Kornimate/medical-research-clean huggingface dataset:
pharmacogenetic study of mirtazapine response in depressed patients

Conditions: Depression

Summary: the purpose of this study is to determine whether pharmacogenetic study predict mirtazapine responsiveness in advance before the appearance of the drug effect until 4-6 weeks after administration of mirtazapine.

the purpose of this study is 1. to determine whether genomic differences between drug responders and nonresponders predict the response of mirtazapine and 2. to construct the prediction model for mirtazapine treatment in depressed patients in order to aid to select the genetically matching drug.

Eligibility criteria:
inclusion criteria: 1. eligible patients were enrolled in the clinical trials program of hte samsung medical center geropsychiatry and affective disorder clinics(seoul, korea). they received a semistructured diagnostic interview, the samsung psychiatric evaluation schedule. the affective disorder section of the samsung psychiatric evaluation schedule uses the korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, fourth edition. 2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians exclusion criteria: 1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks 2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant axis i psychiatric disorder.

Keywords: pharmacogenomics prediction of mirtazapine response depressed patients mirtazapine response adverse event
risk factors of meconium obstruction and respiratory distress syndrome in preterm infants

Conditions: Meconium Obstruction of Prematurity; Respiratory Distress Syndrome in Premature Infant

Summary: although the pathophysiology of meconium obstruction of prematurity (mop) is not clear, it is known that the decrease of the intestinal peristalsis due to decreased intestinal perfusion during antenatal or perinatal period. recently, the level of citrulline has been used as an index of function and injury of the small intestine state. this study aimed to evaluate citrulline level of cord blood as a marker for early detection and observe changes in intestinal blood flow in mop patient. and we aimed to confirm the efficacy of the at/et ratio (ratio of the pulmonary artery time-to-peak velocity interval to the right ventricular ejection time) of the prenatal pulmonary artery as a noninvasive predictor of neonatal respiratory distress syndrome.


Eligibility criteria:
inclusion criteria: * premature infants born less than 34 weeks from mother with pregnancy induced hypertension, pre-eclampsia or eclampsia exclusion criteria: * major congenital anomalies * infants with hypotension while using inotropics
financial navigation program for improving financial toxicity among breast cancer in china

Conditions: Breast Neoplasm Female; Financial Toxicity; Financial Navigation

Summary: the goal of this study is to access the impact of a financial navigation program on improving financial toxicity among patients with breast cancer in china. the main questions it aims to answer are: * does the intervention alleviate participants' financial toxicity? * does the intervention enhance participants' cost-related health literacy? * does the intervention improve participants' shared decision-making? * does the intervention reduce participants' perceived stress? researchers will compare the financial navigation program with usual oncology care to evaluate its effectiveness. participants will receive the comprehensive financial navigation, including: * needs assessment; * cost-related health education, mainly including topics regarding communication of cost, treatment-related cost, health insurance policies, and family support; * resource and service referral; * personalized counseling.


Eligibility criteria:
inclusion criteria: * newly diagnosed with breast cancer and undergoing surgery during this admission; * female, age 18 years or older; * receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy; * eastern cooperative oncology group performance status 0-2; * provided informed consent to participate in this study. exclusion criteria: * diagnosed with ductal carcinoma in situ (dcis) * presence of any serious psychiatric disorders; * cognitive impairments; * difficulty in reading, writing, or communicating in chinese.
standard therapy given with or without combination chemotherapy in treating patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. it is not known whether giving chemotherapy in addition to standard therapy is a more effective treatment for lung cancer. purpose: randomized phase iii trial to compare the effectiveness of standard therapy given with or without combination chemotherapy in treating patients with non-small cell lung cancer.

objectives: i. assess whether the addition of cisplatin-based chemotherapy to standard treatment improves survival in patients with non-small cell lung cancer. outline: this is a randomized study. patients are randomized to 1 of 2 treatment arms. arm i: patients undergo primary surgery, radical radiotherapy, radiotherapy with surgery, or best supportive care. arm ii: patients undergo treatment as in arm i. beginning within 10 weeks after surgery or radical radiotherapy or as soon as possible after diagnosis, patients receive 1 of the following regimens: regimen a: patients receive cisplatin iv on day 1 followed by vindesine on days 1 and 8. regimen b: patients receive mitomycin, ifosfamide, and cisplatin on day 1. regimen c: patients receive mitomycin, vinblastine, and cisplatin on day 1. regimen d: patients receive vinorelbine on days 1 and 8 and cisplatin on day 1. treatment in all 4 regimens repeats every 3 weeks for 3 courses. patients are followed at 3 months, 6 months, 1 year, and then annually thereafter. projected accrual: a total of 1,800 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: histologically confirmed non-small cell lung cancer being treated with primary surgery, radical radiotherapy, surgery plus radiotherapy, or best supportive care patient characteristics: age: adult performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: no inadequate renal function other: no other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer must be fit enough to receive therapy prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: see disease characteristics prior radical radiotherapy allowed surgery: see disease characteristics prior surgery allowed

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
intracytoplasmic sperm injection preparation in infertile women

Conditions: Infertility

Summary: infertility is a common gynecological problem is women

intracytoplasmic sperm injection is one of the aisted reproduction techniques that help to solve this problem

Eligibility criteria:
inclusion criteria: * women who have infertility with age between 20 -42 years exclusion criteria: * women who has ovarian or endometrial factor of infertility
impact of intravenous caffeine on atrial electrical properties and potential arrythmia induction

Conditions: Atrial Fibrillation

Summary: this "how caffeine induces atrial tachyarrhythmias" trial will be a multi-center, randomized, double-blinded trial of intravenous caffeine versus placebo among patients undergoing pulmonary vein isolation procedures for atrial fibrillation(af).

the mechanism by which caffeine might change cardiac electrophysiologic properties is largely unknown. most of the prior studies conducted have evaluated the correlation based on the premise of oral consumption. one caveat among such study designs can be underreporting or overreporting the amount of caffeine ingested. to this date, no clinical trials exist that has studied the in vivo effects of caffeine to assess the atrial refractory period and conduction velocity and its potential to cause atrial or ventricular ectopy or sustained arrythmia induction including atrial tachycardia(at)/atrial fibrillation(af)/ventricular tachycardia(vt)/ventricular fibrillation(vf). as it is hypothesized that decreasing the atrial refractory period can render atria more prone to fibrillation. the pulmonary veins have proven integral to af pathophysiology, the relationship between pulmonary vein electrophysiology and lifestyle factors in particular has not previously been assessed. it is also not clear if caffeine increases the risk of af on those patients with known af diagnosis. to bridge this gap, a randomized controlled trial is proposed to assess the effects of intravenous caffeine on atrial activity during af ablation procedures.

Eligibility criteria:
inclusion criteria: all adult patients from 21-90 years of age with new onset paroxysmal atrial fibrillation presenting in sinus rhythm or af of recent onset (the latter confirmed by sinus rhythm documented no more than 1 week prior) undergoing af ablation will be included in the study. exclusion criteria: patients will be excluded if any of the following were identified: 1. history of substance abuse or alcoholism. 2. left ventricular ejection fraction \<50%. 3. liver dysfunction. 4. pregnancy. 5. inability to give informed consent. 6. amiodarone uses within 1 month prior to procedure. 7. aad use within 24 h prior to the procedure 8. severe intolerance to caffeine.
a study of flibanserin in breast cancer survivors on tamoxifen or aromatase inhibitors

Conditions: Breast Cancer; Hyposexual Desire Disorder

Summary: the purpose of this study is to determine if it is feasible for women to take both flibanserin and tamoxifen for the duration of the study. this study is also trying to find out if flibanserin improves or has any effect on hyposexual desire disorder/hsdd in women who are taking tamoxifen for breast cancer.


Eligibility criteria:
inclusion criteria: * women age 21 and older * able to swallow tablets * history of stage 0-iii breast cancer that is estrogen and/or progesterone receptor positive * history of breast cancer with no current evidence of disease and have completed primary treatment with any combination of surgery, radiation and/or chemotherapy at least 3 months ago and is currently on tamoxifen, an ai, or ovarian suppression. * has been taking tamoxifen, an ai, ,or ovarian suppression for at least 3 months. * has lfts within 2 times the upper limit of normal proven by a comprehensive metabolic panel (cmp) performed within 6 months of protocol enrollment and while the patient was on tamoxifen, an ai, or ovarian suppression * patients meet criteria for the diagnosis of hsdd as defined by the dsm-iv and isswsh consensus paper. the criteria states that there must be a decrease in sexual desire and this must be a change for at least 3 months from what it was previously. personal distress resulting from this change must occur. initial screening will take place with the decreased sexual desire screener, a 5-question screening tool developed and validated to aid clinicians in making the diagnosis of hsdd. a "yes" response to the first 4 questions on the screener is consistent with hsdd. * patients must agree to follow the guidelines for alcohol consumption during the 24 weeks of treatment on study * english speaking * able to participate in the informed consent process exclusion criteria: * active secondary cancer requiring cytotoxic chemotherapy * history or current diagnosis of metastatic breast cancer. * unwillingness to follow alcohol guidelines while taking flibanserin * hepatic dysfunction (more than 2 times the upper limit of normal for alt, ast, t.bili or alk phos) proven by comprehensive metabolic panel (cmp) performed within 6 months of protocol enrollment and while the patient was on tamoxifen or an ai * patients on strong cyp3a4 inhibitors including ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan * patients on moderate cyp3a4 inhibitors including amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, grapefruit juice * non-english speaking * unable to participate in the informed consent process

Keywords: tamoxifen flibanserin hyposexual desire disorder
the pk characteristics of the co-administration of rosuvastatin and telmisartan/amlodipine and jlp-1401 in healthy male volunteers volunteers

Conditions: Hypertension With Dyslipidemia

Summary: the pk characteristics of the co-administration of rosuvastatin and telmisartan/amlodipine and jlp-1401 in healthy male volunteers volunteers


Eligibility criteria:
inclusion criteria: * healthy male volunteer, age is over 19 years body weight is over 55kg, the result of body mass index(bmi) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2 * subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial * subject who has the ability and willingness to participate the whole period of trial exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. * subjects who are allergic to investigational drug. * subjects who have a medical history which can affect the clinical trial. * systolic bp \> 140mmhg or diastolic bp \> 90mmhg) * ast or alt \> x 2 unl * history of drug abuse or positive drug screening. * participation in other drug studies within 3 months prior to the drug administration. * whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
clinical experience investigation of symbicort turbuhaler as maintenance therapy and reliever therapy

Conditions: Bronchial Asthma

Summary: the purpose of the investigation is to confirm the safety of patients receiving symbicort turbuhaler as maintenance and reliever therapy ( symbicort smart) under the post-marketing actual use.

symbicort turbuhaler 30/60 clinical experience investigation for treatment with symbicort as maintenance therapy and as needed in response to symptoms

Eligibility criteria:
inclusion criteria: * patients receiving symbicort turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period

Keywords: bronchial asthma symbicort turbuhaler
e-health resilience program for chronic spine pain

Conditions: Back Pain; Neck Pain

Summary: this study will examine a e-health resilience based program, jool, for chronic spine pain patients through the following aims: aim 1: to test the effectiveness of a resilience based program known as jool aim 2: to evaluate the characteristics of the participants most likely to benefit from this treatment

this is a pilot rct in which 150 patients with chronic spine pain will be randomized to one of two arms: (1) a group that downloads the jool mobile application resilience program; and (2) a control group.the primary outcome will be a change in physical function.

Eligibility criteria:
inclusion criteria: * patient of the um back \& pain center * primary diagnosis of neck or back pain (spine pain) * age 18-70 * english speaking * able to provide consent * willing to download the mobile application and comply with study procedures * antidepressant medications stable for ≥ 4 weeks * no plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g. back surgery, physical therapy, behavioral therapy exclusion criteria * having known psychotic disorder or the presence of another psychiatric condition (e.g. severe depression \[hads scores ≥ 15\], suicidal ideation) or cognitive impairment (e.g. severe dyslexia, tbi) limiting ability to give consent and/or participate fully in the study * currently undergoing psychotherapeutic care at the back \& pain center because many of the concepts that are the focus of this study are already employed in that treatment * other factors that at the discretion of the investigators would adversely affect study participation.
animated cartoons and cooperation in young children receiving inhaled medications

Conditions: Patient Compliance; Inhalation Spacers

Summary: up to 50% of infants and young children cry during the administration of their inhaled treatment for their asthma. this results in decreased lung deposition, and thus decreased effectiveness of their inhaled treatment. the objective of this study is to evaluate whether animated cartoons can increase the cooperation of young children with asthma who are not cooperative during the delivery of their ics therapy through a pmdi/spacer.


Eligibility criteria:
inclusion criteria: * dyad parent-child. * parent must be 18 years or older and own a smartphone which can record videos and display animated cartoons. * child must be 6-47 months old, and require an inhaled corticosteroid therapy, and use a pressurized metered-dose inhaler and a spacer, and have difficulties in cooperation at least half of the time on the last week. exclusion criteria: * children with a medical history of epilepsy, or visual or hearing impairment not corrected by an appropriate device/treatment. * parents not speaking french or english. * parents not able to run the mobile application used to record the videos of the child despite repeated explanations.
nutritional treatment for the amelioration of traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: to test the feasibility of administering a commercially available neurotrophic oral nutritional supplement (ons) for adult patients with acute traumatic brain injury at the royal london hospital.

the study will be a randomised controlled non-blinded trial of adult patients with acute traumatic brain injury at the royal london hospital. there will be randomisation to one of two non-blinded trial groups: 1. usual standard nhs care (control group) 2. usual standard nhs care plus daily oral dose of souvenaid® ons the trial protocol will commence between 3-7 days after admission. the trial timeline provides a summary of intervention and assessments. the trial will last 12 months. the first 6 months will be the formal trial with two groups and follow up assessments. this will be performed on intention to treat basis. after this initial phase the investigators will provide an opportunity for all participants from either group (control or treatment) to take souvenaid® ons for a further 6 months with a clinical follow up appointment.

Eligibility criteria:
inclusion criteria: * adult between 18 yrs and 80 yrs of age * acute traumatic brain injury with confirmed radiological features exclusion criteria: * allergies to fish oil/milk/soya * medical history of galactosaemia * non-traumatic aetiology to head injury * unable to receive enteral nutrition * craniectomy during admission (loss of integrity of skull convexity) * concurrent active neurological disease * pregnancy or breastfeeding
post-traumatic stress disorder focused psychodynamic psychotherapy

Conditions: PTSD

Summary: this is a randomized controlled trial of trauma-focused psychodynamic psychotherapy (tfpp) in comparison with tau (at the va) in a 2:1 ratio in 75 veterans with ptsd who have not responded to standard treatment at the va.

veterans with ptsd are a highly vulnerable population with tremendous disability and unmet needs. few va patients with ptsd now actually receive evidence-based psychotherapy because current exposure-based treatments have low uptake. the project goal is to expand the range of ptsd psychotherapy treatments available at veterans administration medical centers. this pilot trauma recovery proposal takes the next step in translating a brief efficacious psychotherapy developed and tested for panic disorder, panic focused psychodynamic psychotherapy (pfpp) for veterans with ptsd at the va new york harbor healthcare system (va nyhhcs). pfpp was developed, manualized, and studied in rcts over the past two decades. we hope that trauma-focused psychodynamic psychotherapy (tfpp), an adaptation of pfpp, with its high response rates in panic disorder with/without agoraphobia, and non-exposure protocol, will fill crucial gaps in veteran care. a major challenge facing psychotherapy research is translating and implementing efficacious therapies to the community. no psychodynamic psychotherapy for anxiety or ptsd has achieved this in the us. this pilot rct represents a paradigm shift in its approach to trauma. tfpp will be the only ptsd treatment for veterans to incorporate veterans' input into refinement of the treatment as this project progresses. tfpp targets aspects of traumatic experience and approaches veterans' lives more broadly than the symptom-focused treatments the va currently offers our traumatized veterans.

Eligibility criteria:
inclusion criteria: * reporting moderate ptsd, as defined by a caps score of \>40 * have at least one of the following history with cpt and/or pe: * offered and declined * dropped out of treatment * been determined unsuitable by their treatment team * received treatment but continue to experience symptoms meeting entrance criteria. * require stabilization on psychiatric medication for 2 month period prior to entry into study to avoid confounding treatments exclusion criteria: * presence of scid-5 assessed psychotic disorder, bipolar disorder, or substance use that would interfere with trial demands * severe suicidality that would require immediate crisis management * organic mental syndromes, delirium, or unstable medical conditions that would interfere with trial demands * inability to meet trial demands.

Keywords: psychotherapy psychodynamic psychotherapy