Kornimate/medical-research-clean huggingface dataset:
diaphragm structure and function in children

Conditions: Respiratory Muscle Training

Summary: the purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children.

during the first study visit, participants will undergo a series of pulmonary function and muscle performance tests followed by treadmill walking trials at different speeds with concurrent expired gas analysis via a face mask. the participants will then perform a training program for the breathing muscles at home for 6 weeks. the research team will follow up each week via telehealth visits to support training. after the 6-week training program, participants will return in-person for a follow-up visit and will undergo the same series of assessments as the first visit.

Eligibility criteria:
inclusion criteria: * age range 6-12 years of age exclusion criteria: * history of neuromuscular, cardiac, or pulmonary disease * known intellectual or developmental problems that would preclude the ability to assent * ruptured eardrum * recent injury or condition (less than 6 months ago) that precludes strength testing or walking * recent (less than 2 weeks ago) or current respiratory or other type of illness

Keywords: diaphragm control of breathing exercise
assessing the impact of a mode of vitamin d supplementation (sequential dose vs daily dose) on the incidence of hypercalciuria in subjets aged from 2 to 18 years

Conditions: Transient Hypercalciuria

Summary: recommendations for vitamin d supplementation for subjets between 2 and 18 years offer strong sequential doses of vitamin d: 2 times 100 000 units in spaced winter period of 3 months. data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training randall plates, essential step lithogenesis calcium oxalate. knowing the links between vitamin d and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin d, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. this increased sensitivity to vitamin d may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.


Eligibility criteria:
inclusion criteria: * children aged 2 to 17 years included * obtaining informed consent of the parents signed * participants aged 18 years included
antibiotic-related serious adverse events in obese patients treated for bone and joint infection

Conditions: Obesity

Summary: it exists recommendations to get an optimal antibiotic treatment for bone and joint infection and prescription of antibiotics in the bone and joint infections on material meets certain obligations: the micro-organism must be known, the antibiotic therapy must be started in association, obtaining high plasma levels, use of molecules having good bone circulation. it is recommended to initially administer treatment with intravenous route and to propose an oral relay, under conditions. it is recommended to administer the antibiotic treatment for at least 6 weeks. the dosages of antibiotics are adapted to the weight of patients in order to respond to those recommendations. but little is known about the optimal dose of treatment to give to obese patients (bmi\>=30) and the frequency of serious adverse events in these patients in which the dosage is then higher can be more important compared to non-obese patients. the aim of the study is then to evaluate the risk of occurrence of serious adverse events in obese patients and to identify risks factors. this study consists in a retrospective cohort of obese patients treated for a bone or joint infection and having had a serious adverse event. several data are collected concerning: demographics data, treatment responsible of the serious adverse event (molecules, dosage, route), description of the serious adverse event, residual rate for vancomycin.


Eligibility criteria:
inclusion criteria: * patients (i.e age ≥ 15 year-old) with bone and joint infection * with or without implant * for which the bmi is \>=30 * having had a serious adverse event related to the antibiotic treatment. exclusion criteria: * none

Keywords: serious adverse event bone and joint infection obesity dose adjustment
efficacy of early home-based cardiac rehabilitation program for patients after acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study was to evaluate the effect of this cr program on the improvement of myocardial function using the three-dimensional speckle tracking echocardiography (3d-ste) in ami patients.

the effect of early short-term home-based cardiac rehabilitation (cr) program on left ventricular function in acute myocardial infarction (ami) patients is not clear yet.

Eligibility criteria:
inclusion criteria: * being aged 18-65 years with a confirmed ami diagnosis * being suitable for the cr program * undergoing pci at the entry exclusion criteria: * known ischemic heart disease, heart valvular lesions, intra-ventricular conduction disturbances, malignant arrhythmia, cardiac shock, and poor echocardiographic conditions to take ste examination
efficacy study of combined prasugrel and bivalirudin versus clopidogrel and heparin in myocardial infarction

Conditions: Myocardial Infarction

Summary: randomized comparison of two different anticoagulation strategies: prasugrel plus bivalirudin versus clopidogrel plus heparin in patients with acute myocardial infarction undergoing emergency catheterization and coronary intervention.

primary percutaneous coronary intervention (ppci) is the preferred reperfusion strategy for patients with acute st-segment elevation myocardial infarction (stemi). additional anticoagulation therapy prior or during intervention plays an important role in the short- and long-term outcomes after ppci. two separate studies have shown significant benefit against conventional therapy based on clopidogrel and heparin for two recently approved drugs: the direct thrombin inhibitor bivalirudin and the thienopyridine prasugrel. in the horizons-ami trial, bivalirudin after pretreatment with clopidogrel resulted in improved net clinical outcomes. however, during the first 24 hours after ppci an increase in the stent thrombosis rate was observed with bivalirudin therapy. prasugrel has been shown to be superior to clopidogrel in patients with acute coronary syndromes undergoing pci. the benefit in reduction of ischemic complication was even greater in the subset of patients with stemi without any increase in the bleeding risk and with a significant reduction in the stent thrombosis rate. expectedly, the synergic actions of prasugrel and bivalirudin may maximize the benefit of antithrombotic therapy for stemi patients undergoing ppci.

Eligibility criteria:
inclusion criteria: 1. patients presenting within 24 hours from the onset of symptoms with stemi 2. informed, written consent 3. in women with childbearing potential a pregnancy test is obligatory. exclusion criteria: 1. age \< 18 years 2. cardiogenic shock 3. active bleeding; bleeding diathesis; coagulopathy 4. history of gastrointestinal or genitourinary bleeding \<2 months 5. refusal to receive blood transfusion 6. major surgery in the last 6 weeks 7. history of intracranial bleeding or structural abnormalities 8. suspected aortic dissection 9. heparin-induced thrombocytopenia 10. any previous stroke 11. prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index mi 12. known relevant hematological deviations: hb \<100g/l, thromb. \<100x10\^9/l 13. use of coumadin derivatives within the last 7 days 14. chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), cox-2 inhibitors, prasugrel 15. known malignancies or other comorbid conditions with life expectancy \<1 year 16. known severe liver disease, severe renal failure 17. known allergy to the study medications 18. previous enrollment in this trial 19. pregnancy

Keywords: myocardial infarction clopidogrel prasugrel bivalirudin primary pci
prognostic factors for treatment responses in patients with active lupus nephritis at sohag university hospital

Conditions: We Aim to Examine the Predictors of Sustained Complete Renal Remission in Patients With Lupus Nephritis at Sohag University Hospital

Summary: systemic lupus erythematosus (sle) is an autoimmune disease which may give rise to multiple organ involvement because of immune complex deposits. lupus nephritis (ln) is one of the severe manifestations of systemic lupus erythematous (sle) and a common cause for end-stage renal disease, significantly affecting the survival of sle patients immunosuppressive treatment is the major therapy for active ln. generally, at least six months are needed to assess treatment responses failure to respond to immunosuppressive therapy can lead to a worsening of renal function

this study will be prospectively analyzing the clinical data of ln patients who received standard immunosuppressive therapy and were regularly followed up at our center for more than six months. these patients will not change treatment regimen during the six months. as remission is an independent predictor of good long term prognosis in lupus nephritis. we aim to examine the predictors of sustained complete renal remission in patients with lupus nephritis at sohag university hospital and to analyze data of lupus nephritis patients to find parameters that can predict remission and improve outcome of our cases

Eligibility criteria:
inclusion criteria: * o patients diagnosed with ln at sohag university hospital * patients in regular follow-up for more than six months after immunosuppressive therapy * baseline urinary protein/creatinine ratio (upcr) more than 1 g/g * baseline c3 less than 55 mg/ dl * no change in immunosuppressive therapy within six months exclusion criteria: * o patients with incomplete pathological data and the number of glomeruli being \<10 per biopsy specimen * age \<14 years old end-stage renal disease (esrd) status on admission (sustained estimated glomerular filtration rate (egfr) \<15 ml/min per 1.73m2) * patients with advanced comorbid conditions like advanced liver cirrhosis or heart failure or malignancy
a study of seltorexant in participants with probable alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to investigate the effect of seltorexant versus placebo on the sum of agitation and aggression domain scores (a plus a) of the neuropsychiatric inventory-clinician rating (npi-c) in participants with probable alzheimer's disease (ad) with clinically significant agitation/aggression.


Eligibility criteria:
inclusion criteria: * participant has received a diagnosis of probable alzheimer disease (ad) (diagnostic and statistical manual of mental disorders-5 \[dsm-5\]) with the following characteristics at screening: clinical dementia rating (cdr) global score greater than or equal to (\>=) 1; mini-mental state examination (mmse) total score of 10 to 24 (inclusive) * participant meets the criteria of a syndrome diagnosis of agitation based on international psychogeriatric association (ipa) consensus clinical and research definition of agitation in cognitive disorders for at least 2 weeks before screening * participant meets the criteria of neuropsychiatric inventory (npi-12) agitation/aggression (a/a) domain score \>= 4 with frequency score \>= 2 at screening and baseline with no more than 35 percent (%) of improvement in npi-12 a/a domain score from the screening to baseline assessments * female participants must be postmenopausal before study entry (amenorrhea for at least 12 months) * body mass index (bmi) within the range 18-40 kilograms per square meter (kg/m\^2) (inclusive) exclusion criteria: * participant fulfils diagnostic criteria for non-alzheimer's dementia: example, frontotemporal dementia (ftd), diffuse lewy body dementia (dlbd), and post-stroke dementia, based on clinical history. (participants may be included with mixed ad/vascular dementia) * participant has a clinically significant acute illness within 7 days prior to study intervention administration * participants with a history of delirium within 30 days prior to or during screening * participant with a cause of agitation that is not secondary to dementia (such as pain) or significant history of aggression prior to dementia based on investigator judgment * participants who are not stable on concomitant medications or take prohibited medications
to determine if there are pharmacokinetic interactions at plasma or intracellular level between nucleosides and tenofovir

Conditions: HIV

Summary: the purpose of this study is to evaluate if there are pharmacokinetic interactions between the nrti 3tc and abv, and the tdf nucleotide. for this purpose, the intracellular and plasma levels of 3tc and abv will be compared in patients given these nucleosides with tdf and 30 days after the interruption of the tdf.

there is clear evidence of pharmacokinetic interaction between ddi+tdf. however, the interaction between tdf and other nrtis, mainly at intracellular level, has not been so well studied. since all the nrtis are anabolized at intracellular level by numerous kinases, and are transported by passive carrier systems, the interaction may be between tdf and other nrtis. this study aims to investigate the pharmacokinetic interactions between the tdf and the nucleosides abacavir (abv) and lamivudine (3tc) at plasma and intracellular level. with this objective, intracellular and plasma levels will be analysed in a group of patients that receive the combinations 3tc +tdf, abv+tdf and 3tc+abv+tdf together with lopinavir/rtv or nevirapine. subsequently, in a second phase of the study, in the group of patients given abv and/or 3tc + tdf + lopinavir/rtv, the pharmacokinetic determinations will be repeated after a 4-week interruption of the tdf .

Eligibility criteria:
inclusion criteria: 1. hiv+ patients aged above 18 years. 2. undetectable hiv viral load in the last determination 3. patients capable of correct compliance according to clinical criteria. 4. patients on triple haart therapy for the previous 3 months including 3tc and/or abv and tdf, with a pi (lopinavir/ritonavir) or an nnrti (nevirapine) 5. women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study. 6. ability to provide informed consent. exclusion criteria: 1. incorrect therapeutic compliance over the four weeks before the beginning of the study. 2. interruption or withdrawal from therapy during follow-up. 3. concomitant treatment with any drug which according to the clinician's criterion may interact with the investigational antiretrovirals, such as other antiretrovirals. 4. triple haart therapy including nevirapine (for phase ii) 5. documented or suspected resistance to abv, 3tc or lopinavir/rtv (for phase ii).

Keywords: intracellular concentrations plasma concentration abacavir tenofovir lamivudine (3tc) pharmacokinetic interactions
pulmonary embolism: mechanism and therapeutic innovation

Conditions: Pulmonary Embolism

Summary: to explore the pathogenesis, therapy and outcome of pulmonary embolism (pe) and chronic thromboembolic pulmonary hypertension (cteph).

the study recruited consecutive outpatients or hospitalized patients diagnosed with pulmonary embolism (pe cohort) and chronic thromboembolic pulmonary hypertension (cteph cohort). the follow-up of all patients was performed annually by phone or outpatient visit. the main outcomes were bleeding, recurrent events, and survival. the objective of the study was to explore the pathogenesis, therapy and outcome of pe and cteph.

Eligibility criteria:
inclusion criteria: * all hospitalized patients or outpatients diagnosed with pe or cteph; * age ≥18. exclusion criteria: * refused informed consents.

Keywords: pulmonary embolism chronic thromboembolic pulmonary hypertension mechanism therapy outcome
safety, pk, pd, dosing, and efficacy of rls-0071for the treatment of hospitalized patients with steroid-refractory acute graft-versus-host disease

Conditions: Steroid Refractory GVHD

Summary: this study is a open label prospective dose-ranging escalation and expansion trial to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, dosing, and efficacy of rls-0071 for the secondary treatment of acute graft-versus-host disease (agvhd) in hospitalized patients who are steroid-refractory.


Eligibility criteria:
inclusion criteria: * male or female adults or adolescents (\>12 years old). * hospitalized with steroid-refractory agvhd (grade ii-iv) after allo-hsct * anticipated hospital length-of-stay of at least 1 week from the time of rls-0071 initiation. * no plans to add additional gvhd treatment medications or to add, dose-adjust, or discontinue gvhd prophylactic medications during the 7-days of rls-0071 treatment. * neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count \>500/ml for at least 3 consecutive measurements and not supported by growth factor supplementation * weight \>40 kg and ≤ 140 kg at screening. exclusion criteria: * has received more than 1 allo-hsct * current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for agvhd * previous failure of ruxolitinib treatment * uncontrolled gi infection * endoscopic and biopsy testing (if performed) that definitively rules out lower gi agvhd * chronic gvhd * participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-hsct was performed. * unresolved toxicity or complications (other than agvhd) due to the allo-hsct * any corticosteroid therapy for indications other than agvhd at doses of methylprednisolone or equivalent \>1 mg/kg per day within 7 days of enrollment. * severe organ dysfunction unrelated to underlying agvhd * known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (peg) * significant liver disease that is unrelated to gvhd * moderate to severe kidney disease * currently breast feeding. * known pregnancy, a positive pregnancy test at screening, or lactation for wocbp. * active hepatitis b virus (hbv) or hepatitis c virus infection that requires treatment or human immunodeficiency virus (hiv)-1 or hiv-2. * active sepsis
preoperative counseling in cholecystectomy

Conditions: Vomiting; Nausea; Postoperative Pain; Feeling

Summary: the investigators examined whether a written plus verbal preoperative counseling for patients undergoing open cholecystectomy would improve perioperative symptoms such as nausea, vomiting and pain.

this was a randomized, single-blinded, clinical study carried out at the julio muller university hospital (mato grosso state, brazil). this study was conducted according to the guidelines laid down in the declaration of helsinki and all procedures involving human subjects/patients were approved by the hospital research ethics committee registered under number 697/cep-hujm/09. written informed consent was obtained from all patients. except for the preoperative counseling which was received only by the intervention group, all patients received the same protocol of perioperative care. the main endpoint of the study was the presence and the intensity of postoperative symptoms such as nausea, vomiting and pain. a questionnaire containing a visual analogue scale (vas) was applied 24h after the operation to measure the intensity of postoperative pain, nausea and the well-being. the vas consisted of a horizontal line, 100 mm in length, anchored by word descriptors at each end to represent the lowest and the highest intensity of all the symptoms analyzed. the patient was asked to mark in the straight line the point that most likely represents the symptom at the moment. the vas score of each individual was determined by measuring in millimeters from the left end of the line to the point marked. the questions were: "how severe was your pain during this period of 24h after the operation?", "how severe was the intensity of your nausea during this period of 24h after the operation? ", and "how great is your well-being at the present moment". for the first two questions the words at each end of the line were "no pain" and "severe pain", and "no nausea" and "severe nausea". for the well-being question the words were "no well-being" and "greatest well-being". the vomiting was also recorded as a categorical variable (yes or no). the length of stay and postoperative complications were also collected.

Eligibility criteria:
inclusion criteria: * adult age (18-65 years-old), * both sexes and * candidates for an elective open cholecystectomy exclusion criteria: * having diabetes mellitus, * chronic kidney failure, * chronic liver disease, * serum bilirubin \> 2 mg/dl, * body mass index (bmi) \> 35 kg/m2, * american anesthesiologists association (asa) score \> 3, * gastro-esophageal reflux, * gastroparesis or intestinal obstruction. patients with any non-compliance with the study protocol, who had the choledochus opened or associated operations, who experienced severe intraoperative complications (any type of shock, cardiac arrest or coagulations problems) or experienced prolonged (\> 4 h) operative time were also excluded.

Keywords: vomiting nausea postoperative pain feeling
fetal thymus involution as a predictor of adverse neonatal outcomes

Conditions: Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)

Summary: the thymus gland is a specialized organ in the chest that plays a central role in the adaptive immune system throughout development until puberty. in response to stress, the fetal thymus gland may shrink, or involute. the investigators propose a prospective cohort study that will enroll pregnant women admitted to labor and delivery for the management of preterm labor and/or preterm premature rupture of membranes from 28-36 weeks gestation. based on sonographic thymus measurements, the investigators will develop a clinical prediction tool to identify babies who are at increased risk for adverse neonatal outcomes. a reliable non-invasive predictor of adverse neonatal outcome using thymic ultrasound measurements has the potential to affect clinical management, improve outcomes for premature babies, and direct further research efforts.


Eligibility criteria:
inclusion criteria: * singleton pregnancy between 28-36 weeks gestation * active spontaneous preterm labor symptoms (contractions, cervical dilatation and/or pprom) exclusion criteria: * non-singleton pregnancies * gestational hypertension/preeclampsia * major fetal anomalies * known fetal aneuploidy * intrauterine fetal demise

Keywords: pprom pregnant preterm premature, labor