Kornimate/medical-research-clean huggingface dataset:
the use of synovial biopsies in predicting response to biologic therapy in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: sybra is an open-label, phase 3, randomized controlled clinical trial that aims to assess the use of synovial biopsies in predicting response to biologic therapy in patients with rheumatoid arthritis that have failed disease-modifying drugs. the project has the potential to help change the current practice by offering the best treatment option. the decision to choose the best treatment for a particular patient is especially important in the context of the growing number of therapies available as a first-line option and the lack of specific biomarkers to predict response to treatment.


Eligibility criteria:
inclusion criteria: * subject should be capable of consent * age 18 and older * classified as rheumatoid arthritis as per eular/acr criteria 2010 * failed one dmard (methotrexate, leflunomide, sulfalsalazine, hydroxychloroquine) * can be on steroid dose \<7.5mg * quantiferon negative * hepatitis b, c negative * no recent history (\<5y) of malignancy exclusion criteria: * overlap syndrome * previously treated with a biological medication * heart failure nyha iii/iv * active tuberculosis * active infections * previous history of dvt, pe, or stroke * other significant comorbidities that will prevent them from taking any biologic medication as per eular guidelines on treating rheumatoid arthritis 2020. * pregnancy

Keywords: rheumatoid arthritis synovial biopsy biologic therapy
assess the immune response following primary vaccination with gsk biologicals' tritanrix™-hepb/hib-menac vs tritanrix™-hepb/hiberix™ given at 6,10 & 14 wks of age to infants who received hepatitis b vaccine at birth

Conditions: Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Summary: this study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (hiv) \& hepatitis b surface antigen (hbsag). the purpose of this study is to demonstrate in infants who received a birth dose of hepatitis b vaccine that tritanrix™-hepb/hib-menac vaccine is at least as good as tritanrix™-hepb/hiberix™ with respect to immunogenicity of the hepatitis b antigen.

randomized study with two groups to receive one of the following vaccination regimens: * gsk biologicals' tritanrix™-hepb/hib-menac * gsk biologicals' tritanrix™-hepb/hiberix™

Eligibility criteria:
inclusion criteria: * healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for hiv \& hbsag, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. exclusion criteria: * known exposure to diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease since birth. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination. * a family history of congenital or hereditary immunodeficiency. * major congenital defects or serious illness. * any neurologic disorders or seizures. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * a birth dose of hepatitis b vaccine given outside the frame of this study.
effects of ly450139 dihydrate on subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purposes of this study are to determine: * the safety of ly450139 dihydrate and any side effects that might be associated with it. * how much ly450139 dihydrate should be given and how long it may be detected in blood. * to determine if ly450139 dihydrate may have an effect on a protein found in blood, called a beta. this protein is studied in subjects with alzheimer's disease. * to collect and store samples from blood and spinal fluid for research related to alzheimer's disease and similar (neurodegenerative) diseases or inflammation (irritation) that may provide information on how subjects respond to ly450139 or other medications. length of study: approximately 29 weeks. number of office visits: 11 for most subjects: initial visit, every other week during 14 weeks of study drug treatment, and 2 follow-up visits. at no cost, approximately 45 eligible participants will receive: * study medication * study-related diagnostic and laboratory evaluations


Eligibility criteria:
inclusion criteria: * at least 50 years of age and diagnosed with mild to moderate probable alzheimer's disease * fluent in reading and speaking english and have a reliable study partner (caregiver) (someone who is in frequent contact and can make sure study medication is being taken correctly). * if currently treated with certain drugs for alzheimer's disease, doses must be the same for at least the last 2 months prior to starting study drug. exclusion criteria: * cannot be currently using or require maoi antidepressants (such as selegiline or eldepryl(r)), antipsychotics, benzodiazepines, calcium channel blockers for heart disease, and propanolol. * cannot have a clinically significant and/or uncontrolled condition or other significant disease, including a condition requiring treatment with warfarin or heparin; or have had or currently have a peptic ulcer, reflux disease, or gastrointestinal (gi) bleeding.
a study to evaluate the efficacy and safety of vx-150 in treating subjects with pain caused by small fiber neuropathy

Conditions: Small Fiber Neuropathy

Summary: this is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy of vx-150 for the treatment of pain caused by small fiber neuropathy.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg * diagnosis of small fiber neuropathy, as per european federation neurological societies (efns)/american academy of neurology (aan) guidelines, with pain for at least 3 months prior to screening * reduction below the 5th percentile of sex and age-adjusted normal values in epidermal nerve fiber density on punch skin biopsy at the distal site of the leg performed at screening * normal nerve conduction studies (ncs), including presence of sural response. * average nrs score between ≥4 and ≤9 reported in the daily diary on days -7 through -1 exclusion criteria: * history in the past 10 years of malignancy except for squamous cell skin cancer, basal cell skin cancer, and stage 0 cervical carcinoma in situ * history of connective tissue disorders, sarcoidosis, sjögren's syndrome, amyloidosis, fabry's disease, celiac disease, lyme disease, autoimmune disorders * a known or clinically suspected infection with human immunodeficiency virus or hepatitis b or c viruses * current clinically significant liver or kidney dysfunction * current uncontrolled thyroid dysfunction * a diagnosis of diabetes, hba1c ≥8% at screening * history of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) * concomitant severe pain conditions which may impair self-assessment of pain due to small fiber neuropathy other protocol defined inclusion/exclusion criteria may apply.
efficacy and safety of valcyte® as an add-on therapy in patients with malignant glioblastoma and cytomegalovirus (cmv) infection

Conditions: Glioblastoma Multiforme; Cytomegalovirus Infection

Summary: the purpose of this study is to investigate if treatment of cmv infection by antiviral drug valcyte (r) affects the clinical outcome of glioblastoma multiforme in patients with local cmv infection in tumor tissue. the investigators' hypothesis states that cmv infection promotes tumor development and disease progression and inhibits immune responses against the tumor.


Eligibility criteria:
inclusion criteria: * glioblastoma grade iv * cytomegalovirus detected in tumor * at least 90% resection of tumor exclusion criteria: * decreased kidney function * pregnancy * neutropenia * thrombocytopenia * patient not tolerating the drug

Keywords: glioblastoma multiforme cytomegalovirus infection antiviral treatment valganciclovir
visual performance of patients implanted with a multifocal iol

Conditions: Cataract; Refractive Lens Exchange

Summary: the goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. the main question it aims to answer is: what is the visual performance and patient satisfaction twelve months post-operatively? participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.


Eligibility criteria:
inclusion criteria: * age 18 years or older; * patients scheduled for bilateral at elana 841p phacoemulsification cataract extraction or femtosecond-laser-assisted-cataract-surgery (cataract grades of 1, 2, 3 on the locsiii scale) and iol implantation (cataract or prelex) with a maximum of 28 days between both implantations; calculated iol power within the limited iol diopter range of +15.0d to +27.0d * no visual acuity limiting pathologies other than cataract; * corneal astigmatism of \<1.0 d; * availability, willingness, and sufficient cognitive awareness to comply with examination procedures; * written informed consent for participation in the study and data protection. exclusion criteria: * corneal astigmatism of ≥1.0 d; * difficulty for cooperation (distance from their home, general health conditions); * history of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, oht, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.); * visual field loss which has an impact on visual acuity; * use of systemic or ocular medication that might affect vision; * patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus; * pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions); * capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome); * cataract grades of 4, 5 or 6 on the locsiii scale ; * surgeries with incision size of ≥2.75mm ; * immediate sequential bilateral cataract surgery ; * concurrent participation in another device investigation; * usage of contact lenses during participation.

Keywords: cataract multifocal iol
polyp detection with the endorings™: a randomized tandem colonoscopy study

Conditions: Colon Cancer

Summary: to compare the adenoma miss rate with the endorings™ vs. the adenoma miss rate with standard view colonoscopy. to compare the polyp miss rate with the endorings™ vs. the polyp miss rate with standard view colonoscopy.in addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.

patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. each enrolled subject will undergo two "back-to-back" procedures. subjects in group a (study group) will undergo a standard view colonoscopy followed immediately by an endorings™ colonoscopy. subjects in group b (control group) will undergo an endorings™ colonoscopy followed immediately by a standard view colonoscopy. results from the two groups will be analyzed and compared, with primary outcome measures being adenoma miss rate and polyp miss rate. secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results. subjects will be followed through a 24 hour and a 7-days telephone interview for analysis of unexpected adverse events. clinical results will be analyzed using various statistical measures of significance. multi-center study with up to 126 patients. up to 126 treated patients (2 groups of 57 patients +6 drop-out patients) will be enrolled into the study.

Eligibility criteria:
inclusion criteria: * subject between the ages of 40 and 75 * the patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; * written informed consent must be available before enrollment in the trial exclusion criteria: * patients with a history of colonic resection; * patients with known (or newly diagnosed) inflammatory bowel disease; * patients with a personal history of polyposis syndrome; * patients with suspected chronic stricture potentially precluding complete colonoscopy; * patients with diverticulitis or toxic megacolon; * patients with a history of radiation therapy to abdomen or pelvis; * patients with a hemorrhagic diathesis * patients with acute lower gi bleeding * pregnant women and women with childbearing potential without adequate contraception * patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Keywords: polyp/adenoma miss rate colonoscopy add-on device enhanced screening
combined application of remote and intra-coronary ischemic conditioning in acute myocardial infarction

Conditions: Myocardial Infarction, Acute

Summary: infarct size is a major determinant of prognosis after ami. evidence indicates that the combination of intracoronary ischemic conditioning (icic) and remote ischemic conditioning (ric) can significantly reduce infarct size in stemi patients. whether the combination of these two interventions may improve clinical outcome after stemi remains unknown. the objective of the present study is to determine whether combination of icic and ric can improve stemi patients clinical outcome at 6 months.


Eligibility criteria:
inclusion criteria: * all (male and female) patients, aged over 18, * presenting within 12 hours of the onset of chest pain, * for whom the clinical decision was made to treat with percutaneous coronary intervention (pci), * st segment elevation ≥ 0.2 mv in two contiguous ecg leads, * written informed consent obtained or oral informed consent certified by a third party. non inclusion criteria: * patients with cardiogenic shock, * patients with uncontrolled (treated or untreated) hypertension (\> 180/110 mmhg), * patients with loss of consciousness or confused, * patients without health coverage, * patient with any legal protection measure, * female patients currently pregnant (oral diagnosis) or women of childbearing age who were not using contraception. exclusion criteria: patients with main occlusion localized on : * lad: distal or ostial segment, * non dominant rca / cx: mid or distal segment, * dominant rca / cx: distal segment, * any other arteries apart lad/cx/rca; patients with evidence of coronary collaterals to the risk region (rentrop score ≥ 2); patients with an opened (timi \> 1) culprit coronary artery on initial admission coronary angiography or a failed pci (final timi=0).

Keywords: st-elevation myocardial infarction
effect of nt-probnp guided treatment of chronic heart failure

Conditions: Heart Failure, Congestive

Summary: the purpose of this study is to determine whether nt-probnp guided treatment of chronic congestive heart failure will reduce heart failure related morbidity and mortality compared to therapy guided by standard clinical judgement.


Eligibility criteria:
inclusion criteria: * admission because of congestive heart failure * elevated nt-probnp levels on admission exclusion criteria: * life-threatening cardiac arrhythmias * urgent intervention * severe lung disease * presence of life threatening disease * signed informed consent for other study * mental or physical status not allowing written informed consent. * unwillingness to give informed consent * patients undergoing haemodialysis or continuous ambulatory peritoneal dialysis (capd)

Keywords: nt-probnp
a clinical trial of a self-management education program for people with chronic stable angina

Conditions: Chronic Stable Angina

Summary: the purpose of this clinical trial was to determine the effectiveness of a supportive and educational self-management program for improving health-related quality of life (hrqol), angina symptoms, and self-efficacy and resourcefulness to self-manage for chronic angina patients. 130 participants were enrolled in the trial for 3 months. the program, entitled the chronic angina self-management program, (casmp) was found effective for improving hrqol, angina symptoms, and self-efficacy to manage symptoms, compared to usual care.


Eligibility criteria:
inclusion criteria: medical diagnosis of coronary artery disease ccs class i-iii angina for at least 6 months speak, read, understand english - exclusion criteria: mi/bypass last 6 months ccs class iv angina a major cognitive disorder -
kinesiophobia in the parents of hemophilia patients

Conditions: Hemophilic Arthropathy

Summary: recurrent joint bleedings lead to the development of a debilitating arthropathy in the patients with hemophilia (pwh). this hemophilic arthropathy (ha) is characterized by chronic pain, periarticular atrophy and a limited range of motion. ha affects the perceived quality of life in the pwh. this painful situation can lead to catastrophizing thoughts that movement and physical activity will result in further pain and injury, when that painful situation is perceived as threatening. one component of this fear-model includes fear of movement, or kinesiophobia (kp). kp is defined as an irrational and disadvantaging fear of physical movement and activity resulting from feeling vulnerable to painful injury or reinjury. patients with kp develop the belief that movements will lead to re-injury and pain. over time, this leads to decreased physical activity, avoidance of daily tasks, functional decline, reluctance to use extremities, and in advanced stages, may result in depression and reduced quality of life. although factors associated with kp have been examined in various diseases groups such as chronic low back pain, fibromyalgia, osteoarthritis, migraine, coronary artery disease and rheumatoid arthritis, there is limited research on kp and its predictors in pwh. to the best of our knowledge there is still no any research about effects of ha to the pwh parents' behavior differences especially regarding to kp. this study aimed to find out whether there is kp or not in the parents of patients with ha.


Eligibility criteria:
inclusion criteria: parents of pwh and parents of healthy children were included. exclusion criterias: * parents who failed to complete evaluation instruments * difficulty in understanding and writing the psychosocial evaluation questionnaires themselves * parents whose child has another health problem * parents who failed to sign the informed consent document exluded from the study.

Keywords: kinesiophobia hemophilic arthropathy
endorings colonoscopy for adenoma detection

Conditions: Adenoma

Summary: adenoma detection rate (adr) in colon cancer screening is most important for avoiding colon cancer development. recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the adr. this work is the first german randomized controlled trial comparing standard colonoscopy with endorings-assisted colonoscopy. endorings is a new fda approved device that is attached to the distal tip of the colonoscope. better polyp detection is suspected by flattening the mucosal folds during withdrawal


Eligibility criteria:
inclusion criteria: * indication for colonoscopy (screening, surveillance, diagnostic) * age ≥ 45 years * ability to give informed consent exclusion criteria: * pregnancy * age \<45 years * known colonic strictures * chronic inflammatory bowel disease * active inflammation * s/p colonic resection * bleeding disorder

Keywords: adenoma polyp endorings colonoscopy endoscopic device colon cancer screening
efficacy and safety of oltipraz for liver fat reduction in patients with non-alcoholic fatty liver disease except for liver cirrhosis

Conditions: Non-alcholic Fatty Liver Disease

Summary: dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (ampk) activators, prevent insulin resistance through ampk-dependent p70 ribosomal s6 kinase-1 (s6k1) inhibition. and it is well known that the modulation of s6k1 by oltipraz inhibited the development of insulin resistance and hyperglycemia through the ampk-s6k1 pathway.also some research reported that lxrg (a member of the nuclear hormone receptor)-mediated increases in srebp-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits lxrg and srebp-c. therefore, oltipraz inhibits fatty acid synthesis through ampk-s6k1 pathway and lxrg-srebp-1c pathway in liver.


Eligibility criteria:
inclusion criteria: * patients over 19 under 75 years of age * patients with non-alcoholic fatty liver disease except for cirrhosis * patients who have abnormal alt, ast * patients who are satisfied with laboratory test * patients who agree to contraception * patients who can keet the diet exclusion criteria: * over 2 ratio of ast to alt * type 1 diabetes mellitus (insulin-dependent diabetes mellitus) or type 2 diabetes mellitus(not controlled) * disorder in liver function with an exception of non-alcoholic fatty liver * patients with malignant tumors * patients who have been taken drugs induced fatty liver within 8 weeks of participation in this study * patients who has been taken any medications that could affect the treatment for nafld within 4 weeks * patients who have been taken vitamin e (≥ 800 iu/day), thiazolidinediones, orlistat within 12 weeks * patients who had a bariatric surgery less than 6 month prior to the participation in the study * patients who are judged by investigator that participation of the study is difficult due to disease as follow; * any history of immune disorder * patients who have received treatment that may affect liver function within 1 month prior to the participation in the study * patient who has been administered other investigational product within 1 month prior to the participation in the study * patient who is not allowed to get mrs test: pacemaker, shunt and etc * pregnant or nursing women * anti-hiv antibody (+) * patient who considered ineligible for participation in the study as investigator's judgment