Kornimate/medical-research-clean huggingface dataset:
renal denervation by mdt-2211 system in patients with uncontrolled hypertension

Conditions: Uncontrolled Hypertension

Summary: the objective of this study is to demonstrate that the mdt-2211 renal denervation system is a safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic, as best available antihypertensive therapy

the htn-j study is a multi-center, prospective, unblinded, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. bilateral renal denervation will be performed using the mdt-2211 renal denervation system - a percutaneous system that delivers radiofrequency (rf) energy through the luminal surface of the renal artery.

Eligibility criteria:
inclusion criteria: * individual is ≥ 20 and ≤ 80 years old at time of randomization. * individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 6 weeks prior to screening) that is expected to be maintained without changes for at least 6 months. * individual has an office systolic blood pressure (sbp) of ≥ 160 mmhg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit * individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study. exclusion criteria highlights: * individual has an estimated glomerular filtration rate (egfr) of \< 45 ml/min/1.73 m2 * individual has an ambulatory blood pressure monitoring (abpm) 24 hour average sbp \< 135 mmhg * individual has type 1 diabetes mellitus * individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, cpap, bipap) other than nocturnal respiratory support for sleep apnea. * individual has primary pulmonary hypertension. * individual is pregnant, nursing or planning to be pregnant.

Keywords: hypertension vascular diseases cardiovascular diseases renal denervation
efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension

Conditions: Hypertension

Summary: this study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.


Eligibility criteria:
inclusion criteria: * male or female 18 years of age and older * diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm hg but \< 180 mm hg and mean seated diastolic blood pressure ≥ 95 mm hg and \<110 mm hg exclusion criteria: * - patients with sever hypertension: systolic ≥ 180 mm hg or diastolic ≥ 110 mm hg * diabetes with fasting glucose \> 126 mg/dl or on existing anti-diabetic medication * history of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hypertension high blood pressure diuretics valsartan
pvp iodine vs chlorhexidine in alcohol for disinfection of the surgical site

Conditions: Surgical Site Infections

Summary: prospective cluster-randomized multicenter cross-over trial to prove non-inferiority of pi compared to chx in preoperative skin antisepsis

surgical site infections (ssis) are the most common nosocomial infections in surgical patients causing significant increases in morbidity, mortality, and health care costs. as they are usually caused by components of the normal skin flora, disinfection of the surgical site with an antiseptic skin preparation is standard practice prior to any surgical intervention. the most commonly used disinfectants are either chlorhexidine in alcoholic solution (chx) or pvp iodine in alcoholic solution (pi) this prospective cluster-randomized multicenter cross-over trial is to prove non-inferiority of pi compared to chx in preoperative skin antisepsis in abdominal and cardiothoracic surgery in regard of ssis.

Eligibility criteria:
inclusion criteria: - undergoing cardiac or certain types of abdominal surgery (colorectal surgery, cholecystectomy, herniotomy, appendectomy and bariatric surgery) which are routinely followed up by the study centers during the study period exclusion criteria: * contraindication to the use of either one of the compounds ( chx: intolerance to any of the compounds of the preparation, application on cornea, wounds or mucosal membrane. pi: hyperthyroid disease, intolerance to any of the compounds, iodine allergy, 2 weeks prior to radio- iodine treatment, dermatitis herpetiformis duhring, application on cornea, wounds or mucosal membranes) * emergency surgical intervention * patients refusing general consent for use of personal data

Keywords: chlorhexidine in alcoholic solution pvp iodine in alcoholic solution preoperative skin antisepsis
myoslow lens study to control myopia in children

Conditions: Myopia

Summary: a prospective, randomized, controlled double masked trial to assess the performance of myoslow lens in slowing myopia progression in children. the following study measures will be assessed: * demographics and medical history * current spectacles * best corrected visual acuity (bcva) assessed by measurement and summation (m\&s) system * biometry * cover test * stereopsis * ocular motility * pupil responses * cycloplegic refraction * fundus examination * vision related quality of life using the questionnaire pediatric refractive error profile (prep)2 * adverse events


Eligibility criteria:
inclusion criteria: * children, 6-12 years old * spherical equivalence refraction (ser): -1.00 to -5.00 diopter (d). * astigmatism and anisometropia of 1.50 d or less. * best corrected visual acuity (bcva) (6 / 7.5) or higher. exclusion criteria: * eye and systemic disorders. * previously treated for myopia
research for specific proteins of interest for the serological diagnosis of bird fancier's lung

Conditions: Avian Hypersensitivity Pneumonitis

Summary: this study aims at identifying bird proteins useful for diagnostic tests to determine the cause of bird fancier's lung (bfl).

allergic diseases are an important part of health concerns in europe and in countries "industrialized". among them are distinguished from hypersensitivity pneumonitis (hp), consecutive to repeated inhalation of organic substances (bacteria, fungi, avian proteins ...). as with other hp, the bfl is a invalidating disease, but usually not lethal if the patient reduced sufficiently early exposure to antigens. associated symptoms include breathing difficulties a dry cough, a general fatigued state accompanied by a fever and a rapid and pronounced weight loss. these clinical signs may be similar to a flu-like condition, difficult to discern from other respiratory disease. diagnosis is based on a set of clinical, radiological and biological arguments that are often discussed. using these criteria as predictors would increase opportunities to diagnose hp without using invasive clinical examinations such as biopsy and bronchoalveolar lavage. although serology is a useful argument for the diagnosis, its value is often criticized. thus, significant variations in performance of serological tests are observed from one provider to another and, for the same supplier, from one batch to another. this issue could be raised by the use of recombinant antigens. the principle is to use only to the reaction the purified protein of interest produced by genetic engineering. the parasitology-mycology department has acquired expertise in the research of proteins of interest for serology allergic diseases and in the manufacture of recombinant antigens. thus the work of the team have identified proteins of interest for the diagnosis of two hp of occupational origin and translates this expertise to identify pigeon's proteins and study the feasibility of this research. for this project, the pigeon droppings (columba livia), collected from different breeders in the region were identified as antigenic source. the objective of the hypersens project is to extend the problematic to other species of birds and understand the specific species of antigenic proteins. the aim is also to identify and produce recombinant proteins that will identify the cause of avian hypersensitivity pneumonitis.

Eligibility criteria:
inclusion criteria: * exposure known about birds * non-smoker * absence of compatible respiratory symptoms with a hp exclusion criteria: * farmer, * smoker, * pregnancy and feeding, * minor subject, * known immunizing deficit
best treatment for women with both (polycystic ovary syndrome) pcos and subclinical hypothyroidism

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Subclinical Hypothyroidism; Female Infertility

Summary: the goal of this randomized controlled trial is to compare letrozole alone versus letrozole plus levothyroxine for ovulation induction in infertile women with both pcos and subclinical hypothyroidism. the main questions it aims to answer are: is letrozole plus levothyroxine superior to letrozole alone in achieving ovulation in these patients? does combining levothyroxine with letrozole lead to higher pregnancy and live birth rates compared to letrozole alone? participants will be randomized into two groups: group 1 will receive letrozole only, starting at 2.5 mg daily from day 3 to 7 of the menstrual cycle. the dose will be increased up to 7.5 mg if no ovulation occurs, for a maximum treatment period of 6 months or until pregnancy is achieved. group 2 will receive letrozole at the same doses as group 1 plus 25 mcg levothyroxine daily.


Eligibility criteria:
inclusion criteria: age between 20-40 years bmi between 18-35 kg/m2 meet diagnostic criteria for pcos based on the rotterdam consensus criteria and eshre/asrm modifications (2018): oligo- and/or anovulation clinical and/or biochemical signs of hyperandrogenism polycystic ovaries on ultrasound subclinical hypothyroidism defined as tsh level between 5-10 miu/l with normal free t4 infertility duration ≥ 1 year intact ovaries and uterus, confirmed by physical exam and imaging normal semen analysis in male partner no tubal or peritoneal factor contributing to infertility effective contraception if not attempting conception willing and able to provide informed consent exclusion criteria: known thyroid disease or on thyroid medications abnormal thyroid function tests other than subclinical hypothyroidism hyperprolactinemia presence of other causes of infertility such as: moderate to severe male factor infertility bilateral tubal occlusion or peritoneal factors stage iii-iv endometriosis ovarian failure or insufficiency (high fsh or low amh) previous diagnosis of any type of congenital adrenal hyperplasia uncontrolled diabetes (hba1c \>8%) history of deep vein thrombosis or thromboembolic events any contraindication to letrozole or levothyroxine previous use of letrozole or levothyroxine in past 6 months current or suspected pregnancy breastfeeding inability to comply with treatment and follow-up procedures

Keywords: letrozole levothyroxine pcos subclinical hypothyroidism
child steps for youth mental health in maine sustainability

Conditions: Anxiety; Depression; Trauma; Behavior Problems

Summary: the overarching goal of this project is to study the sustainability of match-adtc within community mental health clinics, to learn what is needed for evidence-based practices (ebps) to take root and thrive within a public system.

in this project, the investigators are randomizing children to wave 1 (previously match trained) or wave 2 (newly match trained) and using a clinical monitoring system (trac) to measure youth outcomes over time. participating therapists receive weekly match consultation provided by the judge baker children's center/harvard university research team or by maine clinic supervisors who are match associate consultants. the investigators are also developing and testing new low-cost measures of match treatment and consultation fidelity to explore the feasibility of more sustainable measures of match adherence. study data will be used to answer questions about the sustainability of match in the public sector.

Eligibility criteria:
inclusion criteria: * 6 - 15 year old child and their caregivers * seeking services at community mental health clinics * primary problem or disorder related to anxiety, traumatic stress, depression, or conduct problems, or any combination of the four problems exclusion criteria: * child is younger than 6 years or older than 15 years on the day of the phone screen. * child has attempted suicide within the past year. * schizophrenic spectrum disorder (including mdd with psychotic features) * autism or another pervasive developmental disorder (e.g., pdd nos, asperger's disorder, child disintegration disorder, rett's disorder) * anorexia nervosa * bulimia nervosa * mental retardation * no relevant t-scores validate target disorders * adhd identified as primary reason for seeking treatment at phone screen * child's medication has not been regulated for one month or longer

Keywords: children youth adolescents anxiety depression trauma behavior problems evidence-based treatments manualized cognitive-behavioral therapy mental health
assessment of a b-mode ultrasound technique for the measurement of carotid artery intima-media thickness

Conditions: Atherosclerosis; Myocardial Infarction

Summary: this minimal risk protocol is designed to assess the reproducibility of b-mode ultrasound measurements of carotid intima media thickness (imt) when the scans are performed in cc radiology and read using a computerized edge reader. up to 20 volunteers will have two ultrasounds performed within a 6-month period. imt thickness is used as a surrogate marker for atherosclerosis and may be of value in clinical trials.

this minimal risk protocol is designed to assess the reproducibility of b-mode ultrasound measurements of carotid intima-media thickness (imt) when the scans are performed in cc radiology and read using a computerized edge reader. up to 50 volunteers will have two ultrasounds performed within a 6-month period. imt thickness is used as a surrogate marker for atherosclerosis and may be of value in clinical trials.

Eligibility criteria:
adult (age 18 or older). desire to participate in the study; willing and able to provide informed consent. no history of stroke or carotid disease.

Keywords: atherosclerosis cardiovascular disease computerized edge reader myocardial infarction risk factor
controlled trial of valacyclovir in infectious mononucleosis

Conditions: Infectious Mononucleosis

Summary: the hypothesis is that an antiviral drug (valacyclovir) will reduce the amount of epstein-barr virus (ebv) in the mouths of university students with infectious mononucleosis (mono) while being a safe drug. because ebv is the cause of mono, it is expected that reduction of the amount of virus could result in faster recovery from the disease.

university of minnesota students 18 years of age or older who are referred by the boynton student health service during the first 7 days of infectious mononucleosis are eligible to participate. all of the subjects who enroll will be allowed to complete the study, but only the information from those students who truly have mono due to a primary infection with ebv as determined by laboratory tests will be used for the results. the students will be assigned by chance(randomized)either to receive the antiviral drug valacyclovir at a dosage of a 1 gram tablet every 8 hours for 14 days or no antiviral drug. nine research clinic visits over 180 days are scheduled for clinical exams, histories, and collection of mouth and blood samples. the amount of ebv in the mouth and blood will be measured by a molecular virology research test called real-time taqman polymerase chain reaction. the severity of illness will be evaluated using a scale that measures the degree of physical activity and intensity of symptoms. the safety of the drug will be monitored by periodically checking the blood cell counts, and assessing liver and kidney function among other parameters. personnel who do the lab work and analyze the data will not know the subjects' study drug assignments so that the data can be collected and analyzed objectively. the study will remain open to enrollment until 20 subjects with laboratory-confirmed primary ebv have been enrolled and followed for at least 2 weeks. the study will end when all subjects complete all scheduled study visits.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of infectious mononucleosis with onset no more the 7 days before enrollment; willingness to sign informed consent * willingness to provide blood and oral washing samples at regular intervals * females must have a negative urine pregnancy test and agree to use effective contraception (barrier or hormonal) for the first 30 days of the study if assigned to valacyclovir * corticosteroids are permitted only if prescribed by the subject's primary physisican for treatment of this acute disease exclusion criteria: * previous history of mono * pregnant or breast feeding * end-stage renal or liver disease * immunosuppressed due to underlying medical disease and/or immunomodulating medications prior to enrollment * onset of present illness \>7 days ago

Keywords: infectious mononucleosis epstein-barr virus valacyclovir quantitative pcr
gene therapy for achromatopsia (cnga3)

Conditions: Achromatopsia

Summary: a clinical trial of adeno-associated virus vector (aav) cnga3 retinal gene therapy for patients with achromatopsia

cnga3 retinal gene therapy for patients with achromatopsia

Eligibility criteria:
inclusion criteria: * are aged years or over * have achromatopsia confirmed by a retinal specialist investigator exclusion criteria: * are females who are pregnant or breastfeeding * have participated in another research study involving an investigational medicinal therapy for ocular disease within the last 6 months * have any other condition that the investigator considers makes them inappropriate for entry into the trial
ruxolitinib with calcineurin inhibitor and methotrexate vs. calcineurin inhibitor plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for hla-haploidentical hematopoietic stem cell transplantation

Conditions: Graft Versus Host Disease

Summary: low dose ruxolitinib with calcineurin inhibitor and methotrexate vs. calcineurin inhibitor plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for hla-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (atg) system.

the is a prospective, randomized two-arm, and multicenter study. to compare the efficacy and safety of low-dose ruxolitinib combined with calcineurin inhibitor and methotrexate vs. calcineurin inhibitor plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for hla-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (atg) system.

Eligibility criteria:
inclusion criteria: 1. patients must be diagnosed with malignant hematological disease. 2. aged 12-70 years. 3. received hla-haploidentical hematopoietic stem cell transplantation. 4. received myeloablative conditioning 5. karnofsky score ≥70. 6. creatinine clearance ≥60 ml/min (according to the cockcroft-gault formula). (7) liver and kidney function: aminotransferase (ast) and alanine aminotransferase (alt) ≤ 3 × upper limit of the normal range (uln), total bilirubin ≤ 2 × uln; serum creatinine ≤ 1.5 × uln. 8) left ventricular ejection fraction (lvef) ≥ 50% on echocardiography (echo). 9) life expectancy \>12 weeks. 10) voluntarily signed the consent form and could understand and comply with the requirements of the study. exclusion criteria: 1. active autoimmune disease, such as sle, rheumatoid arthritis, etc. 2. current clinically significant active cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by new york heart association (nyha) functional class, or a history of myocardial infarction within 6 months prior to enrollment. 3. other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes). 4. human immunodeficiency virus (hiv) infection. 5. cirrhosis of the liver, active hepatitis. 6. pregnant or lactating women. 7. patients who are concurrently enrolled in any clinical trials of similar drugs.

Keywords: graft versus host disease ruxolitinib hla-haploidentical hematopoietic stem cell transplantation
a randomized trial of l-735,524, an inhibitor of the hiv protease enzyme, and interleukin-2 in persons infected with hiv (note: only for patients who previously completed niaid 93 cc-113)

Conditions: HIV Infections

Summary: the purpose of this trial is to study l-735,524, which is an inhibitor of the hiv protease enzyme. it will be used with interleukin-2 in patients infected with hiv.


Eligibility criteria: