Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of impt or imrt for breast cancer

Conditions: Breast Cancer; Proton Therapy; Intensity Modulated Radiation Therapy; Efficacy and Safety; Radiotherapy, Adjuvant

Summary: the purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (impt) and intensity-modulated radiation therapy (imrt) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. impt or imrt will be administered to the whole breast, chest wall, and/or regional lymph nodes. a boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

eligible breast cancer patients will receive either preoperative, postoperative, or definitive radiotherapy based on the mdt's recommendation. patients with indications for treatment will receive either the impt or imrt technique. the specific technique will be chosen based on the benefits of impt, patient preference, and reimbursement policies after discussion between the doctor and the patient. the primary endpoint is the occurrence of any acute radiation-induced toxicities of grade ≥2. patients will be monitored for at least five years to evaluate acute and late radiation-induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Eligibility criteria:
inclusion criteria * aged ≥18 years old * karnofsky performance status (kps) score ≥70 * histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician. * er (estrogen-receptor), pr (progesterone-receptor), her2 (human epidermal growth factor receptor 2), and ki67 testing must be performed on the primary breast tumor. * women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation. * ability to understand and willingness to participate in the research and sign the informed consent form. exclusion criteria * pregnant or lactating women. * severe non-neoplastic medical comorbidities that may interfere with treatment or study participation. * active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity. * patients with contraindications to undergoing impt or imrt, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.

Keywords: postoperative radiotherapy preoperative radiotherapy impt imrt breast cancer efficacy toxicity
effectiveness of probiotic supplementation on crying time in infantile colic

Conditions: Colic, Infantile

Summary: this study aims to investigate the effectiveness of lactobacillus reuteri dsm17938 supplementation on infantile colic in indonesian infants.

infantile colic is a problem faced by many parents and caregivers. there is no evidence that medications does help in this situation. the etiology of infantile colic is still unknown. lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.

Eligibility criteria:
inclusion criteria: * otherwise healthy infants * infantile colic according to roe iv criteria * full term infants * birth weight 2500 - 4000g * exclusively breast milk or partially breastfed * mothers last education degree is senior high school exclusion criteria * clinically suspected allergy * consumption of probiotics, antibiotics, ppi * failure to thrive
a study to learn about the study medicine - zavicefta in patients with sepsis or loss of kidney function in japan

Conditions: Infectious Diseases

Summary: the purpose of this study is to learn about the safety and how effective is zavicefta under actual clinical practice in japan. zavicefta is a combination of avibactam sodium and ceftazidime hydrate. this study is seeking for patients with: * sepsis (a very serious infection in your blood caused by germ (a bacteria)) or * renal impairment (loss of kidney function) who are administrated with zavicefta for the first time. subjects will take part in this study from the start date of receiving zavicefta (day 1) to day 28.


Eligibility criteria:
inclusion criteria: 1. patients who received zavicefta for the first time after the launch of zavicefta 2. patients who received zavicefta for an infectious diseases indicated for zavicefta 3. patients with diagnosis of sepsis and/or renal impairment (creatinine clearance ≤ 50ml/min) at the start of the treatment with zavicefta 4. individuals who understand the nature of this study and give consent for the provision of the information collected in this study to third parties and the use of the information for other than intended use exclusion criteria: there are no exclusion criteria for this study.

Keywords: sepsis; renal impairment; zavicefta; avibactam; ceftazidime
haematologic predictors and clinical outcome in cardiac surgery

Conditions: Cardiac Disease

Summary: the outcome predictors for cardiac surgery has been popular for many researchers and clinicians. determining risk factors before surgery reduce morbidity and mortality after surgery. some routine blood results have been used as predictors for cardiac surgery but none of the researches studied red cell distribution width, mean platelet volume, platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. this study focused on these parameters and to see whether these parameters can be predictors for cardiac surgery.


Eligibility criteria:
inclusion criteria: * elective, on-pump cardiac surgery exclusion criteria: * emergent cases * pediatric cases * congenital surgery * heart transplantation

Keywords: cardiac surgery open heart surgery hemogram
safety and immunogenicity study of aleph inactivated split influenza vaccine

Conditions: Healthy

Summary: the objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily chinese-marketed trivalent vaccine.

a total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). systematic and local adverse reactions were reported for 28 d after the vaccination. antibody levels were detected through hemagglutination inhibition assay before vaccination (baseline) and 28d after the vaccination.

Eligibility criteria:
inclusion criteria: * more than three years in good healthy exclusion criteria: * current infectious fever or acute disease * upper respiratory infectious symptom within 6m * a history of allergy * laboratory confirmed influenza * autoimmune disease * have get influenza vaccine since 2008

Keywords: inactivated split influenza vaccine immunogenicity safety consistence
efficacy, safety, and immunogenicity of v260 in healthy chinese infants (v260-024)

Conditions: Rotavirus Gastroenteritis

Summary: this study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of rotateq™ (v260) in healthy chinese infants. approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with v260 or placebo will be enrolled and randomized (1:1) to receive either v260 or placebo. participants will also receive the routine china expanded program on immunization (epi) vaccines (oral poliovirus vaccine \[opv\] and diphtheria, tetanus, and acellular pertussis vaccine \[dtap\]) either staggered or concomitantly with v260 or placebo. all participants will be followed for efficacy and safety. immune responses to opv and dtap will be evaluated in a subset of participants. the primary hypothesis of the study states that v260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.


Eligibility criteria:
inclusion criteria: * healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at the time of the first study vaccination * parent/legal guardian agrees to participate by giving written informed consent and is willing and able to comply with study requirements exclusion criteria: * history of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery * history of intussusception * impairment of immunological function, including severe combined immunodeficiency (scid) * acute disease, severe chronic disease, or chronic disease during the acute period * uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological disease * hypersensitivity to any component of the rotavirus vaccine, opv, or dtap * prior receipt of any rotavirus vaccine * fever, with an axillary temperature \>=37.5 °c (or equivalent) within 24 hours before study vaccination (study vaccination can be deferred until complete resolution of febrile illness) * clinical evidence of active gastrointestinal illness * received intramuscular, oral, or intravenous corticosteroid treatment since birth (topical, ophthalmic, and inhaled steroids are permitted) * resides in a household with an immunocompromised person * receipt of a blood transfusion or blood products, including immunoglobulins * participation in another interventional study within 14 days before the first study vaccination or during the study * receipt of an investigational or non-registered product other than the study vaccine within 30 days before the first study vaccination or during the study * for participants in immunogenicity arms: inability to obtain a blood specimen at randomization visit (note: the visit may be rescheduled so that a baseline specimen may be obtained); history of polio, diphtheria, tetanus, or pertussis disease; previous vaccination against diphtheria, tetanus, pertussis, or poliomyelitis * any condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
myocardial fibrosis progression in duchenne and becker muscular dystrophy - ace inhibitor therapy trial

Conditions: Myocardial Fibrosis; Muscular Dystrophies

Summary: this trial intends to evaluate myocardial fibrosis progression in duchenne and becker muscular dystrophy, as well the influence of ace inhibitors in fibrosis progression. additionally, this study aims to determine genetic predictors of cardiac involvement in these dystrophies.

duchenne and becker muscular dystrophies (dmd/bmd) are diseases characterized by progressive skeletal muscle degeneration and replacement by fibrofatty tissue. data on cardiac involvement (defined as myocardial fibrosis), effect of ace-inhibitors and specific genetic mutations on myocardial involvement detected by cardiac magnetic resonance (cmr) is lacking. the study will include 76 patients with dmd/bmd. all patients will be referred to two cmrs for assessment of ventricular function and myocardial fibrosis. patients with myocardial fibrosis and normal left ventricle ejection fraction (lvef) will be randomized into two groups, each group receiving ace-inhibitor treatment or no treatment for cardiomyopathy. a genetic profile will be performed in every patient to identify possible mutations related to cardiac involvement.

Eligibility criteria:
inclusion criteria: * patients with biopsy-proven muscular dystrophy of duchenne or becker exclusion criteria: * contraindications to cardiovascular magnetic resonance imaging

Keywords: cardiac magnetic resonance myocardial fibrosis muscular dystrophies
babyq's: randomized controlled trial of health messaging in pregnancy and infancy

Conditions: Pregnancy Related; Infant Development

Summary: this randomized controlled intervention evaluates the effect of a mobile health behavioral intervention to test messages to reduce sugar-sweetened beverage intake during pregnancy and infancy. the study team will perform a prospective, longitudinal, interventional, randomized control trial by recruiting 300 wic families during the first 1,000 days of life (pregnancy through infant age 2 months) at consecutive women, infants, and children (wic) visits to test two interventions compared to a control group. the study team will implement a mobile-based messaging intervention allocate participants to one of 3 arms for a 1 month period: 1) negative message frames, 2) positive message frames, and 3) attention control.

childhood obesity prevalence soared over the past four decades with a 10-fold increase globally from 1975-2015 and healthy people 2020 has declared obesity a national health priority. socioeconomic and racial/ethnic disparities in obesity exist and may be widening. these disparities are apparent by age 2 years with recent national data showing that hispanic children continue to have highest obesity prevalence (15.6%) and on-hispanic black children have 2-fold higher obesity prevalence (10.4%) compared to non-hispanic white (5.2%) counterparts. the first 1,000 days describes the period from pregnancy through child age 2 years, and is increasingly recognized as a critical period for development of childhood obesity and its adverse consequences. several risk factors are consistently associated with later childhood obesity during the first 1,000 days and are more prevalent among low socioeconomic groups and racial/ethnic minorities. these modifiable risk factors mediate the development of racial/ethnic disparities in later childhood obesity. sugar-sweetened beverage (ssb) consumption during the first 1,000 days is a risk factor for childhood overweight/obesity, and has been linked to dental caries, lower child cognition, and the adverse child health consequences. recent evidence shows that maternal ssb consumption during pregnancy and infant ssb consumption in the first year of life are associated with childhood obesity later in life. thus, interventions to curb ssb consumption and promote healthy beverage intake in urban, low-income hispanic/latino families must start early in life, yet few ssb-specific interventions have ventured to do so.

Eligibility criteria:
inclusion criteria: * pregnant women age 18 years or older or; legal caretakers of infants under 24 months enrolled in wic * can respond to questions in english or spanish * report use of a mobile device using ios or android * give permission to enroll in messaging system exclusion criteria: * pregnant women with chronic medical conditions that may impact their nutrition behaviors * families whose eligible child has chronic conditions that interest with growth or feeding

Keywords: sugar-sweetened beverages early life nutrition first 1000 days
apical patency and postoperative pain.

Conditions: Pain Postoperative

Summary: the purpose of this study is to determine whether maintaining an apical patency causes postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.

apical patency (ap) is a procedure that prevents accumulation of soft and hard tissue debris within the cement canal. however, some rcts indicate that maintaining an ap causes postoperative pain, whilst some rcts pointed out there is no difference in terms of pain when ap has been performed. we, therefore, would like to conduct a rct to increase the sample size of the previously performed rcts to do an systematic review.

Eligibility criteria:
inclusion criteria: * mature permanent teeth having plural necrosis and apical periodontitis exclusion criteria: * systemic disorders * diabetes * pregnancy * less than 18 years of age * immunocompromised * patients who had taken antibiotics in the past 1 month * patients who had a positive history of analgesic use within the past 3 days * previously accessed teeth

Keywords: apical patency root canal treatment
cohort follow-up: progression and consequences of chronic kidney disease.

Conditions: Chronic Renal Diseases; Renal Function Disorder

Summary: this study aims to conduct a prospective collection of clinical and para-clinical data in patients with chronic renal diseases to identify disease progression factors, markers of renal function, and the pathophysiology of chronic renal diseases complications.

chronic renal diseases have a growing incidence and prevalence in france, with significant consequences in terms of morbidity and mortality, especially cardiovascular, and public health. it is necessary to know better: * the mechanisms leading to the progression of the chronic renal diseases * markers to quantify renal function and progression of the chronic renal diseases * the pathophysiology of chronic renal diseases complications, cardiovascular, nutritional, or mineral metabolism in particular. this study aims to conduct a prospective collection of clinical and para-clinical data in patients with chronic renal diseases to identify disease progression factors, markers of renal function, and the pathophysiology of chronic renal diseases complications.

Eligibility criteria:
inclusion criteria: * patients with chronic renal disease, stage 2 to 5, non-dialysis patients over the age of 18, * followed in the nephrology department of the bordeaux university hospital * agreeing to participate in nephrotest * affiliated with social security. exclusion criteria: * patients under 18 years * patients with acute or rapidly progressive renal failure * patients with severe comorbidities or comorbidities that are life-threatening in the short term (\<1 year) * patients who did not give their written consent to be included in the study * major incapacitated patients and psychiatric patients admitted to hospital
deep brain stimulation in severe obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: deep brain stimulation is an established treatment for movement disorders. new indications for deep brain stimulation are under investigation, among them severe and treatment-resistant obsessive-compulsive disorder. here, the investigators investigate clinical outcomes, safety and mechanism of action of dbs in the bnst in a series of 11 participants with severe therapy-refractory ocd.


Eligibility criteria:
inclusion criteria: * severe ocd according to the diagnostic and statistical manual of mental disorders: dsm-iv * ybocs score of at least 25/40 * disease duration of ≥5 years with persistent disabling symptoms despite adequate trials with at least 3 different serotonergic acting antidepressants, augmentation with antipsychotics, and cbt * only patients between 18 and 65 years of age who could understand and comply with instructions and provide their own written consent. exclusion criteria: * current psychotic or substance abuse disorder * clinically significant medical disorder, or previous brain surgery

Keywords: deep brain stimulation bed nucleus of stria terminalis obsessive-compulsive disorder
operative versus conservative treatment of scaphoid fractures

Conditions: Scaphoid Fracture

Summary: the aim of this study is to compare the time to return to previous activity level between operative treatment and non-operative cast immobilization of patients with an acute complete fracture of the middle part of the scaphoid, without any dislocation or comminution visible ct-scan.


Eligibility criteria:
inclusion criteria: * mature skeleton * isolated, acute complete fracture of the mid third of the scaphoid exclusion criteria: * acute fractures of both hands * one hand missing * other injuries than scaphoid fractures * rheumatoid, osteoarthritis or polyarthritis * previous soft tissue injuries of the hand * drug or alcohol abuse * participant in trial during the previous month

Keywords: return to work scaphoid fracture operative treatment activity level
ppi-amoxicillin for h. pylori treatment

Conditions: Helicobacter Pylori Infection

Summary: this randomized controlled clinical trial will identify the additional benefit of bismuth or metronidazole in proton pump inhibitor-amoxicillin-containing therapy for helicobacter pylori first-line treatment. the completion of this trial will expand new therapy for the treatment of helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.


Eligibility criteria:
inclusion criteria: * participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (icf). * 18-75 years old on the day of signing the icf. * helicobacter pylori infection confirmed by 13c-urea breath test or rapid urease test. * have not received helicobacter pylori eradication treatment before. exclusion criteria: * have received hp eradication treatment. * patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases. * subjects or guardians refused to participate in the trial. * alcohol and/or drugs abuse (addiction or dependence) or poor compliance with doctor's judgment. * have taken antibiotics, bismuth, ppi or chinese traditional medicine 4 weeks before treatment. * pregnant or lactating women. * active peptic ulcer. * allergic to drugs used in the trial. * any other circumstances that are not suitable for recruitment.
single-incision laparoscopic cholecystectomy versus traditional laparoscopic cholecystectomy

Conditions: Biliary Dyskinesia; Gallstones; Cholecystitis; Cholelithiasis

Summary: this study will compare single incision laparoscopic surgery (sils) cholecystectomy to traditional laparoscopic cholecystectomy (lc), focusing on patient-reported outcomes and cost.

single-incision laparoscopic surgery (sils) is accepted as a form of surgical treatment. traditional laparoscopic cholecystectomy (tlc) is well tolerated, with a low complication risk and high patient satisfaction; thus a sils procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.

Eligibility criteria:
inclusion criteria: * patient recommended to undergo cholecystectomy * patient age 18-80 * patient competent to give his/her own informed consent * patient speaks english without the need for an interpreter exclusion criteria: * additional procedures planned during same surgery * patient deemed inappropriate for tlc or sils cholecystectomy

Keywords: laparoscopic cholecystectomy quality of life biliary cholic chronic cholecystitis symptomatic cholelithiasis