Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of triptorelin 3-month formulation in chinese children with central precocious puberty.

Conditions: Central Precocious Puberty

Summary: the purpose of this research was to confirm the effectiveness and safety of the study drug, triptorelin pamoate 15mg 3-month formulation, in a chinese population of central precocious puberty (cpp) children.


Eligibility criteria:
inclusion criteria: * onset of development of secondary sex characteristics before 8 and 9 years in girls and boys, respectively breast development in girls or testicular enlargement in boys according to the tanner method: stage ii * pubertal response of lh to gnrh stimulation test (stimulated peak lh ≥5 iu/l) * difference between bone age (ba) (according to greulich and pyle method) and chronological age (ca) \>1 year * girls with tanner staging ≥2 for breast development and enlarged uterine length and several follicles with diameter \>4 mm in the ovary at screening visit; boys who have testicular volume ≥4 ml at screening visit * age \< 9 years old for girls and \< 10 years old for boys at initiation of triptorelin treatment * weight at least 20 kg * subjects will qualify for the extension phase if they sign the corresponding specific consent form, are still benefiting from treatment at the end the primary study and have not experienced any unacceptable safety issues. exclusion criteria: * gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion * non-progressing isolated premature thelarche * presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. participants with hamartomas not requiring surgery are eligible * evidence of renal (creatinine \>1.5 x upper limit of normal (uln)) or hepatic impairment (bilirubin \>1.5 x uln or alanine aminotransferase (alt)/aspartate transaminase (ast) \>3 x uln) * any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use except topical steroids, renal failure, diabetes, moderate to severe scoliosis) * prior or current therapy with a gnrh agonist (gnrha), medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (igf-1) * diagnosis of short stature, i.e. \>2.25 standard deviation (sd) below the mean height for age * major medical or psychiatric illness that could interfere with study visits * known hypersensitivity to any of the test materials or related compounds * use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the screening visit.
pharmacogenomics validation for imatinib in chronic myeloid leukemia

Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Summary: this is a multicenter, retrospective, observational study to validate a pharmacogenetics model for imatinib metabolism and resistance in patients with chronic myeloid leukemia among patients in different independent cohort.

1. the activity of imatinib(im) is mediated by blocking the activity of bcr/abl tyrosine kinase in cml cells. however, some of the patients failed to achieve optimal response, and a substantial proportion of patients develop resistance to im. 2. im is a substrate for the adenosine triphosphate binding cassette (abc) transporters, abcb1 and abcg2, while the active uptake of im into cells is mediated by the human organic cationic transporter-1 (hoct1). also, im is metabolized through first pass drug metabolism by the cytochrome p450 - cyp3a4 and cyp3a5. in addition, it is delivered in a bound form with a plasma protein referred to α1-acid glycoprotein (agp). 3. accordingly, the intracellular or systemic level of imatinib should be influenced by these factors such as abcb1, abcg2, hoct1, cyp3a4, cyp3a5 or agp genes. inter-individual variability of 5 candidate genes associated with drug transport/metabolism (i.e. abcb1, abcg2, hoct1, cyp3a4/3a5 and agp) could affect the expression of corresponding proteins, thus influencing the treatment outcomes of imatinib therapy. 4. in the investigators' previous study, the investigators reported the cumulative incidences of mcyr and ccyr was significantly affected by the predictive model using 2 genotypes and disease stage. these predictive models for ccyr/mmor or lor/treatment failure seemed to work well. however, external validation of these predictive models is warranted especially using ethnically different independent cohort.

Eligibility criteria:
inclusion criteria: * chronic myeloid leukemia of any stage including chronic phase, accelerated or blastic phase. * age\>18 years * complete set of clinical data available for review (demographic data, stage, treatment history, cytogenetic reports, and latest bcr/abl rq-pcr results) * treated with imatinib mesylate at least 3 months exclusion criteria: * treated with imatinib mesylate less than 3 months * not agree with the intention of this study

Keywords: imatinib drug resistance pharmacogenetics
a study of low and standard-dose ticagrelor after intervention for acs patients

Conditions: Acute Coronary Syndrome; Coronary Stent Implantation

Summary: this study is to evaluate the safety and efficacy of 60mg ticagrelor plus 100mg aspirin to prevent major adverse cardiovascular and cerebrovascular events in one years after drug-eluting stents implantation for chinese acs patients compared with 90mg ticagrelor plus 100mg aspirin


Eligibility criteria:
inclusion criteria: 1. subject must be at least 18 years of age 2. patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome 3. subject understand the study requirements and the treatment procedures and provided informed consent before the procedure exclusion criteria: 1. female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study 2. active bleeding 3. known hypersensitivity or contraindication to study medications 4. non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment). 5. subjects with cerebral hemorrhage history 6. subjects with stroke history in half a year 7. subjects with malignant tumor 8. subjects with whom oral anticoagulants are needed
evaluation of the bodyguardian end-to-end remote monitoring platform in an outpatient heart failure population

Conditions: Congestive Heart Failure

Summary: we will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system

the overall objective of our research is to test, adapt, refine and validate the bodyguardian technology and related end-to-end remote monitoring system to be used outside usual medical care environments to reduce hospital readmissions and facilitate independent living for heart failure patients. an important component of our overall strategy for continued development and refinement of the remote monitoring system is the incorporation of iterative behavioral evaluations to facilitate assessment and refinement in order to optimize adherence, utilization, and usability for patients as well as efficiency and functionality for providers.

Eligibility criteria:
inclusion criteria: * outpatients * stable new york heart association class i-iii hf (defined as no admissions for \> 1 year) * recruited from the mayo heart failure clinic, including 15 men and 15 women * age \> 50 years * reside in olmsted county exclusion criteria: * hospital admission for hf within past year * dementia * overall life expectancy \< 2 months * blindness * pregnancy or women able to become pregnant * skin allergy to adhesives * inadequate cell phone coverage (international patients or international travel during study period) * documented ejection fraction of \>40%

Keywords: congestive heart failure
bile reflux gastropathy: prevalence and risk factors after therapeutic biliary interventions

Conditions: Dyspepsia; Heartburn; Bile Reflux

Summary: bile reflux gastropathy is caused by the backward flow of duodenal fluid into the stomach. a retrospective cohort study was performed to declare if the therapeutic biliary interventions cause bile reflux gastropathy, and to estimate its prevalence and risk factors, and to evaluate the gastric mucosa endoscopic and histopathologic changes.

bile reflux gastropathy is a pathological condition in the form of the backward flow of duodenal fluid that consists of bile, pancreatic juices, and secretions of the intestinal mucosa into the stomach and esophagus, causing mucosal lesions. bile acids, in combination with gastric acid, have been shown to cause bile reflux gastropathy symptoms (heartburn, regurgitation, epigastric pain, etc.). bile reflux gastropathy frequently occurs after gastric surgeries that that damages the pyloric sphincter, and after biliary surgeries and procedures as cholecystectomy, endoscopic sphincterotomy (est), endoscopic stenting, or choledochoduodenostomy that cause the sphincter of oddi malfunction.\[4\] bile gastropathy is a normal physiological event in a prolonged fasting period (primary bile reflux gastropathy).in non-responsive individuals to ppi medication, the total prevalence of biliary reflux was 68.7%. these people have acid and bile reflux at the same time and have never had biliary surgery. endoscopic retrograde cholangiopancreatography (ercp) became an increasingly popular modality for both the diagnosis and the treatment of biliary tract disorders. it represents one of the most demanding and technically challenging procedures in gastrointestinal endoscopy, which must be performed effectively and safely by operators with substantial training and experience to maximize success and safety. cholecystectomy is a surgical operation of gallbladder removal. it can be performed either laparoscopically, using a video camera, or via an open surgical technique. pain and complications caused by gallstones are the most common reasons for cholecystectomy.

Eligibility criteria:
inclusion criteria: * postoperative patients (months to years postcholecystectomy (group 1) and therapeutic biliary procedures (group 2) with persistent upper git symptoms ( heartburn, regurgitation dysphagia , dyspepsia ,nausea and epigastric pain) and/or gerd symptoms with history of poor response to prokinetics, mucosa-protective medicines, h2-blockers and/or proton-pump inhibitors (ppi). exclusion criteria: * included unstable cardiopulmonary, neurologic, or cardiovascular status, other causes of biliary diseases (cbd strictures, and hepatolithiasis), structural abnormalities of the esophagus, stomach, or small intestine, patients who underwent bariatric surgery out of the scope of the study, patients on long-term non-steroidal analgesics, and patients on oral contraceptive drugs.

Keywords: bile reflux cholecystectomy ercp bilirubin
sensor-based characterization of depression

Conditions: Unipolar Depression

Summary: this is a longitudinal study where individual with major depressive disorder (mdd) will be monitored for 12 weeks. the study aims to develop an objective, sensor-based, algorithm able to detect the presence of depression as well as predict treatment response. measurement-based treatment is considered optimal and the development of a valid passive, objective, behavioral and biological assessment of depressive symptoms that does not rely on clinician interviews will improve monitoring and ultimately improve treatment significantly.

in this longitudinal study 100 individuals with major depressive disorder (mdd) will be monitored for 12 weeks. data will include self-report surveys, in-person assessments, physiological features derived by wearable devices and socialization and activity data derived by mobile applications. the study will utilize advanced statistical methods to integrate different sources of passive sensor-based behavioral and physiological data to develop models able to detect depression and predict treatment response.

Eligibility criteria:
inclusion criteria: 1. adults (ages 18-75), 2. able to read, understand, and provide written informed consent in english, 3. meet criteria for a primary psychiatric diagnosis of current major depressive disorder 4. hamilton depression rating scale (hdrs) total score ≥ 18, 5. must have measurable skin conductance/electrodermal activity (as assessed at the screening visit), 6. must own a working smartphone and use it regularly, 7. must own a windows pc (or tablet) or a mac computer (or laptop), 8. must have access to internet service every day. 9. must have started antidepressant medications, changed medication dosage, or started therapy within 3 weeks exclusion criteria: 1. active drug or alcohol use disorder in the past 3 months, 2. history of psychotic disorder, 3. history of mania or hypomania, 4. epilepsy or history of seizure disorder (including pnes), narcolepsy, alzheimer disease, parkinson's disease, als, severe tbi, dementia, ms, cerebral palsy, and neuralgia. 5. untreated hypothyroidism, 6. unstable medical disease, 7. cognitive impairment that would impede adherence to study procedures, 8. acute suicide or homicide risk, 9. current treatment with electroconvulsive therapy, vagal nerve stimulation therapy, deep brain stimulation, transcranial magnetic stimulation therapy, or phototherapy, 10. cannot comprehend or communicate in english, 11. lack of working smartphone or lack of daily access to internet service, 12. inability to measure skin conductance/electrodermal activity (as assessed at the screening visit), and 13. inability or unwilling to, at minimum, wear the physiological sensor (e4) wristbands, download monitoring apps, and fill out the surveys. 14. participants with more than two treatment failures (more than two adequate trials of meds on the basis of atrq) in the current mood episode.

Keywords: depression sensors
a study of bms-833923 with cisplatin and capecitabine in inoperable, metastatic gastric, gastroesophageal, or esophageal adenocarcinomas

Conditions: Stomach Neoplasms; Esophageal Neoplasms

Summary: the purpose of this study is to determine the maximum tolerated dose (mtd) of bms-833923 administered in combination with cisplatin and capecitabine as first-line therapy in subjects with inoperable metastatic gastric, gastroesophageal or esophageal adenocarcinomas.


Eligibility criteria:
for additional information, please contact the bms oncology clinical trial information service at 855-216-0126 or email mycancerstudyconnect@emergingmed.com. please visit www.bmsstudyconnect.com for more information on clinical trial participation. inclusion criteria: * esophageal, gastric, or gastroesophageal adenocarcinoma that has spread and cannot be treated with surgery. the diagnosis must be confirmed by a trained pathologist. * prior radiation therapy is allowed in certain circumstances - discuss with your doctor. * individuals who have had surgery may be eligible after recovering from the procedure. * individuals who have received chemotherapy for the treatment of their disease within the past 6 months are not eligible. chemotherapy given more than 6 months ago is permitted. * individuals with spread of their cancer to the brain are permitted in certain circumstances - talk with your doctor. exclusion criteria: * significant heart disease. * women pregnant or breastfeeding. * women able to bear children who are unwilling or unable to use an acceptable method to avoid pregnancy. * uncontrolled medical condition or active infection * inability to swallow pills. * inability to undergo a blood draw, in which a needle is used to obtain blood from a vein in your arm. * individuals receiving another drug not approved by the food and drug administration (fda) or similar agency in another country. * prisoners or individuals currently receiving treatment for a mental or physical illness as an inpatient in a hospital. * individuals who have experienced pancreatitis, an inflammation of the pancreas, in the past, or who have had a computed axial tomography (ct) scan showing pancreatitis.
effectiveness of a family-based intervention for adolescent suicide attempters (the safety study)

Conditions: Suicide

Summary: this study will evaluate the effectiveness of an individually tailored suicide prevention treatment program called safety in reducing suicide and suicide attempts in adolescents.

suicide is consistently a leading cause of death among adolescents in the united states, making suicide prevention a serious public health concern. the risk factors for suicide vary but are often related to depression and other mental disorders, substance abuse, a major stressful event, and family history of suicide. despite the morbidity and mortality associated with suicide attempts in adolescents, there is a lack of empirically supported treatment strategies and consensus regarding the best practices for suicide prevention. the safety intervention is an individually tailored treatment strategy that integrates family- and community-based interventions and cognitive behavioral therapy and links youth to needed services and resources. safety may be an effective means of reducing suicide attempts and improving mental health in at-risk adolescents. this study will evaluate the effectiveness of safety in reducing suicide and suicide attempts in adolescents. this study will be divided into two phases. participants in phase i will all receive 12 weeks of the family-based cognitive behavioral therapy intervention safety. phase i will be used to develop the intervention manual, protocols, and adherence measures for safety in phase ii. phase i participants will undergo assessments at baseline and week 12. assessments will last 90 minutes and will include a series of interviews and questionnaires concerning family, general health, and mental health-related issues. participants in phase ii will be assigned randomly to receive 12 weeks of safety or enhanced usual care. the frequency of sessions, which will involve both youth and parent participants, will vary on the basis of the individual needs of participants. safety sessions will be individually tailored for each participant's specific needs and will include the following elements: (1) family- and community-based interventions aimed at mobilizing family and community networks that support youth safety, adaptive behavior, and reasons for living; (2) cognitive behavioral treatment modules that focus on decreasing suicidality and preventing repeat suicide attempts; and (3) an individualized care linkage strategy that links youth to needed services and resources. at baseline, week 12, and month 6, all youth and parent participants will undergo the same assessments that were performed during phase i.

Eligibility criteria:
inclusion criteria: * suicide attempt or repetitive self-harm in the 3 months before study entry exclusion criteria: * psychosis * substance dependency * immediate risk of out-of-home placement * symptoms/conditions that would interfere with assessment and/or intervention protocols

Keywords: suicide attempts adolescents suicidal adolescent suicide attempters
drug-induced brugada syndrome research database

Conditions: Brugada Syndrome; Arrhythmia; ICD

Summary: all patients with drug-induced brugada syndrome who are evaluated and followed at each participating centers will be recorded in this register. within this register a characterization of patients and therapy will be done. prognostic factors of adefined clinical relevant endpoints will be evaluated.


Eligibility criteria:
inclusion criteria: * all consecutive patients with drug-induced brugada syndrome exclusion criteria: * missing informed consent form * missing contact informations for follow up
non-invasive assessment of skeletal muscle loss in cancer patients - phase ii

Conditions: Cachexia

Summary: the overall aim of this research is to develop a non-invasive approach to evaluate the production of 3-methylhistidine (3mh)in cancer patients, as a potential means of determining which patients are at high risk for future development of cancer induced skeletal muscle atrophy. rationale: the approach is based on the hypothesis that after an oral dose of deuterated 3-methylhistidine (d-3mh), the slope of the terminal portion of the decay curve (\> 12 hours post-dosing) for the tracer/tracee (d-3mh/3mh) in the free 3mh pool is proportional to the rate constant for myofibrillar protein degradation and can be determined from spot urine samples.

the long-term objective of this research is to develop a non-invasive approach for assessment of de novo 3mh production in cancer patients early in the course of the disease as a way of assessing which patients are at high risk for future development of skeletal muscle atrophy. the approach is based on: 1) the known increase in de novo production of 3-methylhistidine (3mh) from muscle protein breakdown in said patients as a consequence of their unique disease-host interactions, and 2) earlier demonstration that de novo 3mh production can be measured in vivo using isotope dilution. during this phase-ii project, we propose to conduct a statistically powerful prospective investigation to demonstrate that measurement of the slope of the terminal decay curve (rate constant) with our approach in newly diagnosed cancer patients predicts future development of muscle wasting. we expect the outcome of the combined phase-i and phase-ii research to lead to the early identification of elevated muscle catabolism in at-risk patients so that medical intervention can prevent future muscle atrophy.

Eligibility criteria:
inclusion criteria: * (1) histological or cytological evidence of nsclc without curative options; * (2) over 18 years of age; * (3) patient reported weight loss of ≤5% of usual body weight in the last 6 months; * (4) life expectancy of greater than 6 months based on the judgement of treating physician; * (5) serum creatinine ≤1.5 times the upper limit of normal; and * (6) willing and able to give informed consent. exclusion criteria: * 1) malabsorption, intractable vomiting or gastrointestinal obstruction * 2) congestive heart failure * 3) edema or ascites * 4) liver function test results that will preclude administration of prescribed therapy * 5) pregnant, nursing, or, if of child-bearing age, unwilling to use contraceptives

Keywords: cachexia sarcopenia de novo deuterated
testing strategies to improving warfarin adherence

Conditions: Atrial Fibrillation; Deep Venous Thrombosis; Dilated Cardiomyopathies

Summary: we are performing a research study to learn more about the control of an individual's blood thinning (anticoagulation) on warfarin. individuals from an anticoagulation clinic are being asked to participate in order to see if a lottery which provides the opportunity to win money in combination with the use of the med-emonitor might be useful in helping patients to achieve better control of their anticoagulation therapy. half of the participants will be enrolled in the lottery arm and the other half will be a control group who will receive the med-emonitor only.


Eligibility criteria:
inclusion criteria: * 21 years old age or older * on warfarin managed at the ac clinic * target inr 2.0-3.0 or 2.5-3.5 * at maintenance phase of therapy (defined as stable inr with stable warfarin dosing over at least 2 consecutive visits) exclusion criteria: * do not have access to telephone line * unwillingness to participate or to sign a consent form(refusal) * inability to participate because of advances dementia, advanced alzheimer's disease or other impairment affecting ability to provide informed consent and/or quality data or utilize the med-emonitor * participation in a current study that does not permit participation in another study * end stage or terminal illness with anticipated life expectancy of 6 months or less * inr over the upper limit for the individual's range at the time of enrollment (e.g.,\>3.0 or \>3.5, depending on the target range) * diagnosed with antiphospholipid antibody syndrome or abnormal inr prior to starting warfarin

Keywords: warfarin adherence mechanical heart valves