Kornimate/medical-research-clean huggingface dataset:
comparison of video-based versus written patient education on atopic dermatitis

Conditions: Atopic Dermatitis; Atopic Eczema; Infantile Eczema; Hand Eczema

Summary: the purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' knowledge of atopic dermatitis and their disease severity, measured by the patient-oriented eczema measure (poem), after viewing the educational materials.

we plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' understanding of atopic dermatitis and their disease severity. subjects randomized to the video-based education arm will be instructed to watch a video on the classifications, aggravating factors, and treatment of atopic dermatitis. subjects randomized to the written education arm will receive written information on the classifications, aggravating factors, and treatment of atopic dermatitis. the contents of the video and the written educational materials will be comparable. at the end of the study period, 3 months later, subjects will be interviewed regarding their comprehension and attitude towards video-based and written education materials. additionally, we will use the patient-oriented eczema measure (poem) questionnaire to assess the difference in subjects' disease severity between the 2 arms.

Eligibility criteria:
inclusion criteria: * 18 years of age or older at time of consent, may be men or women. * able to adhere to the study visit schedule and other protocol requirements. * capable of giving informed consent. exclusion criteria: * non-english speaking individuals.

Keywords: patient education dermatology patient education atopic dermatitis atopic dermatitis education atopic eczema infantile eczema hand eczema
the effect of cycle ergometer with biofeedback on deep sensation in elderly patients with knee osteoarthritis

Conditions: Knee Osteoarthritis; Sensation Disorders

Summary: the aim of the randomized controlled study is to investigate the effects of the cycle ergometer with biofeedback on deep sensation in elderly people who has knee osteoarthritis

participants will be randomly divided and registered into 2 groups: thera-train tigo group (tg) or control group(cp) for 20 participants 20 minute tens, 5 minute ultrasound, 10 times with 2 sets quadriceps isometric exercise will be applied. the other 20 participants will use thera-train tigo for 20 minute in addition to tens, us, quadriceps isometric exercise. conditions of the participants will be measured before(1st day) and after(15th day) a span of 3 week treatment. we will use demographic information questionnaire, western ontario and mcmaster universities (womac) osteoarthritis index, physical activity scale for the eldery (pase) and 6 minute walking test for all patients. then we will measure knee vibration sense with diapason. knee joint position sense will be measured with a digital goniometer.

Eligibility criteria:
inclusion criteria: knee osteoarthritis (kellgren-lawrance score between 1-3) exclusion criteria: * previous knee surgery * diabetus mellitus * thyroid disease * visual deficit * gait disorder * mental disability * presence of neuropathy

Keywords: knee osteoarthritis deep sensation cycle ergometer biofeedback
promri affirm study of the evia/entovis pacemaker with safio s pacemaker leads

Conditions: Cardiac Disease

Summary: this investigation is designed to demonstrate the clinical safety of the evia/ entovis pacemaker system when used under specific mri conditions.

in the past, mr scans were always contraindicated for pacemaker patients. if particular prerequisites and conditions are fulfilled, mr scans can now be conducted on patients with biotronik's evia/entovis pacemakers in combination with the safio s pacemaker leads, scheduled to be part of this clinical study. the specific mri conditions for this investigation with the evia/entovis pacemaker family and safio s pacemaker leads are defined in the study protocol

Eligibility criteria:
inclusion criteria: * pacemaker system consisting solely of the evia/entovis pacemaker and safio s pacemaker leads * the pacemaker system has to be implanted, repositioned or exchanged at least 5 weeks prior to enrollment * age more than 18 years * understand the nature of the procedure * able and willing to complete mri testing * able and willing to activate and use the cardio messenger * give written informed consent * able to complete all testing required by the clinical protocol * ability to measure atrial and/or ventricular pacing threshold(s)\* (at 0.4 ms) * all pacing thresholds do not exceed 2.0v @0.4ms. * available for follow-up visit at the investigational site * patient body height greater or equal to 140 cm * pectoral implantation * the ascertained lead impedance is between 200 and 1500 ohms. exclusion criteria: * no evia/entovis /safio s pacemaker system implanted * pacing threshold(s) (at 0.4 ms) and sensing amplitudes are not measurable * meet one or more of the contraindications * being pregnant * have a life expectancy of less than three months * cardiac surgery already scheduled in the next three months * enrolled in another cardiac clinical investigation * have other medical implants that may interact with mri, e.g. abandoned pacemaker/icd leads, lead extensions, other active medical devices, non-mri compatible devices (e.g. mechanical tricuspid valve) * have other metallic artifacts/components in body that may interact with mri

Keywords: pacemaker therapy magnetic resonance imaging (mri) evia/entovis
perioperative portal vein pulsatility as a postoperative prognostic indicator in pulmonary endarterectomy

Conditions: Pulmonary Hypertension; Thromboembolism, Pulmonary; Perioperative/Postoperative Complications; Venous Hypertension; Cardiac Failure

Summary: the investigators aim to evaluate the utility of portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death in patients undergoing elective or urgent pulmonary endarterectomy for thromboembolic pulmonary hypertension. the investigators' hypothesis is that the portal vein pulsatility fraction, measured using transesophageal echocardiography immediately after weaning of cardiopulmonary bypass, is proportional to the risk of developing subsequent end-organ dysfunction in the postoperative setting.

while transesophageal echocardiography is recommended in patients with known or suspected cardiovascular pathology which may impact outcomes, no study has evaluated it's perioperative use in pulmonary endarterectomy surgery. most pulmonary endarterectomy patients suffer from severe pulmonary hypertension, right heart dysfunction and central venous hypertension. postoperative complications are closely related to the importance of residual postoperative pulmonary hypertension and right ventricular dysfunction. a portal vein pulsatility fraction of 50% or more in the perioperative setting might indicate right ventricular dysfunction and/or hypervolemia-related severe venous congestion, which may be responsible for multiple organ dysfunction and significant morbidity or mortality in critically ill patients. the investigators believe pulmonary endarterectomy patients with a high portal vein pulsatility fraction immediately after weaning from cardiopulmonary bypass have a greater risk of developing postoperative persistent organ dysfunction and/or death. in this prospective descriptive study, the investigators will evaluate portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death 7 days after pulmonary endarterectomy. left and right global longitudinal strain after weaning from cardiopulmonary bypass will also be evaluated as potential indicators of a higher risk of persistent organ dysfunction plus death 7 days after surgery.

Eligibility criteria:
inclusion criteria: * 18 years or older * elective or urgent pulmonary endarterectomy exclusion criteria: * absolute or relative contraindication to the use of transesophageal echocardiography, * hepatic cirrhosis, * portal vein thrombosis, * concomitant coronary artery bypass grafting, * patient refusal or unable to give informed consent

Keywords: transesophageal ultrasound tee portal vein pulsatility splenic vein pulsatility venous congestion strain right ventricular dysfunction pulmonary hypertension venous hypertension
caprivi: community acquired pneumonia: treatment with avelox® in hospitalized patients

Conditions: Pneumonia

Summary: the aim of this study is to obtain data from hospitalized community acquired pneumonia (cap) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability. as this is a non-interventional observational study, routine clinical practice is observed. the application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.


Eligibility criteria:
inclusion criteria: * adult hospitalized patients with a diagnosis of cap (based on local medical practice) and decision taken by the investigator to treat with moxifloxacin and to start treatment with intravenous administration. the local moxifloxacin product information must be considered. exclusion criteria: * contraindications stated in the local moxifloxacin product information; warnings and precautions must be considered.

Keywords: community acquired pneumonia
gemcis plus pd-1/pd-l1 inhibitor in advanced biliary tract cancer: efficacy and immune microenvironment （btc-im-1）

Conditions: Advanced Biliary Tract Cancer

Summary: to evaluate the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (btc) patients receiving first-line standard therapy with gemcitabine/cisplatin (gemcis) combined with pd-1/pd-l1 inhibitors.

this is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (btc) patients receiving first-line standard therapy with gemcitabine/cisplatin (gemcis) combined with pd-1/pd-l1 inhibitors. the primary endpoint is objective response rate (orr), with secondary endpoints including disease control rate (dcr), duration of response (dor), time to response (ttr), progression-free survival (pfs), overall survival (os), and immune profiling of tumor tissue and peripheral blood before and after treatment.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * histologically confirmed unresectable/metastatic cholangiocarcinoma (intrahepatic, extrahepatic, or gallbladder). * no prior systemic anticancer therapy (chemotherapy, targeted therapy, or immunotherapy). * planned to receive gemcis+pd-1/pd-l1 inhibitor as standard first-line treatment. * ≥1 measurable lesion per recist 1.1. * ecog performance status 0-1. * adequate organ function: * anc ≥1.5 × 10⁹/l, platelets ≥100 × 10⁹/l, hemoglobin ≥9 g/dl. * total bilirubin ≤1.5 × uln, ast/alt ≤3 × uln (≤5 × uln if liver metastases). * creatinine ≤1.5 × uln or crcl ≥60 ml/min. * willing to provide archival/fresh tumor tissue and peripheral blood samples. * signed informed consent. exclusion criteria: * prior systemic therapy. * active autoimmune disease requiring immunosuppression. * active infection requiring iv antibiotics. * hiv-positive or active hbv/hcv infection (hbsag+ with hbv dna ≥2000 iu/ml; hcv rna+). * symptomatic cns metastases. * pregnancy/lactation. * any condition compromising protocol compliance or data interpretation per investigator.
blood glucose control with biochaperone insulin lispro compared to insulin lispro (humalog®) after ingestion of a standardized meal

Conditions: Diabetes Mellitus Type 1

Summary: the addition of biochaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection. this trial is intented to compare the post-prandial blood glucose control of biochaperone insulin lispro and humalog® when injected after a standardized meal as well as the pharmacokinetic profile of biochaperone insulin lispro and humalog® in subjects with type 1 diabetes mellitus. this is a double-blinded, randomized, controlled, two-period crossover phase ib trial to compare the blood glucose control after ingestion of a standardized meal, with biochaperone lispro at 0.2u/kg and humalog at 0.2u/kg.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus ≥ 12 months * treated with multiple daily insulin injections or csii ≥ 12 months * bmi 18.5-28.0 kg/m² (both inclusive) * hba1c%≤9% exclusion criteria: * type 2 diabetes mellitus * receipt of any trial product within 60 days prior to this trial * clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease * presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator * known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption. * any systemic treatment with drugs known to interfere with glucose metabolism * use of any tobacco or nicotine-contained product within one year prior to screening
evaluation of muscle mirna as biomarkers in dystrophinopathies

Conditions: Muscular Dystrophies; Becker Muscular Dystrophy; Duchenne Muscular Dystrophy

Summary: duchenne muscular dystrophy (dmd) , caused by mutations in the dmd gene, is the most common and most severe progressive dystrophy of the child. although the development is rapidly progressive , there is variability in the severity of the disease between dmd patients that do not correlate with the type of mutations in the dmd gene. there are no easily measurable biomarkers for monitoring the dmd or moderate form of the disease, becker muscular dystrophy (bmd ) . micrornas (mirnas) are involved in most cellular processes , and their expression pattern is a signature of the state of a cell . they represent a potential class of diagnostic and prognostic biomarkers. some are specific for the skeletal myogenesis , and changes in their pattern of expression are associated with muscle diseases including muscular dystrophy. the levels of muscle- specific mirnas are indeed greatly increased in the serum of dmd and bmd compared to control patients . the main objective of this is to validate the use of serum muscle-derived micrornas as biomarkers of dmd patients (compared with healthy subjects). secondary objectives are i) to investigate the relationship between circulating levels of these mirnas and the severity of the dystrophinopathy (dmd vs bmd) and also the progression of the disease (longitudinal study), ii) to assess the specificity of these markers for dystrophinopathy (comparison with other patients with muscular dystrophy), iii) to test candidate mirnas recently identified but not yet analyzed in the serum of patients. clinical data and samples will be recorded at each regular consultation. mirna levels will be quantified using real time quantitative rt-pcr.


Eligibility criteria:
inclusion criteria: * patient suffers from dystrophinopathy or other muscle dystrophy, * healthy volunteers * signed informed consent * social insurance exclusion criteria: * patients or parents have not signed the informed consent,

Keywords: muscle dystrophies dystromirs longitudinal study mirna
study of efficacy, safety, and tolerability of lna043 in patients with knee osteoarthritis

Conditions: Osteoarthritis

Summary: the study will determine the optimal dosing regimen of lna043 in patients with knee osteoarthritis (oa).

this study is a 2-period, multicenter, randomized, parallel-group, double-blind, placebo-controlled study consisting of a 2-year core period, followed by a 3 year extension period. the primary objective of this study is to assess the efficacy of lna043 compared to placebo at week 104 as measured by the mean change from baseline in cartilage thickness using qmri of the target knee

Eligibility criteria:
inclusion criteria: * males and females between 40 and 75 years of age * body mass index (bmi) \< 40 kg/m2 * diagnosis of primary tibiofemoral knee oa by standard american college of rheumatology clinical and radiographic criteria * and other criteria as specified by the protocol exclusion criteria: * participants with radiographic knee oa k-l grade = 4 on the non-target knee * arthroscopy of the target knee within the 6 months prior to screening * hemoglobin \< 8.5 g/dl (85 g/l) or platelet count \< 100,000/μl * and other criteria as specified by the protocol

Keywords: lna043 knee arthritis oa knees
natalizumab re-initiation of dosing

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objectives of this study are to further evaluate the safety of natalizumab (tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (ifn-β), glatiramer acetate (ga), or other multiple sclerosis (ms) therapies.

study 101-ms-322 (nct00306592) is conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab of former clinical trial participants in studies c-1801 (nct00027300), c-1802 (nct00030966), and c-1803 (nct00097760). this study includes participants in north america. in parallel with the conduct of this study, a similar study, 101-ms-321 (nct00297232) is initiated for participants in europe and the rest of the world. the primary purpose and primary outcome for both studies are identical, therefore, the combined week 48 data from both studies are presented. in addition, after 48 weeks, participants from 101-ms-322 (nct00306592) can enter study 101-ms-321 (nct 00297232), which is considered the long-term treatment period of 101-ms-322 (nct00306592).

Eligibility criteria:
inclusion criteria: * ms subjects who completed study c-1801 (nct00027300), c-1802 (nct00030966), or c-1803 (nct00097760) and completed a dosing suspension safety evaluation (neurological examination and magnetic resonance imaging \[mri\] scan) * considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (pml) based on medical history, physical examination, or laboratory testing (results from the dosing suspension safety evaluation from study c-1808 \[nct000276172\] may be used) * other protocol-defined inclusion criteria may apply exclusion criteria: * considered by the investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the dosing suspension safety evaluation from study c-1808 may be used), or due to prior immunosuppressive treatment * history of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies * other protocol-defined exclusion criteria may apply

Keywords: multiple sclerosis ms
acute hemodynamic response to carvedilol in predicting survival in acute on chronic liver failure patients - a pilot study.

Conditions: Acute on Chronic Liver Failure

Summary: various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as hvpg (whvp - fhvp), svr, heart rate, cardiac output, cardiac index, blood pressure (systolic, diastolic and mean), spo2. routine treatment of the patients will be continued as per the institute protocol. these patients will be assessed for the liver transplant free survival at 28 days and complications \[pht related bleed, aki, infections, he\] within 90 days; transplant-free survival rate at 90 days; evolution of the aarc score for 2 wk.


Eligibility criteria:
inclusion criteria: 1. patients of aclf (apasl criteria) - jaundice (serum bilirubin ≥ 5 mg/dl and coagulopathy (inr ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, 2. age 18-70 yrs 3. baseline hvpg ≥ 12 mmhg. exclusion criteria: 1. contraindications to nsbb (heart rate \< 65 /min, bp \< 110/65 mm hg, asthma, heart failure), 2. portal vein thrombosis, 3. hepatocellular carcinoma, 4. hvoto, 5. he grades 2-4, 6. nsbb therapy within 5 days, 7. pregnancy, 8. lactation, 9. planned for lt in the next 12 weeks 10. no consent.
perfusion and dual energy computer tomography in hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the aim of this study is to evaluate the hepatic perfusion computer tomography and dual energy computer tomography in the assessment of tumor characterization of hepatocellular carcinoma in patients with resectable hepatocellular carcinoma by comparing the quantitative parameters computer tomography obtained with the pathological data of the surgical specimens.

dual-energy computer tomography and perfusion computer tomography (general electric revolution hight definition gemstone™ spectral imaging) will be performed in all patients. iodine concentration and quantitative perfusion parameters of the hepatocellular carcinoma and surrounding liver parenchyma data will be compared with the pathological results.

Eligibility criteria:
inclusion criteria: * a diagnosis of hepatocellular carcinoma made according to the guidelines of the american association for the study of the liver * affiliation to a national health insurance * an indication for hepatic resection during the decision-making stage * a request for a pre-operative computer tomography in our radiology unit * an affiliation to a social security * informed consent given by the patient exclusion criteria: * previous treatments of hepatocellular carcinoma (medicated or surgical) * patient under tutorship or curatorship * pregnant or lactating woman

Keywords: perfusion computer tomography dual-energy computer tomography
flow measurements in functional csf shunts and off-shunt locations with a second-generation thermal device

Conditions: Hydrocephalus

Summary: this study compares the performance of two generations of non-invasive cerebrospinal fluid (csf) shunt flow assessment devices. measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.


Eligibility criteria:
inclusion criteria 1. a ventricular csf shunt with a region of overlying intact skin appropriate in size for application of the study device 2. signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 3. signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 4. verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision exclusion criteria 1. presence of an interfering open wound or edema in the study device measurement area 2. patient-reported history of serious adverse skin reactions to silicone-based adhesives 3. previous participation in a rhaeos clinical study in which flowsense device measurement data were acquired 4. patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days 5. participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study