Kornimate/medical-research-clean huggingface dataset:
prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with nivolumab (i-rene trial)

Conditions: Metastatic Renal Cell Carcinoma

Summary: prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with nivolumab (i-rene trial)

prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with nivolumab (i-rene trial)

Eligibility criteria:
inclusion criteria: * written informed consent * metastatic renal cell carcinoma (a clear-cell/ not clear-cell) * progression to previous treatment with tyrosine kinase inhibitors * patients candidates for ii-line therapy with nivolumab (or tyrosine kinase inhibitors-in the control arm) exclusion criteria: none

Keywords: metastatic renal cell carcinoma predictive factors
integrated rf and b-mode deformation analysis for 4d stress echocardiography

Conditions: Coronary Artery Disease

Summary: the specific aim of this clinical trial is to translate the investigators new 4de (three sptial dimensions pluse time) stress echocardiographic method to patients with coronary artery disease referred for clinically indicated dobutamine stress/rest echo to evaluate the reproducibility of the technique in this clinical setting.


Eligibility criteria:
inclusion criteria: * at least 18 years of age, referred for clinically indicated dobutamine rest/stress tte * provide written informed consent to participate in the study * availability for repease rest/stress tte within on eweek of clinically indicated study exclusion criteria: * unable to give informed consent * unstable hemodynamics that would not allow for repease rest/stress dobutamine transthoracic imaging * recurrent life threatening arrhythmias * heart rate \>110 bpm * inadequate windows for transthoracic imagine * patients that have a narrow-angle glaucoma (contraindication for atropine) * change in cardiac medications or management including, coronary revascularization beween intial and repeat tte study.
urinary tract infections rates using 50% dextrose plus washout versus normal saline as cystoscopy fluid

Conditions: Hysterectomy

Summary: our study will compare the rates of postoperative urinary tract infections (uti) between patients who undergo cystoscopy using 50% dextrose injection plus bladder washout versus normal saline after hysterectomy for benign indications. primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. this will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

this will be a prospective cohort study of the rate of utis after cystoscopic distention media of normal saline with maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications. a pre-operative urine culture will be obtained via mid-stream clean catch prior to administration of routine pre-operative prophylactic antibiotics. at 6-9 days post-operatively, a repeat urine culture will be obtained via mid-stream clean catch. appropriate treatment will be administered if the urine culture is positive.primary outcome will be rates of urinary tract infections at 6-9 days post-operatively. this will be defined as a urine culture yielding greater than 100,000 gram-negative colony-forming units per milliliter.

Eligibility criteria:
inclusion criteria: * preoperative scheduling cpt codes for hysterectomy exclusion criteria: * discharged home with indwelling foley catheter * indwelling foley catheter \> 24 hours * ureteral injury * chronic immunosuppression * history of diabetes * recurrent utis (≥2 infections in six months or ≥3 infections in one year) * reported chronic kidney disease * renal anomalies
combination effect of optical defocus and low dose atropine in myopia control

Conditions: Myopia

Summary: the purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.

this study is a two-arm randomised controlled trial with a 18-month duration. participants will be healthy hong kong chinese schoolchildren with low to moderate myopia. the aim is to determine the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. optical defocus will be delivered by defocus incorporated multiple segments (dims) spectacle lenses. a total of 112 hong kong chinese children aged 7 to 12 years (56 in each group) will be recruited and randomly allocated into two groups. one group will receive low dose atropine (0.01%) plus dims spectacles (atd group); another one will receive low dose atropine (0.01%) plus single vision spectacles (at group). they must have no prior or current myopia control treatment, have no ocular or systemic diseases/abnormalities that affect visual function, refractive development or spectacle lens wear, and no previous intraocular or corneal surgery. they must not have allergy to atropine. their cycloplegic refraction and axial length will be monitored every six months for 18 months. the changes in refractive errors and axial length between groups will be compared.

Eligibility criteria:
inclusion criteria: * age at enrollment: 7 to 12 years * ethnicity: hong kong chinese * myopia: -0.75d (in spherical equivalent) or above in both eyes * astigmatism: -1.50d or less in both eyes * anisometropia: 1.50d or less (in spherical equivalent) between two eyes * best corrected monocular visual acuity (va): 0.04 logmar or better * ocular health: no abnormalities in both internal and external ocular health * systemic health: no abnormalities such as cardiac and respiratory diseases * binocular vision: no strabismus, diplopia, suppression and other binocular abnormalities * normal colour vision * no previous refractive surgery or use of myopic control interventions, such as atropine, orthokeratology, and specialized spectacle lenses and contact lenses for myopic control * able to wear the prescribed spectacles * no known allergy to atropine exclusion criteria: * eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.) * previous intraocular or corneal surgery * colour vision deficiencies * systemic disease that may affect vision, vision development (e.g. diabetes mellitus, hypertension, down syndrome, etc.) * systemic disease that are contradictory to atropine (e.g. asthma, cardiac diseases, etc.) * previous gas permeable, soft bifocal, or orthokeratology contact lenses wear or bifocal / progressive addition lens spectacles wear or use of atropine or pirenzepine (longer than one month of usage) * previous or current participation in myopia control studies * allergy to cyclopentolate hydrochloride or atropine

Keywords: myopia control defocus atropine
comparison of the efficacy of levofloxacin-based sequential therapy and triple therapy as second line therapy

Conditions: Eradication Rate for Helicobacter

Summary: to compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy

about 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. eradication will be confirmed with 13c-urea breath test 6 weeks after therapy.

Eligibility criteria:
inclusion criteria: * h. pylori infected patients who failed from first line therapy will be eligible in this study exclusion criteria: * patients were excluded from the study if any one of the following criteria was present: * children and teenagers aged less than 20 years, * history of gastrectomy, * gastric malignancy, including adenocarcinoma and lymphoma, * previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and ppi (lansoprazole), * contraindication to treatment drugs, * pregnant or lactating women, or * severe concurrent disease

Keywords: h pylori eradication
voclosporin in adolescent and pediatric subjects with lupus nephritis

Conditions: Adolescent Lupus Nephritis; Pediatric Lupus Nephritis

Summary: the purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescent and pediatric subjects with active lupus nephritis (ln).

this is a 24 week, dose escalation study of voclosporin in addition to standard of care with mycophenolate mofetil (mmf) and steroids, consisting of 3 treatment periods: period 1 is double-blind, placebo controlled receiving 15.8 mg twice daily, period 2 is open-label receiving 23.7 mg twice daily, period 3 is open-label receiving 15.8 mg twice daily.

Eligibility criteria:
key inclusion criteria: * previous diagnosis of systemic lupus erythematosus (sle) as per the 2019 eular/ acr classification criteria. * subjects with kidney biopsy confirmed active lupus nephritis. exclusion criteria: * estimated glomerular filtration rate (egfr) \<60 ml/minute/1.73 m2 at screening. * current or medical history of: * congenital or acquired immunodeficiency. * clinically significant drug or alcohol abuse prior to screening. * malignant neoplasm. * lymphoproliferative disease or previous total lymphoid irradiation. * known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis b or c virus infection at any time prior to screening. * active tuberculosis (tb) or known history of tb/evidence of old tb if not taking prophylaxis with isoniazid. * currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. * other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes. * currently taking or known need for any of the following medications: * immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (cnis) and live attenuated vaccines, initiation or dose change of ace inhibitors/arbs within 4 weeks prior to randomization, iv corticosteroids and iv immunoglobulin within 2 weeks prior to screening, strong cyp3a4/5 inhibitors and inducers within 2 weeks prior to randomization.

Keywords: lupus nephritis calcineurin inhibitors voclosporin adolescents pediatrics
role of omalizumab in reducing the incidence of oxaliplatin-induced hypersensitivity reaction

Conditions: Colon Cancer

Summary: pilot study to evaluate the activity of omalizumab in the prevention of recurrent oxaliplatin hypersensitivity reaction (hsr) in oxaliplatin-sensitive patients. the study will also evaluate the safety of omalizumab (xolair) when administered in this setting.

this is an open label single arm pilot study studying the effects of omalizumab in the treatment of oxaliplatin hypersensitivity reaction (hsr) for patients with stage iv gi cancer.

Eligibility criteria:
inclusion criteria: * clinically evident hsr to oxaliplatin, with symptoms of flushing, urticaria, pruritus, rash, and/or dyspnea without bronchospasm that emerge during or shortly after of oxaliplatin infusion * responding (complete or partial) or stable disease according to recist criteria while undergoing treatment with oxaliplatin containing regimen or need to resume an oxaliplatin based regimen in the setting of well-documented recent oxaliplatin hypersensitivity reaction * histologically confirmed stage iv gi cancer (ajcc 7th edition) currently sensitive to oxaliplatin containing chemotherapy regimen * age 18 years or older * ecog performance status 0-2 * adequate bone marrow, liver, and kidney function. (wbc \> 1500 cells/ul, platelets \> 50,000/ul, alt/ast \< 5xuln (unless due to liver metastasis), creatinine \< 2.0 mg/ld) * willing to give written informed consent, adhere to the visit schedules and meet study requirements exclusion criteria: * prior history of severe reactions to oxaliplatin as characterized by the presence of hemodynamic instability, significant respiratory symptoms or potential airway compromise * history of hypersensitivity reaction to xolair or any ingredient of xolair * concurrent therapy with investigational agents * use of any other investigational agent in the last 15 days and all toxicity of prior therapy resolved * psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule * women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding * patients with severe medical conditions that in the view of the investigator prohibits participation in the study

Keywords: oxaliplatin omalizumab
genetics of recurrent early-onset depression

Conditions: Depression

Summary: this nationwide study will create a dna collection to permit qualified scientists to search for depression-related genes. more than 750 families with at least two siblings who have experienced major depression are needed for the study. participants will be interviewed about psychiatric and family history, and will be asked to provide a small blood specimen. the identification of predisposing genes can lead to greater understanding of the brain mechanisms involved in severe depression which can in turn lead to the discovery of new treatments. a certificate of confidentiality from the federal government ensures that all information will be strictly confidential. blood specimens are identified only by code number (not by name). reimbursement is provided.

studies of patterns of major depression in families suggest that 50 to 70% of the predisposition to major depression is caused by genes. people with recurrent depression and earlier ages of onset have more relatives with depression. there are probably at least several interacting genes, rather than a single gene as in some disorders. the identification of predisposing genes is likely to lead to greater understanding of the brain mechanisms involved in severe depression. this could lead to the discovery of new treatments. this study will create a dna collection to permit qualified scientists to search for depression-related genes. more than 750 families with at least two siblings who have experienced major depression are needed for the study. participants in this study will be interviewed about psychiatric and family history, and will be asked for a small blood specimen. interviews can be conducted in person or by telephone. for telephone interviews, blood sample collection will be arranged at a location and time convenient for the participant. participants will also be asked for help in inviting other family members to participate. no family member will be contacted without the permission and assistance of another participating family member. for information on a related study, please follow this link: http://clinicaltrials.gov/show/nct00260182

Eligibility criteria:
inclusion criteria: * families that have at least two adult siblings (brother/brother; sister/sister; brother/sister) who have experienced major depression. * depression must be recurrent (more than one episode). * depression must have started at age 30 or less in one sibling, and at age 40 or less in the other sibling. exclusion criteria: * participants cannot have bipolar i (manic-depressive) disorder or schizophrenia.

Keywords: depression depressive disorder family genes genetic techniques genetics linkage (genetics) nuclear family recurrence severity of illness index
aromatherapy massage for itching management in liver diseases

Conditions: Aromatherapy; Massage; Liver Diseases; Itching; pH Level; Skin Moisture

Summary: the aim of this study is to determine the effect of aromatherapy massage on itching, comfort, skin ph level and skin moisture in individuals with liver disease. research hypotheses: h1: aromatherapy massage has an effect on the level of itching in individuals with itchy liver disease. h2: aromatherapy massage has an effect on the general comfort level in individuals with itchy liver disease, h3: aromatherapy massage has an effect on skin ph level in individuals with itchy liver disease. h4: aromatherapy massage has an effect on skin moisture in individuals with itchy liver disease.

this randomised controlled trial was conducted in order to examine study effect of aromatherapy massage on itching, comfort, skin ph level, and skin moisture among individuals with liver diseases

Eligibility criteria:
inclusion criteria: * patients who volunteered to participate in the study, * with a diagnosis of chronic liver disease (liver cirrhosis (primary biliary cirrhosis, alcoholic, cardiac, post-necrotic, cryptogenic cirrhosis, wilson's cirrhosis, hemochromatosis), chronic viral hepatitis), * had no cognitive impairment, * were not included in the pre-application, * could answer questions, * itch score of above 3 (with visual analogue scale). exclusion criteria: * patients are taking antipruritic treatment, * have itchy skin disease before, ulcer, eczema, etc. in the area to be applied * patients with dermatological problems, any swelling or signs of inflammation in the area ---to be treated, neuropathy or loss of sensation in the area to be treated * patients with allergic to tea tree oil, perfume, or cosmetics, * diagnosed with cancer

Keywords: aromatherapy massage liver diseases itching
a study of abemaciclib in participants with varying degrees of liver impairment

Conditions: Hepatic Insufficiency

Summary: the study involves a single dose of a study drug called abemaciclib taken by mouth. the purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. in addition, the tolerability of the study drug will be evaluated. this study will last approximately 3 weeks for each participant, including check-in and follow-up.


Eligibility criteria:
inclusion criteria: * female participants must be of non-child-bearing potential * have a body mass index of 18 to 40 kilograms per square meter (kg/m²) exclusion criteria: * no history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders * have known allergies to abemaciclib, related compounds, or any components of the formulation * no human immunodeficiency virus (hiv) infection or antibodies
phase ii trial of focal cryotherapy for prostate cancer

Conditions: Prostate Cancer

Summary: the current standard of care treatment for prostate cancer confined to the prostate is surgical removal or irradiation of the entire prostate gland. this is effective at curing cancer but result in damage to critical adjacent structures such as the urinary sphincter muscle and erectile nerves resulting in impaired urinary continence and erectile dysfunction. the concept of focal therapy is to treat just the dangerous focus of cancer in the prostate while monitoring the rest of the gland, thus avoiding impairment of urinary continence and erectile function. we aim to evaluate the degree of preservation of continence and erectile function and early oncological outcomes in patients undergoing focal therapy of the prostate using cold energy or cryo- ablation. in this study, we seek to evaluate patient reported outcomes in urinary, sexual, bowel and general health areas at fixed time points after focal cryo-ablation in selected patients with low-volume, localized cancer. the primary goal of this study is to demonstrate whether there is a deterioration of scores in these health areas over 1 year of follow-up. the secondary goal is to measure cancer control at 1 year re-biopsy. further goals include longer follow-up to monitor cancer progression rates and impact on patient survival.


Eligibility criteria:
inclusion criteria: * psa (prostate specific antigen) ≤ 20 * biopsy gleason score ≤ 4+4 * mpmri shows no gross extracapsular extension * mpmri shows index lesion volume \< 3 ml * ≤ 2 biopsy confirmed lesions on mpmri exclusion criteria: * american society of anesthesiologist score \>3 * very high grade cancer (gleason score \> 4+4) * \>2 index lesions * multifocal cancer (any other gleason \>3+3 present and/or gleason 3+3 at \> 3 biopsy cores at another site) - not eligible for mpmri * not fit for robotic transperineal saturation biopsy
mindfulness as a method of improving the well-being, quality of life and health of primary school pupils

Conditions: Anxiety; Depression

Summary: this study evaluates the short and long-term effect of 5-10 minutes daily mindfulness and compassion training in school among children aged between 6-16 years old. the mindfulness intervention will last for 10 weeks and the results will be compared to children who do not perform mindfulness in school. due to practical reasons, the study is not randomized; classes are instead placed in the mindfulness or control group. anxiety, mental, physical and social health, quality of life, and school performance will be evaluated via questionnaires and school registries, before and after the intervention and thereafter once a year until the end of ninth grade (age 16 years). long term health (diagnoses, medical consumption, and drug prescriptions) and family income (proxy for socioeconomic status) will be followed in regional and national registries until 25 years of age. the hypothesis of the study is that mindfulness can prevent mental disorders and anxiety, and increase well-being in children and adolescents. the primary aim is to subsequently evaluate if regular, daily, mindfulness and compassion training (5-10 minutes) prevents anxiety and mental disorders in children and adolescents. secondary aims are to evaluate 1) the effect of mindfulness on daily life, quality of life, and health in school pupils; 2) the effect of mindfulness on school performance; 3) the effect of mindfulness and compassion on the class room environment; 4) the effect of potential individual, family, and school-level risk factors on mental health in children and adolescents; 5) the effect of mindfulness on these potential risk factors. sessions are led by school teachers who have been educated in mindfulness. their own levels of stress and mindfulness will be evaluated by a questionnaire and compared to teachers in control classes both before and after the intervention. the teachers will also be interviewed to evaluate the effect of mindfulness on the class room environment. in a sub-study, the effect of mindfulness on brain structure and function will be examined by magnetic resonance imaging in school pupils aged 15-16 year old. this will be preceded by a pilot study, in which feasibility of the method is tested in the target group. to achieve sufficient statistical power, taking into account a cluster effect to adjust for grouping of the pupils, 1750 children and adolescents will be recruited. written informed consent is a prerequisite for participation.


Eligibility criteria:
inclusion criteria: * school pupils in grade 0-9 exclusion criteria: * no exclusion criteria

Keywords: mindfulness children anxiety depression mental disorder risk factor