Kornimate/medical-research-clean huggingface dataset:
persica 002 phase 1b pp353 vs placebo in the treatment of low back pain

Conditions: Chronic Low-back Pain

Summary: a phase 1b study to investigate the efficacy of pp353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.

a 2-part study. in the first part the safety, tolerability and pharmacokinetics will be assessed in up to 6 participants. in the second part, the safety, tolerability and efficacy of pp353 will be assessed in up to 40 participants.

Eligibility criteria:
inclusion criteria: * aged between 18 and 70 years, inclusive. * chronic low back pain in the area associated with vertebral body endplate bone oedema (modic 1) or vertebral body endplate bone oedema and fat (modic 1 and 2) at a single lumbar level. * average lbp nrs score at screening and at day 1 pre-randomisation ≥ 4 on chronic pain medication and ≥ 6 if not on chronic pain medication; it should be higher than the leg pain nrs score * rmdq-23 score ≥ 9 at screening and at day 1 pre-randomisation. * current episode of chronic low back pain has lasted for ≥ 6 months at the time of randomisation. * bodyweight of ≥ 50 kg and ≤ 120 kg. * failure of standard of care therapies used by their treating physician exclusion criteria: * any vertebra with modic 2 only lesions which: 1. in the opinion of the investigator, after deep palpation of the vertebral spine, is contributing to the low back pain and/or 2. are present within 2 vertebrae from the target lumbar disc. * the target lumbar disc has lost more than half its original anticipated height at the centre or it is \< 5mm in height over the central 15 mm portion * a clear alternative cause for back pain * gross facet joint degeneration or cases where the investigator believes the primary pain generator to be the facet joints * interventional back procedure in the 6 months prior to screening or major surgery in the 12 weeks prior to screening * history of alcohol abuse or drugs of abuse in the past 2 years * any other significant illness * previously been treated with antimicrobial agents for their low back pain or previously received any antimicrobial intradiscal injection.

Keywords: back pain low back pain lower back pain modic
smoking-cessation: a spanish-language clinical trial

Conditions: Smoking Cessation; Tobacco Dependence

Summary: the purpose of this study is to develop and test a series of culturally relevant and appropriate booklets in spanish, designed to assist hispanic smokers in quitting smoking and remaining smoke-free.

study aim 1: to transcreate the existing english-language 10 "stop smoking for good" booklets and accompanying 9 supportive "my story" pamphlets into a series of culturally relevant and acceptable materials for spanish-speaking smokers who prefer to receive health information in spanish. the adaptation of the intervention materials will be based upon the findings from a systematic formative evaluation employing a heterogeneous group of hispanic/latino smokers representing diverse subcultural groups. study aim 2: to test the efficacy of the self-help intervention developed in study i among spanish-speaking smokers in a randomized controlled trial. participants (500) will be randomized to receive the spanish-language version of the stop smoking for good (ss-sp) intervention or usual care (uc) comprising an existing booklet from nci. investigators hypothesize ss-sp will produce higher abstinence rates than uc through 24 months. secondary aim: test moderator variables to improve targeting the intervention. moderator analyses will be exploratory, without strong a priori hypotheses.

Eligibility criteria:
inclusion criteria: * all except study i; phase i focus group: monolingual spanish, or bilingual spanish-english and prefer receiving educational health materials in spanish. * study i; phase i focus group only: able to speak and read in english and spanish. * ≥ 1 year history of smoking * smoking ≥ 5 cigarettes per week * age ≥ 18 years * not currently enrolled in a face-to-face smoking cessation program

Keywords: smoking cessation self-help spanish language
trunk extension endurance among physical therapy students

Conditions: Spine Injury

Summary: college students from physical therapy department will be assigned into four groups. participants will be tested for trunk extensors endurance and will be given endurance training program to do at home for 6 to 8 weeks. spinal mobility and lower extremity mobility will be measured. isokinetic outcome measures for extension and flexion at two different speeds will also be measured at baseline, after 6 and 8 weeks.

active physical therapy students who are healthy and free from any significant pain at the spine will be recruited to participate in intervention endurance training. participants will be assigned into four equal groups; doing trunk extension form lying on stomach while breathing normally and arching trunk backwards as long as tolerated. group one will have arms above head, group two will have hands behind head, group three will have hands parallel to the trunk, and group four will receive instructions only and will act as control group. spinal mobility of forward bending, backwards bending, right and left side bending will be taken. straight leg raising and quadriceps flexibility will also be taken. isokinetic measurements including peak torque, peak torque/body weight, average peak torque, work and average power will be taken at baseline, 6 and 8 weeks. participants will have a training volume of 2 sets of 10 repetitions, 2 minutes rest in between, 2x/day for 6 to 8 weeks. endurance timing will be measured in seconds using stop watch. if participant managed to maintain the trunk extension position for 4 minutes, time is recorded and it is considered as ceiling time.

Eligibility criteria:
inclusion criteria: * active college student free from any spinal pain or pain 3/10 on pain intensity numeric pain rating scale, willing to participate exclusion criteria: * have had spinal surgery or pain at the spine more than 3/10 on pain intensity numeric pain rating scale.

Keywords: trunk extensors; endurance, peak torque, power, work
effects of head elevation on intracranial pressure in children

Conditions: Head Injury

Summary: head injury is the most common cause of mortality and acquired disability in childhood. it is common to elevate the head of patients at risk for increased intracranial pressure, although it is not clear if it is always beneficial. every severe pediatric traumatic brain injured patient will have an optimal head position that prevents rising pressure in the brain.

head injury is the most common cause of mortality and acquired disability on childhood. management of children at risk for intracranial hypertension is both complex and increasingly controversial. also, effect of head position on intracranial pressure, cerebral perfusion pressure, adn cerebral venous outflow in the pediatric population has not been studied. we will examine the effect of head positioning on icp, cpp, and cerebral venous outflow in pediatric patients at risk for intracranial hypertension. the hypothesis is that icp will be reduced with improvement in cerebral venous outflow by each patient having their own optimal head position.

Eligibility criteria:
inclusion criteria: * neonates, children, and adolescents * intracranial pressure monitor in place exclusion criteria: * severe multiorgan system failure * hemodynamic instability sufficient to preclude changes in head position

Keywords: elevated intracranial pressure inadequate cerebral perfusion secondary brain damage
superiority of maci® versus microfracture treatment in patients with symptomatic articular cartilage defects in the knee

Conditions: Articular Cartilage Defect

Summary: the objective of this trial is to demonstrate superior efficacy and safety of maci compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.

this is a prospective, randomized, open-label, parallel-group, multicenter study designed to investigate the outcome of maci implant versus arthroscopic microfracture in the treatment of articular cartilage defects in the knee in patients between ages of 18 and 55 years. all patients who meet the eligibility criteria and are considered suitable for inclusion will have a cartilage biopsy taken prior to randomization to study treatment. eligible patients will then be randomized during the index arthroscopy procedure to receive either maci implant or microfracture treatment. patients randomized to treatment with maci implant will return within approximately 4 to 8 weeks of the index arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. patients randomized to microfracture will undergo the procedure during the index arthroscopy. patients will be assessed post-arthroscopy and post-arthrotomy at intervals during 2 years follow-up. evaluations include adverse events, functional and pain outcomes, arthroscopic and histologic evaluation and magnetic resonance imaging (mri).

Eligibility criteria:
inclusion criteria: * symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement exclusion criteria: * known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin * severe osteoarthritis of the knee * inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders * prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a maci implant.

Keywords: cartilage legions symptomatic focal cartilage defects microfracture maci autologous chondrocyte
mri,gene and cognitive performance study of patients with cerebral white matter lesions(wmls)

Conditions: Cerebral White Matter Lesions

Summary: the purpose of this study is:1)to observe topological organization in brain structural and functional networks in cerebral white matter lesion patients and to evaluate the association between impairment of cognitive function and cerebral structural and functional networks in those patients;2)to indicate the role of genetic factors in the occurrence and prognosis of cerebral white matter lesions

100 patients with cerebral white matter lesions and 100 normal controls will be observed. all of them will receive mri scan(t1wi,t2wi,t2flair,mra,swi,asl,dti and fmri) and the assessment of the neuropsychological function (mmse,auditory verbal memory test,trail-making test-a and -b,symbol digit modalities test,digit span test,clock drawing test,hamd) intending to analyse topological organization in brain structural and functional networks in cerebral white matter lesion patients and to evaluate the association between impairment of cognitive function and cerebral structural and functional networks in those patients.furthermore,dna will be extracted from the blood sample of all participates to perform high-throughput sequencing. mri scan and neuropsychological function assessment will be performed repeatedly after 1,3 and 5 years.

Eligibility criteria:
inclusion criteria: * mri diagnosis of cerebral white matter lesions must be able to measure his(her) neuropsychologic function no severe stroke history and no physical disability patients aged 40 to 85 based on china's relevant laws, the patient himself agreed to participate in this study, a good compliance.patients himself/herself must sign informed consent moreover exclusion criteria: * unable to undergo examinations due to disturbances of consciousness or medical conditions serious complications including severe heart failure, hepatic dysfunction, renal insufficiency,or shock ad,parkinson's disease, malignant tumor, ms and other autoimmune diseases toxic and metabolic encephalopathy cerebral white matter lesions caused by cadasil and other confirmed monogenic disease

Keywords: crebral white matter lesions brain networks mri dti fmri cognitive impairment gene
cost effectiveness analysis of critical care in resource limited setting

Conditions: Critical Illness

Summary: the purpose of this study was to examine the cost effectiveness of critical care in a middle income country with limited resources. the main study hypothesis was that critical care is cost effective in low resources setting.

the investigators objective was to calculate the cost effectiveness of treatment of critically ill patients in a medical icu of a middle income country with limited access to icu resources. methods: consecutive critically ill medical patients treated in a recently established medical icu in sarajevo, bosnia and herzegovina, were prospectively recorded and a subsequent cost utility analysis of intensive care in comparison to hospital ward treatment from the perspective of health care system was performed. incremental cost effectiveness was calculated using estimates of icu versus non-icu treatment effectiveness based on a formal systematic review of published studies. decision analytic modeling was used to compare treatment alternatives. sensitivity analyses of the key model parameters were performed.

Eligibility criteria:
inclusion criteria: * patients treated between june 1 2011 and june 29 2012 in the medical icu exclusion criteria: * patients who stayed in the icu less than 24 hours and * hospital readmissions

Keywords: critical care intensive care health related quality of life cost benefit analysis
perioperative dexamethasone reduces postoperative pain and nausea after periacetabular osteotomy

Conditions: Pain; Postoperative Nausea; Amount of Postoperative Opioid Use in Milligrams

Summary: the purpose of this study is to assess the effect of dexamethasone on postoperative pain and nausea after periacetabular osteotomy.

bernese periacetabular osteotomy (pao) is a standard procedure with good mid and long-term results. postoperative pain is a great concern and postoperative pain management of great importance. high demand for opiates and the associated side effects especially nausea limit the postoperative rehabilitation. promising results to reduce postoperative pain and nausea have been achieved by perioperative dexamethasone, which has a strong anti-inflammatory effect reducing pain and inflammation as well as a strong anti-emetic effect, especially in total hip replacement. it is our goal to compare the effect of perioperative intravenous dexamethasone (3x 4mg amp. fortecortin =12mg prior to surgery and 3x4mg amp. fortecortin = 12mg at 8.00am of the first postoperative day) to a control group (placebo) (3ml saline solution postoperative day 1 at 8.00am) regarding pain level, opiate consumption, postoperative nausea and patient satisfaction. a double-blinded prospective randomized control trial including up to 60 patients receiving elective unilateral pao will be conducted.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * general anasthesia * elective periacetabular osteotomy for any reason * written informed consent as documented by signature (appendix informed consent form) * competent german language skills exclusion criteria: * chronic pain patient, chronic lower back pain * steroid or immunosuppressive drugs used within 6 months of surgery * renal failure, hepatic failure * relevant allergies * pregnancy/ breast feeding * contraindications for fortecortin treatment according to swissmedic * previous enrollment into the current study * participation in another study with investigational drug within the 30 days preceding and during the present study * known or suspected non-compliance, drug or alcohol abuse illness according to "warnings and precautions of dexamethasone and nacl"
evaluation of the predictive value of blood levels of angiopoietin 1 and endothelial internal tunica cell kinase 2 in patients with ovarian cancer treated with chemotherapy associated to bevacizumab

Conditions: Ovarian Cancer

Summary: this is a monocentric prospective observational pilot study of translational research in women with advanced ovarian epithelial cancer. the main purpose of this study is to evaluate the predictive value of response to treatment with bevacizumab of the circulating levels of ang1, tie2 and vegf before start of therapy. secondary aims of the study are to explore the predictive value of response / resistance to bevacizumab of changes in circulating levels of ang1 and tie2 during treatment and at progression of disease, and to explore the possible role of circulating vegf in the modulation of bioavailability of bevacizumab.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * diagnosis of histologically confirmed advanced epithelial ovarian carcinoma * women eligible for treatment with a chemotherapy regimen in combination to bevacizumab (cohort a) * women eligible for treatment with a chemotherapy regimen not associated to antiangiogenic drugs (cohort b) * evaluable disease according to recist 1.1 criteria * patient informed consent signature prior to any study-specific procedure exclusion criteria: * history of other malignancy within 5 years prior to study entry (except for cutaneous basal cell carcinoma or adequately treated carcinoma in situ of the cervix ).

Keywords: ovarian cancer angiopoietin 1 tunica interna endothelial cell kinase 2 vegf bevacizumab
efficacy and safety of ganovo (danoprevir) combined with ritonavir in the treatment of sars-cov-2 infection

Conditions: COVID-19

Summary: evaluation of the efficacy and safety of danoprevir sodium tablet combined with ritonavir for sars-cov-2 infected patients.

given no specific antiviral therapies for covid-19 approved yet and danoprevir sodium tablet, an oral hepatitis c virus protease inhibitor, approved in china in june 2018 , this open, controlled trial will evaluate the efficacy and safety of danoprevir sodium tablet in hospitalized patients infected with sars-cov-2.

Eligibility criteria:
inclusion criteria: 1. aged 18-75 years old; 2. pneumonia patients with sars-cov-2 infection were confirmed to be positive by rt-pcr and clinical manifestations. the diagnosis standard refers to the diagnosis and treatment plan for pneumonia with sars-cov-2 infection (current trial version); 3. patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days); 4. women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration; 5. agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration; 6. patients who voluntarily sign informed consent. exclusion criteria: 1. the pneumonia patients with severe sars-cov-2 infection met one of the following conditions: respiratory distress, rr≥30 times / min; or sao2 / spo2≤93% in resting state; or arterial partial pressure of oxygen (pao2) / concentration of oxygen (fio2) ≤300mmhg (1mmhg = 0.133kpa); 2. pneumonia patients with severe sars-cov-2 infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with icu monitoring treatment; 3. severe liver disease (such as child pugh score ≥c, ast \> 5 times upper limit); 4. patients with contraindications specified in the instructions of danoprevir and ritonavir tablets; 5. patients who plan to take protease inhibitors other than danoprevir and ritonavir simultaneously during the trial. 6. the pregnancy test of female subjects in the screening period was positive; 7. the researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.).
optimization of blood pressure management after acute ischemic stroke and its prognostic significance

Conditions: Ischemic Stroke; Hypertension

Summary: boss-trial i is a phase 2 clinical trial with the following objectives; 1. to prove the feasibility of a bluetooth-equipped sphygmomanometer system in real-world clinical practice and wireless connection to the main server; 2. to prove the feasibility of the bp management strategy, including the pre-specified bp range, bp management algorithm, and behavioral; and 3. to gather information for the phase 3 trial including bp variability indices and their potentials as a treatment guidance.

* elevated blood pressure is an established risk factor for recurrent stroke and vascular events in ischemic stroke survivors, but * current guideline (jnc viii) has omitted or only partially covered a number of practical and important issues as follow; * when and how we measure blood pressure? * is it justifiable to apply the same blood pressure threshold for office bp and home bp? * should stroke survivors be treated by the same bp goal for non-stroke subjects? * is it justifiable to apply the universal bp threshold for different mechanisms of ischemic stroke? * is it really about only blood pressure or might it really be "beyond blood pressure?" * lifestyle modification should accompany all the pharmacological intervention but is usually in adequate to initiate behavioral changes. * frequent bp measurement at home will provide more detailed and reliable information than occasional office bp's.

Eligibility criteria:
inclusion criteria: * ischemic stroke survivors within 7 days after onset * ≥19 year-old male or female * medically and neurologically stabilized enough to take bp-lowering medication * mean systolic blood pressure ≥135 mm hg during two days between at least 24 hours after onset and randomization (whether bp-lowering medication was prescribed or not) * capable of taking oral medication * capable of operating a wireless bluetooth-equipped sphygmomanometer system and being expected to follow required procedures of the clinical trial * patients who provided written informed consent exclusion criteria: * pregnant, puerperium ≤30 days or on breastfeeding * enrolled in other interventional clinical trial * being transferred to rehabilitation center or institutionalized * being expected to have cerebral artery interventions within 3 months after randomization * known allergic reactions to olmesartan, amlodipine or hydrochlorothiazide * known severe hepatic disease * advanced kidney dysfunction requiring dialysis * being unlikely, in the opinion of the investigator, to comply with the clinical trial protocol or being unsuitable for any other reason.

Keywords: behavioral intervention prespecified medication algorithm bluetooth-equipped sphygmomanometer