Kornimate/medical-research-clean huggingface dataset:
new combination inhaler (flutiform hfa mdi 100/10 µg and 250/10 µg) in patients with asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug flutiform hfa mdi (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma.


Eligibility criteria:
ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring. inclusion criteria: * history of asthma for at least 12 months. * documented use of inhaled corticosteriod for at least 4 weeks prior to screening visit demonstrate fev-1 of 40-80% of predicted normal values at screening and baseline visit. * documented reversibility of 15% within 6 months of screening visit or at screening visit (15% increase from pre-fev-1 levels following albuterol inhalation). * symptoms of asthma during run-in. * females of childbearing potential must have a negative urine pregnancy test at screening and baseline visits. females are eligible only if they are not pregnant or lactating and are either sterile or using acceptable methods of contraception. * must otherwise be healthy. * provide written informed consent. wishes of minors must be respected. exclusion criteria: * life-threatening asthma within past year or during run-in period. * history of systemic corticosteroid medication within 3 months before screening visit. * history of omalizumab use within the past 6 months. * history of leukotriene receptor antagonist use, e.g., montelukast, within the past week. * current evidence of history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. * upper or lower respiratory infection within 4 weeks prior to screening visit or during run-in period. * significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[copd\], cystic fibrosis, bronchiectasis). * known human immunodeficiency virus (hiv)-positive status. * smoking history equivalent to "10 pack years". * current smoking history within 12 months prior to screening visit.

Keywords: asthma fluticasone propionate formoterol fumarate pressurized metered does inhaler hydrofluoroalkane mild to moderate-severe asthma
ziprasidone in the treatment of borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: objective: the aim of this double-blind, placebo-controlled study was to evaluate the efficacy and tolerability of ziprasidone in the treatment of adult patients with borderline personality disorder (bpd). method: sixty bpd patients were included in a 12-week, single-center, double-blind, placebo-controlled study. the subjects were randomly assigned to ziprasidone or placebo in a 1:1 ratio following a two-week baseline period. the clinical global impression scale for use in bpd patients (cgi-bpd) was the primary outcome measure, and other scales and self-reports related to affect, behavior, psychosis, general psychopathology domains and clinical safety were included.

the american psychiatric association (apa) guidelines for the treatment of borderline personality disorder recommend that pharmacological treatment for bpd has an important adjunctive role, especially for diminution of symptoms such as affective instability, impulsivity, psychotic-like symptoms, and self-destructive behavior. studies conducted with low doses of conventional antipsychotics have showed significant improvements in specific symptoms such as hostility, impulsiveness, mood, and psychotic symptoms. the introduction of atypical antipsychotics, with a more favorable tolerance profile, increases clinicians' options for treating bpd. olanzapine has proven its efficacy in four double-blind, placebo-controlled clinical trials in patients with bpd. ziprasidone is an atypical antipsychotic with a pharmacological action on serotonergic, dopaminergic and adrenergic receptors. it has proven to be effective for schizophrenia, schizoaffective and acute mania disorders and the incidence of side effects is low. although clinical findings and the pharmacological activity of ziprasidone suggest the drug may have therapeutic benefits in bpd patients, no controlled studies have yet been conducted in these patients. we carried out a randomized, double-blind, placebo-controlled study to evaluate efficacy and tolerability of ziprasidone in the management of bpd patients with moderate-high clinical severity.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of borderline personality disorder * age between 18 and 45 years * clinical global impression of severity (cgi-s)scores \>4 exclusion criteria: * no comorbidity with schizophrenia, drug-induced psychosis, organic brain syndrome, alcohol or other substance dependence, bipolar disorder, mental retardation, or major depressive episode in course * current use of medically accepted contraception in the case of female patients.

Keywords: borderline personality disorder ziprasidone
progesterone supplementation for hiv-positive pregnant women on anti-retrovirals

Conditions: HIV-1 Infection

Summary: in pregnancy, cart is considered optimal for maternal health and for preventing the emergence of resistance that could compromise further care. in canada, the majority of hiv-positive pregnant women receive a pi-based cart regimen. in the past, therapy was generally deferred until after the first trimester (if not required for maternal health) to minimize any unknown risk of teratogenicity. however, as treatment is now started earlier in hiv infection and as perinatal transmission rates are lowest in those with prolonged suppression of viral load during pregnancy, women are increasingly commencing cart either before conception or earlier in pregnancy. multiple reports and cohort studies provided data suggesting an association between pi-based cart use and preterm birth, low birth weight, and small for gestational age (sga) babies, although conflicting data exist. in the general population progesterone supplementation is widely used, is well tolerated, is considered safe, and is beneficial to prevent recurrent pre-term birth and increase birth weight. the investigators experimental findings suggest that pi use during pregnancy is associated with declines in progesterone levels that correlate with fetal growth, and that progesterone supplementation can improve pi-induced fetal growth restriction. the investigators preliminary findings in hiv+ pregnant women suggest that pi-use is associated with declines in progesterone levels, which correlate with birth weight percentile. since hiv-positive women have higher rates of pre-term delivery and low birth weight that may be magnified by the use of pis, then progesterone supplementation could be of benefit to neonatal health in the context of hiv-positive pregnancy.


Eligibility criteria:
inclusion criteria: * documented hiv-1 infection * on (stable) or initiating a cart regimen containing either ritonavir-boosted lopinavir (lpv/r), atazanavir (atz/r) or darunavir (drv/r) * pregnant up to 24 weeks gestational age * singleton pregnancy * 18 years or older * ability to give informed consent exclusion criteria: * hypersensitivity or allergy to soya or peanut (non-active ingredient supplement in prometrium) * contraindications to intravaginal progesterone use including: * documented hypersensitivity to prometrium * active or history of breast cancer, * active or history of arterial thromboembolitic disease (e.g. stroke, myocardial infarction, coronary heart disease) * active or history of venous thromboembolism (e.g. deep venous thrombosis or pulmonary embolism) or active thrombophlebitis * any prior neoplasia, except for skin * abnormal vaginal bleeding * known lethal fetal anomaly * any contraindication to continuation of pregnancy * inability to communicate in english * prior participation in this trial
evaluation of pressure applying efficiency in multi-layer bandaging

Conditions: Lymphedema

Summary: lymphedema is a condition characterized by excess accumulation of protein rich tissue fluid in interstitial spaces. it is a progressive chronic disease and without appropriate management may result in serious complications. in israel, patients are referred to physiotherapists certified in treatment for lymphedema. according to the international society of lymphology (isl) the best treatment is a holistic, multidiscipline approach. amongst the different methods of lymphedema management, the use of compression is the only treatment that has shown to be effective in randomized controlled trials. the isl recommends that patients with lymphedema in the lower limb ought to bandage their leg with multi-layer bandaging on a daily basis for a period of two to four weeks. a new classification system for compression bandages was recommended; pressure of \<20 mmhg was categorized as mild, 20-40 mmhg as medium, 40-60 mmhg as strong and ≥60 mmhg as very strong. in patients with leg edema, bandages with strong pressure were shown to be the most effective. however, in the presence of a venous ulcer on a lymphatic leg, pressure between 35 and 45 mmhg is the widely accepted range for sufficient and safe compression. the use of measurement instruments is currently the only realistic method for determining the actual pressure achieved beneath the bandage. however, it is neither economical nor feasib¬le nor is it realistic in terms of time. recent studies show that many healthcare professionals use inadequate sub-bandage pressure. no study so far has focused on therapists that are trained in lymphatic treatment. in spite of correct pressure bandaging importance, the question whether physiotherapists succeed in correctly applying it is left unanswered. the main purpose of this study is to evaluate the pressure applying efficiency in multi-layer bandaging among physiotherapists in israel who treat lymphedema. 34 physiotherapists trained in lymphatic treatment will be recruited for this research. each volunteer will receive a questionnaire concerning their self-perceived competence in the application of compression bandages. afterwards, two practical trials will be held a week apart in which the subjects will be asked to apply bandages using strong and medium pressure. using picopress®, pressure will be measured directly after bandaging and two hours later. our hypothesis is that the majority of therapists will properly apply medium or strong pressure on the lower limbs.


Eligibility criteria:
inclusion criteria: * physical therapists trained in lymphatic treatments exclusion criteria: * have not treated a lymphatic patient in the past two years
the effects of high dose pancreatic enzyme replacement therapy after pancreatoduodenectomy

Conditions: Pancreaticoduodenectomy

Summary: up to now, the studies concerning nutritional assessment after pancreatic resection were rare. the low-dose pancreatic enzyme treatment after pancreatectomy showed no significant benefit in terms of nutritional status. this study is a multicenter randomized phase iv study by using high-dose norzyme® (40,000 iu) to evaluate quality of life and nutritional status after pancreaticoduodenectomy.

there are not enough studies evaluating nutritional parameters in patients with pancreatic resection. after pancreatic surgery, there are several ways to improve patient condition in terms of quality of life including nutrition. in the investigators previous study, pancreatic enzyme supplement through the administration of norzyme® 25000 iu containing lipase 25000 iu, amylase 22500 iu, and protease 1250 iu after various type of pancreatectomy to improve quality of life and nutritional status failed to prove its effectiveness. after administration of low-dose norzyme® (25000 iu), some patients showed weight gain, but statistically significant conclusions were not obtained mainly because of various types of pancreatectomy and low supplementary dosage of pancreatic enzyme. therefore, the investigators design this study to find out the effect of high-dose norzyme® (40000 iu) on weight gain, quality of life, stool habit change, and nutritional status in patients with pancreaticoduodenectomy. the investigators will evaluate the effectiveness and adequacy of high-dose pancreatic supplementary treatment through a randomized, placebo-using, single-blinded, and multicenter study.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * ecog performance status : 0,1,2 * patients who underwent pancreaticoduodenectomy or pylorus preserving pancreaticoduodenectomy * stool elastase ≤200, preoperatively and postoperatively * patients consented to this study exclusion criteria: * patients with comorbidities such as liver cirrhosis, chronic renal failure, heart failure, and inflammatory bowel disease which can affect the assessment of quality of life or nutritional status * patients underwent major abdominal organ surgery such as gastrectomy and colon resection which can affect the assessment of quality of life or nutritional status * patients with locoregional recurrence or distant metastasis * patients which were not able to progress diet and medication within 10 days after surgery * patients with pork allergy

Keywords: pancreaticoduodenectomy nutritional status quality of life biochemical marker
theta burst brain stimulation in diabetic neuropathy patients with neuropathic pain: investigating neural mechanisms

Conditions: Diabetic Neuropathy, Painful

Summary: the purpose of the study is to determine the effects of a newer form of non-invasive brain stimulation (called transcranial magnetic stimulation or tms) as a treatment in patients with painful diabetic neuropathy to examine its effects on their understanding of their pain experience.

the proposed brain stimulation technique in this study is an investigational procedure that has not been approved by the u.s. fda for treating pain linked to diabetic neuropathy, but it has been approved to treat depression. the study will use surveys to monitor how participant's body changes as their understanding of their pain experience changes. participants will be randomized (like the flip of a coin) to receive brain stimulation at one of two brain regions which are involved in the processing and understanding of the pain experience.

Eligibility criteria:
inclusion criteria: * patients with type ii diabetes mellitus. * age 18-75 years. * diagnosed by a physician with diabetic neuropathy/ distal symmetric polyneuropathy/ diabetic polyneuropathy. * patients under physician care at virginia commonwealth university health systems in the neurology clinic/ neurology department and the endocrinology clinic * neuropathic pain for at least 3 months. * neuropathic pain signs and symptoms identified using pain detect questionnaire. * current pain score ≥3 or higher (0='no pain' and 10='worst possible pain'). * pain medication dosage stable for at least 4 weeks exclusion criteria: * non-neuropathic chronic pain * another concurrent cause of neuropathic pain * any history of epilepsy, drug-resistant migraine, and/or any presence of ferromagnetic implant, cardiac pacemakers, implanted insulin pumps, neurostimulators, cochlear implants and surgical clips or medical pumps. * limited english proficiency * pregnant patients

Keywords: transcranial magnetic stimulation non-invasive brain stimulation
safety and efficacy study of daclizumab high yield process (dac hyp) to treat relapsing-remitting multiple sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the primary objective of this study is to determine whether dac hyp, when compared to placebo, is effective in reducing the rate of relapses between baseline and week 52. the secondary objectives are to determine whether dac hyp is effective in reducing the number of new gadolinium (gd)-enhancing lesions, reducing the number of new or newly-enlarging t2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.


Eligibility criteria:
key inclusion criteria: * multiple sclerosis (ms) subjects who have a confirmed diagnosis of relapsing-remitting ms according to mcdonald criteria #1-4 and a baseline expanded disability status scale (edss) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria: * have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (mri) demonstrating lesion(s) consistent with ms , or * show evidence of gadolinium-enhancing lesions of the brain on an mri performed within the 6 weeks prior to randomization. key exclusion criteria: * diagnosis of primary progressive, secondary progressive, or progressive relapsing ms * history of malignancy * history of severe allergic or anaphylactic reactions or known drug hypersensitivity * history of abnormal laboratory results based on investigator judgment * history of human immunodeficiency virus (hiv) or other immunodeficient conditions * history of drug or alcohol abuse within the 2 years prior to randomization * an ms relapse that has occurred within the 50 days prior to randomization and/or the subject has not stabilized from a previous relapse prior to randomization * positive screening for active infection with hepatitis b virus or hepatitis c virus * varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening * exposure to varicella zoster virus within 21 days before screening. * abnormal blood tests at screening: hemoglobin ≤9.0 g/dl, platelets ≤100 × 10\^9/l, lymphocytes ≤1.0 × 10\^9/l, neutrophils ≤1.5 × 10\^9/l, alanine aminotransferase/serum glutamate pyruvate transaminase (alt/sgpt), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (ast/sgot), or gamma-glutamyl-transferase \>2 times the upper limit of normal (uln) and serum creatinine \>uln. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: ms multiple sclerosis
increasing exercise capacity of patients with heart failure by wii gaming

Conditions: Heart Failure

Summary: the study objectives are to determine the effectiveness of structured access to a wii game computer compared to motivational support only in heart failure patients on exercise capacity and daily activity. secondly, to determine the effectiveness of structured access to a wii game computer compared to motivational support only in heart failure patients on the combined endpoint of death, readmission and quality of life. the following research questions will be addressed: * what is the effectiveness of structured introduction and access to a wii game computer in patients with heart failure to improve their exercise capacity compared to patients with heart failure in a control group who only receive motivational support? * what is the effectiveness of structured introduction and access to a wii game computer in patients with heart failure compared to patients with heart failure in a control group who only receive motivational support to increase their daily physical activity, decrease health care use and improve quality of life? * what are experiences of heart failure patients and how is their exercise motivation when they are introduced and instructed to play with a wii game computer?

substudy hf-wii plus mediyoga in this substudy medical yoga will be tested in a randomized group next to the wii and the control group in the hf-wii study and therefore the substudy will be called hf-wii plus mediyoga. in addition to the usual treatment and information about rehabilitation and daily activities for heart failure patients, this group will train a 60-minute yoga class twice a week. patients will sit on chairs or yoga mats to perform yoga. each patient will perform a total of 20-24 sessions over a 12-weeks period. a session will include 10 min warm-up and breathing exercises, 40 minutes of yoga postures and finally 10 min relaxation and meditation. at the end of each session, participants have the opportunity to discuss their experiences or questions. at the first visit, participants will receive a cd and a booklet with yoga postures and instructions. patients are encouraged to train medi yoga at home with a target of one session a day. all yoga sessions will be conducted by a certified medicare yoga instructor.

Eligibility criteria:
inclusion criteria: * diagnosed with hf (nyha i-iv) (independent of ejection fraction: both patients with a preserved ejection fraction (hfpef) or reduced ejection fraction (hfref) can be included) * older than 18 years, there is no upper age limit * speak/understand the language of the country where the intervention is taken place exclusion criteria: * the patient is expected to be unable to use the nintendo wii due to visual (see a tv screen at a distance of 3 m) cognitive (assessed by the hf nurse or cardiologist) or motor impairment (the patient should be able to swing his arm at least 10 times in a row) * the patient has restrictions that would them unable patients to fill in data collection material * the patient has a life expectancy shorter than 6 months
vitamin k supplementation to reduce deficiencies in adults with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) patients are at risk for vitamin k deficiencies. supplementation for fat-soluble vitamins a, d, and e is well established, but in cf, there is little data for vitamin k concerning the optimal dose and frequency of supplementation. beyond its known role in coagulation, research has highlighted the role of vitamin k for bone health and the control of blood sugar levels. however, after pulmonary complications, the risk of diabetes and bone diseases are two important and frequent complications of cf. patients with cf being at risk of vitamin k deficiencies, this vitamin could play a role in these complications.

the investigators propose a pilot study (carried out to assess its feasibility on a larger scale) to evaluate if a supplement of vitamin k improves vitamin k serum levels in cf patients by comparing: * group a: a vitamin k supplement of 2mg, every day for 6 months * group b: a vitamin k supplement of 7mg, twice a week for 6 months

Eligibility criteria:
inclusion criteria: * diagnosed with cf * aged above 18 years * pancreatic insufficient * subjects with an ogtt test in the last 12 months or subjects who are diabetic exclusion criteria: * receive or have received, in the last 6 months, a supplement of vitamin k (dose greater than 500 mcg per day) * subjects with a pulmonary function under 30% * subjects with severe gastrointestinal disease (crohn disease, coeliac disease and recent (\<1 year) history of intestinal occlusion). * subjects with a history of liver disease (severe or transplant) * known allergy or intolerance to phylloquinone (oral form of vitamin k) * pregnancy (current or planned in the next 6 months) * subjects with signs of active secondary infections should wait at least 1 month after the end of antibiotic treatment in order to be included in the study.

Keywords: vitamin k supplementation nutrition diabetes