Kornimate/medical-research-clean huggingface dataset:
a study to evaluate mezigdomide in combination with carfilzomib and dexamethasone (mezikd) versus carfilzomib and dexamethasone (kd) in participants with relapsed or refractory multiple myeloma (successor-2)

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of the study is to compare mezigdomide (cc-92480/bms-986348) with carfilzomib and dexamethasone (mezikd) against carfilzomib and dexamethasone (kd) in the treatment of rrmm: successor-2.


Eligibility criteria:
inclusion criteria - participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:. i) myeloma-protein (m-protein) ≥ 0.5 grams/deciliter (g/dl) by serum protein electrophoresis (spep), or. ii) m-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (upep) or,. iii) for participants without measurable disease in spep or upep: serum free light chain levels \> 100 mg/liter (l) (10 mg/dl) involved light chain and an abnormal κ/λ free light chain ratio. * participant has received at least one prior line of anti-myeloma therapy. note: one line can contain several phases (e.g., induction, \[with or without\] hematopoietic stem cell transplant, (with or without) consolidation, and/or \[with or without\] maintenance therapy). * participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-cd38 monoclonal antibody (mab) (participants who were intolerant of an anti-cd38 mab and received \< 2 cycles are still eligible). * participant achieved minimal response or better to at least 1 prior anti-myeloma therapy. * participant must have documented disease progression during or after their last antimyeloma regimen. exclusion criteria * participant who has had prior treatment with mezigdomide or carfilzomib. * participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: bms-986348 cc-92480 carfilzomib dexamethasone multiple myeloma mezigdomide
dalbavancin in real clinical practice in spain

Conditions: Skin Diseases, Bacterial; Skin Diseases, Infectious

Summary: the aim of this study is to describe the real clinical use of dalbavancin in spain between january 2018 and december 2019.

dalbavancin is a new lipoglycopeptide approved for the treatment of absssis (acute bacterial skin and skin-structure infections) with activity against gram-positive pathogens, including mrsa. dalbavancin has unique pharmacokinetics properties, with a terminal half-life of 14.4 days, permitting a single intravenous dosing. dalbavancin has shown a favourable efficacy and safety profile in patients with absssi in randomized controlled trials. however, information regarding daily clinical practice is limited. the main objective of this study is to describe the real clinical practice with dalbavancin in spain.

Eligibility criteria:
inclusion criteria: 1. adult man and woman (≥ 18 years) at the time of receiving dalbavancin 2. patients receiving at least one dose of dalbavancin between 1st january 2018 and 31st december 2019 3. patients with medical follow-up information registered in clinical records for about 90 days after completing the treatment 4. written informed consent requested according to local regulation, iec and protocol requirements exclusion criteria: 1. patient enrolled in a clinical trial in which treatment with dalbavancin is managed through a protocol
thoracic sympathetic ganglion block inadvertent spread

Conditions: Thoracic; Sympathetic Ganglion, Injury

Summary: this study wants to identify the incidence of inadvertend intercostal or epidural spread of thoracic sympathetic block

clinically, sympathetic blocks (sb) have been used widely to relieve the symptoms of smp or to differentiate between smp and sympathetically independent pain. in order to an sb has a diagnostic value, it requires the successful disturbance of the sympathetic activity for a proper duration of time. for the diagnosis of smp using an sb, it is essential achieving complete interruption of the sympathetic activity while preserving the sensory and motor function. the sympathetic trunk at lumbar region runs on the anterolateral surface of the vertebral column from l1 to l4 levels, and deep to the medial aspect of the psoas major muscle. therefore, the investigators can hardly find epidural contrast spread during lumbar sb due to an anterior location of lumbar sympathetic ganglion to the lateral vertebral body. however, frequent psoas muscle injection can be encountered due to a close proximity of lumbar sympathetic ganglion. in contrast to lumbar sympathetic ganglion, the thoracic sympathetic ganglion is not separated from somatic nerves by muscles and connective tissue. moreover, the upper thoracic ganglion runs on the posterior surface of vertebral column with close proximity to adjacent epidural region. this difference of thoracic sympathetic ganglion leads to a frequent epidural and intercostal spread if the investigators perform thoracic sb. such spread to epidural and intercostal space lowers the diagnostic value of thoracic sb. in addition, serious adverse outcome can be encountered if neurolytic agent is injected into epidural or intercostal space for the purpose of thoracic sympathectomy. considering the diagnostic value and safety of thoracic sb, evaluation of actual incidence of occurrence of intercostal and epidural spread is important.

Eligibility criteria:
inclusion criteria: * complex regional pain syndrome * lymphedema after breast cancer surgery exclusion criteria: * coagulopathy * infection * previous spine fusion at thoracic level
study to evaluate the efficacy and safety of oral administration with nemonoxacin and levofloxacin in patients with cap

Conditions: Pneumonia

Summary: 1. this study will test the safety and efficacy of tg-873870 (nemonoxacin) compared with levofloxacin in adult patients with community-aquired pneumonia (cap) 2. to investigate the population pharmacokinetics (ppk) of nemonoxacin in adult patients with cap after continuous oral administration and determine the pharmacokinetic (pk)/pharmacodynamic (pd).

community-acquired pneumonia (cap) remains a leading cause of death in both developing and developed countries. in the choice of antibacterial agents used to treat cap, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. tg-873870 (nemonoxacin), a non-fluorinated quinolone (nfq), is a selective bacterial topoisomerase inhibitor. this study will test the safety and efficacy of tg-873870 (nemonoxacin) compared with levofloxacin in adult patients with community-aquired pneumonia (cap). besides,the population pharmacokinetics (ppk) of nemonoxacin in adult patients with cap after continuous oral administration and determine the pharmacokinetic (pk)/pharmacodynamic (pd).

Eligibility criteria:
inclusion criteria: 1. ages between 18 and 70; 2. weighs between 40 \~ 100 kg, and bmi ≥ 18 kg/m2; 3. must have a clinical diagnosis of cap 4. chest x-ray shows new or persist/progressive infiltrates 5. if female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control) 6. the patient is able to take the drug orally. exclusion criteria: 1. patients with cap that, in the investigator's judgment, is severe enough to require hospitalization for intravenous antibiotic therapy and/or supplemental oxygen therapy with icu support 2. known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease \[copd\] is not exclusionary) 3. clinically significant conduction or other abnormality on 12-lead ecg, or qtc interval 4. potassium is \< 3.5 mmol/l 5. any known disease that seriously affect the immune system 6. active hepatitis or decompensated cirrhosis; 7. have used quinolones or fluoroquinolones within 14 days before enrollment 8. patients who are being or will be on a long-term medication of steroids

Keywords: ofloxacin levofloxacin ofloxacin hydrochloride
prevalence of diabetes mellitus among patients treated with atypical and conventional antipsychotics

Conditions: Schizophrenia; Bipolar Disorder; Diabetes Mellitus

Summary: this pilot study hypothesizes that diagnosed and undiagnosed prevalence of diabetes mellitus may differ across antipsychotioc medications in a community mental health center. the study further hypothesizes that control of diabetes among diagnosed cases may be suboptimal.

study of longitudinal incidence proved impractical within the limitations of the project.

Eligibility criteria:
inclusion criteria: * patients treated with antipsychotic medication at a community mental health center exclusion criteria: * none
evaluate immune response approximately 5 to 6 years after receiving different formulations of gsk bio hep b vaccine

Conditions: Hepatitis B

Summary: to evaluate the persistence of antibodies against hepatitis b, approximately 5 to 6 years after the first dose of the hepatitis b in the primary vaccination study.

all subjects who participated in the primary vaccination study, where subjects who received gsk biologicals' hepatitis b vaccine and who will consent to participate in this long-term follow-up study, approximately 5 to 6 years after the primary vaccination study. the study will be conducted in only 3 centres out of the 4 centres in the primary vaccination study.

Eligibility criteria:
inclusion criteria: * subjects should have participated in the primary study and should have received the first primary dose of vaccination more than five years ago and less than six years ago before blood sampling in this long-term follow-up study. * written informed consent obtained from the subject for the long-term follow-up.
the effect of remote limb ischemic preconditioning for carotid artery stenting

Conditions: Stroke; TIA; Coronary Stenosis

Summary: remote limb ischemic preconditioning is neuro-protective and anti-inflammatory for ischemia- reperfusion injury. as the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and diffusion-weighted magnetic resonance imaging (dw-mri)to determine the extent of its neuro-protective and anti-inflammatory effect.

background: brain ischemia and injury contributed to perioperative morbidity and mortality in carotid artery stenting. remote ischemic preconditioning (ripc) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. to investigate whether remote preconditioning protects the brain injury in patients undergoing elective carotid artery stenting, a randomized trial will be performed in current study. designing 60 patients will be randomized to carotid artery stenting with ripc group or conventional carotid artery stenting group (control). ripc consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmhg for 5mins followed by deflating the cuff for 5mins. cerebral injury was assessed by s-100b, nse, hs-crp and mmse test in different time points.

Eligibility criteria:
inclusion criteria:patients referred for elective carotid artery stenting were participate in the study at the time of scheduling for operation. 1. symptomatic patient, as evidenced by transient ischemic attack (tia), amaurosis fugax, minor or non-disabling stroke(in the hemisphere supplied by the target vessel), within 180 days of the randomization date. 2. discrete lesion located in the internal carotid artery(ica), and the degree of carotid stenosis ≥50% defined as: stenosis ≥70% by ultrasound. stenosis ≥50% by angiography (based on nascet criteria) 3. appropriate for carotid stenting. candidates for carotid artery stenting meet all other inclusion requirements. exclusion criteria: 1. evolving stroke 2. untoward reaction to anesthesia 3. intolerance or allergic reaction to associated medications, including aspirin(asa) and clopidogrel. 4. prior major ipsilateral stroke that may confound study endpoints. 5. severe dementia. 6. hemorrhagic transformation of an ischemic stroke within the past 60 days. 7. chronic atrial fibrillation. 8. mi within previous 30 days. 9. high risk surgical candidate defined as the crest test. 10. bilateral upper limb arteries are severe stenotic or occlusion.

Keywords: mmse nse s100b hscrp dwi-mri
comparisons of the impact of duloxetine versus imipramine on therapeutic efficacy, psychological distress, sexual function, urethral and bladder wall structure and blood flow in women with stress urinary incontinence: a randomized controlled study

Conditions: Stress Urinary Incontinence

Summary: to assess the impact of duloxetine and imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

to assess the impact of duloxetine and imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Eligibility criteria:
inclusion criteria: - stress urinary incontinence exclusion criteria: 1. take monoamine oxidase 2. myocardial infarction critical,cardiovascular insufficiency (such as room blocking, arrhythmia, blood-soaked heart failure, myocardial infarction, stroke and excessive heartbeat). 3. allergy to duloxetine or imipramine 4. uncontrolled angular glaucoma patients 5. pregnant women
study of safety and efficacy in patients with malignant rhabdoid tumors (mrt) and neuroblastoma

Conditions: Malignant Rhabdoid Tumors (MRT); Neuroblastoma

Summary: lee011 is a small molecule inhibitor of cdk4/6. lee011 has demonstrated in vitro and in vivo activity in both tumor models. the primary purpose of this study was to determine the maximum tolerated dose (mtd) and/or recommended dose for expansion (rde) in pediatric patients and to delineate a clinical dose to be used in future studies. this study was also to have assessed the safety, tolerability, pk and preliminary evidence of antitumor activity of lee011 in patients with mrt or neuroblastoma.

due to lack of efficacy, enrollment in the study was stopped at the end of dose escalation (sites were notified of the early enrollment halt on 7-aug-2014) and the dose-expansion part was not conducted. due to halted enrollment and/or lack of complete responses (cr) and partial responses (pr), efficacy analysis was only performed in terms of ttp for the patients treated during the dose-escalation part at the maximum tolerated dose (mtd) and recommended dose expansion (rde).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of mrt or, neuroblastoma or in dose escalation part, other tumors with documented evidence of d-cyclin-cdk4/6-ink4a-rb pathway abnormalities (dose escalation part only), * patients with cns disease should be on stable doses of steroids for at least 7 days prior to first dose of lee011 with no plans for escalation. * in expansion part, patients must have at least one measurable disease as defined by recist v1.1. * patients must have a lansky (≤ 16 years) or karnofsky (\> 16 years) score of at least 50. exclusion criteria: * prior history of qtc prolongation or qtcf \> 450 ms on screening ecg. * patients with the following laboratory values during screening: * serum creatinine \> 1.5 x upper limit of normal (uln) for age * total bilirubin \>1.5 x uln for age * alanine aminotransferase (alt)/serum glutamic pyruvic transaminase (sgpt) \> 3 x uln for age; aspartate aminotransferase (ast)/serum glutamic oxaloacetic transaminase(sgot) \> 3 x uln for age except in patients with tumor involvement of the liver who must have ast/sgot and alt/sgpt ≤ 5 x uln for age. for the purpose of this study, the uln for sgpt/alt is 45 u/l. * patients who are currently receiving treatment with agents that are metabolized predominantly through cyp3a4/5 and have a narrow therapeutic window and/or agents that are known strong inducers or inhibitors cyp3a4/5 are prohibited. in particular, enzyme-inducing antiepileptic drugs (eiaeds). * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for the study.

Keywords: lee011 phase 1 pediatric cdk4/6 inhibitor dose escalation malignant rhabdoid tumors mrt neuroblastoma
a double-blind randomized placebo-controlled study comparing epanova and fenofibrate on liver fat in overweight subjects.

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD; Hypertriglyceridemia

Summary: this study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in sweden to assess the effect of omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic resonance imaging (mri) in patients with over-weight and hypertriglyceridemia.


Eligibility criteria:
inclusion criteria: - provision of informed consent * men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture * have serum triglycerides ≥1.7 mm * have liver fat content as assessed by mri \>5.5% * have a body mass index (bmi) \>25 and ≤40 kg/m2 , exclusion criteria: - history of or presence of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. * creatinine clearance \<60 ml/min at screening (cockcroft-gault formula). * severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (ast) \>3x upper limit of normal (uln) and/or alanine aminotransferase (alt) \>3x uln * total bilirubin \>2.0 mg/dl (34.2 µmol/l) * type 2 diabetes, as defined by who criteria e.g. fasting plasma glucose \>7.0 mm or use of antidiabetic therapy * any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator. this includes signs of liver disease other than nafld that motivates further investigations of treatment based on clinical judgement * recent history (past 12 months) of drug abuse or alcohol abuse. alcohol abuse was to be defined as \>14 drinks per week (1 drink = 35 cl beer, 14 cl wine, or 4 cl hard liquor) or as judged by the investigator

Keywords: omega-3 carboxylic acid
a trial of camrelizumab for injection in combination with famitinib malate capsule and paclitaxel for injection(albumin bound) in advanced solid tumors of patients

Conditions: Advanced Solid Tumors

Summary: the study is being conducted to evaluate safety, tolerability and preliminary efficacy of camrelizumab for injection in combination with famitinib malate capsule and paclitaxel for injection(albumin bound) for advanced solid tumors of patients. to explore the reasonable dosage of dosage regimen of combination therapy for advanced malignant tumors of patients.


Eligibility criteria:
inclusion criteria: 1. male or female aged ≥18 years and ≤75 years at the time of signing the icf; 2. dose escalation period: histopathologically documented incurable advanced malignancies with standard treatment failure; 3. at least one measurable lesion that meets recist 1.1 criteria in case of solid tumors; 4. an eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 1; 5. life expectancy ≥3 months; 6. adequate organ functions as defined; 7. ability to understand and voluntarily agrees to participate by giving written informed consent for the study. exclusion criteria: 1. the imaging examinations shows the tumor invades large blood vessels; or as the assessment of the investigator, the tumor is highly likely to invade important blood vessels which would cause fatal bleeding during treatment; 2. the imaging examinations shows significant pulmonary cavitary tumors occurs with the bleeding risk as the investigator's assessment; 3. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, or spinal cord compression; 4. uncontrollable pleural effusion, pericardial effusion or peritoneal effusion, with clinical symptoms; 5. severe bong injury caused by metastatic tumor of bone; 6. prior malignancy (other than current malignant tumor) within 3 years before the first dose of study treatment; 7. history of autoimmune diseases; 8. evidence or history of arterial/venous thrombosis within 6 months before the first dose; 9. patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy; 10. when receiving immune checkpoint inhibitors previously, myocarditis related with immune, ≥ grade 2 of pneumonia related with immune or ≥ grade 3 of other adverse reactions related with immune occurred.
patients' experiences during endodontic treatments performed by hospital externs at the chru of brest

Conditions: Endodontic Disease

Summary: root canal treatment (rct) consists in eliminating infected and / or inflammatory tissues inside the root canal system of the tooth by a chemo-mechanical preparation and then filling the latter in a three-dimensional, bacteriostatic and durable way to allow healing. this treatment is commonly carried out and can sometimes be long and tedious, as for example on molars with several roots. according to numerous studies, patients consider endodontic treatments as one of the most stress-inducing dental procedures. another study also reports satisfaction during root canal treatment in public health service. there is a paucity in literature about patients'experience of endodontic treatment when they are carried out by dental students. the main objective of this study is to investigate patients' experience of root canal treatment in brest dental university hospital through a qualitative methodology, with individual interviews, a verbatim transcription, followed by a qualitative analysis . this type of research can enable to keep a broad approach of patients' experience and to stay faithful to it.

volunteer patients are recruited during their endodontic treatment in brest dental hospital. at the end of the treatment, the patients are asked to take part in an individual interview. the interview is carried out by a single investigator with the help of a question route, until data saturation. the interviews are transcribed verbatim and anonymously by the main investigator. the interviews are read by qualitative analysis by two investigators in order to determine codes, gathered in categories. then, the results will be written and discussed in an article.

Eligibility criteria:
inclusion criteria: * patients of legal age who volunteered to participate in the study, having formulated their non-opposition * patients having been treated in the dental department of brest dental university hospital by a dental student for an endodontic (=root canal) treatment exclusion criteria: * patient who has formulated his opposition * patients not requiring endodontic treatment * minor patients * patients treated by the consultants or residents * patients taking opioids, powerful psychotropic drugs or having taken atarax® before the treatment or interview * patients who are cognitively impaired or have a disability that impairs comprehension (hearing, speech) * patients under the influence of drugs or alcohol

Keywords: patient experience stress satisfaction confidence