Kornimate/medical-research-clean huggingface dataset:
phase ii trial of erlotinib and concurrent palliative thoracic radiation therapy for non-small cell lung cancer (pearl)

Conditions: Non-small Cell Lung Cancer

Summary: to improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and * symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cgy/10 fractions); and * at least 18 years of age. exclusion criteria: * previous erlotinib therapy; or * planned concurrent chemotherapy; or * expected survival of less than 3 months; or * ecog performance status of 3 or 4; or * multiple cns metastasis or a single cns lesion that has not demonstrated radiologic stability (screening ct/mri or head not required); or * granulocyte count \<1,500/mm3, platelet count \<100,000/mm3, or haemoglobin \<9.0g/dl; or * sgot (ast) or sgpt (alt) \> 2.5 times (x) upper limit of normal (uln) in the absence of known liver metastases or \> 5 x uln in case of known liver metastases; or * alkaline phosphatase (alp) \> 2.5 x uln; or * serum bilirubin \> 1.5 uln; or * serum creatinine \> 1.5 uln or creatinine clearance \< 60 ml/min; or * serum calcium beyond uln; or * patients requiring systemic anti-fungal therapy, clarithromycin, phenytoin, or oral anticoagulation therapy (see appendix vi for complete list of medications); or * a history of interstitial lung disease; or * known sensitivity to erlotinib; or * pregnancy, lactation, or parturition within the previous 30 days; or * unwillingness or inability to complete the required assessments of the trial; or * mental incompetence, including psychiatric or addictive disorders which would preclude meaningful informed consent; or * history of recurrent conjunctivitis or keratitis or other inflammatory changes of the surface of the eye. * geographically inaccessible for treatment or follow-up evaluations; or * involved in an ongoing therapeutic trial.

Keywords: non-small cell lung cancer palliative radiation tarceva palliative thoracic radiation therapy
sga-induced metabolic syndrome in bipolar youth

Conditions: Bipolar Youth Treated With Second-generation Antipsychotics

Summary: the investigators tested the hypothesis that long-chain omega-3 (lcn-3) fatty acid supplementation will attenuate the adverse cardiometabolic effects of second-generation antipsychotics exposure in first-episode adolescent manic patients.

following acute (6-week) open-label treatment with quetiapine, first-episode adolescent manic patients (ages 10-17 years) were randomized to double-blind adjunctive treatment with long-chain omega-3 (lcn-3) fatty acids or placebo for 24 weeks to investigate protective effects on the of adverse cardiometabolic events and weight gain during quetiapine maintenance therapy. they will have 6 visits over a 24-week period.

Eligibility criteria:
inclusion criteria: * dsm-iv-tr criteria for bipolar disorder, type i, manic or mixed episode * baseline ymrs score \> 20 * ages 10-17 years * tanner scale stages iii-v * no prior exposure to sga medications * fluent in english * provision of written informed consent by a legal guardian and written assent by the subject * manic or depressive symptoms do not result entirely from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation and rapid symptom resolution * if female and of child bearing potential, agrees to use one of the following method of birth control: complete abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive. for phase ii, additional inclusion criteria are * receiving a stable therapeutic dose of quetiapine for a minimum of 1 week (i.e., patients who achieved remission (ymrs total score 7 during phase i) * not requiring concomitant use of antidepressant or mood-stabilizer medications (see section c.4.c. concomitant medications). exclusion criteria: * iq \< 70, as determined by the wechsler abbreviated scale of intelligence * positive pregnancy test (to avoid teratogenesis) * a history of major cardiovascular or neurological illness * any lifetime dsm-iv-tr substance use disorder (nicotine dependence is permitted) * a lifetime dsm-iv-tr diagnosis of any pervasive developmental disorder * any history of a hematological disorder in themselves or a first-degree relative will be excluded (since omega-3 fatty acids may be associated with anti-thrombotic effects). similarly, concomitant use of medications with anticoagulant effects (e.g. aspirin) will be prohibited * allergy to fish/seafood; 8) currently taking omega-3 fatty acid supplements

Keywords: bipolar disorder second-generation antipsychotics obesity cardiometabolic risk
intravitreal bevacizumab for choridal neovascularization secondary to age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: to report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab (avastin, roche, rio de janeiro, brazil) in patients with choroidal neovascularization secondary to age-related macular degeneration.

we conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. patients underwent snellen visual acuity testing, optical coherence tomography (oct) imaging and ophthalmoscopic examination at baseline and follow-up visits.

Eligibility criteria:
inclusion criteria: * age related macular degeneration with juxtafoveal and subfoveal cnvm: recurrent cnvm following pdt and ttt with ivta. patient who could not afford pdt, macugen or lucentis which is fda approved. * myopic cnvm, idiopathic cnvm, inflammatory cnvm and other conditions associated with cnvm. * refractory macular oedema due to vein occlusion, pseudophakia, clinically significant macular oedema (csme) etc. that affects vision and does not respond adequately to usual treatment methods. * proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with pdr. exclusion criteria: * patients with poor compliance * patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of stroke or myocardial infraction (\< one year). (physician clearance was obtained for all patients). * patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.

Keywords: bevacizumab amd complications visual acuity oct age macular degeneration
effects of sugarcut® unripe guava fruit extract on blood glucose regulation

Conditions: PreDiabetes

Summary: guava (psidium guajava) belongs to the myrtle family. it is a tropical and subtropical fruit native to the americas. ripe guava fruit is sweet and delicious. it is rich in vitamins a, c and trace elements such as phosphorus, calcium and magnesium. in traditional medicine, guava fruit can be eaten raw, and the roots can treat stomach problems, abdominal pain, dysentery, and diabetes; the leaves can treat diabetes, abdominal pain, rheumatism, antipyretic, stomachache, anthelmintic, cholera, vomiting, diarrhea, enteritis and other symptoms. guava leaf extract contains polyphenols. studies have shown that guava leaf has antioxidant, blood sugar regulating and anti-cancer effects. not only guava leaves, research has found that guava fruits are rich in vitamins, fiber and antioxidants, which have anti-inflammatory and anti-cancer effects. preliminary research has found that the extract of red guava young fruit has more active ingredients - saponins and total polyphenol content, and its antioxidant capacity is also higher than that of mature guava. in vitro studies have found that guava fruit extract can increase the expression of glut4 gene and promote the entry of blood sugar into cells. at the same time, guava fruit extract can inhibit the formation of final glycated proteins (ages). the purpose of this study is to explore the effect of guava fruit extract on blood sugar regulation in humans and to evaluate its potential to be developed as a blood sugar regulation supplement.

this trial adopted a double-blind placebo-controlled parallel testing design. subjects will be randomly assigned to the placebo group and the sugarcut® guava extract group, with 30 people in each group. before the trial (week 0), subjects are required to undergo fasting blood collection and height, weight, and blood pressure examinations. afterwards, the test samples were given to the subjects for 8 consecutive weeks, and they were reviewed for evaluation at the 4th and 8th weeks, and fasting blood collection and height, weight, and blood pressure examinations were performed.

Eligibility criteria:
inclusion criteria: 1. adults aged 20-60. 2. fasting blood glucose level is between 100 \~ 126 mg/dl. exclusion criteria: 1. patients with renal insufficiency and kidney dialysis. 2. cancer patients. 3. those taking blood sugar regulation-related drugs. 4. have a history of guava allergy 5. people suffering from mental illness 6. pregnant and breastfeeding women 7. long-term use of blood sugar regulating supplements
temozolomide 12 cycles versus 6 cycles of standard first-line treatment in patients with glioblastoma.

Conditions: Glioblastoma

Summary: the purpose of this study is to show if prolonging treatment with temozolomide to 12 cycles improve progression-free survival in patients with glioblastoma included in this study, randomized according to o6-methylguanine-dna-methyltransferase (mgmt) methylation status and residual disease or not, to receive an additional 6 cycles of temozolomide.


Eligibility criteria:
inclusion criteria: 1. ability to understand and sign the informed consent document . 2. age greater than or equal 18. 3. patients with glioblastoma according to who classification (glioblastoma ) who received chemo- radiotherapy and temozolomide -based chemotherapy ( stupp scheme ) and have completed 6 cycles of adjuvant temozolomide (with or without bevacizumab) in the context of standard treatment without presenting progression of disease. 4. availability of tumor tissue from the first surgery for centralized histological review , for determining the mgmt study if you have not done in the center of origin. (if they were made in the center of origin the result of the center will be accepted ). 5. stable dose of dexamethasone in the inclusion never above corticoids dose received in cycle 6 of the adjuvant . 6. index greater than or equal 60 % karnofsky. 7. all patients must show no progression of disease in a brain nuclear magnetic resonance (nmr) as defined in rano established criteria before randomization . 8. basal nmr study on a maximum of 6 weeks prior to inclusion, in which no progress is observed and is permitted to manage the care 6th cycle ( nmr performed after the 6th cycle of adjuvant is also acceptable as long as no progression was observed). 9. adequate bone marrow reserve : hematocrit greater or equal 29% , white blood cell\> 3,000 , ran greater or equal 1,500 cells / ul , platelets greater or equal 100,000 cells / ul. 10. creatinine \<1.5 times the upper limit of normal (uln) of the laboratory performing the analysis. 11. serum bilirubin \<1.5 / uln; sgot , sgpt \< 2.5 times the upper limit of normal of the laboratory performing the analysis. serum \< 3/uln alkaline phosphatases . 12. effective contraceptive method in patients and their partners. exclusion criteria: 1. less than 5 years of any previous invasive neoplasia. in situ cervical carcinoma or basal cell skin carcinoma accepted. 2. concomitant treatment with other investigational agents (other concomitant bevacizumab) . 3. presence of any clinically significant gastrointestinal abnormalities that may affect the decision , transit or absorption of study drug , such as the inability to take medication in tablets by mouth. 4. presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol. 5. concurrent disease that prevents the continuation of temozolomide treatment. 6. presence of leptomeningeal dissemination. 7. pregnant or breastfeeding. 8. positive patients receiving combination antiretroviral therapy in hiv
reduced dexamethasone pre-medication dose in elderly patients receiving weekly docetaxel

Conditions: Breast Cancer; Lung Cancer

Summary: this study is to explore the feasibility of an alternative dose of dexamethasone pre-medication in older breast and lung cancer patients who are receiving weekly docetaxel chemotherapy.

dose-limiting edema and effusions associated with cumulative docetaxel administraton have necessitated the recommendation that all patients should be premedicated with oral corticosteroids such as dexamethasone prior to docetaxel administration. dexamethasone pre-medication may also decrease the incidence and severity of acute hypersensitivity reactions associated with docetaxel administration. however, administration of weekly dexamethasone can cause additional untoward side effects, especially in the older population. if the data from this phase ii study is encouraging, a study to evaluate an even lower dose of dexamethasone can be conducted.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years; * breast or lung cancer patients to receive docetaxel therapy as per protocol; * corticosteroid administration, other than what is prescribed in this protocol, is not permitted during study participation, except topical administration and for adverse events; * performance status ecog 0-2; * peripheral neuropathy ≤ 1; * adequate kidney and liver functions * signed study-specific informed consent exclusion criteria: * patients who have received an investigational drug within 4 weeks of registration; * prior or concurrent malignancies (other than surgically treated carcinoma in situ; * serious medical or psychiatric illness which would prevent informed consent; * life expectancy \< 3 months; * active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled.

Keywords: elderly weekly
therapeutic exercise in patients with hemophilia

Conditions: Hemophilia

Summary: objectives: to assess the efficacy of performing a therapeutic exercise program, compared with usual care, on pain relief, range of movement and self-perceived quality of life in patients with hemophilia design: quantitative, experimental, longitudinal and prospective study. subjects: male patients between 30 and 45 years old, with hemophilia type a or b and with knee, ankle or elbow arthropathy caused by hemophilia. participants may be undergoing a pharmacologic treatment with intravenous viii and/or ix factor methods: participants in the experimental group will an intervention based on therapeutic exercise. one therapist will instruct the patients during two sessions (each lasting approximately 1 hour). participants will be asked to continue this program at least twice a week. meanwhile, those in the control group will receive usual physical therapy care, based on a more passive approach, including self-assisted joint mobilization and muscle stretching. those in the control group will be also instructed to perform the protocol at home, at least twice a week. the intervention protocol in both groups will last three months


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hemophilia type a or hemophilia type b. * knee, elbow or ankle arthropathy caused by hemophilia * pharmacological treatment based on using viii or ix factor concentrates. exclusion criteria: * presence of viii fix inhibitors. * having received anti-inflammatory treatment using arcoxia (etoricoxib) * having undergone a surgical intervention at the target joint. * patients enrolled in other research which implies doing physical exercise.

Keywords: hemophilia therapeutic exercise physical therapy randomized controlled trial pain perception range of movement
the compliance project concerning people with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to determine whether individual and/ or system orientated interventions can help the problem of people with schizophrenia dropping out of their drug treatment

50% of people with schizophrenia do not take the prescribed medication leading to repeating relapses with loss of social and cognitive skills. the individual intervention is based on "motivational interviewing" by miller and "concordance strategies" by r. gray.it is a cognitive behavioral therapy. the system orientated intervention is building on principles from quality assurance and clinical risk managing. it seeks to improve the quality in the medical treatment by use of standards, monitoring, audit and root cause analysis,and thereby trying to find weak points in the system and subsequently improve the common practice.

Eligibility criteria:
inclusion criteria: * diagnoses of schizophrenia or schizoaffective psychosis * 23 years or more * ethnic dane * living in the city of odense. exclusion criteria: * not subject to legal action
the influence of post-transjugular intrahepatic portosystemic shunt hepatic encephalopathy

Conditions: Portal Hypertension; Hepatic Encephalopathy

Summary: through a multicenter randomized controlled trial of tips to prevent post-hepatitis b cirrhosis of esophagogastric varices, the incidence of hepatic encephalopathy, the rate of stent patency, the incidence of rebleeding and survival in the left and right branches of the portal vein were compared.

the most common cause of cirrhosis in china is hepatitis b virus infection; post-hepatitis b cirrhosis with gastroesophageal variceal hemorrhage is common in clinical practice; recent studies \[14\] found that implantation of 8 mm diameter is compared with the use of 10 mm diameter stents. the membrane stent significantly reduced the incidence of he after tips without affecting the shunt effect. to further evaluate the effect of "left/right branch of shunt portal" on hepatic encephalopathy after tips, we intend to conduct the following studies: for individual etiology (post-hepatitis b cirrhosis), the only indication (to prevent recurrent rupture of gastroesophageal varices) ), implanted 8mm diameter viatorr stent, unified he evaluation criteria, and stratified multi-center randomized clinical trial study with child classification, hope to guide tips in line with china's national conditions through the high-level evidence-based medical evidence obtained.

Eligibility criteria:
inclusion criteria: 1. the patient's gender is not limited, ≥ 18 years old and ≤ 75 years old; 2. clinically diagnosed post-hepatitis b cirrhosis; 3. history of esophageal varices venous rupture confirmed by endoscopy, re-bleeding after standard treatment; 4. liver function child a or b; 5. imaging (ct or mri) suggests that the left/right first branch of the intrahepatic portal can construct a shunt; 6. platelet count ≥ 50 × 109 / l; 7. prothrombin time (pt) does not exceed the upper limit of the normal control for 3 seconds; 8. serum creatinine concentration ≤115umol/l; 9. patients and their families agree to join the clinical trial and sign an informed consent form. exclusion criteria: 1. imaging confirms portal vein thrombosis; 2. patients who have undergone previous surgical treatment of portal hypertension (including splenectomy, surgical disconnection or shunt); 3. combine any malignant tumor; 4. history of previous hepatic encephalopathy; 5. consolidation of intractable ascites; 6. pulmonary artery pressure \> 40 mmhg, left ventricular ejection fraction \< 50%, congestive heart failure or severe valvular insufficiency; 7. others: persistent active bleeding, vital signs can not be maintained, blood ammonia ≥ 100, total bilirubin \> 51umol / l failed to improve after symptomatic treatment; combined active infection, especially biliary system inflammation; female patients are pregnant or lactation; severe contrast allergy.
prevention of post operative urinary retention after thoracic surgery trial

Conditions: Urinary Retention Postoperative

Summary: the objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery.

the objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery. primary outcomes being measured are the enrollment rate, protocol adherence rate and participant drop out.

Eligibility criteria:
inclusion criteria ( 2 or more of the following risk factors): * male sex * age greater than or equal to 40 years * history of diabetes mellitus * prior pelvic irradiation * use of indwelling thoracic epidural analgesia * prior history of urinary retention and international prostate specific score greater than or equal to 1. exclusion criteria: * active treatment of benign prostatic hyperplasia (bph) * hypersensitivity or allergy to tamsulosin hcl * active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date * active urinary tract infection * history of urological disorder specified as urethral stricture, bph, bladder or prostate malignancy. * history of urological surgery (transurethral resection of the prostate, transurethral resection of the bladder, bladder suspension, prostatectomy) * underlying neurological disorders resulting in impaired bladder function * any known contraindication to the use of tamsulosin hcl * nursing/ breastfeeding women * use of intraoperative bladder catheter * patients for whom cataract and/or glaucoma surgery is scheduled. * patients on strong inhibitors of cyp3a4 (e.g., ketoconazole), on moderate inhibitors of cyp3a4 (e.g., erythromycin), on strong (e.g. paroxetine), on moderate (e.g., terbinafine) inhibitors of cyp2d6 or in patients known to be cyp2d6 poor metabolizers. * patients with a serious or life-threatening sulfa allergy * patients with severe hepatic insufficiency * patients with severe renal impairment (creatinine clearance of \<10 ml/min) * patients with a serious or life-threatening sulfa allergy

Keywords: urinary retention thoracic surgery urinary catheter