Kornimate/medical-research-clean huggingface dataset:
treatment after irinotecan-based frontline therapy: maintenance with erbitux (in patients wtras mcrc)

Conditions: Metastatic Colorectal Cancer

Summary: national multicentric phase ii trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line folfiri plus cetuximab in mcrc patients with kras and nras wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed colorectal cancer 2. kras and nras wild-type genes after analysis of mutation status from the primary tumour or metastasis 3. non resectable metastatic disease in a curative intent 4. no prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion 5. at least one measurable tumour target (higher than 20 mm) according to recist criteria, which has never been irradiated 6. life expectancy above 3 months 7. performance status ≤2 (who) 8. patient ≥18 years-old 9. acceptable blood test 10. patient having signed a written informed consent form exclusion criteria: 1. known and/or symptomatic brain metastases 2. known allergy to one of treatment components 3. neurological or psychiatric condition which could interfere with good treatment compliance 4. current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation 5. other severe conditions such as: respiratory failure. history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest ct scan 6. clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization 7. concomitant severe infection 8. history of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.) 9. patient already included in another clinical trial with an investigational molecule 10. prior treatment with anti-egfr antibodies (e.g. panitumumab (vectibix® or cetuximab / erbitux® ) or treatment with small egfr inhibitor molecules (e.g., erlotinib / tarceva®) 11. pregnant female, likely to be or currently breastfeeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment 12. those deprived of their freedom or under guardianship 13. impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons

Keywords: metastatic colorectal cancer cetuximab maintenance
increasing the effectiveness of the diabetes prevention program

Conditions: Overweight; Obesity

Summary: the diabetes prevention program (dpp) is highly effective in promoting weight loss in overweight and obese individuals (e.g., 7% average loss of body weight), and thereby reducing the risk of developing weight-related health consequences. one-on-one dpp sessions, however, are costly and the group-delivered dpp version, the group lifestyle balance program (glb), is less effective (4% average loss of body weight). the aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the glb by integrating habit formation techniques, namely if-then plans and their mental practice, into the program. the study will provide evidence-based data on the effectiveness of an enhanced glb intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems.

please see brief summary.

Eligibility criteria:
inclusion criteria: * men and women * ages of 18 and 75 * overweight or obese (bmi 28-45 kg/m2) * sedentary (\< 200 min/week of moderate or vigorous exercise) * waist circumference of \>= 88cm for women and \>= 102cm for men exclusion criteria: * diabetes (hemoglobin a1c \< 7.0%). * taking the medication metformin (used for treating pre-diabetes or diabetes) * having been pregnant in the past 6 months or planning on becoming pregnant in the next 2 years * currently undergoing treatment for cancer * using medication that affects body weight (e.g., loop diuretics) * being unable to participate in regular moderate physical activity * having severe uncontrolled hypertension (\> 190/100mm hg) * being unable to communicate in english or french * being diagnosed with bulimia nervosa, currently active major depression, or other severe psychiatric disease (including dementia); * suffering from a heart attack, stroke, or heart failure within the past 6 months * experiencing excessive weight loss (more than 10 pounds or 4.54 kilograms) in the past 3 months * currently participating in another weight loss program * having had bariatric surgery in the past 2 years or plans on getting it in the near future * planning on moving away from montreal within the next year * having another member of one's household enrolled in the program.

Keywords: group-delivered diabetes prevention program obesity overweight lifestyle change healthy eating weight loss exercise cognitive-behavioral intervention implementation intentions mental imagery mental practice if-then plans
inod™ ultrasound-guided needle biopsy system study

Conditions: Solitary Pulmonary Nodule; Multiple Pulmonary Nodules; Biopsy, Fine-Needle

Summary: the purpose of this study is to collect information on the inod™ system's safety and ability to see the inod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses.

this post-market study intends to further demonstrate the ability and safety of the inod™ ultrasound guidance system and inod™ ultrasound biopsy needle to perform transbronchial needle biopsy of endobronchial lesions, peripheral lung nodules, or lung masses under real-time ultrasound visualization. this is a prospective, multi-center case series of standard of care peripheral lung nodule biopsy procedures with up to 115 subjects at up to 10 centers.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. subject willing and able to comply with study procedures and provide written informed consent to participate in study. 3. subject with a predominantly solid, peripheral lung lesion, 1 cm to 5 cm in diameter measured along its longest cross sectional diameter on axial ct imaging (obtained within 4 weeks per standard of practice) with the intention to undergo a clinically indicated bronchoscopic evaluation under routine clinical care. if the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up at least 80% of the lesion. a. "peripheral" lesion in this study will be pragmatically defined as any lesion in the lung parenchyma that the clinician feels cannot be accessed successfully using the convex probe endobronchial ultrasound bronchoscope. 4. subject for whom the decision to pursue biopsy has been made by the treating physician and agreed upon by the subject. exclusion criteria: 1. subjects with pure ground glass opacity or a subsolid target lesion, and/or a ground glass opacity for which less than 80% of the lesion is solid identified by chest ct. 2. subjects who have medical contraindication to undergo conventional flexible or robotic bronchoscopy and standard of care radial ebus-guided cytological assessment evaluations, as determined by the investigator. 3. subjects with known coagulopathy. 4. subjects who are pregnant or nursing mothers. 5. subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor. 6. use of intraprocedural cone beam ct, fixed ct or augmented fluoroscopy

Keywords: post-market pulmonary lesions inod r-ebus
adjunctive glycine for obsessive compulsive disorder

Conditions: Obsessive Compulsive Disorder

Summary: the purpose of this study is to determine whether individuals with obsessive compulsive disorder who will take a preparation of the amino acid glycine in addition to their current treatment, may experience improvement in their symptoms.

individuals with obsessive compulsive disorder (ocd) often find inadequate relief, even with the best of currently available treatments. some evidence suggests the the neurotransmitter glutamate may be a useful target for new treatments for ocd. the amino acid glycine, if given orally in adequate dosages, can have specific effects on one particular glutamate receptor molecule in the brain, that might be helpful with oc symptoms. this randomized, double-blind protocol will have study participants who suffer with ocd take either a glycine preparation or placebo for 12 weeks. clinical measures (e.g., y-bocs, nimh-oc) will be recorded at each visit to determine whether those taking the glycine experience clinical benefit.

Eligibility criteria:
inclusion criteria: * diagnosis of ocd present for at least 1 year * male or female, age 18 to 65 * stable medication regimen for 12 weeks prior to study entry * at least moderately severe oc symptoms exclusion criteria: * active substance use disorder within the last 6 months * comorbid schizophrenia, schizoaffective disorder, bipolar disorder, tic disorder, tourette disorder, schizotypal personality disorder * hoarding as the principal ocd symptom * insulin-dependent diabetes mellitus * pregnant or breastfeeding

Keywords: ocd obsessive compulsive disorder glycine
vaccine therapy in preventing flu in children with acute lymphoblastic leukemia

Conditions: Infection; Leukemia

Summary: rationale: flu vaccine may help the body build an immune response and decrease the occurrence of flu in children who are receiving chemotherapy for acute lymphoblastic leukemia. purpose: clinical trial to study the effectiveness of vaccine therapy in preventing flu in children who have acute lymphoblastic leukemia.

objectives: * determine the immune response, in terms of the formation of protective antibody titers to influenza, in children with acute lymphoblastic leukemia treated with split-virus trivalent influenza vaccine. * correlate the formation of protective antibody titers following immunization with the absolute neutrophil counts and absolute lymphocyte counts in these patients at the time of vaccination. outline: this is a multicenter study. patients are stratified according to current treatment for acute lymphoblastic leukemia (consolidation chemotherapy vs maintenance chemotherapy vs off therapy for the past 6 months). patients receive split-virus trivalent influenza vaccine intramuscularly once or twice at 4 weeks apart for 2 doses. patients are followed at week 5. patients receiving 2 doses of vaccine are also followed at week 9. projected accrual: a total of 175 patients (50 receiving consolidation therapy, 75 receiving maintenance therapy, and 50 off therapy) will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * diagnosis of acute lymphoblastic leukemia * in first remission after completion of induction chemotherapy * currently on active treatment or * completed treatment within the past 6 months patient characteristics: age: * 1 to 20 at time of diagnosis performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified pulmonary: * no acute respiratory distress other: * no history of guillain-barre syndrome * no history of hypersensitivity to chicken eggs, egg products, or components of influenza virus vaccine, including thimerosal * no febrile illness with fever over 100.4 degrees f * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * at least 7 days since prior antibiotic or antiviral therapy except prophylactic antibiotics

Keywords: childhood acute lymphoblastic leukemia in remission infection
modulating energy density in time-restricted eating

Conditions: Insulin Resistance; Body Weight

Summary: the goal of this randomized controlled trial is to test the effect of time-restricted eating (14-hour fast, 10-hour eating window) of a low-energy dense diet (reduced calories per gram of food) in older adults with obesity and insulin resistance. the study aims to determine if modulating the energy density of the diet reduces: 1. insulin resistance and 2. body weight. researchers will compare the groups: 1. following time-restricted eating and given a diet reduced in energy density or 2. following time-restricted eating and given a diet typically consumed in this population

the study is an eight-week randomized controlled double-blinded clinical trial. participants will follow time-restricted eating (14-hour fast, 10-hour eating window), and will be randomized to a diet low in energy density or the usual diet. meals will be prepared in a metabolic kitchen and dispensed to participants. dietitians will monitor dietary compliance. a blood sample will be drawn and body weight will be measured before starting the intervention and after completing it.

Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≥ 30kg/m2. 2. mini-mental state examination (mmse) \> 25 3. geriatric depression scale-15 (gds-15) \< 9 4. homeostatic model assessment of insulin resistance (homa-ir) ≥ 3. exclusion criteria: 1. diagnosis of type 2 diabetes received more than five years ago 2. diagnosis of type 1 diabetes 3. evidence of clinically significant renal dysfunction or disease 4. history of malignancy during the past five years 5. being treated with systemic steroids, olanzapine, or clozapine 6. being treated with prescription medications for obesity 7. being treated with thiazolidinediones, glucagon-like-receptor agonists, dipeptidyl peptidase iv inhibitors, and insulin 8. weight change \> 3 kg in the preceding three months 9. any disease or condition that precludes testing of the study outcomes or makes it unsafe to consume the foods being tested in the study, or subjects are otherwise deemed to be unsuitable for participation in the study (determined by the investigative team)
efficacy and safety of subcutaneous secukinumab in adults with moderate to severe scalp psoriasis

Conditions: Chronic Scalp Psoriasis

Summary: this study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments.


Eligibility criteria:
inclusion criteria: * chronic scalp psoriasis for at least the previous six months * moderate to severe scalp psoriasis as defined by a pssi score of ≥12 and 30% or higher of scalp surface area affected * must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy. exclusion criteria: * forms of psoriasis other than chronic plaque * drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors) * ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, uv therapy) * prior exposure to secukinumab (ain457) or any other biologic drug directly targeting il17a or il-17ra receptors * use of other investigational drugs within 30 days prior to study entry, or within a period of 5 half-lives of the investigational treatment, whichever is longer * active, ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab * active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment * other protocol-defined inclusion/exclusion criteria may apply

Keywords: scalp psoriasis, plaque psoriasis, secukinumab, ain457, biologic, monoclonal antibody, psoriasis, ain457a
dnaj peptide for relieving rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a small protein called dnaj peptide may help people with rheumatoid arthritis (ra) by preventing their immune system cells from attacking their own tissues. the purpose of this study is to determine if small amounts of dnaj peptide can "re-educate" immune cells in people with ra so that the cells stop attacking joint tissues.

immune modulation is a promising new approach for the treatment of ra. studies have shown that immune cells in the joints of people in the early stages of ra react strongly against dnaj peptides from bacteria. these immune cells may also cross-react with human dnaj peptides in the joints to cause inflammation. dnaj may help ra by "re-educating" the immune system and dampening the abnormal inflammatory immune response in ra. this study will last 7 months. participants will be randomly assigned to receive either dnaj or placebo by mouth. at screening, participants will have medical history, physical, and medication assessment. at screening, at 6 study visits every month after the start of treatment, and at 1 month follow-up, participants will have a joint exam, blood and urine collection, and will fill out a questionnaire about their condition.

Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis as defined by the revised american college of rheumatology (acr) 1987 criteria. evidence of active disease will be based on at least six swollen or nine tender joints. * diagnosis of rheumatoid arthritis of less than 5 years * reactivity to dnaj * agree to use acceptable methods of contraception * able to understand and sign informed consent exclusion criteria: * patients taking more 7.5 mg of prednisone or disease modifying agents other than hydrochloroquine or sulfasalazine (i.e., gold, penicillamine, azathioprine, cyclophosphamide, methotrexate, cyclosporine, or anti-tnf agents) * serum creatinine greater than 1.5 mg/dl * sgot less than sgpt * alkaline phosphatase greater than 2 times age/sex adjusted normal values * hematocrit of less than 30 * platelets less than 130,000 * history of lymphoma * any active malignancy or cancer requiring treatment in the last 5 years, except for nonmelanoma skin cancers and carcinoma of the cervix in situ * medical or psychiatric condition or active serious infection * pregnant or breastfeeding

Keywords: ra immune modulation oral tolerance peptide dnaj
effects of tai chi chuan with different doses on cognitive function in elderly patients with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: to determine the impact of tai chi chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment.

taking mci as a potential gateway, early intervention to delay the occurrence of dementia has become an important consensus in this field. exercise is an important means to improve cognitive function in mci, but the effect of exercise is influenced by the dosage. tai chi chuan, is a moderate intensity aerobic exercise. previous studies by our team and others had confirmed its effect on cognitive function in mci. however, the dose parameters of tai chi chuan exercise varied in these studies, and the dose-response relationship is still unclear. the purpose of this study is to explore the dose-response relationship between different volume of tai chi chuan exercise and cognitive function（global cognition and cognition of subdomains）in elderly mci patients.

Eligibility criteria:
inclusion criteria: 1. presence of mild cognitive impairment, not demented; 2. age ≥ 60 years old; 3. informed consent and voluntary participation. exclusion criteria: 1. geriatric depression scale score ≥ 9 points 2. cognitive impairment caused by other reasons, taking drugs, poisoning, etc; 3. suffer from severe musculoskeletal system diseases and other contraindications to exercise and are not suitable for tai chi training, such as those who suffer from stroke, parkinson's disease, and have a history of lower limb arthritis, hip and knee joint replacement, etc; 4. patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases; 5. individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation; 6. individuals with uncontrolled hypertension (systolic blood pressure greater than 160mmhg or diastolic blood pressure greater than 100mmhg after medication); 7. participating in other experiments that influence this study; 8. engaged in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time.

Keywords: tai chi chuan cognitive function dose-response
bariatric dose-ranging study with dexmedetomidine

Conditions: Abdominal Surgery Patients

Summary: after obtaining informed consent,80 morbidly obese asa ii-iii patients undergoing laparoscopic bariatric surgery procedures would be randomly assigned to one of four study groups at utswmc at dallas.hemodynamic paarameters, recovery times, postoperative pain scores, the need for rescue analgesics and side effects will be recorded.the purpose of this study is to determine the optimal linfusion rate of dexmedetomidine for maintaining cardiovscular stability during general anesthesia.


Eligibility criteria:
inclusion criteria: subjects may be included in the study only if they meet all of the following criteria: 1. age 18 to 70 years 2. undergo laparoscopic bariatric surgery requiring general anesthesia 3. be capable of giving informed consent 4. asa physical status i-iii ( appendix 1) exclusion criteria: 1. subjects will be excluded from the study for any of the following reasons: 2. with history of hypertension and allergy to dexmedetomidine 3. patients who have greater than first degree heart block. 4. performing major intracavitary surgery procedures 5. patients who are pregnant or breast-feeding 6. history of alcohol or drug abuse
effects on the qt interval of covid-19 coronavirus infection

Conditions: Coronavirus Infection; Intensive Care Patients

Summary: the present study aims to evaluate the impact of covid-19 disease and its treatment on ventricular repolarization, assessed by measuring the qtc interval, in patients admitted to the critical care unit.

coronavirus infection of severe acute respiratory syndrome covid-2 is characterized by a broad clinical spectrum ranging from asymptomatic infection, mild upper respiratory tract disease and severe viral pneumonia with respiratory failure and even death, with many patients hospitalized with pneumonia. in addition, the infection can have a direct impact on cardiovascular disease including the development of arrhythmias, although the exact incidence is not known. treatments administered for covid-19 infection have the potential to produce adverse cardiovascular effects including prolongation of the qt interval and development of arrhythmias. relevant clinical data that may affect the qt interval and specifically the medication the patient has received will be recorded. the specific treatment administered for covid-19 will be recorded as the concomitant medication of the critical patient that may have an impact on the qt interval. analytical data will also be collected on plasma levels of ions such as potassium, calcium and magnesium, blood gases, renal and hepatic function parameters and cardiac markers.

Eligibility criteria:
inclusion criteria: * patients admitted to intensive care units for covid-19 infection with an ecg record exclusion criteria: * patients in critical care unit without covid-19 infection

Keywords: qt interval, ventricular repolarization