Kornimate/medical-research-clean huggingface dataset:
comparison of e-learning and face-to-face learning in cardiopulmonary exercise test training

Conditions: Exercise Test; Learning

Summary: the main purpose of this study is to compare the effect of teaching cardiopulmonary exercise test (cpet) via e-learning and face-to-face to doctors receiving postgraduate medical education (pgme).

cpet is the most objective and valuable test for the cardiopulmonary rehabilitation (cpr) program to be planned for back-up for patients with cardiopulmonary diseases. cpet is performed in a small number of centers in turkey, in physical medicine and rehabilitation (ptr) units. depending on the equipment available during specialty training, not all specialty students can access this training. cpet is the first test performed for planning cardiopulmonary rehabilitation (cpr). according to the results, an appropriate cpr plan is made for the patient. cpet indications, contraindications, application of the test, evaluation of the test with patient samples, and appropriate interventions for complications that may develop during the test are important. it is important that all specialist students have access to this training. the aim of this study is; to evaluate the impact of e-learning with pgme and to reach all specialist students in the future, if necessary, based on the results. the focus of this study is to examine the changes in doctors' success levels, motivations, distance education attitudes, cognitive flexibility and anxiety levels, especially in the pre- and post-training periods, and to compare these changes with face-to-face training.

Eligibility criteria:
inclusion criteria: * those who gave consent, * graduates of the faculty of medicine and currently receiving specialist training, * those who can do what the training requires during the training period (participating in live classes, answering scales, etc.) exclusion criteria: * those who cannot attend the training program regularly * in addition, those who cannot attend more than 4 classes with or without an excuse will be excluded from the study.

Keywords: e-learning face-to-face learning cardiopulmonary exercise test training
platelet-directed whole blood transfusion strategy for malaria

Conditions: Severe Malaria; Thrombocytopenia

Summary: open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.

the platform trial is a single-center, open-label randomized controlled trial of whole blood transfusion for severe malaria complicated by thrombocytopenia. the trial will recruit 132 zambian children 6 months to 15 years old with severe malaria defined according to modified who criteria with concomitant thrombocytopenia, defined here as a platelet count ≤75,000/ul, who do not otherwise have a current indication for transfusion according to current guidelines. children will be randomized 1:1 to whole blood transfusion or no whole blood transfusion and followed to hospital discharge or death. the trial is nested within the children and adults with severe malaria (chasm) cohort, a prospective observational study of severe malaria.

Eligibility criteria:
inclusion criteria: * age \<5 years * platelet count ≤75,000/ul * hemoglobin \>5 and ≤9 g/dl * p. falciparum parasitemia ≥500 parasites/ul * diagnosis of severe malaria meeting world health organization (who) criteria * ability and willingness of the legal guardian to comply with study protocol for the duration of the study * residence within health clinic catchment area * signed informed consent obtained from the parent or legal guardian of the participant exclusion criteria: * residence in foster care or children otherwise under government supervision * residence outside the hospital catchment area, or plan to leave the area * presence of any other condition or abnormality which, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data * any contraindication to whole blood transfusion

Keywords: malaria plasmodium falciparum zambia
a study to assess the efficacy of ro5459072 in participants with primary sjogren's syndrome

Conditions: Sjogren's Syndrome

Summary: this is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of ro5459072 treatment on disease activity and symptoms of sjogren's syndrome in adult participants with moderate to severe primary sjogren's syndrome. the total duration of the study for each participant will be approximately 18 weeks (including screening).


Eligibility criteria:
inclusion criteria: * a diagnosis of primary sjogren's syndrome according to the revised american-european consensus group (aecg) criteria * essdai score greater than or equal to (\>/=) 5 * esspri score \>/=5 * elevated serum titers of anti-sjogren's-syndrome-related antigen a (anti-ssa) and/or anti-sjogren's-syndrome-related antigen b (anti-ssb) antibodies at screening * negative pregnancy test at screening and baseline (for women only) * willing to comply with the study procedures and restrictions, including measures to prevent pregnancy and restrictions on sperm donation exclusion criteria: * a diagnosis of secondary sjogren's syndrome according to the revised aecg criteria * severe complications of sjogren's syndrome * systemic immunosuppressant therapy, cyclophosphamide, or b-cell depleting therapy within 6 months prior to the screening visit * corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day * a positive test result for hepatitis b (hbv), hepatitis c (hcv), or human immunodeficiency virus (hiv), or tuberculosis, or any other active viral, fungal, yeast or bacterial infection at screening * a history suggesting reduced immune function or any other conditions predisposing participants to serious infection * a history of lymphoma, myeloma or monoclonal gammopathy of unknown significance (mgus), or any other malignancies within the past 5 years * a diagnosis of fibromyalgia or significant depression * having any concomitant disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the individual * participation in an investigational drug or device study within 3 months prior to screening * inability to comply with the study protocol for any other reason * women who are lactating, breastfeeding or planning to nurse * using other prohibited medication (moderate or potent inhibitors of cyp3a4; strong inducers of cyp3a4; strong inhibitors of the transporter p-glycoprotein \[p-gp\]; sensitive substrates of cyp3a4 with a narrow therapeutic index)
radiographic progression of infiltrated caries lesions in-vivo

Conditions: Dental Caries

Summary: this study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.

a 3-year longitudinal, prospective, randomized control clinical trial (rct) is designed incorporating a split-mouth intra-oral design. young volunteers (14-35 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by infiltrating the lesions. the infiltration protocol included application of on-market materials and applicators, and was performed in one session.

Eligibility criteria:
inclusion criteria: * 14-35 year old subjects * decayed-missing-filled permanent teeth (dmft) ≥ 3 * having at least two early caries lesions in approximal posterior tooth surfaces * lesion visible on radiograph exclusion criteria: * current participation in another clinical study * medically compromised subjects * hyposalivation * pregnancy * allergic to methylmethacrylates * allergic to latex * symptomatic teeth

Keywords: dental caries proximal surfaces posterior teeth carious lesions tooth diseases preventive therapy
effectiveness and safety of ustekinumab intensification in crohn's disease

Conditions: Crohn Disease

Summary: the primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.

this study evaluates the efficacy and safety of intravenous administration at regular intervals of ustekinumab. it consists of escalation treatment period (week 0 to 52); and safety follow up visit (24 weeks after last dose). study assessments will include harvey-bradshaw index (hbi), physician global assessment score (pga), laboratory evaluations, endoscopic evaluation, review of concomitant medications and adverse events (aes).

Eligibility criteria:
inclusion criteria: * agree to participate in the study * with active crohn's disease * undergoing ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician * hbi ≥ 5 before ustekinumab therapy * over 18 years of age exclusion criteria: * who had received ustekinumab for an indication * pregnant or nursing * l4 type * history of enterectomy or enterostomy related to disease * who used total enteral nutrition for more than 2 weeks due to complications such as obstruction, abscess and perforation after starting ustekinumab therapy * pregnant and lactating women

Keywords: ustekinumab dose escalation crohn's disease
non-invasive markers of esophageal function in adults

Conditions: Dysphagia

Summary: the investigator proposes to study electrical activity reflective of esophageal motility in adults noninvasively by the use of multichannel electroesophagogram (eesg) and magnetoesophagogram (mesg) recordings.

dysphagia, or difficulty with swallowing, is a common symptom affecting nearly 9.4 million individuals or 4% of the us population. high resolution esophageal manometry is currently considered the gold standard test for evaluation and diagnosis of esophageal motility disorders, but given that it requires trans-nasal placement in a conscious patient, this test is highly uncomfortable and associated with significant patient dissatisfaction. there are currently no noninvasive tests or markers available to test esophageal function and motility. in the upper gastrointestinal system, as in the heart, disruption of the electrical syncytium in disease produces measurable dysrhythmia. recent modifications of the standard electrogastrogram (egg) that have increased the number of leads to 25 (termed high-resolution egg) have allowed enhanced spatio-temporal resolution of electric slow wave activity, and newer analytic techniques. additionally, the magnetogastrogram (mgg) overcomes many of the inherent limitations of the standard egg. the goal of this proposal is to harness similar technologies applied to the esophagus to develop high-resolution electroesophagogram (eesg) and magnetoesophagogram (mesg) as noninvasive clinical methods to quantify esophageal function and motility disorders, which could guide intervention for a large number of adult patients. the main aims in this proposal are to develop a mathematical model of esophageal function and characterize phenotypes of esophageal motility disorders using eesg/mesg in healthy controls and esophageal dysmotility patients and determine how eesg/mesg rhythm and pattern abnormalities relate to physiologic function.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age who are undergoing hrm for routine standard of care evaluation for esophageal motility. * normal control participants (ages ≥ 18 years) who have no known gastrointestinal complications. exclusion criteria: * those with claustrophobia who cannot lie still under the squid for the length of time required * due to interference with signal acquisition, subjects with contraindication to undergoing an mri scan as noted in the mri safety checklist by vanderbilt university medical center (such as with heart pacemakers, metal implants, or metal chips or clips) will not undergo squid, but can still be eligible to do cutaneous eesg. * morbid obesity (these patients are potentially unable to lie under the current generation of squid devices) * patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded
clinical and immunologic impact of perinatal sars-cov-2 (covid-19) infection

Conditions: Covid19; Pregnancy Related; Neonatal Infection

Summary: this is a multi-center prospective study that aims to investigate the clinical and immunologic impact of sars-cov-2 infection in pregnant women and neonates. the goal is to recruit 200 sars-cov-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. clinical data will be collected from women and neonates. upper airways samples will be obtained from both for bio-markers investigation. finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.

covid-19, the disease caused by the novel coronavirus sars-cov-2, has led to an unprecedented global pandemic affecting persons of all ages. pregnant women are in a physiologic immunosuppressed situation and have a greater risk and severity of respiratory infection. however, considerable uncertainty exists regarding the potential for vertical transmission (prenatal/congenital or perinatal) of sars-cov-2 from infected pregnant women to their newborns and its potential clinical consequences. this study attempts to provide evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around covid-19 require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; trasnplacental and human milk antibody transfer and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission.

Eligibility criteria:
inclusion criteria: * pregnant women hospitalized presenting with: 1. fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty) 2. diagnoses of pneumonia with no other explainable cause. exclusion criteria: * none
untreated follicular lymphoma treated with obinituzumab in a non-interventional study (urban)

Conditions: Follicular Lymphoma

Summary: to evaluate the effectiveness and safety of obinutuzumab in clinical routine in 1l fl measured by the % of relapse within 24 months from start of therapy.

this observational study has been planned to evaluate the effectiveness of obinutuzumab in combination with chemotherapy in previously untreated advanced fl patients, in the real world setting in italy. the study will allow to collect real-life data in a significant number of italian patients when compared to participants in pivotal studies of obinutuzumab and thus will allow to verify in routine practice (after physician hands-on) the effectiveness and safety management in 50 reference sites all over the country.

Eligibility criteria:
inclusion criteria: * signed informed consent according to local regulations, after performing at least 2 cycles of induction treatment with obinutuzumab and chemotherapy, within 1 year from beginning of treatment exclusion criteria: * any contraindications to obinutuzumab therapy according to local label for specific indication; * concomitant participation in an interventional clinical study; * participants not receiving treatment for untreated follicular lymphoma with obinutuzumab according to standard of care and in line with local labeling.
a study evaluating sotorasib platinum doublet combination versus pembrolizumab platinum doublet combination as a front-line therapy in participants with stage iv or advanced stage iiib/c nonsquamous non-small cell lung cancers (codebreak 202)

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: the primary objective of this study is to compare progression-free survival (pfs) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of nonsquamous stage iv or advanced stage iiib or iiic nsclc with kras p. g12c mutation and negative for pd-l1 expression by central testing or local laboratory testing confirmed through central testing * no history of systemic anticancer therapy in metastatic/non-curable settings * eastern cooperative oncology group (ecog) ≤ 1 exclusion criteria: * mixed histology nsclc with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology * participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved * symptomatic (treated or untreated) brain metastases * gastrointestinal (gi) tract disease causing the inability to take oral medication * myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina * prior therapy with a kras g12c inhibitor

Keywords: oncology lung cancer pd-l1 kras p.g12c sotorasib pembrolizumab carboplatin pemetrexed codebreak 202 nsclc pd-l1 negative amg 510 lumakras ® lumykras ®
validation of the moisturemeterd in local edema by histamine

Conditions: Lymphedema

Summary: in lymphedema there is increase in water content of the tissue. we studied a device (moisturemeterd) which is suitable to detect water contact in the tissue. although the apparatus is commercially available, no validation study had been performed in vivo with local edema. we designed a validation study for inter- and intra observer variability and the reproducibility in vivo by histamin induced local edema

the multiprobe delfin moisturemeterd is a unique and compact water-specific instrument for the measurement of water content of biological tissues. it measures the dielectric constant values of the skin and subcutaneous tissues non-invasively and locally in a few seconds. the dielectric constant value is directly proportional to the amount of water in the tissue. as lymphedema produces local water content increase, we are interested if the device is suitable for daily use in lymphedema patients. therefore we designed a protocol to measure the results with a moisturemeter in a standardized edema formation by histamin induced scratch test edema. this method is well known in type i allergy testing. the aim of the study is: 1. research the inter- and intra observer variability 2. measure the reproducibility of edema formation in a standardized edema formation

Eligibility criteria:
inclusion criteria: * patients 18 years or older; * coming for intra-cutaneous allergy scratch test; * gender: male and female. exclusion criteria: * patients who have a pacemaker or other inbuilt stimulator; * lymphoedema; * patients who have an infection; * patients with skin problems in research area. * no use of anti-histamines medication

Keywords: local edema dielectric constant values validation study
prevention of postpartum smoking relapse in mothers of infants in the neonatal intensive care unit (nicu)

Conditions: Smoking

Summary: the investigators hypothesized that an enriched focus on mother-infant bonding during a newborn's hospitalization in the neonatal intensive care unit would reduced the rate maternal postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had quit smoking during or just prior to pregnancy.

mothers of newborns admitted to the neonatal intensive care unit (nicu), who had quit smoking during or just prior to pregnancy where randomized to either the standard of care or smoking relapse prevention group. mothers in both groups were encouraged to remain smoke free following the birth of their babies and were given routine lactation support for breastfeeding during their babies' hospitalization in the nicu. mothers in the smoking relapse prevention group were also given the study intervention, which was enhanced support for maternal-infant bonding by providing information about their newborn's behaviors using books, dvds, and handouts that were appropriate for their baby's gestational age and by encouraging frequent skin-to-skin holding. primary outcomes included duration of smoke-free status and duration of breastfeeding.

Eligibility criteria:
inclusion criteria: * mothers: * who had quit smoking during pregnancy or within one year prior to pregnancy * who had newborns \< 1 week old at the time of admission to our nicu. exclusion criteria: * mothers: * who were smokers at the time of delivery * whose infant's length of stay \< one week * who were not available (jail, adoption) * who had a history of drug use * who did not speak english

Keywords: postpartum smoking relapse breastfeeding
cardiac amyloidosis registry of university hospital leipzig

Conditions: Cardiac Amyloidosis

Summary: this is a clinical registry of patients with cardiac amyloidosis being treated at university hospital leipzig. the aim of the registry is to collect detailed information about clinical events, symptoms, imaging, biomarkers, comorbidities, and treatment from routine patient management which would not be provided by randomized clinical trails.

cardiac amyloidosis is increasingly diagnosed since awareness of the disease and therapeutic options increase. there is evidence from clinical trials about warning signs ("red flags"), diagnostic algorithms, and evidence for specific treatment. however, patients in randomized clinical studies are highly selected and do not necessarily reflect clinical practise. furthermore, large clinical trials do not account for national medical care differences nor provide data about long-term outcome and the associations with comorbidities. clinical registries may reflect broad clinical practise and help to characterize cardiac amyloidosis in terms of epidemiology, application of diagnostic methods, the impact of comorbidities, and real-world clinical course. furthermore, clinical registry studies may validate data from randomized clinical trials, provide information on implementation of treatment, the quality of interventions, monitoring patients during treatment, and inform about the safety of procedures. the cardiac amyloidosis registry aims to collect data from the routine clinical management of patients with cardiac amyloidosis at the tertiary care university hospital leipzig. in particular, obtaining data about clinical events of heart disease, hemodynamic measures from echocardiography and circulation biomarkers, cardiac morphology from different imaging methods, clinical status, functional capacity, quality of life, and impact of comorbidities during the course of the disease will be the goal of this registry.

Eligibility criteria:
inclusion criteria: * confirmed cardiac amyloidosis according to current standards exclusion criteria: * refusal to participate

Keywords: heart failure cardiac amyloidosis restrictive cardiomyopathy
music and adherence home programs post stroke

Conditions: Stroke

Summary: the purpose of this study is to explore whether adherence to upper extremity home programs changes when persons post stroke practice with preferred music.


Eligibility criteria:
inclusion criteria: * ages 40-85 * mild to moderate hemiparesis as determined by a score of 21 to 50 on the fm- ue * at least 6 months post stroke * american english as primary language exclusion criteria: * significant visual impairment as determined by "aphasia-friendly" and age appropriate screening * significant hearing impairment as determined by self-report * actively receiving occupational or physical therapy services for upper extremity motor recovery * severe auditory comprehension impairment such that they cannot understand one-step directions as indicated by a wab-r score below 8/10 on sequential commands subtest * sitting or standing blood pressure of 180/110 or he \> 100 bpm