Kornimate/medical-research-clean huggingface dataset:
long-term antibiotics for treatment and prevention of otitis media in aborignal children

Conditions: Otitis Media

Summary: this clinical trial was conducted in a population where tympanic membrane perforation occurs in 60% infants in the first year of life. nasopharyngeal colonisation (nasal contamination) with pathogenic bacteria occurs within weeks of life and predicts persistent middle ear infection throughout childhood. the trial aimed to assess whether twice daily antibiotics commencing at first detection of middle ear effusion would cure the infection and/or prevent disease progression, compared to placebo. the study was conducted in three remote aboriginal communities in the northern territory of australia. the annual birth cohort was 45. aboriginal infants were seen as soon as possible after birth, and at 2 weekly intervals until middle ear effusion was detected by pneumatic otoscopy and tympanometry. following consent, infants were randomised to either amoxycillin(50 mg/kg/d bd) or placebo equivalent for up to 24 weeks, or until normal middle ear status was detected at 2 consecutive monthly scheduled examinations. at monthly examinations the infant also had a general health check, parents were interviewed, child's medical record was reviewed, and nasopharyngeal swabs were collected.


Eligibility criteria:
inclusion criteria: * australian aboriginal * living in participating remote community * less than 12 months of age exclusion criteria: * less than 32 weeks gestation * chronic condition requiring continuous antibiotic * ear, nose or throat abnormality

Keywords: acute otitis media otitis media with effusion tympanic membrane perforation
efficiency of antibacterial prophylaxis in azacitidine treated patients

Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia

Summary: infections are a major life-threatening complication in patients with myelodysplastic syndrome (mds) or acute myeloid leukaemia (aml). currently there is no guidelines about antibacterial prophylaxis to prevent infections in patients with myelodysplastic syndrome or acute myeloid leukaemia. the investigators will conduct a randomized prospective study to evaluate the benefit of prophylactic antibacterial by levofloxacin on febrile episode in azacytidine treated patients (mds and aml).

this is a randomized prospective study with 2 arms to evaluate the efficacy of levofloxacin prophylaxis in azacytidine treated patients (mds and aml) levofloxacin will be given 500mg/d p.o. for the first three cycles of azacytidine in patients randomized in arm antibacterial prophylaxis. in control arm patients will not received levofloxacin. the expected duration of subject participation is one year after randomization.

Eligibility criteria:
inclusion criteria: * age superior to 18 years old * smd or aml treated with azacytidine (not previously treated) * life expectancy more than 3 months * performance status inferior to 3 * signed inform consent exclusion criteria: * allergy to quinolone * previous event of tendopathy due to quinolone * previous epileptic event * systemic antibacterial prophylaxis the month before enrolment * hiv positive * bacterious infection of indetermined fever * participation to an investigational drug trial * abnormalities in hepatic assessment * qtc superior to 450 ms * pregnant or lactating women * myasthenia * g6pd deficient * severe and uncontrolled diabetes * patient not able to understand trial

Keywords: levofloxacin, antibacterial prophylaxis, febrile episode
bergonie institut profiling : fighting cancer by matching molecular alterations and drugs in early phase trials

Conditions: Solid Tumor; Hematological Malignancy

Summary: this is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease. in this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling. patients included in the bip study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at institut bergonie or another french hospital.

the need to 'personalize' cancer therapy has been recognized, with specific biomarkers which will be used to direct targeted agents only to those patients deemed most likely to respond. this "personalized cancer medicine" requires two critical steps: first, a comprehensive assessment of the biological characteristics of tumors from each individual, and second, validated biomarkers to identify the subgroups of patients who are most likely to benefit from a given therapy and the next-generation sequencing provides unprecedented opportunities to draw a comprehensive picture of genetic aberrations involve in immunotherapy sensitivity and ultimately enable individualized treatment. the main objective of this study is to use next generation sequencing technologies to identify actionable molecular alterations in cancer patients with advanced disease included in the study. this study will provide a fully integrated view of the molecular profile of the tumor for each patient included in the study. such tumor profile will be used by clinicians to tailor therapies of patients in specific early phase clinical trials.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, 2. histology: solid malignant tumor or hematological malignancy, 3. deleted msa9 4. deleted msa9, 5. deleted msa9, 6. deleted msa9, 7. patient with a social security in compliance with the french law relating to biomedical research (article l.1121-11 of french public health code), 8. voluntary signed and dated written informed consent prior to any study specific procedure. exclusion criteria: 1. deleted msa9 2. deleted msa9 3. deleted msa9 4. deleted msa9 5. deleted msa9 6. deleted msa9 7. deleted msa9 8. deleted msa9 9. individuals deprived of liberty or placed under guardianship 10. pregnant or breast feeding women, 11. previous enrolment in the present study.

Keywords: molecular profiling genomic alteration advanced cancer
ability to cope with type 1 diabetes

Conditions: Depression

Summary: the purpose of this study is to learn about the relationship that exists between coping skills and blood glucose control. in addition to this, we will study the effect of type 1 diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic groups, and the duration of diabetes.

coping with type 1 diabetes can be very difficult. type 1 diabetes is a very unique chronic disease because it requires constant attention to several responsibilities such as daily glucose monitoring, multiple daily insulin doses, and strict diet and exercise. several studies have shown that increased rates of poorer glucose control are a result of struggling to cope with type 1 diabetes. this may be due to the fact that many type 1 diabetics experience a feeling of exhaustion, or "burnout," after a certain period of time due to an overwhelming amount of responsibility. in our study we would like to determine how children's ability to cope with diabetes affects glucose control. by completing several questionnaires, we can analyze different kinds of coping skills through a complex scoring system. these scores will then be analyzed in comparison to your glucose control using hba1c.

Eligibility criteria:
inclusion criteria: * subjects must be type 1 diabetic * english/spanish speaking * the legal guardian must be present exclusion criteria: * non-cognitive or mentally ill * under the age of 8.0 years

Keywords: depression socioeconomic status type 1 diabetes mellitus children adolescents
peng block vs. esp block for pediatric hip surgery

Conditions: Hip Dysplasia; Hip Injuries; Hip Fractures; Hip Disease

Summary: the study compares the effectiveness and safety of the pericapsular nerve blockade vs. espb in pediatric patients who underwent hip surgeries.

the study compares the effectiveness and safety of the pericapsular nerve blockade vs. espb in pediatric patients who underwent hip surgeries. in addition, we aim to determine the optimal volume of local anesthetics needed to achieve a satisfactory level of analgesia.

Eligibility criteria:
inclusion criteria: - pediatric patients aged between 0-12 years who will undergo hip surgery exclusion criteria: * a history of chronic pain use of gabapentin/pregabalin for \> 3 months opioid use \> 1 repeated opioid prescription in the last three months * morbid obesity (bmi \> 99th percentile) * infection at block application area * coagulopathy
evaluation of enhanced lithotripsy system (els) in the treatment of urinary stones, a pivotal trial

Conditions: Kidney Calculi; Ureteral Calculi

Summary: the purpose of this study is to evaluate the safety and performance of the els to treat urinary stones. the els is intended to break urinary stones into small fragments that can pass during or after the procedure with less or no discomfort. eligible patients are male or females, age 21 or older, with a single urinary stone in the ureter. participants will undergo the els procedure and then be evaluated 30 days later for the presence or absence of urinary stone fragments on a ct scan. other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.


Eligibility criteria:
inclusion criteria: * male or female aged \>=21 years * provides written informed consent * one urinary stone within the ureter, size \>=5 mm and \<=10 mm * stone is indicated for shock wavve lithotrips per aua 2016 guidelines * urinary stone is present on a ct scan within past 14 days exclusion criteria: * anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment * medical expulsion therapy (e.g., flomax) * non-calcium based stones (e.g., uric acid stones) * untreated uti * presence of abnormal skin conditions in the area to be treated * coagulation abnormality * inability to lay still for 30 minutes * pregnant * abnormal kidney function * any genitourinary history or procedure that has altered anatomy (e.g. urinary tract reconstruction)
efficacy and safety of levetiracetam in routine clinical practice in czech and slovak republics, hungary, and romania.

Conditions: Epilepsy

Summary: to evaluate, over 1 year period, the efficacy and safety of newly prescribed levetiracetam as add-on treatment (pos, myoclonoc seizures in jme and pgtcs in ige) or primary monotherapy (partial onset seizures) in adult and paediatric patients within the approved age limits in routine clinical practice in czech and slovak republics, hungary, and romania. non-interventional study.


Eligibility criteria:
inclusion criteria: * diagnoses of partial onset seizures (pos) with or without secondary generalisation or juvenile myoclonic epilepsy (jme) or another ige with pgtcs * newly prescribed levetiracetam as add-on treatment (pos, myoclonic seizures in jme and pgtcs in ige) or monotherapy (partial onset seizures only) in newly diagnosed patients. newly prescribed means inclusion of the patients in whom a decision has been made to prescribe lev and the first dose is just to be prescribed. * age 4 years or above for partial onset seizures, 12 years or above for ms in jme or pgtcs in ige, 16 years or above for monotherapy * patient written informed consent exclusion criteria: * indications other than those defined in inclusion criteria * history of allergic or anaphylactic reactions to levetiracetam or other pyrrolidone derivatives and excipients included

Keywords: levetiracetam keppra epilepsy efficacy safety
comparison of dynamic distraction systems in proximal interphalangeal joint fractures

Conditions: Proximal Interphalangeal Joint Fracture of the Hand

Summary: fractures of the proximal interphalangeal joints continue to pose significant management challenges. thus the aim of our study is to compare two dynamic finger joint distractors (litos® and ligamentotaxor®) in respect to the radiological standard follow-up examination and functional assessments.


Eligibility criteria:
inclusion criteria: * proximal interphalangeal fracture treated with external dynamic fixator * operative care \<21 days from trauma * age between 18 and 90 years. * male and female exclusion criteria: - additional fractures or disabilities of the hand
rifaximin for preventing relapse of clostridium associated diarrhoea

Conditions: Clostridium Difficile Infection

Summary: clostridium difficile associated diarrhoea is an important cause of morbidity in patients treated with antibiotics, especially in hospital. clinical relapse occurs after up to 30% of initially successful treatments for colitis. preliminary reports suggest that rifaximin, a poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. we plan to carry out a randomised placebo controlled trial to test the hypothesis that rifaximin given in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.

aims i) to examine efficacy of a follow-on course of rifaximin given after a successful initial course of standard treatment, in the prevention of relapse in c. difficile associated diarrhoea (cdad). ii) to examine changes in faecal microbiota in patients given rifaximin vs. placebo. treatment 4 weeks treatment with rifaximin or placebo tablets. tapering dose starting with 2 x 200mg tablets three times a day (total = 1.2g per day) for the 1st 2 weeks, reduced to 1 x 200mg tablet three times a day (total = 0.6g per day) for the 2nd 2 weeks. primary endpoint: the difference in % relapse between rifaximin and placebo at 12 weeks

Eligibility criteria:
inclusion criteria: 1. men / women aged 18 and over (we will also include those adults who lack mental capacity for whom we have a legal representative) 2. successful treatment of clinically diagnosed cdad using standard therapy (metronidazole or vancomycin given according to standard local hospital guidelines). exclusion criteria: 1. woman of child bearing potential and not willing to use at least one highly effective contraceptive method throughout the study 2. male with spouse/partner of child bearing potential and not willing to use condoms 3. pregnant or breast feeding 4. unable to swallow tablets 5. life expectancy of \<4 weeks 6. hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of its excipients (tablet core: sodium starch glycolate type a, glycerol distearate, colloidal anhydrous, silica, talc and microcrystalline cellulose. tablet coating: hypromellose, titanium dioxide (e171), disodium edentate, propylene glycol and red iron oxide e172) 7. \>5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed cdad 8. taking ciclosporin

Keywords: clostridium difficile diarrhoea rifaximin
efficacy and safety study to evaluate vadadustat for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (dd-ckd)

Conditions: Anemia; Dialysis-Dependent Chronic Kidney Disease

Summary: a multicenter, randomized, open-label, active-controlled phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (dd-ckd)

this is a multicenter, randomized, open-label, active-controlled phase 3 study of the efficacy and safety of vadadustat versus darbepoetin alfa for the maintenance treatment of anemia in participants with dd-ckd

Eligibility criteria:
inclusion criteria: * ≥18 years of age * receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to screening * currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during screening * mean screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dl) (inclusive) in the us and between 9.0 and 12.0 g/dl (inclusive) outside of the us * serum ferritin ≥100 nanograms per milliliter (ng/ml) and transferrin saturation (tsat) ≥20% during screening exclusion criteria: * anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss * uncontrolled hypertension * red blood cell transfusion within 8 weeks prior to randomization * anticipated to recover adequate kidney function to no longer require dialysis * severe heart failure at screening (new york heart association class iv) * acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during screening * hypersensitivity to vadadustat, darbepoetin alfa, or any of their excipients

Keywords: akb-6548 chronic kidney disease anemia ckd chronic renal insufficiency renal impairment erythropoietin kidney renal oral anemia treatment hemoglobin hypoxia-inducible factor hif hypoxia-inducible factor prolyl-hydroxylase inhibitor hif-phi efficacy safety phase 3 cardiovascular dd-ckd
a clinical study of the combination of shr8554 injection and shr0410 injection for the treatment of pain after abdominal surgery.

Conditions: Pain

Summary: the primary objective is to evaluate the analgesic efficacy of the combination of shr8554 injection and shr0410 injection compared with shr8554 injection in patients with acute postoperative pain following abdominal surgery


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects requiring elective general anesthesia abdominal surgery 3. conform to the asa physical status classification exclusion criteria: 1. subjects with a history of difficult airway 2. subjects with a history of reflux esophagitis 3. subjects with a history of mental illness 4. subjects with poor blood pressure control 5. random blood glucose ≥11.1mmol/l 6. subjects with abnormal liver function 7. allergies to opioids and other medications that may be used during the trial 8. the investigators determined that other conditions were inappropriate for participation in this clinical trial
aortitis and retroperitoneal fibrosis: evaluation of diagnostic criteria

Conditions: Idiopathic Aortitis; Retroperitoneal Fibrosis

Summary: inflammatory aortitis probably represents a heterogeneous group, and the clinical experience accumulated over the last ten years, shared by the experts of the subject, is that the initial clinical, biological or radiological characteristics should make it possible to differentiate them and dismember the nosological field. this will be an essential first step before studying prognosis, risk factors, and therapeutic options. the search for diagnostic criteria on a large series, similar to the study of classification of vascularites of the acr in 1990, should make it possible to homogenize the diagnoses for the different teams working on the subject, and to begin work collaborations, which alone can improve patient care in the future.


Eligibility criteria:
inclusion criteria: * cases : * all cases of idiopathic aortitis and retroperitoneal fibrosis followed in participating centers over the past 15 years will be collected. * witnesses : * group 1: non-idiopathic inflammatory aortitis: all cases of inflammatory aortitis (apart from idiopathic aortites and isolated retroperitoneal fibrosis) followed in the participating centers over the last 15 years will be collected. * group 2: subjects with noninflammatory aortic disease, atheromatous type or annulo-ectasitic disease, matched by age and sex with cases. this group will be used to define the differential characteristics between idiopathic aortitis and noninflammatory aortic pathology. * group 3: this group will include control subjects aimed at defining radiological normality criteria according to age and sex. as the images are machine-dependent, group 3 controls will be randomly selected from the radiology departments that have performed the scanner or mri of the corresponding control. exclusion criteria: * patients under 18 years of age
does disinfection of the subcutaneous tissue reduce contamination of the operating field with p. acnes?

Conditions: Surgical Incision

Summary: propionibacterium acnes is a pathogen commonly identified in postoperative shoulder infections. a recent study has shown that p. acnes is likely to be disseminated in the operating field from the subcutaneous layer by the manipulation of soft tissues by the surgeon and the instruments. disinfection of the subcutaneous tissue seems to significantly reduce contamination of the operating field during primary shoulder surgery. this study seeks to assess the efficacy of disinfection of the subcutaneous tissue compared to dissection with an electrosurgical unit on p. acnes contamination during primary shoulder surgery.

the investigators are going to study the efficacy of disinfecting the subcutaneous tissue with betadine standard solution during primary shoulder surgery compared to electrosurgical dissection. they will randomize 105 patients on two arms. the control group receiving no disinfection of the subcutaneous tissue but a dissection with an electric cautery(a) and intervention group receiving a disinfection of the subcutaneous tissue (b). they believe that the duration of 4 years is sufficient to recruit the number of patients necessary for this study. all patients 18 years of age or older admitted to valais hospital for primary shoulder surgery and having signed the consent of the study will be eligible. the use of disinfection of the subcutaneous tissue during primary shoulder surgery could reduce contamination of the operating field and theoretically the post-operative infection rate after primary shoulder surgery. the study focuses on disinfection with betadine solution of the subcutaneous tissue during primary shoulder surgery. this action could decrease contamination of the operating field and the infection rate after primary shoulder surgery. this solution is already widely used for disinfecting the skin and traumatic or surgical wounds. the investigators will use it according to the recommendations made in the swiss compendium of medicines. no evidence has been brought to a decrease in this contamination if the dissection is carried out with an electric cautery. scalpel dissection is used as standard in orthopedic surgery as well as in other surgical disciplines.

Eligibility criteria:
inclusion criteria: 1. = or\> 18 years old 2. treated at the valais hospital for primary shoulder surgery. 3. have signed the consent exclusion criteria: 1. \<18 years old 2. history of shoulder surgery 3. history of shoulder infection 4. antibiotic therapy in the 2 weeks preceding the intervention 5. cortisone infiltration in the 6 months preceding the intervention 6. allergy to iodinated contrast agent or cefuroxime 7. allergy to povidone iodine complex or other contraadication to betadine 8. refusal of study terms

Keywords: subcutaneous desinfection, p. acnes, electric cautery
study evaluating dvs-233 sr and venlafaxine er in adult outpatients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to compare the antidepressant efficacy and safety of dvs-233 sr with those of placebo in adult outpatients with mdd.


Eligibility criteria:
inclusion criteria: * men and women 18 to 75 years of age, inclusive. * sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article * subjects must have a primary diagnosis of major depressive disorder exclusion criteria: * treatment with dvs-233 sr at any time in the past * treatment with venlafaxine (immediate release \[ir\] or extended release \[er\]) within 90 days of study day 1 * known hypersensitivity to venlafaxine (ir or er)