Kornimate/medical-research-clean huggingface dataset:
gefitinib with or without chemotherapy in brain metastases from non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer; Brain Metastases; EGFR Mutation

Summary: this is a multi-center phase iii randomized controlled study to assess the efficacy of gefitinib alone and gefitinib combination with pemetrexed/platinum on patients with brain metastasis from non-small cell lung cancer(nsclc) harboring egfr mutation type by intracranial pfs(ipfs),also pfs ,dcr and os.the side effect is evaluated as well.


Eligibility criteria:
inclusion criteria: 1. patient who was confirmed stage iv nsclc with egfr activating mutation and brain metastases by pathologic histology or cytology 2. patients who had never received therapy (including chemotherapy,wbrt,egfr-tki and egfr monoclonal antibody) after diagnosed brain metastases 3. patients had at least three metastatic lesions in brain, or patients with 1-2 intracranial lesions who were not suitable for brain radiotherapy, or patients with 1-2 intracranial lesions who refused brain radiotherapy, at least one intracranial lesion with the longest diameter of \>5 mm 4. adult patients (≥ 18 years and ≤75 years). ecog performance status 0 or 1 life expectancy of at least 12 weeks.,haemoglobin ³ 10.0 g/dl, absolute neutrophil count (anc) ³1.5 x 109/l, platelets ³ 100 x 109/l. total bilirubin £ 1.5 x upper limit of normal (uln). alt and ast \< 2.5 x uln in the absence of liver metastases, or \< 5 x uln in case of liver metastases. creatinine clearance ³ 60ml/min (calculated according to cockcroft-gault formula). 5. patients should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib. 6. able to comply with the required protocol and follow-up procedures, and able to receive oral medications. exclusion criteria: 1. patient was received irradiation of brain. patient with meningeal metastases were confirmed by mri or cytology test of cerebrospinal fluid. 2. patient is received the treatment of phenytoin, carbamazepine, rifampicin, phenobarbital, or st. john's wort. 3. patient was received egfr tyrosine kinase inhibitor or egfr monoclonal antibody. 4. interstitial pneumonia.pericardial effusion, pleural effusion is uncontrolled . 5. any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). 6. any significant ophthalmologic abnormality ,especially severe dry eye syndrome ,keratoconjunctivitis sicca,sjogren syndrome,severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. 7. lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. 8. the symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment
improving sleep among cancer patients: comparison between physical activity and self-administered cognitive-behavioral therapy (cbt)

Conditions: Cancer; Insomnia

Summary: it has been suggested that the practice of physical exercise can improve sleep, but few studies have investigated this issue in the context of cancer, despite the proven benefits of exercise in this population. this randomized-controlled trial (rct) aimed to compare the efficacy of an aerobic intervention program to that of a self-administered cognitive-behavioral therapy (cbt) to improve sleep of cancer patients. forty-one men and women with insomnia symptoms and treated within 6 months for a non-metastatic cancer participated in the study.


Eligibility criteria:
inclusion criteria: * a diagnosis of non-metastatic cancer * adjuvant treatments completed within the past 6 months * insomnia symptoms as defined by a score ≥ 8 on the insomnia severity index * practicing less than 90 minutes of physical exercise per week * able to readily read and understand french * available during a consecutive 6-week period to complete the intervention * written permission from physician to engage in a physical exercise program exclusion criteria: * severe cognitive impairments (e.g., diagnosis of parkinson disease) * severe psychiatric disorder (e.g., severe major depression) * diagnosis of a sleep disorder other than insomnia (e.g., obstructive sleep apnea) * any contraindication for the practice of physical exercise

Keywords: cancer insomnia sleep physical exercise aerobic cognitive-behavioral therapy self-help rct
effect of magnesium supplementation in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: magnesium (mg) is involved in several pathways that could be affected in chronic obstructive pulmonary diseases (copds), namely in the contractility and excitability of neuro-muscolar endothelial cells and low-grade inflammation, a typical state of copd. in this sense, several randomized controlled trials (rcts) confirmed a positive role of mg in asthma since long-period oral supplementation of mg leads to a clinical and spirometric improvement. subjects with copd seem to have a reduced bioavailability of mg probably due to the use of drugs that may increase mg losses (e.g. beta-agonists and cortisones), to a reduced dietary mg intake, and heavy smoking. a recent study showed that the administration of endovenous or aerosol mg sulphate with beta-agonists acutely improve maximum expiratory flow during copd relapses as well as the prolonged treatment with endovenous sulphate mg led to a reduction in pulmonary hyperinflation and increase in muscles involved in respiration, with a consequent clinical and instrumental improvement. these evidences suggest that a chronic supplementation with mg could improve copd in clinical and instrumental parameters, but, at the best of our knowledge, no study was available in this sense.


Eligibility criteria:
inclusion criteria: * adults (\>18 years). * moderate-severe copd (fev1 between 30-80% of theorical values). exclusion criteria: * already taking magnesium or calcium supplementations. * severe renal (creatinine clearance\< 30 ml/min) or hepatic decline or presence of other co-morbidities interfering with outcomes (e.g. dementia). * hypermagnesemia (serum mg\>1.85 mmol/l).
comparing the effectiveness between ritonavir boosted atazanavir and efavirenz for the first hiv treatment

Conditions: HIV Infection

Summary: a selection study in treatment naive hiv patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with epzicom(lamivudine and abacavir) plus efavirenz and epzicom plus ritonavir boosted atazanavir. the superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz)

a selection study in treatment naive hiv patients to compare the virologic success rate of once daily antiretroviral treatment regimens at the 48th week with epzicom(lamivudine and abacavir) plus efavirenz and epzicom plus ritonavir boosted atazanavir. the superior regimen will be hired to the comparative study to the current first line regimen (tenofovir plus lamivudine plus efavirenz) the primary endpoint is antiretroviral effect at the 48th week. the secondary endpoint is;1. evaluation of immunological effect and safety in 48 weeks. 2.evaluation of antiretroviral effect, immunological effect and safety in 49 to 96 weeks.

Eligibility criteria:
inclusion criteria: * serological diagnosis of hiv infection * male aged over 20 years old * cd4 at enrollment between 100 to 300 * body weight over 40kg * enable to obtain the written informed consent exclusion criteria: * patients who are considered unable to complete 48 weeks of study by their physician. * patients who have gastrointestinal symptom which may interfere the absorption of antiretrovirals, or have swallowing problems. * patients who have the history of hypersensitivity with lamivudine. * hepatitis b carrier. * blood test results within 4 weeks prior to the randomization; hemoglobin less than 9g/dl, platelet less than 50,000/mm3, neutrophils less than 1000/mm3, serum total bilirubin more than 2.0mg/dl, got/gpt/ldh more than two times of upper normal limit, serum creatinine more than 1.2mg/dl. * patients who have had radiation or chemotherapy within 4 weeks prior to the randomization or will have the treatment during the study . * patients who have had immunomodulating agent such as systemic use of corticosteroid or interferon within 4 weeks prior to the randomization. inhaled corticosteroid is the exception. * patients who have diabetes, congestive heart failure, cardiomyopathy, or other serious medical condition. * patients with aids defining illness. * patients with known resistant strains to efavirenz, atazanavir, ritonavir, lamivudine and abacavir prior to the study. * patients with acute retroviral syndrome. * patients with psychiatric disorder. * patients whose physician consider the study enrollment inappropriate.

Keywords: hiv infection treatment efavirenz atazanavir ritonavir
reproducibility of glucose fluctuations by standardized exercise for patients with type 1 diabetes - a method study based on continuous glucose monitoring

Conditions: Diabetes Mellitus, Type 1; Exercise; Continuous Glucose Monitoring

Summary: the purpose of this project is to investigate whether the glucose response in type 1 diabetes patients measured using continuous glucose monitoring measurement is reproducible in repeated standardized test sessions that include physical activity.


Eligibility criteria:
inclusion criteria: * type 1 diabetes with a diabetes duration of at least 2 years * age 18-60 years (inclusive) * given informed consent * exercises (at least 30 minutes intentional exercise where participants feel exhausted) one or more times a week * participants agree to use cgm correctly exclusion criteria: * pregnancy * exercising at a high level (five or more times a week with high intensity) * treatment with prednisolone or less than a month ago contestant has been treated with prednisolone * treatment with beta blockers * abuse of alcohol / drugs
"outcomes of surgical removal of foreign body granulomas"

Conditions: Foreign Body Granuloma; Surgery; Complication

Summary: illicit subcutaneous injection of high-viscosity fluids for restoration and improvement of body contour is a growing trend all around the world. many local and systemic complications have been described. local complications include deformity at the site of injection, granulomas and several skin changes like erythema, induration, and plaques (well-circumscribed, elevated, superficial, solid lesion). the investigator designed a single-center, cross-sectional, retrospective, consecutive case series study and evaluated 49 surgeries performed in 35 patients with the history of foreign substances injection for cosmetic purposes and developed local complications. investigators divided 4 groups accordingly to localization of foreign substances (fs). group 1) fs disseminated to both lower extremities and buttocks; group 2) fs isolated to buttocks with moderate to severe skin changes, group 3) fs isolated to lower legs with mild skin changes and superficial ulcerations and 4) fs isolated to lower legs with moderate to severe skin changes and/or ulceration. the investigators treated all patients surgically, which consisted of isolate ultrasonic liposuction for extraction of the material from the affected region (group 1) in-bloc excision and primary closure (group 2), resection plus vacuum assisted closure (vac) and split thickness skin graft (stsg) (group 3) and in-bloc excision and microsurgical reconstruction (group 4). statistical analysis was performed to find relations between type of surgery with complications, reactivation of symptoms, time for reactivation and a disease-free survival test (kaplan meier) was done.


Eligibility criteria:
inclusion criteria: * history of injection of foreign substances for cosmetic purposes * develop symptoms of autoimmune syndrome induced by adjuvants * mild to severe skin changes exclusion criteria: * refuse to participate in the analysis

Keywords: disease-free autoimmune/inflammatory syndrome induced by adjuvants (asia) adjuvant disease
liver transplantation for non-resectable peri-hilar cholangiocarcinoma (litalhica)

Conditions: Perihilar Cholangiocarcinoma

Summary: litalhica is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pcca) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. finally, the study aims to investigate the role of preoperative pet-mri, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.


Eligibility criteria:
inclusion criteria: * diagnosis of pcca (transcatheter biopsy or brush cytology, ca 19-9 \> 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography, or biliary ploidy with a malignant appearing stricture on cholangiography) * disease considered unsuitable for hepatic resection based on tumor location and extent or underlying liver dysfunction * absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes detected on radiological study * no evidence of extrahepatic metastatic disease after chest-abdomen-pelvis ct and pet-mr (or pet-ct) * unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of cbd) or resectable pcca arising in psc * radial tumor diameter \<3 cm * at least six months have passed since the first diagnosis of pcca to the date of inclusion on the liver transplant waiting list * the patient has received at least six months of standard of care (soc) chemotherapy, achieving disease stability or partial response (according to recist criteria version 1.1) at the time of listing for transplantation * absence of medical or surgical contraindication to liver transplantation * signed informed consent, and expected patient cooperation for treatment and follow-up, must be obtained and documented according to good clinical practice and national/local regulations exclusion criteria: * diagnosis of intrahepatic cholangiocarcinoma (icca) * uncontrollable infection * prior radiotherapy or chemotherapy * prior biliary surgical resection or attempted surgical resection * diameter of tumor \>3cm * presence of intra-hepatic metastases * present or past evidence of extrahepatic metastatic disease * transperitoneal biopsy (including percutaneous ecography-guided fna) * prior neoplasms, except those treated curatively for more than 5 years without recurrence * substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study or with the evaluation of study outcomes * pregnant or breastfeeding women * medical-surgical contraindications for liver transplantation * any reason for which, in the investigator's judgment, the patient should not participate in the study

Keywords: liver transplantation
cytologic analysis of distention media as a screening test for endometrial cancer

Conditions: Endometrial Cancer

Summary: the purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.

participants will have a sonohysterography (shg) performed. fluid will be collected after instillation of 5mls of saline and again after an adequate shg is performed. a pathologist will review this fluid to see is cancer cells are present.

Eligibility criteria:
inclusion criteria: * newly diagnosed early-stage endometrial cancer exclusion criteria: * recurrent or persistent endometrial cancer * evidence of distant metastases

Keywords: endometrial cancer sonohysterography
lightpathtm imaging system for ex-vivo assessment of margin and lymph node status in breast cancer surgical specimens

Conditions: Breast Cancer

Summary: this study is a prospective, cross-sectional observational single centre study to assess the feasibility of intra-operative cerenkov luminescence imaging (cli) of breast cancer wide local excision (wle) specimens and dissected lymph nodes. the samples will be imaged using the lightpathtm imaging system. the lightpathtm imaging system which consists of a light-tight box on which are mounted an ultra-sensitive lens and radiation-shielded camera. this study will measure the correlation between margin status of the wle specimen and the metastatic status of dissected lymph nodes as determined by the lightpathtm imaging system and by histopathology. this is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the benefits of the lightpathtm imaging system in clinical practice.

subject's blood glucose level will be measured on the day of surgery. subjects with a blood glucose level \< 12 mmol/l receive an intravenous injection of 5 mbq/kg, up to a maximum 300 mbq of 18f-fluorodeoxyglucose (18f-fdg) prior to surgery. breast cancer surgery will be performed per standard of care. slnb will be performed using a dose of 150 mbq technetium 99 (99mtc) nanocolloid and patent blue dye. the resected wle specimen and lymph nodes will be imaged in the lightpathtm imaging system. a member of the research team who is not the operating surgeon will capture lightpathtm images intra-operatively. prior to cli, the wle specimen will be placed in a specimen holder. cli is performed according to the lightpathtm imaging system instructions for use. all cli will be performed between 1 and 3 hours post injection of 18f-fdg. the wle specimen will then undergo standard of care histopathological analysis with a positive margin defined as either invasive carcinoma or ductal carcinoma in situ (dcis) within 2mm of the specimen surface. lymph nodes will also be examined according to standard of care histopathological analysis. the cli results will not be used to influence any surgical or clinical decision-making. all staff in the operating theatre and the recovery area caring for the patient, and pathology staff processing surgical specimens will wear badge dosimeters. staff handling surgical specimens will also wear ring dosimeters.

Eligibility criteria:
inclusion criteria * females ≥30 years of age with a diagnosis of invasive breast cancer or dcis * scheduled for bcs +/- slnb or alnd * females of childbearing age must have a negative pregnancy test (by beta hcg qualitative analysis), must have had a history of a surgical sterilisation, or must give history of no menses in past twelve months exclusion criteria * surgery or radiotherapy in the operated breast in the past 2 years * neoadjuvant systemic therapy * patients not suitable for bcs * blood glucose level ≥ 12 mmol/l on the day of surgery * known hypersensitivity to 18f-fdg * any patient who is pregnant or lactating

Keywords: cerenkov luminescence imaging, cli, margin status
pulsed dye laser in treating superficial basal cell carcinomas

Conditions: Basal Cell Carcinoma

Summary: pulsed dye laser (pdl) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. robust supporting evidence is, however, lacking due to inconsistent design of available studies. the purpose of this study is to evaluate the pdl's efficacy and safety in treating superficial basal cell carcinoma (sbcc) at low risk anatomical sites in an evidence based study setting.


Eligibility criteria:
inclusion criteria: * histologically confirmed unpigmented sbcc on the trunk and extremities * maximal tumour diameter 30 mm exclusion criteria: * fitzpatrick skin type \>iii * pregnancy * previous bcc treatment within 4 weeks * coagulation disorders * photo sensitizing medication * any indication of poor compliance

Keywords: basal cell carcinoma laser surgery pulsed dye laser randomized controlled trial
a study in recurrent glioblastoma (gb)

Conditions: Glioblastoma

Summary: the purpose of the study is to see whether treatment with ly2157299 on its own, ly2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer


Eligibility criteria:
inclusion criteria: * histological confirmed diagnosis of relapsed intracranial gb * progressive disease (pd) following standard chemoradiation * prior surgical resection allowed * performance status eastern cooperative oncology group (ecog) 0 or 1 * adequate hematologic, hepatic and renal function * discontinued all prior cancer treatments for cancer \& recovered from the acute effects of therapy * tumor specimen must be available for a central pathology review and prognostic and predictive biomarker evaluation exclusion criteria: * moderate or severe heart disease based on new york heart association (nyha) criteria * prior nitrosurea therapy (including lomustine or gliadel) * prior bevacizumab as 1st line treatment for gb (if treatment was concluded 12 months prior to enrollment, the patient may be eligible to participate in the trial) * current acute or chronic myelogenous leukemia * second primary malignancy that may affect the interpretation of results * serious concomitant systemic disorder
multicenter study assessing the efficacy & safety of hydroxychloroquine sulfate in patients with systemic lupus erythematosus or cutaneous lupus erythematosus with active lupus erythematosus specific skin lesion

Conditions: Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus

Summary: primary objective: - to investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (hcq) in patients with cutaneous lupus erythematosus (cle) and systemic lupus erythematosus (sle) with active skin manifestation (clasi \[cutaneous lupus erythematosus disease area and severity index\] activity score is ≥4) concomitant treatment with or without corticosteroid. secondary objectives: * to evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of hcq versus placebo as the reference group in patients with cle and sle with active skin manifestation (clasi activity score is ≥4) concomitant treatment with or without corticosteroid. * to investigate the safety of 16 weeks treatment of once daily regiment of hcq in patients with cle and sle with active skin manifestation concomitant treatment with or without corticosteroid. * to investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of hcq in patients with cle and sle - to investigate the influence of the dose reduction of corticosteroid on cle and sle patients treated with hcq concomitant with corticosteroid * to investigate efficacy of once daily regimen of hcq on systemic symptoms, musculoskeletal symptoms and immunological parameters in sle patients.

total 59 weeks (screening;4 weeks, treatment;52 weeks, follow-up; 3 weeks)

Eligibility criteria:
inclusion criteria : * patients diagnosed as cutaneous lupus erythematosus (cle) exclusion criteria: * patients receiving corticosteroid more than 15mg/day of the equivalent dose of prednisolone. * patients whose clasi activity scores were less than 4 point at the initiation of screening (visit 1) and day1 (visit 2) (evaluated by a dermatology specialist). * patients whose fluctuations of clasi activity scores were ≥20% between visit 1 and visit 2 (evaluated by a dermatology specialist). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.