Kornimate/medical-research-clean huggingface dataset:
telemental health and cognitive processing therapy for rural combat veterans with posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorder

Summary: the immediate objective of this project was to evaluate the clinical effectiveness of a telemental health modality (video-teleconferencing) for providing an evidence-based group intervention (cognitive processing therapy; cpt) to rural oif/oef reservists, national guardsmen, and veterans suffering with ptsd.

the project was a 5-year prospective randomized clinical trial which conducted a direct comparison of the vtc and in-person modalities using rigorous methodology and a sophisticated analysis of equivalency between clinical and process outcome domains. in addition, cost effectiveness of this modality will be addressed. approximately 130 combat reservists, national guardsmen, or veterans were recruited from multiple clinical sites. prospective participants received a comprehensive assessment at baseline to determine eligibility. the exclusion criteria selected are consistent with large ptsd randomized clinical trials as well as research using the cpt protocol with military populations with ptsd. the treatment was delivered twice a week over 6 weeks by a doctoral level psychologist. quality control procedures were incorporated into the study's design to ensure integrity, fidelity and standard administration of the cpt intervention across both conditions. participants received additional assessments at mid-treatment, immediately post-treatment, and at 3 and 6 months post-treatment. outcome domains include: 1) clinical outcomes (symptom severity, social functioning); 2) process outcomes (perception of treatment, satisfaction, group therapy alliance, treatment compliance, and attrition and treatment credibility); and (3) cost-effectiveness outcomes.

Eligibility criteria:
inclusion criteria: * diagnosis of current combat related ptsd determined by the clinician administered pstd scale (caps-iv) * participants taking psychoactive medications have to have a stable regimen for at least 45 days prior to study entry exclusion criteria: * active psychotic symptoms/disorder as determined by the scid for dsm-iv * active homicidal or suicidal ideation as determined by the structured clinical interview * any significant cognitive impairment or history of organic mental disorder as determined by the structured clinical interview * active (current) substance dependence as determined by the scid (lifetime substance dependence/abuse not excluded) * unwillingness to refrain from substance abuse during treatment * female veterans

Keywords: cognitive processing therapy combat veterans ptsd telemental health videoteleconference outcome rural remote cpt vtc
the clinical study to evaluate immunogenicity of epodion® in anemia associated with ckd patients

Conditions: Chronic Kidney Disease (CKD)

Summary: the study was conducted to assess safety and immunogenicity of recombinant human erythropoietin (rhepo) manufactured by daewoong pharmaceutical co., ltd was similar to biological products approved by the drug safety regulatory authority.

this study consisted of a screening period (4 weeks) and treatment period (52 weeks). evaluation for immunogenicity effect using ada (anti drug antibody) detection will be done at weeks 0, 24, and 52 and blood sampling for routine hematological tests as supporting data will be conducted every month following hospital regulation. for each subject, the end of the study is the last day of the blood sample will be drawn in the case of a subject that has left the study (withdrawn), the exit date will be the end of the study. the safety evaluation was conducted based on the incidence of the adverse events local and systemic reactions.

Eligibility criteria:
inclusion criteria: * patients who have anemia associated with chronic kidney disease (ckd) under hemodialysis treatment. * male or female patients aged ≥18 years. * patients with mean hb concentration when screening is around ≤10 g/dl. * patients on stable, adequate dialysis for at least three months (defined as no clinically relevant changes of hemodialysis regimen and/or 23/42 ©emea 2007 dialyzer). * has ever been using epodion treatment in the at least last 1 month. * haemodialysis patients who likely to remain on epodion treatment for 52 weeks. * informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug. exclusion criteria: * history of pure red cell aplasia (prca) or anti-epoetin antibodies. * contraindications for esa therapy. * systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level. * history of uncontrolled hypertension (defined as systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg during screening). * any blood transfusion within the last 2 weeks prior to screening period. * major surgery within 3 months prior to screening period. * myelodysplastic syndrome. * history bleeding disorders (e.g. hemophilia, von willebrand, and any conditions that result when the blood cannot clot properly). * known bone marrow fibrosis (osteitis fibrosa cystica). * known epilepsy. * liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites). * systemic lupus erythematosus. * previously diagnosed with hiv or acute hepatitis infection. * history of malignancy of any organ system within the last 5 year. * pregnancy or lactation period in female patients. * heavy smoker (who smoke over 20 cigarettes daily in average).

Keywords: rh-epo chronic kidney disease erythropoietin alpha
efficacy and safety of prescription omega-3 fatty acid added to stable statin therapy in patients with type 2 diabetes and hypertriglyceridemia

Conditions: Diabetes Mellitus, Type 2; Hypertriglycemia

Summary: assess efficacy and safety of omacor® 4g with statin treatment for lowering tg levels in subjects with type 2 diabetes combined with hyperlipidemia


Eligibility criteria:
inclusion criteria: * ldl-c \ 150mg/dl, patients on statin treatment for at least 6 weeks prior to randomization. * type 2 diabetes * hba1c ≤ 10.0 exclusion criteria: * type 1 diabetes * patients with ppar gamma agonist therapy * patients with acute mi, unstable angina within 6 months * history of malignant tumor within 2 years * women with pregnant, breast-feeding
efficacy and safety evaluation of budesonide/formoterol spiromax® inhalation powder versus symbicort® turbohaler®

Conditions: Asthma

Summary: the primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (bf) spiromax 160/4.5 micrograms (mcg) is as effective as symbicort turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.


Eligibility criteria:
inclusion criteria: * male or female participants 12 years and older as of the screening visit. male or female participants 18 years and older, as of the screening visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adult participants only. * general good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study. * asthma diagnosis: the asthma diagnosis must be in accordance with the global initiative for asthma (gina) exclusion criteria: * history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures. * culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks before the screening visit. in addition, the participant must be excluded if such infection occurs between the screening visit and the baseline visit. * any asthma exacerbation requiring oral corticosteroids within 1 month of the screening visit. a participant must not have been hospitalized for asthma within 6 months before the screening visit. * presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma. * historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular conditions (for example, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine conditions (for example, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, addison's disease, cushing's syndrome), gastrointestinal conditions (for example, poorly-controlled peptic ulcer, gastroesophageal reflux disease \[gerd\]), or pulmonary conditions (for example, chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition became exacerbated during the study. note: other inclusion and exclusion criteria may apply.

Keywords: budesonide/formoterol spiromax® symbicort® turbohaler® asthma
safety, tolerability, pk, and pd of lim-0705 in subjects with impaired glucose tolerance or abnormal homa-ir

Conditions: Impaired Glucose Tolerance; Insulin Resistance

Summary: preliminary research suggests that lim-0705 improves insulin sensitivity with neutral effects on weight in obese and diabetic rodent models. results from a phase 1b clinical study, conducted in healthy volunteers, indicate that lim-0705 and a major metabolite may be potential insulin sensitizers by ogtt.

the primary objective of the study is to evaluate the safety and tolerability of lim-0705 administered for 28 days in adult males and females with impaired glucose tolerance or abnormal homa-ir. secondary objectives include: * examine the pharmacokinetics (pk) of lim-0705 * explore the pharmacodynamics (pd) of lim-0705 in obese adult males and females with impaired glucose tolerance (defined as two-hour plasma glucose levels of ≥140 to ≤199 mg per dl \[7.8 to 11.06 mmol/l\] on the 75-g oral glucose tolerance test \[ogtt\]) or abnormal homa-ir (homa-ir value ≥ 2.5) as measured by change in response to hyperinsulinemic clamp, mixed-meal tolerance test (mmtt) between days -2 and 27 * explore the effect of lim-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels

Eligibility criteria:
inclusion criteria: * males and females, age 18-75 years old, able and willing to provide written informed consent to participate in the study * obesity-induced impaired glucose tolerance or abnormal homa-ir * waist circumference of 40 inches or greater (men) or 35 inches or greater (women) * good physical health based on ekg, electrolytes, ldh, creatinine, urea, ast, alt, alkaline phosphatase, and renal function * male subjects who are sexually active with a female partner of childbearing age must agree to use of 2 effective methods of contraception, including the use of a condom, throughout the course of the study or provide proof of surgical sterility. the second method of contraception must be the use by their female partners of any of the following: a diaphragm with spermicide, a cervical cap with spermicide, an iud, a female condom, or an approved hormonally based contraceptive (e.g., an oral, transdermal, or implanted estrogen or progestin). female subjects must be post menopausal or surgically sterile. exclusion criteria: * bmi equal to or greater than 40 kg/m2 * allergy to onions or red wine * strict vegetarians * use of any non-study medications other than thyroid replacement hormone or anti-hypertensives. use of cardesarten cilexetil is not permitted. note: acetaminophen should not be administered. * use of chemotherapy agents or history of cancer, other than non-metastatic non-melanoma skin cancer that has been completely excised, within 5 years prior to the screening visit
long-term airway clearance therapy in non-cystic fibrosis bronchiectasis

Conditions: Bronchiectasis

Summary: the main aim is to analyze whether the routine use of chest physiotherapy in non cystic fibrosis bronchiectasis (ncfb) improves the cough severity and the quality of life in this population. in addition, the secondary end-points include incidences of exacerbations, changes in lung function, exercise capacity, airways inflammation, sputum analysis and eventual adverse events.

the present project will be a single-blind , randomized, controlled trial of 12-month daily performing chest physiotherapy compared with usual care, followed by a 3-month intervention-free in non-cystic fibrosis bronchiectasis. intervention group will perform daily autonomous airway clearance techniques (positive expiratory pressure technique through acapella device and autogenic drainage technique). patients will receive professional sessions once a month. control group will receive their usual care and educational sessions about their disease. physiotherapist will call them once a month. during the study period the patients' pharmacological treatment remained unchanged

Eligibility criteria:
inclusion criteria: * chronic sputum production during at least 3 months previous enrolment * at least two confirmed exacerbations during the last year * patients able to understand how to perform the airway clearance techniques * clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk) * to be able to provide written, informed consent exclusion criteria: * cystic fibrosis * carry out regular chest physiotherapy. * active haemoptysis during the previous month or recurrent hemoptysis during the last year (more than 4 episodes) * waiting a pulmonary transplant

Keywords: autogenic drainage positive expiratory pressure airway clearance technique quality of life exacerbations chest physiotherapy
derivation of a clinical decision rule for emergency department head ct scanning in seniors who have fallen

Conditions: Fall; Intracranial Bleed

Summary: falls are the leading cause of traumatic death in the elderly with head injury causing half of these deaths. each year, one in three adults over the age of 65 (seniors) fall, and half of these seniors seek treatment at a hospital emergency department (ed). there is a major evidence gap in the study of brain injury diagnosis in seniors, which is problematic for emergency physicians since the number of fall-associated head injuries is rising. ed diagnostic tools for risk stratification of these patients do not exist. the investigators will derive a novel ed clinical decision rule for detecting traumatic intracranial bleeding which will standardize the approach to head ct scans. once validated, the investigators will optimize patient care by ensuring that intracranial bleeding is identified early. by reducing the use of head ct, this decision rule will lead to health care savings and streamlined, patient-centered ed care.

this study is designed to develop a unique clinical decision rule for ed physicians evaluating senior patients who have fallen. clinical decision rules are a common method for standardizing diagnostic decision-making and minimizing misdiagnosis in the ed. each patient will be assessed at their index ed visit by an emergency physician who will record history and examination findings. the primary outcome will be clinically important intracranial bleeding diagnosed with 42 days. patients who return to the ed within 42 days with new confusion, headache, loss of balance, repeat falls, change in behaviour, reduced glasgow coma scale score or other neurological symptoms will also undergo head ct. all intracranial bleeding events will be adjudicated independently.

Eligibility criteria:
inclusion criteria: * 65+ years old * fall within 48 hours of emergency department visit (regardless of presenting complaint) exclusion criteria: * repeat event/visit (already enrolled in the study) * transferred from another hospital * lives outside of hospital catchment area * major trauma (e.g. fall from steps, fall from height, motor vehicle accident, struck by a vehicle, recreational accident) * left emergency department prior to completion of assessment (left against medical advice)

Keywords: elderly clinical decision rule emergency department ct scan bleeding
clinical outcome of pediatric dermatofibrosarcoma protuberans

Conditions: Soft Tissue Neoplasms

Summary: retrospective review of clinical outcome of pediatric dermatofibrosarcoma protuberans (pdfsp) after active invitation

soft tissue sarcoma was rarely seen in pediatric patients, and pediatric dermatofibrosarcoma protuberans (pdfsp) was even rare. to our knowledge, the largest report constituted of 19 cases (five of them had no follow-up (fu) status) (1). so we proposed this retrospective study based on the cancer registry of our hospital. twelve cases who were diagnosed as dfsp before age of 18 were identified. but all of them had been lost of fu for at least two years. so we will try to contact these patients and asked them to be back to our clinic for routine surveillance (history taking and physical exam and optional local image/chest xray) and quality of life (qol) evaluation after pathological review if this clinical study was approved (2)

Eligibility criteria:
inclusion criteria: * patients diagnosed as dfsp before age of 18 after pathological review according to the cancer registry of our hospital exclusion criteria: * age \> 18 at diagnosis

Keywords: pediatric dermatofibrosarcoma protuberans
phosphodiesterase (pde) inhibitors effect on cognitive deficits associated to schizophrenia

Conditions: Schizophrenia; Cognitive Deficits

Summary: phosphodiesterase (pde) inhibitors represent a new group of potential antipsychotic compounds currently under development. one of these is papaverine, an inhibitor of the pde 10 family. the class of pde10 inhibitors have been reported as possible candidates in the treatment of schizophrenia, and may prove an attractive antipsychotic alternative due to the many side-effects of the currently available antipsychotics. it has been proposed from preclinical studies that pde10 inhibitors have the potential to reduce cognitive deficits in schizophrenia and these findings need to be confirmed in a human population, in view of the fact that no other currently registered drug posses these unique properties. the currently proposed project is designed to investigate whether the pde10 inhibitor papaverine indeed have the capacity to reduce cognitive deficits in schizophrenia patients. in order to accomplish this effect, papaverine will be investigated in schizophrenia, with regards to symptomatology, hemodynamic, neurocognition and early information-processing.

the study has a double blind, balanced crossover design. randomized, half of the subjects will be given papaverine (pde10 inhibitor, 300 mg orally) in the first session followed by placebo in the second, and the other half will be treated in the reverse order. there is a minimum of one month between the two test-sessions. after each of the two treatments, the subjects will be tested with both a psychophysiological (the copenhagen psychophysiological test-battery) and neuropsychological test-battery (tests from the cambridge neuropsychological test automated battery, or "cantab"). the project has three phases: in the first phase 10 healthy subjects will be included to determine the kinetics of papaverine-contained release capsules ; in the second phase 30 schizophrenia patients and 30 healthy subjects will be included to determine the impact on cognitive and sensory gating related deficits; finally 10 healthy subjects will be included to determine the effect of papaverine on hemodynamical parameters by the means magnetic resonance scannings.

Eligibility criteria:
inclusion criteria: * diagnosed schizophrenia (who icd 10) * treatment stable (no regulation in medicine for 6 weeks prior) * mono antipsychotic treatment * no regular antidepressants (pn accepted) * no regular benzodiazepines (pn accepted) exclusion criteria: * dependence syndrome * severe physical illness * mri incompatible, non removable objects above shoulders

Keywords: phosphodiesterase inhibitor psychophysiology cognition schizophrenia papaverine
dose-escalating multiple dose study of pd-0360324 in combination with methotrexate in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: this study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of pd 0360324 in patients with rheumatoid arthritis receiving methotrexate.


Eligibility criteria:
inclusion criteria: * diagnosis of ra for at least 6 months based upon the american college of rheumatology (acr) 1987 revised criteria. * must have been treated with methotrexate (≥7.5 mg/week to ≤25 mg/week) for at least 16 weeks immediately prior to enrollment. the dose of methotrexate must be stable for at least 6 weeks prior to enrollment. * females of childbearing potential are required to simultaneously use 2 effective contraceptive methods, 1 of which must be a barrier (condoms, diaphragm or cervical cap) with spermicide. non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception, if the woman could become pregnant from the time of the first dose of study medication until completion of follow up procedures * contact your local site for more inclusion criteria. exclusion criteria: * diagnosis of any other inflammatory arthritis (eg, spondyloarthropathies); or a non-inflammatory arthritis or musculoskeletal condition (eg, osteoarthritis, fibromyalgia) that, in the investigator's opinion, may interfere with clinical assessments. * evidence of active or latent infection with mycobacterium tuberculosis (tb). * use of etanercept, anakinra, or oral dmards with the exception of methotrexate, within the 4 weeks prior to enrollment. use of biological dmards within the 8 (adalimumab or infliximab) or 12 (abatacept) or 56 (rituximab) weeks prior to enrollment. use of oral corticosteroids, acetaminophen, nsaids, and opioids are permitted within the dose ranges defined in the protocol. * contact your local site for more inclusion criteria.