmonary fitness in terms of people with obesity.

the research was carried out in 3 stages. stage 1 was carried out at the department of dietetics and clinical nutrition of the umb. during the visit, the subjects were provided with detailed information concerning the research and every participant signed a voluntary consent to participate in the research. furthermore, an interview questionnaire concerning the duration of obesity and past diseases was collected, and an assessment of the status of nutrition based on anthropometric measurements was carried out, and a body composition analysis was performed using the bioelectroimpedance method using the maltron bioscan 920-2 analyzer. then, patients were issued a referral for laboratory examinations. stage 2 was carried out at the medical laboratory at the university clinical hospital in bialystok, where blood was taken from the ulnar vein (in the amount of 15ml). the concentrations of the following parameters were determined from the blood serum: fasting glucose, fasting insulin, total cholesterol, ldl cholesterol fraction, hdl cholesterol fraction, triglycerides, c-reactive protein (crp), uric acid, creatinine, and aminotrasferases: alanine (alt) and aspartate (ast). on the basis of fasting glucose and fasting insulin, the homa - ir insulin resistance index was calculated. stage 3 was carried out at the maniac gym fitness club in bialystok, where cardiopulmonary fitness was assessed using the modified bruce protocol.

Eligibility criteria:
inclusion criteria: * primary obesity * bmi ≥ 30kg/m2 - ≤ 39,99 kg/m2 * gender: women and men * age: 20-65 lat exclusion criteria: * secondry obesity * bmi ≥ 40 kg/m2 * diabetes type 2 or insulin resistance (occurance or treatment) * endocrine disorders * eating disorders * hormonal contraception/hormone replacement therapy * after steroid therapy * antiretroviral therapy * musculoskeletal dysfunctions * patients after surgery (min 3 months) * bariatric surgery * coronary artery disease * cardiac pacemaker * pregnancy * breast - feeding

Keywords: adipose tissue obesity metabolic disorders
a dose ranging study of opt-302 with ranibizumab in neovascular (wet) amd

Conditions: Neovascular Age-related Macular Degeneration

Summary: a multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of opt-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) amd.


Eligibility criteria:
inclusion criteria: * active subfoveal choroidal neovascular (cnv) lesion or juxtafoveal lesion secondary to age-related macular amd * an etdrs bcva score between 60 and 25 (inclusive) letters exclusion criteria: * previous treatment for wet amd or previous treatment for cnv due to other causes in the study eye * clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the study eye * poorly controlled diabetes mellitus (defined as hba1c\>7%) * any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study
topic cervical anesthesia for pain control during endouterine manual aspiration

Conditions: Pain

Summary: to compare the effectiveness of lidocaine gel plus paracervical blockade vs. paracervical blockade alone in the management of pain during endouterine manual aspiration.


Eligibility criteria:
inclusion criteria: * need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding). exclusion criteria: * allergy to lidocaine.

Keywords: endouterine manual aspiration paracervical blockade lidocaine gel
intra articular ankle fractures

Conditions: Intra-Articular Fractures

Summary: the purpose of this study is to examine the effect of early, percutaneous, intra-articular saline lavage on the undiluted synovial fluid microenvironment during the acute phase following intra-articular fracture of the human ankle. we hypothesize that early intervention with percutaneous joint lavage in the first 0-48 hours after injury will attenuate the production of pro-inflammatory cytokines, mmp's and cartilage breakdown products compared to non-lavaged control subjects at the time of surgical fixation.

saline joint lavage represents a potentially simple, low-risk and minimal-cost intervention which has not been previously studied for the purpose of reducing the post-fracture inflammatory burden in human subjects. open joint lavage at the time of definitive surgical fixation is within the standard of care, but typically occurs greater than 10 days after injury by which time cartilage degradation has already begun. early, saline lavage during initial presentation to the emergency department may theoretically alter the progression of the intra-articular inflammatory response by evacuating the bulk of the developing synovial-fluid fracture hematoma. the vast majority of ankle fractures present to the er or urgent care within a day of fracture. moreover, a large subset of these fractures require reduction (fracture setting) that is painful. it is our standard of care to perform an intra-articular lidocaine injection before reduction. we will take advantage of this standard of care needle insertion to the fractured ankle to perform saline joint lavage to diminish this early inflammatory burden. adult patients presenting to the duke university hospital emergency department with an intra-articular fracture of the ankle joint between 0-48 hours from the time of injury will be eligible for inclusion. patients will be randomized into one of two groups: 1) intra-articular saline lavage, vs 2) no intra-articular saline lavage. intra-articular aspiration of synovial fluid from the injured ankle will occur both at the time of presentation to the emergency department and at the time of surgery. these synovial fluid samples will be analyzed for differences in key pro-inflammatory cytokines, matrix metalloproteinases and cartilage breakdown products to determine if early saline lavage effects the composition of the synovial fluid micro-environment.

Eligibility criteria:
inclusion criteria: * adult subjects (over 18 years of age) * must be treated at duke university hospital emergency department * intra-articular fracture of the ankle joint (any fracture of the fibula or tibia in which the fracture line(s) exit into the cartilage surface of the ankle joint) * subjects presenting between 0-48 hours from the time of injury exclusion criteria: * age \< 18 y.o. * open fracture * nonoperatively treated fractures * subjects presenting \>48 hours from the time of injury
telerehabilitation vs supervised exercises in ms

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a complex neurodegenerative autoimmune disease. people with ms (pwms) have low quality of life (qol) and activities of daily living (adl). exercise is a safe and effective rehabilitation tool for pwms. a structured and personalized exercise program can improve physical fitness, functional capacity, quality of life and modifiable disorders in pwms. on the other hand, telerehabilitation is an alternative rehabilitation method in pwms. the purpose of this study is to investigate the effectiveness of exercise programs and telerehabilitation on adl and qol in pwms, and compare the effects of supervised exercise and home-based exercise programs for the pwms.

participants are randomly assigned to the structured supervised exercise or structured home-based groups. interventions in group 1 (n=15) includes one session per day, 3 days a week over a 12-weeks structured exercise program under the supervision of a physical therapist. group 2 (n=15) includes a 12-week structured home-based exercise program checked and controlled through telerehabilitation three times a week. all measurements pre-post intervention.

Eligibility criteria:
inclusion criteria: patients with: 1. stable period at the time of application to the clinic 2. expanded disability status scale levels between 2 - 6.5 3. appropriate cognitive level to understand the exercises 4. no diseases to affect their participation in exercise programs exclusion criteria: patients with: 1. poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation, 2. a new history of previous attacks 3. no reliable informed consent

Keywords: multiple sclerosis telerehabilitation supervised exercises structured exercise quality of life activities of daily living