Kornimate/medical-research-clean huggingface dataset:
linezolid instead of ethambutol in treatment of drug-susceptible tuberculosis

Conditions: Pulmonary Tuberculosis Without Resistance to Rifampicin

Summary: the current standard short-course treatment for pulmonary tb requires 6 months to complete. this long duration of treatment increases the likelihood of side effects while decreasing patients' adherence to anti-tb drugs. linezolid showed considerable efficacy against refractory multidrug-resistant tb. considering the marked anti-tb effects of linezolid as well as the possible adverse effects of its long-term use, it is rational to use linezolid instead of ethambutol for the first 4 weeks of treatment for drug-susceptible pulmonary tb. through randomized controlled trial, the investigators will evaluate the hypothesis that the use of linezolid instead of ethambutol will increase the sputum culture conversion rate by 15% after 2 months of treatment. patients with tb without resistance to rifampicin will be randomized to the following three arms at a 1:1:1 ratio: arma 1 (control arm), arm 2 (linezolid for 2 weeks instead of ethambutol), arm 3 (linezolid for 4 weeks instead of ethambutol)primary outcome will be sputum culture conversion rate after 2 months of treatment (liquid media).


Eligibility criteria:
inclusion criteria: * males and females aged from 20 to 80 years (20- and 80-year-old patients can participate). * documented sputum xpert mtb/rif assay-positive pulmonary tb at screening. * on current tb therapy (if any) for ≤14 days at the time of enrollment. exclusion criteria: * patients with hiv/aids. * females of childbearing potential, who are pregnant, breastfeeding, or unwilling to avoid pregnancy. * any of the following: i.absolute neutrophil count of \ 2.0 mg/dl. v.aspartate aminotransferase (ast or sgot) of \>100 iu/l. vi.alanine aminotransferase (alt or sgpt) of \>100 iu/l. vii.total bilirubin level of \>2.0 mg/dl. viii.history of optic neuritis or peripheral neuropathy. ix.other significant laboratory abnormalities (i.e., absolute neutrophil count, creatinine level). x.the need for ongoing therapy with ssris, tricyclic antidepressants, serotonin 5-ht1 receptor agonists (triptans), meperidine, buspirone, monoamine oxidase inhibitors (maois), sympathomimetic agents (e.g., pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), or dopaminergic agents (e.g., dopamine, dobutamine).

Keywords: tuberculosis
dexmedetomidine for morphine consumption reduction (dexdor)

Conditions: Burning

Summary: the new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. dexmedetomidine (dex), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use. dex was mainly studied in the bandage procedures for the burned adult. the aim of this study is to evaluate the reducing effect of dex on the morphine use in case of severe burnings for adults, to describe the receivers of dex and to report the procedure of this new molecule.

the new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. dexmedetomidine (dex), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use. dex was mainly studied in the bandage procedures for the burned adult. the aim of this study is to evaluate the reducing effect of dex on the morphine use in case of severe burnings for adults, to describe the receivers of dex and to report the procedure of this new molecule. this study would manage to develop a protocol using dexmedetomidine to reduce the use of morphine for the sedation-analgesia. it expects a sensitization of physicians about the need to form the nurse crew for the autonomous use of a protocol before performing a new evaluation of sedation-analgesia.

Eligibility criteria:
inclusion criteria: * more than 18 years old * hospitalised for severe burning (total burned skin surface higher than 20% and/or smoke inhalation and/or severe comorbidities) * having received a continued dexmedetomidine administration of at least 24 hours for the case group and having received no dexmedetomidine administration for the control group exclusion criteria: * inability to communicate (language barrier, major cognitive disorders) * medical contraindication for dexmedetomidine (hepatocellular insufficiency, hypersensibility, grade ii or iii atrio-ventricular blocks without device, acute brain vascular pathology). * for the control group, pregnancy is a non-inclusion criterion
a study of subcutaneous delivery of jnj-54767414 in chinese participants with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and pharmacokinetic of daratumumab subcutaneously in chinese participants with relapsed or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * multiple myeloma (mm) diagnosed according to the international myeloma working group (imwg) diagnostic criteria * participants must have measurable, secretory disease as defined by any of the following: 1. serum monoclonal paraprotein (m-protein) level greater than or equal to(\>=)1.0 gram/deciliter (g/dl) or \>= 0.5 g/dl for immunoglobulin (ig) a, igd, ige or igm mm; or 2. urine m-protein level \>= 200 milligram (mg)/24 hours; or 3. serum ig free light chain (flc) \>= 10 mg/dl and abnormal serum ig kappa lambda flc ratio if participant does not have measurable m-protein in serum and urine * relapsed or refractory mm after receiving at least 2 prior lines of therapy: received both, a pi (\>=2 cycles or 2 months of treatment) and an imid (\>=2 cycles or 2 months of treatment)in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months); a "line of therapy" is defined as 1 or more cycles of a planned treatment program, radiotherapy, bisphosphonate therapy, or a single short course of steroids (that is, less than or equal to equivalent of cumulative dose of dexamethasone 160 mg within 21 days of 1st dose) would not be considered prior lines of therapy * response (partial response or better based on investigator's determination of response) to at least 1 prior treatment regimen * progressive disease based on investigator's determination of response on or after their last regimen * participant must have an eastern cooperative oncology group (ecog) performance status score of 0 or 1 exclusion criteria: * participant has received daratumumab or other anti-cd38 therapies previously * participant has received prior antitumor therapy as follows, prior to the first dose of study drug: 1. targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; 2. monoclonal antibody treatment for multiple myeloma within 21 days; 3. cytotoxic therapy within 21 days; 4. proteasome inhibitor therapy within 14 days; 5. immunomodulatory agent therapy within 7 days; 6. radiotherapy within 21 days. however, if the radiation portal covered less than or equal to (\<=) 5 percent (%) of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy * participant has had a plasmapheresis within 28 days before cycle 1 day 1 * participant has known meningeal or central nervous system involvement of mm * concurrent medical condition or disease (example \[e.g.\], active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
correlation between pet and advanced mri in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: traditional magnetic resonance imaging (mri) in multiple sclerosis (ms) has enabled clinicians to measure disease activity but there are inherent limitations. clinical/radiographic dissociation can be seen in some patients and the abnormalities are not specific. this pilot study is an opportunity to determine the relationship between quantitative advanced mri measures and oct with pet measurements of microglial activation and myelin health.


Eligibility criteria:
inclusion criteria: * diagnosed with multiple sclerosis according to the 2011 mcdonald criteria. * aged 18 to 60 * high or mixed affinity binder to rs6971 tspo polymorphism exclusion criteria: * pregnant or breastfeeding * suffering from an unstable medical condition * have a neurological or ocular disorder other than ms * any contra-indications to mri
comparison of aprotinin and tranexamic acid in routine cardiac surgery

Conditions: Bleeding and Cardiac Surgery; Allogeneic Blood Transfusion; Aortic Valve Replacement; Coronary Artery Bypass Graft Surgery

Summary: the hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleeding.only patients undergoing first time cabg or first time aortic valve replacement are included in this study.

excessive bleeding during and after cardiac surgery is a serious complication. it exposes patients to the risk of allogeneic blood transfusion or other blood products and the risk of mediastinal re-exploration.antifibrinolytic drugs like aprotinin and tranexamic acid are proven to reduce bleeding tendency and transfusion requirement in cardiac surgery. the efficacy of these drugs is proven, especially for the unspecific proteinase inhibitor aprotinin, however, there are concerns about the safety and the high costs of this drug. there are only limited head-to-head comparisons of these two drugs. in this double-blind, prospective, controlled study the efficacy of aprotinin and tranexamic acid is compared. primary outcome is the 24 hours postoperative drainage blood loss and the percentage of patients requiring allogeneic blood transfusion during the hospital stay. subgroups of patients undergoing cabg surgery or aortic valve replacement are predefined for combined and separate data analysis.the power of the study is calculated for this subgroup-analysis. secondary outcome measurements are molecular marker of activation of hemostasis up to the 5th postoperative day.

Eligibility criteria:
inclusion criteria: * informed consent * patients undergoing primary cabg or aortic valve replacement surgery exclusion criteria: * previous sternotomy * opcab surgery * urgent/emergency operation * coumadin treatment * previous aprotinin exposure * preoperative renal impairment (creatinine \> 2 mg/dl) * patients refusing blood transfusions * no informed consent

Keywords: cardiac surgery blood transfusion antifibrinolytics aprotinin tranexamic acid
attention bias modification versus attention control in treatment of social anxiety

Conditions: Social Anxiety Disorder (Social Phobia); Social Anxiety; Social Anxiety Disorder

Summary: the purpose of this study is to compare the clinical efficacy of treatment using gaze contingent music reward therapy (gc-mrt) with attention control treatment based on a similar paradigm, for social anxiety disorder (sad)

this study examines the possibility that the effectiveness shown for gc-mrt in the treatment of sad leans on attention control rather than bias modification. therefore half of the participants will receive the classic gc-mrt course of treatment while the other half a version of the task with non-emotional stimuli (geometric shapes).

Eligibility criteria:
inclusion criteria: * a signed consent form * men and women between the ages of 18 and 65. * meeting a current diagnosis of social anxiety disorder (sp) according to the dsm-iv. * sp as the primary diagnosis: in cases of co-morbidity, sp will be deemed as the most distressing and clinically significant condition among the co-morbid disorders. * no current pharmaco-therapy. exclusion criteria: * a diagnosis of psychotic or bipolar disorders. * a diagnosis of a neurological disorder (i.e., epilepsy, brain injury). * drug or alcohol abuse. * any current pharmacological treatment. * any current psychotherapeutic treatment. * change in treatment during the study. * poor judgment capacity (i.e., children under 18 and special populations).

Keywords: social anxiety social phobia attention bias modification attention control
clinical effectiveness and safety of intraoperative methadone in patients undergoing laparoscopic hysterectomy

Conditions: Postoperative Pain

Summary: the role of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in patients undergoing hysterectomy remains scarcely explored. a prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative methadone in patients scheduled for same day hysterectomy is therefore conducted.

background with aim: hysterectomy is the most common major gynaecological procedure in the world and hysterectomy on benign indications are increasingly being performed as same-day surgery. therefore, perioperative anaesthesia has moved towards the use of very short-acting opioids with the incitement to speed up extubation and facilitate hospital discharge. however, the potential consequence is that more patients experience pain and discomfort. methadone has several desirable pharmacological features, and a single intraoperative dose of the long acting opioid could therefore theoretically expand the analgesic window and reduce postoperative opioid consumption compared to the more conventional use of short-acting opioids. the aim of this study is to investigate the effect of a single-dose of intravenous intraoperative methadone on postoperative opioid consumption, pain and side effects in patients scheduled for hysterectomy for benign indications. our primary hypothesis is that intravenous perioperative methadone reduces opioid consumption (oral cumulative equivalent dose) by 30% during the first 24 postoperative hours compared to intravenous morphine. methods: 126 patients will be included in an investigator-initiated, prospective, randomised, double-blind, controlled trial with two arms: an intervention arm (methadone 0.2 mg/kg ideal body weight) and a control arm (morphine 0.2 mg/kg ideal body weight). the study will be gcp-monitored, and is approved by the danish health and medicines authority (2018-004351-20) and the central denmark region committees on health research ethics (1-10-72-365-18). hypothesis: the results will probably be applicable to other types of surgery involving visceral pain, and thus the present study has the potential to improve the pain management for a large number of patients undergoing surgery.

Eligibility criteria:
inclusion criteria: - patients scheduled for elective laparoscopic hysterectomy for benign indications exclusion criteria: * american society of anaesthesiologists (asa) physical status iv or v * prolonged qt-interval assessed by electrocardiogram (\> 440 milliseconds) * existing treatment with medications prolonging the qt-interval * hysterectomy due to malignancy or acute bleeding disorders * allergy to study drugs * preoperative daily use of opioids * severe respiratory insufficiency * heart failure * acute alcohol intoxication/delirium tremens * increased intracranial pressure * acute liver disease * acute abdominal pain * liver insufficiency * kidney insufficiency * treatment with rifampicin * breastfeeding * inability to provide informed consent.
study immunology and safety of 60-day treatment of sq grass slit (sublingual immunotherapy)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis

Conditions: Seasonal Allergic Rhinitis

Summary: to investigate the immunologic effects and safety of 60-day treatment of the standardized quality units (sq) grass sublingual immunotherapy (slit)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.


Eligibility criteria:
inclusion criteria: * clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis. * use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis. * positive skin prick test response (wheal diameter ≥3 mm) to phleum pratense. * if asthma, daily use of inhaled corticosteroid (ics) should be ≤400 microgram budesonide or equivalent * moderate or higher level of phleum pratense specific ige (immunoglobulin e) (defined as ≥ige class 2; or ≥0.70 kilo units/liter (ku/l)) exclusion criteria: * reduced lung function (defined as fev1 \< 70% (fev1=forced expiratory volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at visit 1 and visit 2 * clinical history of uncontrolled asthma within 3 months prior to the screening visit

Keywords: grazax
cone beam computed tomography for breast imaging

Conditions: Breast Cancer

Summary: the primary aim of this study is to continue the investigation of cone beam computed tomography (cbct) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast cbct in the study protocol. the goal is to accumulate a body of evidence to provide data to incorporate cbct into the diagnostic work-up of breast lesions.


Eligibility criteria:
inclusion criteria: group i: * females at least 35 years of age of any ethnicity * had a mammogram, read as bi-rads® 1 or 2 * will undergo study imaging no later than four weeks from date of mammogram. * is able to undergo informed consent. group ii: * females at least 35 years of age of any ethnicity * require diagnostic imaging * will undergo study imaging no later than four weeks from date of diagnostic mammogram * is able to undergo informed consent exclusion criteria: group i and group ii: * pregnancy * lactation * subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. * subjects who are unable to tolerate study constraints. * subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) * treatment for enlarged thymus gland as an infant * irradiation for benign breast conditions, including breast inflammation after giving birth * treatment for hodgkins disease * subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) * tuberculosis * severe scoliosis
feasibility and effectiveness of computerized cognitive training in adolescents with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the investigators will conduct a randomized placebo-controlled trial of a computerized intervention targeting cognition in 30 teens with autism spectrum disorder.

given the limited options for treatments to improve the core symptoms of autism spectrum disorder (asd), strategies that could target secondary features of the condition and improve quality of life for affected individuals are critical. neuroplasticity-based cognitive training has been found to improve cognition in youth with attention deficit hyperactivity disorder (adhd) and in adults with schizophrenia. in this trial, the investigators are seeking to extend the relevance of computerized cognitive training to youth with asd. given the literature, the investigators hypothesize that computerized cognitive training will produce gains in untrained cognitive tasks and behavioral ratings of executive functions in youth with asd. the investigators will assess aspects of attention and executive functions in 30 affected youth and randomize them 1:1 to either neuroplasticity based cognitive tests or enjoyable age-appropriate computer games not intended to improve cognition. cognition will be assessed again after 15 hours of training over 6 weeks and then again at a three month follow up.

Eligibility criteria:
inclusion criteria: 1. diagnostic and statistical manual of mental disorders (dsm)-5 asd or previously diagnosed dsm-iv autistic disorder, asperger's disorder or pervasive developmental disorder not otherwise specified (nos) and who continue to manifest symptoms in core domains 2. current asd symptomatology at time of enrollment 3. evidence of decrements in at least one of three target cognitive domains (mental flexibility/abstraction, working memory, or attention). exclusion criteria: 1. intellectual disability 2. a known comorbid neurodevelopmental disorder with possible association with autism (i.e., fragile x syndrome, tuberous sclerosis, angelman syndrome, prader-willi syndrome, williams syndrome, neurofibromatosis, mitochondrial disorder). 3. nonverbal or minimal verbal ability 4. no computer/internet connection at home 5. no family member with e-mail 6. patients likely to have a change in therapeutic treatments within the next 6 weeks

Keywords: autism spectrum disorder neuroplasticity-based cognitive training
patch test skin irritation/sensitization of cetaphil daily facial moisturizer spf 50

Conditions: Skin Irritation

Summary: determine if cetaphil daily facial moisturizer spf 50 proves to be a contact sensitizer or irritant in certain individuals.


Eligibility criteria:
inclusion criteria: * not currently under a doctor's care * free of dermatological or systemic disorder which would interfere with the results * free of any acute or chronic disease * will complete a preliminary medical history form and are in general good health * can read, understand, and sign informed consent exclusion criteria: * under 18 years old * currently under doctor's care * currently taking any medication * history of acute or chronic disease * diagnosed with chronic skin allergies * pregnant or lactating

Keywords: cetaphil daily facial moisturizer spf 50