Kornimate/medical-research-clean huggingface dataset:
pci for patients with es-sclc after rct:a prospective randomized study

Conditions: Small-cell Lung Cancer

Summary: prophylactic cranial irradiation （pci）was verified to decrease the brain metastases rates and improve the overall survival（os）for patients with limited stage small cell lung cancer.we hypothesis that patients with extensive-stage small cell lung cancer after chemotherapy and thoracic radiation can also benefit from pci.

patients with extensive-stage small cell lung cancer achieving cr or pr after chemotherapy and thoracic radiation therapy were randomly divided into observation group and prophylactic cranial irradiation (pci) group to evaluate the effect of pci on survival after radiation therapy for thoracic lesions. to preliminarily analyze the clinical characteristics of patients who would benefit from thoracic radiation therapy plus pci. to explore the optimal treatment modality after chemotherapy + thoracic radiation therapy in patients with extensive-stage sclc.

Eligibility criteria:
inclusion criteria: * 18-65 years old,kps≥70 * pathological or cytological diagnosis of stage iv small cell lung cancer (by using ajcc 7th edition staging criteria); * 1-3 extra-cranial metastatic organs before chemotherapy; 4-6 cycles of ce or ep ； * cr or pr after chemotherapy； * no grade ≥ii side effects; * the estimated overall survival time ≥ 3 months; * no serious medical disease or major organ dysfunction. exclusion criteria: * patients with brain or nervous system metastases; * presence of high grade radiation comorbidities; * patients who are pregnant or lactating

Keywords: small cell lung cancer brain metastases
the effects of postural changes on plantar pressure in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: ankylosing spondlitis (as) is a chronic, rheumatic disease. foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. the purpose of the study is to investigate the relationship plantar pressure distribution and balance, mobility and disease activity in as patients and to compare as patients with and without postural changes and healthy subjects.

ankylosing spondlitis (as) is a chronic, rheumatic disease. reduction in flexibility and mobility is important factors that can cause impairment quality of life, reduction of exercise tolerance and pulmonary capacity with the progression of as. extra articular symptoms such as neurologic, cardiovascular and pulmonary involvement affect morbidity and mortality rate. foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. şahlı et al. concluded that 52% of as patients had foot involvement but 35% of the patients had symptoms. to be determined plantar pressure distribution is important to be decided body weight distribution, postural control and selection of shoes. the purpose of the study is to investigate the relationship plantar pressure distribution and balance, mobility and disease activity in as patients and to compare as patients with and without postural changes and healthy subjects.

Eligibility criteria:
inclusion criteria: * patients who are aged between 18-55 years, * patients who got diagnosed according to modified new york criteria * patients who are being followed at firat university department of rheumatology. exclusion criteria: * patients who have exercise habits * incooperation * malignancy * pregnancy * patients who have changes of medical treatment in the last 3 months * patients who have another disease that can effect pulmonary functions

Keywords: ankylosing spondylitis, posture plantar pressure
investigating the effect of yoga-based breathing styles on the human brain, with a focus on memory

Conditions: Hypoventilation; Hyperventilation

Summary: the goal of this clinical trial is to learn if yoga-based breathing styles could improve memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the implementation of the breathing exercises. the main questions it aims to answer are: * can the memory performance get better ? * can the subjective stress level be reduced ? participants will complete a memory test while doing a specific nasal and oral breathing. they will complete a two-week training period after the test with daily nasal or mouth breathing training or no training at all, depending on the group, the are divided into. researchers will compare the effect of different breathing styles on memory ability among themselves.

the goal of this clinical trial is to learn about the effect of yoga-based breathing styles on the human brain regarding memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the performance of the breathing exercises. the main questions it aims to answer are: * is there an improve of memory performance through performing the controlled yoga-based breathing styles ? * is there a relevant reduction of the subjective stress level through performing the controlled yoga-based breathing styles participants will complete a memory test while performing controlled nasal and oral breathing. they will complete a two-week training period after the test with daily nasal or mouth breathing training or no training at all, depending on the group assignment. researchers will compare the nasal breathing group to the mouth breathing and the comparison group to see if the nasal breathing results in a significant improvement of the memory capacity.

Eligibility criteria:
inclusion criteria: * willingness to take on the 2-week exercises but no new athletic or meditative activities * yoga-naive and without significant prior experience in various meditative or athletic disciplines that ostensibly involve elements of breath control * access to a device with internet access * signing of the consent form to participate in the study exclusion criteria: * known clinically relevant internal or neurological diseases, especially if associated with chronic pathological oxygenation (e.g. copd, severe bronchial asthma, sleep apnea, but also ckd). * history of drug or alcohol abuse * known psychiatric illnesses that currently require therapy (e.g., pronounced claustrophobia) * medication that could falsify the data collected * lack of consent to take note of possible incidental findings * known epileptic seizures, which could be intensified by the visual insertion of the stimuli

Keywords: mnemonic similarity task yoga-breathing memory enhancement
efficacy and safety study of meloxicam versus mefenamic acid in patients with dysmenorrhea

Conditions: Dysmenorrhea

Summary: to access the efficacy and safety of meloxicam 7.5 mg and 15 mg once daily compared with mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea


Eligibility criteria:
inclusion criteria: * female patients between 18 to 40 years * patients experiencing primary (functional) dysmenorrhea during the last 3 consecutive menstrual periods. diagnosis will be based on symptoms and clinical signs: abdominopelvic pain, may radiate to the back and along the thighs; systemic symptoms including nausea, vomit, diarrhoea, headache, fatigue, nervousness, dizziness; the symptomatology should be usually some hours to one day before commencement of visible vaginal bleeding * evaluation of lumbar and/or abdominopelvic pain due to dysmenorrhea \> 35 mm through a 100 mm visual analogue scale (vas) * outpatients * patients granting their written informed consent * therapy with a nsaid (nonsteroidal antiinflammatory drug) is required or recommended exclusion criteria: * known or suspected hypersensitivity to trial drugs or their excipients, analgesics, antipyretics or nasids * analgesic concomitant treatment (between each cycle paracetamol administration will be allowed) * to initiate hormonal contraception or intrauterine devices after inclusion to this trial or during the last 3 months * abdominal surgery or pelvic procedure scheduled during the study * patients with organic dysmenorrhea (endometriosis, salpingitis, adnexitis, uterine retroversion, tubal cysts, ovarian cysts, pathological vaginal secretion, painful pelvic exploration, etc.) * patients with neoplastic disorders * history of recent abdominal or pelvic trauma requiring surgery * peptic ulcer within the past 6 months * pregnancy or breast feeding * asthma, nasal polyps, angioneurotic edema or rash following aspirin or nsaids administration * concomitant treatment with anti-coagulants, including heparin and aspirin, lithium or methotrexate * concomitant administration of other nsaids (including aspirin \> 150 mg daily) or analgesics * confinement to bed rest * administration of any nsaid during two days (three for oxicams) before the first administration of the trial drug * present treatment or treatment within the last two months with corticosteroids * impaired renal function (serum urea \> 125 % of the upper limit of normal range; serum creatinine \> 150 % of the upper limit of normal range) * sever liver injury (alanine amino transferase alat \> 2 x the upper normal range limit or aspartate amino transferase asat \> 2 x the upper normal range limit) * hematological disorder (platelet count \< 100,000/mm\*\*3, leucocyte count \< 3,000/mm\*\*3) * participation in another clinical trial during this study or the previous month * previous participation in this trial * patient unable to comply with protocol * bleeding disorders
package of care to improve retention in art and mortality among treatment naive hiv infected individuals

Conditions: HIV

Summary: this is a cluster randomized trial to determine whether a package of care including rapid antiretroviral therapy (art) initiation, as compared to standard art initiation, improves mortality, retention in care and viral suppression among treatment naive people living with hiv (plhiv) in nepal. package of care includes immediate screening and treatment of opportunistic infections (ois), rapid art initiation and enhanced retention in care using mobile health (mhealth) and weekly/biweekly home-based adherence/ retention support linked to community care centre. standard of care includes screening and management of common ois, baseline assessment (cd4, viral load and other tests), antiretroviral drugs and art follow up.

pran is an open-label trial of 1000 treatment-naive plhiv aged 16 years or more. 1. to evaluate whether a package of care including rapid art initiation \[diagnosis and management of opportunistic infection (oi), rapid art initiation and enhanced adherence support\] is more effective in reducing morbidity and mortality, as compared to standard art initiation, among art naïve plhiv in nepal. 2. to evaluate whether a package of care including rapid art initiation is more effective in improving retention in hiv treatment, as compared to standard art initiation, among art naïve plhiv in nepal. 3. to evaluate whether a package of care including rapid art initiation improves viral suppression among art naïve plhiv in nepal to a higher extent than standard art initiation, 4. to evaluate whether the different components of care act synergistically to improve mortality, retention in care and viral suppression among treatment naive plhiv, as compared to standard art initiation, 5. to assess the cost-effectiveness of this package of care intervention.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 16 years * diagnosed with hiv-infection * art-naive * consent for study participation exclusion criteria: * age less than or equal to 15 years * any previous use of art

Keywords: package of care rapid initiation of antiretroviral therapy advanced hiv disease mhealth acquired immunodeficiency syndrome management of advance hiv disease
psma specific [68ga]-p137 peptide probe for pet imaging in prostate cancer

Conditions: Prostate Cancer

Summary: to study the radioactive uptake of \[68ga\]p137 in the lesion sites of pca patients and evaluate the ability of \[68ga\]p137 to detect psma overexpression in pca patients (especially those with recurrent or advanced pca).

prostate cancer is the most common malignancy of the male reproductive system.prostate specific membrane antigen is a highly specific prostatic epithelial cell membrane antigen, which is highly expressed in solid tumors such as prostate cancer. more than 90% of prostate cancer cells express psma, so psma can be used as an important imaging target for prostate cancer.positron emission tomography has the advantages of non-invasive, high resolution and high sensitivity, etc. the pet tracer based on psma radiographic label is developing rapidly, which is of great significance for the early diagnosis, prognosis and treatment of prostate cancer.used for radionuclide 68ga has a half-life of pet imaging (t1/2 = 68 min) is appropriate, prepared from 68ge-68ga generator, relatively low cost, coordination marking method is simple, easy to realize automatic synthesis technology and advantages of medicine preparation, so 68ga- labeled psma targeted molecular probe in prostate cancer has been widely applied in the diagnosis of disease. \[68ga\]p137 is a novel psma targeted molecular probe labeled with 68ga. dota is used as a bifunctional linker to coordinate with 68ga3+. the labeling method is simple, the biological stability is high, the tumor site has obvious radioactive enrichment, and the imaging effect is superior.this project provides research on \[68ga\]p137 pet/ct imaging for patients with suspected pca, and provides basis for early diagnosis of pca, formulation of treatment plan and efficacy evaluation.

Eligibility criteria:
inclusion criteria: * men over 18 years of age need to undergo \[68ga\]p137 pet/ct examination for suspected prostate cancer. * the patients can fully understand and voluntarily participate in this experiment, and sign the informed consent. exclusion criteria: * significant hepatic or renal dysfunction; * patients with malignant tumors other than prostate cancer within 2 years; * ready to pregnant; * the patient can not tolerate all clinical tests.

Keywords: psma
oral nutritional supplement in reducing surgical site infections

Conditions: Peripheral Vascular Disease; Claudication

Summary: the study aims to evaluate the efficacy of an arginine enriched oral nutritional supplement in the prevention of wound complications in the the wounds of patients post lower limb revascularization.

surgical incisions are associated with a number of possible complications. the reported incidence of surgical site infections at the groin after vascular procedures is between 3% and 30%. this incidence is up to five times higher than the expected incidence of infection in clean cases. risk factors for postoperative surgical site infection in patients undergoing vascular surgery may include age, co-morbidities, use of prosthetic grafts and repeat operations. a systematic review in 2011 concluded that arginine supplemented diets among perioperative patients were associated with a reduced rate of surgical infection and reduced overall length of hospital stay. the study aims are to determine if taking an oral nutritional supplement reduces the rate of wound complications post lower limb revascularization.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective lower limb revascularization surgery * patients aged \>18 years. exclusion criteria: * patients unable to provide informed consent, * emergency cases, * seriously ill patients/unconscious patients, * chronic renal disease, * known inflammatory bowel disease, * known lactose intolerance and not using lactase, * known galactosemia, * pregnancy, * cows milk allergy.
the safety and effectiveness of saquinavir soft gelatin capsules combined with other anti-hiv drugs

Conditions: HIV Infections

Summary: to evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (sqv-sgc) in combination with other antiretroviral drugs.

all patients receive sqv as monotherapy or in combination with other antiretroviral drugs chosen by the investigator and patient. (this study provides only sqv.) patients may not choose another protease inhibitor (pi) as part of their combination therapy; furthermore, patients taking pis other than sqv must undergo a 5-day washout period before study-drug administration. patients are monitored for adverse events and changes in routine laboratory tests, plasma viral load, and cd4+ t cell levels. outcomes are analyzed by stratifying patients according to cd4+ t cell levels and prior history with protease inhibitors.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: antiretroviral treatments other than pis. patients must have: * hiv infection. * no prior experience with pis. (note: * at least 75 percent of patients must be naive to pis.) exclusion criteria concurrent medication: excluded: pis other than sqv. prior medication: excluded: any pis (see note in general criteria--inclusion).

Keywords: drug therapy, combination saquinavir hiv protease inhibitors dosage forms anti-hiv agents
a study to investigate the glucose lowering effects of dextromethorphan alone or in combination with sitagliptin in subjects with type 2 diabetes mellitus (t2dm) after an oral glucose tolerance test

Conditions: Type 2 Diabetes Mellitus

Summary: the study has a randomized, double-blind, placebo-controlled, double dummy and eight-way cross-over design. males with t2dm on a stable metformin monotherapy will be screened for participation in the study. eligible subjects will be randomized to receive dxm 30 mg, dxm 60 mg, dxm 90 mg alone or in combination with sitagliptin 100 mg, sitagliptin 100 mg alone, or placebo (for dxm and sitagliptin) on in total eight treatment days. an ogtt will be started 1 hour after study drug administration and blood glucose will be measured over the next 4 hours. there will be a 3 to 14-day washout period between doses.

this study is performed to determine the optimal dose of dxm that, compared to placebo, decreases glucose excursions following an ogtt. doses of 30 mg, 60 mg and 90 mg dxm were chosen. since dxm 60 mg was effective in the previous study in increasing insulin secretion, this dose will be kept. a lower dose (30 mg) will be given to see whether effects on insulin secretion are present also at lower doses and then translate into a bg lowering action. a higher dose (90 mg) will be added to see whether this way an effect on glucose excursion reduction occurs following an ogtt, (like previously demonstrated with 270 mg dxm) that can be related to an increase of insulin secretion.

Eligibility criteria:
inclusion criteria: 1. signed and dated written informed consent obtained before any study-related activities 2. male subjects with a diagnosis of type 2 diabetes mellitus according to ada criteria at least 4 months prior to screening 3. medical history without major pathology (with the exception of type 2 diabetes) 4. on a stable regimen of metformin monotherapy for at least 3 months 5. aged between 45 and 70 years of age, both inclusive 6. body mass index (bmi) between 25 and 35kg/m2, both inclusive exclusion criteria: 1. subjects with type 1 diabetes, mody or secondary forms of diabetes such as due to pancreatitis 2. history of pancreatitis 3. current or previous treatment with insulin therapy 4. treatment with any hypoglycemic medication other than metformin within the three months prior to screening 5. mean qtc\> 450 msec

Keywords: diabetes mellitus
ct-2103/carboplatin vs paclitaxel/carboplatin for nsclc in women with estradiol > 25 pg/ml

Conditions: NSCLC

Summary: this study is designed to test whether ct-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with nsclc who have estradiol levels \>30 pg/ml.


Eligibility criteria:
inclusion criteria: 1. women with baseline estradiol \>25 pg/ml 2. histologically- or cytologically-confirmed diagnosis of nsclc. 3. ecog performance score (ps) of 0, 1, or 2. 4. patients must meet one of the following criteria have either (1) recurrent disease following completion of radiation or surgery, (2) stage iiib disease and not be a candidate for combined modality therapy (primary radiation therapy or surgery), or (3) stage iv disease. 5. at least 18 years of age. 6. adequate bone marrow function 7. adequate renal function 8. adequate hepatic function 9. life expectancy ≥12 weeks exclusion criteria: 1. known hypersensitivity to the excipients or the study drug (either ct-2103, paclitaxel, or carboplatin that the patient will receive. 2. evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. 3. weight loss \>10% in previous 6 months 4. ldh \> 2.5x iuln 5. both ldh \> 1.5x iuln and ≥ 5% weight loss in previous 6 months 6. bmi \>35 7. any prior systemic chemotherapy for the treatment of lung cancer. this includes systemic radiosensitizers used to treat brain metastases and any biologic agent. 8. local palliative radiotherapy \< 7 days before randomization. 9. radiation with curative intent \< 30 days before randomization. 10. concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. 11. grade 2 or greater neuropathy. 12. evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. 13. clinically significant active infection for which active therapy is underway. 14. investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. 15. unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. 16. pregnant women or nursing mothers.

Keywords: nsclc women ct-2103 paclitaxel carboplatin
phase 3 study of ly353381 vs tamoxifen in women with locally advanced or metastatic breast cancer.

Conditions: Breast Neoplasms

Summary: to determine the safety and efficacy of ly353381 when compared to tamoxifen in women with advanced or metastatic breast cancer.


Eligibility criteria:
inclusion criteria 1. locally advanced or metastatic breast cancer 2. bi-dimensionally measurable disease exclusion criteria 1. prior hormonal therapy

Keywords: cancer metastatic breast cancer hormonal therapy
mast-cell stabilizing effects of olopatadine

Conditions: Allergic Conjunctivitis

Summary: to assess the effects of olopatadine of the release of mast cell histamine


Eligibility criteria:
inclusion criteria: * asymptomatic and not using any topical or systemic medication exclusion criteria: * age

Keywords: subject with clinical history of seasonal allergic conjunctivitis