Kornimate/medical-research-clean huggingface dataset:
safety and antiviral activity study of ach-126,443 (beta-l-fd4c) in treatment-naive adults with chronic hepatitis b virus infection

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study was to determine the safety and anti-hepatitis b virus (-hbv) activity of ach-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis b infection.

evaluation of the safety and antiviral activity of 3 dose levels of ach-126,443 versus lamivudine and placebo over 12 weeks of treatment in the population is described.

Eligibility criteria:
inclusion criteria: * chronic hepatitis b virus (hbv) infection, known to be hepatitis b surface antigen positive ≥ 6 months. * plasma hbv deoxyribonucleic acid level ≥ 100,000 copies/milliliter. * hepatitis b e-antigen positive. * human immunodeficiency virus negative. * basic hematologic and chemistry parameters within acceptable limits (defined in protocol). * no need for excluded medications. * participants of reproductive capability must have utilized 2 approved forms of birth control, one of which must have been barrier protection. exclusion criteria: * human immunodeficiency virus infection. * hepatitis c co-infection. * concurrent systemic antiviral treatment. * previous antiviral treatment for hbv infection within 6 months prior to randomization or treatment with lamivudine for more than 6 months at any time in the past. * previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start. * alcohol abuse. * pregnancy or breast-feeding. * inability to tolerate oral medication. * aspartate aminotransferase \> 7.0 times the upper limit of normal. * alanine aminotransferase \> 7.0 times the upper limit of normal. * any clinical condition or prior therapy that, in the investigators opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements. * use of any investigational drug.

Keywords: e-antigen positive treatment-naive chronic hepatitis b achillion
study evaluating bifeprunox in bipolar depression

Conditions: Bipolar Disorder

Summary: the purpose of the study is to investigate whether eight weeks of treatment with flexible doses of bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder * experiencing a depressive episode

Keywords: depression bipolar disorder
the degree, duration and frequency of insulin resistance in non-operated patients with sepsis

Conditions: Sepsis

Summary: surgery induces insulin resistance lasting for 2-3 weeks. we wanted to elucidate if stress-metabolic, medical conditions carry the same effect.

background: insulin resistance is well documented after surgery in a severity positively correlated to the degree of trauma (thorell et al. 1999; chambrier et al. 2000). similar phenomena have been described in severely ill patients in icu with consequences for the survival (van den berghe et al. 2001; the nice-sugar study investigators 2009). the documentation, however, is scarce and the extent is unknown in acutely ill patients with sepsis. method: adult, consecutive, non-diabetic patients with elevated crp, leukocyte counts, sofa-score of ≥ 2 were monitored with fasting p-c-peptide, blood glucose, crp, leukocyte count and homa-ir at admittance, discharge and at two follow-up visits 2 weeks and 4 weeks after admission. blood glucose levels were measured continuously during the whole study period with a flash glucose monitor mounted on the patients' upper arm. the diagnosis was sepsis, urosepsis, pneumonia, erysipecosis, bacteremia, infection with unknow focus and covid-19.

Eligibility criteria:
inclusion criteria: * elevated crp on acute asdmission * elevated leukocyte count on admission * sofa-score ≥ 2 * diagnosis: bacterial sepsis * full age and authority exclusion criteria: * not able to understand the protocol * not able to co-operate * diabetes mellitus of any kind

Keywords: septicaemia insulin resitance continous blood glucose
medial retinacular plication versus medial patellofemoral ligament reconstruction for recurrent patellar instability

Conditions: Patella, Familial Recurrent Dislocation Of

Summary: the purpose of this study is to determine whether medial patellofemoral ligament reconstruction results in superior functional outcomes compared to medial retinacular plication surgery in cases of recurrent patellar instability.

patients with recurrent lateral patellar instability will be assigned to undergo one of two surgical approaches aimed to prevent recurrent patellar instability and result in improvement in function. one surgical approach will be medial retinacular plication with multiple stitches while the other surgical approach will include medial patellofemoral ligament reconstruction using a hamstring tendon graft. prior to surgery, and then during follow-up after surgery as well as at the completion of minimum two years follow-up after surgery, patients will be asked to complete subjective functional questionaires that will rate their knee function, and to undergo detailed physical examination and objective functional tests that will quantify the success of surgery. the outcomes of the surgical treatment options will be compared to determine whether medial patellofemoral ligament reconstruction results in superior function and patient subjective satisfaction compared to medial retinacular plication only.

Eligibility criteria:
inclusion criteria: * recurrent lateral patellar instability has been described by the patient imaging criteria include: * tt-tg distance (on ct or mri) is between 10-20 mm * insall-salvati index is between 0.9 - 1.2 * trochlea angle is lower than 145 degrees exclusion criteria: * only a single event of lateral patellar instability occured imaging criteria include: * tt-tg distance (on ct or mri) is below 10 mm or above 20 mm * insall-salvati index is below 0.9 or above 1.2 * trochlea angle is above 145 degrees * other concomitant intra-articular patholgies, injuries, and surgeries, besides the patella instability, with were recorded at the lower limbs and did not uneventfuly healed, and as a result cause dysfunction of the lower limbs * significant ligamentous injuries of the knees, including cruciate and collateral injuries, as well as meniscal injuries that interfere with function
biomarkers in bone marrow samples from patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is studying bone marrow samples from patients with acute myeloid leukemia.

objectives: * to rigorously examine fractionated hematopoietic stem and progenitor cells from patients with acute myeloid leukemia (aml). * to define somatic mutations occurring in de novo aml, including the flt3-itd, cebpa, npm1, tet2, asxl1, idh1, and idh2 mutations. * to examine what cellular compartments (lt-hsc, st-hsc, cmp, gmp, and mep) contain the selected mutations and in what order those mutations occur. outline: archived bone marrow specimens are analyzed for sequencing and detection of mutations by sanger-based resequencing of pcr amplicons. results are then compared with the results of age-matched healthy controls.

Eligibility criteria:
disease characteristics: * diagnosis of acute myeloid leukemia * bone marrow samples must meet 1 of the following criteria: * normal karyotype from patients enrolled on ecog-1900 archived at the ecog leukemia tissue bank * live, sortable mononuclear cells prepared at the time of initial diagnosis (slow-frozen in media with 10% dmso or fresh cells shipped immediately * age-matched healthy control samples from commercial providers patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with del(5q) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) untreated adult acute myeloid leukemia adult acute minimally differentiated myeloid leukemia (m0) adult acute myeloblastic leukemia with maturation (m2) adult acute myeloblastic leukemia without maturation (m1) adult acute myelomonocytic leukemia (m4) adult acute monoblastic leukemia (m5a) adult acute monocytic leukemia (m5b) adult erythroleukemia (m6a) adult pure erythroid leukemia (m6b) adult acute megakaryoblastic leukemia (m7)
a comparison of two brief interventions for people with chronic low back pain

Conditions: Low Back Pain

Summary: the goal is to undertake a decentralized randomized pilot feasibility study to inform the methods for a definitive randomized controlled trial (rct) (including recruitment success, participant experience, intervention delivery, safety, outcome measurement and sample size estimation). the main question is if the methods used are feasible for an adequately powered future rct. participants will be randomly allocated to receive either: intervention - oldpain2go® treatment or placebo control - jacobson's progressive relaxation

the project is a virtual randomized control trial and the independent variable is oldpain2go® a novel brief intervention for people with chronic low back pain. the investigators aim to answer the research question: is oldpain2go® an effective intervention for pain and function in people with chronic low back pain - when applied in an adequately powered rct comparing oldpain2go® with placebo? the intervention arm participants will receive oldpain2go® and the control arm participants will receive jacobson's progressive relaxation, as a placebo. the control (placebo) is a commonly used element of treatment, for a wide range of conditions, but is never applied only once (or twice) as a treatment.

Eligibility criteria:
inclusion criteria: * currently suffering from persistent, non-specific, low back pain of six or more months duration * no known tissue damage, structural abnormality, or pathology causing persistent low back pain * aged over 18 years * person's for whom oldpain2go® is indicated as a treatment option, after the standard clinical screening process for the oldpain2go® treatment * has access to digital communication device able to host encrypted secure on-line meetings. exclusion criteria: * any red flags, * any causative (or potentially causative) structural abnormality, or pathology detected or suspected * any concurrent pathology, or condition that would render them unsuitable for on-line virtual assessment and physiotherapy treatment * lack of (or any reason to doubt presence of) mental capacity to give informed consent

Keywords: chronic pain feasibility study
evaluation of the neuroinflammation pattern of bay85-8102 f-18, dpa-714 in probable alzheimers disease patients versus healthy volunteers and radiation dosimetry of f 18, dpa-714 in healthy volunteers

Conditions: Diagnostic Imaging

Summary: pet (positron emission tomography) imaging with bay85-8102 f-18, dpa-714 for investigation of neuroinflammation pattern in probable alzheimers patients versus healthy volunteers and radiation dosimetry in healthy volunteer.


Eligibility criteria:
inclusion criteria: * able to give fully informed consent in writing * males or females aged \>/= 50 years * no significant disease or drug use * absence of any sign of dementia/cognitive impairment in neuropsychological examinationspatients for brain imaging: * patient and designee capable of giving fully informed consent in writing * patient fulfils dsm-iv and nincds-adra criteria for probable alzheimers disease * patient has undergone physical and neurological examination, ecg and test of routine hematological and biochemical parameters prior to radiotracer administration exclusion criteria:- pregnancy or lactation * current unstable medical condition (e.g. unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection)

Keywords: alzheimers disease diagnostic imaging pet/ct diagnosis pet tracer
stroke unit in the philippines: is it effective

Conditions: Acute Stroke

Summary: this study aims to assess the effectiveness of stroke unit in the philippines by comparing the functional outcome between those patient admitted in the general neurology wards and stroke units using modified rankin scale

this study aims to look into functionality of patient admitted in the stroke unit in the philippines

Eligibility criteria:
inclusion criteria: * all consecutive patients admitted in participating sus starting june 2016 during acute stroke (within 7 days from onset), either hemorrhagic or ischemic stroke confirmed by ct-scan or mri, will be included exclusion criteria: * patient who had previous of stroke and secondary cause of intracerebral hemorrhage such as trauma, arteriovenous malformation and aneurysm are not included in the study. those who transferred from other institutions will be excluded. and also, patients who are below 18 years old are excluded in the study
examination of ocular surface effects with administration of travatan z and xalatan

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * 18 years or older. * diagnosis of open-angle glaucoma or ocular hypertension in at least one eye. * intraocular pressure (iop) controlled with bak (benzalkonium chloride) preserved iop-lowering medication for 1 year, with last 6 months on xalatan® monotherapy. * best corrected visual acuity of -0.6 logmar or better in each eye. * other protocol-defined inclusion criteria may apply. exclusion criteria: * treatment with bak preserved artificial tears within 30 days of visit 1. * known or suspected sjogren's disease. * uncontrolled iop. * history or evidence of infectious or inflammatory ocular conditions. * progressive retinal or optic nerve disease. * ocular laser surgery within 3 months of visit 1. * keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of visit 1. * current use of punctal plugs or punctal cautery. * use of systemic medications that has not been stable for 30 days prior to visit 1. * use of contact lens within 30 days of visit 1. * other protocol-defined exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension
fast-track rehabilitation

Conditions: Respiratory Disease; Thoracic Surgery; Lung Cancer

Summary: this study is a prospective observational study which aim to evaluate the feasibility of a total and systematic home respiratory rehabilitation training program in patients who will undergo thoracic surgery, and otherwise tend to define failure reasons.

the aim of this clinical trial is to identify the determining factors which impact a preoperative home respiratory rehabilitation training program success. this success is determined by complete achievement of the program (100%) by the patient. this rehabilitation program is composed by 4 items: * adapted physical activity : 3 averaging cyclo ergometer or physical activity seances per week (25%) * physiotherapy sessions : 8 seances with a physical therapist (25%) * smokers : set up of a program to help give up smoking if active smoker (25%) * dietetics : if unintentionally weight loss (\>5% total weight in 1 month or \>10% in 6 months) or bmi\<21 , nutritional assessment is conducted and dietetic program is initiated(25%) secondary objectives are : * assessment of postoperative event onset (30 days) (atelectasis, fibro-aspiration, time spent in resuscitation unit, intubation, revision surgery). * link assessment of 100% program success and at least one complication onset. * cost assessment of preoperative rehabilitation program * evaluation of mean hospitalisation duration post surgery (30 days) * average cost assessment of hospitalisation stay per patient. this study will include 50 patients over 18 years old, addressed to the home heath care provider agir à dom, for rehabilitation before pulmonary parenchyma exeresis. patients must perform at least 2 items of rehabilitation program previously described. this program is an initiative of a pulmonologist or a thoracic surgeon, who include the patient when the date of surgery is scheduled.

Eligibility criteria:
inclusion criteria: * patients who need a respiratory rehabilitation before thoracic surgery for lung resection. * patients addressed to the home heath care provider "agir à dom", * patients must perform at least 2 items of rehabilitation program (adapted physical activity, diet, physiologist, smoking) exclusion criteria: * patients who participate to another interventional research that may impact this study. * patients unable to get involved to the training program, depending to the investigator's appreciation.

Keywords: home-based training program
dysport® treatment of urinary incontinence in adults subjects with neurogenic detrusor overactivity (ndo) due to spinal cord injury or multiple sclerosis - study 2

Conditions: Urinary Incontinence; Overactive Bladder

Summary: the purpose of this study is to provide confirmatory evidence of the safety and efficacy of two dysport® doses (600 units \[u\] and 800 u), compared to placebo in reducing urinary incontinence (ui) in adult subjects treated for neurogenic detrusor overactivity (ndo) due to spinal cord injury (sci) or multiple sclerosis (ms).


Eligibility criteria:
key inclusion criteria: * urinary incontinence for at least 3 months prior to screening as a result of neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis. * subjects with spinal cord injury must have a stable neurological injury at t1 level or below which occurred at least 6 months prior to screening. * subjects with multiple sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of ms for at least 3 months prior to screening. * subjects must have had an inadequate response after at least 4 weeks of oral medications used in the treatment of ndo (e.g. anticholinergics, beta-3 agonists) and/or have intolerable side-effects. * routinely performing clean intermittent catheterization (cic) to ensure adequate bladder emptying. * an average of at least two episodes per day of urinary incontinence recorded on the screening bladder diary. key exclusion criteria: * any current condition (other than ndo) that may impact on bladder function. * previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other unstable cause of sci. * any condition that will prevent cystoscopic treatment administration or cic usage, e.g. urethral strictures. * current indwelling bladder catheter, or removal of indwelling bladder catheter less than 4 weeks prior to screening. * btx-a treatment within 9 months prior to screening for any urological condition (e.g. detrusor or urethral sphincter treatments). * any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to screening. any implanted neuromodulation device must be switched off at least 4 weeks prior to screening.
health-economic evaluation of interventional pain management compared to pain rehabilitation

Conditions: Chronic Pain

Summary: the overall aim of the study is to evaluate interventional pain management. this is done in three steps: 1. to find matched controls to the patients in the study on cost-effectiveness of ipm and compare the results. 2. to calculate cost-effectiveness of prp during the period 2010-2016, on a national level. 3. to calculate cost-effectiveness of prp during the period 2017-2019, after the changed guidelines for prp in sweden. the two last steps are to provide a background to the results of ipm, and to see if the results in the subgroup of matched controls of prp-patients differ from the results from the whole population.

chronic pain is one of the major health problems globally, according to the who 'global burden of disease' studies. previously, the investigators have performed a study on a feasible approach to be able to treat zygapophyseal joint pain in the thoracic region, similar to the established methods for treatment in the lumbar and cervical regions which have been published. the study showed that there was a significant improvement in health related quality of life (hrqol) after treatment, and that there were no difference in the results depending on if it was the cervical, thoracic or lumbar region that was treated. the study had ethical approval (dnr 2012-446-31m) and is registered here at clinicaltrials.gov. another study explored the health economic aspects of interventional pain management (ipm). the investigators aimed to do this in comparison with pain rehabilitation programs, and therefore further ethical approval was searched and gained (2012-446-31m, 2017-542-32, 2018- 507-32) an health-economic evaluation of only ipm was performed showing that patients after treatment of diagnosed pain-focuses in zygapophyseal joint pain not only improve their hrqol but they also reduce their medication, reduced their health-care consumption and gained in ability to work. the cost per quality adjusted life years gained was below the threshold for cost-effective health-care according to the threshold-levels defined by the national board of health and welfare in sweden. but the investigators need a larger population to select from in order to get matched controls among patients that have been through pain rehabilitation programs. this study therefore aims to explore the national register of pain rehabilitation both in order to find matched controls and in order to make a cost-effectiveness study of pain rehabilitation program as it is performed in sweden.

Eligibility criteria:
inclusion criteria: been through pain rehabilitation program exclusion criteria: -
investigation of coagulation parameters in hereditary haemorrhagic telangiectasia

Conditions: Telangiectasia, Hereditary Hemorrhagic

Summary: we will address coagulation parameters in hereditary haemorrhagic telangiectasia (hht) compared to controls.

the inherited disease hereditary haemorrhagic telangiectasia (hht) causes bleeding from dilated fragile vessels, particularly in the nose and gut. however, many hht patients develop deep venous thromboses and/or pulmonary embolism, necessitating treatments with anticoagulants that further impair control of their haemorrhagic state. our initial observations using general coagulation tests suggest that the blood of hht patients is intrinsically hypercoagulable. we hypothesize that the genetically-determined abnormality in the blood vessels of hht patients leads to alteration in the concentrations or activity of one or several of the proteins which affect blood clotting leading to a hypercoagulable state. we propose to study levels and activity of blood coagulation factors in people with hereditary haemorrhagic telangiectasia and in normal volunteers. this should define the significance and basis for our initial observations, and will have significant implications for the clinical management of hht patients.

Eligibility criteria:
inclusion criteria: * patients with hht and normal controls exclusion criteria: * previous thrombosis, recent ill health