Kornimate/medical-research-clean huggingface dataset:
dlbs1449 in diabetic patients with low hdl

Conditions: Diabetic Patients; Low HDL-cholesterol (< 35 mg/dL); Lifestyle Intervention for at Least 1 Month

Summary: this is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind clinical study for eight weeks of therapy to investigate the clinical efficacy of dlbs1449 in elevating high density lipoprotein (hdl) cholesterol in diabetic patients. the hypothesis of interest for the study is: the administration of dlbs1449 will elevate hdl-cholesterol level from baseline to the end of study significantly higher than the elevation resulted by placebo. in addition, the administration of dlbs1449 at the dose of 150 mg daily will provide a significantly better response than that of the lower dose (dlbs1449 75 mg daily).

there will be three groups of treatment by dosage regimen in this study. eligible subjects will be randomized to receive any of the following regimens: 1) dlbs1449 at a dose of 1 x 75 mg daily, or 2) dlbs1449 at a dose of 1 x 150 mg (two capsules of dlbs1449 75 mg) daily; or 3) placebo, once daily. study medication should be administered once daily, in the evening with meal, for eight weeks. clinical and laboratory examinations to evaluate investigational drug's efficacy and safety will be performed at baseline and at interval of four weeks over 8-week course of therapy.

Eligibility criteria:
inclusion criteria: * male or female 21 - 70 years. * have been diagnosed diabetes mellitus and being treated with lifestyle intervention for at least 1 month prior to screening, with or without antidiabetic agents. * hdl-cholesterol level of \< 35 mg/dl. * triglycerides level of \< 200 mg/dl. * adequate liver and renal function. * statin and/or fenofibrate therapy should have been being regularly taken for \>=3 months at stable dose (only for subjects currently under statin and/or fenofibrate therapy). * able to take oral medication. exclusion criteria: * pregnant or breast-feeding women or willing to be pregnant. * symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * uncontrolled hypertension (sbp \> 160 mmhg and/or dbp \> 100 mmhg). * any other disease state, including chronic/acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation. * concurrent treatment with systemic corticosteroids or herbal (alternative) medicines. * known allergic or hypersensitive to drugs contain similar active substance with the study medication. * participation in any other clinical studies within 30 days prior to screening.

Keywords: dlbs1449 diabetes mellitus hdl-cholesterol
identification of biomarkers and characterization of melasma

Conditions: Chloasma

Summary: melasma (also called chloasma and pregnancy mask) is characterized by pigmented lesions darker than their usual complexion on the faces of affected subjects. the physiopathology of melasma is still poorly understood. to date, the factors that favor the onset of melasma appear to be: genetic predisposing factors, changes in sex hormone levels, and sun exposure. vascularization as well as elastosis also appear to be increased in skin with melasma. the aim of this study is to evaluate the different levels of expression of biomarkers between pigmented melasma lesions and surrounding healthy skin when melasma is highly pigmented but also when it is dormant (ie treated melasma, without uv solicitation in the heart of winter). the goal is to identify and better understand the involvement of different genes and proteins and thus offer more specific ways of care, and therefore effective, for the subjects.


Eligibility criteria:
inclusion criteria: * woman aged 18 to 60 years old included * phototype iii to iv included according to fitzpatrick classification * informed consent signature * subject accepting micro-biopsies on study areas * subject with melasma lesions in the face of moderate to severe intensity defined by clinical rating (physician global assesment static) allowing the realization of micro-biopsies according to the opinion of the investigator exclusion criteria: * subject having planned to stay more than 7 consecutive days in a place with a significant increase in the uv index (ski holidays, travel to the tropics, etc.) * subject with pigmented facial lesions other than those related to melasma. * subject having already presented cicatrization disorders * subject having undergone a physical treatment (radiotherapy ...) on the face, during the last 6 months or planned during the study * chemical peel, laser treatment or dermabrasion, performed on the face in the 3 months preceding the inclusion visit, * application of medication containing hydroquinone or other depigmenting treatments (retinoids, topical steroids) applied to the face in the 2 months prior to the inclusion visit, * applying depigmenting cosmetic products to the face within 4 weeks prior to the inclusion visit
dynamic gait index as a functional gait assessment measure in children with jia

Conditions: Juvenile Idiopathic Arthritis; Childhood Rheumatic Disease

Summary: juvenile idiopathic arthritis (jia) is one of the most common chronic rheumatic diseases seen in childhood. pain, joint swelling and loss of function caused by inflammation significantly reduce the patients' quality of life and lead to muscle weakness, limited range of motion and gait disorders. although there are various clinical assessment methods, there is no functional test in the current literature that evaluates walking in children with jia. the dynamic gait index (dgi) is a functional walking scale that evaluates walking on level ground, walking while changing speed, walking with sideways head turns, walking with vertical head turns, walking with pivot turns, walking by jumping over obstacles, going around obstacles and climbing stairs. while the dga is widely used in the clinical assessment of walking in older adults and other pediatric patient groups, it has not yet been investigated for the assessment of walking difficulties in children with jia. this study aimed to determine whether the dyi is a usable tool for assessing walking in children with jia.


Eligibility criteria:
inclusion criteria: * study group; * having a jia diagnosis according to ilar criteria between the ages of 8-16, * having unilateral knee joint involvement that will affect walking * being compatible, volunteer and cooperative in the study control group; 1. not having any neurological or orthopedic diagnosis 2. being between the ages of 8-16 3. being at a mental level that can understand the commands of the person performing the evaluation exclusion criteria: * study group; * having an additional neurological or orthopedic diagnosis accompanying jia and affecting treatment results, * having lower extremity asymmetry or active lower extremity involvement other than the knee joint that will affect walking. control group; -having any health problem that may affect the study

Keywords: juvenile idiopathic arthritis gait dynamic gait index childhood rheumatic diseases
randomized trial of the positive action program in hawaii schools

Conditions: Character; Violence; Substance Use; Pro-social Behavior; Academic Achievement

Summary: the purpose of this study is to determine the effectiveness of the positive action program on reducing negative behaviors, increasing positive behaviors and improving academic achievement of elementary school students.

this project will: 1) evaluate the efficacy of a comprehensive, multi-grade, multi-year program, the positive action program (pa) designed to reduce student problem behaviors (including drug use and violence), disciplinary referrals and suspensions, and academic underachievement; 2) evaluate the effects of the program on the presumed/theoretical mediator variables; and 3) assess which of these changes in mediator variables actually mediate the effects of the program on behavior and school performance. the hawaiian school district has agreed to implement a randomized trial of the pa program. we randomly assigned schools to pa or control conditions from strata matched on multiple indicators of risk. pa schools will receive the full pa program for four years (the 2002-03 through 2005-06 school years). this includes all materials for all students (at all grades), families, teachers, and principal, plus community kits; training for teachers and other interested staff; and continuous technical support and monitoring by a pa staff person. data on behavior and academic achievement will be obtained from school archival records for all students for all years and, where appropriate for several years prior to the study. students in grades 1 and 3 in the 2001-02 school year and their parents and teachers will also be followed through the project with surveys every year. the subject population will contain equal portions of males and females, and proportionate numbers of the major ethnic groups on oahu (hawaiian or part-hawaiian, white, asian, other). analyses will test for program effects on all hypothesized mediating variables and outcomes, and the hypothesized mediational pathways.

Eligibility criteria:
inclusion criteria: * public elementary schools k-5 or k-6 * all students in the study cohorts exclusion criteria: * schools performing in top 50%

Keywords: curriculum classroom management school-wide climate parent involvement
screening for latent tuberculosis in healthcare workers with quantiferon-gold assay: a cost-effectiveness analysis

Conditions: Latent Tuberculosis Infection

Summary: the ministry of health in israel requires all health-care workers to undergo screening for latent tuberculosis infection (ltbi) prior to starting work. this is based on the mantoux skin test, which is notoriously unreliable. in recent years, more specific and sensitive tests based on interferon-gamma secretion to tb antigens have come to market, and most current evidence shows that many mantoux positive persons do not have ltbi. quantiferon-gold is one of these assays. in this prospective study, we will draw blood for the quantiferon-gold assay in parallel to conventional testing, and perform a cost-effectiveness analysis of the cost of the investigation and treatment of ltbi in health-care workers. we hypothesize that in spite of the cost of screening healthcare workers with quantiferon-gold tests, the reduction in need for ltbi treatment and associated costs will render the test cost-effective.


Eligibility criteria:
inclusion criteria: * health care worker undergoing screening for ltbi exclusion criteria: * previous tuberculosis or treatment for ltbi * immunosuppressed due to drug treatment, hiv, organ transplant * recent tb contacts

Keywords: latent tuberculosis infection health care workers tuberculin skin test mantoux skin test interferon gamma quantiferon cost effectiveness
use of transexamic acid in hip replacement

Conditions: Bleeding; Transfusion Related Complication

Summary: studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. however, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. the present study was designed to verify noninferior efficacy and safety of topical intra-articular txa compared with intravenous txa in primary tha.

treatment of choice for osteoarthritis of the hip, developmental dysplasia of the hip, and osteonecrosis of the femoral head in older patients. in association with the investigators aging society, the number of patients who will need tha may increase significantly in the next few years \[1\]. however, in tha, considerable blood loss remains a major problem, which can lead to a need for allogeneic blood transfusion. such transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, transfusion-related acute lung injury, intravascular hemolysis, transfusion-induced coagulopathy, renal failure, admission to intensive care, and even death. several effective interventions have been developed to reduce blood loss and postoperative transfusion rates, such as preoperative autologous donation, cell salvage, controlled hypotension, regional anesthesia, and the use of erythropoietin and antifibrinolytics. the antifibrinolytics include aprotinin, tranexamic acid (txa), and ε-aminocaproic acid, which have different mechanisms of action \[8\]. txa is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation, and thus interferes with fibrinolysis. compared with other antifibrinolytic drugs, txa is cheaper and safer than aprotinin and more potent than the others. numerous studies have evaluated the use of antifibrinolytics in orthopedic surgery and have shown them to be effective in reducing blood loss. however, the available clinical trials and meta-analyses lack sufficient statistical power to determine the effectiveness of antifibrinolytic agents in total hip arthroplasty.

Eligibility criteria:
inclusion criteria: * unilateral primary tha * diagnosis - not fracture, elective surgery * revision tha exclusion criteria: * known allergy to tna * acquired or congenital coagulopathy * current anticoagulation therapy * preoperative hepatic or renal dysfunction * severe ischemic heart disease (serious cardiac or respiratory disease) * a history of thromboembolic disease * refusal of blood products * pregnancy or breastfeeding

Keywords: total hip arthroplasty transexamic acid
is patient choice of exercise preference important in chronic neck pain?

Conditions: Chronic Neck Pain

Summary: nonspecific chronic neck pain is the third most frequent problem in spain. it has an annual presence between 15% and 50% where women are the most affected. this pain influences the psychosocial state of the person. physical exercise has been shown to be effective in a wide variety of chronic pain conditions, including improving quality of life and emotional problems. design: single-blind, controlled, randomized clinical trial. methods: the study will be approached in the faculty of nursing and physiotherapy of the university of alcalá. 52 subjects with nonspecific chronic neck pain will be selected and randomly divided into two groups. the first group should perform 5 exercises that have been shown to be effective in the management of neck pain selected by the physiotherapist focused on neck pain. the second group must choose, from a list of exercises that have been shown to be effective in the management of neck pain, 5 exercises. both groups should record the pain, the number of repetitions and the series performed. the duration of the intervention will be a total of 8 weeks with evaluations pre-intervention, post-intervention and 4 weeks after the end of the intervention. the objective of this study is to evaluate if the exercise chosen by the patient is better than the exercises selected by the physiotherapist for the variables chronic neck pain, strength of the affected muscles, kinesiophobia and adherence to treatment.


Eligibility criteria:
inclusion criteria: * chronic neck pain exclusion criteria: * spine surgery, shoulder girdle or cervical area surgery, whether traumatic or not. * rheumatic pathology. * impaired cognitive function. * vascular pathology that prevents exercise. * cardiopulmonary pathology that prevents exercise. * fear of any of the tests or measurements to be carried out. * pregnant

Keywords: chronic neck pain physical exercise kinesiophobia cervical strength adherence to treatment
use of aaerosol combined with intravenous antibiotics for the treatment of multidrug resistant gnb pneumonia

Conditions: Ventilator Associated Pneumonia; Multi-antibiotic Resistance

Summary: to investigate use of aerosol combined with intravenous antibiotics for the treat of multi-drug resistance gram negative bacterias diagnosed ventilator-associated pneumonia in intensive care unit in a hospital.

ventilator-associated pneumonia (vap) refers to the endotracheal tube or tracheostomy patients pneumonia after 48h of mechanical ventilation, mechanical ventilation is one of the most common and most serious complications, hospital acquired is an important cause of pneumonia. according to the onset time of vap, vap can be divided into early-onset vap and late-onset vap. the time limit is mechanical ventilation for 4 days, in which early-onset vap (mechanical ventilation ≤ 4d) is mainly caused by pathogens sensitive to most antibacterial drugs (such as methicillin-sensitive staphylococcus aureus, streptococcus pneumoniae, etc.); late-onset vap ≥ 5d occur during mechanical ventilation, mainly caused by multi-drug resistant (multi-drug resistance, mdr) (such as p. aeruginosa, acinetobacter baumannii, methicillin-resistant staphylococcus aureus). some early-onset vaps can also be caused by mdr. therefore, mdr has become the main pathogen of vap, especially gram-negative bacilli. studies have shown that vdr caused by mdr has a mortality rate of 76% and an attributable mortality rate of 20-30%. such bacteria are not sensitive to commonly used antibacterial drugs in the clinic, and sensitive antibiotics, such as aminoglycosides, have a large systemic side effect, thereby limiting clinical use. therefore, in theory, nebulized inhaled sensitive antibiotics can achieve high drug concentrations in lung tissue, and lower blood concentrations can avoid or reduce systemic side effects.

Eligibility criteria:
inclusion criteria: ・after 48 hours of mechanical ventilation diagnosed vap. exclusion criteria: * maternal * who not meet the age limits, * used amikacin within 15 days, * allergic to amikacin, * apache ii score \> 35, * severe neutropenia unrelated to sepsis or meningitis, * unable to retain specimens
stelara for chronic antibiotic refractory pouchitis

Conditions: Pouchitis

Summary: to evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.

this study is a belgian prospective open label multicenter study to evaluate the efficacy and safety of ustekinumab in the treatment of relapsing or chronic antibiotic refractory pouchitis during a 48-week treatment period. twenty subjects with a rpc and ipaa for uc who have developed relapsing or chronic antibiotic refractory pouchitis will be enrolled. all patients will receive intravenously (iv) ustekinumab \~6mg/kg at baseline and subcutaneously (sc) ustekinumab 90mg every 8 weeks thereafter until week 48. all subjects will receive concomitant antibiotic treatment with ciprofloxacin or metronidazole from baseline through week 4. intravenous induction doses will be 260mg for patients \ 85 kg. clinical and biochemical evaluation will be planned every 8 weeks. efficacy will be assessed at week 16 and week 48 using mpdai and pdai scores, therefor a pouchoscopy with biopsy sampling will be performed. patients who do not achieve partial response (reduction of mpdai score by ≥2 points from baseline) at week 16 will be discontinued.

Eligibility criteria:
inclusion criteria: * the subject has a history of ileal pouch-anal anastomosis (ipaa) for ulcerative colitis (uc) * the subject has pouchitis that is (a) relapsing or (b) chronic antibiotic refractory, defined by an mpdai score ≥5 assessed as the average from 3 days immediately prior to the baseline endoscopy visit and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) ≥3 recurrent episodes within the last year, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline endoscopy visit exclusion criteria: * crohn's disease (cd), cd-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (ips), isolated or predominant cuffitis, infectiouw pouchitis, diverting ostomy or mechanical complications of the pouch * previous treatment with an anti-il12/23 or an anti-il23 antibody * any investigational or approved biologic agent within 30 days of baseline * nonbiologic investigational therapy or tofacitinib within 30 days prior to baseline * active or untreated latent tuberculosis (tb) * chronic hepatitis b virus (hbv) infection, chronic hepatitis c virus (hcv) infection, a known history of human immunodeficiency virus (hiv) infection (or is found to be seropositive at screening) or subject is immunodeficient * active severe infection (e.g. sepsis, cytomegalovirus, listeriosis or c. difficile) * history of malignancy or current malignancy
jacobson's progressive muscle relaxation technique with aerobic exercise on cardiopulmonary parameters and quality of life in stage 1 hypertensive individuals

Conditions: Hypertension

Summary: the study is a randomized controlled trial. the purpose of study is to compare the additive effects of jacobson's progressive muscle relaxation technique with aerobic exercise versus aerobic exercise on cardiopulmonary parameters including systolic and diastolic blood pressure, heart rate, respiratory rate, rate pressure product and quality of life in stage 1 hypertensive individuals.

the study will consist of referred stage 1 hypertensive patients by medical specialist/cardiologist. participants will be screened through par-q and ipaq questionnaire. cardiac monitor will be used for assessing the cardiopulmonary parameters. sf-36 questionnaire will be used for assessing the quality of life. informed written consent will be taken after which participants will be recruited into two groups. control group will be provided aerobic exercise while interventional group will be provided jacobson's progressive muscle relaxation technique with aerobic exercise. outcome measures assessment will be done at pre-session, at 2 weeks and after 4 weeks post-intervention

Eligibility criteria:
inclusion criteria: * adults: aged (18-45 years) * gender: both male and female * patients diagnosed with stage 1 hypertension (130-139 / 80-89 mmhg according to aha/acc 2017 guidelines * mild to moderate physical activity level on ipaq questionnaire * individuals who are able to understand and follow the instructions for exercise exclusion criteria: * unstable angina, mi, heart failure, advanced cad patients * severe neurological, musculoskeletal, or gynaecological conditions which limit participation in study * recent history of fracture * morbidly obese (bmi \> 40.0 kg / m2)

Keywords: aerobic exercise quality of life hypertension muscle relaxation