Kornimate/medical-research-clean huggingface dataset:
study to investigate adrenal crisis (six-year follow-up)

Conditions: Adrenal Insufficiency

Summary: patients with adrenal insufficiency are at risk to suffer from life threatening adrenal crisis. the aim of this trial was to reevaluate the frequency of adrenal crisis and risk factors for crisis within a prospective study (six-years follow-up of a former prospective study).

despite established hormone replacement therapy, patients with chronic adrenal insufficiency are at risk of suffering from life threatening adrenal crisis with a considerable mortality. a former prospective study revealed a frequency of about 8 adrenal crisis/ 100 patient years and a crisis associated mortality of 0.5 per 100 patient years for patients; furthermore, patients with a previous adrenal crisis were at higher risk of crisis. the aim of the current trial was to reevaluate the frequency of adrenal crisis and risk factors by contacting the patients of the initial prospective study (see above) within a six-years follow-up. patients are contacted by questionnaire and additionally by phone (in case of an adrenal crisis or implausible statements).

Eligibility criteria:
inclusion criteria: * chronic primary or secondary adrenal insufficiency; hormone replacement therapy with glucocorticoids (hydrocortisone, cortisone acetat, prednisone or prednisolone) * written informed consent exclusion criteria: * adrenal insufficiency due to adrenocortical carcinoma * adrenal insufficiency due to long-term pharmacological glucocorticoid treatment * glucocorticoid doses above 7.5 mg prednisolone equivalent for other reasons than adrenal insufficiency * age younger than 18 years

Keywords: adrenal crisis risk factors
factors associated with poor dengue outcomes in malaysia

Conditions: Dengue Fever

Summary: this study aims to analyse the results of national data collected by the e-dengue information system in order to determine the factors associated with disease outcomes in all patients registered from january 2013 to december 2014.

dengue is the most important arthropod borne viral disease in humans. the world health organization has estimated that more than 70% of the global at risk population live in the who southeast asia and western pacific region, which account for nearly 75% of global disease burden from dengue. the number of reported cases of dengue in malaysia has increased fourfold from 44.3 per 100 000 population in 1999 to 181 per 100 000 in 2007. serologically confirmed cases are approximately half of the number of reported cases. an increase in dengue deaths in the adult populations has been observed since 2002. a study in vietnam showed that women and children appear to have increased risk of dengue shock syndrome and death. children aged 6-10 years had highest risk of dengue shock syndrome (dss). however, mortality was highest in younger children. however, in a study of 560 adult dengue patients in martinique, thomas l et al found that severe dengue were mainly in males, elderly, and presented with abdominal pain, cough and diarrhoea. at present, there is no vaccine or cure for dengue. treatment is mainly supportive and for symptom relief. various measures have been employed to decrease the incidence of dengue - these have been mainly by public health measures. however, 2014 has seen a dramatic rise in the number of confirmed dengue cases as well as mortality. this study aims to analyse the results of national data collected by the e-dengue information system in order to determine the factors associated with disease outcomes in all patients registered from january 2013 to december 2014. an epidemiological observational study will be done by utilizing e-dengue data from year 2013 till year 2014. the inclusion criteria is all dengue cases registered in the e-dengue information system 2013-2014; and there is no exclusion criteria. the primary outcome measurement is the disease outcome which included recovery, hospitalisation and death. all data collected will be analyzed by using descriptive analysis, the prevalence/incidence will be estimated; and regression model will be generated.

Eligibility criteria:
inclusion criteria: * all dengue cases e-dengue information system 2013-2014 exclusion criteria: * nil
pharmacokinetics of micafungin in patients of intensive care units

Conditions: Invasive Candidiasis

Summary: invasive fungal infections (ifis) are a frequent cause of morbidity and mortality in high-risk patients, such as immunocompromised patients. candida is currently the predominant fungal pathogen in these patient populations and is associated with significant morbidity and a high mortality. micafungin (mcf) is a semisynthetic compound belonging to the new class of antifungal agents, the echinocandin lipopeptides, that has potent in vitro and experimental in vivo activity against a variety of pathogenic candida species and aspergillus species. its applied indications are so the treatment and/or the prophylaxis of candida and aspergillus infections. mcf is currently licensed for the treatment of candidiasis at doses of either 100 or 150 mg a day. the efficacy of mcf is linked to the area under the concentration-time curve over 24 h in the steady state divided by the mic (auc0-24/ mic ratio). on one hand: - it was demonstrated that 98% of invasive candidiasis patients with a mcf auc/mic ratio between 3 and 12 achieve microbiological clearance, as opposed to only 85% of those with an auc/mic ratio \ 285 achieve microbiological clearance, as opposed to 82% of those below that exposure level.(1) on the other hand: * it is well known that patients of intensive care units (icu) are characterized by particular pharmacokinetic parameters with higher apparent volume of distribution (vc/f) and/or higher apparent systemic clearance (cl/f). in a population of healthy volunteers, it was observed that cl/f of mcf presents a high interpatient variability.(2) * whether most icus patients achieve optimal auc/mic ratio thresholds at standard doses has not been investigated so far. in particular, lower aucs might be reached in patients having the highest vc/f values. such patients would then be at risk of therapy failure and would benefit from individualized-dosing strategies. in this context, the study of the pharmacokinetics of mcf in critically ill patients seems to be necessary.


Eligibility criteria:
inclusion criteria: * critically ill patients hospitalized in an icu, with suspected or proven invasive fungal infections, for whom the decision has been made to start a treatment based on mcf. * age \> 18 years. * patients willing to give their written informed consent for their participation to the study. * patients affiliated to the french social security system or equivalent. exclusion criteria: * patient for whom a treatment based on mcf has already been started * patient who have benefited from bone marrow transplantation * age \< 18 years * patient under legal protection * patient deprived of liberty * pregnant or breast-feeding woman or woman of childbearing potential without efficient contraception (based on declaration) * patient with any altered mental status or any psychiatric condition that would interfere with the understanding of the study * patient enrolled in another clinical trial testing drugs or therapeutic strategies (including the so-called "exclusion period")
a long-term safety study of eltrombopag in pediatric patients with chronic immune (idiopathic) thrombocytopenic purpura (itp)

Conditions: Purpura, Thrombocytopenic, Idiopathic

Summary: this was an open-label phase iii extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic itp who previously participated in study tra115450. this study allowed dosing of eltrombopag at an individualized dose for each subject based upon platelet count. the starting dose was based on the subject's dose at the end of the tra115450 study. the maximum dose was 75 mg daily.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained from the subject's guardian and accompanying informed assent from the subject (for children over 6 years old). * subjects must be between 1 year and \<18 years of age at day 1. * subjects must have enrolled in tra115450/petit2 study. * subjects must have completed part 1 and part 2 of tra115450/petit2 study. * female subjects of child-bearing potential (after menarche) must have a negative pregnancy test within 24 hours of first dose of study treatment; agree and be able to provide a blood or urine specimen for pregnancy testing during the study; agree to use effective contraception during the study and for 28 days following the last dose of study treatment, and not be lactating. * male subjects with a female partner of childbearing potential must agree to use effective contraception from 2 weeks prior to administration of the first dose of study treatment until 3 months after the last dose of study treatment. exclusion criteria: * subjects with any clinically relevant abnormality, other than itp, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease). * any subject considered to be a child in care, defined as one who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. this can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. the definition of a child in care does not include a child who is adopted or who has an appointed legal guardian.

Keywords: chronic immune thrombocytopenic purpura, itp, eltrombopag olamine, thrombopoietin receptor agonist, pediatrics
psychophysiological effects of lactobacillus plantarum ps128 in preschool children with autism spectrum disorder

Conditions: Autism

Summary: autism spectrum disorders (asd) comprises a complex group of disorders of neuronal development characterized by social and communication impairment along with presence of repetitive and restrictive behaviors. emerging evidences support the gut-brain axis and further microbiota-gut-brain axis. elevated prevalence of gastrointestinal (gi) dysfunction in individuals with asd suggested that targeting gut may benefit patients with asd. lactobacillus plantarum ps128 (ps128) was reported to be a psychobiotic in several animal studies which modulated the levels of neurotransmitters in different brain areas. the current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of ps128 in preschool children with asd.

emerging evidences support the gut-brain axis and further microbiota-gut-brain axis. elevated prevalence of gastrointestinal (gi) dysfunction in individuals with asd suggested that targeting gut may benefit patients with asd. lactobacillus plantarum ps128 (ps128) was reported to be a psychobiotic in several animal studies which modulated the levels of neurotransmitters in different brain areas. the current randomized, placebo-controlled trial was conducted to investigate the psychophysiological effects of ps128 in preschool children with asd.

Eligibility criteria:
inclusion criteria: * fulfill diagnostic and statistical manual of mental disorders fifth version (dsm-v) criteria of autism spectrum disorder * do not take any other probiotics for at least 3 weeks before and during the study period exclusion criteria: * autistic children with other neurodevelopmental disorders or psychiatric diseases * with a clinically significant chronic medical condition, including; anemia, brain malformations, metabolic diseases, epilepsy, organic gastrointestinal disorders (i.e. gastroesophageal reflux, food allergies, irritable bowel syndrome (ibs)) and celiac disease * on anti-fungal, antibiotics, special diet (i.e. gluten-free diet, casein-free diet, high-protein diet, ketogenic diet) and current use of psychiatric medications within the preceding 3 weeks were excluded * known allergy to probiotics

Keywords: autism preschool children
changes in iron markers following iron loading in hemodialysis patients

Conditions: Anemia in Chronic Renal Disease

Summary: the purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.


Eligibility criteria:
inclusion criteria: * hemodialysis for three months minimum * stable epoetin dose for two months minimum * serum ferritin concentration \< 1000 ng/ml * transferrin saturation \< 50% * parathormone concentration \< 800 pg/ml exclusion criteria: * hemoglobin concentration \> 13g/dl * serum ferritin concentration \< 20 ng/ml * vitamin b12 and/or folic deficiency * other hematologic disease than anemia * cancer * hypothyroidism * infectious disease
impact on nutritional practices: sms and interpersonal communication

Conditions: Nutritional Deficiency

Summary: this cluster randomized controlled study aims to add to the evidence base on mhealth interventions by assessing the main effects of delivering nutrition messages on key maternal, infant, and young child nutrition (miycn) behaviors and outcomes through three innovative behavior change strategies. the strategies compared will be: (i) an interpersonal communication strategy using the tanzanian government's mkoba wa siku 1000 maternal, infant and young child nutrition (miycn) curriculum (mws) through clinic- and community-based channels, (ii) the mnutrition sms text messaging module of the government's wazazi nipendeni program, and (iii) the combination of both of these strategies (interpersonal and sms messaging). they will be compared with the current standard of care in tanzania. the goal will be to determine which has the greatest impact on key miycn and hygiene practices and care-seeking behaviors. it will be paired with a costing analysis so that these effects can be understood in the context of their costs.


Eligibility criteria:
inclusion criteria: * mothers of children aged 0-12 mo. or pregnant at time of enrollment * consent to participate in the study exclusion criteria: * unable to consent to participate in the study
comparison of sublingual misoprostol and intravenous oxytocin in active management of the third stage of labor

Conditions: Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol

Summary: sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor

sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor as the data from a pharmacokinetics study suggested that the bioavaiblitiy of misoprostol after sub-lingual administration was higher than those after oral or vaginal administration

Eligibility criteria:
inclusion criteria: * women with aheathy singleton pregnancy in spontaneous or induced labor at term . exclusion criteria: * hypersensitivity/contraindication to prostaglandins antepartum hemorrhage multiple pregnancy cardiac disease malpresentation rhesus- negative mother hypersensitive disorders severe anaemia(hemoglobin\<7g/dl)

Keywords: postpartum hemorrhage
validating non-invasive measurements of central blood pressure in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2; Blood Pressure

Summary: the investigators want to validate two non-invasive devices for the determination of central blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).


Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 2 * age above 18 years exclusion criteria: * atrial fibrillation or other cardiac arrhythmia * known stenosis of aorta or arteria subclavia/brachialis

Keywords: calibration validation transfer function sphygmocor arteriograph
magnesium sulfate in the prevention of post-ercp pancreatitis.

Conditions: Post-ERCP Pancreatitis

Summary: magpep is a multi-centre, randomized, phase iii, double blind, placebo controlled, parallel group trial. it evaluates magnesium sulfate for the prevention of post-ercp pancreatitis. adult patients with a medical indication for ercp are to be randomized (1:1 ratio) to receive either magnesium sulfate or placebo (nacl 0,9%) 60 min before and 6 hours after ercp.

title: prospective, randomized, placebo controlled, phase iii trial to evaluate the efficacy of magnesium sulfate for the prevention of post-ercp pancreatitis study drug: magnesium sulfate indication: post-ercp pancreatitis study design: multi-centre, randomized, phase iii, double blind, placebo controlled, parallel group patient population: adult patients with a medical indication for ercp number of patients: 1376 randomized to two equal groups treatment: patients receive 2 infusions of 500 ml nacl 0,9%: the first one 60 min before ercp and the second one 6 hours after ercp. to the infusions 10 ml of either magnesium sulfate or placebo (nacl 0,9%) will be added.

Eligibility criteria:
inclusion criteria: * medical indication for ercp * first ercp in the patient * signed informed consent forms for ercp and magpep trial exclusion criteria: * privious ercp * hypersensitivity to study medication or similar substances * participation in another clinical trial during the last 4 weeks * addictive disorders * women who are pregnant or breastfeeding * unwillingness or inability to comply with study protocol * acute pancreatitis * renal insufficiency of stage 4 or higher * active hyperthyreosis * symptomatic bradycardia (\<35/min) * known history of myasthenia gravis * av bock \> first degree or other bradycardic disorders of conductivity * liver cirrhosis child c * coagulation disorder * urinary stone diathesis (calcium magnesium ammonium phosphate stones) * patients who are not able to provide informed consent * intake of magnesium during the last 14 days * intake of calcium antagonists

Keywords: magpep, post-ercp pancreatitis, magnesium sulfate
effects of topical dynamic phototherapy on the microbiota of chronic wounds

Conditions: Leg Ulcer

Summary: the main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session tdp.

the secondary objectives of this study are: * to estimate changes in several microbiological parameters over three time periods (before treatment, after applying the metvixia® and after irradiation during a single tdp session). * describe the evolution of the size and appearance of the wound 7d after the start of treatment * describe the potential adverse events associated with a tdp session

Eligibility criteria:
inclusion criteria: * patient correctly informed concerning study implementation, objectives, constraints and patient rights * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient presents with one or more leg ulcers (artieral, venous or mixed) * afebrile patient without periulcerous erythema and who does not require antibiotic therapy * patient who has not received antibiotic treatment during the last 7 days nota bene: patients with multiple ulcers at different stages will be included for the wound corresponding to the highest stage. if the patient has multiple ulcers atn the same stage, the deepest wound will be considered. exclusion criteria: * the patient is participating in another interventional study, has participated in another interventional study with the past 3 months, or is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has a contraindication for a treatment used in this study * patient with an infected leg ulcer treated with antibiotics * patients on curative anticoagulation

Keywords: topical dynamic phototherapy microbiota
preoperative epidural labor analgesia and postoperative pain

Conditions: Cesarean Section

Summary: parturients who undergo emergency cesarean section (c-sec) after experiencing labor pain are likely to develop pain-induced central sensitization. the investigators hypothesized that those without epidural labor analgesia undergoing subsequent emergency c-sec would experience more severe postoperative pain or require more analgesia after c-sec compared to those with epidural labor analgesia. thus, the investigators conducted this retrospective study by grouping parturients undergoing emergency c-sec after experiencing labor pain into two groups (epidural labor group and no epidural labor group) and those undergoing elective c-sec aimed to compare the effect of epidural labor analgesia on postoperative pain severity and analgesic consumption.


Eligibility criteria:
inclusion criteria: * cesarean section(c-sec) under spinal anesthesia exclusion criteria: * patients without accurate medical records * failure of epidural analgesia
could tai-chi help maintain balance of spinocerebellar ataxia patients

Conditions: Spinocerebellar Ataxias; Tai Chi

Summary: spinocerebellar atrophy is the most common autosomal dominant inherited ataxia. there are over thirty subtypes, which characterize neurologic features differently. they all have obvious substantial cerebellar atrophies in image, and unstable gait、ataxia. in general a prevalence of about three cases per 100 000 people is assumed, but this may be an underestimate. progressive neurologic degeneration, in about 10-20 years, will leads to disability or wheelchair-dependent. accompanying with fatigue, downhill course of the disease often made patients depressive and hopeless. the recent review of researches concludes no effective therapy for the disease. the purpose of the investigator's study is to explore the tai-chi exercise effect for spinocerebellar ataxia.


Eligibility criteria:
inclusion criteria: * progressive ataxia accompanied with the observation of cerebellar atrophy on magnetic resonance or computed tomography images * sara score of less than 20 exclusion criteria: * patients with complicated cerebellar disorders, such as multiple system atrophy, parkinson-plus syndromes, secondary cerebellar degeneration from encephalitis, trauma, hypoxia, cerebrovascular diseases, and toxic- or drug-induced cerebellar degeneration * sara score of larger than 20
a study to evaluate the efficacy and safety of ad-209

Conditions: Hypertension, Essential

Summary: the purpose of this study is to evaluate the efficacy and safety of ad-209

condition or disease : hypertension intervention/treatment drug : ad-209 drug : ad-209-1a drug : ad-209-1b drug : ad-209-1c drug : ad-209 placebo drug : ad-209-1 placebo phase : phase 2

Eligibility criteria:
inclusion criteria: * signed informed consent * other inclusions applied exclusion criteria: * orthostatic hypotension with symptom * other exclusions applied
rituximab therapy in follicular lymphoma in combination with chemotherapy - reflect 1

Conditions: Follicular Lymphoma

Summary: the primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.


Eligibility criteria:
inclusion criteria: * new diagnosed stage iii/iv nhls * grades 1, 2 follicular lymphoma need to be treated * mcd20 positive * have an expected survival of 3 months or more * ecog 0-2 grade * normal renal function * alt less than double normal level exclusion criteria: * presence of cns lymphoma * severe infectious disease or organic disease * having another malignant tumor * pregnant or breast-feeding female * organic heart disease, heart failure, ii or higher grade av bundle block. * subject is allergic to rituximab * known hiv infection or chronic hbv infection