Kornimate/medical-research-clean huggingface dataset:
sulfadoxine- pyrimethamine versus weekly chloroquine for malaria prevention in children with sickle cell anemia

Conditions: Sickle Cell Anemia; Malaria

Summary: malaria is fatal and increases the risk of death among children with sickle cell anemia. chemoprophylaxis significantly improves quality of life in these children. in uganda chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. intermittent presumptive treatment with sulfadoxine - pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants. however no studies have been done in uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia. hypothesis : presumptive treatment with sulfadoxine- pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia.

malaria is fatal and increases the risk of death among children with sickle cell anemia. chemoprophylaxis significantly improves quality of life in these children. in uganda chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. intermittent presumptive treatment with sulfadoxine - pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anemia among high risk groups such as pregnant women and infants. however no studies have been done in uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces incidence of malaria among high risk group such as children with sickle cell anaemia. we calculated a sample size of 110 patients in each group for a power of 95% assuming that the incidence of malaria in children receiving weekly chloroquine will be 0.36 and those receiving presumptive treatment with sulfadoxine - pyrimethamine the incidence would be 0.16 according to (schellenberg et al )

Eligibility criteria:
inclusion criteria: * children aged 6 months to 12 years attending sickle cell clinic in mulago hospital during the study period with a negative peripheral smear for parasites, adherence to appointment visits, consent by care takers to participate in the study. exclusion criteria: * patients with known allergy to sulfonamides, patients with severe illnesses requiring urgent admission, patients with documented treatment for malaria in the past one month with sulfadoxine- pyrimethamine. patients on cotrimoxazole prophylaxis

Keywords: sickle cell anemia malaria presumptive treatment sulfadoxine- pyrimethamine children uganda
symbiotics to prevent postoperative infection in colorectal cancer

Conditions: Colorectal Cancer; Surgical Site Infection

Summary: this is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. the researchers will compare incidence of surgical site infection between the study groups.

this is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be randomly selected to receive either a symbiotic formulation or placebo during the perioperative period. the researchers will compare incidence of surgical site infection, detected by clinical examination and complementary tests (ct scans, x-rays, microbiological and hematological tests) between the study groups.

Eligibility criteria:
inclusion criteria: * adults between 18 and 85 years old; * colorectal cancer patients. * ability to understand and signing the informed consent exclusion criteria: * pregnancy (early diagnosis) * reduced intellectual level that could prevent proper understanding of the objectives of the study * patients with rectal cancer undergoing neoadjuvant treatment (chemotherapy and radiotherapy) * use of products with prebiotic, probiotic and / or symbiotic function or fiber module; by more than 3x a week * refusal to participate and / or to sign the consent form free and clear

Keywords: symbiotic colorectal cancer
the effect of nebulized azithromycin as therapy for bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia; Premature; Ventilation, Mechanical

Summary: the aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of bpd in very low birth weight preterm infants when compared with placebo.


Eligibility criteria:
inclusion criteria: 1. gestational age less than 32 weeks and birth weight less than 1500 g. 2. infants who are still in need of respiratory support at day 7 of life (intubated, or by non-invasive mechanical ventilation, including cpap and high-flow nasal cannula, or any form of oxygen therapy). exclusion criteria: * gestational age ≥ 32 weeks. * newborns with congenital cyanotic heart diseases. * obvious major congenital malformations, known syndromes or chromosomal anomalies. * infants with signs compatible with the diagnosis of necrotizing enterocolitis (nec) in the first week of life. * current use of steroids.
the project for managing cardiometabolic risk in women diagnosed with gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus; Continuous Glucose Monitoring

Summary: this study aims to examine the effects of a lifestyle intervention based on a health belief model (hbm) supported by mobile health (mhealth) and the impact of continuous glucose monitoring (cgm) on maternal glycemic parameters, cardiometabolic risk, health behavior and infant's outcomes among women diagnosed with gestational diabetes mellitus (gdm).

background: women with gestational diabetes mellitus (gdm) are more likely to develop cardiometabolic risk (cmr). cmr refers to the risk factors that promote the chance of developing type 2 diabetes mellitus or cardiovascular events. however, using a family-centered approach, the effectiveness of continuous administration of both mobile health management and theoretical based lifestyle intervention from pregnancy to postpartum in preventing women at high risk of gdm from developing cmr has rarely been studied. methods: this randomized controlled trial will recruit 120 gdm pregnant women in northern taiwan. the participants will be randomly assigned to the control group (blood glucose meters (bgm); n=40 people), intervention group 1 (continuous glucose monitoring (cgm); n=40 people), intervention group 2 (hbm-based lifestyle and mhealth intervention + cgm; n=40 people).the comparison group will receive the routine care and finger-prick test for blood glucose monitoring (bgm) during pregnancy.the intervention group 1 will receive cgm during pregnancy. the intervention group 2 will receive a hbm-based lifestyle and mhealth management program on 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum, including cgm during pregnancy.we intend to compare outcome variables among three groups. the outcomes variables will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. the primary outcomes were maternal glycemic parameters, cardiometabolic risk factors, and maternal health behavior. outcomes will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. generalized estimating equation (gee) will be used to examine the trajectories and the effectiveness of the project for managing cardiometabolic risk on cardiometabolic risk and health behavior.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or above 2. pregnant women diagnosed with gestational diabetes mellitus 3. willing to participate in the study exclusion criteria: 1. diagnosed with diabetes mellitus before pregnancy 2. allergic to materials such as tapes (e.g., redness, swelling, itching, pain, blisters, or rashes caused by breathable tapes or patches) 3. abnormal coagulation function

Keywords: gestational diabetes mellitus continuous glucose monitoring health interventions
study evaluating health related utility in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine in australia what effect rheumatoid arthritis has on quality of life, and also to determine the costs that are associated with having rheumatoid arthritis.

at a routine visit to the clinic, patients will be asked to answer questions about their symptoms, have a routine examination by the doctor, fill out a questionnaire that will ask questions about them, about their arthritis, about how it affects their well being and quality of life, and about treatment and costs. the questionnaire will take them about 30 minutes to complete. a blood test may also be required. this ends the patient's involvement with the study.

Eligibility criteria:
inclusion criteria: * male or female patient with clinically defined rheumatoid arthritis diagnosed for at least 3 months * age 18 years or older * ability to complete the study documents in english exclusion criteria: · current participation in a blinded trial of an investigational treatment
cardiovascular biorepository

Conditions: Cardiovascular Diseases

Summary: use biospecimens procured from patients and organ donors to improve understanding of molecular, cellular, and tissue-level processes produced by cardiovascular disease and therapeutic interventions

this is a prospective evaluation of patients undergoing cardiovascular procedures at the university of kentucky medical center.

Eligibility criteria:
inclusion criteria: * all patients undergoing cardiovascular surgery/procedure at the university of kentucky who are at least 18 years of age
bridging active heroin users to hepatitis c treatment using buprenorphine - 1

Conditions: Hepatitis C; Heroin Dependence

Summary: the purpose of this study is to see whether street-recruited heroin users can be successfully treated for hepatitis c after stabilizing them on buprenorphine.

this is a prospective pilot safety study based on the hypothesis that active, street-recruited heroin users can be successfully treated for hepatitis c after stabilization on buprenorphine. eligible subjects will be actively using heroin and have hepatitis c viremia; screening will occur at street-based sites like syringe exchange programs. those who are eligible will sign informed consent, and then be asked to attend 3 weekly educational sessions about hepatitis c and addiction as well as undergo an intake interview. after this, subjects will be inducted onto buprenorphine/naloxone combination therapy (suboxone) and receive this medication for 12-24 weeks. once reaching the 12-24 week study time point, subjects will have the option of a 12-week suboxone taper, or instead of undergoing 6-12 months of hepatitis c treatment with pegylated interferon and ribavirin while being maintained on suboxone. once completing hepatitis c treatment, subjects will undergo a 24-week suboxone taper, or be transitioned to outpatient suboxone therapy by a medical provider.

Eligibility criteria:
inclusion criteria: * active heroin or other illicit opioid use * active hepatitis c * no medical or psychiatric contraindications * able to sign informed consent exclusion criteria: * no opiate dependence * age \<18 * unable or uninterested in attending weekly group sessions

Keywords: heroin addiction
developing and testing an implementation strategy to improve perioperative diabetes care

Conditions: Diabetes Mellitus; Surgery

Summary: optimising glycaemic control during hospital stay reduces the rate of infections, length of stay and mortality, in particular in surgical patients. in this study, we test a strategy to implement optimal perioperative diabetes care in a controlled before and after design in 6 dutch hospitals.

objective/research question optimising glycaemic control during hospital stay reduces rate of infections, length of stay and mortality,in particular in surgical patients. in guidelines and literature recommendations on optimal perioperative diabetes care are described. nevertheless, in daily practice, perioperative glycaemic control is very often not achieved. this study aims at developing an implementation strategy that is tested on feasibility to improve perioperative diabetes care in terms of effectiveness, experiences and costs. design/outcome measures/implementation strategy a step-wise implementation model is applied: 1) recommendations on optimal perioperative diabetes care (e.g. the administration of intravenous insulin, encouragement of diabetes self-management) are systematically translated into quality indicators; 2a) using these quality indicators, current care is measured by performing a medical record search among 400 patients in 6 hospitals; 2b) barriers and facilitators for optimal care are measured by performing interviews with professionals and, e.g. regarding self-management, with patients; 3) based on this information an implementation strategy is developed;4) implementation activities are enacted and 5) evaluated in a controlled before-after design in 6 hospitals providing before and after intervention 400 patients. data analysis to obtain an indication of the effectiveness of the strategy, baseline and post intervention outcomes of intervention hospitals are compared with outcomes in control hospitals, using the quality indicators. experiences of participants in the intervention hospitals will be measured to, if necessary, adapt the strategy to make it more effective and acceptable. economic evaluation a cost analysis of the implementation strategy will take place. implementation costs will be related to the difference in percentage of patients treated as described in the quality indicators before and after implementation. information on the costs and effects at the patient level will also be compared before and after the implementation of the recommendations on optimal care.

Eligibility criteria:
inclusion criteria: * diabetes mellitus and * cardiac surgery or * abdominal surgery or * large joint orthopedic surgery and * duration of surgery minimum one hour exclusion criteria: * rejection to participation

Keywords: diabetes mellitus surgery implementation quality of care quality indicators
air pollution and implantable cardioverter defibrillators

Conditions: Arrythmias

Summary: community based studies have shown increased cardiovascular mortality associated with acute exposures to particulate air pollution. electrocardiographic changes have also been reported in animals exposed to particles in controlled conditions. we have hypothesized that cardiovascular patients may experience life-threatening arrhythmias associated with particulate air pollution episodes. implanted cardioverter defibrillator (icd) devices continuously monitor the heart rhythm, and on detecting arrhythmias can initiate interventions. these devices provide a passive, continuous monitor of cardiac arrhythmias. we are assessing the association between community exposures to air pollution measured by ambient monitors and these cardiac arrhythmias detected by implanted cardioverter defibrillator devices.

records of cardiac arrhythmias detected in patients with implanted cardioverter defibrillators will be linked with measurements of the concentration and constituents of ambient particulate air pollution. time series methods will be used to assess temporal associations, adjusting for seasonal, weekly, and diurnal patterns, meteorology, and co-pollutants. characteristics of subjects showing the strongest air pollution associations will be assessed, as well as effect modification by medication and co-morbidities. icd patients are followed up clinically every three to six months. the icd device is interrogated and data are retrieved by non-invasive radio frequency retrieval from the implanted device. device performance is checked. detected arrhythmias and therapeutic interventions are listed. for each detected episode, date and time is recorded, along with a short electrogram of the heartbeats immediately before and during the event. daily ambient particle mass (pm10 and pm2.5) and particle constituents have been measured in boston since january 1995. the massachusetts department of environmental protection has measured concentrations of gaseous pollutants including carbon monoxide, nitrogen dioxide, ozone, and sulfur dioxide. meteorological factors including temperature, humidity, and barometric pressure have been measured at the national weather service station at logan airport. meteorologic factors and gaseous co-pollutants will be considered as independent predictors of arrhythmic events, and as confounders of the particulate air pollution associations.

Eligibility criteria:
the sample population consists of cardiac patients with implanted cardioverter defibrillator devices attending device clinics at the new england medical center (nemc) cardiac electrophysiology and pacemaker laboratory. all patients with implanted icd devices with event time and date recording living in the greater boston area will be included.

Keywords: arrhythmia cardiac air pollution time series
biocollection on peripheral inflammation

Conditions: Schizoaffective Disorder, Depressive Type; Bipolar Disorder I; Bipolar Disorder II

Summary: most psychiatric research is based on the nosographic classifications used in current practice. at present, there is no diagnostic or prognostic biomarker for psychiatric pathologies commonly used in clinical practice. the study hypothesis is that peripheral inflammatory biomarkers could be common to several psychiatric disorders, in particular psychotic disorders (bipolar disorder, schizophreniform disorder, schizophrenia, depressive episode with psychotic features). the aim of this project is to set up a bio-collection of biological samples (peripheral blood samples) with associated phenotypic data (assessment of various symptoms using standardized scales in patients whose blood is sampled). the setting up of this cohort follows on from work carried out on a psycourse cohort also using a transdiagnostic approach in psychiatry, in order to be able to collaborate within a european research project.


Eligibility criteria:
inclusion criteria: * major patient * patient with one of the following diagnoses confirmed by a psychiatrist: * characterized depressive episode with psychotic features, * bipolar disorder type i * bipolar disorder type ii * schizoaffective disorder * schizophrenia * schizophreniform disorder * patient under psychiatric care at nantes university hospital * patients weighing at least 45kg * patient affiliated to a social security scheme or beneficiary of such a scheme * patient who has given informed consent to participate in the study exclusion criteria: * pregnant, * history of cancer in the last 5 years, * vaccination within the last 4 weeks, * acute or chronic infection, * medical history of organ transplant, * medical history of autoimmune disease, * hearing impairment making it impossible to complete study questionnaires, * patient under court protection
high risk multiple gestation study

Conditions: Trisomy 13; Trisomy 18; Trisomy 21; Sex Chromosome Abnormalities

Summary: the objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. the long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than other currently available screening tests. this will result in fewer unnecessary amniocenteses and chorionic villus sample (cvs) procedures, which are associated with a risk of miscarriage.


Eligibility criteria:
inclusion criteria: * age 18 or older at enrollment * clinically confirmed multiple gestation pregnancy * pregnancy at high risk for genetic aneuploidy as defined below: * confirmed positive aneuploidy by invasive testing * non invasive prenatal testing "high risk" result * serum screening risk of greater than 1:100 * ultrasound abnormalities indicative of aneuploidy * structural abnormality of the posterior fossa * holoprosencephaly * structural cardiac anomaly * omphalocele * nuchal translucency greater than or equal to 3.5 mm or a nuchal fold greater hydrops of unknown etiology * age ≥ 38 years at delivery (if serum screening risk is not less than 1:100) * gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate * able to provide informed consent exclusion criteria: * women carrying singleton pregnancy * surrogate or egg donor used

Keywords: trisomy 13 trisomy 18 trisomy 21 sex chromosome abnormalities monosomy x xxx xxy xyy
open lung peep in thoracic surgery

Conditions: Thoracic Surgery; Ventilation Therapy; Complications

Summary: during thoracic surgical procedures, while ventilating with a protective tidal volume, an open lung approach consisting of a recruitment maneuver followed by an individualized positive end-expiratory pressure (peep) titrated to best respiratory system compliance (open-lung peep, ol-peep) would decrease driving pressure. to test this hypothesis, we performed a multicenter observational study in 17 spanish teaching hospitals of patients undergoing one lung ventilation (olv). in addition, we analyzed the association between the driving pressure and the prevalence of postoperative pulmonary complications (ppcs), and finally the association between the individualized peep and relevant patient preoperative or intraoperative variables.


Eligibility criteria:
inclusion criteria: * patients undergoing one lung ventilation exclusion criteria: * no exclusion criteria
a new prognostic score model for pancreatic ductal adenocarcinoma

Conditions: Neoplasms Pancreatic

Summary: the ajcc tnm staging system is the prevailing method in prognostic evaluation of pancreatic ductal adenocarcinoma (pdac) at present , but it did not include factors such as the tumor immune microenvironment that are known to exert a profound impact on patients'clinical outcome. this study was aimed to develop a comprehensive and effective prognostic score model to predict prognosis and guide clinical management for postoperative pdac patients.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed pdac 2. achievement of surgical resection (including radical or palliative surgery) exclusion criteria: 1. lost to follow-up 2. simultaneous presence of other tumors 3. died in three months after surgery

Keywords: pancreatic ductal adenocarcinoma prognostic model tumor-infiltrating immune cell staging
study evaluating dvs-233 sr in adult outpatients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to compare the antidepressant efficacy and safety of subjects receiving dvs-233 sr versus subjects receiving placebo.


Eligibility criteria:
inclusion criteria: * outpatients * sexually active women participating in the study must use a medically acceptable form of contraception * subjects must have a primary diagnosis of major depressive disorder exclusion criteria: * treatment with dvs-233 sr at any time in the past * treatment with venlafaxine (immediate release \[ir\] or extended release \[er\]) within 90 days of study day 1 * known hypersensitivity to venlafaxine (ir or er)

Keywords: depressive disorder, major melancholia, involutional depression, involutional