Kornimate/medical-research-clean huggingface dataset:
validation of the identification of functional ankle instability (idfai) in italian

Conditions: Ankle Sprains

Summary: the purpose of the study is actually the translation, cultural adaptation and psychometric validation in the italian version of the identification of functional ankle instability (idfai) english version for use in outpatient clinics in non-english subjects to objectify chronic ankle instability.

the hypothesis is to translate and culturally adapt the scale successfully and demonstrate a good factorial structure and psychometric properties, replicating the results of the original english version of the questionnaire

Eligibility criteria:
participants without ankle sprain. 1. age ≥ 18aa 2. speak italian on a daily basis 3. no pathologies or surgical treatments in the lower limbs currently or in the past participants with ankle sprain. inclusion criteria 1. age ≥ 18aa 2. speak italian on a daily basis 3. at least one ankle sprain 4. recurrent sprain to the same ankle and/or sensation of ankle instability and/or 'giving way' exclusion criteria 1. inability to understand written italian 2. acute lower extremity injury occurred in the three months preceding the compilation of the questionnaire 3. history of others lower extremity musculoskeletal diseases or injuries of other joints (i.e, hip, knee), previous ankle fractures or systemic pathologies (i.e., neurological disorders, rheumatoid arthritis) currently or in the past 4. history of surgical treatments in either lower limb (bones, joints, nerves)
complementary/integrative medicine for brain cancer patients

Conditions: Quality of Life; Chemotherapeutic Toxicity; Radiation Toxicity

Summary: nearly a quarter of a million patients are diagnosed each year with tumors of the central nervous system, a third of them malignant. the most common malignant tumor of the brain is the high grade glioma( hgg), whose treatment begins with surgical resection of the tumor, followed by a combined chemo-radiation regimen, with the drug temodal (temozolomide). this treatment is often accompanied by toxic effects (e.g., nausea, headache, constipation, weakness/fatigue, and others), with treatment of these effects limited in their effectiveness and safety. complementary medicine treatments such as acupuncture and touch therapies (reflexology, shiatsu, etc.) have been researched and found to be both safe and effective for some of the toxic effects of oncology treatment regimens. the present pilot study is set to examine the impact of complementary medicine on the toxic effects of the conventional treatment for hgg. the study will include 40 patients and will last for two years, during which patients will be treated with acupuncture and/or touch therapies, this in parallel to their chemo-radiation regimen. the primary study outcome will be the scores on four patient-reported outcome measures (proms): the measure yourself concerns and wellbeing (mycaw) study tool; the functional assessment of cancer therapy, brain cancer (fact-br) questionnaire; the edmonton symptom assessment scale (esas); and the european organization for research and treatment of cancer quality of life questionnaire (eortc qlq-c30). secondary study outcomes will include the safety of the complementary medicine treatments, and adherence to the planned oncology treatment regimen, as measured by the relative dose intensity (rdi) calculation.


Eligibility criteria:
inclusion criteria: * patient aged 18 years and older * diagnosed with high grade glioma (stage iii-iv) * following surgical intervention (tumor resection) * prior to chemo-radiation treatment * signing of informed consent form exclusion criteria: * inability/unwillingness to sign informed consent form * unwillingness of treating oncologist to allow participation in the study

Keywords: complementary/integrative medicine glioblastoma quality of life adherence
study investigating the effect of everolimus monotherapy in patients with advanced non-small cell lung cancer (nsclc)

Conditions: Non-small-cell Lung Carcinoma

Summary: this study will evaluate the efficacy and safety of everolimus treatment of patients with advanced nsclc. the rationale for investigating everolimus in advanced nsclc previously treated with chemotherapy or chemotherapy plus egfr inhibitors, like gefitinib or erlotinib, is based on following: * the medical need for the better therapy for advanced nsclc and limited efficacy of the currently available therapy in advanced nsclc. * postulated association of relevant cell-signaling pathways targeted by everolimus with different aspects of oncogenesis, disease progression, and response/resistance to treatment. * effectiveness of everolimus and rapamycin in preclinical models of lung cancer * early reports of clinical responses to monotherapy with mtor inhibitors in advanced nsclc. there is evidence that an enhanced pi3k/akt/mtor pathway, which is inhibited by everolimus, may be one of the key changes accounting for different aspects of oncogenesis, disease progression, and response/resistance to nsclc cancer treatment. the use of the mtor inhibitor everolimus in treatment of advanced nsclc would be a novel therapeutic approach that proposes to logically manipulate the cell's regulatory pathways to enable control of tumor growth.


Eligibility criteria:
inclusion criteria: * patients with advanced (unresectable or metastatic) nsclc * tissue sample of the metastatic or primary tumor available for pathology evaluation and molecular marker analyses * patients who have received ≤ 2 chemotherapy regimens, one of which must have included cisplatinum or carboplatin, and who have documented evidence of tumor progression (arm 1) * patients who have received ≤ 2 chemotherapy regimens, one of which must have included cisplatinum or carboplatin as well as a small molecule egfr inhibitor (as a separate regimen) with documented tumor progression despite at least 4 weeks therapy with either gefitinib or erlotinib (arm 2) exclusion criteria: * concurrent therapy with agents used otherwise as anticancer therapy (for example, methotrexate for rheumatoid arthritis) * any investigational drug, other than egfr inhibitor (arm 2), within the preceding 4 weeks * chronic treatment with steroids or another immunosuppressive agent * uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases other protocol-defined inclusion/exclusion criteria may apply

Keywords: lung cancer non-small cell everolimus non-small cell lung cancer (nsclc)
study of subcutaneous golimumab in chinese patients with active rheumatoid arthritis despite methotrexate therapy

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety and efficacy of golimumab in chinese patients with rheumatoid arthritis.

golimumab is a type of tumor necrosis factor (tnf)-inhibitor. tnf is a naturally occurring substance in the body, and this substance may cause long-term inflammation. golimumab may help fight disease by blocking the activity of tnf in the body and reducing inflammation and pain. each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). the chance that the patient will get golimumab is 1 to 1, a 50% chance to receive golimumab and a 50% chance to receive placebo. if the patient does not have an improvement in their joints at the week 16 visit compared to when they entered the study, and are in group 1 (placebo group), the patient will receive golimumab 50 mg every 4 weeks starting at week 16. if the patient is in group 2 (golimumab 50 mg), the patient will continue to receive golimumab every 4 weeks starting at week 16. if the patient is in group 1 and is still receiving placebo injections, because there was improvement in their joints at week 16, the patient will receive golimumab 50 mg every 4 weeks starting from week 24. if the patient is in group 2 (golimumab 50 mg) or is already receiving golimumab injections at week 24, the patient will continue to receive golimumab every 4 weeks. safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (e.g., blood pressure), and the frequency and type of adverse events (side effects). the patient will be in the study approximately 56 weeks. patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks from randomization (week 0) until week 48.

Eligibility criteria:
inclusion criteria: - diagnosis of rheumatoid arthritis for at least 6 months * be on a stable dose of methotrexate for 4 weeks * have at least 4 swollen and 4 tender joints exclusion criteria: * prior exposure to biologic anti-tnfalpha agents * inflammatory diseases other than rheumatoid arthritis * treatment with disease modifying anti-rheumatic drug (dmards)/systemic immunosuppressives other than methotrexate during the 4 weeks prior to the first administration of study agent * history of, or ongoing, chronic or recurrent infectious disease

Keywords: rheumatoid arthritis injection golimumab simponi
an open-label, multicentre, long-term extension study of etanercept in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the primary objective of this study was to determine the long-term safety of etanercept in adults with as who had completed study 0881a3-311-eu.

this was an open-label, multicenter extension study that was conducted to evaluate the safety and efficacy of etanercept in the treatment of adult subjects with as who had completed study 0881a3-311-eu. the study consisted of an open-label treatment period of up to approximately 96 weeks.

Eligibility criteria:
1. completed the entire 12 weeks of therapy in study 0881a3-311-eu, or completed at least 8 weeks of therapy and returned for the week 12 visit in study 0881a3-311-eu. 2. negative serum β-hcg pregnancy test at baseline (all women of childbearing potential). 3. sexually active women of childbearing potential had to use a medically acceptable form of contraception. medically acceptable forms of contraception included oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. additionally, the use of condoms was suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy. 4. sexually active men had to agree to use a medically accepted form of contraception during the study. 5. able to reconstitute and self-inject test article or have a designee who can do so. 6. capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed. 7. able to store injectable test article at 2°c to 8°c.
phase iiib, open-label, multi-center study to evaluate safety, tolerability and efficacy of oav101 administered intrathecally to participants with sma who discontinued treatment with nusinersen or risdiplam

Conditions: Spinal Muscular Atrophy

Summary: this was a phase iiib open-label, single arm, multi-center study to evaluate the safety, tolerability and efficacy of oav101b in participants with sma aged 2 to \<18 years after the discontinuation of treatment with nusinersen or risdiplam. the study aimed to enroll approximately 28 participants across each of 2 age brackets (2 to \<6 years, and 6 to \<18 years).

eligible participants received a single oav101b administration of 1.2x1014 vector genomes on day 1 (treatment period) and were followed for a period of 52 weeks. participants were admitted to the hospital on day -1 for pre-treatment baseline procedures. after receiving oav101b on day 1, participants underwent in-patient safety monitoring over the next 48 hours, after which the participant could be discharged, based on investigator judgment.

Eligibility criteria:
inclusion criteria * sma diagnosis * aged 2 to \< 18 years * have had at least four loading doses of nusinersen (spinraza®) or at least 3 months of treatment with risdiplam (evrysdi®) at screening * must have symptoms of sma as defined in the protocol exclusion criteria: * anti adeno associated virus serotype 9 (aav9) antibody titer using an immunoassay is reported as elevated * clinically significant abnormalities in test results during screening * contraindications for lumbar puncture procedure * at baseline, participants are excluded if they received: * nusinersen (spinraza®) or * risdiplam (evrysdi®) within a defined timeframe * vaccinations 2 weeks prior to administration of oav101 * hospitalization for a pulmonary event, or for nutritional support within 2 months prior to screening or inpatient major surgery planned. * presence of an infection or febrile illness up to 30 days prior to administration of oav101 * requiring invasive ventilation

Keywords: zolgensma oav101 avxs 101 gene therapy muscle atrophy sbma spinal and bulbar muscular atrophy spinal muscular atrophy bulbar muscular atrophy muscle function myopathy muscle wasting atrophied muscle loss of muscle strength sma
pilot study on pulsed electromagnetic field therapy for osteosarcopenia

Conditions: Sarcopenia; Osteopenia or Osteoporosis

Summary: this prospective, single-site, single arm pilot study aims to assess the efficacy of pulsed electromagnetic field (pemf) exposure in the reduction of the decline in muscle strength, function and bone mineral density (bmd) in osteosarcopenia.

this prospective, single-site, single-arm pilot study aims to assess the efficacy of pulsed electromagnetic field (pemf) exposure in the reduction of the decline in muscle strength, function and bone mineral density (bmd) in osteo-sarcopenia. for this pilot study, we will recruit 80 participants aged 65 years old and greater with osteo-sarcopenia, to receive pemf therapy, at 1.5mt, once a week for 10 min to alternate lower limb (10 mins each week) weekly for 16 weeks. participants will be followed up at baseline, 4, 8 and 12 and 17 weeks. at each follow-up, falls risk will be assessed by short physical performance battery (sppb), including 6-minute walk and 5 sit-to-stand tests, falls efficacy scale international (fesi), 3min-ns (3 minute nutritional screening) and sarc-f (strength, assistance with walking, rise from chair, climb stairs and falls) questionnaires. muscle strength (hand grip and leg extension) and calf diameter are measured. blood tests, saliva tests, and dexa scans will be done at baseline, immediately after first pemf exposure and week 17 to determine changes in biomarkers for senescence, bone/fat/muscle composition and skeletal muscle mass.

Eligibility criteria:
inclusion criteria: 1. age 65 years old and above, which corresponds to the geriatric patient population seen at the healthy ageing clinics and wards 2. diagnosed with primary osteopenia, including primary osteoporosis, by bmd measurements on dexa scans 3. diagnosed with sarcopenia by sarc-f 4. willing and able to give written informed consent exclusion criteria: 1. presence of metallic implants, pacemakers or insulin pumps 2. presence of rheumatological disease (such as osteoarthritis or rheumatoid arthritis) 3. presence of secondary osteoporosis (such as hyperparathyroidism, steroid-induced osteoporosis) 4. presence of end-stage organ failure, including severe dementia or cancer 5. pregnant women
ph 1b trial with adi-peg 20 plus nab-paclitaxel and gemcitabine in subjects with pancreatic cancer

Conditions: Advanced Pancreatic Cancer

Summary: assessment of safety and tolerability of adi-peg 20 plus nab-paclitaxel and gemcitabine in subjects with advanced pancreatic carcinoma.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of pancreatic carcinoma (dose escalation and mtd expansion components). 2. subjects in the dose-escalation component can have had up to 1 prior line of systemic therapy. subjects with pancreatic carcinoma to be enrolled in the mtd expansion cohort must have untreated, measurable metastatic disease. subjects for the mtd cohort may have received prior adjuvant gemcitabine or fluoropyrimidine based therapy in the adjuvant setting provided more than 6 months has elapsed following completion of adjuvant therapy. 3. unresectable disease or subject refused surgery. 4. progressive disease if treated with chemotherapy, radiotherapy, surgery or immuno-therapy. if prior radiation was given, the measurable disease should be outside the radiation port. 5. measurable disease as assessed by recist 1.1 criteria (appendix a). 6. age ≥ 18 years. 7. ecog performance status of 0 - 1. 8. no prior systemic therapy, immunotherapy, investigational agent, or radiation therapy within the last 4 weeks. radiation therapy for symptomatic relief is allowed within the last 2 weeks. exclusion criteria: 1. serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment. 2. serious underlying lung function abnormality due to the risk of fatal pneumonitis that was caused by the combination of abraxane and gemcitabine 3. grade 2 or higher neuropathy (ctcae v4.0) 4. prior treatment with nab-paclitaxel. 5. pregnancy or lactation. 6. expected non-compliance. 7. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association class iii or iv), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements. 8. subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ grade 1 aes, or deemed irreversible from the effects of prior cancer therapy. aes \> grade 1 that are not considered a safety risk by the sponsor and investigator may be allowed upon agreement with both, including residual neuropathy.

Keywords: argininosuccinate synthetase arginine arginine deiminase
vildagliptin compared to gliclazide as dual therapy with metformin in muslim patients with type 2 diabetes fasting during ramadan

Conditions: Type 2 Diabetes Mellitus

Summary: to evaluate vildagliptin as compared to gliclazide, given in combination with metformin in muslim patients with type 2 diabetes fasting during ramadan.


Eligibility criteria:
inclusion criteria: * confirmed type 2 diabetes diagnosis * plan to fast during ramadan * treated with a combination of metformin and an sulfonylurea (su) for at least 12 weeks and hba1c ≤8.5% at visit 1 * taking a sulfonylurea treatment for less than 3 years prior to visit 1 * body mass index (bmi) ≥22 and ≤45 kg/m2 at visit 1 exclusion criteria: * pregnant or nursing (lactating) women * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. * patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an su component. * inability to comply with the study procedures or medications. "other protocol-defined inclusion/exclusion criteria may apply"

Keywords: type 2 diabetes mellitus ramadan vildagliptin hypoglycemia
the clinical effect of fuke qianjin capsule on chronic pelvic pain caused by pelvic inflammation

Conditions: Chronic Pelvic Pain

Summary: a prospective random control clinical trials to research fuke qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.

fuke qianjin capsule has been widely used in clinical medicine to ameliorate the pain caused by chronic pelvic disease.but random control trials on its effects are few.our study was designed as a prospective random control clinical trials to research its effects.

Eligibility criteria:
inclusion criteria: * subject is a female between the age of 18 and 50. * subject with a history of pelvic inflammatory disease suffered from one of the symptoms below and one of the signs below: symptoms:1.lower abdominal distension or pain;2.lumbosacral soreness. signs:1. enlarged,cable strip-like fallopian tube with mild tenderness palpated on one side or both sides of the uterine;2.restricted movement or adhesion fixed of the uterine;3.the sacral ligaments thicken and harden with mild tenderness. * subject vas score of pelvic pain ≥4 * subject without fertility requirements in 2 months * subject provides written informed consent. exclusion criteria: * subject underwent recurrent urinary system infection or interstitial cystitis * subject underwent irritable bowel syndrome * subject has other complications in addition to chronic pelvis inflammation diseases leading to chronic pelvic pain,such as gynecological malignant disease,irregular vaginal bleeding, endometriosis,adenomyosis,ovarian neoplasm with a diameter \>5cm by ultrasound * subject is pregnant or lactating. * subject has a severe systemic disease, such as cardiovascular system * subject has a history of malignancy or radiotherapy. * subject has undergone any chronic pelvic pain treatment including antibiotics,paregoric,physiotherapy or any other related treatment within 1month prior to randomization. * subject has mental disorder incapable of elementary cooperations. * subject has an allergic history to the experimental drug. * subject has participated in other clinical researches of medicine within 1month prior to randomization.

Keywords: fuke qianjin capsule chronic pelvic pain
the effect of xenical on weight and risk factors

Conditions: Obesity; Heart Diseases

Summary: the purpose of this study is to determine the effect of using the weight loss medication xenical (generic name - orlistat) on weight loss and change in heart disease risk factors in patients of the healthy heart program lipid clinic at st. paul's hospital over a three month period. xenical works by blocking the body's absorption of dietary fat in the gut, allowing it to pass through to be excreted, therefore reducing the intake of fat and calories. this is a pilot study supported by hoffmann-la roche limited which produces xenical. the aim is to investigate whether weight loss will also result in reductions in heart disease risk factors that may allow for less of a need for medications controlling lipid levels, hypertension and plasma glucose.

obesity is associated with numerous chronic diseases and increased cardiovascular mortality. it is also an independent risk factor for cardiovascular disease (cvd) in addition to being associated with diabetes and cvd risk factors. weight loss interventions that target body fat reductions are associated with reductions in cholesterol levels, blood pressure and fasting glucose. xenical (orlistat) is a gastrointestinal lipase inhibitor which results in a reduction in the absorption of exogenous fat. studies of up to two years duration have demonstrated that those taking xenical plus diet lost significantly more weight than those taking placebo plus diet. coincident with this were decreases in cholesterol levels. the use of xenical in type 2 diabetic patients being treated with sulfonylurea resulted in greater discontinuation of the sulfonylurea plus a greater reduction in sulfonylurea dosage compared to placebo. the use of xenical in the clinical environment has the potential to improve cvd risk factors and potentially reduce the burden of other medications.this is a pilot study to investigate the effectiveness of xenical on cardiovascular risk factors in the patients of st. paul's hospital lipid clinic.

Eligibility criteria:
inclusion criteria: 1. body mass index ≥ 27 with one risk factor for cardiovascular disease or overweight/obese individuals with type 2 diabetes on standard hypoglycemic agents 2. recently prescribed xenical at the st. paul's hospital lipid clinic exclusion criteria: 1. patients with previous experience using xenical 2. patients currently using other weight loss medications. 3. unable to provide informed consent. 4. less than 19 years of age

Keywords: obesity weight loss cardiovascular risk factors obesity and obesity related pathology