Kornimate/medical-research-clean huggingface dataset:
influence of glitazones on the vasodilatory effect of high-density lipoprotein (hdl) lipoproteins

Conditions: Type 2 Diabetes

Summary: hdl from patients with type 2 diabetes show a significant reduction of their endothelium-dependent vasodilatory effect. the primary objective of the study is to analyze whether treatment with glitazones (pioglitazone and rosiglitazone)may improve the endothelium-dependent vasodilatory effect of hdl lipoproteins in patients with type 2 diabetes. the secondary objectives are: * to analyze the effect of glitazone treatment on phospholipase a2 * to look for possible differences between the effects of pioglitazone and those of rosiglitazone * to analyze the glycemic response to glitazone therapy according to clinical and biological baseline characteristics.

the study will be performed as follows: at baseline, before initiating glitazone treatment, clinical data will be recorded and blood samples will be obtained for biological measurements (blood glucose, hba1c, total cholesterol, triglycerides, ldl-cholesterol, hdl-cholesterol, liver enzymes), phospholipase a2 measurement and the study of the vasodilatory effect of hdl particles.for this purpose, we will study,using rabbit aorta rings,the ability of hdl to suppress the inhibition of vasodilation that is induced by oxidised ldl. for all the patients included into the study, a treatment by pioglitazone (at an initial dose of 30 mg/day) or rosiglitazone (at an initial dose of 4 mg/day) will be given by randomization. a visit will be performed at week 12, in order to titrate the glitazone dose (up to 45 mg/day for pioglitazone, up to 8 mg/day for rosiglitazone)according to hba1c level and values of self-monitoring blood glucose. at week 24, the last visit will take place. during this visit, clinical data will be recorded and blood samples will be obtained for biological measurements (blood glucose, hba1c, total cholesterol, triglycerides, ldl-cholesterol, hdl-cholesterol, liver enzymes), phospholipase a2 measurement and the study of the vasodilatory effect of hdl particles.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes treated by oral antidiabetic agents (except glitazones) and/or insulin * age\> 18 years * hba1c \> 6.5% exclusion criteria: * renal failure * heart failure * primary hyperlipidemia * pregnancy * treatment that may modify lipid metabolism (glucocorticoids, oestrogens, retinoids, hiv antiviral drugs)

Keywords: diabetes glitazones hdl
effects of fibromyalgia syndrome in patients with systemic sclerosis

Conditions: Systemic Sclerosis; Fibromyalgia

Summary: systemic sclerosis \[ssc\]; is a multisystem disease characterized by immune activation, microvascular disease and fibroblast dysfunction, which is thought to occur as a result of complex and not fully understood interaction between genetic and environmental factors, leading to fibrotic changes in the skin and some internal organs. it is characterized by the deposition of collagen and other matrix components in the skin and some internal organs. it has been shown by evaluating the health assessment questionnaire that it causes disability with increasing frequency over time. although pain cannot be localized too well to be attributed to a particular anatomical area, there are several musculoskeletal pain syndromes that can be detected in patients with systemic sclerosis. these are tendonitis, polyarthritis, rheumatoid arthritis, bursitis and fibromyalgia. while there are several studies on others, the relationship between fibromyalgia syndrome and ssc is not known clearly. as with other connective tissue diseases, fibromyalgia is not considered to be rare in ssc.

there are a few studies on this subject. except for one of these studies, the sensitive point in acr 1990 fms diagnostic criteria set was evaluated. in 2010, acr published new criteria, which may be an alternative method in clinical practice, without sensitive points, including the common pain index and symptom severity scale. it is evaluated with the common pain index and symptom severity scale. this new set of criteria alone is not affected by pain, it is based on patient reporting. therefore, it seems clinically more significant in determining the origin of pain in autoimmune diseases. there was only one study in the literature in which ssc patients are evaluated with the 2010 fms criteria set . therefore, the aim of our study was to evaluate the frequency of fms according to 2010 fms criteria and to investigate its effect on quality of life in our study.

Eligibility criteria:
inclusion criteria: * ssc diagnosis is definitive and diffuse involvement * no additional disease known other than scleroderma (diabetes mellitus, hypertension etc.) * no known additional rheumatic diseases exclusion criteria: * to have depression and / or any psychiatric illness * to use steroid, antidepressant, antiepileptic, regular nsaid usage.

Keywords: fibromyalgia systemic sclerosis quality of life
a clinical registry of orthobiologics procedures

Conditions: Orthopedic Disorder

Summary: the purpose of the registry study is to observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.

this registry was designed to assure that the benefits and knowledge gained by studying clinical outcomes associated with the use of percutaneous orthopedic procedures outweigh the potential risks to the patients. the primary objective of this registry is to observe the improvements in subject-reported clinical outcomes for these procedures used to treat musculoskeletal disorders. secondary objectives include evaluating post-treatment complication, adverse events, re-injections, and surgical intervention. patients receiving percutaneous orthopedic treatments are asked to enroll before receiving treatment and complete a set of baseline questionnaires regarding pain and functionality of the area of the body being treated (i.e. knee, shoulder, spine, etc). follow-up outcomes are collected at 1 month, 3 months, 6 months, 12 months, 18 months, and annually 2-20 years post-injection. subjects are withdrawn from the registry prematurely if a surgical operation occurs.

Eligibility criteria:
inclusion criteria: * candidates must meet all of the following: 1. voluntary signature of the irb approved informed consents, 2. treated with a regenexx procedure 3. have a musculoskeletal condition appropriate for the procedure such as osteoarthritis or internal joint derangement; ligament or tendon injury; intervertebral disc degeneration; protrusion, extrusion, or annular tear; muscle tear exclusion criteria: * none
assessment of long term treatment with testosterone undecanoate in males with hypogonadism

Conditions: Hypogonadism

Summary: this study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * hypogonadal men, aged 18-75 years with low serum total testosterone (tt) levels and symptoms of androgen deficiency exclusion criteria: * tumors of the prostate or the male mammary gland including suspicion thereof. past or present liver tumors or chronic hepatic disease with impairment of liver function, severe acne.
endovascular repair for the descending thoracic aorta

Conditions: Aorta Thoracic; Traumatic Rupture

Summary: most blunt aortic injuries occur in the proximal proximal descending aorta causing acute transection of this vessel. generally, surgical repair of the ruptured segment of aorta is associated with high rates of morbidity and mortality and in this view endovascular treatment seems to be a valid and safer alternative. aim of this study is to review the experience of a single center with endovascular approach for the treatment of acute traumatic rupture of descending thoracic aorta

from april 2002 to november 2014, patients referred to our department with a diagnosis of acute transection of thoracic aorta will be studied by preoperative computed tomography (ct) evaluation in order to perform thoracic endovascular aortic repair (tevar) with left subclavian artery coverage. then patients will be followed up with clinical and instrumental (ct, duplex ultrasound) controls at discharge, 1, 3 and 6 months and yearly thereafter. we will evaluate the presence of major and minor neurological complications, episodes of left arm claudication, cardiovascular, respiratory and bleeding complications. furthermore we will evaluate the technical success of the technique evaluating the onset of failure, collapse, leak or distal migration of the graft.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of acute transection of thoracic aorta; * a time frame range from trauma of 1-10 hours. exclusion criteria: * patients who do not fall into the above categories

Keywords: thoracic aorta trauma endovascular
treatment of lateral elbow tendinopathy

Conditions: Epicondylitis, Lateral Humeral

Summary: this study investigates the treatment effect on lateral elbow tendinopathy of strength training in combination with cortico-steroid injection, dry-needling or placebo in a double-blinded randomized controlled trial.

the prevalence of lateral elbow tendinopathy is prevalence of 1-3%, with a peak incidence between 35-50 years of age (green et al., 2002). the main symptoms are pain over the lateral humeral epicondyle upon palpation and pain full resisted dorsiflexion of the wrist. ultrasonographic changes include hyper-/hypo-echoic areas and increased doppler signal in the most proximal part of the common extensor tendon. the condition is often self-limiting, however full recovery often takes months to years and recurrence is common. several different treatment modalities are used in order to increase tendon healing and decrease time to recovery. deep transverse friction massage showed no significant effect on pain, grip strength or function relative to other physiotherapy modalities (brosseau et al., 2002). anti-inflammatory treatment with nsaid's or corticosteroids is typically effective in the short term, however on a longer term there is a poorer outcome than with other treatment strategies including exercise (coombes et al., 2010). surgery does not seem to have any beneficial effect (buchbinder et al., 2011), and there are no conclusive data regarding the use of orthotic devises for the treatment of lateral elbow tendinopathy (struijs et al., 2002). eccentric exercise of the extensor muscles has been shown to reduced pain, increase muscle strength, and decrease tendon thickness and time to return to sport (croisier et al., 2007). loading of human tendon leads to increased tendon collagen synthesis, and interestingly, tendon tissue sampling (biopsies), which causes a minor trauma to the tendon has been shown to increase the level of growth factors locally and stimulate tendon collagen synthesis (magnusson et al., 2010). it is hypothesized that both minimal tissue damage and anti-inflammatory treatment could increase tendon healing and decrease time to recovery, when combined with mechanical loading.

Eligibility criteria:
inclusion criteria: 1. pain around the lateral part of the elbow joint for more than 4 weeks. 2. pain on palpation of the proximal part of the common extensor tendon. 3. pain reproduced with resisted dorsiflexion of the wrist. 4. dash score \> 30. 5. ultrasonographic appearance consistent with lateral elbow tendinopathy (irregular appearance of the tendon, hypo-/hyper-echoic changes, pathological doppler signal, increased tendon thickness). exclusion criteria: * american society of anesthesiologists (asa) \> 2 (mild systemic disease). * patients with symptoms consistent with differential diagnoses such as: * referred pain, * radiohumeral synovitis and bursitis, * posterior interosseous nerve entrapment (radial tunnel syndrome), * osteoarthritis of the elbow, and * prior injections or acupuncture around the elbow joint within the last 6 months
evaluation of gastric residuals and feedings progression

Conditions: Infant, Premature, Diseases; Nutrition, Enteral

Summary: this study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared with no measurement.

the evaluation of gastric residuals as a measure of enteral tolerance in term and especially preterm newborns is a widely used practice in different centers worldwide. however, until now, it continues to be a controversial practice, since its real usefulness is not clear. our study proposes to evaluate and compare two groups of preterm newborns born between 26 + 0/7 and 33 + 6/7 weeks, randomized to measure or not measure gastric residuals and determine if this practice delays the full feeding achievement.

Eligibility criteria:
inclusion criteria: * preterm infants born between 26+0 to 33+6 weeks post-menstrual gestational age. * enteral feeds starting during the first week of life. * signed informed consent from parents or guardians. exclusion criteria: * perinatal asphyxia * sepsis and hemodynamic instability * major congenital malformations * surgical requirement during the first week of life * hemodynamic instability and vasoactive drugs requirement * moderate or severe respiratory failure with oxygenation index \> 8
bruxism xeomin® intervention trial

Conditions: Sleep Bruxism, Adult

Summary: the purpose of this study is to test whether severe masticatory muscle spasms during sleep (e.g. teeth clenching and grinding, known as "bruxism" in technical jargon) demonstrably decrease after application of botulinum toxin type a (xeomin®). xeomin® has so far been used to relieve spasms of other muscles and is an approved drug in switzerland. this study is now intended to test the suitability of this drug for relaxation of the masseter muscle.

bruxism is a prevalent condition that differentially burdens individuals. the overall objective of this pilot study is to measure the effects of btx-a (xeomin®) injections into bilateral masseter muscles for the management of sleep bruxism and associated symptoms. the hypothesis is that btx-a reduces masticatory muscle activity. the aim of this study is to instrumentally monitor subjects closely over an extended time period of three months before and after application of btx-a. botulinum toxin type a ( btx a; xeomin ® ) temporarily blocks neuromuscular synapses. it is successfully and safely used therapeutically in various types of movement disorders and in chronic migraineurs. the mechanism of action of this treatment is related to a reduction of neurotransmitter release leading to reduced muscle activity. the following null hypothesis will be tested: injections of xeomin® into the masseter muscles bilaterally (25 units per muscle applied with 2 injections in each muscle) have no effect on bruxism measured by a) masticatory muscle activity (1° objective) b) subjects' well-being (2° objective) c) sensitivity of masticatory muscles and jaw joints (2° objective) d) anxiety over tooth wear (2° objective) e) disturbed sleep by bed partner (2° objective) following instruments will be used: 1. wise questionnaires. a comprehensive web-based interdisciplinary symptom evaluation tool. 2. algometer for sensitivity measure of masticatory muscles and jaw joints. 3. bio-signal recorder. parallel to the electromyography (emg) of the masseter muscles, other bio-signals such as a number of electroencephalographic (eeg) derivations, electrooculogram (eog ) as well as an electrocardiogram (ecg) will be recorded, in order to detect sleep stages and better identify bruxism episodes. the device used in this study has been approved for projects nih #2r01de016417-05a1 and #1 r01de028548-01. 4. ultrasound for masseter muscle thickness measure 5. dual-color chewing gum for chewing efficiency measure.

Eligibility criteria:
inclusion criteria: * age 18-90 years; * patients complaining of bruxism and/or bruxism-related symptoms. * sufficient knowledge of german to understand the patient information and the trial arrangement. exclusion criteria: * contraindications for xeomin® treatment such as generalized disorders of muscle activity (myasthenia gravis, lambert-eaton-rooke syndrome); * documented hypersensitivity to one of the components, * local infection of the injection sites; * intake of anticoagulants or muscle relaxing medications; * recreational drugs.
effects of yoga on pulmonary parameters, posture, body awareness and quality of life among chronic smokers

Conditions: Smoking

Summary: the aim of this study is to examine the effects of practicing pranayam (voluntary regulated breathing) and yogasana (standing poses of yoga) with subject education on vital capacity, respiratory muscle strength, spinal flexibility, body awareness, quality of life and nicotine dependence of smokers and non-smokers.

when initial assesments will be completed, volunteers will be assigned to one of two possible sequences by their nicotine dependency. smokers group (sg) or control group (cg). all volunteers will receive an exercise program with asana and pranayam practices with the duration of 4 weeks. all subjects will be assessed in terms of functional capacity, pulmonary functions, thoracic spine range of motion, postural analysis, respiratory muscle strength, body awareness, quality of life and nicotine dependence at the baseline and at the end of the study. data will be collected from all the subjects at baseline and at the end of the study (4 weeks) by the same physiotherapist who also will supervise the exercise sessions.

Eligibility criteria:
inclusion criteria: * voluntary participation in research * young healthy subjects who were aged between 18-60 years with or without daily cigarette smoking habit exclusion criteria: * allergic disorders or respiratory disorders * history of a major surgery in the last 2 years * neurological diseases * cardiovascular diseases which are contraindicates exercise * fractures or orthopedic problems in upper or lower extremities * systemic rheumatical diseases(rheumatoid arthritis, ankylosing spondilitis etc.) systemic diseases and respiratory disorders will be ruled out in the selected subjects by taking their detailed history and by their thorough clinical examination by the researcher.

Keywords: yoga pranayam breathing exercise asana smoking spine health spinal stretches
buprenorphine treatment for opioid dependence

Conditions: Opioid Dependence

Summary: buprenorphine/naloxone (bup/nlx) treatment is effective for the treatment of prescription opioid dependence, previous studies have not determined the optimum dose of bup/nlx for this patient population. the goal of this study is to determine if there are differences in clinical efficacy of bup/nlx tablet in low dose range (less than or equal to 8/2mg) vs. high dose range (greater than or equal to 16, range 16-24mg). the main outcomes of interest will be treatment retention, use of opioids, and the use of other drugs of abuse.

this is a randomized, open-label clinical trial with approximately 9 veteran opioid dependent men and women. veterans were randomized to one of two treatment groups: low dose range of buprenorphine (\<8mg) vs. high dose range of buprenorphine/naloxone (bup/nlx (\<16mg). during induction into buprenorphine, all participants will be started at a dose of 2mg, and this dose will be increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low dose group, and up to 16mg for the high dose group, within a 5 day period. participants will be seen on a daily basis (excluding weekends) for the initial 5 day induction. at the end of the 12-week study, participants will either be referred to a buprenorphine clinic if they wish to continue this medication, or if they wish to be drug free, will undergo detoxification from buprenorphine for up to a 4-week period. follow-up visits, scheduled at 1, 3, and 6 months after study completion.

Eligibility criteria:
inclusion criteria: 1. males and females between the ages of 18 to 65, current dependence on prescription opioids as evidenced by documented prior treatment for opioid dependence, signs of opiate withdrawal as evidenced by a clinical opiate withdrawal scale score of 7 or greater, self-reported history of opioid dependence, and a positive urine toxicology for opiates; 2. willingness to be detoxified from opioids for buprenorphine maintenance ; 3. for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy, with monthly pregnancy tests obtained during study participation. exclusion criteria: 1. use of heroin for more than 4 days in the past month; 2. lifetime history of opioid dependence due to heroin alone; 3. ever used heroin intravenously; 4. requirement for current ongoing opioid treatment for adequate pain management; 5. current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical, 6. serious unstable medical illness including bradycardia or other arrhythmias, major cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine treatment is contraindicated or which at the determination of the md is medically dangerous; 7. serious psychiatric illness including psychosis, bipolar disorder with psychosis: 8. or significant current suicidal or homicidal thoughts necessitating a higher level or care; 9. known allergy or intolerance to buprenorphine.

Keywords: opioid dependence buprenorphine