Kornimate/medical-research-clean huggingface dataset:
hydroxychloroquine in giant cell arteritis

Conditions: Giant Cell Arteritis

Summary: cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. we have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.


Eligibility criteria:
inclusion criteria: * giant celle arteritis with at least 3 acr criteria including a disgnostic temporal artery biopsy * corticosteroid treatment since less than 1 month * age less than 85 years * signed informed consent exclusion criteria: * amaurosis fugax, loss of vision, acute lumb ischemia, angina pectoris or myocardium infarctus, mesenteric ischemia or other vascular complications related to gca * low life expectancy (\<2 years) * corticosteroid treatment since more than 30 days whatever the dosage * primary corticosteroid resistance defined by persistant symptoms despite prednisone for more than 15 days * previous psychiatric troubles induced corticosteroids * hydroxychloroquine contra-indicated

Keywords: giant cell arteritis, hydroxychloroquine, corticosteroid sparing, corticodependence
a open-label study to evaluate the relative bioavailability of samatasvir (idx184) and food effect in healthy male participants (mk-2355-006)

Conditions: Hepatitis C

Summary: the purpose of this study is to: * assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation) * compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting. * determine the amount of study drug that is in the blood after eating a meal. * evaluate the safety of the tablet form of samatasvir in healthy people.

each participant will receive each of the formulations in a crossover design. part a periods 1 and 2: participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on days 1 and 8. part a period 3: all participants will receive samatasvir tablets under fed conditons on day 15. each dose will be separated by a 7-day wash-out period. part b: all participants will receive samatasvir capsules under fed conditons on day 1.

Eligibility criteria:
inclusion criteria: * must be a healthy male with body mass index (bmi) between 18 and 35 kg/m * must agree to use an acceptable double-barrier method of birth control. * must provide written informed consent after the study has been fully explained. exclusion criteria: * history of clinically significant diseases, as determined by the investigator. * safety laboratory abnormalities at screening which are clinically significant. * positive screening test for hepatitis b virus, hepatitis c virus or human immunodeficiency virus (hiv). * use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (otc) medications within 7 days of the starting the study. * current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.

Keywords: hcv hepatitis c virus
evaluation of the use of apple watch features for identification of cardiac arrhythmias

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter

Summary: this post-marketing study is conducted to characterize the ability of apple watch rhythm analysis software to identify atrial fibrillation (af) and facilitate subsequent clinical evaluation among users who contact applecare.


Eligibility criteria:
inclusion criteria: 1. possession of the following at time of eligibility screening: * iphone (5s or later) with ios version 12.1.1 or later defined as iphone model/ios version used to complete screening eligibility. * apple watch (series 1-4) with watchos version 5.1.2 or later defined as apple watch model/watchos paired with iphone used to complete screening eligibility 2. at least one of the following by self-report before consent: * irregular rhythm notification * ecg app classification of atrial fibrillation * ecg app classification of inconclusive defined as "inconclusive," "heart rate over 120," or "heart rate under 50" 3. age ≥ 22 years at time of eligibility screening 4. current resident of the united states at time of eligibility screening, and will reside in the united states for the length of the study 5. proficient in written and spoken english 6. valid phone number associated with iphone, ascertained from self-report 7. valid email address, ascertained from self-report exclusion criteria: 1. shared icloud account 2. shared applewatch
efficacy and safety of roflumilast in japanese patients with bronchial asthma (20 to 70 y) (apta-2217-05)

Conditions: Bronchial Asthma

Summary: the aim of the study is to investigate the effect of roflumilast (apta-2217) on lung function in patients with asthma. roflumilast will be administered orally once daily. the study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). the study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility criteria:
main inclusion criteria: * adult patients with bronchial asthma meeting the guideline for prevention and control of asthma 2003 (jgl 1998, revised 2nd edition) * no change in asthma treatment during the last 4 weeks prior to the registration * non-smokers or ex-smokers for 12 months or more * %fev1 ranging between 60 and 80% main exclusion criteria: * patients with poorly controlled asthma * inhalation therapy exceeding low dose during 4 weeks prior to the registration * concurrent respiratory diseases such as copd considered to affect the efficacy evaluation

Keywords: asthma roflumilast phosphodiesterase 4 inhibitor
assessment of fluid responsiveness by elevation of peep in patients with septic shock

Conditions: Septic Shock

Summary: the aim of the study is to evaluate whether fluid responsiveness of the critically ill patient can be assessed by analysing the peep-induced hemodynamic effects to systolic blood pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left ventricular end diastolic area measured with transesophageal echocardiography (peep-test). the chances are compared to increase of ci after volume expansion (gold standard). in clinical practise, it would be especially relevant if peep-induced changes in arterial pressure variations could be used in evaluation of volume status and fluid responsiveness. however, as echo-derived variables are used in greater extent to guide the treatment with inappropriate evidence, the simultaneous registration of echo-derived hemodynamic measurements is essential in the study design.


Eligibility criteria:
inclusion criteria:• written informed consent by patient or relative * time in icu \< 48 hours * septic shock * pulmonary artery catheter and radial arterial catheter * age 18 - 75 years * sinus rhythm * need for norepinephrine over 0.1 ug/kg/min but otherwise hemodynamically stable i.e no need to change the dose over the last 15min period before the study * mechanical ventilation with sedation * pwcp \<18 mmhg exclusion criteria: * contraindication to elevation of peep ( elevated intracranial pressure, pulmonary hypertension or other contraindication ) * contraindication to fluid challenge * contraindication to tee * previous heart failure, heart valve stenosis of insufficiency

Keywords: norepinephrine infusion under 48 hours in icu
anecortave acetate in patients with exudative age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: the purpose of this study was to evaluate the effect of the dose concentration and administration frequency of anecortave acetate (aa) on visual acuity (va) and lesion size when administered by posterior juxtascleral depot (pjd) every 3 months (aa 15 mg) or 6 months (aa 15 mg, aa 30 mg) in patients with exudative age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of exudative amd and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (cnv) lesion. * other protocol-defined inclusion criteria may apply. exclusion criteria: * less than 50 years of age. * other protocol-defined exclusion criteria may apply.

Keywords: exudative amd age-related macular degeneration (amd)
the pathophysiology of tourette syndrome: a multimodal study

Conditions: Tourette Syndrome

Summary: the purpose of this study is to characterize the functional and anatomical connectivity changes in tourette syndrome and its relation with iron deficiency.

tourette syndrome (ts) is a childhood-onset chronic neuropsychiatric disorder with an increasing prevalence (range 0.05-3%).the investigators previous study showed that lower serum ferritin and iron levels in children with tourette syndrome than in healthy children. the exact mechanism explaining how iron deficiency contributes to the pathophysiology of ts is unclear.one question is whether or not peripheral iron deficiency in children with tourette syndrome can inflence the brain extrapyramid structure and resting state brain function？another question is how well peripheral iron indices correlate with central iron content？ the third question is for ts children with peripheral iron deficiency, oral iron supplement (5mg/kg/d) at least 8 weeks, the peripheral iron indicies return to normal levels, how the brain iron contents and the relative structure and brain function change?, to test the above-metioned hypothesis, functional magnetic resonance imaging (fmri) , diffusion tensor imaging (dti) and susceptibility weighted imaging (swi) are applied to investigate the volume change of extrapyramid structure such as caudate nucleus and putamen, resting-state brain function and brain iron content before and after oral iron supplementation in ts children with peripheral iron deficiency, ts children with peripheral normal iron levels and normal healthy controls. the investigators hope to confirm that iron deficiency may play a causal role in the dopamine metabolism and it helps to further explore the pathophysiology of tourette syndrome and also would contribute to significant advance in the therapeutic option for ts children with peripheral iron deficiency.

Eligibility criteria:
inclusion criteria: * 6-12 years old * characterized by vocal tic and muscle twitch * no positive signs was found through neurological examination, no significant psychomotor retardation, exclusion criteria: * hepatolenticular degeneration * rheumatic chorea * myoclonic epilepsy * history of mental disease or brain trauma

Keywords: tourette syndrome iron deficiency
potential diagnostic and prognostic value of micrornas for the patients of acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating micrornas compared with ctni for suspected acs patients at the emergency department (ed) and intensive care unit (icu).

the present study is a single-center, prospective diagnostic study among patients presenting to the ed or icu within 24 h of onset of chest pain suggestive of suspected acs. we propose to construct the biobank of acs and evaluate the potential diagnostic value of circulating micrornas compared with ctni for suspected acs patients. all the patients are to be followed up for 6 months. final diagnosis was made by an expert panel cardiologist, based on all available clinical information including ctni measurements, ecg, coronary angiography, cardiac exercise tests and information from hospital discharge letters. the concentrations of micrornas will be evaluated by quantitative reverse transcription pcr, using highly specific primers and hybridization probes.

Eligibility criteria:
inclusion criteria: suspected acs patients (stemi, nstemi, and ua): age\>18 years; informed consent. exclusion criteria: patients who will undergo immediate pci; pregnant and lactating women; patients with mental disorders; patients are using other experimental drugs; refusal to provide informed.
accuracy of implant placement for patients with mandibular reconstruction using dynamic navigation and static guides

Conditions: Mandibular Deficiency

Summary: to evaluate and compare the accuracy of implant placement using dynamic navigation technique versus static template technique in patients with bone tissue flap reconstruction of mandibular defects, thus further guiding the clinical application of dynamic navigation systems to assist in conventional implant placement in patients with mandibular defects.


Eligibility criteria:
inclusion criteria: * male or female patients between the ages of 18 and 70 (inclusive) * mandibular defects (including class i defects, limited to the body of the mandible; class ii defects, muscular-mandibular region defects and class iii defects, chin protrusion-muscular-mandibular region defects), which have been reconstructed by mandibular vascularization of free iliac bone, and fibular composite muscular flap grafts for greater than 3 months * normal mouth opening (≥ 40 mm) * trialists voluntarily signed an informed consent form before performing any research-related experimental steps. exclusion criteria: * presence of localized inflammation in adjacent teeth, including uncontrolled periodontitis (periodontal probing to a depth of \>4 mm) * presence of untreated acute and chronic apical periodontitis in adjacent teeth * oral mucosal lesions (e.g., lichen planus) * adjacent teeth with space-occupying lesions (including cysts, tumors, etc.) * systemic diseases affecting bone healing, wound healing and dental implant treatment (e.g., uncontrolled diabetes mellitus, fasting blood glucose ≥ 8.8 mmol/l despite medication) * uncontrolled and unstabilized severe hypertension * contraindications to routine implant surgery and oral surgery * heart disease (class ii or above) * patients with liver or kidney insufficiency or abnormality * obese patients with body mass index (bmi) \> 28 kg/m2 * patients with a history of full-dose radiotherapy, localized radiotherapy to the head or neck * patients requiring long-term high-dose steroid therapy * patients who are receiving or have received in the last 3 months medications (e.g., bisphosphonates) that may affect or promote bone metabolism * consecutive antibiotic therapy or chronic anti-inflammatory therapy (≥3 times per week) within the first 4 weeks of starting the procedure * alcohol or chronic substance abuse * immunocompromised patients * smoking/tobacco equivalents/chewing tobacco \>10 cigarettes per day * physical or mental impairment that interferes with the performance of oral hygiene care * female patients who are pregnant or breastfeeding * patients who, in the opinion of the investigator, have poor compliance and cannot participate in the trial * patients who have participated in a clinical trial of another drug or device within 30 days prior to the start of the procedure (study day 0)
assessment of the analgesic effects of pf-05089771 and pregabalin in healthy volunteers using evoked pain endpoints

Conditions: Healthy

Summary: this study will examine the activity of pf-05089771 and pregabalin, alone and in combination on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg or clinical laboratory tests. •body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). •evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. •subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). •any condition possibly affecting drug absorption (eg, gastrectomy). •a positive urine drug screen
metabolic impact and compliance of controlled, varying, mediterranean diets in pre-surgical prostate cancer populations (provisions)

Conditions: Prostate Cancer

Summary: the study aims to investigate whether following a controlled mediterranean-style diet prior to robotic-assisted radical prostatectomy surgery in patients diagnosed with prostate cancer affects fasting insulin levels and other values that can be measured in blood and tissue samples from surgery.


Eligibility criteria:
inclusion criteria: * males 18 to 80 years old scheduled to undergo radical prostatectomy as per standard of care. * bmi between 18.5 and 40 * ability to read, write, speak, and understand english and/or spanish. * ability to provide informed consent. * willingness to consume provided dietary interventions. * adequate organ and marrow function as assessed by treating clinician(s) which includes: white blood cell count (wbc) ≥2,500/microliter. absolute neutrophil count (anc) ≥1,500/microliter. platelets ≥100,000/microliter. hemoglobin ≥9 g/dl (transfusions permitted) total bilirubin ≤1.5 x the institutional upper limit of normal (uln). for subjects with gilbert's disease ≤3.0 mg/dl. aspartate aminotransferase (ast)/alanine aminotransferase (alt) ≤2.5 x institutional uln. creatinine clearance ≥51 ml/min as defined by cockcroft-gault equation. exclusion criteria: * currently consuming a mediterranean, lower carbohydrate, ketogenic, vegan, vegetarian, high fiber diet (14g fiber \> per 1,000 calories) and/or any supplements (including herbal), vitamins, minerals, that would interfere with diets being tested in the study as determined by dietitian and/or investigators as these diets are highly restrictive and may impact objectives/outcomes in the trial. * previous intolerability to fiber-rich diets. * colitis, irritable bowel syndrome, or other gastrointestinal condition per clinician discretion. * food allergies or other major dietary restrictions. * receiving active medical treatment for type i or type ii diabetes mellitus. * recent weight loss or gain (both intentional and unintentional) as defined by 5%+ body weight in the last 30 days. * undergone any type of weight loss surgery. * any medical contraindications as determined by investigators. * history of diabetic ketoacidosis. * history of gout. * patients that are immunosuppressed (transplant history, on immunosuppression, etc.) as per clinician discretion. * gallbladder removed or plan to remove per clinician evaluation. * other malignancies actively receiving systemic treatment as per clinician evaluation. * previous treatment for prostate cancer. * previous history of pelvic radiation. * patients with impaired decision-making capacity.
trial of levofloxacin as prophylaxis after allogeneic stem cell transplantation (sct)

Conditions: Malignancy; Allogeneic Stem Cell Transplantation

Summary: the purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial infections in the postneutropenic period in patients who have undergone allogeneic stem cell transplantation (sct).


Eligibility criteria:
inclusion criteria: * allogeneic sct * postneutropenic period * written consent exclusion criteria: * fever * antibiotic therapy * neutropenia * refusal by the patient
safety and immunogenicity of an investigational pentavalent meningococcal abcyw vaccine against meningococcal disease in children, toddlers, and infants

Conditions: Meningococcal Immunization; Healthy Volunteers

Summary: this study is the first study of sanofi's pentavalent meningococcal abcyw vaccine clinical development program to be conducted in the pediatric population below 10 years of age. the aim of the study is to assess 2 formulations of the menpenta vaccine compared to licensed meningococcal vaccines when administered alone in children (stage 1) or concomitantly with routine pediatric vaccines in toddlers (stage 2) and infants (stage 3). study details include: the study duration per participant will be up to 12 months for children in stage 1 and toddlers in stage 2 and 16 to-19 months for infants in stage 3.


Eligibility criteria:
inclusion criteria: * aged 2 to 9 years (stage 1) or 12 to 15 months (stage 2) or 56 to 89 days (stage 3) on the day of inclusion * for infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period of period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg and in both cases medically stable as assessed by the investigator, based on the following definition: "medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention * participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the investigator exclusion criteria: participants are excluded from the study if any of the following criteria apply: * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months or since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants) * history of any meningitis infection, confirmed either clinically, serologically, or microbiologically * at high risk of meningococcal infection during the study * known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * individual with active tuberculosis * history of guillain-barré syndrome * for stage 3 infants: history of intussusception * previous vaccination against meningococcal serogroups a, b, c, w, and/or y with an investigational or marketed vaccine * for stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination note: the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.