Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of sr-hgh in comparison with daily hgh in iss patients

Conditions: Establishing Dose of Sr-hGH in ISS Patients

Summary: the purpose of this study is to assess dosing requirements and establish the efficacy of sr-hgh in idiopathic short stature patients (iss). this phase ii study is designed as multi-center, randomized, active comparator-controlled, parallel, open-label. 45 patients were randomized to three arms with 1:1:1 ratio, two arms of sr-hgh and one of daily hgh. two doses of sr-hgh were administered, which are 0.5 and 0.7mg/kg/week. and the other arm received daily hgh at 0.37 mg/kg/week. patients in sr-hgh groups injected on a specific day of the every week for 26 weeks. and patients randomized to daily hgh group injected for 6 days a week. patients visited study centers five times, firstly at screening (visit 1), at randomization (visit 2), after 13th dosing (visit 3), after 26th dosing (visit 4), and finally for follow-up (visit5).


Eligibility criteria:
criteria * are older than or equal to age of 4 * are pre-pubertal (tanner's stage i) * are younger than bone age of 9 in female; of 11 in male * have less than 3 years of a difference in bone and chronological age * have confirmed idiopathic short stature
community oncology setting cost analysis and disease outcomes of taxane use in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this is a retrospective medical record abstraction study. it is a review and evaluation of up to 300 metastatic breast cancer patients treated with abraxane or other taxanes such as paclitaxel and docetaxel to determine the overall cost of care for abraxane compared to other taxanes in the first-line metastatic cancer setting and the cost of care for abraxane compared to other taxanes when broken down by individual components of cost. in addition, the investigators will review the following patient outcomes: response rate, duration of therapy, toxicity, and survival.


Eligibility criteria:
inclusion criteria: * patients that have received abraxane chemotherapy greater than three months from the time of chart review. * patients that have received taxane chemotherapy greater than three months from the time of chart review.

Keywords: metastatic breast cancer breast cancer mbc abraxane paclitaxel taxol docetaxel taxotere
endoscopic sleeve gastroplasty for treatment of obesity

Conditions: Obesity

Summary: emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy. the study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity

the endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a cap-based flexible endoscopic suturing system. post procedure care includes close follow-up by a nutritionist and a psychologist weekly.the outcome assessment included: change in body weight, percentage of loss of excess body weight and adverse effects

Eligibility criteria:
inclusion criteria: obesity willingness and ability of patients to be treated by a multidisciplinary team for at least 1 year - exclusion criteria: prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and neoformative findings ) coagulopathy psychiatric disorders -

Keywords: obesity endoscopic sleeve gastroplasty weight loss
clinical trial for valuation of the effectiveness of lactoferrine in the prevention of sepsis in new premature born. bimonitorization of the antinflammatory mechanisms, antioxidants and the intestinal microbiote.

Conditions: SEPSIS SYNDROME

Summary: to evaluate the efficacy of enteral administration of bovine lactoferrin (blf) in the reduction of probable late sepsis or microbiologically proven in preterm infants with birth weight ≤ 1500 gr and / or gestational age ≤ 32 weeks.

to date there are no published clinical data that jointly assess the impact of direct lf supplementation on oxidative status, on biomarkers of systemic inflammation and on the microbiota of premature infants with or without sepsis. clarification of these additional questions is essential for a better understanding of the benefits and implications of enteral administration of lf in preterm infants. the enteral administration of lactoferrin reduces the incidence of late sepsis in preterm infants of very low birth weight (bmpn). enteral supplementation with lactoferrin in nbwns can have a beneficial effect on the systemic oxidative and inflammatory state, and may contribute to the creation of a healthy faecal microbiota.

Eligibility criteria:
inclusion criteria: * both groups will include male or female children born preterm with birth weight ≤ 1500 g and / or eg ≤ 32 weeks. all tutors of patients, must sign the informed consent. exclusion criteria: * in both groups those subjects who do not meet the age and weight established at birth, have\> 72 hours of life at the time of inclusion, who do not sign informed consent or who have the following morbidities will be discarded: 1) early sepsis or vertical; 2) gastrointestinal congenital anomalies; 3) chromosomopathies; 4) congenital anomalies and / or genetic diseases without survival expectations; 5) severe perinatal hypoxia.

Keywords: bovine lactoferrin late sepsis
association of functional changes in the brain and the perception of pain in patients with chronic inflammatory bowel diseases (ibd)

Conditions: Inflammatory Bowel Disease

Summary: in the study the investigators aim to test whether transcranial direct current stimulation (tdcs)-induced pain reduction is in association with functional changes in the brain measured with magnetic resonance imaging (mri) in patients with chronic inflammatory bowel diseases (ibd). hypothesis: transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases, which is in association with changes in the brain measured via mri.


Eligibility criteria:
inclusion criteria: * inflammatory bowel disease * chronic pain (more than 3 months) * pain (vas \> 3/10) exclusion criteria: * contraindication to transcranial direct current stimulation * contraindications to magnetic resonance imaging (mri) * pregnancy * sever internal or psychiatric condition
cytokine regulation of periradicular pain in humans

Conditions: Chronic Apical Periodontitis of Pulpal Origin

Summary: this clinical trial evaluates the role of cytokines in patients needing root canal treatment with diagnosis of necrotic pulp and chronic apical periodontitis

this study evaluates whether periradicular exudate concentrations of cytokines differ in patients experiencing pain and mechanical allodynia due to pulpal necrosis with an acute exacerbation of a chronic apical periodontitis, as compared to patients with pulpal necrosis with chronic apical periodontitis, but no pain or mechanical allodynia

Eligibility criteria:
inclusion criteria: 1. patient must be at least 16 years of age. 2. clinical indication for non-surgical root canal therapy (nsrct). 3. 1st or 2nd maxillary or mandibular molar 4. diagnosis must be chronic apical periodontitis (cap) with or without symptoms. 5. intact, mature apices. 6. asa i or ii exclusion criteria: 1. failure to meet any of the above 2. previous nsrct 3. previous pulpotomy or pulpectomy 4. suppurative apical periodontitis 5. patients taking medications which can affect their pain rating or medications which effect their immune system ( such as glucocorticoids)

Keywords: pain
interest of placental alpha-microglobulin-1 detection test to assess risk of premature delivery in reunion island

Conditions: Premature Delivery

Summary: prematurity is the leading cause of mortality and perinatal morbidity. despite the many preventive measures and use of tocolytic therapy, the incidence of premature births has not decreased in recent decades. in 2010 the preterm birth rate (single child, born alive) was still 5.5% in france and 11% in the population of reunion. in 50% of cases, premature birth is related to spontaneous premature labor layout without rupture of amniotic membranes, called threat of premature birth.the threat of premature birth, defined by the combination of cervical modifications and regular and painful uterine contractions from 22 weeks of amenorrhea and 36 weeks of amenorrhea + 6days, is the major cause of hospitalization in pathological pregnancies services. but all threat of premature delivery situations do not cause premature delivery. in our service, only 30% of patients hospitalized for threat of premature delivery give birth prematurely in accordance with published international data. the diagnosis of threat of premature delivery is difficult and it is still not possible to differentiate a "false labour" of a "real labour". currently the diagnosis of threat of premature delivery in routine is based on the combination of vaginal examination, the ultrasound, cervical length, but this strategy lacks specificity. in absence of prognostic tool for predicting more reliably the risk of premature delivery in situation of threat of premature delivery, the medical cares are maximalist.: hospitalization, conducting paraclinical investigations, prescription of tocolytics treatments and conducting antenatal corticotherapy. it seems particularly necessary to identify more efficient prognostic criteria that the clinic and ultrasound for judging the severity of threat of premature delivery in other words to predict the risk of premature delivery to adapt and adjust the care of patients after diagnosis of threat of premature delivery.


Eligibility criteria:
inclusion criteria: * all patients received in programmed or emergency consultation; * pregnant, between 24 weeks of amenorrhea and 33 weeks of amenorrhea + 6 days; * with painful regular uterine contractions confirmed by monitoring; * patient affiliated to a social security scheme; * informed consent signed by patient if adult or by legal representant for minor subjects exclusion criteria: * cervical cerclage placement; * proved vaginal infection and/or vaginal ongoing treatment;

Keywords: threat of
study of costs realized after percutaneous coronary intervention employing same day discharge

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine whether the total costs of care associated with uncomplicated elective or low-risk urgent percutaneous coronary intervention (pci) through 30-day follow up are lower among patients who are randomly assigned to same day discharge (sdd) or overnight hospital stay (on).

this is a prospective randomized clinical trial of same day discharge versus overnight stay for patients undergoing uncomplicated elective or low-risk urgent pci with uncomplicated post-pci recovery. the outcome is total cost accrued by patients from the time of index hospital presentation through 30-day post-pci follow-up. conduct of pci procedures and provision of post-pci care will be in accordance with routine institutional practices and will not be protocol-driven. consented patients will be assigned to sdd or on stay using a block randomization schedule. randomization will occur once the patient has completed an uncomplicated 6-hour post pci observation period.

Eligibility criteria:
inclusion criteria: * consecutive patients who undergo elective or low-risk, (i.e., in the setting of unstable angina but not non-st segment elevation myocardial infarction) urgent pci. * no sociodemographic factors that would preclude sdd (prohibitive factors include no family member/friend available to remain with patient until nurse phone call the following day, no working phone, no reliable transportation, home \> 60 minutes from medical infrastructure, unable to obtain/pay for medications). * pci procedures performed between 08/04/14 and 08/03/16. * short term risk of in-hospital death, transfusion or contrast-induced nephropathy during the index hospitalization at or below 1% using blue cross blue shield of michigan cardiovascular consortium (bmc2) pci registry risk prediction models. * no in-lab complications (prolonged angina, acute closure, no reflow, significant or untreated dissection, vessel perforation, side branch occlusion, rescue glycoprotein iib/iiia inhibitor use, ventricular tachycardia or fibrillation requiring cardioversion/defibrillation, tamponade, pulmonary edema, stroke or transient ischemic attack, shock). * contrast volume/calculated creatinine clearance ratio \< 3 * no recurrent chest pain, shortness of breath, hemodynamic instability, bleeding or vascular complications during 6 hours in recovery area post-pci exclusion criteria: * use of rotational atherectomy * use of a glycoprotein iib/iiia inhibitor infusion post-pci

Keywords: coronary artery disease costs cost minimization percutaneous coronary intervention risk score same day discharge
left ventricular dyssynchrony in multipole pacing

Conditions: Heart Failure，Congestive

Summary: left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator.

left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator using a quadripolar left ventricular lead.

Eligibility criteria:
inclusion criteria: * indication for the implantation of a defibrillator with cardiac resynchronisation therapy exclusion criteria: * cardiac surgery, acute coronary syndrome / myocardial infarction, percutaneous coronary intervention within the past 4 weeks * indication for coronary artery revascularisation * atrial fibrillation with insufficient rate control * asa (american society of anesthesiologists) class v or cardiogenic shock * age \<18 years, pregnancy, tutelage * inability to understand the patient consent for or study refusal * anticipated insufficient echocardiographic image quality
essential coaching for every mother, a postpartum text message program for canadian mothers

Conditions: Maternal Distress

Summary: the purpose of this study is to evaluate a text message-based program called essential coaching for every mother which sends daily text messages during the immediate six-week postnatal period. essential coaching for every mother consists of standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health.

this is a 2-group parallel arm randomized controlled trial. participants will be randomized into either the intervention or a control group, stratified by parity. no changes to in-person care will occur. mothers in the intervention group will receive daily text messages from enrollment after birth until six-weeks postpartum. mothers in the control group will receive no content messages. mothers will be recruited both antenatally and postnatally through social media and study posters. all recruitment and participant engagement will occur remotely via text message. women who are 37+ weeks pregnant up to 10 days postpartum will be eligible to send a text to a study specific number and complete an eligibility screening. if determined eligible once they deliver, the participant will be randomized into the intervention or control group and they will be asked to complete an electronic consent form and the baseline survey. participants in the intervention group will start receiving the essential coaching for every mother program based on their delivery date up to six weeks postpartum. mothers in the control group will only receive reminder texts to complete the follow-up surveys. both groups will be asked to complete an online survey at enrolment, six-weeks and six-months postpartum. the investigators aim to recruitment 140 participants in total, 70 per group.

Eligibility criteria:
inclusion criteria: to enroll antenatally, participants must: * be at least 37 weeks pregnant * have daily access to a mobile phone with text message capabilities * are over 18 years of age * speak and read english * live in nova scotia, canada. to enroll postnatally, participants must: * have an infant under 10 days of age * have daily access to a mobile phone with text message capabilities * are over 18 years of age * speak and read english * live in nova scotia, canada. exclusion criteria: * newborn die or are expected to die prior to leaving the hospital * they have no access to mobile phone, either personal or shared * unwilling to receive text messages * decline or withdraw to participate * participated in phase i of this project.

Keywords: maternal self-efficacy postpartum depression postpartum anxiety mobile health education postpartum support
the effects of a supervised exercise program on self efficacy of people living with hiv/aids.

Conditions: HIV Infections

Summary: to evaluate the impact of a supervised exercise program (sep) on self-efficacy,quality of life status and cardiovascular fitness among people with hiv in a 24 week randomised controlled trial.we hypothesised that a combined aerobic and resisted exercise (intervention) would improve these parameters compared to an individual walking program with monthly group forum (control).

with combination antiretroviral therapy, hiv has become a chronic, manageable medical condition. medication adherence is now a critical determinant of patient outcomes. quality of life (qol) rather than just survival has also become an important consideration in hiv management strategies. the role of non-pharmacological interventions such as exercise to enhance self efficacy (which correlates with adherence) and qol among people with hiv requires formal investigation. we evaluated the impact of a supervised exercise program (sep) on self-efficacy among people with hiv in a 24 week, randomised controlled trial of participation in a sep with combined aerobic and resisted exercise (intervention) versus an individual walking program with monthly group forum (control). qol and cardiovascular fitness were also evaluated as secondary endpoints. twenty subjects were enrolled in each arm, and assessments were performed at baseline, 2 month and 6 months, including a generic self efficacy scale, 1 minute heart rate response post 3 minute step test, and a validated hiv-specific qol survey. self efficacy and cardiovascular fitness improved in the intervention but not the control subjects over the study period (p\<0.0001 for both). qol also improved (8 out of 10 dimensions) in the intervention group but not in controls (0 out of 10 dimensions). these data support the use of sep as an important therapeutic intervention for people with hiv, with significant benefits to self efficacy, cardiovascular fitness and qol over six months. importantly, these benefits were not achieved through unsupervised exercise over the same period.

Eligibility criteria:
inclusion criteria: hiv, aged at least 18 years exclusion criteria: * any contraindications to exercise testing and training , severe cognitive impairment * inability to follow instructions, * regular exercise ( participating in 2 or more structured exercise sessions weekly for more than or equal to 6 months prior to enrolment).

Keywords: exercise self efficacy quality of life hiv
pneumoniae epidemiology study in china

Conditions: Pneumococcal Disease

Summary: to determine the proportion of hospitalized pneumonia cases in children aged 60 months or less associated with vaccine-preventable streptococcus pneumoniae serotypes (4, 6b, 9v, 14, 18c, 19f, 23f).

subjects meeting the eligibility criteria, including parental informed consent to collect clinical-epidemiological information, will have a deep respiratory aspirate specimen to determine the etiology of the lower respiratory tract infection. clinicians may obtain other diagnostic specimens, such as pleural fluid, lung tap, cerebrospinal fluid, nasopharyngeal culture, or serum for serological assays, as indicated clinically. the chest radiograph will be taken and read locally according to predetermined criteria and by staff radiologists trained in radiographic criteria for pneumonia. bacterial isolates other than streptococcus pneumoniae will be identified according to standardized procedures. s. pneumoniae isolates will be transported to central laboratories for confirmation of identity, serotyping and antibiotic resistance testing, using standard techniques. serotype will be determined using type-specific sera (quellung reaction). antibiotic susceptibility to penicillin, cefuroxime, ceftriaxone, erythromycin, amoxycillin, ofloxacin, vancomycin, and imipenem be conducted using e-test according to standardized procedures at the central facilities.

Eligibility criteria:
inclusion criteria: * age, 60 months or less * meets study criteria for clinical pneumonia * all the examination are/can be done within (before or after) 72 hours to enrollment time * informed consent obtained from parent or guardian exclusion criteria: * received any pneumococcal vaccine in the past * current or underlying conditions that would pose a hazard in obtaining the deep respiratory aspirate (e.g., bleeding diathesis, severe respiratory compromise and others as determined by clinician) aspirates may be obtained from patients who are intubated * any other medical condition that in the opinion of the clinician/investigator would pose a hazard to the child by participating in the study * children with recurrent pneumonia will enter into the study on only one occasion
the clinical validation of a dried blood spot method for vancomycin and creatinine

Conditions: Vancomycin

Summary: a widely used antibiotic is vancomycin. to ensure adequate exposure to vancomycin, drug doses are adjusted based on whole-blood concentration measurements, a practice known as therapeutic drug monitoring (tdm). the need for tdm of vancomycin is well established, as described in several national and international guidelines, for dose-optimization in order to achieve successful treatment and to prevent toxicity and reduce microbial resistance. a sampling method for tdm that has become more popular over the recent years is dried blood spotting (dbs). dbs is a design of blood sampling consisting of positioning a drop of capillary blood, preferably taken from the finger, on filter paper. unlike venous blood sampling (the current gold standard for tdm of vancomycin), dbs seems to have advantages for the patient. the finger prick is less invasive than venipuncture. dbs also enables patients to perform one or multiple finger prick(s) themselves, with the possibility to sample at multiple time points. due to the fact that vancomycin is nephrotoxic, it would be very efficient and convenient to measure creatinine in the same dried blood spot as the vancomycin. this study is a clinical validation study to validate the dbs assay for vancomycin.


Eligibility criteria:
inclusion criteria: * clinical patients * aged 18 and over * able to understand written information and able to give informed consent * treated with vancomycin * able and willing to undergo a finger prick for dried blood spot sampling * able and willing to fill in a questionnaire exclusion criteria: * unable to draw blood samples for study purposes