Kornimate/medical-research-clean huggingface dataset:
preserve-transplant study

Conditions: Acidosis; Renal Insufficiency; Kidney Transplantation

Summary: the aim of this study is to test if alkali treatment will preserve kidney graft function and diminish the progression of chronic kidney disease in renal transplant patients. additionally the underlying mechanisms of nephrotoxicity of metabolic acidosis will be investigated in this cohort. this study is a multi-center, prospective, randomized, single-blind (patient), placebo-controlled interventional trial to test the superiority of alkali treatment in comparison to placebo on preservation of kidney function in 300 kidney transplant recipients. the duration of the study will be 2 years for the individual participant. the patients will be randomized into 2 arms: intervention arm (sodium hydrogen carbonate, product: nephrotrans®) and placebo arm (placebo comparator). several studies in ckd (chronic kidney disease) patients have shown that alkali therapy slows progression of ckd.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * age ≥ 18 years and able to give informed consent * ≥ 12 months after renal transplantation * stable clinical condition * stable graft function over the last 3 months (creatinine changes ± 15%) * egfr between 15-89 ml/min/1.73 m2 * serum bicarbonate ≤ 22 mmol/l within the last 6 months exclusion criteria: * uncontrolled hypertension or use of \> 4 antihypertensive agents * uncontrolled heart failure * serum potassium \< 3.0 mmol/l * serum sodium \> 150 mmol/l * use of alkali in the preceding 4 weeks * use of mineralocorticoid antagonists, topiramate, carbo anhydrase inhibitors or any drugs with similar effects * history of noncompliance with clinic visits * hereditary fructose intolerance * known hypersensitivity or allergy to the drug used in this study or to peanut, sorbitol, and soy * pregnancy or breastfeeding * intention to become pregnant during the course of the study * lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. * please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * suspected drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: alkali graft acid base metabolic acidosis chronic kidney disease
desloratadine 5, 10 and 20mg in patients with cold urticaria

Conditions: Urticaria

Summary: the primary objective of the study is to assess the dosis of dl which is sufficient to inhibit cold urticaria symptoms.

a total of 30 patients (male and female) with acu will be included in this study

Eligibility criteria:
inclusion criteria: * informed consent signed and dated * reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. a highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some iuds, sexual abstinence or vasectomised partner * outpatients with acu for more than 6 weeks. urticaria symptoms must comprise wheal and itch. * age between 18 and 75 years exclusion criteria: * subjects who are inmates of psychiatric wards, prisons, or other state institutions. existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 amg (arzneimittelgesetz). * the presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria * the presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract) * history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia * history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy * evidence of severe renal dysfunction * evidence of significant hepatic disease (liver enzymes twice the upper reference value) * history of adverse reactions to dl * presence of active cancer which requires chemotherapy or radiation therapy * presence of alcohol abuse or drug addiction * intake of oral corticosteroids within 14 days prior to screening visit * use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to screening visit * use of systemic immunosupressants/immunomodulators like ciclosporine a, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit. * pregnancy or breast-feeding

Keywords: acu acquired cold urticaria
evaluation of ccr2 in patients post myocardial infarction

Conditions: Heart Diseases

Summary: to determine the feasibility of 64cu-dota-ecl1i, an investigational pet imaging drug, at the cellular level in the myocardium for individuals who have suffered a heart attack or who have other inflammatory heart disease.

to determine the feasibility of 64cu-dota-ecl1i to detect ccr2+monocytes and macrophages which are cells that are responsible for protecting tissues from foreign substances in the myocardium by pet/mr and pet/ct.

Eligibility criteria:
inclusion criteria: 1. healthy volunteers: 2. age 21 to 80 years of either sex, any race 3. capable of lying still and supine within the pet/ct and pet/mr scanner for 1 hour and follow instructions for breathing protocol during the ct portion 4. no illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year 5. no known history of cardiac. pulmonary, hepatic, or renal disease or diabetes 6. no history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions 7. able to comprehend and willing to follow instructions for the study procedures as called for by the protocol. inflammatory heart disease 1. age 21 to 80 years of either sex, any race who have suffered a stemi within the past 6 months as well as other forms of inflammatory heart disease including sarcoidosis, myocarditis, cardiomyopathy, injected cardiovascular implantable electronic devices pacemakers/lvad 2. are clinically stable to undergo imaging with either pet/mr or pet/ct. 3. capacity to give written informed consent and ability to follow study procedures 4. pre-menopausal women must have a negative urine pregnancy test within 24 hours prior to the administration of 64-cu-dota-ecl1i. exclusion criteria: healthy volunteers: 1. currently enrolled in another study using an investigational drug 2. angina 3. uncontrolled heart failure 4. uncontrolled hypertension baseline hypotension below 90/50 5. has any condition that in the opinion of the pi or designee that could increase risk to the subject 6. is deemed likely to be unable to perform all research procedures 7. have contraindications to pet/ct imaging like claustrophobia 8. have contraindication to gadolinium 9. pregnant or breastfeeding 10. currently using recreational drubs 11. body weight of more than 300 lbs 12. active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes 13. currently taking any prescription medications 14. presence of an implanted device incompatible with ct or mri scanning inflammatory heart disease 1) clinically unstable including post mi angina, uncontrolled heart failure, sever hypertension, hypotension av block 2) has any condition that in the opinion of the pi could increase risk to the subject 3) claustrophobia 4) contraindication to gadolinium contrast 5) pregnant 6) currently using recreational drugs 7) body weight more than 300 lbs 8) currently enrolled in another study
stress management among latinos with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the primary aims of this study are to: 1. tailor a diabetes stress management intervention for delivery by community health workers (chws) serving an urban latino population. 2. investigate the efficacy of the stress management intervention on glycemic control. secondary aims of this study are to: 3. investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity. study hypothesis: a chw-led group-based diabetes education model enhanced with stress management education will improve glycemic control more than chw-led group-based diabetes education alone.


Eligibility criteria:
inclusion criteria: * latinos age 18 or older that are ambulatory * spanish speaking * diagnosed with type 2 diabetes for at least 1 year * hemoglobin a1c levels greater than 7.0 exclusion criteria: * medical instability or medical treatment requiring inpatient care * diagnoses of bipolar disorder or thought disorder (or taking medications prescribed for either); current substance abuse or dependence disorder * current suicidality or history of suicide attempt * history of psychiatric hospitalization * taking antidepressant medications prescribed for the treatment of depression accompanied by either a) changes to the antidepressant regimen within previous 6 weeks, or b) anticipated changes to the regimen during period of study. such patients will be deferred and re-evaluated for eligibility after 6 months

Keywords: type 2 diabetes
effect of short term ovarian suppression on androgen overproduction in overweight girls with androgen excess

Conditions: Hyperandrogenemia; Obesity; Polycystic Ovary Syndrome

Summary: this study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. the investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (rhcg).


Eligibility criteria:
inclusion criteria: * overweight (\>85th bmi%) females * early to late puberty (expected age range 7-18) * hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same tanner stage) * screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (lh), lipids, testosterone, prolactin, dheas, e2, glucose, and insulin and decreased follicle-stimulating hormone (fsh) and/or sex hormone-binding globulin (shbg) exclusion criteria: * screening labs outside of age-appropriate normal range * hemoglobin \<12 mg/dl and hematocrit\<36% (subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. if still \<36%, they will be excluded.) * morning cortisol \<5 g/dl * 17-hydroxyprogesterone \>295 ng/dl * history of cushing's syndrome or adrenal insufficiency * pregnant
a cohort study of congenital cytomegalovirus infection among pregnant women and their newborns in china

Conditions: Congenital Cytomegalovirus Infection; Cytomegalovirus Infection Reactivation

Summary: the purpose of this study is to assess the risk of congenital cytomegalovirus (ccmv) infection in newborns born to seropositive women.

this study will be conducted at several maternal and child health hospitals (mchhs) in china and the research activities will be integrated with routine medical services during pregnancy at the study sites.the investigators will build a perspective cohort study enrolling \~8000 pregnant women elder than 18 and following up their newborns at specific mchhs.as a first step, the investigators will work with these hospitals to recruit the subjects. after being informed, the participants' remaining blood and urine samples (after their medical examinations) at their early, medium and late stages of pregnancy will be collected , and their newborns' urine and saliva samples will be collected after delivery. the aim of this study is to enroll 5000 series mother-newborns.

Eligibility criteria:
inclusion criteria: * females aged 18 and older * pregnancy confirmed by ultrasound * come to mchhs for "pregnancy registry" within 24 weeks of pregnancy exclusion criteria: * not capable of complying with study procedures, or having a psychosis, two-stage affective psychosis, or have a tendency to suicide * having any autoimmune diseases (include systemic lupus erythematosus, rheumatoid arthritis), immunodeficiency (e.g. aids), chronic disease history such as cancers

Keywords: cytomegalovirus
hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities

Conditions: Pectus Excavatum

Summary: this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test


Eligibility criteria:
inclusion criteria: * patients seeking treatment of a pectus excavatum * haller index \> 3.2 * desire for treatment * age between 15 and 40 years old exclusion criteria: * cognitive impairment * pregnancy * contraindication to exercise stress test or general anesthesia * coagulation disorders

Keywords: pectus excavatum cardiac output transthoracic impedancemetry
efficacy and toxicity of bepotastine 1,5% pf vs olopatadine 0,2% with bak on allergic conjunctivitis treatment

Conditions: Allergic Conjunctivitis

Summary: the present study will be carried out to evaluate the antiallergic efficacy of bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with allergic conjunctivitis. the antiallergic efficacy will be evaluated by the reduction of ocular signs and symptoms and by the resolution of non-ocular symptoms (rhinorrhea, congestion, and nasal pruritus), as well as the effect of the preservative and its relationship with the cytotoxicity of the ocular surface. also will evaluate the safety of both products.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old. * clinical diagnosis of allergic conjunctivitis and active allergy with at least 2 points on itching and hyperemia scale. * patients with history of allergic conjunctivitis. * patients who accept no to wear contact lens during the duration of the trial. * patients who accept no to use any other medication by any delivery route. * patients with intraocular pressure controlled (less than 18 mmhg) exclusion criteria: * patients who have undergone refractive surgery within the 6 months prior to the start of the study * patient with ocular or systemic active diseases * patients who are participating in another trial * patients who have used eye medication in the last 15 days and/or who have received anti-inflammatory drugs (corticosteroids and/or nsaids) and/or antihistamines by mouth or intravenous. * patients hypersensitive to any component of the products: bepotastine besilate, sodium chloride, monosodium phosphate dihydrate, sodium hydroxide, olopatadine hydrochloride, benzalkonium chloride, dibasic sodium phosphate, hydrochloric acid, edetate disodium or povidone k29 / 32. * women who are breastfeeding and pregnant.
a study of ly2409021 in participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the intent of this study is to assess the safety of ly2409021 in participants with type 2 diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal physician. the study treatment is expected to last 12 months (52 weeks).


Eligibility criteria:
inclusion criteria: * have been treated with a stable dose of metformin for at least 3 months and have been treated with an optimally effective and stable dose of an sulfonylurea for at least 6 months prior to screening. * hba1c value between 7.0% and 10.0%, inclusive. * body mass index (bmi) between 20 and 45 kilograms/square meter (kg/m\^2), inclusive. exclusion criteria: * known type 1 diabetes mellitus. * more than 1 episode of severe hypoglycemia within 6 months prior to screening. * two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening. * severe gastrointestinal disease that may significantly impact gastric emptying or motility or having undergone gastric bypass or gastric banding surgery. * previous history or active diagnosis of pancreatitis. * positive hepatitis b surface antigen or hepatitis c antibody. * clinical signs or symptoms of liver disease, or hepatic aminotransferases (aminotransferase or alanine aminotransferase) greater than 2.0× upper limit of normal (uln) or elevated alkaline phosphatase (greater than uln) unrelated to bone metabolic disease. * elevated total bilirubin level (greater than uln), clinically suspicious signs/symptoms of cirrhosis or history of cirrhosis. * current diagnosis, personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia (men), or von hippel-lindau. * contraindications for magnetic resonance imaging.
a comparison of the efficacy and safety of topiramate versus placebo in treating tremor of unknown cause.

Conditions: Essential Tremor

Summary: the purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo in treating patients with tremor of unknown cause.

essential tremor is a very common form of tremor, occurring in up to 5% of people. it may be inherited. in 90% of patients, the tremor is in the hands; however, it can also be in the head, voice, legs, jaw, and tongue. essential tremor may be treated by the blood pressure medicine propranolol or the anti-seizure drug primidone. the drawbacks of these drugs are that they tend to lose effectiveness over time, and they may cause side effects. researchers believe that topiramate, an anti-seizure drug, may be effective in treating essential tremor. in this double blind, placebo-controlled study, patients with essential tremor will start at a low dose of topiramate (25 milligrams) or placebo. the dose will be gradually increased over 12 weeks to a maximum of 400 milligrams daily, taken in two divided doses. then, each patient will stay on the established dose for the next 12 weeks. during the next phase of the study, the patients will slowly reduce the dose until they stop taking the study drug, after which, patients have the option of taking up to 600 milligrams of topiramate (not placebo) in a 14-week extension of the study. this study was designed to investigate the hypothesis that topiramate will be more effective than placebo in the treatment of essential tremor as measured by the clinical rating scale for tremor (trs) and is well tolerated. the trs is a three part scale that measures tremor location/severity rating, specific motor tasks/function rating, and functional disabilities resulting from tremor. safety evaluations are assessed throughout the study. topiramate or placebo, starting with a dose of 25 mg, then gradually increased over 12 weeks up to 400 mg daily (two 100-mg tablets taken by mouth twice a day) and continued on this dose for 12 weeks in the maintenance phase; up to 600 milligrams of topiramate in the open-label phase.

Eligibility criteria:
inclusion criteria: * current symptoms of essential tremor based on the tremor investigational group (trig) criteria * dominant upper extremity posture or action intention tremor of 2 (moderate) to 4 (severe) * in good health otherwise exclusion criteria: * patients with abnormal neurologic signs other than essential tremor * taking more than one anti-tremor medication * taking drugs known to cause tremors * with physical damage to the nervous system or parkinson's disease * known to be abusing drugs or alcohol * women who are pregnant or breast-feeding

Keywords: tremor essential tremor
rasagiline for gait treatment

Conditions: Parkinson Disease

Summary: gait disturbances are very common and are a major cause for losing of independency in patients with advanced parkinson's disease (pd). the medical treatment of gait disturbances in advanced pd is very difficult and in many cases the classical dopaminergic treatment has no clinical benefit or even can worsen the instability and increase falls. rasagiline, a new mao-b inhibitor who has recently been approved all over the world for the treatment of early and late stages pd has been suggested to have a special effect of gait in patients with advanced pd (largo sub-study).


Eligibility criteria:
inclusion criteria: * patients with pd who experience motor response fluctuations and have gait disturbances at on and off (tuag \>10 secs in on and 14 secs in off) treated with a stable dose of antiparkinsonian medications for the last month. patients must be able to identify both situations * able to walk for 2 minutes at the off and on state * non-demented (mmse= or \> to25) exclusion criteria: * severe orthopedic problems * orthostatic hypotension on basal visit * severe, troublesome on dyskinesias * dementia (mmse \<25) * major depression * active psychosis or on anti-psychotic medications * patients who are unlikely to complete the full protocol. * patients who have tried rasagiline and stopped because of side effects or lack of symptomatic effect * treatment with selegiline for the last 2 months * any contraindication according smpc

Keywords: parkinson disease gait