Kornimate/medical-research-clean huggingface dataset:
endoscopic stenting for chronic abdominal pain

Conditions: Chronic Pancreatitis

Summary: the prospective sham randomized study will evaluate the role of endoscopic stenting inpatients with chronic pancreatitis and chronic abdominal pain.

endoscopic stenting is increasingly used for the treatment of a variety of pancreatic disorders. although a number of studies suggest that pancreatic stenting relieves abdominal pain in approximately 70% of patients, there has been no randomized study. since any intervention may improve pain, the effectiveness of endoscopy cannot be ascertained without a true placebo arm or sham therapy group. the study will aim to determine the effectiveness of pancreatic stents in relieving chronic pain in the setting of chronic pancreatitis. since these procedures do carry risk, a placebo controlled fashion is used for this study

Eligibility criteria:
inclusion criteria: * all patients referred to the principal investigator for chronic pancreatitis will be enrolled. exclusion criteria: * there are no gender nor racial exclusion.
impact-aml: randomized pragmatic clinical trial for relapsed or refractory aml

Conditions: Refractory Acute Myeloid Leukemia; Early Relapses of Acute Myeloid Leukemia

Summary: the primary objective is to evaluate the efficacy and toxicity of high versus low intensity therapy options in patients with refractory forms and early relapses of acute myeloid leukemia (r/r aml) who are scheduled for allogeneic hematopoietic stem cell transplantation (allohsct).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * primary refractory aml; * early relapsed aml; * a signed informed consent to participate in the study. exclusion criteria: * late relapsed aml; * isolated extramedullary relapse; * mrd relapse without development of bone marrow relapse of aml; * acute promyelocytic leukemia; * previous refractoriness or loss of response during ongoing venetoclax therapy; * previous allohsct; * pregnancy and/or lactation period; * refusal of patients with preserved reproductive potential to use highly effective methods of contraception during the period of participation in the study; * lack of signed informed consent to participate in the study; * failure of the subject to follow the study protocol; * participation in any other clinical trial; * uncontrolled infectious complications; * ecog ≥ 3; * history of other malignancies within the past 3 years, excluding squamous cell and basal cell skin cancers, carcinoma in situ of the cervix, breast, or other non-invasive malignancies, which, in the opinion of the investigator, are considered adequately treated and have a minimal risk of recurrence within 3 years; * chronic kidney disease with gfr ≤ 30 ml/min/1.73 m2 (according to the ckd-epi creatinine equation); * severe cardiac pathology: 1. uncontrolled arterial hypertension; 2. stable angina iii-iv functional classes; 3. unstable angina and/or myocardial infarction less than 6 months before inclusion in the study; 4. heart failure stages iib-iii, nyha functional classes iii-iv 5. uncontrolled cardiac rhythm disturbances (≥ 2 grade ctcae 5.0) or clinically significant ecg abnormalities. * cirrhosis classes b-c according to the child-pugh classification * increased liver function tests above the following values: 1. total bilirubin \> 1,5 above the normal range; 2. ast, alt \> 10 above the normal range. * major surgical interventions underwent less than 14 days before inclusion in the study.

Keywords: acute myeloid leukemia relapse of aml refractory aml allogeneic stem cell transplantation
mobile health intervention for active tuberculosis

Conditions: Tuberculosis; Adherence, Medication

Summary: the purpose of this study is to evaluate and further refine a mobile support tool for patients receiving treatment for active tuberculosis. half of participants will receive support and monitoring using a mobile phone software application and usual care, while the other half will receive usual care.

tuberculosis (tb) remains a top ten leading cause of death globally despite it being a largely curable disease. new effective treatment supervision strategies are needed particularly in low-resource high tb burden settings and a potential solution is in the hands of nearly every patient - a mobile phone. modern modular design mobile phone software applications ("apps") hold great promise to address this unmet need. current technologies allows for rapid design modification based on end user needs, implementation of native operating system (e.g., android) versions for users with inconsistent internet access, and the integration of the patients' experiences with electronic health records using industry standards. apps can perform multiple functions (e.g., automated reminders, symptom tracking, secure messaging, multi-media education). to date, few tb related apps have focused on patients as users, and none support patient engagement in self-management of their care or direct adherence monitoring. the research objectives are to understand end user needs and other stakeholder needs to build, refine, and pilot test an app to support patients self-administering treatment for active tb.

Eligibility criteria:
inclusion criteria: * subject is starting tb treatment for the first time * subject has no known tb drug resistance * subject is hiv negative (self-reported or documented) * subject owns or has regular access to a mobile phone that can access the internet and is able to operate the mobile phone to communicate or have someone able to assist. exclusion criteria: * severely ill (i.e., requiring hospitalization) * reside in the same household with another study participant * history of known drug resistance and hiv co-infection because their care is managed separately and the treatment regimens and duration differ.

Keywords: mobile health
absolute bioavailability study with bexagliflozin

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine the absolute bioavailability of bexagliflozin following a single oral dose co-administered with an intravenous dose.


Eligibility criteria:
inclusion criteria: * body-mass index (bmi) between 18.0 kg/m2 and 32.0 kg/m2 * no nicotine and tobacco consumption in the past 3 months * willing and able to be confined to the clinical research facility as required by the protocol exclusion criteria: * clinically significant history of allergy to drugs or latex * history of alcohol or drug dependence in the past 12 months. * donation of a significant amount of blood in the past 2 months * willing to use an adequate form of birth control during the study and for 90 days after discharge from clinic * exposure to investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
non- vs partial controlled weightbearing after multiple knee ligament reconstruction

Conditions: Knee Injuries

Summary: this is a prospective randomized controlled trial with the purpose to determine if patients undergoing isolated posterior cruciate ligament (pcl) reconstruction, or isolated medial collateral ligament (mcl) reconstruction, or combined pcl, anterior cruciate ligament (acl), fibular collateral ligament (fcl), posterolateral corner (plc), and mcl reconstructions (or any combination of multiple ligaments) can safely begin partial controlled weightbearing for the first six weeks after surgery.

patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery: 1. non-weightbearing 2. partial weightbearing an immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with pcl reconstructions. specific aims 1. primary aim: to determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation. 2. primary aim: to determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation. 3. secondary aim: to determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups. the current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.

Eligibility criteria:
inclusion criteria: * ≥ 14 years old, \<60 * reconstruction of pcl alone * reconstruction of mcl alone * reconstruction of combined multiligament injuries (pcl+ (fcl, plc, acl, mcl)) * reconstruction of multiligament injuries (acl+mcl) * males or females * is willing and able to comply with the clinical trial plan and able to understand and sign the patient informed consent form. exclusion criteria: * \< 14 years old * \>60 years old * pregnant * revision pcl reconstructions * previous or concurrent vascular injury (vascular bypass procedure) * associated fractures requiring concurrent surgery * concurrent meniscal root or radial repair surgery

Keywords: anterior cruciate ligament (acl) multiple knee ligament reconstruction
evaluation of hepatitis b virus (hbv) dna test as point of care tool

Conditions: Hepatitis B

Summary: this is a cross sectional observational study to asses the performance of two novel hbv dna testing methodologies; a) dried blood spot sampling and b) fingerstick capillary blood using the xpert® hepatitis b virus viral load assay. both novel testing methodologies will be compared with venous blood tested using a gold standard hbv dna assay. the sensitivity and specificity of the two novel testing will be evaluated. hbv viral load tests are essential to guide antiviral treatment eligibility and effectiveness. however, many people are unable to access these tests, particularly those living in remote or limited resources settings given high cost, or unavailable infrastructure. simple, affordable and accessible hbv viral load tests are required to increase global access to hbv testing and treatment to meet the who hbv elimination targets. the genexpert diagnostic systems, the most common molecular point-of-care platform globally, has the potential to provide simple and affordable hbv viral load tests. dried blood spot testing is also an affordable and accessible testing methodology particularly suited to remote and resource limited settings. this proof-of-concept study will assess the feasibility and diagnostic performance of xpert® hbv viral load test and dried blood spot testing for the quantitation of hbv dna from fingerstick capillary samples.

this study will be a cross-sectional observational study and will assess the performance of a novel fingerstick hbv viral load and dried blood spot tests within a total of 300 participants who will be recruited across a network of hepatitis clinics in sydney, australia. no treatment will be administered as part of this study. the xpert hbv cartridge will be adapted to use fingerstick capillary blood instead of processed whole blood, and it's performance measured against a gold standard venous blood hbv dna assay. dried blood spot hbv dna testing performance will also be measured against the gold standard venous blood hbv dna assay. secondary objectives of the study are to: 1) evaluate diagnostic performance of the xpert® hbv viral load assay compared to standard of care testing, by patients' hepatitis b e-antigen status (among e-antigen positive and e-antigen negative patients). 2) evaluate diagnostic performance of the xpert® hbv viral load assay compared to standard of care testing, by hbv treatment status (among treatment naïve patients and those receiving treatment). 3) evaluate diagnostic performance of the xpert® hbv viral load assay compared to standard of care testing, by hbv dna levels (among patients with hbv dna \ 200,000 iu/ml).

Eligibility criteria:
inclusion criteria: * have voluntarily signed the informed consent form, 18 years of age or older, hbsag positive exclusion criteria: * nil
amlodipine on blood flow of preovulatory follicle in polycystic ovarian patients

Conditions: Female Infertility Associated With Anovulation

Summary: on the basis of the current study, amlodipine seems to be a promising drug on improving uterine, ovarian blood flow, size of pre-ovulatory follicle, midluteal progesterone level and pregnancy outcome in patients with pco.

to know if amlodipine has vasodilator effect on ovarian ar. in pco patient.

Eligibility criteria:
inclusion criteria: * demographic features including females in age of ≥20 \& ≤35, and bmi of ≤39. * infertility secondary to polycystic ovary , the choice of polycystic ovary patients will be according to the rotterdam consensus workshop (rotterdam, 2004), and the diagnosis of polycystic ovary by ultrasonography will be made according to adams et al. criteria which are the most often cited (adams et al., 1985).the rotterdam criteria as follows: * oligo- or anovulation. * clinical and/or biochemical signs of hyper androgynism * the presence of polycystic ovaries on ultrasound scan. ultrasound findings of enlarged ovaries with multiple small cysts (10-12 or more of 2-9 mm in diameter) scattered around the periphery and highly echogenic stroma exclusion criteria: * including other causes of infertility diagnosed during infertility work up. * patients refused to participate or to continue study. * also, hepatic, cardiac, and hypotensive patients will be excluded from the study.

Keywords: pco amlodipine
irinotecan in treating young patients with refractory or recurrent hepatoblastoma

Conditions: Liver Cancer

Summary: rationale: drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma.

objectives: primary * determine the biological activity of irinotecan hydrochloride, when given on a prolonged schedule, in terms of response rate and rate of early progression, in young patients with refractory or recurrent hepatoblastoma. secondary * determine the duration of response in patients showing stable disease or an objective response (partial or complete response) to this drug. * determine the time to progression and overall survival of patients treated with this drug. * determine the rate of resectability in patients treated with this drug. * determine the toxicity of this drug in these patients. outline: this is a multicenter study. patients receive irinotecan iv over 1 hour on days 1-5 and 8-12. treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. patients undergo evaluation for tumor resectability after courses 2, 3, or 4. patients whose disease is considered resectable at any of these time points proceed to surgery. after completion of study treatment, patients are followed periodically. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of hepatoblastoma * refractory or recurrent disease * failed prior first-line or second-line treatment * metastatic disease allowed * measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral ct scan * elevated serum alpha-fetoprotein (afp) allowed * no hepatocellular carcinoma patient characteristics: * lansky performance status 50-100% in patients ≤ 10 years of age or karnofsky performance status 50-100% in patients \> 10 years of age * life expectancy \> 8 weeks * hemoglobin \> 8 g/dl * absolute neutrophil count \> 1,000/mm\^3 * platelet count \> 100,000/mm\^3 * serum bilirubin ≤ 2 times normal * ast/alt ≤ 2 times normal * serum creatinine ≤ 3 times normal * normal metabolic parameters (i.e., serum electrolytes, glucose, calcium, and phosphate) * not pregnant or nursing * no severe uncontrolled infection or enterocolitis prior concurrent therapy: * recovered from toxicity of prior therapy * no chemotherapy within 3 weeks prior to study entry * no prior irinotecan * no other concurrent anticancer therapy

Keywords: childhood hepatoblastoma recurrent childhood liver cancer
impact of number of rank of b-lactam antibiotics on emergence on multidrug resistant bacteria

Conditions: Resistant Infection; Antibiotic Resistant Infection; Beta Lactam Resistant Bacterial Infection; Bacterial Resistance

Summary: this study evaluates the impact of rank of beta lactam antibiotics on emergence of mutlidrug resistant bacteria colonization in intensive care it's retrospective case controle study. cases are colonized patient by multidrug resistant bacteria hospitalized in intensive care during the fist hospitalization in intensive care. temoin are patients with the same characteristics than case but no colonized by multidrug resistant bacteria.

the emergence of multidrug resistant is a wordwide problem. b lactam resistant increase. the antibiotic prescription impact this problem. b lactam antibiotic is prescribed everyday in intensive care unit. the switch of antibiotic is common. antibiotic classes inclue a lot of rank with different spectum that impact the occurrence of resistant.

Eligibility criteria:
inclusion criteria: * all patient hospitalized more than 48 hours in intensive care unit in besançon between january 2016 and december 2017 exclusion criteria: * patient under guardianship * patient allergic to beta lactam * colonization with mutidrug resistant the first week of hospitalization in intensive care unit

Keywords: antibiotic resistant multidrug resistant beta lactam
the effects of azt and ibuprofen on hiv-infected patients with hemophilia

Conditions: HIV Infections; Hemophilia A

Summary: to determine if platelet dysfunction and/or pharmacologic drug interaction occurs in patients taking both azt and ibuprofen, which might account for enhanced bleeding tendency.


Eligibility criteria:
inclusion criteria patients must have: * hemophilia. * hiv-seropositivity confirmed by western blot. prior medication: required: - azt for study patients. allowed: - ibuprofen. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: hospitalization for opportunistic infection, bacterial infection or malignancy. concurrent medication: excluded: * azt (for control group). * antibiotics or other medication for opportunistic infection, bacterial infection, or malignancy. patients with the following prior conditions are excluded: hospitalization for opportunistic infection, bacterial infection, or malignancy. required: * ibuprofen. * azt 1-2 gm daily (for study patient) or not taking azt (for control).

Keywords: blood platelets ibuprofen drug interactions zidovudine hemophilia a
study to evaluate the efficacy, safety, and tolerability of luvadaxistat in participants with cognitive impairment associated with schizophrenia

Conditions: Schizophrenia

Summary: study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.

a phase 2, randomized, double-blind, parallel, placebo-controlled study with a 6- or 12-month open-label extension. the study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (pk) of treatment with luvadaxistat when administered orally once daily as an adjunctive treatment on improving symptoms of cognitive impairment associated with schizophrenia (cias).

Eligibility criteria:
key inclusion criteria: participants must meet all of the following inclusion criteria: 1. completed written informed consent. 2. participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures. 3. diagnosis of schizophrenia as defined by the diagnostic and statistical manual of mental disorders (dsm-5). 4. the initial diagnosis of schizophrenia must be ≥1 year before screening. 5. the participant is currently receiving a stable regimen of psychotropic medications. 6. participant has stable symptomatology ≥3 months before the screening visit. 7. the participant must have an adult informant. 8. a body weight of at least 45 kilograms (kg) and a body mass index (bmi) of 18.0 to 45.0 kg/meter squared (m\^2), inclusive. key exclusion criteria participants will be excluded from the study if they meet any of the following criteria: 1. pregnant or breastfeeding or plans to become pregnant during the study. 2. exhibit more than a minimal level of extrapyramidal signs/symptoms. 3. schizophrenia diagnosis occurred before 12 years of age. 4. lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder. 5. recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions. 6. considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 6 months before screening. 7. diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening. 8. positive drug screen for disallowed substances. 9. any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments.

Keywords: schizophrenia cognitive impairment luvadaxistat nbi-1065844 tak-831 cias bac erudite neurocrine
efficacy trial of 3804-250a in the prevention of cold illnesses

Conditions: Common Cold

Summary: the purpose of this study is to evaluate the efficacy of 3804-250a in the prevention of the common cold. the study will also evaluate whether 3804-250a prevents rhinovirus infection, a virus that causes many common colds.

rhinovirus infections are the most frequent cause up to 80% of cold illnesses during the fall rhinovirus season. while viral upper respiratory infections are generally mild and self-limited, they are associated with an enormous economic burden both in lost productivity and in expenditures for treatment. rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma. marketed treatment options for rhinovirus consist primarily of symptomatic cold remedies have only modest effects on specific cold symptoms. 3804-250a is under investigation for the prevention of rhinovirus infection by interruption of person-to-person transmission appears to be technologically and economically feasible. the study is a randomized, double-blind, placebo controlled, multi-site, parallel design clinical trial conducted in the natural setting. the study will be conducted during a 10-week period during the fall rhinovirus epidemic season. healthy, normal subjects will be recruited and randomly assigned to the av lotion or placebo control group. subjects will use the assigned test product on a defined schedule and will record the presence of cold illness symptoms daily. subjects will return to the study site every week during the study for review and clarification of study diary entries, for review and assessment of compliance, for specimen collection for rhinovirus pcr.

Eligibility criteria:
inclusion criteria: * healthy normal * good general health exclusion criteria: * pregnancy * insulin dependent diabetes * daily smoker * skin disease on the hands/wrists * immunological disorders * occupation involving frequent handwashing * common cold symptoms

Keywords: cold, common rhinovirus