Kornimate/medical-research-clean huggingface dataset:
pain neuroscience education and physical exercise program in fibromyalgia

Conditions: Fibromyalgia

Summary: this study evaluates the effects of a pain neuroscience education (pne) and physical exercise (pe) program in women with fibromyalgia. the intervention group receives pne and pe program supervised by a physiotherapist and a family doctor and the control group standard care, in primary care.

objectives: to evaluate the effectiveness of a pne and pe in patients with fibromyalgia (fm). design: quasi-experimental, controlled, non-randomized study, in primary care facilities. intervention: 6 weekly sessions (2 hours each), and a reminder session one month later. main measurements: compliance with fm criteria, assessed using the widespread pain index (wpi) and the severity of symptoms (ss) questionnaires, impact of fm in daily life (fibromyalgia impact questionnaire: fiq) and quality of live. assessments are made at baseline, one month following the 6th session, and during the 6- and 12-month follow-up.

Eligibility criteria:
inclusion criteria: * women with fm (2010 american college of rheumatology diagnostic criteria for fibromyalgia) * women ≥ 18 years * agree to participate in the study and sign informed consent. exclusion criteria: * oncological pain * motor control alteration that prevents the execution of the planned pe program * patients with associated pathologies that make it impossible to perform physical exercise program * any disabling mental illness or intellectual deficit that prevents understanding the contents of pne program

Keywords: central nervous system sensitization chronic pain fibromyalgia neuroscience patient education
a study to evaluate 608 in patients with non- radiographic axial spondyloarthritis (nr-axspa)

Conditions: Axial Spondyloarthritis

Summary: this study will evaluate the effect and safety of 608 in patients with nr-axspa.

the purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo in patients with nr-axspa.

Eligibility criteria:
inclusion criteria: 1. female and male patients at least 18 years of age at the time of screening. 2. diagnosis of axial spondyloarthritis according to ankylosing spondylo arthritis international society (asas) axial spondyloarthritis criteria 3. objective signs of inflammation (magnetic resonance imaging (mri) or abnormal c-reactive protein) 4. total back pain as measured by nrs ≥ 4 at baseline exclusion criteria: 1. patients with other uncontrolled active inflammatory diseases. 2. clinical laboratory tests and other tests that reveal abnormalities with clinical significance 3. patients who have active hepatitis b, hepatitis c or hiv infections as determined by positive results at screening. 4. history of cancer. 5. known or suspected history of immunosuppression. 6. known with allergic or intolerant to mometasone furoate spray or 608/placebo.

Keywords: non-radiographic axial spondyloarthritis
microbiological characterization and nasal carriage rates of methicillin resistant staphylococcus aureus (mrsa) in vancouver downtown eastside

Conditions: Nasal Colonization With MRSA Bacteria

Summary: we plan to compare data from 300 nasal swab in vancouver's downtown eastside taken in 2001 to data obtained in 2005. the nasal carriage rate of mrsa and the specific characteristic of each mrsa found will be analyzed. a limited amount of associated information will be obtained

mrsa samples will be characterized by pulse field gel electropheresis. an 9 item questionnaire will be administered.

Eligibility criteria:
inclusion criteria: patient had a microbiological sample submitted from the emergency department of the study hospital from 2001- 2005 which grew mrsa. exclusion criteria:

Keywords: mrsa, usa300, cmrsa-10, cmrsa-6, soft tissue abscesses
imiquimod 5% cream in the treatment of external genital or perianal warts in hiv+ patients

Conditions: Warts

Summary: imiquimod 5% cream in the treatment of external genital or perianal warts in hiv+ patients

to evaluate the percentage of hiv+ subjects successfully treated with haart, with total clearance (100%) of baseline external genital or perianal warts within 16 weeks of treatment with imiquimod 5% cream.

Eligibility criteria:
inclusion criteria: 1. subject able to understand and willing to give written informed consent. 2. subject ≥ 18 and \< 70 years of age. 3. male or female with an hiv infection documented by serology (enzyme linked immunoabsorbent assay (elisa)), western blot assay, or hiv viral load. 4. treated with haart for at least six months and compliant with the treatment. 5. evidence of efficacy of haart: total cd4+ lymphocyte counts of ≥ 200 cells/mm3 and plasma hiv rna level \< 104 rna copies/ml within four weeks prior to the treatment initiation visit. 6. presence of at least one visible genital or perianal wart as determined by clinical diagnosis. 7. total wart area \> 10 mm2 and ≤ 4000 mm2 (diameter \> 0.4 cm and ≤ 7.1 cm) 8. karnofsky performance status ≥ 70 %. 9. accepting to abstain from sexual intercourse when study drug is on the skin. 10. in case of a coexisting aids-defining illness, both this illness and any treatment being received for it must have been stable for the four weeks preceding enrolment in the trial. 11. if female and of childbearing potential, have negative urine pregnancy tests, and willing to use a medically acceptable method of contraception during the 16-week treatment period. subjects were considered to be of childbearing potential unless the uterus or both ovaries had been removed or they were two or more years postmenopausal. for this study, the following were considered to be acceptable methods of contraception: * surgical sterilization, defined as tubal ligation of the subject or a vasectomy of the subject's partner if that subject is in a monogamous heterosexual relationship (at the investigator's discretion) * oral, injectable, or implantable contraceptives * condoms (with spermicide) * diaphragm/cervical cap (with spermicide) * intrauterine devices (iuds) * complete abstinence (at the investigator's discretion) exclusion criteria: 1. women pregnant or lactating; 2. treatment within four weeks prior to the treatment initiation visit and throughout the entire study with: * any genital wart therapy, or immunomodulators * systemic antiviral drugs other than acyclovir, valacyclovir, or famcyclovir and other than haart

Keywords: external genital and perianal warts
pilot study of ursodesoxycholic acid in non-alcoholic steatohepatitis

Conditions: Serum Levels of ALAT Transaminases; Serum Markers for Fibrosis and Hepatic Inflammation

Summary: this is a phase ii study with direct individual benefit. it is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed with non-alcoholic steatohepatitis. the hepatoprotective effects of ursodesoxycholic acid may ameliorate the hepatic impairment associated with non-alcoholic steatohepatitis leading to subsequent significant decreases in transaminase elevations and non-invasive markers for hepatic fibrosis a positive response is defined as a significantly larger decrease in average alat levels between the time of inclusion in the study and the end of the treatment for the ursodesoxycholic acid group as compared to the placebo group. the duration of the study will be 12 months. an end of treatment evaluation (eot) will take place at the end of the 12th month of treatment.


Eligibility criteria:
inclusion criteria: * greater than 18 years of age. * hepatic biopsy consistent with non-alcoholic steatohepatitis: presence of \>20% steatosis associated with hepatocyte swelling and/or intralobular necrosis within the last 18 months. * serum levels of alat and/or asat \> 50 ui/l at the time of screening (with at least 3 elevated transaminase values within the last 12 months). exclusion criteria: * hepatic biopsy not performed within the last 18 months. * a single normal transaminase value within the last 12 months. * treatment with ursodesoxycholic acid within the last 12 months. * loss of more than 15% body weight between the time of the liver biopsy and the time of screening. * alcohol consumption of \>20 g/day for women and \> 30 g/day for men * hepatitis from other causes: chronic viral hepatitis b or c, elevated ferritin levels associated with c282y homozygosity, primary biliary cirrhosis, primary sclerosing cholangitis, well documented auto-immune hepatitis (specific autoantibodies, hypergammaglobulinemia, consistent histologic changes), alpha1 antitrypsin deficiency, wilson's disease, hiv infection. * nash from secondary causes: long term amiodarone administration, corticosteroid therapy, anti-obesity surgery within the last 2 years, tamoxifen. * child's type b or c cirrhosis. * presence of hepatocellular carcinoma. * treatment with rosiglitazone or pioglitazone currently or during the 3 preceding years, treatment with vitamin e within the 6 months prior to screening. * women who are pregnant or nursing. * unavailability of hepatic biopsy slides for centralized interpretation.
haemodynamics and function of the atria in congenital heart disease by cardiovascular magnetic resonance

Conditions: Coarctation of the Aorta; Tetralogy of Fallot; Transposition of the Great Arteries

Summary: the purpose of this study is to determine whether patients with repaired congenital heart disease show differences in size or function of their heart atria compared to normal controls and depending on the nature of their heart disease.

atrial function is important for good ventricular filling and function. in patients with impaired cardiac function, atrial contraction is even more important. so far, the size and function of the atria have been assessed two-dimensionally by angiography and by echocardiography. however, these do not allow exact characterization of the volumetric changes of the atria during the cardiac cycle. recently, cardiac magnetic resonance (cmr) has been used to assess size and function of the left atrium in adults. little data are available about function and volume of the atria in children and the role of the atria in congenital heart disease (chd). the study will recruit patients with chd (n=40) and normal controls (n=10). the patient group will be composed by patients suffering from the following conditions: coarctation of the aorta (n=10), tetralogy of fallot (n=10), transposition of the great arteries after atrial switch (senning procedure) (n=10), transposition of the great arteries after arterial switch operation (n=10). the study consists of measurements of sizes and function of the right and the left atrium, respectively, by examining three-dimensional volume changes across the heart cycle, and of phase contrast measurements of blood flow across the valves of the heart.

Eligibility criteria:
inclusion criteria: * ability to perform repetitive breath holds of 10-15 seconds each * written informed consent of the patients or their legal guardians exclusion criteria: * patients requiring general anaesthesia * residual cardiac findings which might potentially influence the size and function of the atria

Keywords: atria, heart function, atrial heart defects, congenital cardiovascular abnormalities congenital abnormalities tetralogy, fallot transposition of great arteries coarctation of the aorta
treatment of early nasal polyposis with topical triamcinolone

Conditions: Nasal Polyps

Summary: the purpose of this study is to compare the effectiveness of intranasal triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis.

nasopore, a bio-absorbable nasal dressing, may offer an alternative route of sustained steroid drug delivery. the use of topical targeted intranasal steroids may prevent the routine adverse effects of oral steroids while maintaining the same therapeutic / clinical efficacy.

Eligibility criteria:
inclusion criteria: * age \> 18 years * patients with early nasal polyposis exclusion criteria: * age \< 18 years * patients with active sinus infections * patients on long term steroids * allergy or sensitivity to steroids * patients with antrochoanal polyps * patients who received topical steroids by bio-resorbable sponge or oral steroids

Keywords: treatment
sensory changes from chest drains

Conditions: Thoracotomy; Chronic Pain

Summary: does chest drains contribute to the post thoracotomy pain syndrome


Eligibility criteria:
inclusion criteria: * age \> 18 * able to cooperate * able to speak and read danish exclusion criteria: * repeat surgery * cognitive dysfunction * other nerve injury on the thorax * abuse (medicine/ alcohol etc)

Keywords: thoracotomy chronic pain persistent post-surgical pain
determining disease activity biomarkers in individuals with takayasu's arteritis

Conditions: Takayasu's Arteritis

Summary: takayasu's arteritis is a rare disorder that causes swelling and damage to the large arteries in the body, such as the aorta. in order to ensure proper treatment, measuring disease activity is critical. the purpose of this study is to establish new biological markers (biomarkers) to assess the severity of disease in people with takayasu's arteritis.

takayasu's arteritis is a chronic inflammatory condition that affects the aorta, the largest blood vessel in the body, and its branches. inflammation causes segments of the vessels to become narrowed, blocked, or even stretched, possibly resulting in aneurysms. the disease is very rare but most commonly occurs in young asian women. symptoms may include arm pain with use, decreased or absent pulses, lightheadedness or dizziness, headaches, and visual disturbances. many individuals with takayasu' arteritis, however, have no apparent symptoms despite disease activity. additionally, current tests used to measure vessel inflammation are considered unreliable and inconsistent. it is therefore very difficult to determine the extent of disease activity in a person with takayasu's arteritis. this study will use novel scientific methods to establish new biomarkers that can be used to monitor disease activity in individuals with takayasu's arteritis. these biomarkers may be used to help direct clinical care and assist in future drug development. study visits will occur monthly for the first year, then every 3 months thereafter for the remainder of the study. blood and urine collection will occur at every visit. a physical examination, disease assessment, and review of medications will occur every 3 months; participants may also be asked to complete various questionnaires. diagnostic testing, which may include chest radiograph, echocardiogram, magnetic resonance imaging, or angiography, will occur every 6 months. tobacco, alcohol, and drug use will be assessed on a yearly basis. participants may have additional study visits if a disease flare or disease-related complications occur during the study.

Eligibility criteria:
inclusion criteria: * evidence of arteriogram abnormalities compatible with takayasu's arteritis (includes conventional dye angiography, magnetic resonance angiography, or computed tomography angiography) * evidence of one of the following criteria: 1. age at disease onset of 50 years or younger 2. claudication of the arms or legs 3. decreased brachial artery pulse (one or both arteries) 4. blood pressure difference between the arms of at least 10 mm hg 5. bruit over the subclavian arteries or aorta * parental consent for children under the age of 18 exclusion criteria: * arteriographic lesions that could be entirely due to atherosclerosis * fibromuscular dysplasia * cogan's syndrome * behcet's disease * sarcoidosis * kawasaki disease * giant cell arteritis (large vessel vasculitis and at least 50 years old) * syphilis or other infectious forms of large vessel vasculitis

Keywords: vasculitis
urine ph and urinary tract infection

Conditions: Urinary Tract Infections; Urinary Stone

Summary: urinary tract infections (uti) affect the urine ph and may lead to salt precipitation such as struvite. bacteria with urease activity are known to alkalinise urine, but not much is known on how ph is changing over time during uti. this study aims at following urine ph progression at the time of diagnosis of uti and during the treatment phase. description of the change in urine ph over time will help understanding the risk of struvite formation and potential timing of intervention.

adults presenting with uti symptoms will be screened for infection and instructed to monitor urine ph during the course of treatment and 1 week after. urine ph will be measured by the patients using calibrated ph-stix. type of bacteria, antibiotics, and the type of diet will be monitored during the study.

Eligibility criteria:
group 1. cystitis inclusion criteria: * symptoms of dysuria, pollakiuria, no fever and * urine-stix positive for leucocytes or positive culture (\>10e5 cfu/ml) group 2. pyelonephritis inclusion criteria: * unilateral flank pain, pollakiuria, dysuria, fever (\>38.5°c) and * urine-stix positive for leucocytes or positive culture (\>10e5 cfu/ml) exclusion criteria (both groups): * known urinary tract anatomic abnormalities * presence of a urine catheter * sepsis - septic shock * patient taking drug interfering with urine ph (diuretics, citrate, acetazolamide, topiramate,...) * patients with uti diagnosed in the preceding month * patients having received antibiotics during the preceding month * male patient with a diagnosis of prostatitis * presence of infected kidney cyst * patient with diabetes * pregnant female * patient with obstructive pyelonephritis

Keywords: urine ph
study evaluating efficacy and safety of pf-04965842 in subjects aged 12 years and older with moderate to severe atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: b7451013 is a phase 3 study to evaluate pf-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. the efficacy and safety of two dosage strengths of pf-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * 12 years of age or older with a minimum body weight of 40 kg * diagnosis of atopic dermatitis (ad) for at least 1 year and current status of moderate to severe disease (\>= the following scores: bsa 10%, iga 3, easi 16, pruritus nrs severity 4) * recent history of inadequate response or inability to tolerate topical ad treatments or require systemic treatments for ad control exclusion criteria: * unwilling to discontinue current ad medications prior to the study or require treatment with prohibited medications during the study * prior treatment with jak inhibitors * other active nonad inflammatory skin diseases or conditions affecting skin * medical history including thrombocytopenia, coagulopathy or platelet dysfunction, q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator * pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Keywords: atopic dermatitis atopic eczema eczema jak janus kinase
experimental therapeutics in essential tremor using cerebellar transcranial direct current stimulation

Conditions: Essential Tremor

Summary: the purpose of this study is to determine whether transcranial cathodal direct current stimulation (tdcs) delivered over the cerebellum can improve essential tremor.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 65 years * important essential tremor (bilateral postural and/or action tremor since more than one year) * normal physical and neurological examination, except for essential tremor * insufficient efficiency of usual essential tremor's treatment * no treatment altering the cortical excitability * agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential * mini-mental status score \>24 exclusion criteria: * age \ 65 years * current neurological or psychiatric illness other than essential tremor * individual who is on medication which is known to lower seizure threshold * previous history of seizure, loss of conciousness or current active epilepsy * contraindication for mri or tms study * intake of antiepileptic medications for essential tremor (barbiturates, gabapentine, topiramate, clonazepam), within the 7 days preceeding the first visit * alcohol intake within the 24 hours preceeding the first visit * pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control * individual who have mms ≤ 24/30 or patients legally protected or inability to provide an informed consent * simultaneous participation in another clinical trial * patients who are not enrolled at social security

Keywords: essential tremor cerebellum transcranial direct current stimulation electrophysiology
placebo-controlled trial with vitamin d to prevent worsening/relieve aromatase inhibitor-induced musculoskeletal symptoms in breast cancer patients

Conditions: Breast Cancer; Musculoskeletal Disease

Summary: the third generation oral aromatase inhibitors (ais) are increasingly being used in the management of estrogen receptor positive breast cancer. one of the issues related with administration of oral ais is their side effects, particularly on the musculoskeletal system. although the prevalence and importance of arthralgia and myalgia occurring in bc patients receiving adjuvant ais are evident, the mechanisms clearly explaining these invalidating symptoms are unknown. in this project, we aim to unravel the interaction between vitamin d and musculoskeletal adverse events experienced by ai users. we will also evaluate how vitamin d supplementation affects ai-induced musculoskeletal symptoms in breast cancer patients, by means of a randomized placebo-controlled double blind clinical trial. we will assess changes in the musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and also monitor serum igf-i and estrogen levels together with bone resorption and formation markers.


Eligibility criteria:
inclusion criteria: * postmenopausal status * currently being treated with an ai in the adjuvant setting (minimum for 8 weeks) * aimss as determined by new or worsened musculoskeletal complaints following ai therapy * vitamin d deficiency (\<30ng/ml) * caucasian exclusion criteria: * hormone replacement therapy last 6 months * current use or in the last 12 months of bisphosphonates * tamoxifen use in last 6 months * history of kidney stones * history of hypercalcemia/hypercalciuria or hyperthyroidism * paget's disease of the bone * current use of digitalis/digoxin or thiazide diuretics * current use of vitamin d (or multivitamin) supplementation should be stopped