Kornimate/medical-research-clean huggingface dataset:
early treatment with sofosbuvir (sof) and ledipasvir (ldv) to prevent hcv recurrence after liver transplantation (olt)

Conditions: Hepatitis C Viral Infection

Summary: the study is a single centre, single arm, open-label, proof of concept study enrolling 20 adult primary liver transplant recipients with genotype 1 hcv infection. subjects will receive sofosbuvir (sof) and ledipasvir (ldv) starting at time of liver transplantation (olt) and continues for 12 weeks. subjects will be receive 24 week post-treatment follow up.

hepatitis c viral infection (hcv) leading to end-stage liver disease is the leading indication for liver transplant worldwide. hcv recurrence following liver transplantation is universal, associated with 100-fold increase in viremia levels, and runs at an accelerated course, leading to graft cirrhosis in up to 30% of patients within 5 years. successful eradication of hcv post transplant normalizes the long term survival of hcv positive liver transplant recipients. this study aims to treat hcv infection starting at the time of transplant. the study is a single centre, single arm, open-label,proof of concept study enrolling 20 adult primary liver transplant recipients with genotype 1 hcv infection. subjects will receive sofosbuvir (sof) 400 mg and ledipasvir (ldv) 90 mg as a fixed dose combination (fdc) tablet starting at time of liver transplantation (olt) and continues for 12 weeks. subjects will receive 24 week post-treatment follow up. the study will investigate if the patient has achieved sustained virological response (svr) 12 weeks after cessation of treatment (svr12). furthermore, safety and efficacy of this treatment regimen beginning at the time of transplant will be investigated.

Eligibility criteria:
inclusion criteria: * recipient of a first (primary) live or deceased (after brain or cardiac death) donor liver transplant * willing and able to provide written informed consent * male or female, age 18-70 years old * medical meld score ≤30 at time of transplant (calculated based on serum bilirubin, creatinine and inr, i.e. not taking exception points into account) * quantifiable hcv rna at time of listing or transplant evaluation * hcv genotype 1a or 1b infection * female patients must have a negative pregnancy test at enrolment exclusion criteria: * liver re-transplantation * recipients of multiple solid organ transplants * estimated gfr \<30ml/min at time of transplant * participants transplanted for fulminant hepatic failure * participants co-infected with hbv or hiv * previous treatment with a sofosbuvir or ledipasvir containing regimen * participation in an interventional clinical trial within 1 month prior to enrolment * known allergies or hypersensitivity to sofosbuvir or ledipasvir * pregnancy and/or lactation

Keywords: liver transplant genotype 1 hcv infection sofosbuvir (sof)/ ledipasvir (ldv) sustained virological response (svr12 )
pediatric helmet cpap pilot study

Conditions: Bronchiolitis, Viral; Pneumonia, Viral; Pneumonia, Bacterial

Summary: this a research study to find out whether giving continuous positive airway pressure (cpap) through a helmet is the same or better than giving cpap through a facemask, nasal mask, or nasal prongs. cpap can help kids with lung infections breathe easier. the machine delivers pressurized air, which may help people with lung infections breathe more easily. doctors routinely use a facemask, nasal mask or nasal prongs to give cpap for kids with lung infections, but the researchers want to know whether using helmet cpap is the same or better.

prior clinical trials have demonstrated efficacy of helmet cpap in adults with acute respiratory distress syndrome, superior tolerance and improved respiratory scores compared to nasal/facial cpap in infants, and no major safety concerns were identified with the use of helmet cpap. this is a prospective pilot study to (1) determine if infants and pediatric patients requiring cpap in the picu will tolerate helmet cpap for at least four hours, and (2) measure changes in the respiratory rate, oxygen saturation, heart rate and blood pressure over four hours. if helmet cpap is found to be well tolerated in this small cohort, a larger study comparing it directly to other cpap interfaces will be conducted.

Eligibility criteria:
inclusion criteria: * one month to 5 years of age (inclusive) admitted to the picu with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask cpap for at least four hours but less than 48 hours, and parental informed consent. exclusion criteria: * age less than 1 month or greater than 5 years * positive for covid-19 * need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (bpap) * unresponsiveness (gcs 8 or less) * hypotension as defined as a systolic blood pressure less than 5th percentile for age * existing head or neck trauma, known or suspected air leak syndrome (pneumothorax, pneumomediastinum, subcutaneous emphysema), known or suspected increased intracranial pressure * non-english speaking parent
identification of airway structures necessary for airway access via the skin

Conditions: Upper Airway Obstruction

Summary: literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation. the study will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage in patients, using different methods including application of ultrasonography.

literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation. the researchers will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage of a healthy subject with different methods including application of ultrasonography.

Eligibility criteria:
inclusion criteria: * anaesthesiologist exclusion criteria: * unvillingnes to participate
simultaneaous detection of quantitative somatic alterations using the qantitative multiplex pcr of short fluorescent fragments method (qmpsf) in stage ii-iii colon cancer: a prospective study

Conditions: Colorectal Cancer; Stage II and III

Summary: lymph node involvement remains the main criteria for postoperative chemotherapy in patients with colon cancer (cc) without distant metastasis. to date, the prognostic value of the somatic quantitative molecular alterations such as loss or gain of genomic region is not established in cc. aims \& methods: using the one-step screening method based on the quantitative multiplex pcr of short fluorescent fragments (qmpsf), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage ii-iii cc. patients and methods. we enrolled and collected all baseline characteristics of patients operated for a stage ii-iii cc with storage frozen tissues. the qmpsf was based on a simultaneous amplification of 9 selected target genomic sequences from literature: dcc (18q21); egfr (7p12); p53 (17p13.1); blk (8p23-p22); c-myc (8q24.12); apc (5q22.2); erbb2 (17q12); stk6 (20q13.31); nr21 (14p11.1) and two control: dcohm (5q31.1); hmbs (11q23.3). comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral tissue allowed us to identified gain or loss genomic region. the primary end-point was the local and/or distant recurrence and relation between clinical and single or combined molecular alterations and recurrence were evaluated.


Eligibility criteria:
inclusion criteria: * age over 18 * localized colon cancer * proven adenocarcinoma * surgery r0 * no metastatic disease * stage ii or iii * who performance status 0, 1 or 2 * availaible frozen tissue * written consent * no major co-morbidities exclusion criteria: * metastatic disease * hereditary colorectal cancer * rectal cancer

Keywords: colorectal cancer stage ii and iii somatic quantitative molecular alterations qantitative multiplex pcr of short fluorescent fragments method (qmpsf)
lung ultrasound in children with severe malaria

Conditions: Severe Malaria

Summary: a prospective cohort study, with 171 children admitted for severe malaria that will be included in the cohort. the study will take place in kinshasa, democratic republic of congo. the primary objective is to evaluate the prevalence of five pre-specified pulmonary diagnoses that can be facilitated by the use of lus (normal lung or acidotic breathing, ards, concomitant pneumonia, hydrostatic pulmonary oedema, pleural effusion).

a prospective cohort study, with 171 children (between 1 - 14 years) admitted for severe malaria that will be included in the cohort. the study will take place at the maluku district hospital, located in kinshasa, democratic republic of congo. lung ultrasound will be performed on admission, h24, and unscheduled timepoints (in case of respiratory deterioration during hospital stay). lung auscultation and peripheral capillary oxygen saturation (spo2) will be assessed at each time points. all children will be observed from admission to hospital discharge. at 30 days a phone call will be made by the study staff to follow up clinical conditions of the child. the total duration for each subject's participation in the study is approximately 1 month. the study period is approximately 12 months funder: the wellcome trust (itpa grant) wt-itp-2019/005

Eligibility criteria:
inclusion criteria: * children aged between 1 and 14 years; * admitted for confirmed severe malaria (i.e. positive peripheral blood slide for malaria parasite and/or positive rapid diagnostic test for malaria in combination with one or more clinical or laboratory severity criteria detailed below). * informed consent signed clinical features of severe malaria * cerebral malaria; a glasgow coma scale of less than 11 or a blantyre coma scale less than 3 in preverbal children * respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate \> upper normal limit for age) * jaundice (visible jaundice) * circulatory collapse or shock: age \ 12 systolic blood pressure \ 3 seconds * spontaneous bleeding * multiple generalized convulsions: more than two episodes within 24h * prostration, i.e. generalized weakness so that the patient is unable to sit, stand or walk without assistance laboratory features and other findings * metabolic acidosis (venous plasma bicarbonate \< 15mmol/l or base excess \< -2.2meq/l) * severe anaemia (age \ 12: hematocrit \< 20% or hemoglobin \< 7 g /dl) * hypoglycaemia (\< 2.2mmol/l or \< 40mg/dl) * hyperparasitaemia defined as \> 10% * hyperlactataemia (venous lactate \< 5 mmol/l) * kidney dysfunction (blood urea \>20mmol/l) exclusion criteria: * co-morbidity which, in the judgement of the investigator or treating physician, would place the subject at undue risk or interfere with the patient's treatment or results of the study. e.g. immediate transfer needed.

Keywords: severe malaria lung ultrasound prevalence of pulmonary diagnoses
non interventional study in bipolar disorder and schizophrenia with zeldox

Conditions: Bipolar Disorder; Schizophrenia

Summary: investigation of the impact of zeldox on metabolic parametres in patients with bipolar disorder or with schizophrenia and impact of the treatment for the quality of life

observational survey consecutive patient sampling

Eligibility criteria:
inclusion criteria: manic and mixed episodes of up to moderate severity in patients with type i and ii bipolar disorder and schizophrenia; either first diagnosed or repeated episodes. exclusion criteria: patients with a history of hypersenzitivity to ziprasidone. previous insufficiency of the ziprasidone´s treatment. the break of the previous therapeutic condition.
association between dietary pattern and glycemic control among type 2 diabetes patients in the unites arab emirates

Conditions: Dietary Habits

Summary: poor glycemic control in patients with type 2 diabetes (t2d) is due to multiple factors and suboptimal dietary pattern is one of them .assessing eating/dietary patterns (combinations of different foods or food groups) among individuals with diabetes may be beneficial in understanding the focus areas of dietary modification among the emirati community and further developing dietary interventions for management of t2d. only a few observational studies are reported in this region exploring the eating practices, although none to the investigators knowledge described the frequency of consumption of food groups in the t2d patients in the united arab emirates(uae). hence, in this study the investigators aim to describe the trends in frequency of consumption of food groups and analyze the association of frequency of food item consumption and glycemic control among the t2d uae patients. this retrospective cross sectional study will include the data from hospital information system of 800+ t2d patients to describe the trends in frequency of consumption of food groups and analyze the possible association of frequency of food group/item consumption and glycemic control.

type 2 diabetes (t2d) burden is not only increasing globally but also in the middle east region. dietary intake plays a crucial role in ameliorating glycemia and other risk factors ,the aim of this study is to describe the trends in frequency of consumption of food groups and possible association with glycemic control among thet2d uae patients. this retrospective cross-sectional study was conducted among 800+ t2d diabetic aged ≥ 18 years, attending rashid centre for diabetes and research(rcdr) centre located in uae during january 2011 until january 2015. the dietary data will be collected from hospital records generated by dietitians after an interview based consultation using a structured pre-tested questionnaire. multiple regression techniques will be used for model building, to determine the separate contribution of known confounders and food items with high carbohydrate and glycemic control.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * uae nationals, * both males and females. * age between ≥ 18years exclusion criteria: * patients underwent bariatric surgery * pregnant women

Keywords: dietary pattern glycemic control type 2 diabetes uae
menstrual complaints in adolescents and adults

Conditions: Dysmenorrhea; Heavy Menstrual Bleeding; Daily Activities; Menstrual Cramps; Menstrual Cycle; Menstrual Distress (Dysmenorrhea); Menstrual Health Intervention; Menstrual Pain; Mobile Health; Mobile Health Technology (mHealth)

Summary: the aim of this study is to investigate the prevalence of menstrual complaints and their impact on daily life activities (school/work absence, absence from social activities, sports) in adults and adolescents.

this study was an online prospective cohort study and consisted of using the menstruatie educatie kalender (menstruation education calendar) application (mek app) daily for at least one cycle with a questionnaire before and after the use of this application. participants consisted of postmenarchal adolescents and adults with a menstrual cycle with monthly bleeding. the study involved minimal effort for participants: a baseline questionnaire at the start of the study, requiring approximately 10 minutes; daily app use for at least one cycle, taking around 20 seconds each day; and a final questionnaire at the end of the study, lasting about 10 minutes. participants received no compensation for participating and the use of the mek app was free. previous research on menstrual complaints in adolescents has considered sample sizes of approximately 1,000 participants to be representative of the population. since this prospective cohort study about adolescent's menstrual complaints involved repeated measurements, and the literature suggested that repeated measurements of outcome variables increase study power and reduce the required sample size, this study aimed to include a total of 900 adolescents and 900 adults. the study results were reported using descriptive statistical analyses. to compare dichotomous outcomes the chi-square test or the fishers' exact test was used. depending on the data distribution, the student's t-test or mann-whitney u test was used to compare continuous outcomes. mixed effects logistic regression was used for the association between menstrual complaints and the impact on daily life activities. the statistical analysis was performed in ibm spss statistics version 28 using a two-sided p-values. p-values under 0.05 were considered statistically significant.

Eligibility criteria:
the inclusion criteria were * post-menarcheal adolescents and adults aged 12-60 years, * having a menstrual cycle with monthly bleeding (also with an intra-uterine device or use of contraceptive pills), * speaking dutch (mek-app is available in dutch only); * having a smartphone with the operating system android or ios and * obtaining informed consent from the participant and the parents of the participants aged 12-16 years. the exclusion criteria were * amenorrhea * incompleted questionnaires * not using the mek-app for at least one period

Keywords: dysmenorrhea heavy menstrual bleeding menstrual complaints impact of menstrual complaints daily activities adolescents adults
cardiovascular benefits of acai polyphenols in volunteers at risk of metabolic syndrome

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to carry out a randomized double blind controlled trial in 30 male subjects to investigate the effect of acai consumption on acute changes in vascular function, and to other cardiovascular markers. as a secondary aim the study will allow us to characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour period.


Eligibility criteria:
inclusion criteria: * male, 30-65 aged, bmi 25-35 kg/m2, cholesterol \<8 mmol/l. exclusion criteria: * female, bmi \ 35 kg/m2, cholesterol \>8mmol l-1, elevated fasting blood sugar \> 6.5 mmols l-1 , elevated systolic blood pressure \>150 mmhg, history of stroke or heart attack within the previous 12 months, current smoking, taking lipid lowering, blood pressure lowering or anti-blood clotting medication or taking micronutrient supplements.

Keywords: flow-mediated dilation acai polyphenols
treatment and prevention of severe anemia in pregnant zanzibari women

Conditions: Anemia; Low Birth Weight; Neonatal Mortality

Summary: the purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in zanzibar, tanzania. the two packages are standard of care as described by the who (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and enhanced care (standard of care plus daily multivitamins and a 2nd dose of anthelminthic.)

this is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. the specific aims are: aim 1: to evaluate the efficacy of the current internationally recommended standard of care, as described by the who, for the prevention of severe anemia among pregnant zanzibari women. this aim will be achieved through a pre-post intervention comparison. aim 2: to evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant zanzibari women. aim 3: to evaluate the efficacy of the current internationally recommended standard of care, as described by the who, for the cure of severe anemia among pregnant zanzibari women. aim 4: to evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant zanzibari women.

Eligibility criteria:
inclusion criteria: * pregnant woman exclusion criteria: * not a permanent resident of the community

Keywords: anemia birth weight neonatal mortality tanzania pregnancy
effect of preoperative education based on roy adaptation model

Conditions: Orthopedic Disorder

Summary: this research was conducted as a randomized controlled experiment to determine the effect of the education given by the physiological mode of roy adaptation model in patients with hip or knee arthroplasty on physical adaptation and mobility.

the research was conducted between 01.11.2017 - 01.04.2018 at the orthopedics and traumatology surgery service of a private university hospital in istanbul. in the study, the number of samples to be taken; the training, the training group control group mobility scale scores between the observer at least 5% of the study considering that would make a difference, and power 80%, α=0.05 and power analysis adopted by participants for each group were calculated and it was determined that there should be at least 27. the sample was composed of 78 individuals 41 experimental and 37 control. patients' physical adaptation and mobility were evaluated using the patient mobility scale and observer mobility scale and physical adaptation assessment form. randomization of the study was achieved by planning patients who met the inclusion and non-inclusion criteria for training and control groups sequentially, without dividing them into hip or knee arthroplasty. in the randomization table, those with the number 1 are assigned to the training group.

Eligibility criteria:
inclusion criteria: can read and write in turkish a sufficient level of education to understand study procedures and training exclusion criteria: hospitalized due to fracture mental disability neurological disease undergone the same operation before received similar training before

Keywords: roy adaptation model hip arthroplasty knee arthroplasty physical adaptation preoperative education