Kornimate/medical-research-clean huggingface dataset:
a study to compare how effective is encorafenib plus binimetinib in real-world and clinical trial settings

Conditions: Metastatic Melanoma

Summary: brief summary the purpose of this study is to compare how effective, encorafenib plus binimetinib is in the real-world and clinical trial settings. and produce results to show that combining data on encorafenib plus binimetinib from both the real-world and clinical trial settings is possible for future research studies. this study group is identified from the database who: * have taken at least 1 order or administration of encorafenib plus binimetinib treatment after the confirmation of having metastatic melanoma after 27 june 2018. * are at least 18 years of age at the time of first encorafenib plus binimetinib initiation (index date). * had never received encorafenib plus binimetinib or had received first-line immunotherapy at the start of the study. * have ecog status of 0 or 1 at the index date. * have available data on the number of deaths in an area or group of people. patients will be followed from the date that the patient started the first encorafenib plus binimetinib treatment (treatment initiation) up to their last date of data availability. last date of data availability could be the date of following events: patient lost to follow up at the clinic, death, or end of the database (january 2020). the database timeframe is june 2018 to january 2020.


Eligibility criteria:
inclusion criteria: * diagnosis of melanoma (international classification of diseases 9th or 10th revision clinical modification - icd-9-cm: 172.x; icd-10-cm: c43.x) and secondary malignancy or metastasis (icd-9-cm: 196.x, 197.x, 198.x; icd-10-cm: c77.x, c78.x, c79.x). * confirmed braf v600e/v600k activating mutation reported in the data based on laboratory or genetic analysis results. * at least 1 order or administration of enco+bini treatment exclusion criteria: * patients without information on mortality * patients with ecog performance status ≥ 2 (at the time of randomization for patients from columbus, during the baseline period for patients in flatiron electronic health record) * patients with a history of or concurrent uveal or mucosal melanoma, basal cell or squamous cell carcinoma (as per trial inclusion criteria); this exclusion will also be applied to rwd patients
identifying prognostic factors in patients receiving tegafur-uracil for stage ii colon cancer that was completely removed by surgery

Conditions: Colorectal Cancer

Summary: rationale: studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict which patients will respond to treatment. purpose: this laboratory study is looking at prognostic factors in patients receiving tegafur-uracil for stage ii colon cancer that was completely removed by surgery.

objectives: * identify the prognostic factors in patients with curatively resected stage ii colon cancer receiving adjuvant chemotherapy with tegafur-uracil. * identify predictive factors of chemosensitivity to this regimen in these patients. outline: available tumor tissue samples are analyzed by real-time reverse transcriptase-pcr for ts, dpd, tp, oprt, vegf, cyclooxygenase-2, and fpgs; by pcr for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. the candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the colon or rectosigmoid * stage ii disease * must be registered on clinical trial tmdu-bri-cc-05-01 * must have resected tumor tissue available * no hereditary colorectal cancer patient characteristics: * ecog performance status 0-1 prior concurrent therapy: * not specified

Keywords: stage ii colon cancer stage ii rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum
a trial of setmelanotide in patients with congenital hypothalamic obesity (sub-study of nct05774756)

Conditions: Hypothalamic Obesity; Multiple Pituitary Hormone Deficiency Genetic Form; Septo-Optic Dysplasia; Optic Nerve Hypoplasia; Childhood-onset Combined Pituitary Hormone Deficiency; Pituitary Stalk Interruption Syndrome

Summary: this is a sub-study of study rm-493-040 (nct05774756). the goal of this sub-study is to learn how well setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with congenital hypothalamic obesity (cho). to determine how well setmelanotide works and how safe it is, patients with cho will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.


Eligibility criteria:
key inclusion criteria: 1. diagnosis of multiple pituitary hormone deficiency (mphd), or septo-optic dysplasia (sod), or optic nerve hypoplasia (onh), or childhood-onset combined pituitary hormone deficiency (cphd), or pituitary stalk interruption syndrome (psis) with at least one pituitary deficiency and a body mass index (bmi) of ≥30 kg/m2 for patients ≥18 years of age, or bmi ≥95th percentile for age and sex for patients 4 to \<18 years 2. age 4 years and older 3. weight gain associated with the hypothalamic injury and a bmi of ≥30 kg/m2 for patients ≥18 years of age or bmi ≥95th percentile for age and sex for patients 4 to \<18 years of age 4. agree to use a highly effective form of contraception throughout the study and for 90 days after the study key exclusion criteria: 1. diagnosis of prader-willi syndrome (pws) or rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (rohhadnet) 2. weight loss \>2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in bmi for patients aged 4 to \<18 years 3. bariatric surgery or procedure within last 2 years 4. diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior 5. current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease 6. significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion) 7. history or close family history of skin cancer or melanoma 8. participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose 9. previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide 10. inability to comply with once daily (qd) injection regimen 11. if female, pregnant and/or breastfeeding. 12. if receiving hormone replacement therapy, dose has remained stable for at least 2 months before screening other protocol defined inclusion/exclusion criteria may apply.

Keywords: melancortin 4 receptor, mc4r
sexual effects of transdermal or vaginal testosterone

Conditions: Female Sexual Dysfunction; Postmenopausal Symptoms; Testosterone Deficiency; Testosterone Adverse Reaction

Summary: the aim of the study is to elucidate the role of testosterone treatment in postmenopausal women's sexual function and their therapeutic safety.

-general to evaluate the therapeutic efficacy of testosterone treatment in sexual dysfunction in postmenopausal patients. -specifics 1. to evaluate the prevalence of different sexual dysfunctions in postmenopausal patients, classifying them according to diagnostic and statistical manual of mental disorders 5th (2013): * female sexual desire / arousal disorder; * female orgasm disorder; * pelvic or genital pain / penetration disorder; 2. to evaluate the response on climacteric symptoms after testosterone replacement using the kupperman menopausal index;

Eligibility criteria:
inclusion criteria: * brazilian women with menopause time from 2 to 6 years; * active sex life; * absence of severe depression and anxiety, as evidenced by the beck (depression specific) and beck (anxiety specific) questionnaires; exclusion criteria: * disabling diseases; * use of medicines that inhibit sexual desire; * inability to answer the questionnaires; * altered routine exams and comorbidities: * severe hypertension with blood pressure measurement \> 160 mmhg (maximum) or/and 90 mmhg (minimum) in two measurements * clinical or subclinical thyroid dysfunction: thyroid-stimulating hormone over 4 * triglyceride dyslipidemia\> 400 * presence of occult blood in stool * hyperprolactinemia * fasting blood glucose\> 100 * presence of osteopenia or osteoporosis * birads score greater than or equal to 3 on mammography * presence of endometrial echo\> 4mm on transvaginal ultrasound * presence of changes in oncotic colpocytology * diagnosis after psychological screening for moderate to severe anxiety / depression.

Keywords: sexual effects of transdermal or vaginal testosterone low sexual desire postmenopause transdermal testosterone vaginal testosterone
a study of tirzepatide (ly3298176) plus mibavademab compared with tirzepatide alone in adult participants with obesity

Conditions: Obesity

Summary: the main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. the study will last about 74 weeks and may include up to 19 visits.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) of ≥30 kilogram/square meter (kg/m²) and ≤40 kg/m² * willing to learn how to self-inject study intervention (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study intervention; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study intervention) * male or female contraceptive use by participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. exclusion criteria: * have a history of diabetes mellitus, including type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm), history of ketoacidosis, or hyperosmolar state/coma * have a self-reported change (increase or decrease) in body weight \>5 kilogram (kg) within 3 months prior to screening * have a family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia (men) syndrome type 2 * have acute or chronic hepatitis * have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years

Keywords: glucagon-like peptide-1 (glp-1) leptin incretin weight maintenance
dietary approach to stop hypertension with sodium (na) reduction for chinese canadians

Conditions: Hypertension

Summary: the study examined the feasibility of the dietary approach to stop hypertension with sodium (na) reduction for chinese canadian (dashna-cc) intervention and its potential effects on blood pressure, health-related quality of life, and health service utilization. half of participants received usual care while the other half received the dashna-cc intervention.

hypertension has been identified as the most important risk factor for cardiovascular diseases and accounts for a large proportion of stroke, myocardial infarction and heart failure in the chinese population. while unhealthy diet has been identified as a modifiable risk factor for hypertension, there is a lack of culturally sensitive dietary intervention targeting chinese canadians. the 8-week dashna-cc intervention incorporated dietary approach to stop hypertension (dash) diet, sodium reduction with the food therapy of traditional chinese medicine, and included an intervention manual, two sessions of classroom instruction delivered in mandarin, and a 20-minute telephone follow-up.

Eligibility criteria:
inclusion criteria: * were at least 45 years old; * had a systolic blood pressure 140 to 159 mmhg, or a diastolic blood pressure 90 to 99 mmhg, based on pre-intervention baseline assessment; * were able to understand (listen) and speak in mandarin, read and write in chinese; and * had access to a telephone. exclusion criteria: * used antihypertensive medications or other medications that raise or lower blood pressure during the previous three months; * used tcm or professional tcm counselling to decrease blood pressure during the previous three months; * used insulin or oral hypoglycemic agents during the previous three months; * had a history of a cardiovascular event (stroke, myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass surgery, or other arteriosclerotic cardiovascular disease related therapeutic procedure) during the previous three months; * had a history of congestive heart failure; * had a cancer diagnosis or treatment during the past two years; * had special dietary requirements; * were pregnant, breast feeding, or planned for pregnancy prior to the anticipated end of study; * were a household member of another dashna-cc participant; or * planned to leave the area prior to the anticipated end of study.

Keywords: hypertension immigrant dietary intervention lifestyle modification
biofeedback training in patients with advanced lung cancer - a pilot study

Conditions: Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)

Summary: this is a pilot study to test the hypothesis that biofeedback-mediated stress management (bfsm) training can be used to reduce distress and enhance quality of life in patients with non-small cell lung cancer (nsclc). most patients with advanced nsclc have significant physical symptoms, but even those who do not have physical symptoms have high levels of anxiety and depression.

biofeedback-mediated stress management (bfsm) involves helping patients to visualize the reactions which their own bodies have to stressful situations (increased heart rate, increased skin conductance, increased muscle tension, decreased digital peripheral temperature, decreased heart rate variability) and then teaching them to control these reactions, using standard stress management and relaxation techniques, coupled with computerized physiological feedback. the feedback helps patients to understand that deep relaxation is helping their bodies as well as their minds. several small studies of bfsm training in cancer populations have been successful at helping with side effects of chemotherapy and radiation, but the effects of bfsm on distress and quality of life (qol), particularly in nsclc patients, have not been studied.

Eligibility criteria:
inclusion criteria: * patients with a new diagnosis of advanced (stage iv) non-small cell lung cancer (nsclc) * ecog performance status 0-1. * plan to receive care at the taussig cancer center. exclusion criteria: * non-local patients, who will not have the ability to return for 8 study visits. * patients who are unable to speak and understand english readily, * patients with significant cognitive impairment.

Keywords: advanced (stage iv) non-small cell lung cancer (nsclc) biofeedback-mediated stress management (bfsm)
regenerative medicine of articular cartilage: characterization and comparison of chondrogenic potential and immunomodulatory adult mesenchymal stem cells

Conditions: Knee Osteoarthritis

Summary: articular cartilage can be the seat of many diseases including osteoarthritis and traumatic defaults. the cartilage has no intrinsic ability to repair resulting at long term in function loss in the joints. currently available treatments are not satisfactory in the long term, the use of mesenchymal stem cells appears to be promising due to their ability to multipotency and immunomodulation properties. this project aims to determine the most appropriate source for regenerative medicine of cartilage stem cells from tissue taken during arthroplasty in patients with osteoarthritis. these cells will be tested for different chondrogenic markers. the success of this project will consider the implementation of a strategy for regenerative medicine in bone and joint diseases.


Eligibility criteria:
inclusion criteria: * patients aged over 18 years * patients with knee osteoarthritis * patients requiring total knee arthroplasty * patients who signed the consent form exclusion criteria: * patients aged less than 18 years * major patients under guardianship * pregnant woman * infectious pathology or progressive tumor * refusal to participate in the study * state of immunosuppression * congenital or acquired malformation resulting in a deformation of the knee

Keywords: mesenchymal stem cells articular cartilage tissue engineering immunomodulation osteo-arthritis
periostin levels in children with adenoid hypertrophy

Conditions: Adenoid Hypertrophy

Summary: periostin is a matricellular protein that has been shown to be a marker of type 2 inflammation associated with airway eosinophilia. matricellular proteins are highly expressed at sites of injury or inflammation. periostin involves tissue fibrosis and remodeling in the nasal mucosa in some of the otolaryngologic diseases. the up-regulation of periostin expression has been shown in allergic rhinitis, chronic rhinosinusitis with nasal polyps , and aspirin intolerant asthma. in the light of these findings the investigators aimed to evaluate the relation between adenoid hypertrophy and periostin levels.

a total of 40 patients-age ranged between 2 and 12 years- were planned to enroll in the study prospectively. patients that were scheduled to undergo adenoidectomy were included in the study group (adenoid group). the control group comprised of 20 healthy children who had previously been treated for anemia in the out-patient clinic of the pediatrics department and were clinically healthy with normal complete blood cell counts at their follow-up visits. serum samples were obtained from the two groups. the samples were centrifuged at 1500 g for 5 minute and stored in -80 oc for later analysis of periostin levels. adenoid tissue and normal mucosal tissue samples were obtained from the adenoidectomy patients and stored in -80 oc for later homogenization and measurement of periostin levels.

Eligibility criteria:
inclusion criteria: * the patients that were scheduled for adenoidectomy * healthy subjects that had not any kind of allergy, adenoid hypertrophy symptoms exclusion criteria(for adenoid group): * the subjects that had any kind of corticosteroid treatment 1 month prior to surgery, and antihistaminic treatment 2 weeks prior to surgery exclusion criteria(for control group): * to have allergic rhinitis symptoms * to have high total ige levels * to have positive skin prick test * to have acute respiratory tract infection * to have asthma to have any kind of endocrin disease

Keywords: adenoid hypertrophy periostin
self-administered cognitive personalized training in early psychosis

Conditions: First Episode Psychosis (FEP)

Summary: the overall objective of scope is to improve early intervention in psychosis by providing an innovative ehealth tool that will enable personalized cognitive training, adapted to the individual's cognitive abilities. cognitive remediation improves quality of life and functional outcome in patients with chronic psychosis. it would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. however, cognitive dysfunctions are often overlooked in fep and cognitive remediation is not always accessible. new technologies can provide us with youth-friendly, non-stigmatizing tools, such as self administered, training applications so that all first-line clinical settings or professionals, and in fine all patients, can have access, wherever they live, to personalized cognitive training focusing on impaired functions. early psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training. our background hypothesis is that promoting neuroplasticity by cognitive training could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients experiencing fep and that this effect is modulated by individual brain plasticity abilities.


Eligibility criteria:
inclusion criteria: * adolescent and young adults, both genders, aged 16 to 35, * seeking help in one of the recruiting centers, * newly diagnosed as experiencing an episode of psychosis (reaching criteria as described in the comprehensive assessment of at risk mental states (caarms) within the year * written informed consent signed (and from one legal guardian for minors). exclusion criteria: * severe and unstabilized medical conditions, * insufficient level in reading and/or french language, * absence of medical insurance, * participation in another intervention trial, * enforced hospitalization (aspdt, asppi, aspre), * intellectuel deficiency (iq\&lt;70), and / or sensorimotor deficits incompatible with the cognitive training,

Keywords: first episode psychosis (fep), schizophrenia cognitive personalized training adolescents and young adults fep personalized cognitive training chronic psychosis biological testing metabolic alterations
a pilot study of daytrana tm in children with autism co-morbid for attention deficit hyperactivity disorder (adhd) symptoms

Conditions: Autism; Attention Deficit Hyperactivity Disorder

Summary: this is an open-label study of the efficacy of daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with autism spectrum disorders. twenty patients will be enrolled and treated with 10-30 mg of daytrana for a total of eight weeks. changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. acceptability of the transdermal route of administration in this population will also be assessed. the researchers hypothesize that daytrana is a safe and effective medication for children with autism spectrum disorders who have symptoms of inattention, hyperactivity and impulsivity.

the design will be an open-label trial of eight weeks duration with 20 children with autism co-morbid for adhd. the subjects will receive 7 days of 10 mg of daytrana. the children will be seen weekly for assessment for 4 weeks then every two weeks until the eight week period is complete. after each week of treatment, response will be reassessed and the dose will be increased stepwise to 15 mg, 20 mg, 30 mg unless there are excessive side effects, in which case, the dose will be reduced to the previous dose or the patch wear time may be revised.

Eligibility criteria:
inclusion criteria: * between 6 and 11 years * autism spectrum disorder * attention deficit hyperactivity disorder * stimulant medication-free at study entry * no clinically significant abnormalities that preclude safe participation * sufficient developmental level (\~3 yrs) * able to keep appointments * able to communicate effectively * teacher cooperation exclusion criteria: * received an investigational medication in the previous 30 days * current medication treatment is effective and well-tolerated * medical conditions that affect patient safety * maois within one month * hypertension * bipolar disorder or psychosis * anticonvulsants * psychotropic medication or health food supplement * tourette disorder * seizure disorder * neurological condition * structural heart disease

Keywords: autism autism spectrum disorders adhd