Kornimate/medical-research-clean huggingface dataset:
hcv (hepatitis c virus) viral and host genotyping (il28b, interleukin 28b) in china

Conditions: Hepatitis C

Summary: the primary objective of this study is to estimate the distributions of hcv viral/human genotypes (including il28b and inosine triphosphatase, itpa), and hcv rna level among itpa gene among 1000 han ethnic chinese patients with hcv who are antiviral treatment naive at the time the study is conducted.

a sample of 1000 han ethnic chinese male or female who are ≥ 18 years old with a recent confirmation of anti-hcv-antibody positive and hcv rna positive but antiviral treatment naive from 28 university affiliated hospital in china. the primary objective of this study is to estimate the distributions of hcv viral genotyping(ie, genotype 1 through 6 and their known subtypes), and host genotypes, both inosine triphosphatase (itpa) gene, and il28b. this study also collects other data including patients' demographic and clinical characteristics. there is no active antiviral treatments and no follow-up in this study.

Eligibility criteria:
inclusion criteria: * male or female * han ethnic * ≥ 18 years old * recent confirmation of anti-hcv-antibody positive and hcv rna positive 30 days prior to the recruitment * antiviral or interferon treatment naive exclusion criteria: * \< 18 years old * not han ethnic * treated by antiviral before this study

Keywords: hcv viral genotypes host genotypes il28b itpa rna china
a randomized study of azetukalner versus placebo in major depressive disorder

Conditions: Major Depressive Disorder

Summary: x-nova2 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with major depressive disorder (mdd)


Eligibility criteria:
key inclusion criteria: * adults ≥18 and ≤74 years of age and experienced their first major depressive episode (mde) prior to 50 years of age * body mass index (bmi) ≤40 kg/m2 * meets the diagnostic and statistical manual of mental disorders fifth edition text revised (dsm-5-tr) criteria for current major depressive disorder and is currently in an mde, confirmed using the mini international neuropsychiatric interview (mini) * participant's current mde has a duration of ≥6 weeks and ≤24 months. key exclusion criteria: * participant has a primary diagnosis of a mood disorder other than mdd. * participant has a history of any of the following: mdd with psychotic or catatonic features; mdd with mixed features; bipolar i or ii disorder; obsessive-compulsive disorder; schizophrenia, primary thought disorder, or other psychotic disorder. * participant has a current diagnosis of any of the following: mdd with seasonal pattern; depression with peripartum onset; posttraumatic stress disorder; antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); panic disorder and/or agoraphobia; adhd treated with a psychostimulant, diagnosed during the current mde, or with unstable symptoms, as judged by the investigator. * participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening. * participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or ≥2 lifetime suicide attempts. * participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening. * participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization. * participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current mde as determined by the antidepressant treatment response questionnaire (atrq). * participants with medical conditions that may interfere with the purpose or conduct of the study * participant is pregnant, breastfeeding, or planning to become pregnant.

Keywords: depression antidepressant xen1101 azetukalner
biotronik conduction system pacing with the solia lead - solia csp s

Conditions: Sinus Node Dysfunction; Bradycardia; Atrioventricular Block

Summary: the purpose of the bio-conduct study is to demonstrate the safety and effectiveness of the biotronik solia csp s pacing lead when implanted in the left bundle branch area (lbba). safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. efficacy will be assessed by evaluating implant success rate.


Eligibility criteria:
inclusion criteria: * patient is a candidate for implantation of a biotronik pacemaker system, per standard guidelines. single chamber, dual chamber, and crt-p systems are allowed. * patient has an implant planned to utilize left bundle branch area (lbba) pacing within 30 days of consent * patient is able to understand the nature of the study and provide written informed consent * patient is available for follow-up visits on a regular basis for the expected duration of follow-up * patient accepts home monitoring® concept * patient age is greater than or equal to 18 years at time of consent exclusion criteria: * patient meets a standard contraindication for pacemaker system implant * patient is currently implanted with a pacemaker or icd device * patient has had a previous unsuccessful attempt to place a lead in the lbba * patient has planned cardiac surgical procedures or interventional measures within 3 months after implant * patient is expected to receive a heart transplant within 12 months * patient life expectancy less than 12 months * patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder * patient reports pregnancy at the time of enrollment * patient is enrolled in any other investigational cardiac clinical study during the course of the study
understanding cardiac events in breast cancer

Conditions: Breast Cancer; Cardiotoxicity; Cardiomyopathies; Chemotherapeutic Toxicity; Heart Failure; Oncology

Summary: in ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9 irish women will be diagnosed with breast cancer in their lifetime. there is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts. this research is focused on evaluating pathways for identifying, managing, and overcoming side effects of cancer therapies that can negatively impact quality-of-life and overall outcomes for women during and after cancer treatment. the cardio-oncology research team at guh plan to capitalize on their expertise in both cancer care and cardiology to develop a care pathway for cancer patients who are at increased risk of developing heart disease.

establishment of a cardio-oncology assessment and surveillance pathway for breast cancer patients undergoing adjuvant systemic chemotherapy at guh and the assessment of the feasibility of trialing this approach for risk assessment and early detection of ctrcd in a multicenter, prospective rct which will inform future development of clinical services for cancer patients nationally and later internationally. study design: this study is a prospective, single arm, pilot feasibility study. study population: the study will focus on adult female patients diagnosed with stage i-iii breast cancer (bc). data analysis and statistics: the pcore investigators have established collaboration with biostatisticians at the insight sfi centre for data analytics within university of galway for analysis of the multi-component dataset from ucare. questionnaire data to assess health related qol (quality of life) and physical activity will be collected at baseline and at 6-monthly intervals at 3, 6 and 12 months throughout the study period. clinically important differences in physical activity levels or hr-qol scores will be recorded as per the tool specific scoring systems. multivariate analysis will be performed for association between hrqol measures and predictors in patients undergoing breast cancer treatment. baseline to 6, 12, 18 and 24 month changes in hrqol over time will be described in subgroups defined by their treatment characteristics and tumor and host response to therapy (both oncologic and cardio-toxic).

Eligibility criteria:
inclusion criteria: * women aged ≥ 18 years * ability to read and understand english * breast cancer stage i- iii planned to receive systemic chemotherapy exclusion criteria: * patients not for systemic chemotherapy with curative intent * patients who are unable to co-operate with the study protocol * patients who are unable to give informed consent

Keywords: cardio oncology
biopotentials for clinician satisfaction with sedation in colonoscopy

Conditions: Bowel Disease

Summary: nurse-administered propofol sedation has become the standard procedure for colonoscopy in germany. although patient satisfaction with this method is high, there is little data about the satisfaction of the examiner and factors that might negatively influence this satisfaction. often due to the fact that the sedated patient usually expresses pain by movements of the body and paralinguistic sounds the examination has to pause until the next propofol bolus induces a deeper sedation. in order to measure the correlation of examiner satisfaction and negative factors the investigators initiated this prospective observational study. during this study examiner satisfaction and the correlation with observer reported pain (movements and paralinguistic sounds) will be measured. additionally different biopotentials (electromyography, skin conductance level, body temperature, pulse) of the patient will be recorded during the examination and feature pattern will be correlated to the observer reported pain in order to detect pain before the expression of pain leads to a pause in the colonoscopy examination. other factors that might influence examiner satisfaction, like duration to reach the caecum and duration of polypectomy will additionally be evaluated.


Eligibility criteria:
inclusion criteria: * age above 18 * asa classification i to ii * indication for colonoscopy with propofol sedation * written informed consent exclusion criteria: * pregnancy

Keywords: colonoscopy biosignals pain sedation
a first-in-human study of jab-8263 in adult patients with advanced solid tumors

Conditions: Solid Tumors, Adult

Summary: this is a phase 1, first-in-human, open-label study of jab-8263 to determine the maximum tolerated dose (mtd), recommended phase 2 dose (rp2d) and assess the dlt. 30 subjects with advanced solid tumor will be enrolled.

jab-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (bet) proteins. the objectives of this study are: to determine the maximum-tolerated dose (mtd) and assess the dose-limiting toxicity (dlt) of jab-8263 as a single agent to adult subjects with advanced solid tumors to assess the safety and tolerability of jab-8263 to characterize the pharmacokinetic (pk) parameters and pharmacodynamics (pdc) to evaluate preliminary antitumor activity of jab-8263

Eligibility criteria:
inclusion criteria: subjects must meet all the following criteria in order to be included in the research study: 1. subject must be ≥18 years-of-age at the time of signature of the informed consent form (icf). 2. eastern cooperative oncology group (ecog) performance status score of 0 or 1. 3. subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists. 4. subjects with life expectancy ≥3 months. 5. patients must have at least one measurable lesion as defined by recist v1.1. 6. patients who have sufficient baseline organ function. exclusion criteria: 1. history (≤3 years) of cancer that is histologically distinct from the cancer under study. 2. known serious allergy to investigational drug or excipients 3. active brain or spinal metastases 4. history of pericarditis or grade ≥2 pericardial effusion 5. history of interstitial lung disease. 6. history of grade ≥2 active infections within 2 weeks 7. known human immunodeficiency virus (hiv) infection 8. seropositive for hepatitis b virus (hbv) 9. seropositive for hepatitis c virus (hcv), or hcv-rna viral levels are not detectable. 10. any severe and/or uncontrolled medical conditions 11. history of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident 12. impaired cardiac function or clinically significant cardiac diseases 13. qtcf \>470 msec at screening 14. history of medically significant thromboembolic events or bleeding diathesis 15. unresolved grade \>1 toxicity 16. history of malignant biliary obstruction 17. pregnant or breast-feeding
magnetic resonance imaging (mri) viability: comparison of myocardial viability by positron emission tomography and mri

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare cardiac mri with positron emission tomography (pet) with fluorodeoxyglucose (fdg) to determine if cardiac mri images are as good as, or better, than pet with fdg.


Eligibility criteria:
inclusion criteria: * pet-fdg ordered to assess myocardial viability exclusion criteria: * contraindicated for mri * pregnant * age \<25 yrs

Keywords: cad
radio frequency ablation versus stripping of great saphenous vein in management of primary varicose veins , comparative study

Conditions: Varicose Veins

Summary: varicose veins are one of the most common diseases worldwide it constitutes a progressive disease which during its course it produces complications that usually prompt the patient to seek medical care. epidemiological studies of the incidence and prevalence of varicose veins found that the majority of adults would develop it over the course of their lifetime; women were found to be four times likely as men to develop it, the incidence of varicose vein occurrence increases with age. varicose veins are defined as tortuous dilated veins after or associated with incompetent valves.


Eligibility criteria:
inclusion criteria: * inclusion criteria: -. • adult patients with primary non complicated varicose veins which match the criteria suitable for the procedure exclusion criteria: * patients with tortuous gsv that could not allow passage of the sheath, laser fiber, non-palpable distal pulsation. * inability to ambulate, patients with previous history of deep venous thrombosis (dvt) and pregnant women were excluded from the study.
register of telaprevir and boceprevir in routine clinical practice

Conditions: Hepatitis C

Summary: know through routine clinical practice the effectiveness and safety of current treatment of hepatitis c virus, genotype 1, for patients who have never been treated and for patients who have been previously treated


Eligibility criteria:
inclusion criteria: * patients infected by hepatitis c virus, genotype 1 * indication of treatment with telaprevir or boceprevir in f3 and f4 fibrosis exclusion criteria: * being taking part in other * inability to follow a monitoring * contra-indications on triple therapy * coinfected with hiv and hbv (hepatitis b virus)

Keywords: hcv hepatitis c telaprevir boceprevir clinical practice
long term use of somavert (pegvisomant) for a regulatory post marketing commitment plan

Conditions: Acromegaly

Summary: the objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the lpd (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

all the patients whom an investigator prescribes the first somavert (pegvisomant) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: patients need to be administered somavert (pegvisomant) in order to be enrolled in the surveillance. exclusion criteria: patients not administered somavert (pegvisomant).
safety of the intramuscular route of the anti-flu vaccine in patients receiving oral anticoagulation therapy

Conditions: Influenza

Summary: until now, the best administration route of the anti-flu vaccine for patients receiving long term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has not been recommended because it may increase the risk of muscular haematoma. although this practice is widely extended, no significant differences between the safety of both routes have been found. some authors, analysing a small group of patients, affirm that the anti-flu vaccine can be administered safely by the intramuscular route on patients receiving long term oral anticoagulation therapy, while a previous opinion article recommended the subcutaneous route without any scientific evidence. due to this, the investigators have done a clinical trial with the aim of determining the safety and effectiveness of the flu-vaccine intramuscular route in patients receiving long term oral anticoagulation therapy and also to analyse the possible interactions between the vaccine and the oral anticoagulant treatment.

phase iv, simple blind, 2-parallel groups, multicentric randomized trial where each patient will receive a single dose of the recommended by the who anti-flu vaccine for the 2003-2004 period, the control group will receive it subcutaneous and intervention group intramuscular. the assignation to each group will be randomized. the study included 4 basic areas of barcelona city. three visits have been scheduled for each patient: moment 0, 24 hours and 10 days after the vaccination, and a 7 month follow up period to control the incidence of the flu.

Eligibility criteria:
inclusion criteria: * patients with oral anticoagulation therapy * patients who agree to be vaccinated * patients who agree to participate in the study * patients older than 18 exclusion criteria: * allergy or hypersensibility to egg, chicken proteins, any component of the vaccine (neomycin, octoxinol-9 or formaldehyd) * inr greater than 4 in the past 2 months * previous major bleeding * patients with dementia or with legal tutoring

Keywords: influenza vaccines acenocoumarol drug administration routes anticoagulants
influence of reward and punishment on goal-directed and habit learning in adolescent anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the proposed study of adolescents with anorexia nervosa (an) will examine the association of behavioral differences in constructs of decision making, brain structure and connectivity, and eating disorder (ed) symptoms. this study tests the novel hypothesis that goal-directed and habit learning for reward and punishment is altered in an and is uniquely associated with divergent symptoms and differences in corticostriatal connectivity and microstructural integrity. we will recruit 78 females currently ill with an and 26 controls ages 13-17 to investigate how goal-directed and habit learning for reward and punishment correspond to 1) clinical symptoms collected via interviews, self-report assessments, and ecological momentary assessment (ema), and 2) brain structure and connectivity in the resting state. data collection will rely on a technology called functional magnetic resonance imaging (fmri).


Eligibility criteria:
inclusion criteria: an group: * between the ages of 13 and 17 years old * meet dsm-v criteria for an-r or an-bp * medically stable per american academy of pediatrics and the society of adolescent medicine requirements, at least 75% adjusted ideal body weight, but still symptomatic as assessed by the eating disorders examination and clinical report * be at least 75% of adjusted ideal body weight healthy control group: * between the ages of 13 and 17 years old exclusion criteria: all groups: * psychotic illness/other mental illness requiring hospitalization * current dependence on drugs or alcohol defined by dsm iv criteria. additionally, positive test results for drug use on the day of the scan, apart of marijuana, will result in cancelling or rescheduling the scan because acute use will impact mri measures. * physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight * neurological disorder, neurodevelopmental disorder, or history of head injury with \>30 min loss of consciousness * any contraindication to undergoing an mri * primary obsessive compulsive disorder or primary major depressive disorder additional exclusion criteria for an group: * if taking other psychotropic medication, any change in dosage in the 2 weeks before scanning additional exclusion criteria for healthy control group: * meet or met criteria for the diagnosis of any psychiatric disorder in their lifetime * any history of binge eating or purging behaviors, including self-induced vomiting, laxative or diuretic misuse * use of any psychoactive or other medication known to affect mood or concentration in the last 3 months * have maintained 90% to 120% ideal body weight since menarche
fatty acids and attention deficit and hyperactivity disorder symptoms

Conditions: Child Behavior Problem; Attention Deficit Hyperactivity Disorder; Fatty Acid Deficiency

Summary: this study aimed to evaluate the longitudinal association between n-6:n-3 lcpufas ratio in cord blood and child adhd symptoms at 4 and 7 years old. this study was based on the inma project, a population-based birth cohort in spain. higher cord blood n-6:n-3 ratio was associated with higher subclinical adhd symptoms during early and mid-childhood.


Eligibility criteria:
inclusion criteria: * age 16 years or older * singleton pregnancy * no use of assisted reproductive techniques * intention to deliver at the reference hospital * ability to speak and understand spanish or a local language
nir- and multifrequent impedance spectroscopy on the skin in type 1 diabetes

Conditions: Diabetic Neuropathy

Summary: the aim of the study is to examine the suitability to detect diabetic neuropathy using nir and impedance.

the aim of the study is to examine how suitable a hand-held measuring probe (ddd-probe) using nir (near infrared light) as well as impedance (conductivity), is to detect early signs of diabetic neuropathy. the ddd-probe is put directly on the skin and is measuring by the use of light and impedance.

Eligibility criteria:
inclusion criteria: * men with type 1 diabetes (who criteria) * age 35-50 years * duration of diabetes \> 10 years exclusion criteria: * p-creatinine\> 120 micromol/l * other acute or chronic disease, or type of treatment that makes the patient unsuitable to participate, valuated by the investigator * non intact skin on the measuring spots * the patient is unable to understand the informed consent

Keywords: near infrared light diabetic neuropathy sensory neuropathy autonomic neuropathy vagus sudomotor function monofilament impedance