Kornimate/medical-research-clean huggingface dataset:
vis-rx prime micro-imaging catheter study

Conditions: Coronary Artery Disease

Summary: to study the performance of the gentuity® hf-oct imaging system and vis-rx prime® micro-imaging catheter when used to obtain images of coronary arteries in patients who are undergoing cardiac catheterization and are candidates for interventional procedures. the study will evaluate ease of catheter use by physicians using the catheters, image quality and overall performance. the patient's involvement in the study ends when the cardiac catheterization/interventional procedure is completed.

this is a single arm, unblinded, multi-center, clinical evaluation that will be performed at 3 to 5 investigational sites in the united states with subjects who undergo hf-oct imaging as part of their cardiac catheterization procedure. this study will evaluate a range of device operators (interventional cardiologists) as well as patients and vessels consistent with the product labeling. the operator evaluation will be determined post use of the device using a likert grading scale. clear image length of the acquired hf-oct image will be measured by an independent core lab. safety will be monitored through the interventional procedure and adverse events that are potentially related to either the device or the procedure will be recorded, evaluated and analyzed.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * patients willing and able to provide written informed consent to participate in evaluation * patients who are candidates for transluminal interventional procedures for their coronary arteries (also known as pci) exclusion criteria: * bacteremia or sepsis * major coagulation system abnormalities * severe hemodynamic instability or shock * acute renal failure * disqualified for coronary artery bypass graft surgery * disqualified for percutaneous coronary intervention * patients currently enrolled in another study to evaluate an investigational device or medication * any target vessel which has undergone a bypass procedure the lesion-specific exclusion criteria assessed from angiography are: * total occlusion * coronary artery spasm * large thrombus (as visible under angiography)
the edmonton randomised controlled trial of nidcap - based developmental care

Conditions: Infant, Premature

Summary: nidcap based developmental care is a method of looking after preterm infants that is guided by the infant's behavioural cues, and that actively involves parents in the care of their infant. there is limited evidence that outcomes for infants are improved if they receive nidcap based care. this study evaluates the effects of introducing nidcap based care to a level iii neonatal intensive care unit, in the post - surfactant era, and also evaluates its effects on developmental outcomes at age 18 months.

this rct differs from previous trials in that it is conducted in the post - surfactant era \[an intervention that has greatly changed clinical neonatology\]. the number of infants required to demonstrate a clinically relevant outcome \[length of hospital stay\] has been calculated a priori. the infants will be tracked for outcome data after transfer to peripheral nurseries \[a reality in today's healthcare environment\], allowing generalisability of results to other high risk, referral neonatal intensive care units. neurodevelopmental outcomes will be evaluated at 18 months; \[these data are sparse from previous studies\]. this rct will therefore demonstrate whether nidcap based care is truly an effective intervention for the very low birth weight infant.

Eligibility criteria:
inclusion criteria: * birth weight between 500g to \<1250g * gestational age \</= 32 weeks * birth weight between 3rd to 97th percentile for gestational age * survival to \>48 hr age * at least one parent speaks english or a language spoken by study investigator * twins eligible if both meet all criteria exclusion criteria: * chromosomal abnormalities * major congenital anomalies * maternal drug and /or alcohol use in pregnancy * congenital infection * decision made to withdraw intensive care treatments, or discussion about this already initiated with family

Keywords: preterm infant behaviour developmental care nidcap family centred care neurodevelopmental outcome, preterm infant
treatment interruption of natalizumab

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab. the main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks: * when ms symptoms return, and * if other drugs for ms may help control ms symptoms during the natalizumab-interruption period. this study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.


Eligibility criteria:
major criteria include: * a diagnosis of a relapsing form of ms * treatment with natalizumab according to locally approved prescribing information * other protocol defined inclusion/exclusion criteria may apply

Keywords: ms
a study to evaluate abt-450 with ritonavir (abt-450/r) and abt-267 in japanese adults with chronic hepatitis c virus infection

Conditions: Chronic Hepatitis C Infection

Summary: this study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of abt-450 (also known as paritaprevir) with ritonavir (abt-450/r) and abt-267 (also known as ombitasvir) in adult japanese patients with chronic hepatitis c virus genotype 1b (hcv gt1b) or genotype 2 (hcv gt2) infection who were previous treated with pegylated interferon/ribavirin (pegifn/rbv).

this multicenter, randomized, open-label, parallel-arm, combination treatment study consisted of a treatment and post-treatment phase, divided into 2 cohorts: 1) chronic hcv gt1b- infected, pegifn/rbv treatment-exposed japanese adults; and 2) hcv gt2-infected, pegifn/rbv treatment-exposed japanese adults. the treatment phase evaluated the antiviral activity, safety, and pharmacokinetics of a range of abt-450/r and abt-267 doses for 12 to 24 weeks. the post-treatment phase evaluated the evolution and persistence of viral resistance to abt-267 and abt-450.

Eligibility criteria:
inclusion criteria: * females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile * chronic hepatitis c, genotype 1b (hcv-gt1b) or genotype 2 (hcv gt2) infection (hcv rna level greater than 10,000 iu/ml at screening) previously treated with pegylated interferon/ribavirin (pegifn/rbv). * subject's hepatitis c virus genotype is subgenotype 1b and subject was a null responder or partial responder, or * subject's hepatitis c virus genotype is subgenotype 2 and subject was a null responder, partial responder, or relapser (null responder: received at least 10 weeks of pegifn/rbv for the treatment of hcv and failed to achieve a 2 log10 iu/ml reduction in hcv rna at week 12; partial responders: received at least 20 weeks of pegifn/rbv for the treatment of hcv and achieved ≥ 2 log10 iu/ml reduction in hcv rna at week 12, but failed to achieve hcv rna undetectable (hcv rna \< lower limit of detection \[\< llod\]) at the end of treatment; relapsers: received at least 1 course of pegifn/rbv for the treatment of hcv and was undetectable at the end of treatment, but hcv rna was detectable within 24 weeks of treatment follow-up). exclusion criteria: * significant liver disease with any cause other than hcv as the primary cause * positive screen for drugs or alcohol. * positive hepatitis b surface antigen or anti-human immunodeficiency virus antibody. * use of contraindicated medications within 2 weeks of dosing * previous use of any investigational or commercially available anti-hepatitis c virus agent other than pegifn/rbv, including previous exposure to abt-450 or abt-267.

Keywords: japanese hepatitis c genotype 2 genotype 1b paritaprevir ombitasvir ritonavir viekirax combination tablets
preoperative levosimendan and heart failure

Conditions: Heart Failure; Hip Fracture

Summary: the purpose of this study is to investigate the safety and efficacy of levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.


Eligibility criteria:
inclusion criteria: * acute surgery. hip fracture * patient with cardiac failure (ef \< 35%) or known coronary disease * at least 2 of 11 comorbidities * patient has to use at least one heart failure medication * symptoms of heart failure * nt-probnp \> 2000pg/ml exclusion criteria: * \< 18 years old * participants in other pharmacological study * abuse of medicaments or alcohol * pregnant or breastfeeding women * ami at admission * hocm * serious aortic stenosis (\< 1 cm2) * sustained ventricular tachycardia * earlier episodes of "torsades de pointes" * sustained heartbeat \> 120/minute * systolic bp \< 90 mmhg * surgery planned not before 2 hours of study medication can be infused preoperative * cardiac surgery * dementia * s-k \< 3 mmol/l * allergy levosimendan * serious liver failure (known class c child-pugh score) * serious kidney failure (gfr \< 30 ml/min.) * prolonged qtc-interval (male qtc \> 0,43 s, female qtc \> 0,45 s)
screening and identifying hepatobiliary diseases via deep learning using ocular images

Conditions: Ophthalmology; Artificial Intelligence; Hepatobiliary Disease

Summary: artificial intelligence may provide insight into exploring the potential covert association behind and reveal some early ocular architecture changes in individuals with hepatobiliary disorders. we conducted a pioneer work to explore the association between the eye and liver via deep learning, to develop and evaluate different deep learning models to predict the hepatobiliary disease by using ocular images.


Eligibility criteria:
inclusion criteria: * the quality of fundus and slit-lamp images should clinical acceptable. * more than 90% of the fundus image area including four main regions (optic disk, macular, upper and lower retinal vessel archs) are easy to read and discriminate. * more than 90% of the slit-lamp image area including three main regions (sclera, pupil, and lens) are easy to read and discriminate. exclusion criteria: * images with light leakage (\>10% of the area), spots from lens flares or stains, and overexposure were excluded from further analysis.

Keywords: hepatobiliary disease artificial intelligence eye images
effect on music therapy on quality of recovery after gynecological laparoscopy

Conditions: Quality of Recovery After General Anesthesia; Post Operative Pain

Summary: in the present study, we intended to evaluate the effect of music intervention on postoperative pain, nausea, and comprehensive recovery quality in patients undergoing gynecological laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status classification i and ii, * undergoing gynecological laparoscopic surgery exclusion criteria: * any hearing impairment, * known psychiatric or memory disorder * alcohol or analgesics abuse * inability to complete quesationnaires
influence of progesterone administration on drug-induced qt interval lengthening

Conditions: Prolonged QT Interval in EKG and Sudden Death

Summary: female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia (irregular heartbeat) known as torsades de pointes (tdp), which is associated with prolongation of the corrected qt (qtc) interval on the electrocardiogram (ecg). mechanisms for this increased risk in women are not well-understood. qtc interval duration has been shown to fluctuate throughout the phases of the menstrual cycle. evidence indicates that the qtc interval response to drugs that may cause tdp is greater during the menses and ovulation phases of the menstrual cycle, during which serum progesterone concentrations are lowest, and lesser during the luteal phase, during which serum progesterone concentrations are highest. additional evidence from our laboratory suggests that progesterone may be protective against tdp. specific aim 1: establish the influence of oral progesterone administration as a preventive method by which to diminish the degree of drug-induced qt interval prolongation in women. working hypothesis: oral progesterone administration effectively attenuates enhanced drug-induced qt interval response in women. to test this hypothesis, progesterone or placebo will be administered in a crossover fashion to women during the menses phase of the menstrual cycle. qtc interval response to low-dose ibutilide, a drug known to lengthen the qt interval, will be assessed. the primary endpoint will be individually-corrected qt interval (qtci) response to ibutilide, in the presence and absence of progesterone, which will be assessed by: 1) effect on maximum change in qtci, and 2) area under the qtci interval-time curves (auec). at the conclusion of this study, we will have established that oral progesterone administration is a safe and effective method of attenuating drug-induced qt interval prolongation.


Eligibility criteria:
inclusion criteria: * female * age 21-40 years * premenopausal exclusion criteria: serum potassium ,\< 3.6 meq/l * serum magnesium \< 1.8 mg/dl * serum hemoglobin \< 9.0 mg/dl * serum hematocrit \< 26% * hypertension * coronary artery disease * heart failure * liver disease * kidney disease * serum creatinine \> 1.5 mg/dl * taking hormone contraceptives * baseline bazett's correct qtc interval \> 450 ms * family history of long-qt syndrome, arrhythmias, sudden cardiac death * concomitant use of any qt prolonging drug * pregnancy * weight \< 45 kg * unwillingness to use non-hormonal forms of birth control during the study period

Keywords: torsades de pointes progesterone clinical trial risk reduction electrocardiography
cost- effectiveness and quality of life assessment in mood disorder

Conditions: Bipolar Disorder

Summary: to evaluate the effectiveness of three systematic interventions for bipolar disorder (bd) mixed episodes using medications available in the brazilian public healthcare system (sus), and assessment of the quality of life of these patients. a randomized pragmatic trial was conducted. an algorithm was developed for the treatment of episodes of bipolar mixed episodes.

the study design was that of a pragmatic randomized clinical trial to evaluate the effectiveness of treatments for mood disorders in a public healthcare context in the city of porto alegre, in southern brazil. the algorithm was originally developed for the treatment of mixed episodes by a delphi panel of experts from psychiatric associations in brazil. all subjects provided an informed consent form, in writing, in order to participate in the study protocol, which was approved by the institutional ethics committee. procedures and measurements of the study the subjects under evaluation were selected and they followed the stages defined by the treatment protocol: 1. sample selection by being referred from the primary healthcare clinics in the municipality; 2. informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects; 3. screening for bd mixed episodes with the use of the patient health questionnaire (phq-9), and hypomanic symptoms checklist brazilian version (hcl -32-bv); 4. diagnostic evaluation through the mini international neuropsychiatric interview (mini) and clinical interview for individuals with positive results in the screening instruments; 5. baseline and demographic assessments using standardized semi-structured interviews in the first and second visits; 6. in each clinic visit, the severity of the symptoms were evealuated using the clinical global impression scale (cgi), hamilton rating scale for depression (hrsd), and young manic rating scale (ymrs); 7. biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.

Eligibility criteria:
inclusion criteria: 1. ages between 18 and 65; 2. bd current acute mixed episode; 3. total capacity to understand and respond to self-applied instruments; 4. the presence of symptoms in the last 30 days; 5. abstinence for at least 30 days for drug addicts. exclusion criteria: 1. presence of organic brain syndrome (obs); 2. pregnancy or lactation; 3. criteria for psychiatric hospitalization.

Keywords: cost effectiveness bipolar disorder mixed episodes quality of life
replication of the lead-2 diabetes trial in healthcare claims data

Conditions: Diabetes

Summary: investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. the investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

this is a non-randomized, non-interventional study that is part of the rct duplicate initiative (www.rctduplicate.org) of the brigham and women's hospital, harvard medical school. it is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. investigators assume that the rct provides the reference standard treatment effect estimate and that failure to replicate rct findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original rct finding.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus \[0,0\] days * 3 or more recorded hba1c values \[-365, 0\] days * at least two dispensing claims for metformin \[-180,0\] days * 1 or more recorded hba1c values \[-90,0\] days * age between 18-80 \[0,0\] days exclusion criteria: * cancer, malignant neoplasm, or men2 \[-1,825,0\] days * use of other anti-diabetic medications \[-180,0\] days * cirrhosis or hepatic decompensation \[-180,0\] days * viral hepatitis b or c \[-180,0\] days * stage 5 ckd, esrd, dialysis or renal transplant \[-180,0\] days * mi or hf \[-180,0\] days * treatment with anti-vegfi or photocoagulation \[-180,0\] days * hypertensive crisis or uncontrolled hypertension \[-180,0\] days * two diagnoses of hypoglycemia \[-180,0\] days * alcohol/drug abuse/dependence \[-180,0\] days * dementia and brain damages or non-compliance \[-180,0\] days * pregnancy \[-180,0\] days * type 1 dm, dka, or other metabolic acidosis \[-180,0\] days * systemic corticosteroids \[-90,0\] days
exploratory study to assess the efficacy and safety of a triple combination for acute pain treatment in patients with temporomandibular joint disorders (tmjd).

Conditions: Temporomandibular Joint Disorders

Summary: the objetive of this study is to explore the efficacy and safety of a triple combination of ibuprofen, magnesium and ascorbic acid for acute pain treatment in tmjd patients


Eligibility criteria:
inclusion criteria: 1. tmd dysfunction syndrome patients of rdc/tmd groups ia and/or ib (+/- iiia and/or iiib); with moderate to severe pain (vas \>4), refractory to conservative treatment (including splint / local prosthesis) 2. subjects between 18 and 65 years. 3. body weight within the normal range (imc index between 19 and 30) expressed as weight (kg) /height (m2). 4. physical condition according to asa i or ii (american society of anesthesiologists) 5. having not participated in previous clinical trial during the three months preceding the setting-up of this study. 6. free acceptance to collaborate in the study, expressed by signature of written informed consent by the participant exclusion criteria: 1. patients who are pregnant or breastfeeding. 2. patients who have a consumption of enzyme-inducing drugs within the 30 days prior to the study: carbamazepinam, nevirapine, phenobarbital, rifampin, secobarbital and st. john's wort. 3. patients who are consuming: acetaminophen, acetyl salicylic acid, bemiparina, clonixidina, oral anticoagulant, heparin and derivatives, systemic corticosteroids, pemetresed, digoxin, phenytoin, lithium, methotrexate, salicylates, nsaids, antacids containing aluminum, such as algeldrato, magaldrate, morphine and its derivatives. patients who have been medicated with nsaids or morphic derivatives for the treatment of pain of tmd prior to attending the consultation will be included whether, they meet a washout period of 8 to 12 hours (depending on the medication taken) before being included in the study. 4. patients with underlying systemic pathology candidate to receive drug treatment with analgesic. 5. in patients with a history of gastrointestinal bleeding or perforation related to previous treatment with nsaids. peptic ulcer / active or recurrent gastrointestinal hemorrhage (two or more episodes of ulceration) or proven hemorrhage. 6. patients with active ulcerative colitis or crohn's disease. severe heart failure. severe renal dysfunction. severe hepatic dysfunction. 7. patients with urolithiasis by oxalate 8. history of alcoholism or drug dependence within 3 months prior to the screening visit, and / or, history of psychotropic drugs consumption within 3 months prior to the screening visit. 9. heavy consumer of stimulating beverages (\>5 coffees, teas, or cola drinks per day). 10. history of drug allergy, idiosyncrasy or hypersensitivity. 11 patients with cerebrovascular bleeding or other active bleeding 12 patients with bleeding diathesis or other bleeding disorders .

Keywords: temporomandibular joint pain ibuprofen magnesium vitamin c