Kornimate/medical-research-clean huggingface dataset:
bendamustine versus fludarabine in chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. this study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine. patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. the primary objective was to achieve non-inferior progression-free survival with bendamustine.


Eligibility criteria:
inclusion criteria: * histologically or immunologically confirmed chronic b-cell leukemia * refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen * disease stage ii-iv according to rai or b/c according to binet staging system, respectively * eastern cooperative oncology group (ecog) performance status of 3 or better * negative pregnancy test/ adequate method of contraception exclusion criteria: * t-cll, pll (prolymphocytic leukemia) * presence of richter's transformation * first-line treatment containing either fludarabine or bendamustine * acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin \> 5mg/dl), renal system (creatinine \> 2 mg/dl), or metabolic disorders * secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)

Keywords: relapsed
laparoscopy-assisted ercp in patients with altered gastric anatome

Conditions: Biliary Disease; Pancreas Disease

Summary: the purpose of this research study is to collect data on the technical aspects of lasparoscopy-assisted ercp and patient outcomes to help guide future medical care of patients with roux-en-y gastric bypass surgery.

patients would have had a roux-en-y gastric bypass in the past that had altered their gastric anatomy. now they have developed bilary and/or pancreatic problems that require and ercp. with their altered gastric anatomy a standard ercp would not be possible. thus they are scheduled for a laparoscopy-assisted ercp.

Eligibility criteria:
inclusion criteria: * age 18 years and older * altered gastric anatomy * scheduled to undergo laparoscopy-assisted ercp exclusion criteria: * any contraindications to performing endoscopy * participation in another research protocol that could interfere or influence the outcomes measures of the present study. * the subject is unable/unwilling to give informed consent

Keywords: laparoscopy assisted ercp altered gastric anatomy
fresh-dose: families responsibility education support health-dual options for sustained effectiveness

Conditions: Overweight; Obesity

Summary: the objective of the study is to evaluate whether a less intensive intervention, guided self-help family based treatment (gshfbt), is non-inferior to the more intensive family based treatment (fbt) for childhood obesity on child weight loss over 18-months. cost-effectiveness of both treatments will also be compared.

the primary aim of this project is to determine whether gshfbt is non-inferior to fbt for childhood obesity on child weight loss. four assessments will be conducted; baseline (month 0), month 6 (post-treatment), and at month 12 and month 18. assessments will include the following for child and parent: anthropometry, physical activity, nutrition, and cost-effectiveness. cost-effectiveness will be calculated from a societal perspective and a third party payor perspective. this program of research has the potential to advance the standard of practice for children who are overweight or obese by providing a less intensive but more cost-effective intervention.

Eligibility criteria:
1. an overweight child age 7-12, whose bmi is ≥ 85th percentile but does not meet criteria for severe obesity (i.e., bmi ≥120% of the 95th percentile or an absolute bmi ≥ 35 kg/m2 , whichever is lower for age and gender) 2. the parent willing to participate can read english at a minimum of a 5th grade level 3. parent and child willing to commit to attending all treatment and assessment sessions and be randomized to either treatment arm 4. child or parent is free from psychiatric illness than may affect participation; 5. child does not have any medical conditions that impact weight or may affect participation in physical activity or treatment 6. child is not taking medications that may impact their weight (unless medication dosage is stable and not for the purpose of impacting weight and appetite)

Keywords: obesity overweight overeating body mass index treatment intervention family based therapy weight children
pharmaceutical care for diabetes type 2 patients: a randomised controlled trial

Conditions: Diabetes Mellitus

Summary: the objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for diabetes type 2 patients. patients will be randomly allocated to the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical care at baseline and follow-up visits over 6 months).


Eligibility criteria:
inclusion criteria: * 45-75 years * body mass index \>= 25 * diabetes treatment for at least 12 months * regular visitors of the participating community pharmacy exclusion criteria: * patients taking only insulin (no oral antidiabetic drugs)
integrated pulmonary index as a predictor of respiratory compromise in critically ill patients

Conditions: Respiratory Failure

Summary: the integrated pulmonary index (ipi) is a newly developed index for respiratory monitoring. however, there is limited evidence on its effectiveness and usefulness in critically ill patients. the purpose of this study is to evaluate the clinical relevance of the ipi as a predictor of respiratory compromise in critically ill patients.

recent developments aim to use multiple parameters to detect ares. application of smart algorithms that combine individual physiological variables into one index may increase the ability to detect a true adverse respiratory event while avoiding false alarms and limiting alarm fatigue. an example of such a multiparameter index is the integrated pulmonary index or ipi™, which integrates oxygen saturation (spo2), respiratory rate (rr), end-tidal pco2 (petco2) and heart rate (hr) into a single integer value of 1-10 that represents adequacy of respiratory condition of the patient using a fuzzy logic inference mathematical model; scores ≥ 8 points are within normal range and those ≤ 4 points suggest requirement of interventions. the ipi algorithm summarizes the state of ventilation and oxygenation at the point in time. previous studies reported that ipi correlated with respiratory physiological parameters of patients undergoing sedation for surgeries or for colonoscopy. up to our knowledge, the clinical relevance of the ipi as a predictor of respiratory compromise in critically ill patients has not been discussed before.

Eligibility criteria:
inclusion criteria: * critically ill patients aged 18 years or older of both genders admitted to the intensive care unit exclusion criteria: * age \< 18 years' old * morbid obesity * mechanical ventilation * hemodynamic instability. * thoracotomy and cardiac surgery
evaluation of long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence

Conditions: Malaria

Summary: in the past decade, massive scale-up of insecticide-treated nets (itn) and indoor residual spraying (irs), together with the introduction of artemisinin-combination treatments, have led to substantial reductions in malaria prevalence and incidence in african highlands. however, rising insecticide resistance and increased outdoor transmission have greatly hampered the effectiveness of itn and irs because the current indoor-based interventions do not target the outdoor-biting mosquitoes. therefore, new supplemental interventions that can tackle outdoor transmission and pyrethroid insecticide resistance are urgently needed. the central objective of this study is to determine the efficacy and cost-effectiveness of epa-approved long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence in western kenya highlands.

in the past decade, massive scale-up of insecticide-treated nets (itns) and indoor residual spraying (irs), together with the use of artemisinin combination treatments, have led to major changes in malaria epidemiology and vector biology. along with the significant reduction in overall malaria prevalence and incidence, extensive use of insecticides has created large selection pressures for resistance in the malaria vector populations and for potential outdoor transmission, which appears to be limiting the success of itns and irs. because irs and itn have little impact on outdoor resting and early biting vectors, outdoor transmission represents one of the most important challenges in malaria control. therefore, new interventions that can augment the current public health measures to reduce outdoor transmission are urgently needed. larval control has historically been very successful and is widely used for mosquito control in many parts of the world, except in africa. factors limiting the use of larvicides include high costs associated with frequent habitat re-treatment. now a new us epa-approved long-lasting formulation, potentially effective for 6 months is available. the central objective of this study is to determine the effect of long-lasting microbial larviciding on the incidence of clinical malaria and reduction of transmission intensity. our hypothesis is that addition of long-lasting microbial larviciding to ongoing itn and irs programs will lead to significant reductions in both indoor and outdoor malaria transmission and malaria incidence.

Eligibility criteria:
inclusion criteria: * all clinical malaria cases from participated local hospitals and clinics. exclusion criteria: * infants younger than 6 months.

Keywords: long-lasting microbial larvicide intervention cluster randomised controlled trial anopheles mosquito
carbon dioxide insufflation colonoscopy in ibd patients

Conditions: Colonoscopy; Carbon Dioxide; Inflammatory Bowel Disease

Summary: carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. so far, it has not been studied in inflammatory bowel disease patients. the study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. so far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. they are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.the study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Eligibility criteria:
inclusion criteria: * known diagnosis of crohn´s disease and ulcerative colitis * indication for diagnostic colonoscopy * informed consent * unsedated or minimally sedated procedure (\< 3 mg of midazolam) exclusion criteria: * planned incomplete or therapeutic procedure * deep sedation or general anesthesia * intestinal resection longer than ileocecal resection * isolated gastroduodenal or jejunal location of crohn´s disease (l4) * ulcerative proctitis (e1)

Keywords: colonoscopy carbon dioxide inflammatory bowel disease
effectiveness of cotton vs. waterproof cast padding

Conditions: Developmental Dysplasia of the Hip

Summary: this study aims to: 1) investigate the effectiveness of waterproof spica cast using delta-dry® pantaloon and cast padding (bsn medical, usa) versus standard gortex pantaloon with cotton cast padding in maintaining the femur fracture and developmental dysplasia of the hip reduction after application of hip spica; 2) evaluate the overall quality ratings of both cast paddings from the perspectives of the patient and the clinicians; and 3) determine the cost difference between the both cast paddings.


Eligibility criteria:
inclusion criteria: * paediatric patients (\<6 years old) diagnosed with developmental dysplasia of the hip or femur fracture who present to texas children's hospital and plan to be treated with a spica cast. exclusion criteria: * patients with thigh diameter more than 13.4 inches will be excluded because of the size limitation of the delta-dry pantaloon * patients with femur fracture who present for treatment more than 2 weeks from the date of injury, comminuted fracture, non-displaced fracture, or with other surgical comorbidity
a study of livtencity (maribavir) in adults with cytomegalovirus (cmv) infection after transplantation in south korea

Conditions: Cytomegalovirus (CMV)

Summary: cytomegalovirus (cmv) is a common virus that infects many people. it can cause serious illness in people with weak immune systems especially in those undergoing transplants. livtencity (maribavir) is a medicine approved for treating cmv infection in adults after transplant in south korea. the main aim of this study is to learn how safe and effective livtencity (maribavir) is in treating adults with cmv infection after transplant in a routine clinical practice setting. during the study, a participant's data will be collected for about 5 months (20 weeks). the study does not have fixed visits to the hospital, but it is recommended to visit the study doctor approximately 6 times during study.


Eligibility criteria:
inclusion criteria: * participants with post-transplant cmv infection and/or disease who are refractory and/or resistant to one or more prior therapy including ganciclovir, valganciclovir, cidofovir or foscarnet. * participants with age greater than or equal to (\>=) 19 years. * initiate first treatment course with maribavir. * voluntarily consent to participate in the study. exclusion criteria: * participants for whom livtencity tablet (maribavir) is contraindicated as per product label. * participants previously treated with maribavir in any study or as marketed drug. * participants actively participating in other clinical trials of post-transplant cmv infection treatment or with other experimental treatments.

Keywords: drug therapy
effect of xpert mtb/rif on patient outcomes

Conditions: Tuberculosis

Summary: a parallel-group prospective cohort study among adult persons living with hiv/aids to study the effect of a new tb diagnostic test, xpert mtb/rif on: 1) tb case detection; 2) time to tb diagnosis and tb treatment; 3) presumptive tb patient drop-out from the tb diagnostic "cascade" before starting tb treatment; and 4) loss to follow-up after initiation of tb treatment.

the centre for infectious disease research in zambia (cidrz) in collaboration with the zambian national tb program (ntp) and the ministry of health (moh) will provide near point-of-care xpert testing at a high-volume anti-retroviral treatment (art) clinic in lusaka, zambia. a total 892 study participants will be enrolled into two parallel cohorts-an "xpert" and a "standard of care" (soc) cohort over a 7-month period. the xpert cohort will enrol participants at the health centre implementing xpert. the soc cohort will enrol participants from one health centre offering the standard of care (sputum smear microscopy plus clinical evaluation). a parallel-group prospective cohort study will be conducted by following participants in one cohort from each site for 210 days from the time of sputum submission, allowing sufficient person-time to observe all outcomes of interest, including completion of a standard course of att as well as patient drop-out and loss to follow-up. a systematic facility assessment survey using an adapted version of the who service availability and readiness assessment tool will be conducted. key informants will be interviewed.

Eligibility criteria:
inclusion criteria: * able to spontaneously expectorate at least 2 sputum samples, in accordance with ntp guidelines * intend to continue receiving care at the respective study sites for at least 7 months * willing to provide locator information and allow contact by phone or home visit in the case of loss to follow up after initiating att exclusion criteria: * received tb treatment within 60 days prior to enrolment and/or were diagnosed with tb within the last 6 months * cannot spontaneously expectorate sputum * are already enrolled in another study with might interfere with implementation of this study protocol * provided a sputum sample that results in a contaminated tb culture result a key informant will be eligible for inclusion in the sara facility survey component of the study if they meet the following criteria: * 18 years of age or older * clinic staff member at either chilenje health centre or chelstone health centre * have previously been attached to, or are otherwise familiar with, departments offering hiv, tb and/or laboratory health services exclusion criteria: -unwilling or unable to provide verbal informed consent in english

Keywords: extra-pulmonary tuberculosis multiple drug resistant tuberculosis mycobacterium tuberculosis human immunodeficiency virus
bioavailability of medium chain triglycerides (mcts) in comatose patients with acute brain injury (abi)

Conditions: Injuries, Acute Brain; Severe Trauma Brain Injury (sTBI); Subarachnoid Hemorrhage, Aneurysmal

Summary: this study will be targeting patients suffering from acute brain injury (abi), including those with severe trauma brain injury (stbi) and those with aneurysmal sub arachnoid hemorrhage (asah). this clinical study is an open-label, non-randomized, single-center, exploratory metabolic study. the primary objective is to determine changes from baseline (before enteral administration of peptamen af) in plasma and brain extracellular levels of mcfas and ketone bodies in stbi patients upon peptamen af nutritional support.


Eligibility criteria:
inclusion criteria: * comatose patients (defined by an initial glasgow coma scale (gcs) \< 9) following stbi or asah. * female or male, aged \>18. * abnormal head ct-scan (contusions, hematoma). * intracranial monitoring with cmd, \[pbto2\] and \[icp\] probes as part of standard of care. * written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests. * written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study exclusion criteria: * signs of brain death or expected brain death within 48h. * pregnancy. * hemodynamic instability (circulatory shock, requiring vasopressors). * renal or liver insufficiency . * chronic intestinal disease. * patients requiring parenteral nutrition . * currently participating or having participated in another clinical trial during the month preceding the study
randomized controlled trial of cognitive therapy based self help manual for depression

Conditions: Depression

Summary: while cbt (cognitive behaviour therapy)has been found to be effective in treating depression in west, only limited amount of research has been conducted to find assess its effectiveness in low and middle income countries. we have developed culturally sensitive cbt during the last few years in pakistan. pakistan has high rates of depression. and there is currently a need to develop and test evidence based treatments which are culturally sensitive and cost effective. in this project we will be assessing the effectiveness of a culturally sensitive cbt based self help intervention for depression in pakistan against care as usual, using a randomized controlled design.


Eligibility criteria:
inclusion criteria: * all those who fulfil the diagnosis of depressive episode (f32) or recurrent depressive disorder (f33 except 33.4 ) using icd10 rdc (international classification of diseases, research diagnostic criteria), scored 8 or more on hads (hospital anxiety and depression scale) depression sub-scale, are between the ages of 18-60 and either patient or the carer has at least 5 years of education. exclusion criteria: * the exclusion criteria include; excessive use of alcohol or drugs (using icd 10 rdc for alcohol or drug abuse or dependence) significant cognitive impairment (for example learning disability or dementia) and active psychosis.

Keywords: culture, depression, cognitive therapy, behaviour therapy,
reduction of risk for contrast induced nephropathy

Conditions: Contrast Induced Nephropathy

Summary: the reduction of risk for contrast-induced nephropathy (reicin) study is the largest prospective multicenter data base for cin flowing coronary angiography (cag) or percutaneous coronary intervention (pci). the reicin study has the potential to characterize contemporary cin incidence, modified risk factors and prognosis, so that to identify strategiaes to reduce risk of cin following cag/pci.

this is a multicenter prospective observational study collecting data on over 5000 cag patients admitted to department of cardiology in 12 hospitals from january 2013. data will be collected for more than 1 year on all patients undergoing cag with or without pci older than 18 years without baseline end-stage renal failure needing renal replacement therapy or renal transplantation. data to be collected includes demographic information, admission diagnoses and co-morbidities, biomarkers and details on preventive hydration and medications used contrast-induced nephropathy (cin) is the primary endpoint, defined as a ≥ 0.5 mg/dl or 25% increase in serum creatinine (scr) from baseline during the first 48 to 72 hours after the procedure.

Eligibility criteria:
inclusion criteria: 1. patients referred to cag or pci; 2. age ≥ 18 years 3. submit informed consent and adhere to the study protocol exclusion criteria: 1. fail to undergo cag/pci or die during the procedure； 2. end-stage renal diseases or renal replacement； 3. pre-procedural unstable renal funciton (acute increase in serum creatinine more than 0.5mg/ml in the past 24 h)； 4. intravascular administration of a contrast medium within the previous 48 hours； 5. allergic to contrast medium; 6. pregnancy, lactation or malignant tumoror life expectancy\< 1 year; 7. the use of renal toxicity drugs (non-steroidal anti-inflammatory drugs, aminoglycoside drugs, cyclosporine, cisplatin etc) within 48 h before cardiac catheter surgery and the whole process of the research; 8. refer to receive renal artery angiography or surgical valve replacement in patients with rheumatic heart disease； for exclusion creteria 7, patients admited and taked aspirin are included in the study.

Keywords: contrast-induced nephropathy contrast medium creatinine clearance coronary angiography diabetes chronic kidney disease predictive