Kornimate/medical-research-clean huggingface dataset:
methotrexate polyglutamate levels as a marker for the clinical outcome in the treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective is to determine whether erythrocyte polyglutamate levels are associated with objective clinical response in patients with rheumatoid arthritis after oral administration of low-dose methotrexate.the secondary aim of this study is to compare the efficacy and safety of standard dose methotrexate versus a higher starting dose.

the folate antagonist methotrexate (mtx) is currently one of the most widely used drugs for the treatment of rheumatoid arthritis (ra).although mtx is very effective and well tolerated, the major drawback is the large interpatient variability in the clinical response.mtx is intracellularly converted by folylpolyglutamate synthetase (fpgs) to methotrexate polyglutamates (mtxpgs), which enhance the intracellular retention of mtx. furthermore, the γ-linked sequential addition of glutamic acid residues inhibits finals steps in the de novo purine and pyrimidine biosynthesis, resulting in anti-proliferative and anti-inflammatory effects.76 adult, mtx-naive patients who fulfill the american college of rheumatology criteria (acr) for ra with a disease activity score in 28 joints (das-28) \> 3.2 are enrolled at two sites in vienna (austria).clinical status is assessed by the number of joint counts and the health assessment questionnaire (haq).patients are randomly assigned to receive either a standard dose or a higher starting dose of 25 mg orally. in week 5, a subcutaneous dose of 25 mg is administered to each patient to get a reference level (bioavailability of 100%).the patients participate for 16 weeks, in which blood samples are collected at weeks 1, 2, 5, 6, 10 and 11 to perform pharmacokinetic analyses and metabolite measurements.the determination of erythrocyte mtxpg-levels is performed by using a hplc technique.the primary outcome is the objective clinical response (measured in a rheumatic score, das-28), secondary outcome parameters are quality of life and routine laboratory parameters used in rheumatology. this clinical outcome will be correlated with mtx pharmacokinetics in blood, mtxpg kinetics in erythrocytes, and their impact on the folate pathway.

Eligibility criteria:
inclusion criteria: * mtx-naive * age \> 18 years * das-28 \> 3.2 * american college of rheumatology-criteria for ra * chest-x-ray * informed consent * prednisolon \< 10 mg a day exclusion criteria: * pregnancy * lactation * renal and hepatic impairment * malignant diseases (last 5 years) * contraindications * human immunodeficiency virus (hiv), hepatitis b and c

Keywords: rheumatoid arthritis mtx polyglutamates clinical outcome
ultrasound visceral slide test for prediction of periumblical adhesions before gynecologic laparoscopic surgery

Conditions: Periumbilical Adhesions

Summary: ultrasound visceral slide test for prediction of periumbilical adhesions before gynecologic laparoscopic surgery: a prospective cohort study. the investigators are planning to conduct a prospective study to evaluate if there is an effect of abdominal wall thickness and body mass index on slide distance of visceral organ during ultrasound examination.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective laparoscopic surgery for any gynecologic indication. exclusion criteria: * emergency laparoscopic surgery * patients under age 18
deoxycholic acid injection for the treatment of superficial lipomas

Conditions: Lipoma

Summary: the purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.

a lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. for the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Eligibility criteria:
inclusion criteria: * one or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics: * history of slow growth followed by dormancy, and stable for at least 6 months. * greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive * discrete, oval to rounded in shape, not hard or attached to underlying tissue * located on the trunk, arms, legs, or neck * stable body weight with a body mass index of less than 30 kg/m² * signed informed consent exclusion criteria: * absence of significant medical conditions that could affect safety * history of surgical treatment for lipomas * treatment with an investigational agent within 30 days before atx-101 treatment
study of extended release niacin/laropiprant on lipids (0524a-067)

Conditions: Primary Hypercholesterolemia; Mixed Dyslipidemia

Summary: this is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed dyslipidemia to study the effects of er niacin/laropiprant on lipids.


Eligibility criteria:
inclusion criteria: * patients 18 to 80 years of age with primary hypercholesterolemia or mixed dyslipidemia * patients will be eligible for the study if their ldl-c values are within protocol specified range and meet other entry criteria exclusion criteria: * patient whose ldl-c values are not within protocol specified range
effect of topical imiquimod on lentigo maligna

Conditions: Lentigo Maligna

Summary: the purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of lentigo maligna (lm) (acquired pigmented macule present for more than 12 months with no change in skin surface texture or contour, no palpability, diameter \>10 mm, sited on the head or neck). the lower anatomical limit is the root of the neck - a line joining the medial end of the clavicles with the medial insertion of trapezius. * histological findings consistent with lm (increased numbers of atypical melanocytes confined to the epidermis, sun damaged skin) in one or more 4mm punch biopsies(s) from the darkest area, reported by a pathologist with expertise in the diagnosis of melanocytic lesions, and part of a recognised nhs skin cancer multi-disciplinary team. * the upper limit of the lesion is not defined by size, but it must be suitable for complete surgical excision using a 5 mm lateral margin. * the outline of the lesion must be easily defined visually in daylight around its entire circumference. * patient fit enough and willing to undergo surgery as required by the protocol. exclusion criteria: * clinical or histological evidence of invasive melanoma including any palpability of the lesion, or clinical and/or histological evidence of regression or dermal invasion * aged less than 45 years * recurrent lm - the index lesion must not have been previously treated * life expectancy of less than 12 months * other skin lesions which may compromise the ability to complete this study, such as co-existing or adjacent melanoma or non-melanoma skin cancer. co-existing adjacent actinic keratoses would not exclude the patient from the study * women of childbearing potential, who are pregnant, plan to become pregnant during their study participation or breastfeeding. * unable to give informed consent. * hypersensitivity to imiquimod or to any of the excipients (methylhydroxybenzoate (e218), propylhydroxybenzoate (e216), cetyl alcohol and stearyl alcohol). * taking immunosuppressive medication. * taking part in any other intervention study.
movement disorder survey in east china

Conditions: Primary Dystonia; Hemifacial Spasm

Summary: movement disorder involve recurring or constant muscle contractions causing squeezing or twisting movement, such as hemifacial spasm, blepharospasm, cervical dystonias etc. the most common focal dystonia was cervical dystonia in western countries according to previous studies, which is different from china in chinese neurologists' opinion. and there is no such survey. so the investigators are conducting a movement disorder survey in east china to confirm it.


Eligibility criteria:
inclusion criteria: * patients seeking treatment in movement disorder clinics(include naive or may have previously been to clinics) exclusion criteria: * patients who have received this movement disorder survey

Keywords: dystonia hemifacial spasm cervical dystonia blepharospasm
efficacy of juc as hand rub evaluated by using european standard 1500

Conditions: Infectious Disease Transmission

Summary: juc is a commercially available wound care spray. it is evaluated for the efficacy when using as a hygienic hand rub following the protocol described in the european standard en 1500:1997 "chemical disinfectants and antiseptics - hygienic handrub - test method and requirement (phase 2/step 2)". a crossover study to compare the juc solution with 60% (v/v) propan-2-ol by using escherichia coli k12 nctc strain 10538 as test organism.

before the intervention, the bactericidal activity of juc was validated in accordance with the pren 12054. a total of 15 volunteers were recruited, hands were washed immediately prior to the intervention. then, both hands of each volunteer were immersed into a contamination fluid of e. coli. then, hand rub was performed with juc or alcohol. culture samples were collected before and after the hand rub by rubbing the fingertips and thumb tips of each hand ont he base of a petri dish containing appropriate medium. the culture inoculation, incubation, appropriate dilutions, and colony count were performed.

Eligibility criteria:
inclusion criteria: * healthy and absence of significant illness exclusion criteria: * visible wounds on hands

Keywords: juc hand rub european standard
comparison of ergon instruments-assisted soft tissue mobilization with compressive myofascial release

Conditions: Plantar Fasciitis

Summary: the objective of this study is to investigate the effects of virtual reality and motor imagery along with routine physical therapy in motor function and balance in patients with parkinson disease.

this randomized control trial is the single blinded, single centered study. standard protocol items: recommendations for interventional trials guidelines are used as study protocol. sixty three patients of parkinson disease (modified hoehn and yahr stages i-iii) will randomly allocate into three groups. group a will be given a 60 min session of virtual reality along with routine physical therapy. group b will be given a 60 min session of motor imagery along with routine physical therapy. group c will be given a 40 min session of routine physical therapy and after a short period of rest,20 min for walking and cycling. these treatment sessions will be given to each group at every alternative day (3 days per week) for 12 weeks. outcome measures are 1. berg balance scale 2. activities specific balance confidence scale 3. the unified parkinson disease rating scale (part iii) the assessments will be recorded at baseline, at 6th and 12th weeks of therapy, and after one month of discontinuation of therapy.

Eligibility criteria:
inclusion criteria: * inability to achieve 20 degrees of active dorsiflexion, * heel pain, * mid foot pain, * heal swelling, * mid foot swelling, * achilles' tendon tightness diagnosed on the base of windlass test exclusion criteria: * recent foot injury, * fracture, * infections, * surgical procedures, * tendon injury, * hypermobility, * neuromuscular disorders, * impaired sensation, * open sores, * skin disease, * active deep vein thrombosis or thrombophlebitis, * bruises, * varicose veins, * burn scars

Keywords: plantar fascitis randomized control trial myofascial release soft tissue mobilization ergon instruments comparison
efficacy of a modified banxia xiexin decoction for the "wei-pi" syndrome (postprandial distress syndrome)

Conditions: Postprandial Distress Syndrome

Summary: the study aims to evaluate the efficacy of a modified banxia xiexin decoction (bxd) for wei-pi through a randomized, waitlist controlled trial.

after being informed about the study plan, potential risk and benefits, all subjects will give written informed consent prior to participation and undergo eligibility screening. eligible participants will be randomized, in a 1:1 ratio, into bxd group and waitlist group.

Eligibility criteria:
inclusion criteria: * permanent resident of hong kong with age from 18 to 60 * have a diagnosis of wei-pi (postprandial distress syndrome, ie. at least one of bothersome postprandial fullness (ie, severe enough to impact on usual activities) and bothersome early satiation (ie, severe enough to prevent finishing a regular-size meal) at least three days per week for the last three months, with symptom onset at least six months before diagnosis exclusion criteria: * pregnancy or pregnancy planners * abnormal liver function (up to twofold the upper normal reference level of alt)\[14\] or kidney function (estimated creatinine clearance \< 80 ml/min)\[15\] * history of diagnosed gastric structural abnormalities through endoscopy /history of gastric removal surgery * have g6pd deficiency * alcohol or drug abuser * taking chinese medicine within one month * unable to read/understand and sign the informed consent document

Keywords: chinese medicine postprandial distress syndrome wei pi banxia xiexin decoction
comparative study of a smartphone-linked self-monitoring system versus a traditional one for improving metabolic control and compliance to self-monitoring of blood glucose

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to demonstrate the superiority of ibgstar as a component of the diabetes treatment vs. traditional blood glucose self-monitoring system for improving glycemic control after 6 months in young patients with type 1 diabetes. the study is intended also to demonstrate the superiority of ibgstar as a component of the diabetes treatment vs. usual blood glucose self-monitoring system for improving the compliance to self monitoring of blood glucose after 6 months.

the planned study duration will be 20 months (5 quarters) with screening/enrollment of 7 months, followed by 2-3 weeks of a qualification phase, a 6 month experimental phase, plus a 6 month follow-up in the post-trial observational phase.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * males and females * age between 14-24 years * any diabetes duration * cared for by the diabetes center for at least 1 year * hba1c ≥ 8% * basal bolus treatment (any insulin) * poor compliance with self-monitoring of blood glucose (less than 30% of the recommended blood glucose measurements recorded in the glucose meter in the two previous weeks, i.e. \<16 blood glucose measurements in the last two weeks) * written informed consent obtained from patient or legal representative (for minor) exclusion criteria: * treatment with other insulin regimen or continuous subcutaneous insulin infusion * refusal or inability to give informed consent to participate in the study * patients with short life expectancy * patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment * requirement for concomitant treatment that could bias primary evaluation * patients with high likelihood of being unavailable for 6 and/or 12 months visits * subject is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study * current addition/abuse of alcohol or drugs * severe visual or dexterity impairment * patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study * pregnant or breast-feeding women * subjects unlikely or unable to comply with the protocol requirements
observation of microvessels and invasion in early colorectal lesions by nbi

Conditions: Colorectal Neoplasms

Summary: combined with magnifying endoscopy,narrow-band imaging (nbi) contrasts microvascular architecture on lesion surface.the histology of early colorectal lesions could be predicted under nbi view.however,its capability for estimating invasion depth remains to be verified.the study is based on the hypothesis:nbi can predict histology and invasion depth,combined with the verification of microvessel count and mmp-7 expression.

the microvessel count (mvc) is a classical method of assessing histologic grade.to verify whether nbi could predict histology through microvascular architecture,we measured lesion microvessels by immunohistochemistry.on the other hand,we applied immunohistochemistry of matrix metalloproteinase-7 (mmp-7) to validate the capability of nbi for estimating invasion depth.mmp-7 is directly involved in the processes of growth, invasion, and metastasis of colorectal cancer.our target was to clarify the diagnostic accuracy of magnifying nbi in early colorectal lesions,combined with the verification of microvessel count and mmp-7 expression.

Eligibility criteria:
inclusion criteria: * patients of early colorectal lesions with capillary pattern(cp) type ii\&iii,initially detected by white-light view and then examined by nbi with magnifying endoscopy. exclusion criteria: * lesions with cp type i; * cp type iii lesions with an obvious appearance of advanced cancer; * lesions that had underwent biopsy; * patients with inflammatory bowel disease(ibd) or familial adenomatous polyposis(fap) * patients with previous colorectal surgery; * having conditions associated with cardiac,hepatic,renal,and coagulopathy diseases.

Keywords: narrow band imaging,microvessels,matrix metalloproteinase-7
cognitive behavioral therapy and chronic pain self-management within the context of opioid reduction: the empower study

Conditions: Chronic Pain

Summary: the proposed study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care. this project will provide patients taking opioids and physicians with the specific evidence they need to choose the most effective route to pain control, reduced pain interference, opioid reduction, and improved role function, thereby improving patient care. the aims of this study are to (1) reduce or contain prescription opioid use while maintaining pain control and (2) compare the effectiveness of the chronic pain self-management program (cpsmp), cognitive behavioral therapy for chronic pain (pain-cbt), and no behavioral treatment within the context of patient-centered collaborative opioid tapering (taper only). the acronym empower stands for effective management of pain and opioid-free ways to enhance relief.


Eligibility criteria:
inclusion criteria: * chronic non-cancer pain (≥ 6 months in duration) * currently receiving prescription opioids (≥ 10 medd) for ≥ 3 months exclusion criteria: * unable to provide informed consent * unable to participate in group treatments in a meaningful way (e.g., evident cognitive impairment or lack of english fluency) * moderate to severe opioid use disorder

Keywords: opioid, taper, behavioral treatment for pain, randomized
the effect of an acute bout of exercise on high-sugar meal induced endothelial dysfunction

Conditions: Endothelial Dysfunction

Summary: the purpose of this study is to determine if postprandial (after a meal) endothelial (inner lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of exercise

endothelial dysfunction is due to an imbalance between vasodilating and vasoconstricting substances produced by the endothelium. an imbalance in these substances limits the ability of the blood vessel to relax in response to a shear stress stimulus. endothelial dysfunction is a major risk factor for cardiovascular disease. high-sugar intakes result in postprandial hyperglycemia and endothelial dysfunction. exercise may attenuate the endothelial dysfunction induced by a high-sugar meal. there are only two studies that have examined the effect of exercise on endothelial dysfunction induced by high-sugar intake. both studies found that a bout of aerobic exercise attenuated the impaired flow mediated dilation induced by high-sugar ingestion. neither study measured important markers of endothelial dysfunction such as blood nitric oxide, endothelin i, and angiotensin ii concentrations, however. in addition, whether the same results apply to older post-menopausal women is unknown. understanding how acute exercise affects meal-induced endothelial dysfunction in older women is important given that age is related to endothelial dysfunction and cardiovascular disease.

Eligibility criteria:
inclusion criteria: * post-menopausal women * must be 45-70 years exclusion criteria: * use of medications or supplements to lose weight * following a weight loss diet * smoking * heavy alcohol consumption * diabetes * heart disease * stroke * liver disease * kidney disease * untreated thyroid disease * anemia * uncontrolled hypertension * pulmonary disease that prevents exercise * orthopedic problems that prevents exercise * arthritis problems that prevent exercise * musculoskeletal problems that prevent exercise.
efficacy study of zd6474 to treat multiple myeloma cancer

Conditions: Multiple Myeloma

Summary: the primary objective is to assess the efficacy of zd6474 when given orally to patients with relapsed multiple myeloma. a minimum of 15 and a maximum of 30 evaluable patients will be entered on study


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma. * patients must have a minimum serum m-protein level \>=10g/l on serum protein electrophoresis or for patients with light chain only disease, a minimum bence-jones protein of 1g/24 hr. * patients must have received prior treatment for multiple myeloma: patients may have received 1 or 2 prior regimens of oral alkylating based chemotherapy and must have relapsed following treatment (\>= 3 months) or patients may have relapsed following high dose chemotherapy and sct as first line treatment provided they have not had any other treatment. * lab at inclusion of agc \>= 1.0 x10_9/l and platelets \>= 50 x10_9/l bilirubin, ast and/or alt \ = 4.0 mmol/l; calcium and magnesium within normal limits· * patients may not have had \> 2 prior regimens of chemotherapy and/or prior thalidomide treatment. * patients may not have had any non-alkylating based chemotherapy. exclusion criteria: * patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \>= 5 years. * pregnant or lactating women. women of childbearing potential must have a negative pregnancy test within 7 days prior to registration and must be using effective contraception throughout the study. * patients who have relapsed during treatment with oral alkylating chemotherapy. * patients who have received more than 2 prior regimens of chemotherapy. * patients who have received excluded medication or have excluded medical conditions. * patients who have received any non-alkylating based chemotherapy regimens as initial therapy, or as therapy for recurrent disease.

Keywords: relapsed multiple myeloma