Kornimate/medical-research-clean huggingface dataset:
omitting clinical target volume in radical treatment of unresectable stage iii non-small cell lung cancer

Conditions: Immunotherapy; Intensity Modulated Radiation Therapy; Radiotherapy; NSCLC

Summary: simultaneous radiotherapy followed by adjuvant immunotherapy is the standard treatment modality of unresectable stage iii nsclc. our preliminary study confirmed that the treatment of ctv-omitted imrt regimen did not compromise the pfs or os and significantly reduced the incidence of severe radiation pneumonia and radiation esophagitis. the purpose of this study was to observe the role of radiotherapy modalities that omit ctv in the context of immunotherapy for nsclc.


Eligibility criteria:
inclusion criteria: * •patients with advanced (stage iiia or iiib ajcc 7) nsclc that was histologically or cytologically inoperable * ecog whole body status (performancestatus,ps) level 0 or 1 * the estimated survival time is more than 12 weeks, 18 \~80 years old * laboratory results within 2 weeks prior to radiotherapy met the following criteria: ① neutrophil count \> 1,500/ mcl heathko-pilot oncology research fund; ② platelet \> 50,000/ mcl; ③ total bilirubin \< 1.5 times of the normal upper limit value; ④ast(sgot)/alt(sgpt) \< 2.5 times of the normal upper limit; ⑤ serum creatinine \< 1.5 times of the normal upper limit value; ⑥ the results of coagulation function examination were within the normal range * women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug. for men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug * understand and voluntarily sign written informed consent * the investigator judged that the patient had good compliance exclusion criteria: * malignant pleural/pericardial effusions, previous thoracic radiotherapy or chemotherapy * uncontrolled concurrent diseases, including but not limited to symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade iii hypertension, liver insufficiency, renal insufficiency, uncontrolled diabetic blood sugar, arrhythmia, mental illness or social condition, etc. * pregnant or nursing women * the patient has no history of intracranial hemorrhage or spinal cord hemorrhage * hiv-positive patients receiving combination antiretroviral therapy * active tuberculosis * major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study * prior allogeneic stem cell or solid organ transplantation * researchers determine other conditions that may affect the conduct of clinical studies and the determination of their findings

Keywords: imrt immunotherapy ctv
smart-tv application for the self examination of the distance visual acuity in macular edema patients

Conditions: Low Vision; Macular Edema; Refractive Errors

Summary: primary objective of our study is the development and validation of an application for smart-tvs for the self-examination of the distant visual acuity of patients diagnosed with macular edema.

present study aims to develop and validate an application installed in smart-tvs. this application will be referred to patients suffering from macular edema, allowing the self-examination of the patient in terms of distant visual acuity. the development of a simple but reliable way of self-examination of distant visual acuity would bring beneficial results in the overall management of these patients as significantly would reduce the flows to the outpatient ophthalmology clinics of the nss hospitals, would serve the purposes of the social distancing imposed by the current state of the pandemic but also any analogous situation and would help the patient to be vigilant and actively involved in the management of his disease.

Eligibility criteria:
inclusion criteria: * age-dependent macular degeneration * diabetic macular edema exclusion criteria: * corneal diseases * glaucoma * psychiatric disorders * inability to cooperate

Keywords: smart features smart-tv app
impact of hidradenitis suppurativa on quality of life functions

Conditions: Hidradenitis Suppurativa; Quality of Life

Summary: the goal of this study is to get a better understanding of the impact of hidradenitis suppurativa (hs) on the quality of life of patients with this condition. patients with hs will be asked questions about demographics including gender, age, and ethnicity. they will also be asked to complete questionnaires to determine how their skin condition affects their life. study participation will last for 1 day, with potential for follow-up in the future. we hope this information will help us improve our treatment for this skin condition.

the goal of this study is to get a better understanding of the impact of the skin condition, hidradenitis suppurativa, on quality of life function of patients. patients with hs will be asked questions about demographics including gender, age, and ethnicity. they will also be asked to complete questionnaires to determine how their skin condition affects their life. the questionnaires include beck depression inventory form, which gives us information how you feel about your skin condition and how it changes your mood; dermatology life quality index (dlqi), which gives us information about how your skin condition affects your quality of life; skindex, which gives us more specific information about how your skin condition affects your quality of life; sf-36 health survey, which gives us information about your general health status; the quality of life enjoyment and satisfaction questionnaire- short form (q-les-q-sf), which gives us information on your enjoyment and satisfaction of your life; and the employment/productivity health economic questionnaire, which will give us more information on your work and school status as well as household income. study participation will last for 1 day, with potential for follow-up in the future. through potential follow up visits we hope to determine the longitudinal effect of treatment modalities on qol through future survey performance of the patient cohort. we hope this information will help us improve our treatment for this skin condition.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hidradenitis suppurativa * subject age \>/= 18 years * able to be evaluated by a montefiore physician exclusion criteria: * no clinical diagnosis of hidradenitis suppurativa * subject age \< 18 years * subject unable to understand or answer provided questionnaires * unable to evaluated by a montefiore physician

Keywords: hidradenitis suppurativa quality of life
serum and urine titanium levels in children with early onset scoliosis treated with growth-sparing instrumentation

Conditions: Early-Onset Scoliosis Deformity of Spine

Summary: the investigators are conducting research to compare serum and urine titanium levels in children with early onset scoliosis who are being treated with certain types of metal spinal rods. these rods include traditional growing rods (tgr), magnetically-controlled growing rods (mcgr), and vertical expandable prosthetic titanium rib (veptr). children with metal rods may have elevated serum and urine titanium levels. these levels may remain elevated over time. the investigators will collect serum titanium levels from children with metal rods and children without metal rods to see if there are differences in their titanium levels. the investigators will then collect a second serum titanium level from children with metal rods at least 6 months later to see if the participants titanium levels remain elevated over time. the investigators will also collect urine titanium levels from children with metal rods to see if titanium is excreted in the urine.


Eligibility criteria:
inclusion criteria: cases: patients with early onset scoliosis treated with traditional growing rods (tgr), magnetically controlled growing rods (mcgr), and the vertical expandable prosthetic titanium rib (veptr). controls: patients with operative fractures. exclusion criteria: cases: patients who had a previous limited spinal fusion, conversion from one type of gsi to another, tgr with stainless steel or cobalt chromium instrumentation, and indwelling implants for 6 months or less. controls: patients with indwelling implants or prior implant insertion and removal.

Keywords: titanium levels
conversation with family doctor to increase covid-19 vaccine uptake

Conditions: COVID-19

Summary: the investigators will randomise individuals from family doctors' lists of patients that are at risk of severe coronavirus disease 2019 (covid-19), and that are not registered as having taken the vaccine against the disease. the patients will be randomised to receiving a phone call from their family physician where the participants are given the opportunity to raise questions they might have around vaccination. the investigators will assess whether this has an impact on vaccine uptake.


Eligibility criteria:
inclusion criteria: * belonging to group at risk of severe covid-19 exclusion criteria: -

Keywords: health services research quality improvement
s9914: combination chemotherapy plus filgrastim in untreated extensive-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. purpose: phase ii trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.

objectives: i. assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel, carboplatin, topotecan, and filgrastim (g-csf). ii. determine the side effects and toxicity of this regimen in these patients. outline: patients receive topotecan iv over 30 minutes on days 1-4 and paclitaxel iv over 1 hour followed by carboplatin iv over 1 hour prior to topotecan on day 4. patients receive filgrastim (g-csf) subcutaneously once daily beginning on day 5 and continuing until blood counts recover. g-csf must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy. treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 6 months for 3 years. projected accrual: a total of 75 patients will be accrued for this study over 18 months.

Eligibility criteria:
disease characteristics: histologically or cytologically proven, previously untreated extensive stage small cell lung cancer (sclc) brain metastases allowed if: asymptomatic or previously treated with radiotherapy and/or surgery measurable or evaluable disease outside the area of prior surgical resection or a new lesion must be present patient characteristics: age: 18 and over performance status: swog 0-2 life expectancy: not specified hematopoietic: absolute granulocyte count at least 1,500/mm3 wbc at least 3,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.25 times upper limit of normal (uln) sgot or sgpt no greater than 2.5 times uln renal: creatinine no greater than uln creatinine clearance at least 50 ml/min other: not pregnant or nursing fertile patients must use effective contraception no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage i or ii cancer that is in complete remission prior concurrent therapy: biologic therapy: no prior systemic biologic therapy for sclc chemotherapy: no prior systemic chemotherapy for sclc endocrine therapy: not specified radiotherapy: see disease characteristics no prior radiotherapy for sclc surgery: see disease characteristics at least 2 weeks since prior thoracic or other major surgery and recovered

Keywords: extensive stage small cell lung cancer
a study of mdx-1106 in patients with selected refractory or relapsed malignancies

Conditions: Carcinoma, Non-Small-Cell Lung; Colorectal Cancer; Malignant Melanoma; Renal Cancer; Prostate Cancer

Summary: to evaluate the safety, tolerability, efficacy, and pharmacokinetics of mdx-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer

six patients enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (mtd) during the dose-escalation portion of the study. patients who respond may receive additional doses of drug.

Eligibility criteria:
inclusion criteria: * relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma * prior treatment must have been completed at least 4 weeks prior to enrollment * no untreated primary or metastatic brain or meningeal tumors * ecog ps 0 or 1 * meet all screening laboratory values exclusion criteria: * history of severe hypersensitivity reactions to other monoclonal antibodies * active autoimmune disease or a documented history of autoimmune disease * prior therapy with an anti-pd-1 or anti-ctla-4 antibody * active infection * concurrent medical condition requiring the use of immunosuppressive medications

Keywords: malignancies cancer non small cell lung cancer lung cancer colorectal cancer adenocarcinoma melanoma malignant melanoma renal cancer renal carcinoma carcinoma prostate cancer prostate adenocarcinoma recurrent or treatment refractory malignancies
safety and tolerability of ferric carboxymaltose (fcm) versus standard of care in treating iron deficiency anemia

Conditions: Anemia

Summary: the objective of this study is to evaluate the safety of fcm in patients with anemia who are not dialysis dependent.


Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years of age and able to give informed consent * iron deficiency is the primary etiology of anemia * screening visit central laboratory hemoglobin (hgb) ≤ 11g/dl * screening visit ferritin ≤ 100ng/ml or ≤ 300 ng/ml when tsat was ≤ 30% exclusion criteria: * previous participation in a fcm trial * known hypersensitivity reaction to fcm * requires dialysis for treatment of chronic kidney disease * current anemia not attributed to iron deficiency * received iv iron, rbc transfusion(s), or antibiotics 10 days prior and during the screening phase * anticipated need for surgery * ast or alt greater than 1.5 times the upper limit of normal * received an investigational drug within 30 days of screening * pregnant or sexually-active females who are not willing to use an effective form of birth control
betaine metabolism of patients with homocystinuria

Conditions: Homocystinuria

Summary: oral treatment with betaine is conventionally used for patients with inherited homocystinurias. these conditions include a first group of patients with a cystathionine β-synthase (cbs) deficiency and a second group of patients with remethylation defects. the aim of betaine therapy is to reduce level of total plasma homocysteine. daily dosages and rhythm of administration proposed in the literature vary between 100 to 250 mg / kg / d in 2 to 4 doses. these dosages are not based on validated data and several publications mention much higher dosages particularly when total homocysteine is not controlled. these practices may be unnecessary or even detrimental given the fact that high doses of betaine could for example lead to secondary folate deficiency.

oral treatment with betaine is conventionally used for patients with inherited homocystinurias. these conditions include a first group of patients with a cystathionine β-synthase (cbs) deficiency and a second group of patients with remethylation defects. the aim of betaine therapy is to reduce level of total plasma homocysteine. daily dosages and rhythm of administration proposed in the literature vary between 100 to 250 mg / kg / d in 2 to 4 doses. these dosages are not based on validated data and several publications mention much higher dosages particularly when total homocysteine is not controlled. these practices may be unnecessary or even detrimental given the fact that high doses of betaine could for example lead to secondary folate deficiency.

Eligibility criteria:
inclusion criteria: * ≥1 year and children \<18 years, * homocystinuria confirmed enzymatically or molecularly divided into 2 groups: * cbs deficiency remethylation defects (cbic defect and mthfr deficiency) * diagnosis of homocystinuria since more than 1 year * continuous treatment of hyperhomocysteinemia in the last 12 months exclusion criteria: * deficits in cystathionine beta-synthase b6-responsive * pregnancy * breast-feeding * young pubescent girls not using effective contraception
small intestinal bacterial overgrowth obese

Conditions: Gastric Bypass; Blind Loop Syndrome; Bacterial Overgrowth Syndrome; Chromatography, Gas

Summary: the objective of this research is to determine the incidence of microbial overgrowth of the small intestine before and after a gastric bypass. for this purpose, the study is based on the analysis of the expired hydrogen h2 with gas chromatography before surgery and at 1, 3, 6, 12, 18 and 24 months.


Eligibility criteria:
inclusion criteria: * severe obesity (bmi\>35kg/m² with at least one comorbidity or bmi\>40kg/m² without comorbidity) and after medical care for at least 6 months * patient who will follow bariatric surgery by bypass gastric * social insurance affiliation * signature of the informed consent exclusion criteria: * contraindication criteria for bariatric surgery (cognitive or mental severe disorders, severe and non-stabilized eating disorders, etc.) * chronic inflammatory bowel disease (crohn's disease, hemorrhagic rectocolitis) * previous intestinal surgery * antibiotic periodicity treatment of less than 3 months * other diseases responsible for bacterial overgrowth * pregnancy or breastfeeding

Keywords: gastric bypass intestinal bacterial overgrowth syndrome gas chromatography
study of the effects of bms-919373 on the electrical activity of the heart using pacemakers

Conditions: Atrial Fibrillation

Summary: to determine the effect of our compound (bms-919373) on electrical activity of the heart using pacemakers.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria * age 18 years to 85 years. * eligible patients will have a dual-chamber permanent pacemaker. * women who are not of childbearing potential. exclusion criteria - patients with a history of atrial fibrillation (af) that is either:. i) permanent (i.e. patients are only in af and never in sinus rhythm) or. ii) persistent (i.e. patients who's episodes of af are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded. * history of transient ischemic attack (tia) or stroke in the last 12 months. * history of clinically significant ventricular arrhythmia (not including isolated monomorphic premature ventricular contractions (pvcs)). such arrhythmias are marked by loss of consciousness, emergent cardioversion or defibrillation or unstable vital signs requiring medical intervention. * complete heart block. * planned surgery, endovascular intervention or cardioversion within the study period. * history of atrial fibrillation. * other protocol-defined inclusion/exclusion criteria apply.
optimal bupivacaine dose for initiation of labor epidural techniques

Conditions: Labor Pain; Analgesia

Summary: to estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ed90) via the epidural (dpe or epl) technique in women undergoing labor.

the primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ed90) via the epidural (dpe or epl) technique in women undergoing labor induction or augmentation; we hypothesize that we will be able to determine the ed90 of bupivacaine for each technique with adequate precision to inform the optimal doses.

Eligibility criteria:
inclusion criteria: 1. parturient with no major co-morbidities 2. singleton, vertex gestation at term (37-42 weeks) 3. less than or equal to 5 cm dilation 4. desire to receive epidural labor analgesia 5. numerical rating scale greater or equal to 5 (nrs 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request. exclusion criteria: 1. current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. any contraindication to the administration of an epidural technique 3. history of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent 4. current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. history of uterine rupture). nb: exception-trial of labor after cesarean delivery (tolac) will be eligible. 5. evidence of anticipated fetal anomalies

Keywords: dural puncture epidural technique epidural technique neuraxial labor analgesia bupivacaine local anesthetic agent
study of the glycemic effects of nebivolol compared with metoprolol and hctz in diabetic hypertensive patients

Conditions: Hypertension; Type 2 Diabetes Mellitus

Summary: this study will evaluate the effects of nebivolol on glycemic control compared with metoprolol and hctz in patients with hypertension and type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * male or female, 18-85 years of age * blood pressure in the range of 130 to 179/80 to 109 mmhg * currently using either an ace inhibitor or an arb alone or (an ace inhibitor or an arb and up to two other drugs for treatment of high blood pressure). (patients may be on both an ace inhibitor and arb, but would need to be taken off one.) * stable medication regimen for high blood pressure for at least one month prior to screening * stable type 2 diabetes mellitus for at least 3 months prior to screening that is controlled by any or all of the following: diet and antidiabetic medications that may include fixed-dose insulin * hgba1c 6.5 to 8.5% (this is measured at the screening visit) exclusion criteria: * use of any beta blocker within one month prior to screening * use of clonidine within 3 months prior to screening * diagnosis of hyperthyroidism as evidenced by abnormal lab markers * any disorder requiring the intermittent or chronic use of systemic corticosteroids * diagnosis of hyperthyroidism as determined by lab markers done at screening * active liver disease as determined by lab markers * kidney impairment; estimated gfr \< 60 ml/min/1.73 m2 * history of heart attack, clinically significant arrhythmia, unstable angina, coronary angioplasty/bypass surgery, stroke, or tia in 3 months prior to screening * chronic heart failure * drug or alcohol abuse within 2 years prior to screening * history of sensitivity to any beta blocker, hctz, sulfa drug, or calcium channel blocker * participation in another research study within 30 days prior to screening

Keywords: nebivolol bystolic ™ hypertension diabetes