Kornimate/medical-research-clean huggingface dataset:
studying breast cancer risk in women who are brca1/brca2 mutation carriers

Conditions: brca1 Mutation Carrier; brca2 Mutation Carrier; Breast Cancer

Summary: rationale: studying samples of dna in the laboratory from women who are brca1/brca2 mutation carriers may help doctors learn more about cancer and identify biomarkers related to cancer. purpose: this research study is looking at breast cancer risk in women who are brca1/brca2 mutation carriers.

objectives: * to identify potential genetic modifiers of breast cancer risk by contributing data and genetic information obtained from women who are brca1/brca2 mutation carriers enrolled in clinical trial gog-0199 to an international consortium of clinical cancer genetics investigators (cimba). outline: this is a multicenter study. patients are stratified by study, country of residence, ethnicity, and birth cohort. joint analyses of brca1 and brca2 mutation carriers are further stratified by mutation. previously collected dna samples are analyzed for genetic variants in selected candidate genes (rs16942 in brca1, rs2237060 in rad50, "snp3", and rs2241193 in igfbp5). the single nucleotide polymorphism (snp) data from this study and selected demographic, clinical, and epidemiological data obtained from the baseline questionnaire administered in the gog-0199 study are submitted to the consortium of investigators of modifiers of brca-associated cancer (cimba) central database. the epidemiological and snp data contributed to the central database are then distributed to the investigators responsible for analysis of a particular snp or set of snps from a candidate gene or genetic pathway.

Eligibility criteria:
disease characteristics: * known positive brca1/brca2 mutation carrier * with or without a personal history of breast cancer prior to enrollment in clinical trial gog-0199 * currently enrolled in clinical trial gog-0199 and meets the following criteria: * completed baseline questionnaire (bq-199) * provided information on prior breast cancer history, including date of diagnosis * provided complete data from the dna analysis on the genetic variants of interest * signed an approved informed consent and authorization permitting release of personal health information * hormone receptor status not specified patient characteristics: * menopausal status not specified prior concurrent therapy: * see disease characteristics

Keywords: breast cancer brca1 mutation carrier brca2 mutation carrier
association between cardiac arrhythmias and glycemic variability in patient with type 2 diabetes monitored through freestyle libre and bluetooth technology.

Conditions: Diabetes; Arrhythmias; Atrial Fibrillation; Heart Failure

Summary: the aim of this study is to investigate the association between hypoglycemia, glycemic variability and cardiac arrhythmias in patients with diabetes type ii (t2d) already implanted with implantable cardiac defibrillator (icd) and monitored remotely through bluetooth technology and cgm (continuous glucose monitoring).

studies have shown that, when diabetes is present, there is a 35% to 60% greater risk of developing atrial fibrillation (af). diabetic patients with af had a 61% increase in total mortality, a 77% increase in cardiovascular death and a 68% increase in heart failure. the greatest risk with the combination of af and type 2 diabetes mellitus (t2d) is a 79% increase in thromboembolic risk, particularly stroke.hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with t2d. however, these conclusions need to be tempered by the limitations of all studies available to date, making it difficult to determine the onset and burden of af, especially when it is not a monitored end-point.since prospective randomized trials would be unethical, future research should focus on establishing whether such a link exists by employing an observational design and taking advantage of modern tools for long-term, real-life monitoring.

Eligibility criteria:
inclusion criteria: 1. patient already wearing cieds (implantable cardiac electronic device) with bluetooth technology 2. diabetes type ii, no insulin-treated 3. over 18 years of age 4. patient in sinus rhythm at the time of the enrollment 5. ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations exclusion criteria: 1. subject who is, or is expected to be inaccessible for follow-up 2. pregnancy 3. patients with persistent and longstanding persistent af

Keywords: diabetes type ii cardiac arrhythmias
a study to identify an optimal dose of qcz484 in mild to moderate hypertensive patients

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of qcz484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension

phase 2b, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of qcz484 with mild to moderate hypertension (htn). multiple doses of qcz484 will be tested against placebo, administered as subcutaneous injection.

Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. males or females aged 18 to 75 years. 3. diagnosis of hypertension. 4. hypertension treatment naive or on maximum 2 anti-htn medications and able to undergo washout for 4 weeks. 5. mean sitting sbp ≥140 mmhg measured by obpm and mean 24 hr sbp ≥130 mmhg and \<160 mmhg measured by abpm. 6. participants able to understand and comply with study procedures. exclusion criteria: 1. known history of secondary hypertension. 2. orthostatic hypotension. 3. laboratory parameter assessments outside of range at screening. 4. evidence of hepatic disease. 5. medical condition, other than hypertension, requiring treatment with raas inhibitor. 6. any history of congestive heart failure. 7. current or history of intolerance to acei and/or arbs. 8. clinically significant cardiac arrhythmias, high-grade av block and third-degree av block within 6 months prior to screening. 9. acute myocardial infarction (ami) or unstable angina, or any percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg) within 12 months prior to screening. any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to screening. other protocol-defined inclusion/exclusion criteria may apply

Keywords: qcz484 hypertension
mindful eating intervention using eats up app: effects on body composition and insulin resistance in obese adolescents

Conditions: Adolescent Obesity; Eating Behaviors; Nutrition Status; Blood Glucose; Body Fat Composition

Summary: the goal of this experimental study is to develop and evaluate the effectiveness of a mindful eating intervention (mei) model integrated with the digital application eatsup for improving body fat percentage among obese adolescents in indonesia. the study aims to address the rising prevalence of adolescent obesity and its associated health risks, such as insulin resistance and cardiometabolic syndrome, by promoting mindful eating habits and healthy lifestyle behaviors. the main questions it aims to answer are: * is the mei model valid and acceptable for use among obese adolescents? * does the mei model reduce: * body fat percentage? * waist-to-height ratio (whtr)? * homeostatic model assessment of insulin resistance (homa-ir)? * does the mei model improve eating behavior scores compared to a control group over 12 weeks? participants will: * use the eatsup app, designed to monitor calorie intake/output and deliver mindful eating and nutrition education. * receive training on mindfulness-based eating practices, along with guidance on balanced nutrition and physical activity.


Eligibility criteria:
inclusion criteria: * aged 15-18 years old * agreed to be involved in research proven by signing informed consent and assent * indicated as obesity by bmi-age nutritional status and body fat percentage exclusion criteria: * subject is on a dietary treatment or has a serious condition (e.g. chronic infectious disease, and undergoing drug therapy) * subject with special needs (cannot use internet, cannot communicate normally)
a phase 1b/2a study evaluating amg 232 in metastatic melanoma

Conditions: Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology; Oncology Patients; Tumors; Melanoma

Summary: phase 1b/2a, open-label, sequential dose escalation and expansion study of amg 232 in combination with trametinib and dabrafenib in subjects with metastatic melanoma followed by a direct comparison of amg 232 combined with trametinib and dabrafenib versus trametinib combined with dabrafenib alone.

the study will be conducted in 3 parts: part 1 - dose escalation, part 2 - dose expansion and part 3, a randomized phase 2a. in both part 1 and 2, subjects will be enrolled open-label into 1 of 2 arms. for both arm 1 and arm 2, the part 1 dose escalation is aimed at determining an amg 232 maximum tolerated dose (mtd) with a fixed dose of the combination drug(s) and evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of each combination. part 2 dose expansion will enroll subjects to receive therapy with a dose and schedule of amg 232 selected from the corresponding part 1 dose escalation. in part 2 subjects will be enrolled to confirm safety and tolerability and to assess clinical activity prior to proceeding to part 3, phase 2a. in phase 2a, subjects will be randomized open-label in a 1:1 ratio to receive amg 232 in combination with trametinib plus dabrafenib versus trametinib plus dabrafenib alone. only part 1 of the study was enrolled and the study did not proceed into phase 2.

Eligibility criteria:
inclusion criteria: subjects must have histologically or cytologically confirmed metastatic cutaneous or mucosal melanoma, able to swallow and retain orally administered medication, adequate hematological, renal, hepatic, and coagulation laboratory assessments exclusion criteria: clinically significant bleeding within 4 weeks of screening, current use of warfarin, factor xa inhibitors, and direct thrombin inhibitors, infection requiring anti-infective treatments within 1 week of study enrollment, anti-tumor therapy, major surgery within 28 days

Keywords: metastatic melanoma
the efficacy of mk-8291 in participants with post-herpetic neuralgia (phn) with allodynia (mk-8291-012)

Conditions: Postherpetic Neuralgia

Summary: this study aims to determine whether mk-8291 is effective in reducing pain in participants with post-herpetic neuralgia (phn) with allodynia. the primary hypothesis is that when compared to placebo, treatment with mk-8291 reduces the change from baseline in participant-reported pain intensity by 1 on an 11-point numeric rating scale.


Eligibility criteria:
inclusion criteria: * non-pregnant female (and/or partner) agrees to use two acceptable methods of birth control throughout the trial until 2 weeks after the last dose of treatment * female is postmenopausal or surgically sterile * has a clinical diagnosis of phn with allodynia for at least 3 months duration after healing of rash * has a body mass index (bmi) =\< 35 kg/m\^2, inclusive * is in good health, with exception of phn * is on a stable dose for at least 30 days prior to screening if taking any of the following: opioids, non-opioids, paracetomol, non-steroidal anti-inflammatory drugs (nsaids), aspirin, antidepressants * is a nonsmoker or has not used nicotine or nicotine containing products for at least prior 3 months exclusion criteria: * has a non-phn chronic pain state * has a history of clinically significant and inadequately treated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * has a history of malignant cancer * has a history or presence of esophagitis * has a history of significant multiple and/or severe allergies (e.g. food, drug, latex), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * is positive for hepatitis b surface antigen, hepatitis c antibodies, or human immunodeficiency virus (hiv) * had major surgery, donated or lost approximately 500 ml of blood within 4 weeks prior to screening * has participated in another investigational trial within 4 weeks prior to screening * has a history of risk factors for torsades de pointes, has hypokalemia or hypomagnesemia * has a history or presence of clinically significant cardiac arrhythmia, taking substances with the target of reducing heart rate and or exercising endurance sports * has had an injection of local anesthetics or steroids in the region affected by phn, within 35 days prior to randomization * anticipates using prescription and non-prescription drugs or herbal remedies during trial * consumes excessive amounts of alcoholic or caffeinated beverages * uses cannabis, any illicit drugs, or has a history of drug (including alcohol) abuse within 12 months of screening visit
effect of local infiltration analgesia in total hip arthroplasty

Conditions: Post-operative Pain

Summary: the purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ml) versus placebo on acute postoperative pain intensity after total hip arthroplasty. the hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.

in spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. we therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ml) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. the technique is widely used as standard treatment in many european centers despite its limited evidence.

Eligibility criteria:
inclusion criteria: * elective total hip arthroplasty * able to speak and understand danish * able to give informed consent exclusion criteria: * alcohol or medical abuse * allergies to local anesthetics * age \< 18 years * daily use of opioids or glucocorticoids * pregnancy or breastfeeding * opioid intolerance * obesity defined as bmi\>40 kg/m2 * diabetic neuropathy and rheumatoid arthritis

Keywords: postoperative acute pain total hip arthroplasty local infiltration analgesia
measuring smoking behaviors while using varenicline

Conditions: Nicotine Dependence

Summary: this study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. we also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.

this study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline. behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes. the primary hypothesis for the study is to observe decreases in smoking topography, an objective measure of smoking behavior or puffing, on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. we will also examine puffing and nicotine cigarette choices during lab visits at baseline, and days 7 and 21. we also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus potentially increasing the efficacy of varenicline.

Eligibility criteria:
inclusion criteria: * self report minimum 10 daily cigarettes * self report smoking every day past 5 years * between the ages 21-65 * self report intention to try to quit smoking in the next 6 months exclusion criteria: * self reported use of any nicotine-containing products other than non-menthol cigarettes * self reported history or current treatment of substance abuse (other than nicotine dependence) * self reported alcohol use greater than 25 standard drinks per week; * currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen) * self reported history or current diagnosis of any axis 1 disorders except past depression * self reported serious or unstable disease within past year * self reported history of epilepsy or seizure disorder; * self reported history or current diagnosis of copd (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension * self reported kidney function impairment * any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications * less than 5 years of daily smoking * any medical condition or concomitant medication that could compromise participant safety or treatment * provide a baseline carbon monoxide (co) reading \< 10 ppm * self reported use of non filtered cigarettes * inability to provide informed consent or complete any of the study tasks as determined by the principal investigator and/or study physician

Keywords: smoking nicotine varenicline
tdf long term study

Conditions: HIV-infected Thai Children

Summary: this study will assess the safety and efficacy of generic tdf from governmental pharmaceutical organization (gpo) in hiv-infected children

tdf is a nucleotide reverse transcriptase inhibitor (nrti) which can be taken only once per day and continues to have good efficacy even in patients who have resistance to other nnrti in the absence of k65r mutation. tdf is a choice for patients with nrti resistance, or those that require once-daily regimen to improve adherence. currently, tdf has not been approved by the us fda for children less than 18 years, but pediatricians has been using tdf in children who have treatment failure because of limitation of a more appropriate pediatric arv. the thai national guideline for pediatric 2009 recommend the use of tdf in children who have failed the first line therapy with multi-nrti mutation and are more than 30 kilograms or have tanner stage 4 or more. however, the problem is that there is no pediatric tdf formulation. the available preparation of 300 mg tear drop tablet, if cut in half, may increase dosing errors, more or less by 18-37%. this will affect the blood level and/or toxicities. therefore, the thai governmental pharmaceutical organization (gpo) has produced a generic tdf formulation that can be used in hiv-infected children. this study will assess the safety and efficacy information in children using this generic pediatric tdf formulation.

Eligibility criteria:
inclusion criteria: * children who are changing to tdf due to adherence problem or treatment failure * children who are already on tdf due to their clinical indication exclusion criteria: * child/caretaker refuse to participate in this study * cannot adhere to the study schedule

Keywords: tdf-based regimen hiv-infected children thai generic safety and efficacy renal status to assess effect of tdf on renal problem in hiv-infected children receiving tdf-based once daily regimen to compare the effectiveness and clinical usefulness of different tools of adherence
interaction effect of asthma and aeroallergen category on the psychological status in allergic rhinitis patients

Conditions: Hypersensitivity; Psychologic Factors in Physical Conditions Classified Elsewhere; Respiratory Tract Diseases; Allergic Rhinitis

Summary: allergic rhinitis (ar) and asthma are considered as "one airway, one disease". although there is increasing evidence for an association between allergy and depression, it remains unknown if the relationship between ar and asthma has extra influence on the psychological status of the patients. the aim of our study was to investigate the influence pattern of asthma on the psychological status in ar patients. the symptom checklist-90 (scl-90) was employed to analyze the psychological status of 524 individuals with ar. independent sample t-tests, one-way anova and multivariate anova were used for data analyses.


Eligibility criteria:
inclusion criteria: * patients suffered from rhinitis symptoms such as nasal itching, sneezing, nasal obstruction and running nose, all patients had not undergone any medicine therapy in the past one week; nasal endoscopy showed a pale and edematous nasal mucosa, nasal discharge and swollen inferior turbinates. every nasal symptom was scored on visual analog scale (vas, 0-3 score) respectively. a score of 0 indicated no nasal symptom, 1 indicated slight nasal symptoms, 2 indicated obvious nasal symptom, but which could still be endured, and 3 indicated obvious nasal symptoms that could not be endured; * age between 16 to 60 years; * a positive skin prick test (spt)to at least one allergen, the level of response equal to or exceeding ++. the following inhalant allergens were tested: der p; der f; animal hair; trees; grasses; cereals; mugwort; dandelion; giant ragweed; chenopodium album; humulus; locust; blatella germanica; pine; plantain; curvularia lunata; candida albicans; penicillium notatum; alternaria tenuis and aspergillus fumigatu. the reactions were evaluated based on the mean wheal diameter at 15 minutes after application of the extracts. the mean diameters of each allergen wheals were calculated from the sum of the largest measurement across the wheal and the largest wheal measurement perpendicular to this divided by two. in addition, we calculated the skin index (si) as the ratio of allergen weal diameter divided by the histamine weal size. the spt result for each allergen was defined in terms of the si value as follows: +: si≤0.5; ++: 0.5\ 2.0. exclusion criteria: * ar combined with hypertension, diabetes or other chronic diseases; * ar combined with tumor in the nasal cavity; * ar combined with eczema; * acute infection in the past one week; * failure to complete the questionnaires; * ar patients undergoing negative life events.

Keywords: allergic rhinitis psychological status asthma aeroallergen
efficacy of topical cysteamine in nephropathic cyctinosis

Conditions: Nephropathic Cyctinosis; Corneal Cystine Crystals

Summary: the aim of this study is to evaluate the efficacy of topical cysteamine eye drops in the treatment of corneal cystine crystals deposits in patients with nephropathic cystinosis.

a total of 26 patients with nephropathic cystinosis were included in this prospective study. patients were evaluated for improvement of corneal cysteine deposits crystals and photophobia following treatment with topical 0.55% cysteamine eye drops.

Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of nephropathic cystinosis * leucocyte cystine concentration level of more than 2.0 nmol half-cystine/ mg protein * clinical evidence of tissue deposition of cystine and tissue damage due to cystinosis exclusion criteria: * allergy to cysteamine

Keywords: cysteamine nephropathic cystinosis cystine crystals