Kornimate/medical-research-clean huggingface dataset:
impact of videoconference updates in neonatal intensive care unit on parental stress of preterm infants (visio-neonat)

Conditions: Preterm Infants; Parent-Child Relations; Parental Stress; Post Partum Depression; Neonatal Intensive Care Units; Videoconferencing

Summary: the aim of the study is to test the effect of daily videoconference updates between parents of preterm newborns and health care providers which also offer them the possibility of seeing their child on the parental stress in a neonatal intensive care unit (nicu).


Eligibility criteria:
inclusion criteria: * parents with a preterm child born between 24 weeks and 34 weeks and 6 days of gestational age, hospitalized in our nicu during recrutment period * which agreed participating to the study after having complete information about it and sign a consent. exclusion criteria: * parents with a preterm child with another pathology than prematurity or with a lenght of stay in the nicu less than 7 days * parents refusing to participate to the study * parents not having videoconference equipment or internet access at home * parents not understanding or speaking good enough french.
measles vaccination at health system contacts

Conditions: Measles Vaccine; Hospital Admission; Mortality; Non-specific (Heterologous) Effects of Vaccines

Summary: in addition to protecting against measles infection, measles vaccine (mv) strengthens the individual's ability to combat infections in general - mv has beneficial non-specific effects (nse) lowering the risk of death and admissions by around 30%. in guinea-bissau 30% of children do not receive a routine mv scheduled at 9 months of age, putting both the individual child's health and measles eradication at risk. who recommends vaccination at health system contacts, including those for curative services. at the paediatric ward of the national hospital in guinea-bissau, there are more than 2600 yearly contacts with measles-unvaccinated children aged 9-59 months, but no vaccines are given. in a randomised controlled trial, we will assess the effect of providing mv vs placebo to 5400 children at hospital contacts (at discharge or after an out-patient consultation) to test the hypothesis that mv reduces the risk of admission or death (composite outcome) by 25% over the subsequent 6 months.


Eligibility criteria:
inclusion criteria: * measles-unvaccinated children * 9-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital simao mendes. exclusion criteria: * axil temperature \>38.0 * mid upper arm circumference \<110 mm
safety and efficacy study of fipamezole in treatment of motor dysfunctions in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine whether fipamezole is effective in the treatment of levodopa-induced dyskinesia in advanced parkinson's disease.

this study is a multi-center, double-blind, placebo-controlled, multiple dose escalating, safety, tolerance, pharmacokinetics, and efficacy study of fipamezole administered in parkinson's disease patients who are concomitantly being treated with a combination product of levodopa with a dopamine decarboxylase inhibitor (ddi) and possible other antiparkinson medication. approximately 30 sites in the us and india will participate in this study. the patients will be randomized into one of four treatment arms to receive either fixed or ascending doses of fipamezole (from 30 to 90 mg tid) or placebo. for efficacy assessments, levodopa-induced dyskinesia is assessed using a standardised rating scale. time spent in 'off' state or in 'on' state without dyskinesia, 'on' with non-troublesome dyskinesia or 'on' with troublesome dyskinesia, is assessed using patient diaries. impact of dyskinesia on daily activities is quantified using a pdys-26 questionnaire. to explore potential positive or negative impact of fipamezole on cognitive functions, the study includes two cognitive tests. finally, the study includes investigator assessments of cgi-i scales for dyskinesia, parkinson's disease, and clinical condition in general.

Eligibility criteria:
main inclusion criteria: * idiopathic parkinson's disease. * levodopa/ddi associated peak-dose dyskinesia which is at least moderately disabling and present for ≥25% of the waking day (updrs part iv, items 32 and 33, each ≥ 2). * stable parkinson's medication for at least 1 month prior to randomization. * hoehn and yahr stages 1 to 4 during 'off' period. * demonstrated ability to comprehend and give informed consent. * ability to complete patient diary. main exclusion criteria: * other clinically significant conditions apart from those typically associated with parkinson's disease. * intake of medication associated with exacerbation of dyskinesia or with extrapyramidal side effects and tardive dyskinesia or induction of liver enzymes; neuroleptics; or specified drugs known to be substantially metabolized through the following cytochrome p450 isoenzymes: 1a2, 2b6, 2c19, 2c9, 2d6, and 2e1. * use of st. john's wort or ginkgo biloba within 48 hrs prior to randomization and until the last treatment day with the study medication. * intake of an investigational drug within 30 days prior to initial screening.

Keywords: dyskinesia movement disorders basal ganglia diseases jp-1730 parkinson end-of-dose wearing off fluctuations
esp block in vats: programmed intermittent bolus versus continuous infusion on quality of recovery

Conditions: Pain, Acute; Surgery

Summary: fascial plane blocks, such as esp, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. however, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. to best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for erector spinae plane block for mits in terms of patient centred outcomes such as quality of recovery.

minimally invasive thoracic surgery (mits) has been shown to reduce postoperative pain, reduce tissue trauma and contribute to better recovery as compared to open thoracotomy. however, it still causes significant acute post-operative pain. our mater research group has shown that fascial plane blocks such as the erector spinae plane block (esp) contribute to post-operative analgesia after mits. case reports have described the improved quality of analgesia following esp using programmed intermittent boluses (pib) instead of continuous infusion. it is hypothesised that larger, repeated bolus doses provide superior analgesia, possibly as a result of improved spread of the local anaesthetic. evidence for improved spread of local anaesthetic may be found in one study which demonstrated that pib increased the number of affected dermatomal levels compared to continuous infusions for continuous paravertebral blocks. similarly, with regard to labour epidural analgesia, pib provides better analgesia compared with continuous infusion. because fascial plane blocks, such as esp, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. however, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. to the best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for erector spinae plane block for mits in terms of patient-centered outcomes such as quality of recovery.

Eligibility criteria:
inclusion criteria: * male and female aged \> 18 * able to provide written informed consent * asa grade i - v * vats surgery * weight \> 55kg exclusion criteria: * absence of or inability to give informed consent * pre-existing infection at block site * severe coagulopathy * allergy to local anaesthesia (or another contraindication to block performance) * previous history of opiate abuse * pre-existing chronic pain condition * pre-existing dementia (due to need to co-operate in completing qor-15 score day after surgery * postoperative admission to icu for continued ventilation * bmi \> 40 kg/m2

Keywords: regional anesthesia erector spinae block vats quality of recovery acute pain
low dose decitabine + modified bucy conditioning regimen for high risk acute myeloid leukemia undergoing allo-hsct

Conditions: Acute Myeloid Leukemia; Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning

Summary: the purpose of this prospective, open-label, randomized multicenter study is to evaluate the safety and efficacy of low dose decitabine in combination with modified bucy vs modified bucy as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia (aml) undergoing allogeneic hematopoietic stem cell transplantation (allo-hsct).

allo-hsct is the most effective treatment stratagey for high risk acute myeloid leukemia. at present, modified bucy is the standard conditioning regimen for aml undergoing allo-hsct in our institute. however, relapse occured in as high as 30-50% high risk aml patients after allo-hsct. thus, the best conditioning regimen for this subgroup remains to be optimized. low dose decitabine in combination with chemotherapy have been shown to improve comple remission rate of high risk aml patients. to reduce the relapse rate after allo-hsct, low dose decitabine is added in the modified bucy regimen. in this study, the safety and efficacy of low dose decitabine + modified bucy vs modified bucy myeloablative conditioning regimens in high risk undergoing allo-hsct are evaluated.

Eligibility criteria:
inclusion criteria: * age 12 to 60 years. * diagnosis of high-risk acute myeloid leukemia at the time of transplant. ("high-risk" aml features are defined by the following: relapsed or primary refractory aml; secondary aml（aml secondary to myelodysplastic syndrome(mds) or treatment-related aml); extramedullary leukemia; adverse cytogenetic abnormalities of monosomy 5, monosomy 7, or deletion of 5q; or presence of flt3 positive internal tandem duplication (flt3/itd+), particularly high allelic ratio.) * patient must have adequate pre-transplant organ function. exclusion criteria: * age \ 60 years. * uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen. * any other severe concurrent diseases, or have a history of serious organ dysfunction. * pregnant or lactating females.
study for rapid diagnosis of postoperative abdominal infection

Conditions: Postoperative Infection; Abdominal Surgery; Intra-abdominal Infection; Postoperative Fever

Summary: this is a prospective and exploratory study, which utilizes non-targeted metagenomic next-generation sequencing (mngs) detecting drain fluid from patients who are suspected of postoperative abdominal infection. this study aims to explore the clinical value of mngs in the rapid diagnosis of postoperative abdominal infection, to refine the pathogenic bacteria spectrum, and to establish a novel procedure for postoperative abdominal infection diagnosis.


Eligibility criteria:
inclusion criteria: 1. patients who receive abdominal operations with routinely abdominal drainage placement. 2. abdominal infection is suspected by the clinicians, and one of the following conditions is met: 1. temperature ≥38℃; 2. one of the following laboratory indicators: wbc≥10×10\^9/l, pct≥0.5ng/ml, hscrp≥100mg/l. exclusion criteria: 1. patients who are diagnosed with the abdominal infection before surgery. 2. evidence of non-abdominal infection is clear and could explain the clinical symptoms.
a study of rx108 in patients with locally advanced or metastatic solid tumors

Conditions: Locally Advanced Solid Tumors; Metastatic Solid Tumors

Summary: rx108 is a novel, potent, small-molecule inhibitor of na+/k+-atpase. the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk) and efficacy of rx108 in patients with locally advanced or metastatic solid tumors.

this is a open-label, two-part study comprised of a dose escalation part and a dose expansion part. in the dose escalation part, rx108 will be administered in ascending doses to evaluate the safety and tolerability of rx108 and determine the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d). the dose expansion part will assess the safety, pharmacokinetics, and efficacy of rx108 at the rp2d.

Eligibility criteria:
inclusion criteria: * histologically confirmed locally advanced or metastatic cancer that has failed all systemic therapies known to confer clinical benefit * eastern cooperative oncology group (ecog) performance status of 0 or 1 * minimum age of 18 years * adequate hematologic, hepatic and renal function * written informed consent * must agree to use adequate contraception (females and males) exclusion criteria: * history of certain cardiac abnormalities * history of inadequate pulmonary function * symptomatic brain metastasis * treatment with prohibited medications * known contra-indication to digoxin * treatment with any unapproved therapies for cancer, or any other anti-cancer therapy within 3 weeks * any toxicity related to prior treatment must have resolved to grade 1 or less, with the exception of alopecia * clinically significant active infection requiring systemic antibiotic treatment * females who are pregnant or breastfeeding

Keywords: locally advanced metastatic solid tumor
potential role of gum arabic as immunomodulatory agent among covid 19 patients

Conditions: COVID 19

Summary: to study the efficacy of gum arabic as an immuno modulator and anti-inflammatory agent among covid 19 seropositive patients..half of participants will receive gum arabic and the other half will receive placebo

randomized placebo controlled trial including covid 19 seropositive patients will be treated with 30 gram per day for 4 weeks, compared to placebo group treated for the same duration in positive covid 19 patients. blood samples will be taken first at base line level, after two weeks and after the intervention after satisfying the inclusion and exclusion criteria. the main objective is to assess the effect of gum arabic (acacia senegal) on immune system among covid-19 patients. the outcome of this project understand sars-cov-2 immune response in covid patients and the effect of gum arabic (acacia senegal) consumption to counteract progression of the disease

Eligibility criteria:
inclusion criteria: * covid 19 infected as proved by real time pcr (polymerase chain reaction) .( newly diagnosed) exclusion criteria: * intubated patients on parental treatment

Keywords: gum arabic immunomodulator
reduction of exit site infection in peritoneal dialysis patients

Conditions: Peritoneal Dialysis Catheter Infection

Summary: in peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. in our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. therefore we decided to change the exit-site care in our unit. this is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.

peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal membrane for exchange of fluids and dissolved substance . a catheter is surgically inserted with one end in the abdomen and the other protruding from the skin, in order to allow fluid exchange. the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis - a cause of morbidity and treatment failure. infection prevention is based, among other measures, on aseptic handeling of catheter exit-site. in our dialysis unit, we noticed a rise in pseudomonas exit-site infection and other organisms associated with contaminated water. therefore we decided to change the exit-site care in our unit. similar to central catheters handeling, we decided to cover the catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic regimen. this is a prospective observational single center study. all peritoneal dialysis patients in our institue will be counseled about change in exit-site care. for prevention of water exposure the patients will use stoma bags around the catheter during showers. after the shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is applied (mupirocin) and dressed with a clean gauze. the patients will be followed for 3 years for adverse events. the number of infectious episodes will be recorded and compared to historical data (january 2015-december 2017).

Eligibility criteria:
inclusion criteria: * peritoneal dialysis patients capable to sign an informed consent or have an official guardian exclusion criteria: * patient's refusal

Keywords: peritoneal dialysis exit site infection peritonitis
evaluation of the effectiveness of transforaminal epidural injections in lumbar disc herniation or radiculitis

Conditions: Low Back Pain

Summary: to evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. to evaluate and compare the adverse event profile in all patients.

recruitment is indicated in patients with chronic low back and lower extremity pain secondary to lumbar disc herniation and/or lumbar radiculitis of at least 6-months duration, non-responsive to conservative management with nsaids, physical therapy, chiropractic treatment, and exercises. this is a single center study performed in an interventional pain management referral center in the united states. the study involves 120 patients studied in 2 groups with 60 patients in each group. randomization includes sequence generation, allocation concealment, implementation, and blinding. data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. statistical methodology includes chi-squared statistics, fisher's exact test, t-test, and paired t-test with significance evaluated at p value \< 0.05.

Eligibility criteria:
inclusion criteria: * patients with disc herniation or radiculitis * patients who are 18 years of age * patients with a history of chronic function-limiting low back and lower extremity pain of at least 6 months duration * patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements exclusion criteria: * previous lumbar surgery, radiculitis secondary to spinal stenosis without disc herniation * uncontrollable or unstable opioid use * uncontrolled psychiatric disorders * uncontrolled medical illness either acute or chronic * any conditions that could interfere with the interpretation of the outcome assessments * pregnant or lactating women

Keywords: chronic low back pain lumbar disc herniation lower extremity pain lumbar radiculitis local anesthetic steroid lumbar transforaminal epidural injection
the effect of glyceryl trinitate and diamox on cerebral haemodynamics.

Conditions: Migraine

Summary: after infusion / injection of glyceryl trinitrate and diamox it is wished to study the effect of drugs on the cerebral haemodynamics such as cerebral blod flow and cerebral blod volume.

experimental headache model open a unike opportunity to study the pathophysiological mechanisms behind headache in general and migrane in particular. previous studies have used various techniques to study the cerebral haemodynamics as a basis for the headache pathophysiology. we wish to use a 3-tesa mri so study the cerebral haemodynamics after application of various pharmacological substances. the most used experimental headache model is the glyceryl trinitrate model (gtn). where infusion of the no donor gtn induces headache and changes in the cerebral arteries. on the other hand injection of diamox (acetazolamide) apparently causes increase of the cerebral blod flow with out dilation of the arteries. we wish to study the precise effect of gtn and diamox on the cerebral haemodynamics such as cerebral blod flow (cbf) and cerebral blod volume (cbv) via a 3-tesla mri.

Eligibility criteria:
inclusion criteria: * healthy volunteers; men and women age 18-50 years. * weight 50-100 kg exclusion criteria: * tension type headache more then once per month during the last year. * other primary headache types. * daily use of medication. * pregnant or lactating women. * headache on the trail day or 24 hours prior to the trial. * contraindications to mri. * hypotension og hypertension. * other significant medical conditions judged by the doctor in charge.
a study to evaluate morf-057 in adults with moderately to severely active uc

Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative

Summary: this is a phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of morf-057 in adult patients with moderately to severely active ulcerative colitis (uc).

this is a phase 2b randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of three active dose regimens of morf-057 plus a placebo regimen in study participants with moderately to severely active uc. after completion of the 12-week induction period, participants may be switched to a different active morf-057 regimen during the maintenance period. those randomized into the placebo group in the induction period will be switched to receive an active morf-057 regimen during the maintenance period.

Eligibility criteria:
inclusion criteria: * has signs/symptoms of moderate to severe uc for at least 3 months prior to screening * has evidence of uc extending at least 15 cm from the anal verge * demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for uc (e.g., biologic agents, janus kinase \[jak\] antagonists, or sphingosine-1-phosphate \[s1p\] receptor agonists) * subject has no prior exposure to approved or investigational anti-integrin therapies * agrees to abide by the study guidelines and requirements * capable of giving signed informed consent exclusion criteria: * diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or crohn's disease or has clinical findings suggestive of crohn's disease * has positive findings on a subjective neurological screening questionnaire * has a concurrent, clinically significant, serious, unstable comorbidity * previous treatment with vedolizumab or other licensed or investigational integrin inhibitors * participation in any other interventional study or received any investigational therapy within 30 days * previous exposure to morf-057 and/or a known hypersensitivity to drugs with a similar mechanism to morf-057 * unable to attend study visits or comply with study procedures

Keywords: ulcerative colitis (uc) inflammatory bowel disease (ibd) a4b7 moderate-to-severe integrin emerald