Kornimate/medical-research-clean huggingface dataset:
oral sodium fusidate (cem-102) versus oral linezolid for the treatment of acute bacterial skin and skin structure infections

Conditions: Acute Bacterial Skin and Skin Structure Infections

Summary: phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral cem-102 loading dose regimen compared to oral linezolid in the treatment of subjects with absssi

the primary objective is to demonstrate the non-inferiority of oral cem-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for early clinical response (ecr) in the intent to treat (itt) analysis set in subjects with acute bacterial skin and skin structure infections (absssi). subjects with an absssi caused by suspected or documented gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment

Eligibility criteria:
inclusion criteria: * adolescents between 12 to 18 years old must weigh \>60 kg * patients diagnosed with absssi with at least one systemic sign of infection * diagnosed with cellulitis, major cutaneous abscess, or wound infections (traumatic or surgical) * surface redness, edema or induration must be of a minimum surface area of 75 cm2, or extending ≥5 cm from the peripheral margin of the abscess * suspected or documented absssi caused by a gram-positive pathogen exclusion criteria: * involving a chronic diabetic foot infection (diabetic foot ulcer) * involving burns * involving an anatomical location (e.g. perirectal area) where the incidence of gram-negative and/or anaerobic pathogen involvement is likely * documented bacteremia associated with the current absssi * known severe renal impairment, as indicated by estimated crcl \<30 ml/min (by cockcroft-gault calculation) * evidence of significant liver disease: alt \>3x uln, or direct bilirubin \>uln; known cirrhosis with decompensation (i.e. child-pugh class b or c disease)

Keywords: fusidic acid skin infection
randomized clinical trial of standard fmt treatments

Conditions: Clostridium Difficile

Summary: this is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent c. difficile infection (rcdi). approximately 200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized intestinal bacteria obtained from either single or three donors (group 1 receiving healthy microbiota collected from single donor 90g stool for 2 consecutive days; group 2 receiving healthy microbiota collected from three donors 90g stool for 2 consecutive days). all subjects will be followed for approximately 180 days following fmt treatment for safety.

the endpoints of the study are to evaluate the efficacy and safety of lyophilized product by capsules obtained either from single or three donors and the prevention of subsequent bouts of cdi in 60 days post fmt.

Eligibility criteria:
inclusion criteria: 1. male and female subjects 18 years of age or older. 2. sexually active male and female subjects of childbearing potential agree to use an effective method of birth control during the study. 3. female subjects of childbearing potential will be asked if they could be pregnant. if the subject is unsure a pregnancy test will be completed 4. subject/lar willing and able to provide informed consent. 5. able to follow study procedures and complete the follow-up questionnaire for safety. 6. subject must have an attending physician who will provide non-transplant care (either pi of this study or referring physician). 7. medical history of ≥ 3 bouts of cdi in outpatient or ≥ 2 bouts of cdi in inpatient with either group having ≥ 2 positive fecal tests for c. difficile toxin and at least one bout of cdi within 6 months of enrollment. 8. received at least two courses of standard-of-care antibiotic therapy for cdi. exclusion criteria: 1. unable to take capsules orally. 2. requiring systemic non-c. difficile antibiotic therapy within 14 days prior to fmt. 3. unwilling to stop taking non-dietary probiotics 24-96 hours prior to fmt. 4. unable to stop taking bile acid sequestrants (e.g. cholestyramine) 24-96 hours prior to fmt. 5. unable to stop use of drugs with cdi activity: oral vancomycin, oral or iv metronidazole, fidaxomicin, rifaximin or nitazoxanide 24-96 hours prior to fmt and after fmt. 6. receipt of cdi monoclonal antibodies as treatment for the most recent bout of cdi. 7. life expectancy of \< 6 months. 8. in the opinion of investigator, subject for any reason, should be excluded from the study.
exploring the benefits of pelvic floor muscle training on bladder, bowel, and sexual function in people with spinal cord injury

Conditions: Spinal Cord Injury

Summary: the goal of this trial is to learn about the feasibility and benefits of delivering a pelvic floor muscle training program to people with motor-incomplete spinal cord injury. the main questions it aims to answer are: 1. to evaluate the feasibility of delivering a pelvic floor muscle training program to people with spinal cord injury. the investigators will examine recruitment rate, compliance and adherence to the intervention and other study protocols, adverse events, and participant perspectives of the study protocols. 2. to explore the potential effectiveness of pelvic floor muscle training on pelvic floor, bladder, bowel, and sexual function. participants will be asked to complete a pelvic floor muscle training program for 3 months. at the beginning, middle, and end of the program, researchers will conduct a series of tests to determine the feasibility and potential effectiveness of this program.


Eligibility criteria:
inclusion criteria: * are at least 19 years of age. * have a non-progressive, motor-incomplete spinal cord injury that is at or above the t12 neurological level at least 12 months ago. * have symptoms of bladder, bowel, and/or sexual dysfunction that are caused by your spinal cord injury. * have stable management of spinal cord related secondary health concerns (e.g., spasticity, neuropathic pain). * are able to speak and understand english. exclusion criteria: * are currently pregnant, have been pregnant within the past 6 months, or are planning to become pregnant in the next 6 months. * have had urogenital surgery within the past 12 months. * have received botox bladder injections within the past 4 weeks, or anticipate receiving an injection in the next 6 months. * have presence of severe medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. examples include, but are not limited to pressure sores, cardiovascular disease, and unmanaged diabetes. * have any permanent metal fixtures in their head (excluding dental fillings), or pacemakers, stimulators, or implanted medication pumps. * have a history of seizures, are taking medications that lower the seizure threshold, or experience recurring headaches. * have a condition for which exercise is contraindicated.

Keywords: spinal cord injury pelvic floor muscle training bladder bowel sexual health
utility of lung ultrasound in the estimation of extravascular lung water in pediatric population

Conditions: Pulmonary Congestion; Congenital Heart Disease; Post-Op Complication

Summary: increased extravascular lung water (evlw) may increase mortality and morbidity in cardiopulmonary pathology. many factors can cause increased extravascular lung water and pulmonary edema after cardiac surgery. this includes left ventricular failure, acute mitral regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ards) and sepsis. the clinical assessment of lung water ranges from auscultation to radiological methods to invasive measurements like dye dilution or thermodilution studies. lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung water. lung ultrasound has been validated against auscultation, chest x-rays, ct chest as well as the bedside gold standard, transpulmonary thermodilution in adults. critically ill children are more susceptible to complications and worsened outcomes from increased evlw. lung ultrasound correlates with clinical and radiological endpoints, but has not been validated against invasive objective measures like transpulmonary thermodilution. evaluation of transpulmonary thermodilution setups in the pediatric population has shown different normal values and cutoffs compared to adults, possibly due to differential rates growth and development. it is aimed to investigate the correlation of lung ultrasound based indices of extravascular lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and evaluate their sensitivity and specificity.


Eligibility criteria:
inclusion criteria: * aged under 12 years, * undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease, * aristotle score ≤9, * with prior written informed consent exclusion criteria: * neonates, * children with any chest wall deformity, * children with known lung disease, active infection, * those weighing less than 3.5 kg.

Keywords: lung ultrasound transpulmonary thermodilution
ergometer cycling after replacement of the hip or knee joint

Conditions: Osteoarthritis

Summary: despite the widespread use of hip and knee replacement surgery, there is a considerable lack of consensus regarding postoperative treatment and rehabilitation, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices. in particular there are no recommendations regarding the use of ergometer cycling after hip or knee replacement surgery. therefore the investigators initiated a multicenter controlled clinical trial evaluating the effect of ergometer cycling versus no ergometer cycling after hip or knee replacement surgery.


Eligibility criteria:
inclusion criteria: * patient who is about to receive unilateral hip or knee replacement surgery on an elective basis of diagnosis of osteoarthritis or femoral head necrosis exclusion criteria: * a history of septic arthritis * hip fracture * intraoperative complications * history of implant surgery on the joint to be operated on * rheumatoid arthritis * amputations * inability of complete the questionnaires because of cognitive or language difficulties
a study to assess the efficacy and safety of empasiprubart versus ivig in adults with multifocal motor neuropathy

Conditions: Multifocal Motor Neuropathy (MMN)

Summary: the main purpose of this study is to compare empasiprubart and ivig in adult patients with mmn. the study consists of a double-blinded part a (empasiprubart, ivig) and an open-label part b (empasiprubart). the maximum study duration for participants is up to 49 months.


Eligibility criteria:
inclusion criteria: * is at least 18 years of age and the local legal age of consent for clinical studies * has a confirmed diagnosis of definite or probable mmn at screening according to the efns/pns 2010 guidelines * has responded to ivig in the past 5 years. * is receiving ivig at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle * is receiving a maintenance regimen (no change in frequency, and no change in dose \>10%) of ivig for at least 8 weeks before screening (or at least 10 weeks for participants receiving ivig once every 5 weeks) * minimum converted weekly ivig dose of ≥0.125 g/kg * has documented immunization against encapsulated bacterial pathogens (n meningitidis and s pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before first study drug administration exclusion criteria: * besides the indication under study, known autoimmune disease (eg, sle) or any other medical condition that would confound the study results or put the participant at undue risk * clinical signs or symptoms suggestive of neuropathies other than mmn, such as motor neuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)
prevention of cow's milk allergy in children

Conditions: Milk Hypersensitivity

Summary: impact of fermented milk in prevention of cow's milk allergy in new born and infants


Eligibility criteria:
inclusion criteria: * mother before the 5th month of pregnancy * mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy * mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy * atopic mother or father and at least another atopic member (sister or brother) * parents having given written informed consent * adhesion to eviction regimen for mother and child * parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician) exclusion criteria: * mother in an exclusion period from another study * parents refusing to sign the informed consent * infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator * known or suspected immunodeficiency in the family

Keywords: allergy cow's milk sensibilisation fermented milk infant formula
multi-center clinical study on neonatal hyperbilirubinemia

Conditions: Quality Improvement; Hyperbilirubinemia, Neonatal

Summary: eight hospitals in china will participate in the study, which aims to decrease the incidence of severe hyperbilirubinemia.

through a prospective cohort study of healthy term and near-term infants, the study tries to truly reflect the epidemiology, intervention status, and outcomes of neonatal hyperbilirubinemia and the cost. hopefully, by improving the quality of management of neonatal jaundice,we can explore and obtain a healthy term and near-term jaundice management model suitable for china's national condition, which can eventually reduce the incidence rate of neonatal severe hyperbilirubinemia and bilirubin encephalopathy.

Eligibility criteria:
inclusion criteria: term or near-term neonates with gestational age ≥35w and birth weight ≥2000g. exclusion criteria: infants admitted to a higher level of intervention before discharge.

Keywords: quality improvement hyperbilirubinemia screening follow-up
colospot study : assessment by epispot of circulating tumor cells in patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: treatment of metastatic colorectal cancer needs chemotherapy in most of the cases. during these last years, many new chemotherapies and targeted therapies have been developed improving significantly the overall survival of patients. however, the choice of the therapeutic sequences becomes difficult due to the lack of validated predictive biomarkers of their efficiency. indeed, only the mutation of the k-ras oncogene is a predictive factor of non-efficacy of the anti-egfr antibodies. it is thus crucial to identify new biomarkers to propose the best personalized 1rst line therapeutic sequence. one idea would be to enumerate and characterize the circulating tumor cells (ctc) which, as it has been described in a recent study realized by cohen et al. in patients with metastatic colorectal cancer, would give us an early evaluation of the therapeutic efficiency. in this context, the investigators have developed an innovative technology, the epispot assay (patent of the university medical center of montpellier), that allows the detection \& characterization of viable ctc in the peripheral blood. the epispot technology has been already evaluated in the breast and prostate cancer. thus, the investigators would like to perform a prospective study on a cohort of patients with metastatic colorectal cancer to confirm, with this technology, the predictive value of ctc count for the efficacy of the treatment.

in the aim to study a homogeneous cohort of patients, the investigators will only recruit patients in first line of treatment and treated by 5-fu (iv), irinotecan et bevacizumab combination.

Eligibility criteria:
inclusion criteria: * age \> 18 years * colon or rectum adenocarcinoma (based on the histology) * visceral metastases (synchronous and/or metachronous) * metastatic disease measurable with the recist 1.1 criteria * who performance status 0, 1 or 2 * life expectancy\>3 months when starting the treatment * chemotherapy in metastatic 1rst line combining a protocol of conventional chemotherapy combining 5-fu and irinotecan (folfiri, xeliri) associated with bevacizumab * follow-up of at least one year * collection of the written consent * social security affiliation exclusion criteria: * 2nd line chemotherapy and beyond * history of other cancers considered not cured * active and progressive infection or other serious disease that may not allow the patient to receive the treatment * refusal to participate * patient unable to express his consent * pregnant women * patient unable to be followed-up for at least one year * current participation to another clinical trial * patients under guardianship * vulnerable people protected by the law

Keywords: bevacizumab circulating tumor cells treatment efficiency
effect of prophylaxy of amiodarone and propranolol and amiodarone with propranolol in prevention of atrial fibrillation post coronary artery bypass graft

Conditions: Atrial Fibrillation

Summary: atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently b-blockers are the class i indication to prevent af post cabg. we decide to evaluate use of propranolol and amiodarone separately and together to find a better prophylaxis for af peri-cabg

in this double blind randomized study 240 consecutive patients underwent elective coronary artery bypass grafting, being randomized prospectively into three groups, propranolol (p) (n=80), amiodarone (a) (n=80) and amiodarone with propranolol (ap) (n=80). all groups received their medications from 7 days preoperatively and continued their medications for 5 days post cabg.

Eligibility criteria:
inclusion criteria: * patient who are going to have elective cabg * signing informed consent exclusion criteria: * ef\<35% * bradycardia\<60 per min * hypotension\< 100 mmhg

Keywords: atrial fibrillation coronary bypass amiodarone propranolol coronary artery bypass graft (cabg)
compare ceftazidime-avibactam + metronidazole versus meropenem for hospitalized adults with complicated intra-abdominal infections

Conditions: Complicated Intra-Abdominal Infection

Summary: the purpose of this study is to evaluate the effects of ceftazidime avibactam plus metronidazole compared to meropenem for treating hospitalized patients with complicated intra-abdominal infections.

a phase iii, randomized, multicenter, double blind, double-dummy, parallel-group, comparative study to determine the efficacy, safety, and tolerability of ceftazidime avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults

Eligibility criteria:
inclusion criteria: * 18 to 90 years of age inclusive * female patient is authorized to participate if at least one of the following criteria are met: 1. surgical sterilization 2. age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments 3. age \<50 years and postmenopausal as defined by documented lh and fsh levels in the postmenopausal range plus amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments 4. patient has a negative serum pregnancy test (serum ß-human chorionic gonadotropin \[ß-hcg\]) within 1 day prior to study entry, and agrees to use highly effective contraception methods during treatment and for at least 7 days after last dose of iv study therapy * intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis * confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections exclusion criteria: * patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. other intra-abdominal processes in which primary etiology is not likely to be infectious * patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation * patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis * patient is considered unlikely to survive the 6 to 8 week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality

Keywords: ceftazidime meropenem metronidazole anti-bacterial agents anti-infective agents antiprotozoal agents antiparasitic agents ciai, complicated intra-abdominal infection