Kornimate/medical-research-clean huggingface dataset:
transcranial magnetic stimulation effects on pain perception

Conditions: Gastric Bypass Surgery Pain Management

Summary: the purpose of this research study is to investigate the effects of transcranial magnetic stimulation on pain perception. tms is a non - invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures)

to test whether rtms over the left prefrontal cortex significantly reduces post-operative pain and pca use following gastric-bypass surgery relative to sham and an active control, in a mood- independent manner. note that the active control is still mentioned in the aims and hypotheses, but was apparently removed from the study design. to determine the effects of timing (one immediately following surgery and one 4 hours later) and dose of tms (0, 1, or 2 sessions of active rtms) on post-operative pain and pca use; to determine the effects of tms on post-surgical recovery time (time to discharge) and clinical outcomes at 1-month, 3- months and 6-months follow-up. again an active control is mentioned, though this was removed from the design. it appears that this aspect of the proposal was not edited to reflect the new study design. in the new design, 108 participants received two 20 minute sessions of 10 hz rtms (110% of motor threshold) over the left dorsolateral prefrontal cortex (one immediately following surgery and one 4 hours later). participants were randomly assigned to receive two sessions of real rtms, two sessions of sham, 1 real then 1 sham, or 1 sham then 1 real rtms treatments.

Eligibility criteria:
inclusion criteria: * adult gastric by-pass patients 18 to 60 years old exclusion criteria: * non gastric by -pass patients.
measuring electrical resistance of different tissues on the outer surface of the heart

Conditions: Cardiomyopathies; Ventricular Dysfunction; Myocardial Infarction; Arrhythmia

Summary: this is a research study to evaluate the electrical properties of heart tissue. the purpose of this study is to determine the impedance (electrical resistance) of different tissues on the outer surface of the heart. this may be important for distinguishing scarred heart muscle from fat that can be seen on the surface of the heart. this information may eventually be utilized in patients that undergo a procedure (called catheter ablation) for the treatment of life-threatening heart rhythms. investigators expect a detectable difference between the impedance of normal and infarcted myocardium (approximately 50 ohms).

the treatment of cardiac arrhythmias with endocardial catheter ablation has evolved rapidly over the past few decades. at the time of this writing, the ablation of almost all atrial and ventricular arrhythmias has been described in the literature. multiple energy modalities (e.g. radiofrequency, cryotherapy) and approaches (e.g. retrograde aortic, transseptal puncture) have been described, yet ablation of some rhythms is not as successful as others. the realization that ventricular tachycardia (vt) in the setting of chagas disease can originate in the epicardium has lead to the development of a percutaneous, transthoracic epicardial approach to mapping and ablation of this arrhythmia. this approach has now been applied to patients with vt in the setting of ischemic and nonischemic heart disease at many centers throughout the world. traditional mapping technologies are utilized on the epicardium to define scarred heart tissue and locate the vt circuit. it is well known that human hearts display a variable amount of fat overlying the epicardium. not only is the coronary vasculature embedded in a layer of adipose tissue, but the rest of the heart may have areas of epicardial fat. as fat is an insulator and does not generate or easily conduct electrical activity, current mapping techniques may classify epicardial fat incorrectly as myocardial scar. this may have important effects on the ability to diagnose and treat arrhythmias with epicardial ablation.

Eligibility criteria:
inclusion criteria: * all adult patients undergoing elective cardiac surgery for coronary artery disease (with or without normal heart function) or valvular disease (with normal heart function) at the hospital of the university of pennsylvania under the direction of y. joseph woo md will be eligible. exclusion criteria: * patients undergoing emergent surgery and patients with idiopathic cardiomyopathy, infiltrative cardiomyopathies and hypertrophic cardiomyopathies will be excluded.

Keywords: ventricular arrhythmia myocardial infarction ventricular dysfunction coronary artery disease structural heart disease arrhythmia cardiomyopathies
basal insulin for type 2 diabetes patients treated in outpatient clalit clinics

Conditions: Type 2 Diabetes

Summary: treatment of diabetes mellitus type ii with basal insulin, for patients treated in clalit outpatient clinics that are not adequately controlled with current treatment.

patients with diabetes treated in outpatient clinics will be recruited by their primary care physician. recruitment period will be 3 months per center and each patient will be followed for 7 months diabetes specialists will be responsible for 50-65 primary care physicians. the specialists will advise and direct the primary care physician through the whole study period. the study protocol includes patients treated with different types of non short- acting insulin. insulin lantus (including dose) will be started by the primary physician, if needed after consulting the diabetes specialist. the treatment should follow the study protocol. patients will have 3 pre-scheduled visits in their clinic: 1. at the beginning of study. 2. after 3 months. 3. at study end (after 6 month). an additional telephone contact will take place 1 month after last visit. to evaluate adherence to therapy data collecting: data including hba1c, fpg,current diabetic treatment, dose of insulin lantus, and relevant additional diseases\\complaints will be collected at each visit. additional information as demographic data, medical history will be collected at beginning of study. safety: hypoglycaemic episodes will be recorded

Eligibility criteria:
inclusion criteria: 1. type ii diabetic patients 2. hba1c \>8.0% (result from preceding 4 months) 3. written informed consent 4. life expectancy of at least 1 year. 5. patients' agree to discontinue current long acting insulin (if applicable). 6. patients who according to their gp are eligible to the study. exclusion criteria: 1. type i diabetes 2. pregnancy and\\or lactation. 3. allergy to basal insulin 4. patients suffering from a disease that requires repeated hospitalizations e.g.: severe chf, sever renal failure, active malignancy. 5. patients who are not able to give consent. 6. patients face difficulties in mobility and/or verbal communication with the treating physician. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: diabetes hba1c
sars-cov-2 seroprevalence and seroconversion among employees of the universitair ziekenhuis brussel following mrna covid-19 vaccination

Conditions: SARS-CoV Infection

Summary: a novel zoonotic coronavirus was discovered in wuhan (hubei province, china) mid-december 2019 and was named severe acute respiratory syndrome coronavirus 2 (sars-cov-2). the virus rapidly spread to the rest of the world, including europe and explicitly affects the respiratory system, generating coronavirus disease 2019 (covid-19). this study is a monocentric interventional prospective and retrospective cohort study. after signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. sample storage and analysis will be performed at the laboratory of microbiology of the uz brussel. to document sars-cov-2 seroprevalence and seroconversion among employees of the uz brussel after mrna vaccination for sars-cov-2, namely at 8 weeks after first vaccination, 6 months after first vaccination and 12 months after first vaccination.

a novel zoonotic coronavirus was discovered in wuhan (hubei province, china) mid-december 2019 and was named severe acute respiratory syndrome coronavirus 2 (sars-cov-2). the virus rapidly spread to the rest of the world, including europe and explicitly affects the respiratory system, generating coronavirus disease 2019 (covid-19). uz brussel employees presenting symptoms suggestive of covid-19 are offered to be tested with real-time pcr on nasopharyngeal swabs. as asymptomatic infections have been described and as the pcr can be negative when taken late after onset of symptoms, serologic tests can be performed. the sars-cov 2003 epidemic demonstrated that serological assays were a useful diagnostic tool of non-acute infections. although it is still uncertain whether convalescing patients have a risk of re-infection, recent data suggest that sars-cov-2 antibodies could protect at least for some time from subsequent viral exposures. as the covid-19 pandemic had devastating medical, economic and social consequences, safe and effective prophylactic vaccines were urgently needed. and thus several candidate vaccines against sars-cov-2 have been developed. during the first weeks of the vaccination campaign, the health care workers of the uz brussel, were invited to receive the bnt162b2 (pfizer) vaccine. consequently, the investigators aim to prospectively document the sars-cov-2 seroprevalence and seroconversion among vaccinated employees of the uz brussel, at three different time points, namely 6 weeks (+/- 2 weeks; t1), 6 months (+/- 1 month; t2) and 12 months (+/- 1 month; t3) after the second vaccination.

Eligibility criteria:
inclusion criteria: * any adult employee of the uz brussel at t1 who has been vaccinated at the uz brussel with mrna covid-19 vaccine (comirnaty®) between the 19th of january and the 5th of february 2021 after participating to phase 4 of the covemuz study (with a maximum of 5 days difference between blood drawel and vaccination) and has provided a signed informed consent. exclusion criteria: * uz brussel employees not active during the inclusion period (t1).
a clinical trial comparing isolite® vs. cotton roll isolation in the placement of dental sealants

Conditions: Dental Caries on Pit and Fissure Surface

Summary: the purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under isolite vs. cotton roll isolation. this study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.

104 regular patients at the college of dentistry department of pediatric dentistry clinics, ages 6-16 years, will be invited to participate in this study. matched contralateral pairs of first and second molars and premolars will be randomized to receive sealants with the use of the device (isolite) for isolation or with the use of cotton roll isolation. all sealants will be placed by pediatric dentistry residents. sealants will be placed on first and second permanent molars that have a matched contralateral molar requiring a sealant as well. photographs may be taken of the sealants on the day of placement and at a 6-month and 12 month recalls. retention of the sealants will be evaluated and scored by calibrated pediatric dentists.

Eligibility criteria:
inclusion criteria: * healthy patients: american society of anesthesiologists (asa) i or ii * good cooperation: frank1 3 or 4 * aged between 6-16 years old at the day of sealant placement * minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars. exclusion criteria: * teeth with a history of past or current caries * teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies * teeth with clinical or radiographic evidence of pathology * teeth with a history of restoration or sealant * patients who are poorly behaved

Keywords: pit and fissure sealants isolation permanent teeth children isolite® dental caries
clinical aml registry and biomaterial database of the study alliance leukemia (sal)

Conditions: Acute Myeloid Leukemia (AML)

Summary: this is a registry study in adult patients with newly diagnosed or refractory/relapsed acute myeloid leukemia. investigator's sites: 51 sites in germany. primary objectives: * identification of epidemiological data on aml: age, prognostic factors and subgroup distributions. incidence and age distribution are compared with the data of population-related tumor registry. * evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (rfs) / time to relapse (ttr), calculation of cumulative incidence of relapse (cir) and overall survival (os) * documentation of treatment strategy

see brief summary

Eligibility criteria:
inclusion criteria: * aml according to the who (world health organization) diagnostic criteria, including acute promyelocytic leukemia * age ≥ 18 years. there is no upper age limit. * signed written informed consent exclusion criteria: * there are no exclusion criteria
energy expenditure and body composition in pseudohypoparathyroidism 1a

Conditions: Pseudohypoparathyroidism Type 1A; Albright Hereditary Osteodystrophy

Summary: the investigators would like to learn more about the metabolic consequences of pseudohypoparathyroidism type 1a in children, adolescents and adults with this condition. people with pseudohypoparathyroidism 1a are at risk for development of obesity. to better understand the cause of overweight or obesity, investigators are measuring body composition and resting energy expenditure (ree), which is the amount of calories burned while completely at rest. the investigators also want to determine the amount of body fat.

pseudohypoparathyroidism 1a (php1a) is a disorder that is associated with many endocrine problems. people with php1a are at risk for the development of obesity. the objective of the study will help determine if obesity is related to abnormalities energy expenditure, meaning that people with php1a may not burn as many calories while at rest as those without the disorder. in order to further evaluate obesity in php1a, investigators are planning to measure resting energy expenditure (ree), which is the amount of calories burned while completely at rest. investigators will also evaluate body composition by looking at measures of growth and development and determining the amount of body fat using dual energy x-ray absorptiometry (dxa) as well as blood and urine biologic markers of obesity. the investigators plan to evaluate people with php1a at all weights.

Eligibility criteria:
inclusion criteria: * diagnosis of pseudohypoparathyroidism 1a * any body weight exclusion criteria: * absence of above diagnosis

Keywords: pseudohypoparathyroidism albright hereditary osteodystrophy
effect of bg00012 on lymphocyte subsets and immunoglobulins in subjects with relapsing remitting multiple sclerosis (rrms).

Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Summary: the primary objective of the study is to evaluate the effect of bg00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (rrms). a secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (alcs) and immunoglobulins (igs) during the first year of treatment.


Eligibility criteria:
key inclusion criteria: * subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. * must have a confirmed diagnosis of rrms according to the revised mcdonald criteria (2010) \[polman 2011\] key exclusion criteria: * history of or positive test result at screening for: * human immunodeficiency virus * hepatitis c virus antibody * hepatitis b infection * drug or alcohol abuse within 1 year prior to screening. * prior treatment with any of the following: * cladribine * mitoxantrone * total lymphoid irradiation * alemtuzumab * t-cell or t-cell receptor vaccination * any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab * treatment with any of the following medications or procedures within 6 months prior to baseline (day 1): * dmf (given as fumaderm®) or bg00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior dmf exposure * cyclosporine * azathioprine * methotrexate * mycophenolate mofetil * intravenous (iv) ig * plasmapheresis or cytapheresis note: other protocol defined inclusion/exclusion criteria may apply

Keywords: tecfidera dmf dimethyl fumarate
study of the biological mechanisms associated with the immunogenicity in anaplastic large cell lymphoma ( alcl ) alk +

Conditions: ALCL

Summary: to study the correlation between the polymorphism of the main immunity genes and progression-free survival in alcl of the child.


Eligibility criteria:
inclusion criteria: * every patients treated according to copad-igr, hm 89,91 and 97 and alcl99 protocols and included in related studies * clinical data registered in sfce database * signed consent form exclusion criteria: * no alk expression on tumour * no consent signed
pilot study of varenicline to treat opioid dependence

Conditions: Chronic Pain; Opioid Dependence

Summary: the objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.


Eligibility criteria:
inclusion criteria * age\>=21 years * use of opioids at admission to prc, with daily morphine equivalent dose\>=60mg * be able and willing to participate fully in all aspects of the study including one month follow-up after completion of prc * ability to provide informed consent exclusion criteria * currently using varenicline or other pharmacotherapy for nicotine dependence * currently pregnant, lactating, or likely to become pregnant during the trial and not willing to use an acceptable form of contraception; * history of a major cardiovascular event in the past 6 months including unstable angina, acute myocardial infarction, stroke, or coronary angioplasty; * known varenicline allergy * use of any medication (e.g., methadone, suboxone) as maintenance therapy for opiate addiction * identification of illicit drugs (e.g., marijuana, cocaine) on the baseline urine toxicology screen

Keywords: varenicline chantix chronic pain opioid dependence
identification and treatment of the liability to develop schizophrenia

Conditions: Schizophrenia

Summary: this study seeks to determine whether adult, non-psychotic, first-degree relatives of schizophrenic patients who show specific neurocognitive deficits and negative symptoms will show improvements in these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone.


Eligibility criteria:
inclusion criteria: * having at least one first-degree biological relative with schizophrenia and their age is between 19 and 59. * desire to participate in a medication trial. * is able to provide informed consent. * having moderate levels of negative symptoms, defined as 6 items rated 3 or higher on the scale for the assessment of negative symptoms (sans). * scoring two or more standard deviations below normal in at least one of three cognitive domains: vigilance/working memory, long-term verbal memory, and executive functions. * scoring at least one standard deviation below normal in a second cognitive domain. exclusion criteria: * iq less than 80. * formal education less than 10 years. * history of psychotic disorders. * history of treatment with an antipsychotic medication. * a substance abuse diagnosis within 6 months of diagnosis. * a head injury with documented loss of consciousness exceeding 5 minutes (or subsequent cognitive deficits). * a history of neurologic disease or damage. * a medical condition with significant cognitive sequelae. * a history of electroconvulsive treatment.

Keywords: negative symptoms neuropsychological deficits cognitive function diagnostic prevention
human mesenchymal stem cells for acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: this is a phase 1, open label, dose escalation, multi-center clinical trial of allogeneic bone marrow-derived human mesenchymal stem cells (hmscs) for the treatment of acute respiratory distress syndrome (ards). the purpose of this study is to assess the safety of hmscs in patients with ards.

the primary objective of this study is to assess the safety of intravenous infusion of allogeneic bone marrow-derived human mesenchymal stem cells (hmscs) in patients with ards.

Eligibility criteria:
inclusion criteria: patients will be eligible for inclusion if they meet all of the below criteria. criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment: acute onset (defined below) of: 1. a need for positive pressure ventilation by an endotracheal or tracheal tube with a pao2/fio2 ratio \< 200 with at least 8 cm h2o positive end-expiratory airway pressure (peep) 2. bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph 3. no clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates. in addition to meeting inclusion criteria, enrollment must occur within 96-hours of first meeting ards criteria per the berlin definition of ards. exclusion criteria: 1. age less than 18 years 2. greater than 96 hours since first meeting ards criteria per the berlin definition of ards 3. pregnant or breast-feeding 4. prisoner 5. presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years 6. any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% 7. moderate to severe liver failure (childs-pugh score \> 12) 8. severe chronic respiratory disease with a paco2 \> 50 mm hg or the use of home oxygen 9. patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest). 10. major trauma in the prior 5 days 11. lung transplant patient 12. no consent/inability to obtain consent 13. moribund patient not expected to survive 24 hours 14. who class iii or iv pulmonary hypertension 15. documented deep venous thrombosis or pulmonary embolism within past 3 months 16. no arterial line/no intent to place an arterial line 17. no intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol 18. currently receiving extracorporeal life support (ecls) or high-frequency oscillatory ventilation (hfov)

Keywords: acute respiratory distress syndrome acute lung injury allogeneic bone marrow-derived human mesenchymal stem cells