Kornimate/medical-research-clean huggingface dataset:
longitudinal therapeutically non-interventional study of msrv-env burden in patients with multiple sclerosis disease

Conditions: Multiple Sclerosis (MS); Relapsing-Remitting MS; Primary Progressive MS; Secondary Progressive MS; Clinically Isolated Syndrome (CIS)

Summary: this study intends to explore evolution of msrv expression by analyzing the levels of msrv transcripts in blood, as well as the levels of the msrv-env protein in serum of ms patients. the study will be conducted over one year in four cohorts of patients with different forms of ms (remitting-relapsing ms i.e. rrms, primary-progressive ms i.e. ppms and secondary-progressive ms i.e. spms) and in clinically isolated syndrome (cis) patients who have suffered a single clinical event but do not comply with diagnosis criteria for definite ms. the msrv rna and msrv-env protein levels will be correlated with the clinical evolution of patients and with the reverse transcriptase activity, inflammatory markers assessed by cytokines levels. a control group of healthy subjects will be included (the study, gn-e-003, is performed in parallel and is part of another dedicated protocol).


Eligibility criteria:
inclusion criteria: * signature of an informed consent; * male or female between 18 and 60 years of age; * patients with ppms (revised mcdonald criteria 2010) or patients with spms or cis or patients with rrms (revised mcdonald criteria 2010) ideally without ifn beta therapy at the t0 visit for rrms patient only. exclusion criteria: * positive serology for hepatitis b or c or hiv; * acute infection at inclusion; * severe psychiatric disorder; * autoimmune disease other than ms; * pregnancy or breastfeeding; * heavy smokers i.e. more than 10 cigarettes per day; * history of alcohol or drug abuse in the last 3 years; * participation in a clinical trial (within the last 3 months).

Keywords: multiple sclerosis (ms) relapsing-remitting ms primary progressive ms secondary progressive ms clinically isolated syndrome (cis) multiple sclerosis associated retrovirus (msrv) msrv envelop protein (msrv-env) temelimab
remimazolam versus propopol based total intravenous anesthesia for breast surgery

Conditions: Hypotension

Summary: comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia

the purpose of this study was to investigate whether remimazolam-based general anesthesia could reduce the incidence of hypotension in patients undergoing breast surgery under general anesthesia compared to propofol-based general anesthesia. the purpose of this study is to establish and test the hypothesis that the incidence of hypotension under general anesthesia based on remimazolam will be less than that of propofol based general anesthesia. in addition, this study compares the proportion of patients who require a vasopressor, the time taken for anesthesia induction, the time to recover from anesthesia, postoperative pain, the incidence of postoperative nausea and vomiting, the quality of postoperative recovery, and patient satisfaction.

Eligibility criteria:
inclusion criteria: * adult patients over the age of 19 undergoing elective breast cancer surgery under general anesthesia at seoul national university hospital exclusion criteria: * patients with acute narrow-angle glaucoma/ shock or coma/ acute alcohol poisoning/ sleep apnea/ alcohol or drug dependency/ severe or acute respiratory failure/ galactose intolerance/ lapp lactase deficiency/ glucose galactose malabsorption/ severe hypersensitivity to dextran. * patients with myasthenia gravis/ pulmonary heart disease/ chronic obstructive pulmonary disease/ bronchial asthma * patients with cardiovascular diseases such as ischemic heart disease/ coronary artery disease/ angina pectoris/ myocardial infarction/ atherosclerosis/ arrhythmia/ cerebrovascular disease/ and stroke * patients with chronic renal failure * patients with severe hepatic impairment (child pugh class c) * patients with american society of anesthesiology score iii or higher * patients with hypersensitivity to propofol and soy or peanuts * epilepsy patients * patient with fat metabolism abnormality * patients with high intracranial pressure * pregnant woman * patients unable to use supraglottic airway due to poor dental condition * in cases that the researcher judges to be unsuitable for this clinical trial
dose-range finding treosulfan-based conditioning

Conditions: Hematological Malignancies

Summary: evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² treosulfan resp., combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell transplantation of patients with hematological malignancies, but non-eligible to standard conditioning treatment.


Eligibility criteria:
inclusion criteria: 1. patients with a haematological chemosensitive malignancy indicated for an allogeneic transplantation, but presenting an increased toxicity risk for classical (high-dose busulfan or standard-dose total body irradiation) conditioning therapies (remission criteria ref. to appendix l): * cml in first or subsequent chronic phase * nhl in 2nd cr/pr, chemosensitive pr after autologous transplantation ; cll in 2nd or subsequent cr/pr * relapsed morbus hodgkin (mh) after autologous transplantation * multiple myeloma (mm) stage ii and iii according to durie and salmon * aml in 2nd cr/pr or high-risk aml in 1st cr/pr high-risk defined for example by the following: * cytogenetics: -5/5q, -7/7q, del(5q), abnormalities of 3q, complex karyotype (\> 3 abnormalities), or * pr after 1 cycle of induction therapy * all in 2nd cr/pr or high-risk all in 1st cr/pr high-risk defined as follows: * leukocytes \> 3000/µl (b-linage) or \> 100000/µl (t-linage); * pro-b-all, pre-t-all * cytogenetics: t(9;22)/bcr-abl; t(4;11)/all1-af * mds (patients without prior chemotherapy may be included) 2. availability of an hla-identical sibling donor (mrd) or hla-identical unrelated donor (mud) or one mismatch (out of the 6 standard markers) sibling donor (1 mismrd): • hla-identity defined by the following markers: a, b, drb1. dqb1 must be recorded. 3. age \> 18 years 4. karnofsky index \> 80 % 5. adequate contraception in female patients of child-bearing potential 6. co-operative behavior of individual patients 7. written informed consent exclusion criteria: 1. completely chemotherapy-resistant disease 2. severe cardiac insufficiency, severe cardio-vascular or other severe concomitant diseases 3. symptomatic malignant involvement of the cns 4. active infectious disease 5. hiv-positive or active hepatitis infection 6. impaired liver function (bilirubin \> 1.5 x upper normal limit; transaminases \> 3.0 x upper normal limit) 7. impaired renal function (creatinine-clearance \ 1.5 x upper normal limit). 8. pleural effusion or ascites \> 1.0 l 9. pregnancy or lactation 10. known hypersensitivity to fludarabine and/or treosulfan 11. parallel participation in another experimental drug trial

Keywords: treosulfan allogeneic stem cell transplantation conditioning therapy
comparison of different prophylaxis regimens for moderate to severe hemophilia a pediatric patients

Conditions: Hemophilia A

Summary: title: comparison of different prophylaxis regimens for hemophilia a pediatric patients principal investigator: assistant professor darintr sosothikul, md research question: does different factor viii dosage effect outcome of hemophilia treatment in term of breakthrough bleeding, number of hospital stay and day-off from school? type research: clinical research study design: single center clinical trials concise methodology: 1. study population: children with hemophilia a who received treatment at kcmh from may 2015 to march 2016 will be enrolled in this study. the consent will be obtained before the study. 2. observation and measurement: 1. history, interesting clinical data and laboratory data will be recorded in clinical record form (crf) 2. measurement: i. complete blood count (cbc), factor viii level, factor viii inhibitor level ii. number of breakthrough bleedings, number of hospital stay and day-off from school iii. joint score from hemophilia joint health score 2.1 iv. eq-5d-5l quality of life assessment score 3. data analysis: the p-value of less than 0.05 will be considered statistically significant. mann-whitney test will be used to test correlation of these variables (cbc, factor viii level, factor viii inhibitor level, number of breakthrough bleedings, number of hospital stay, day-off from school, hemophilia joint health score 2.1, eq-5d-5l quality of life assessment score) sample size: 16 patients potential impacts: the outcomes of different factor viii concentrate dose between 15-20 u/kg/dose 2 times/week and 35-40 u/kg/dose 1 time/week will be revealed. these outcomes include number of breakthrough bleeding, number of hospital stay, day-off from school, joint health and quality of life. the result of this study will guide further study on optimal dose and duration of factor viii treatment of hemophilia a patients in the future.


Eligibility criteria:
inclusion criteria: * hemophilia patients with moderate (factor level 1-3%) or severe (factor level \<1%) severity exclusion criteria: * platelet count less than 100,000 /mm3 or other bleeding tendency * hemophilia patients who have fviii inhibitor \>0.6 bu (modified nijmogen method) * hemophilia patients who have no bleeding symptoms

Keywords: moderate hemophilia a severe hemophilia a intermediate dose prophylaxis low dose prophylaxis
hypofractionated radiotherapy for localized prostate cancer (with cyberknife or with imrt)

Conditions: Prostatic Neoplasms

Summary: to demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and effective in the treatment of low-risk localized prostate cancer.


Eligibility criteria:
inclusion criteria:- eligible patients will have clinical stage t1c through t2b, initial psa level \<10 and a biopsy gleason score of 3+3 or 3+4 with fewer than 50% of biopsy cores involved. * patients who have had any form of prior curative treatment (surgery, radiotherapy, cryotherapy) will not be eligible. a prior course of hormone therapy of less than 3 months duration will be allowed. * adult men will be considered. * no life expectancy restrictions will apply. * performance status will not be considered. * no requirements for organ or marrow function will be made * ability to understand and the willingness to sign a written informed consent document. exclusion criteria:- no prior prostate treatment will be allowed. * the use of other concurrent investigational agents will not be allowed. * no exclusion requirements due to co-morbid disease or incurrent illness. * no requirements regarding history of allergic reactions. * pregnancy or nursing patients is not applicable (ie. patients are male).
evaluation of treatments for allergic rhinitis (rhinal 2)

Conditions: Allergic Rhinitis

Summary: the goal of this clinical study is to perform a post-market clinical follow-up of 2 medical devices (liquid bandage in the form of a spray : allerspray g (product a - code aag), pcns (product b - code pc) indicated for symptomatic treatment of allergic rhinitis. this follow-up will consist in collecting real-life clinical data to confirm the safety and efficacy of medical devices used in the treatment of allergic rhinitis of adults patients while allowing an assessment of the product's risk/benefit ratio. the main questions it aims to answer are: * primary objective : evaluate in real life the tolerance of medical device a and b used in the treatment of allergic rhinitis. * secondary objectives : evaluate the efficacy of medical device a and b on allergic rhinitis and the quality of life using the device a and b. no comparison group will be constituated because of the type of study (post market follow up) and no comparison between device a and b will be done. 58 participants (29 for medical device a and 29 for medical device b) with allergic rhinitis will be asked to : * use medical device a or b during 2 weeks (from inclusion visit to end of study visit), * complete each day at home a diary (recording intensity of 4 nasal symptoms, adverse events, concomitant treatments), * complete " quality of life evaluation (sleep, daily activities, fatigue, irritability) " at inclusion visit and end of study visit.


Eligibility criteria:
inclusion criteria: * " score for allergic rhinitis " ≥ 8 * age ≥ 18 * able to refrain from using any treatment for allergic rhinitis or any other treatment that could interfere with the purpose of the study, * effective contraception for women of reproductive age, * cooperation and understanding sufficient to comply with the requirements of the study, * acceptance to give written consent and inscription to vrb french platform for the duration of the study, * affiliation to the french social security system, exclusion criteria: * known hypersensitivity to any of the components of the evaluated products, * use of any treatment to treat allergic rhinitis, * pregnant or breastfeeding women, * participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding eur 6000 over the 12 months preceding the start of the trial, * benefiting from a measure of legal protection (guardianship, deprivation of liberty, safeguard of justice), * having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test

Keywords: post-market clinical study follow up allergic rhinitis
safety of interferon gamma-1b with rituximab in non-hodgkin's lymphoma patients

Conditions: Non-Hodgkin's Lymphoma

Summary: evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b (ifn g-1b) administered 3 times per week with rituximab for 4 weeks, in patients with progressive or relapsed low-grade non-hodgkin's lymphoma (nhl) international study with sites in the czech republic and poland


Eligibility criteria:
* relapsed or progressive low-grade/follicular nhl who are candidates for rituximab therapy * patients who were on other therapy including chop or radiation * previous therapy must have concluded 30 days prior to enrollment * demonstrable cd20-positive tumor population in lymph nodes or bone marrow

Keywords: lymphoma
a clinical trial assessing the impact of the availability of inhaled insulin on glucose control

Conditions: Diabetes Mellitus

Summary: to assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * failing two or more oral anti-diabetic agents exclusion criteria: * asthma, copd * smoking
comparing nose & mouth breathing during exercise

Conditions: Healthy

Summary: the purpose of this study is to compare physiological responses in cardiovascular variables between nose and mouth breathing at rest and during exercise.

breathing patterns can affect the cardiovascular system. little is known about how nose versus mouth breathing affects cardiovascular variables (blood pressure, heart rate, etc.) at rest and during exercise. it has been suggested that breathing through the nose can cause calmness and lower blood pressure. however, research is needed to examine the extent to which breathing through the nose affects cardiovascular variables at rest and during exercise. therefore, we will compare cardiovascular variables between nose-only and mouth-only breathing. the rate of breathing will be fixed (using an audible metronome) for both breathing conditions (nose-only vs mouth-only) based on an individual's free breathing (i.e., no breathing cues) breathing rate.

Eligibility criteria:
inclusion criteria: * body mass index: ≤30 kg/m2 * resting blood pressure: ≤140/90 mmhg exclusion criteria: * overt cardiovascular (e.g., diagnosed hypertension), respiratory, neurological, renal, liver, and/or metabolic health condition * current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes)
sapien m3 efs: early feasibility study of the edwards sapien m3 system for the treatment of mitral regurgitation

Conditions: Mitral Regurgitation; Mitral Disease

Summary: this study will evaluate the safety and functionality of the sapien m3 system in patients with symptomatic, severe mr and will provide guidance for future clinical study designs utilizing the sapien m3 system.

prospective, single-arm, multicenter early feasibility study

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. mr ≥ 3+ 3. nyha functional class ≥ ii 4. high risk of cardiovascular surgery 5. hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure 6. the study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. exclusion criteria: 1. mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve 2. cardiac imaging evidence of intracardiac mass, thrombus or vegetation 3. significant risk of lvot obstruction 4. severe right ventricular dysfunction 5. lv ejection fraction \<30% 6. patient is inoperable 7. prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment 8. need for aortic, tricuspid or pulmonic valve replacement 9. presence of mechanical aortic valve prosthesis 10. history of cardiac transplantation 11. history of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism 12. clinically significant untreated coronary artery disease requiring revascularization 13. any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days. 14. stroke or transient ischemic attack within 90 days of the procedure 15. myocardial infarction within 30 days of the procedure 16. active bacterial endocarditis within 180 days of the procedure 17. inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy 18. leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states 19. hospitalization for chf or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days. 20. irreversible, severe pulmonary hypertension 21. patients with renal insufficiency or receiving renal replacement therapy 22. liver disease or significantly abnormal liver function test results 23. refusal of blood products 24. female who is pregnant or lactating 25. estimated life expectancy \< 12 months 26. participating in another investigational drug or device study

Keywords: transcatheter mitral valve replacement sapien m3
role of psychoanalysis in prevention of girl child maltreatment and neglect

Conditions: Abuse Neglect; Social; Deprivation, Maltreatment Syndrome (Infant or Child)

Summary: in india, precisely northern states, skewed sex ratios, female feticide and higher child mortality rates for girls have become serious concern. the female child mortality as a result of son preference have increased during the last several decades .since families cannot know the sex of the fetus due to indian government policies, maltreatment and serious neglect has been tools to ensure there are few survivors.


Eligibility criteria:
inclusion criteria: * families having girl child before * high risk families with high expectation of having son exclusion criteria: * families having son before * relocation and moving out of town during study period * not ready to consent for intervention

Keywords: gender discrimination psychoanalysis randomized controlled trial
221ad302 phase 3 study of aducanumab (biib037) in early alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the clinical dementia rating-sum of boxes (cdr-sb) score as compared with placebo in participants with early ad. secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by mini-mental state examination (mmse), ad assessment scale-cognitive subscale (13 items) \[adas-cog 13\], and ad cooperative study-activities of daily living inventory (mild cognitive impairment version) \[adcs-adl-mci\].


Eligibility criteria:
key inclusion criteria: * must meet all of the following clinical criteria for mci due to ad or mild ad and must have: * a clinical dementia rating (cdr)-global score of 0.5. * objective evidence of cognitive impairment at screening * an mmse score between 24 and 30 (inclusive) * must have a positive amyloid positron emission tomography (pet) scan * must consent to apolipoprotein e (apoe) genotyping * if using drugs to treat symptoms related to ad, doses must be stable for at least 8 weeks prior to screening visit 1 * must have a reliable informant or caregiver key exclusion criteria: * any medical or neurological condition (other than alzheimer's disease) that might be a contributing cause of the subject's cognitive impairment * have had a stroke or transient ischemic attack (tia) or unexplained loss of consciousness in the past 1 year * clinically significant unstable psychiatric illness in past 6 months * history of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to screening * indication of impaired renal or liver function * have human immunodeficiency virus (hiv) infection * have a significant systematic illness or infection in past 30 days * relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities * any contraindications to brain magnetic resonance imaging (mri) or pet scans * alcohol or substance abuse in past 1 year * taking blood thinners (except for aspirin at a prophylactic dose or less) note: other protocol defined inclusion/exclusion criteria may apply

Keywords: aducanumab biib037
the effect of personal activity intelligence versus 10,000 steps daily on cardiorespiratory fitness

Conditions: Obesity; Physical Activity

Summary: a high physical fitness can prevent cardiovascular disease. which form of exercise training is efficient at improving fitness is well known. the challenge is to get people to do it. personal activity intelligence (pai) is an algorithm developed for this challenge. it gives a score that tells the users whether they are active enough to achieve the maximum health benefit of exercise based on their heart rate. it has been shown that people who obtain 100 pai a week have less cardiovascular disease, but intervention studies showing that pai can improve physical fitness are so far lacking. step counters have received a lot of attention and 10 000 steps a day is a common recommendation, but little is known about the physiological adaptations to this intervention. this study will compare the effect of physical activity with a value of 100 pai points a week with 10 000 steps a day in healthy, but overweight (body mass index \> 25) participants between 30 and 50 years of age.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 25 * low physical activity (less than 50 pai points calculated from a questionnaire) exclusion criteria: * cancer diagnosis * cardiac arrhythmia * angina * previous myocardial infarction * lung disease * heart disease * uncontrolled hypertension * kidney disease * orthopedic or neurological limitations * planned surgery during the intervention * participation in other research studies conflicting with the current study

Keywords: exercise actigraphy prevention and control cardiorespiratory fitness