Kornimate/medical-research-clean huggingface dataset:
study to evaluate the efficacy and safety of tel/aml/ctd in elderly patients with essential hypertension

Conditions: Essential Hypertension

Summary: this study is to compare the efficacy and safety of telmisartan, amlodipine, and chlorthalidone fixed-dose combination and telmisartan, amlodipine, and hydrochlorothiazide in elderly patients with essential hypertension uncontrolled by telmisartan and amlodipine combinations

this is a phase iv, randomized, open-label, superiority, comparative study evaluating the efficacy and safety of telmisartan, amlodipine, and chlorthalidone fixed-dose combination) versus telmisartan, amlodipine, and hydrochlorothiazide in eledrly patient with essential hypertension uncontrolled by telmisartan and amlodipine combinations.

Eligibility criteria:
inclusion criteria: 1. participants who have been fully informed about the purpose, content, and characteristics of investigational product, and have voluntarily agreed in writing 2. aged ≥ 65 with essential hypertension 3. patient with uncontrolled essential hypertension at screening * if already taking antihypertensive drugs, mean sitting systolic blood pressure (mssbp) must be 140 mmhg ≤ mssbp \< 200 mmhg * if not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (mssbp) must be 160 mmhg ≤ mssbp \< 200 mmhg exclusion criteria: 1. patient who has history of drug allergic reactions 2. known hypersensitivity to components of the investigational product 3. patient who is unable to stop taking prohibited drugs 4. test results showing the following values at screening * the change of mssbp ≥ 20 mmhg and msdbp ≥ 10 mmhg on target arm between 1st and 2nd measurements 5. pregnant or lactating women 6. patient who is unable to maintain proper night sleep 7. malnutrition, starvation, debilitating factors, a person who is being forcibly detained for the treatment of mental or physical 8. administration of other investigational products within 3 months prior to screening. 9. an impossible one who participates in clinical trial by investigator's decision

Keywords: telmisartan/amlodipine/chlorthalidone fixed-dose combination
partners in care diabetes self-management intervention

Conditions: Type 2 Diabetes

Summary: type 2 diabetes is common among native hawaiians and pacific peoples. diabetes related complications decrease quality of life and can result in early morbidity. the purpose of the partners in care diabetes self-management educational intervention is to teach participants how to manage their diabetes to avoid or delay diabetes-related complications and how to better work with their health care team.

this is a feasibility study using a randomized controlled trial (rct) design in which 100 native hawaiians (nhs) and other pacific islanders (pps) will be randomized to either a 3-month diabetes self-management group (dsmg; n=50) or a delayed intervention control group (cg; n=50). participants in the dsmg will receive culturally-tailored, group diabetes self-management education delivered in a community setting by trained community peer educators. to meet this objective, we have partnered with four community-based organizations: 1) hawai'i maoli association of hawaiian civic clubs, 2) ke ola mamo native hawaiian health care system, 3) kokua kalihi valley comprehensive family services, and 4) kula no nā po'e hawai'i. these four organizations provide services to a large number of pacific people to include, but not limited to, native hawaiians, samoans, filipinos, and chuukese. they already have intervention research experience as members of the pili 'ohana cbpr project. the 3-month face-to-face intervention will be community-based and community-led by trained community peer educators from these four partnering community organizations. individuals with a hemoglobin a1c (hba1c; average blood sugar levels) \>=8% will be recruited for the study because they represent the most at-risk for diabetes-related complications. over a 1-year accrual period, the community partners will recruit and enroll 100 eligible nhs and pps (25 participants per a participating community), as well as deliver and evaluate the intervention in their respective community settings. the primary outcomes of our study are hemoglobin a1c and self-reported diabetes specific quality of life. secondary outcomes are cholesterol levels (including hdl, ldl, total cholesterol, and triglycerides), blood pressure, body mass index, and psychosocial adaptation.

Eligibility criteria:
inclusion criteria: 1. self-reported native hawaiian, filipino, or other pacific islander ethnic background, 2. adults age \>=18 years, 3. english-speaking, 4. physician-diagnosed type 2 diabetes, and 5. baseline hemoglobin a1c \>=8% exclusion criteria: 1. survival less than 6 months, 2. planning to move off island or out of state during the study period, 3. pregnancy, 4. any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., major psychiatric illness).

Keywords: diabetes behavioral intervention diabetes self-management native hawaiians health disparities
peptide-pulsed vs. rna-transfected dendritic cell vaccines in melanoma patients

Conditions: Melanoma Stage III or IV

Summary: dendritic cells (dcs)are the most potent antigen-presenting cells of the immune system, as such they are able to direct the immune system specifically against cancer cells. currently dcs are used in clinical vaccination studies and immunological and clinical responses have been observed. for inducing anti-tumor immunity, the dcs have to be loaded with tumor antigen (i.e. molecular structures that are presented by the tumor, that are recognized by the immune system). currently most studies use tumor peptides (small protein fragments) for this purpose. this approach has several disadvantages: only patients with a certain hla-type can be treated and the immune response that is induced by the vaccine is limited to the used peptides. these disadvantages do not exist when the dcs present antigen which is endogenously processed, for example after rna transfection. for this reason we investigate the immunogenicity of dcs that are pulsed with peptides or transfected with mrna encoding melanoma associated antigens in stage iii and iv melanoma patients.


Eligibility criteria:
inclusion criteria: for both stage iii and iv * histological proof of cutaneous melanoma * melanoma expressing both gp100 and tyrosinase, each in approximately 20% or more of cells by immunohistochemistry staining, * hla type a2 and/or a3, with known hla-dr4 expression, * wbc \> 3.0 x 109/l, lymphocytes \> 0.8 x 109/l, platelets \> 100 x 109/l, serum creatinine \< 150 μmol/l, serum bilirubin \< 25 μmol/l. * expected adequacy of follow-up, * written informed consent. for stage iii only * stage iii melanoma according to the 2001 ajcc criteria. * start of treatment within 2 months of lymph node dissection for melanoma stage iii for stage iv only -stage iv melanoma according to the 2001 ajcc criteria. limited tumor burden; ldh \< 2x upper limit of normal exclusion criteria: for both stage iii and iv * no autoimmune disorders, no concomitant use of immunosuppressive drugs, * no serious concomitant disease, no serious active infections, no other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin, * no known allergy to shell fish (contains klh) are excluded. * no pregnancy or lactation, for stage iii only: * no signs or symptoms of distant metastases as defined by normal history, physical examination, chest x-ray and serum ldh. * no concomitant or previous systemic treatment for melanoma for stage iv only: * no clinical signs of cns metastases, in patients with a clinical suspicion of cns metastases, a ct scan of the brain should be performed to exclude this. * no prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed.

Keywords: dendritic cells melanoma vaccine immunotherapy rna peptides
fluoride varnish community trial

Conditions: Dental Caries; Oral Disease; Costs

Summary: this cluster-randomized controlled community trial aimed to assess the efficacy and costs of fluoride varnish application for caries prevention in a high-risk population in south africa.

despite advances in oral health, dental caries remains a significant problem - particularly in disadvantaged communities in low- and middle-income countries. a study in the western cape region, which was conducted between 2001 and 2015, reported for example a caries prevalence of 84% for 6-years-old (smit 2017), highlighting the need for oral health programs and cost-effective interventions. fluoride varnish offers hereby a feasible possibility to supplement toothbrushing programs in order to improve fluoride delivery and consequently caries prevention. however, many studies failed to confirm the benefits of fluoride varnish for caries prevention, which may partially be explained by the fact that many of these studies were conducted in high-income countries, in which the caries increment is low due to a wide access to fluoride. this study, thus aimed to further validate the benefits of fluoride varnish application specifically in a primary school setting within a peri-urban, low socio-economic, high-caries risk community in south africa.

Eligibility criteria:
inclusion criteria: * reception grad or grade 1 (age 4-8) * signed consent form * good general health exclusion criteria: * any allergies (especially sticking plaster) * history of asthma * chronic ulcerated gums * chronic stomatis * participation in other study (except lifesmart)

Keywords: caries fluoride varnish dental health costs
music listening: a mechanistic trial

Conditions: Critical Illness

Summary: a randomized within-subject crossover trial to compare the effects of live and recorded music listening on biomarkers of stress and pain among children receiving mechanical ventilation in the pediatric intensive care unit.

children who are critically ill and receiving mechanical ventilation are at increased risks for experiencing high levels of stress and pain, which negatively impacts immediate and long-term health. the current standard of care for treating stress and pain is to provide analgesic and sedative medications, which are associated with increased risk of delirium and posttraumatic stress disorder. this randomized within-subject crossover trial will compare the effects of live and recorded music listening on biomarkers of stress and pain among children receiving mechanical ventilation in the pediatric intensive care unit, to identify the key components of a music listening intervention and explore its mechanism of action, i.e., the biological pathway through which music listening decreases stress and pain.

Eligibility criteria:
inclusion criteria: * 2 months -17 years old * intubated and receiving mv * expected to have a picu stay of \>72 hours exclusion criteria: * primary caregiver does not read, write, and speak english * the child is not expected to survive the picu stay * the child has deafness in both ears, has a history of musicogenic epilepsy, is receiving neuromuscular blockade infusion * the child has a diagnosis of covid-19 * the child was admitted for a new traumatic brain injury

Keywords: mechanical ventilation pain stress anxiety
deep substrate mapping versus activation mapping for vt

Conditions: Ventricular Tachycardia

Summary: substrate-based deep mapping and activation mapping are two of the main techniques used for guiding ventricular tachycardia (vt) ablation. there is no data comparing directly the extent of applicability, procedural results, and the long-term outcomes between the two mapping strategies.this randomized clinical trial aims to test whether activation mapping is superior to deep mapping to reduce ventricular tachycardia recurrence. the primary endpoint of the study is to compare recurrence-free survival rate of ventricular tachycardia at 12 months and procedural feasibility of substrate-based deep mapping versus activation mapping for vt ablation.


Eligibility criteria:
inclusion criteria: * patients with an implanted icd (all brands) * patients with the indication for ventricular tachycardia ablation (both first and redo procedures), supported by ensite 3d mapping system, for the following disease aetiologies: previous mi, myocarditis, arrhythmogenic right/left ventricular dysplasia * age: 18 years or more. * a participant is willing and able to give informed consent for participation in the trial and is available to respect the assessments described in the protocol and informed consent form. exclusion criteria: * contraindication to anticoagulants. * presence of thrombi. * presence of mitral and aortic prosthetic valve. * recent (less than 3 months) myocardial infarction, unstable angina, or coronary artery bypass. * ventricular tachycardia caused by reversible pathology. * life expectancy less than 1 year, according to the investigator. * contraindications to the use of ablation/diagnostic catheters or to cardiac catheterization. * female participant who is pregnant, lactating, or planning pregnancy during the course of the trial.

Keywords: deep substrate mapping activation mapping
topical administration of 0.15% ganciclovir gel for cmv anterior uveitis / endotheliitis

Conditions: Cytomegalovirus Anterior Segment Infection; Anterior Uveitis; Endotheliitis

Summary: objective of this study is to investigate the intracameral level of ganciclovir following topical application of 0.15% ganciclovir gel (virgan©) for cytomegalovirus (cmv) anterior uveitis and endothelitis. thirty patients who are diagnosed with cmv anterior segment infection, either uveitis or endothelitis, who have a positive aqueous real time pcr (rt-pcr) and/or positive tetraplex pcr for cmv and have not had any form of ganciclovir treatment in the past 1 month, will be recruited in the study after taking an informed consent. with active cmv anterior segment infection confirmed by a positive aqueous real time pcr (rt-pcr) and have not had any form of ganciclovir treatment in the past 1 month were recruited in the study. patients were given 0.15% ganciclovir gel 1cc 5 times a day for 6 weeks. following 6 weeks of treatment, tears and aqueous samples will be collected. aqueous will be sent for rt-pcr for cmv status. ganciclovir drug level in both tears and aqueous will be measured by hplc method. clinically, degree of the intraocular inflammation, intraocular pressure (iop) and central corneal thickness (cct) will be recorded at baseline and post-treatment.


Eligibility criteria:
inclusion criteria: * age between 21 and above * patients who are diagnosed with anterior uveitis or endotheliitis with a positive aqueous real time pcr (rt-pcr) and/or positive tetraplex pcr for cytomegalovirus (cmv) * patients with relapses and recurrent anterior segment disease that is pcr positive for cmv in aqueous * have not been on virgan or any other form of ganciclovir therapy for the past 1 month * consent to undergo anterior chamber tap and give aqueous and tear samples for the study * able to undergo relevant tests (corneal pachymetry and laser flare cell photometry) * able to come for subsequent follow-up visits exclusion criteria: * cmv anterior uveitis with associated retinitis * other causes of hypertensive anterior uveitis / endotheliitis such as hsv, vzv infection * patients who have been on any form of (topical, local or systemic) ganciclovir therapy for the past1 month. * patients who are allergic to ganciclovir * patients who will require systemic or intra-vitreal ganciclovir therapy * immunocompromised patients * positive for hiv, hep b and hep c * not keen on participating in the study * patients who are incapable, either by law or mental state, of giving consents in their own right. * patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol * patients who are pregnant or breastfeeding * any other specified reason as determined by the clinical investigator.

Keywords: cytomegalovirus uveitis endotheliitis ganciclovir
improving quality of colonoscopy using a 3d-imager

Conditions: Pain During Colonoscopy

Summary: coloscopy may be a painful procedure for the patient. this is due to a loop-formation of the coloscope. a 3d-real time imager produced by olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. we want to investigate whether the 3d-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy

results published in holme et.al. gastrointestinal endoscopy 2011;73:1215-1222.

Eligibility criteria:
inclusion criteria: * all patients referred for coloscopy on an out-patient basis exclusion criteria: * pregnancy * pacemaker * lack of ability to understand information given * prior resection of the colon/rectum * demanding analgetics prior to start of procedure

Keywords: pain patient satisfaction
the optimal timing of vaccination in pregnancy

Conditions: Pertussis/Whooping Cough

Summary: the central aim of this study is to investigate the optimal timing of vaccination in pregnant women. therefore, pregnant women will be vaccinated against pertussis at different timepoints and blood and breast milk samples will be taken at several timepoints. the main objectives are to assess the impact of timing on humoral and cellular immune responses in pregnant women, on antibody characteristics transferred across the placenta and on transplacental transport efficiency. the impact of maternal pertussis vaccination and timing of maternal pertussis vaccination on breastmilk antibody composition will also be investigated, as well as the impact of vaccination during pregnancy on the mucosal uptake of breastmilk iga antibodies by the infant respiratory and gastrointestinal tract.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent. * willing to be vaccinated with a tdap vaccine during pregnancy. * intend to be available for follow-up visits and phone call access until 6 months postpartum. * influenza and covid-19 vaccination during pregnancy (as per belgian recommendations) is allowed. exclusion criteria: * vaccinated with an ap containing vaccine during the last 5 years * significant mental illness (e.g. schizophrenia, psychosis, major depression) * serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (hiv) infection...). * systemic treatment with immune suppressive medication, including chronic steroid use of \> 10 mg prednisone or equivalent. * anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk. * previous severe reaction to any vaccine * high risk for serious obstetrical complications.
pearl intervention to reduce depression among adults with epilepsy

Conditions: Depression; Epilepsy

Summary: the purpose of this study is to test the effectiveness of a home-based depression treatment intervention called "program to encourage active, rewarding lives (pearl)". we hypothesize that over a 12-month period, compared to usual care, those receiving the pearl intervention will show more improvement with their depression, have higher quality of life and function, and use fewer medical services.

compared to non-depressed individuals with epilepsy, those with depression have significantly higher rates of suicide, lower social and occupational functioning, decreased quality of life independent of seizure frequency, and higher non-psychiatric health care utilization. adults with epilepsy are more likely to be homebound as a result of reduced function and restrictions in driving, opportunities to obtain enhanced quality of care for depression may be limited. this study tests the effectiveness of a home-based multi-modal depression treatment intervention called program to encourage active, rewarding lives (pearl). pearl consists of problem solving treatment, social and physical activation, pleasant events scheduling, support and education regarding antidepressant medication use as well as psychiatric consultation and recommendations regarding initiation or adjustment of antidepressant medications. in a sample of adults with epilepsy who have minor depression, major depression and/or dysthymia, we hypothesize that over a 12-month period, compared to usual care, those randomized to the pearl intervention will: achieve higher levels of depression response and remission, achieve higher quality of life and function, and utilize less non-psychiatric health care. by providing a multi-modal, home-based stepped collaborative care intervention for adults with depression and epilepsy, this program will offer practical alternatives to usual care and will provide a program for improving depression outcomes, quality of life and potentially, epilepsy outcomes.

Eligibility criteria:
inclusion criteria: * home address within 30 miles of seattle * diagnosis of epilepsy (icd-9 code 345.xx) * appointment in the uw rec or neurology clinic in the past 2 years and currently enrolled in this clinic. * current age older than 18 years * diagnosis of major depression, minor depression or dysthymia * ability to speak/read english exclusion criteria: * alcohol and/or substance abuse/dependence based on a score greater than 1 on 4-item validated cage-aid * cognitive impairment based on a score less than 3 on a 6-item validated cognitive screen * diagnosis of bipolar disorder, schizophrenia/schizoaffective disorder or other psychotic disorder * women who are pregnant or nursing * terminal medical illness * those currently seeing or planning to see a psychiatrist * those with suicidal ideation nearly every day

Keywords: depression epilepsy problem-solving therapy mental health neurology home-based health care community-based program collaborative care