Kornimate/medical-research-clean huggingface dataset:
improving the quality of care for children with acute malnutrition in uganda

Conditions: Malnutrition, Child

Summary: this is a cluster rct in 6 health centres in uganda, testing supportive supervision to improve health outcomes and quality of care of children with malnutrition

introduction malnutrition in children is highly prevalent in west nile region. according to a recent analysis of data available from the health management information system (hmis) and official registers, the health outcomes of children suffering from malnutrition and treated at health center (hc) level in arua region are not reaching the international standards (75% cured rate as for the international sphere standards). this despite the availability of clear national guidelines for treatment, thus suggesting possible deficiencies in the quality of care provided. lack of supportive supervision may be one of the reason explaining substandard outcomes. methods this is a cluster randomised controlled trail (rct) with health centers (hc) as unit of randomisation. the six largest hc in arua district will be randomised in two groups, intervention (quality improvement group) and control. the intervention will aim at improving the quality of care provided at hc level, and as a consequence, the health outcomes of children. the main intervention will consist of enhances nutritional supervision (high frequency supervision, specific to nutritional services), while the control will be standard care (no intervention). complementary intervention will include training and networking activities for hc staff. outcomes of the study will include: health outcomes (recovered, non recovered, defaulters, transferred, died); process outcomes (satisfaction and knowledge of staff); cost outcomes (cost for the health system and for the families) and equity outcomes (access to care and health outcomes by wealth quintile). relevance of the study the study will inform, with a robust design, about the efficacy and cost-efficacy of a quality improvement intervention for ameliorating the health of children suffering from malnutrition in uganda. currently no other study with rct design explored the efficacy of supportive supervision as a quality improvement intervention. this study will therefore fill an important knowledge gap.

Eligibility criteria:
for the primary outcomes, the study sample will consists of children with malnutrition treated at in health center (hc) in arua district inclusion criteria: 1. children 6 months-5 years 2. diagnosis of sam or mam according to national criteria (10) sam: weight-for-height \<- 3 standard deviation (sd) from the mean based on the who 2006 standards (11). mam: weight-for-height \ -3 standard deviation (sd) from the mean based on the who 2006 growth reference standards . exclusion criteria: 1. not matching the above criteria for sam and mam 2. refusal to participate/ consent 3. unable to adhere to study follow up procedures
pulse oximeter screening in congenital heart disease

Conditions: Congenital Heart Disease

Summary: pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. this study provides an update on the implementation of pulse oximetry screening in turkey

the early detection of life-threatening, critical congenital heart defects in newborn babies still presents an important clinical challenge. most defects are amenable to intervention but timely diagnosis (ie, before presentation with cardiovascular collapse or death) is crucial. in high-income countries, examination and, increasingly, antenatal ultrasound have formed the basis of screening, but test accuracy of these procedures is variable and many babies with critical congenital heart defects are discharged before diagnosis. pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. this study provides an update on the implementation of pulse oximetry screening in turkey

Eligibility criteria:
inclusion criteria: * babies within the first 24-72 hours followed up in well baby nurseries * babies prior to discharge, if discharged before 24 hours of age, * babies ≤5 days and still followed up in well baby nurseries * babies born ≥35 gestational weeks exclusion criteria: * babies within the first 12 hours of life * babies \>5 days of life * babies with a gestational age of \>35 weeks * babies with major congenital anomaly except congenial heart disease * babies who had a prenatal diagnosis of congenital heart disease
a study comparing risankizumab to placebo in participants with active psoriatic arthritis including those who have a history of inadequate response or intolerance to biologic therapy(ies)

Conditions: Psoriatic Arthritis (PsA)

Summary: the purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (psa).

the study consists of a screening period (approximately 35 days), period 1, period 2, and a 20-week follow-up period. period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group period. period 2 is the long-term period and starts at week 24. to maintain the blind to the original treatment allocation, treatment at the week 24 visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. at week 28 and for the remaining dosing visits (to week 316), all participants receive open-label risankizumab 150 mg every 12 weeks. participants remain blinded to the original randomization allocation for the duration of the study. the total study duration is 336 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of psoriatic arthritis (psa) with symptom onset at least 6 months prior to the screening visit and fulfillment of the classification criteria for psa (caspar) at screening visit. * participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the screening visit and baseline. * diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at screening visit. * participant has demonstrated an inadequate response or intolerance to biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csdmard) therapy(ies). exclusion criteria: * participant is considered by investigator, for any reason, to be an unsuitable candidate for the study. * participant has a known hypersensitivity to risankizumab.

Keywords: keepsake 2 risankizumab
ibi188 combination therapy in solid tumors

Conditions: Solid Tumors; Lung Adenocarcinoma; Osteosarcoma

Summary: a phase ib study aim to evaluate the efficacy, safety, and tolerability of ibi188 combination therapy in subjects with advanced malignancies


Eligibility criteria:
inclusion criteria: 1. patients with locally advanced or metastatic solid tumors cannot be cured by surgery or other local treatments . 2. aged ≥ 18 years (≥ 12 years is acceptable in cohort c). 3. able to provide archived or fresh tumor tissue samples for biomarker assessment. 4. have at least one measurable lesion according to recist version 1.1. 5. eccg ps score of 0-2. 6. adequate organ and bone marrow functions . 7. life expectancy ≥ 12 weeks. 8. female subjects of childbearing potential or male subjects with partners of childbearing potential should take effective contraceptive measures throughout the whole treatment period and until 6 months after treatment. 9. must voluntarily sign the informed consent form (icf), and be able to follow all study requirements and procedures. for the subjects enrolled in cohort c who are ≥ 12 and \< 18 years old, in addition to obtaining the child's own consent, their guardians should provide informed consent and sign the icf. exclusion criteria: 1. previous exposure to any cd47 antibody, sirpα antibody, cd47/sirpα recombinant protein or other inhibitors that act in the same pathway. 2. previous exposure to any anti-programmed death receptor 1 (pd-1) or anti-programmed death-ligand (pd-l1) antibody (except cohort c). 3. concurrent participation in another clinical study. 4. the last dose of anti-tumor therapy is within 4 weeks before the first dose of study treatment. 5. have undergone major surgical procedures within 4 weeks prior to the first dose of study treatment or planned to receive major surgery during the study treatment. 6. presence of toxicities (excluding alopecia and fatigue) induced by previous anti-tumor therapy that has not recovered to grade 0 or 1 as assessed by national cancer institute (nci) common terminology criteria for adverse events (ctcae) v5.0 prior to the first dose of study treatment. 7. known hypersensitivity to ibi188 or any ingredient in the study drug product. 8. history of other primary malignancies. 9. female subjects who are pregnant or lactating. 10. other ineligible conditions considered by the investigator.
12 month athena study: everolimus vs. standard regimen in de novo kidney transplant patients

Conditions: Kidney Transplantation; Renal Transplantation

Summary: this study was designed to evaluate the renal function comparing certican based immunosuppressive regimens with two different cnis (tacrolimus or cyclosporin a) versus a standard treatment with mycophenolic acid and tacrolimus in de novo renal transplant recipients.


Eligibility criteria:
inclusion criteria: * patient who had received a primary or secondary kidney transplant * patients who were willing and from whom written informed consent was obtained * kidney allograft with a cold ischemia time (cit) \< 30 hours * negative pregnancy test prior to study enrollment exclusion criteria: --multi-organ recipients * former graft loss due to immunological reasons * patients who received a kidney from a non-heart beating donor * a-b-0 incompatible transplants * a current panel reactive antibody (pra) level of \> 20% * existing antibodies against the hla-type of the receiving transplant * a known hypersensitivity/contraindication to any of the immunosuppressants * use of other investigational drugs * patients with thrombocytopenia (platelets \< 100,000/mm³), with an absolute neutrophil count of \< 2,000/mm³ or leucopenia (leucocytes \< 3,000/mm³), or hemoglobin \< 8 g/dl * significant mental illness * history of malignancy during the last five years * hiv positive * uncontrolled hypercholesterolemia or hypertriglyceridemia * drug or alcohol abuse * pregnant or breast feeding women

Keywords: transplant renal transplant rejection,allograf rejection xenograft rejection host vs graft disease kidney transplant
postural and clinical outcomes of snags treatment in cervicogenic dizziness patients: a randomised controlled trial

Conditions: Cervicogenic Dizziness; Rehabilitation

Summary: previous works demonstrated the relationship between postural disturbances and reduction in cervical range of motion (crom) in patients suffering from cervicogenic dizziness (cgd). since sustained natural apophyseal glides (snags) have been proposed as an effective treatment, the aim of the present study was to evaluate how clinical measures could be affected in patients with cervicogenic dizziness undergoing snags.


Eligibility criteria:
inclusion criteria: * accepted criteria will be operationalized to achieve the clinical suspicion of cervicogenic dizziness as following: 1. exclusion of these differential diagnoses: a. migrainous vertigo b. vertigo of central origin c. benign paroxysmal positional vertigo (bppv) d. meniere disease e. vestibular neuritis f. vertigo induced by drugs g. psychogenic vertigo (anxiety and/or panic disorder and/or phobia) h. orthostatic hypotension 2. presence of a subjective feeling of dizziness associated with pain, movement, rigidity, or certain positions of the neck at least from 3 months; 3. cervical pain, trauma, and/or disease 4. if from traumatic origin, there has to be a temporal proximity between the onset of dizziness and the neck injury. diagnosis is positive if criteria 1 to 3 are fulfilled. as for criterion 2, dizziness had to occur during the same period than neck pain occurred and dizziness had to be proportional to the severity of the neck pain that generally fluctuates in time. criterion 4 addresses cervicogenic dizziness occurring after a neck trauma exclusion criteria: * presence of trauma or recent surgery in the head, face, neck, or chest; * an otorhinolaryngological diagnosis of central or peripheral vertigo * receiving physiotherapy during the study period. * history, physical examination and a thorough clinical otoneurological examination will be devised to exclude extracervical causes of dizziness. * in order to exclude vestibular hypofunction, video head impulse test - and the technique proposed in previous studies will be used to study the vestibulo-ocular reflex.

Keywords: cervicogenic dizziness sustained natural apophyseal glides posturography testing fast fourier transform cervical range of motion
delivery of inhibitors of lysyl oxidase (lysolox) on serial angioplasty and time to restenosis

Conditions: Arteriovenous Fistula Occlusion

Summary: the narrowing of dialysis fistulae or grafts is a near universal problem in patients with end-stage renal disease (esrd) and requires patients to undergo repeated angioplasty or mechanical opening of the fistula.

the failure of dialysis accesses remains a leading cause of morbidity and medical costs among esrd subjects. the underlying etiology for dialysis access failure is uniformly due to progressive narrowing of the vessel lumen leading to stasis and thrombosis of the access. the luminal narrowing of arteriovenous fistulae (avfs) is due to progressive hyperplasia of vessel intima and subsequent infiltration of smooth muscle cells into the vessel media. areas of stenosis within avfs are characterized by dense neointimal hyperplasia, infiltration of vascular smooth muscle cells and expansion of extracellular matrix material. additionally, varying types of vascular injury increase the rate of collagen and elastin deposition within the medial and serosal areas of the vessel.

Eligibility criteria:
inclusion criteria: * age 18 and \< 90 years old * receiving stable out-subject hemodialysis for a minimum of 3 months * have a lower arm or upper arm avf that has been cleared for use by the vascular surgeon or interventional nephrologist * have agreed to participate voluntarily and signed and dated an irb approved, subject informed consent form * dysfunctional dialysis fistula: any subject with * two or more venous pressure readings exceeding 250 mmhg for a minimum of 5 minutes at a blood flow of 500mls/min within a single dialysis run and a documented reduction in kt/v by \> 0.2; or * patients with venous pressures \> 250 mm hg on two or more days within a 30 day period or * patients who on physical exam are found to have palpable obstructions, post-stenotic dilation of the access or evidence of prolonged post-dialysis bleeding. * any patient with one of the above conditions will be to have a dysfunctional avf. this definition will be applied to the screening of study subjects as well as the determination of recurrent fistula dysfunction at 12 months. exclusion criteria: * scheduled for surgical revision of the fistula; * have been in another investigational (non-approved) drug or device study within the previous 30 days; \*\*have a known allergy to any component of the investigational product (drug or device) * subjects with a "hero graft" will be excluded from the study * subjects having received a stent for correction of a prior stenosis will be excluded from the trial * subjects with more than \> 3 hemodynamically significant stenosis at one time (with the exception of a central venous stenosis) * subjects who are pregnant will be excluded from the trial (pregnancy test will be performed on subjects of child bearing potential). a urine pregnancy test will be utilized.
human brain natriuretic peptide (bnp) (or nesiritide) to help heart, kidney and humoral function.

Conditions: Left Ventricular Diastolic Dysfunction

Summary: the purpose of this research study is to evaluate the effects of cardiac hormone replacement with sq (subcutaneous or under the skin) injection of bnp (brain natriuretic peptide, a hormone produced by the heart) on the pumping ability of the heart, kidney function and levels of different hormones in the blood in response to an intravenous salt solution.

prior to initiation of the study, subjects will be stabilized for at least one week on a no added salt diet (120 milliequivalent (meq) na/day) which will be maintained during the study. participants in this study will be randomized to receive bnp or placebo (an inactive, saline shot). the participant will need to give themselves a shot in their stomach (similar to diabetics giving themselves insulin) twice a day for twelve weeks. the study requires a screening visit to determine eligibility and discuss the study. at this visit a blood draw for heart and liver function and a six minute walk will be done. there will also be two other outpatient visits and two inpatient stays, for 48 hours, in the clinical research unit at st. marys hospital. during the two overnight stays, blood and urine samples will be done to get heart and kidney function as well as a research echocardiogram. an acute saline load (0.9% normal saline 1.25 ml/kg/min for 1 hour) will be given and blood and urine samples collected after enrollment, the study lasts for twelve weeks. it is planned to treat 2 subjects with active drug per each placebo subject to improved the precision of between group comparison.

Eligibility criteria:
inclusion criteria: * subjects with ejection fraction of greater than 50% with moderate or severe diastolic dysfunction as assessed by doppler echocardiography * no signs or symptoms of congestive heart failure and who have not been hospitalized for heart failure exclusion criteria: * myocardial infarction (mi) within 3 months of screening * unstable angina within 14 days of screening, or any evidence of myocardial ischemia * significant valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis * severe congenital heart diseases * sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening * second or third degree heart block without a permanent cardiac pacemaker * stroke within 3 months of screening, or other evidence of significantly compromised central nervous system (cns) perfusion * total bilirubin of \> 1.5 mg/dl or other liver enzymes \> 1.5 times the upper limit of normal (mg/dl = milligrams per deciliter) * serum creatinine of \> 3.0 mg/dl * serum sodium of \ 160 meq/dl (milliequivalents per deciliter) * serum potassium of \ 5.0/dl * serum digoxin level of \> 2.0 ng/ml (nanograms per milliliter) * systolic pressure of \< 85 mm hg (millimeters of mercury) * hemoglobin \< 10 gm/dl (grams per deciliter)
comparison of train of four, tetanus 50 and 100 hz recovery after rocuronium block reversed by neostigmine

Conditions: Postoperative Residual Curarization

Summary: despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. while this train of four ratio threshold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 hz stimulation showed a marked fade. this result has been observed in absence of reversal agent administration. therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 hz and tetanus 100 hz stimulation in patient receiving rocuronium during general anesthesia and reversed by an anticholinesterase agent (neostigmine). neostigmine will be injected once four muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (40 µg/kg) in accordance with the clinical practice worldwide admitted. two questions have to be investigated. first, is this dose of neostigmine sufficient to allow a complete recovery of tetanus stimulations ? second, due to the pharmacological properties of neostigmine, does a recurarisation phenomenon occur following repeated tetanus stimulations ? the attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.


Eligibility criteria:
inclusion criteria: * asa clinical status 1 to 3 informed consent obtained before anesthesia induction exclusion criteria: * asa clinical status 4 emergency surgery scheduled surgery in prone position hepatic or renal disease bmi higher than 35 allergy to rocuronium or neostigmine
safety and efficacy of mbi 226 for the prevention of central venous catheter-related bloodstream infections

Conditions: Sepsis; Bacteremia; Fungemia

Summary: central venous catheters (cvcs) are used in patient care for such purposes as the administration of medication, fluids, blood products and for functions such as hemodialysis and plasmapheresis. however, the use of cvcs can cause complications such as life-threatening bloodstream infections (bsi). bsis are caused by organisms from the skin's surface tracking down the catheter's outer surface. the organisms grow on the catheter surface (catheter colonization) which is followed by seeding into the bloodstream. bsis can be difficult to treat and the mortality rate is as high as 35% in intensive care patients with a catheter-related bsi. it is estimated that up to 70,000 patients in the us die each year from catheter-related bsi. mbi 226 is a new drug that, when applied to the skin surrounding the catheter insertion site, may prevent organisms on the skin from migrating down the catheter and entering the bloodstream and therefore decrease the incidence of catheter-related bsi in patients with cvcs.


Eligibility criteria:
inclusion criteria: * patients undergoing non-cuffed arterial and/or central venous catheterization. * patients able to give signed informed consent. * concurrent antibiotic therapy is permitted. exclusion criteria: * treatment with an experimental topical, antibacterial, or antifungal drug within the previous 30 days. * patients who are scheduled to receive catheters impregnated/bonded with an antimicrobial substance. * patients requiring arterial or central venous catheterization for less than 48 hours or longer than 28 days. * second or third degree burn patients. * patients with a suspected or known bloodstream infection or local catheter insertion site infection. * patients with a known allergy to adhesive tape or adhesive bandages. * patients with a medical condition that the investigator believes may interfere with the safety of the patient or the intent or conduct of the study. * routine non-complicated post-operative cabg patients. * the disinfection procedure for catheter insertion did not include povidone-iodine.

Keywords: central venous catheter bloodstream infection cvc catheter colonization local catheter site infection