Kornimate/medical-research-clean huggingface dataset:
open-label duloxetine monotherapy in the treatment of posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorders

Summary: the purpose of this study is to determine whether duloxetine (cymbalta®) is an effective treatment in reducing the symptoms of posttraumatic stress disorder (ptsd).

duloxetine has established efficacy for treatment of major depression, generalized anxiety disorder and diabetic peripheral neuropathic pain. chronic ptsd is often treated with antidepressants, in fact there are only two fda-approved treatments for ptsd. yet many chronic ptsd patients, especially male combat veterans, have a limited response to antidepressant treatment (baker et al, 1995; cañive et al, 1998; hertzsberg et al 2000) and new pharmacotherapies should be investigated.

Eligibility criteria:
inclusion criteria: * male or female patients ages 18 or older of any ethnic background meeting dsm-iv criteria for ptsd * score of at least 60 on the caps-sx at baseline * competent to give informed consent * if female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential * patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the baseline visit (treatment phase); two weeks prior in the case of fluoxetine or in the case of an maoi * other medications, if any, must have been kept stable for at least one month prior to the baseline visit exclusion criteria: * known hypersensitivity to duloxetine or any of the inactive ingredients * females who are pregnant or breastfeeding * use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in concomitant medications section) within one week prior to the baseline visit and throughout the study period * use of fluoxetine or an maoi within two weeks * concomitant use of narrow therapeutic index medications or medications that are likely to have a clinically significant drug interaction with duloxetine * medical conditions that may prevent safe administration of duloxetine including end stage renal disease, clinically significant renal impairment (crcl \<30 ml/min), hepatic insufficiency, cardiac disease, or pulmonary disease * patients with uncontrolled narrow-angle glaucoma * alcohol or drug abuse or dependence within three months of study entry as defined by dsm-iv criteria * alcohol use may not exceed 12 drinks per week or 5 drinks per drinking episode during the course of the study. * a current or past history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder * suicidal or homicidal ideation or other clinically significant dangerous behavior * currently seeking compensation or increase in compensation for the effects of the trauma * initiation or change in psychotherapy within 3 months of study entry

Keywords: post traumatic stress disorder duloxetine antidepressants
risk factors for recurrence of primary bile duct stones

Conditions: Common Bile Duct Stones

Summary: recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. however, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. the aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.

recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. however, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. the aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone. this study is patient-control setting study. firstly, from july 2007 through february 2014, all the patients who were performed ercp will be enrolled. the inclusion criteria is the patients with common bile duct stone. the exclusion criteria is patients with biliary stenosis, psc, retained gb stone, or who were lost to follow-up. the main outcome is the association between periampullary diverticulum, common bile duct angle, and recurrent cbd stone. this will be evaluated by univariate and multivariate analyses.

Eligibility criteria:
inclusion criteria: * patients who were performed ercp due to cbd stone or calculous cholangitis exclusion criteria: * patients with biliary stricture, psc, retained gb stone, or who were lost to follow-up.

Keywords: common bile duct stones diverticulum
local proof of concept of evira in abu dhabi study

Conditions: Childhood Obesity; Adolescent Obesity; Treatment Adherence

Summary: evira is a digital treatment tool developed for treatment of childhood obesity. through daily weighings at home using a special scale together with a message function in the evira application, parents and the clinicians can easily follow the child's weight development. the primary aim of this study is to evaluate its efficacy for childhood obesity treatment in abu dhabi, with a secondary objective to establish non-inferiority compared to outcomes in a cohort in stockholm, sweden.

obesity remains a critical global health concern. traditional treatment often yields limited results, necessitating innovative solutions. in this study, participants aged 6-15.9 years with obesity at the sheikh shakabout medical city in abu dhabi, will be asked for participation. if agreed to participate, they will use a digital treatment tool as a complement to behavioral treatment.the treatment is based on outcome goals set by the treatment staff together with the family. briefly, the families follow the child's weight outcome via daily weight measurements and the outcome is shown graphically in the mobile application as bmi sds with the bmi sds weight goals as background. the staff will provide support to the families via the app. the staff is encouraged to react and contact the families if the weight goals are not reached or if they fail to perform the daily weighings. regular physical visits at baseline, 3 months, and 6 months, alongside questionnaire assessments, will facilitate data collection via electronic case report forms. the purpose of this study is to evaluate the treatment tools efficacy for childhood obesity treatment in abu dhabi. furthermore, the study aims to establish non-inferiority compared to outcomes in stockholm, sweden (referred to as the "stockholm cohort"), on 107 children and adolescents who were treated with the same treatment method between october 2018 and august 2019 (clinicaltrials.gov id: nct04323215).

Eligibility criteria:
inclusion criteria: * age \>6.0 and \<16.0 years of age at inclusion * obesity according to international obesity task force (iotf) * willingness to participate in an obesity treatment proof of concept trial * family ability to communicate e.g. write and read messages in the mobile application * parents having a smart phone and an email address exclusion criteria: * morbid obesity defined as iso-bmi\>40 kg/m2 independently of age * endocrine disorders other than well controlled hypothyroidism * metabolic disorders of importance for weight control * treatment for depression and other psychiatric disorders during the last 6 months before inclusion * pharmacological treatment of importance for weight control * hypothalamic or monogenic obesity, e.g. syndromes and mb down * severe neuropsychiatric disorders that could affect study compliance * eating disorders requiring therapy during the last six months before inclusion or observed at the inclusion screening.

Keywords: digital health home-weighing obesity treatment treatment outcome
study to evaluate the efficacy and safety of saxagliptin co-administered with dapagliflozin in combination with metformin compared to sitagliptin in combination with metformin in adult patients with type 2 diabetes who have inadequate glycemic control on metformin therapy alone

Conditions: Type 2 Diabetes

Summary: study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean hba1c over a treatment period of 26 weeks.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * patients with type 2 diabetes mellitus (t2dm) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (hba1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit * subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening * bmi \> 20.0 kg/m2 at the enrollment visit * males and females, age ≥18 years old at time of screening visit * women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of study drug * women must not be breastfeeding exclusion criteria: * clinically diagnosed with type i diabetes, known diagnosis of maturity onset diabetes of young (mody), secondary diabetes mellitus or diabetes insipidus * history of diabetic ketoacidosis * any of the following cardiovascular (cv)/vascular diseases within 3 months of the enrollment visit * myocardial infarction * cardiac surgery or revascularization (coronary artery bypass surgery coronary artery bypass graft \[(cabg)\]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty \[(ptca)\]) * unstable angina * unstable congestive heart failure (chf) * transient ischemic attack (tia) or significant cerebrovascular disease * unstable or previously undiagnosed arrhythmia * congestive heart failure, defined as new york heart association (nyha) class iii and iv, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40% * renal disease * hepatic diseases * hematological and oncological disease/conditions * hemoglobin ≤ 11.0 g/dl (110 g/l) for men; hemoglobin ≤ 10.0 g/dl (100 g/l) for women * abnormal free t4
combination of decitabine and temozolomide in the treatment of patients with metastatic melanoma

Conditions: Malignant Melanoma

Summary: the combination of tmz and dac may effect dual modulation of dna repair genes resulting in improved clinical response.

primary objectives: * phase i: to determine the safety, tolerability, and phase ii recommended dose of the combination of extended schedule tmz and dac. * phase ii: to determine the efficacy, as measured by overall response rate, of the combination of extended schedule tmz and dac given at the phase ii recommended dose to patients with metastatic melanoma. secondary objectives: * to determine pharmacokinetics of the combination of tmz and dac in patients with metastatic melanoma. * to determine, in peripheral blood mononuclear cells (pbmc) and tumor tissue, the pharmacodynamic effects of the combination of tmz and dac on promoter methylation and expression of selected genes and correlate these with response. * to determine the progression-free survival of patients treated with the combination of tmz and dac.

Eligibility criteria:
inclusion criteria: * patients who have non-resectable stage iiib or stage iv metastatic melanoma that have progressed despite prior therapies. * life expectancy of at least 12 weeks. * ecog performance status of 0, 1 and 2. * ≥18 years of age. * patients who have not received any other chemotherapeutic, biological or investigational agent within 28 days of study drug administration. * first line and active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for \>4 weeks or \>2 weeks if treated with stereotactic radiosurgery, remain eligible) exclusion criteria: * any evidence of renal dysfunction (proteinuria, estimated creatinine clearance from serum creatinine test of \<60 ml/min). * impaired hepatic function (liver enzymes greater than twice the upper limit of normal or bilirubin \> 2.0 except in patients with gilbert's syndrome). * prior treatment with alkylating agents (including tmz and dtic). * active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for \>4 weeks remain eligible). * active infections or serious general medical conditions. * female patients of child-bearing age who are not on adequate contraception, or are pregnant or breast-feeding.

Keywords: decitabine temozolomide metastatic melanoma non-resectable stage iiib melanoma stage iv melanoma tmz dtic promoter methylation skin cancer chemotherapy
engaging church health ministries to decrease coronavirus disease-19 vaccine hesitancy in underserved populations

Conditions: COVID-19

Summary: this study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of covid-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved black communities.

this study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of covid-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved black communities. a total of 98 participants from three-to-five churches will be randomized to an intervention group that will receive counseling from their health ministers on the benefits of getting vaccinated, boosted, and tested, or to a delayed intervention control group. the effects of the intervention on the primary outcome, change in vaccine/booster hesitancy, will be assessed by a questionnaire that will be administered to both groups at baseline and after three weeks. following the three-week control period, the delayed intervention control group will also receive the intervention and again be administered the questionnaire. questionnaires will be used to obtain more granular information on sources of vaccine/booster hesitancy and for their vaccine-related decisions.

Eligibility criteria:
inclusion criteria: * age ≥ 18 y * not having received an initial covid-19 vaccine or a booster vaccine at the recommended interval * having vaccine or booster hesitancy * able to understand and speak english * willing to engage with the church's health ministry via in-person or virtual/phone sessions exclusion criteria: * none
craving network neurofeedback

Conditions: Overweight or Obesity

Summary: this project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior.

aim 1 of this study is to test whether neurofeedback from the craving network is associated with reduced craving network strength. aim 2 of this study is to test whether neurofeedback from the craving network is associated with reduced food craving and changes in eating behavior. aim 3 of this study is to test whether neurofeedback from the craving network is associated with changes in resting state functional connectivity.

Eligibility criteria:
inclusion criteria: * ages 18 to 60 years * body mass index \>25 kg/m2 * \>2.37 food craving inventory score exclusion criteria: * use of anti-obesity medications * weight-reduced state defined as \>10% weight reduction in the past 6 months. * nicotine use * current diagnosis of neurological or psychiatric disorder * obesity-related diseases such as type-2 diabetes * contraindications to mri * baseline scanning with motion \>0.15mm frame to frame displacement.
the role of human milk oligosaccharides and microbiomes on infantile colic and atopic dermatitis in term infants

Conditions: Infantile Colic; Breast Feeding; Atopic Dermatitis; Infant Formula

Summary: background: human milk oligosaccharides (hmo) and microbiota are both key factors for infants to shape the gut flora and develop the immune system. breastfed infant is beneficial to prevent the occurrence of infantile colic (ic) and atopic dermatitis (ad), which may through shaping a healthy microbiota. however, the gut microbiota biomarkers representing ic and ad have not yet been discovered. in addition, the effectiveness of supplement of hmo in infant formula reduce the incidence of ic and ad in infants is still debate.

purpose: to investigate the preventive role of hmo-supplement formula on ic and ad in term infants in a clinical trial. method: the investigators will enroll three cohorts (exclusive breastfeeding, formula feeding, and hmo-supplement formula feeding infants) for research. the investigators collected samples of serial baby feces from subjects at 0, 1, 2, 4, 6, 12 months in this study. the fecal microbiota composition will be analyzed by detecting 16s-rrna using next generation sequencing method. the demographic data and incidence of ic (0-5 months) and ad (0-12 months) was followed and recorded.

Eligibility criteria:
inclusion criteria: 1. new born 2. gestational age of \>= 37 weeks 3. birth weight greater than 2500 gm exclusion criteria: 1. born with perinatal insults 2. mother with antimicrobial agents 1 month before delivery 3. congenital abnormalities related to growth 4. major disease admitted to level ii or nicu

Keywords: breast milk microbiota infant health human milk oligosaccharides prebiotics
the incidence of difficult intubation in obese versus non-obese patients

Conditions: Airway Obstruction

Summary: the aim of our study is to identify the incidence of difficult endotracheal intubation in patients with normal bmi undergoing surgery under general anaesthesia in our hospital and compare it to that of obese patients.


Eligibility criteria:
inclusion criteria: * elective surgery * bmi\< 30 for normal bmi group * bmi \> 30 for obese group exclusion criteria: * known previous difficult airway * pediatric patients. * emergency patients
compassionate use of asparaginase and pembrolizumab combination theaapy for nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma (NPC)

Summary: the goal of this study is to investigate the outcomes of patients with locoregionally advanced nasopharyngeal carcinoma (la-npc) or recurrent-metastatic nasopharyngeal carcinoma (rm-npc) treated with a combination of immune checkpoint blockade (icb) and asparaginase.

this study is being conducted to investigate the synergistic effect of combining asparaginase with immune checkpoint blockade (icb) in tumor-bearing mice. findings indicate that asparaginase enhances cd8+ t cell activation, and previous reports have shown that nasopharyngeal carcinoma (npc) patients exhibit a lower response rate to icb treatment. this study aims to determine whether the combination therapy of asparaginase and icb is more effective or less effective compared to the standard icb-only approach for patients with locoregionally advanced (la-npc) or recurrent-metastatic npc (rm-npc). participants are being enrolled who have previously received icb but continue to experience disease progression.

Eligibility criteria:
inclusion criteria: patients who have previously received immune checkpoint blockade therapy but are still experiencing disease progression - exclusion criteria: active autoimmune disease -

Keywords: npc icb asparaginase
standard treatments of very-early stage hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Very-early Stage

Summary: the aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, mri showed that the degree of tumor necrosis, and overall survival rates of the therapies between pei, mva and rfa, and make the standard for minimally invasive treatment of very early stage hcc.


Eligibility criteria:
inclusion criteria: 1. preoperative clinical, imaging and tumor markers were diagnosed as hepatocellular carcinoma 2. tumor diameter\<2cm 3. child-pugh class a liver function 4. without major organ dysfunction 5. male or female patients \> 18 years and \<=70 years of age 6. voluntary participation in this clinical trial exclusion criteria: 1. other anticancer treatment before therapy 2. patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer 3. patients with other diseases that may affect the treatment of this treatment 4. history of other malignant tumors 5. patients who are participating in other clinical trials 6. pregnant, lactating women

Keywords: treatments hepatocellular carcinoma
pulmonary vein ablation versus amiodarone in the elderly

Conditions: Atrial Fibrillation

Summary: the purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (af) pulmonary vein isolation (pvi) using rf ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of af.

atrial fibrillation (af) is the most common arrhythmia. the prevalence of af is highly age dependent as 70% of af patients is between 65 and 85 years old. with increasing life expectancy, af prevalence will increase 2,5 times during the next 50 years and constitute an even more important health concern. in younger patients pulmonary vein ablation is an accepted procedure with superior efficacy compared to medical treatment. in this study the safety and efficacy of pvi in patients over 70 years old will be evaluated.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years at moment of screening, able to sign informed consent. * documented paroxysmal af in association with complaints in the last year, with at least 2 episodes of complaints attributed to af in the previous 2 months. * paroxysmal af documented with at least one ecg with sinus rhythm not after cardioversion in the last year. * no prior use of amiodarone in the last 6 months and no usage longer than 4 weeks in total. exclusion criteria: * ef \< 35 % or description of "poor left ventricular function" on echocardiogram. measurement should not be older than 6 months at moment of screening. * aortic, mitral, pulmonary or tricuspid valve regurgitation or stenosis, if graded severe (grade \>3) * acute illness: unstable angina, infectious disease. * primary structural or electrical heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, brugada syndrome, long qt syndrome. * reversible causes (thyroid dysfunction, uncontrolled hypertension, ischemia). * previous ablation. * contraindications for amiodarone; liver dysfunction (serum alanine aminotransferase \>2.5 times upper limit); thyroid dysfunction; chronic lung disease; baseline qtc \>460 ms. sinus node dysfunction (pause more than 3 seconds in sinus rhythm); second or third degree av-block. * contraindications for anti-coagulation: prior life threatening hemorrhage under use of vitamin k antagonists. * any myocardial infarction or pci in previous 6 months. * cabg in previous 6 months. * renal dysfunction: creatinine clearance \<45 ml/min * severe co-morbidity. life expectancy less than 1 year. * thrombus in left atrium * untreatable allergy to contrast media

Keywords: atrial fibrillation pvi ablation elderly patients efficacy