Kornimate/medical-research-clean huggingface dataset:
pilot study of pregabalin and prediction of treatment response in patients with postherpetic neuralgia

Conditions: Postherpetic Neuralgia

Summary: the primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in postherpetic neuralgia.

the study was stopped on 26 april 2013 due to feasibility issues (low enrollment) not safety. the overall risk-benefit of lyrica has not changed at all due to termination of this trial. only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.

Eligibility criteria:
inclusion criteria: * subjects must have pain present for more than 3 months after the healing of the herpes zoster skin rash. * at screening (v1) and baseline (v2), subjects must have a score of \>=4 on the numeric rating scale for pain (1 week recall period). * at baseline (v2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be \>=4. exclusion criteria: * subjects having other severe pain that may confound assessment or self evaluation of the pain due to phn. * neurolytic or neurosurgical therapy for postherpetic neuralgia * skin conditions in the affected dermatome that could alter sensation.
open label study of pharmacokinetics and safety of dose of adefovir dipivoxil in children and adolescents with hbv

Conditions: Hepatitis B

Summary: open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis b.

children and adolescents with chronic hepatitis b and compensated liver, hbeag-positive and serum hbv dna positive (greater than or equal to 1 x 100,000 copies/ml by roche amplicor monitor pcr) received doses of adefovir dipivoxil in a cross-over design. subjects aged 2-11 received two single doses (0.14 mg/kg and 0.3 mg/kg liquid formulation) and subjects 2-17 received one dose (10 mg liquid formulation).

Eligibility criteria:
inclusion criteria: * males and females between the ages of 2 and 17 (inclusive) with chronic hepatitis b as evidenced by the following: * hbsag positive for a minimum of 6 months * hbeag positive and hbv dna greater than or equal to 1 x 100,000 copies/ml at screening * children and adolescents with compensated liver disease * alt levels greater than or equal to 1.2 upper limit of normal (applicable to 7- to 17-year-old children and adolescents only)

Keywords: hepatitis b adefovir dipivoxil children adolescents pharmacokinetics
idb injection combined with ptns for managing children with oab not responding to monotherapy

Conditions: BOTOX; Percutaneous Tibial Nerve Stimulation

Summary: this study aimed to evaluate the outcome of simultaneous intradetrusor botox (idb) injection and percutaneous tibial nerve stimulation (ptns) for management of children with recurrent wetness since at least 6 months.

overactive bladder is a syndrome characterized by symptoms of urgency, with or without urgency incontinence, usually with increased daytime frequency and nocturia. the neurogenic or myogenic bladder dysfunction can lead to the symptoms that characterize overactive bladder. normal bladder contraction occurs when the muscarinic receptors in the detrusor muscle are stimulated with acetylcholine. although the pathogenesis of overactive bladder is not fully explained; sensitization of afferent nerves, deactivation of inhibitory mechanisms, and the emergence of contractions similar to primitive voiding reflexes are shown as pathogenetic mechanisms. another hypothesis is that the number of intercellular connections among detrusor myocytes increase, and these cells are spontaneously stimulated. in addition to the fact that the etiopathogenesis cannot be explained clearly and due to the intense relationship with the autonomic nervous system, undesirable systemic side effects are common in treatments applied.

Eligibility criteria:
inclusion criteria: * children with non-neurogenic overactive bladder defined after exclusion of neurogenic causes not responding to medical treatment for 6 months, and * aged of 7-16 years * presenting with recurrent night-time with occasional day-time wetness for overactive bladder. exclusion criteria: * recurrent oab manifestations within less than 6 months after the previous monotherapy * obstructive urinary tract diseases * a history of pelvic surgery * anatomical abnormalities * neurogenic bladder * syndromes that affect the bladder functions * either current infection that was evidenced by urinalysis and culture or within the last two months * systemic diseases inducing liability for wetness

Keywords: overactive bladder
a study to evaluate the efficacy and safety of abt-493/abt-530 in renally impaired adults with chronic hepatitis c virus genotype 1 - 6 infection

Conditions: Chronic Hepatitis C Virus (HCV) Infection

Summary: the purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with the abt-493/abt-530 combination regimen in adults with chronic hcv genotype 1 - 6 infection and chronic severe renal impairment.


Eligibility criteria:
inclusion criteria: * chronic hepatitis c virus (hcv) infection * screening laboratory results indicating hcv genotype 1 - 6 (gt1 - 6) infection. * subject must be hcv treatment-naïve or have failed previous hcv treatment. * subjects with underlying chronic renal impairment (estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2 as estimated by the mdrd method at screening, including those requiring dialysis). * non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis. exclusion criteria: * history of severe, life-threatening or other significant sensitivity to any excipients of the study drug. * female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. * recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. * positive test result at screening for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab). * hcv genotype performed during screening indicating co-infection with more than 1 hcv genotype; hcv gt3 infected, treatment-experienced subjects were excluded. * patients who failed a previous regimen containing protease inhibitor (pis) and/or nonstructural protein 5a (ns5a) inhibitors.

Keywords: treatment-naïve hcv gentoype 2 non-cirrhotic chronic hepatitis c hcv gentoype 5 hcv gentoype 4 hcv gentoype 6 hcv gentoype 1 compensated cirrhotic treatment-experienced hcv gentoype 3
association between tmao and diabetes

Conditions: Type2 Diabetes

Summary: background: the association of trimethylamine-n-oxide (tmao), a microbiota dependent metabolite from dietary choline and carnitine, with type 2 diabetes was inconsistent. objective: the investigators planned to investigate the association between plasma tmao and newly diagnosed type 2 diabetes as well as whether the association could be modified by the tmao-generating enzyme flavin monooxygenase 3 (fmo3) polymorphisms. design: this is an age- and sex-matched case-control study of 2694 participants: 1346 newly diagnosed cases of type 2 diabetes and 1348 controls. the patients of newly diagnosed type 2 diabetes were consecutively recruited from those attending for the first time the outpatient clinics of department of endocrinology, tongji medical college hospital, wuhan, china, from 2012 january to december 2014. concomitantly, the investigators recruited healthy individuals who were frequency-matched by age (±5 years) and sex to patients from an unselected population undergoing a routine health check-up in the same hospital. the inclusion criteria for controls and newly diagnosed type 2 diabetes were: age ≥ 30 years, body mass index (bmi) \< 40 kg/m2, no history of a diagnosis of diabetes and no history of receiving pharmacological treatment for hyperlipidaemia or hypertension. patients with clinically significant neurological, endocrinological or other systemic diseases, as well as acute illness or chronic inflammatory or infective diseases, were excluded from the study. all the participants enrolled were of chinese han ethnicity. all the participants gave informed written consent to the study and did not take any medication known to affect glucose tolerance or insulin secretion before participation. the study was approved by the ethics committee of the tongji medical college. concentrations of plasma tmao were measured, and fmo3 e158k polymorphism (rs2266782) were genotyped.


Eligibility criteria:
inclusion criteria: * concomitantly, we recruited healthy individuals who were frequency-matched by age (±5 years) and sex to patients from an unselected population undergoing a routine health check-up in the same hospital. * the inclusion criteria for controls and newly diagnosed type 2 diabetes were: age ≥ 30 years, body mass index (bmi) \< 40 kg/m2, no history of a diagnosis of diabetes and no history of receiving pharmacological treatment for hyperlipidaemia or hypertension. exclusion criteria: * patients with clinically significant neurological, endocrinological or other systemic diseases, as well as acute illness or chronic inflammatory or infective diseases, were excluded from the study.

Keywords: trimethylamine-n-oxide type2 diabetes enzyme flavin monooxygenase 3 polymorphisms
influence of pioglitazone for renal transplant function in diabetics

Conditions: Diabetes Mellitus; Kidney Transplantation; Proteinuria

Summary: the purpose of this study is to test whether pioglitazone is able to prevent the progression of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.

about 30 % of kidney transplant recipients will develop diabetes mellitus. this condition is a risk factor for graft dysfunction, graft loss and increased mortality of patients. inflammatory reactions within the graft and proteinuria are considered as pathogenetic mechanisms. recent studies indicated that pioglitazone might have beneficial effects on the urinary protein excretion of type 2 diabetic patients with diabetic nephropathy and was able to reduce systemic inflammation. this lead to the hypothesis that pioglitazone could improve proteinuria of kidney transplant patients with diabetes. comparison: effects of pioglitazone vs. placebo on proteinuria and renal function of kidney transplant recipients in a cross over study.

Eligibility criteria:
inclusion criteria: * kidney transplantation(\> 6 months ago) ; stable graft function * diabetes mellitus type 2 * acceptable glycemia (hba1c \< 8%) * creatinin clearance (mdrd)\>30 ml/min 1,73m²) * proteinuria \> 30 mg/24 hr exclusion criteria: * type 1 diabetes * pregnant or breast feeding women * congestive heart failure (\>stage 1 nyha) * creeping creatinin * treatment for rejection within 3 months prior to inclusion * alt, ast \> 2.5 fold the upper limit of normal * uncontrolled hypertension * hypo- or hyperthyroidism

Keywords: posttransplant diabetes mellitus kidney transplantation filtration fraction proteinuria
bedside optical retinal assessment of hypoxic ischemic encephalopathy in infants

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: the purpose of this study is to develop a novel noninvasive bedside optical coherence tomography (oct) imaging technique in newborn infants with hie that improves our ability to assess the range of retinal effects from hie and to diagnose and monitor treatments of hie.


Eligibility criteria:
inclusion criteria: infants are eligible if: * admitted to the intensive care nursery, outborn or inborn, with a clinical diagnosis of hie; and with the approval of the neonatologist * a parent or legal guardian provides written informed consent exclusion criteria: potentially eligible infants will be excluded if: • congenital or chromosomal anomaly that has a profound impact on brain or eye development (e.g. anencephaly, congenital cataract or peter's anomaly) and infants for whom there has been a clinical decision to limit life support.

Keywords: optical coherence tomography newborn infant
efficacy and safety of aju-s56 5% in dry eye syndrome patients

Conditions: Dry Eye Syndromes

Summary: this study is planned to evaluate the efficacy and safety of test drug (aju-s56 5%) compared to control drug(vehicle) in patients with dry eye disease.


Eligibility criteria:
inclusion criteria: * male and female who over 19 years old * moderate to severe dry eye disease patients * must meet all criteria listed below at least in one eye or both eyes. 1. tcss (national eye institute (nei) scale)≥ 4 2. ocular discomfort score (ods) ≥ 3 3. schirmer test(without anesthesia) ≤ 10mm in 5 mins 4. tear break-up time ≤ 6 secs * written informed consent to participate in the trial exclusion criteria: * those who have clinically significant eye disease not related to dry eye syndrome * those who have worn contact lenses before 1week screening visit or have to wear contact lenses or need to wear contact lenses during study period * those who have medical history with intraocular surgery 12months before screening visit * use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks * participation in other studies within 4weeks of screening visit

Keywords: dry eye
cardiac catheterization in cardiac arrest

Conditions: Out of Hospital Cardiac Arrest

Summary: this is a pilot study that will lead to a large randomized control trial (rct), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (ohca) patients.

a pilot multicenter rct. the objectives of the study are: to assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in ohca patients. patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (rosc) following ohca, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. percutaneous coronary intervention (pci) is recommended for culprit lesions found on diagnostic angiography. all patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°c according to local practice. other medical management will be according to standard of care

Eligibility criteria:
inclusion criteria: * glasgow coma scale score \<8 on hospital admission following ohca of presumed cardiac cause. * initial rhythm ventricular tachycardia (vt) / ventricular fibrillation (vf), who achieved rosc sustained for \>20 consecutive minutes exclusion criteria: * st-elevation on any of the ecgs post resuscitation * hypothermia \<30°c * interval from rosc to screening of \>12h * suspected or known acute intracranial hemorrhage or stroke
personalized treatment

Conditions: Eating Disorders; Eating Disorder Symptom

Summary: the personalized treatment study creates an individualized network of symptoms for a participant with a current eating disorder. this network will be used to develop a personalized treatment intervention. this study aims to 1) determine if personalized treatments can be conducted using a network analysis of patient symptoms, and 2) to assess the effectiveness of network-informed personalized treatment for participants with eating disorders.

cognitive behavioral theory proposes that cognitions, behaviors, affect, and physiological symptoms interact with each other to maintain and exacerbate psychiatric disorders (beck, 2011). network theory identifies core symptoms that maintain and promote the spread of ed psychopathology within individuals (borsboom \& cramer, 2013). once identified, core "trigger" symptoms can be directly targeted to disrupt the spread or "activation" of ed behaviors, which would help patients achieve full recovery, and ultimately, prevent relapse. one of the main goals of the personalized treatment study is to create an individualized network for a participant with a current eating disorder, which can be used to develop a personalized treatment intervention. our research questions are: 1) can a personalized treatment plan be conducted from a network analysis of patient symptoms, and 2) how effective is this personalized treatment based off of a network of symptoms.

Eligibility criteria:
inclusion criteria: * current eating disorder diagnosis * at least 18 years of age, * not actively suicidal, * not manic, * not psychotic exclusion criteria: * no current eating disorder diagnosis, * younger than 18 years of age, * active psychosis, * active mania, or * actively suicidal.

Keywords: eating disorder network analysis personalized treatment mobile app
confirmatory study of indacaterol in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study is designed to collect long term safety data of indacaterol (300 µg o.d.) in japanese patients with moderate to severe copd. data from this study will be used for the registration of indacaterol in japan.


Eligibility criteria:
inclusion criteria: 1. diagnosis of copd (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines) and: * smoking history of at least 20 pack-years * post-bronchodilator fev1 \<80% and ≥30% of the predicted normal value * post-bronchodilator fev1/fvc (forced vital capacity) \<70% exclusion criteria: 1. patients who have been hospitalized for a copd exacerbation in the 6 weeks prior to visit 1 or during the run-in period 2. patients who have had a respiratory tract infection within 6 weeks prior to visit 1 3. patients with concomitant pulmonary disease 4. patients with a history of asthma 5. patients with diabetes type i or uncontrolled diabetes type ii 6. any patient with lung cancer or a history of lung cancer 7. patients with a history of certain cardiovascular comorbid conditions 8. patients who have been exposed to indacaterol previously. (except for any patient who enrolled in study cqab149b1302) other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd, chronic obstructive pulmonary disease, indacaterol, long acting β2-agonist
pain management of pecto-intercostal fascial block versus intravenous fentanyl after pediatric cardiac surgery

Conditions: Pediatric Patients; Congenital Heart Surgery

Summary: cardiac surgical patients often experience significant postoperative pain at the median sternotomy site. in pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg today lower doses are often used in order to achieve early extubation at such doses there is no guarantee that the stress response is completely abolished one way to overcome this problem is the use of the local anesthetic technique regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children. pectointercostal fascial block was first described by de la torre in patients undergoing breast surgery. this novel technique blocks the anterior cutaneous nerve which is a branch of the intercostal nerve that gives sensory supply to the skin.

the aim of the current study is to detect the effectiveness of pecto-intercostal fascial block in relieving postoperative pain in noncyanotic pediatric patients undergoing elective cardiac surgery the primary goal of this randomized study is to compare the postoperative pain score in the first postoperative 24 hours and to detect total dose of fentanyl requirements. the secondary goals are intraoperative hemodynamic stress response to surgical stimuli, analgesic consumption in the studied groups, cross-clamping and bypass time, time to extubation, intensive care length of stay, and postoperative complications.

Eligibility criteria:
inclusion criteria: * on pump * elective repair of congenital simple left to right intracardiac shunt * median sternotomy exclusion criteria: * refusal of their guardians * redo cardiac surgery * previous back injury * previous back surgery * kyphoscoliosis * local infection of the skin and subcutaneous tissue at the site of needle puncture * hypersensitivity to local anesthetics * coagulation disorders * renal disease * hepatic disease * pulmonary disease * heart failure * moderate to severe pulmonary hypertension.
pk study of iontophoretic dexamethasone phosphate ophthalmic solution in patients undergoing vitrectomy

Conditions: Vitrectomy

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk) of dexamethasone phosphate ophthalmic solution delivered via the eyegate® ii drug delivery system (egds) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

this is an open-label, multi-center, single-dose, phase 1 clinical trial designed to evaluate the pharmacokinetics (pk) of dexamethasone phosphate ophthalmic solution delivered via the eyegate® ii drug delivery system (egds) in the vitreous humor taken from patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Eligibility criteria:
inclusion criteria: 1. age 18 to 85 years 2. receive, understand, and sign a copy of the written informed consent form exclusion criteria: -
antibiotic therapy for infectious diseases

Conditions: Infectious Disease

Summary: tigecycline is a last-resort antibiotic that is used to treat severe infections caused by extensively drug-resistant bacteria. however, the efficacy and safety data for tigecycline in infectious patients are lacking. the aim of this study is to assess the efficacy and safety of tigecycline in infectious patients using pharmacokinetics and omics.


Eligibility criteria:
inclusion criteria: * critically ill hospitalized males or nonpregnant females aged 18 years with severe infections which the treating clinician was treating with tigecycline exclusion criteria: 1. severe liver dis- eases (e.g., child-pugh score c); 2. patients allergic to tetracycline and tigecycline; 3. those who have participated in other clinical trials, or those who are considered unsuitable by researchers; 4. pregnant women and lactating women.