Kornimate/medical-research-clean huggingface dataset:
dissemination of the cardiovascular risk service

Conditions: Hypertension; Diabetes Mellitus

Summary: the objective of this study is to evaluate the implementation of of a remote, pharmacist-led cardiovascular risk service (cvrs) in 12 large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients.

cardiovascular disease (cvd) causes 2,200 deaths in americans every day with one death every 39 seconds. yet effective implementation of research-based interventions that reduce cvd-related illness and death remains a substantial challenge. the objective of this study is to test the scalability of a pharmacist-led, remote cvd risk and prevention services model in large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients, using a pragmatic cluster-randomized design. this service is called the cardiovascular risk service (cvrs). there are limited data on the barriers and facilitators of implementation to enhance the cvrs in these types of diverse, complex health-systems. therefore, scaling up our effective, innovative team-based intervention will require an assessment of barriers and facilitators to cvrs adoption, implementation, and maintenance. our central hypothesis is that barriers and facilitators to cvrs implementation will vary across diverse primary care offices. we will use mixed methods including interviews, observations, and an innovative physician-pharmacist collaboration survey we developed to predict implementation of pharmacy-based services. the rationale for this proposed study is that overcoming barriers to implementation of a novel strategy to improve secondary prevention of cvd will lead to innovative strategies for broader adoption by health systems throughout the us.

Eligibility criteria:
inclusion criteria: * patient subjects: * english or spanish speaking * seen in the clinic at least once in the previous 12 months * currently has one of the following diseases: 1. diabetes with ha1c 9.0% or greater and/or 2. hypertension (uncomplicated) with systolic blood pressure 150 mm hg or greater exclusion criteria: * inability to give consent * nursing home residence * no telephone * additional patient subject exclusions: * cancer with a life expectancy less than 24 months * pregnancy * diagnosis of dementia * plans to terminate care from the clinic within 24 months
assessing functional capacity in directly and remotely monitored home-based settings: a protocol for a multinational validation study in individuals with chronic respiratory diseases

Conditions: COPD Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease

Summary: the goal of this validation study is to provide further evidence of the metrological properties of the 6-minute stepper test in individuals with chronic obstructive pulmonary disease (copd) or interstitial lung disease (ild). the main questions it aims to answer are: 1. is the 6-minute stepper test valid when compared to the 6-minute walk test and a maximal cardiopulmonary cycling test? 2. does the 6-minute stepper test give the same results when conducted through direct (i.e., therapist in person) and remote (i.e., videoconferencing) monitoring? 3. is the 6-minute stepper test safe when conducted at the home of the individual with direct (i.e., therapist in person) or remote (i.e., videoconferencing) monitoring? participants will: * conduct the 6-minute stepper test (several trials on separate days) * conduct the 6-minute walk test (1 trial on 1 day) * conduct a maximal cardiopulmonary test on a cycle ergometer (1 trial on 1 day) * participate in a semi-structured interview to provide their feedback with regards to the 6-minute stepper test


Eligibility criteria:
inclusion criteria: * adult ≥ 40 years old * diagnosis of chronic obstructive pulmonary disease (golda 2 to 4) or of interstitial lung disease (\&gt; 6 months) * clinically stable for ≥ 4 weeks exclusion criteria: * interstitial lung disease associated with connective tissue disease and sarcoidosis (often accompanied with multisystemic effects) * unstable or severe cardiac condition * invalidating rheumatologic or neurologic condition * weight exceeding maximal limits of exercise equipment (e.g., 130 kg for the stepper) * any other physical condition limiting or contraindicating exercise testing * simultaneous participation in another study requiring changes in medication * recent pulmonary rehabilitation (≤1 year, potential learning bias for the 6-minute walk test and the 6-minute stepper test) * for arm 1 only: use of oxygen therapy (unable to perform gas analysis with oxygen therapy) * for arm 2 only: participation in arm 1

Keywords: chronic obstructive pulmonary disease exercise capacity test interstitial lung diseases physiotherapy rehabilitation telerehabilitation validation study stepper test
muscle status to oral nutritional supplementation in hemodialysis patients with protein energy wasting

Conditions: Muscle Wasting; End Stage Renal Disease on Dialysis

Summary: this multi-centred randomized, open label-controlled trial consists of hemodialysis (hd) patients identified with protein energy wasting (pew) using the international society of renal nutrition and metabolism criteria. intervention provided was oral nutritional supplementation (ons) for 6 months and changes in muscle status in response toward the treatment was measured using ultrasound imaging method pre- and post-intervention.

this study is a multi-centred randomized, open label-controlled trial where a total of 54 hd patients (29 intervention; 27 control) with pew were recruited from government, private and non-governmental organization settings. patients were randomized to either the intervention or control group. the intervention group received ons (475 kcal and 21.7 g of protein), daily for 6 months. both intervention and control group received standard nutritional counseling during the study period. patients who consented were subjected to a screening for identification of pew and other eligibility criteria. patients who fulfilled the inclusion criteria were randomized to either control or intervention group. during the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline, 3rd months and 6th months for changes in muscle status using ultrasound imaging and bio-impedance spectroscopy method, malnutrition inflammation complex syndrome using malnutrition-inflammation score, and other measures indicative of nutritional status including anthropometry, biochemistry, dietary intake and quality of life assessment. these parameters were compared at baseline and 6 months for within and between group differences using general linear model test.

Eligibility criteria:
inclusion criteria: * hd patients receiving standard dialysis treatment (3 sessions per week, 4 hours per session) for \>3 months * aged between 18 to 70 years old * diagnosed with pew using the isrnm criteria exclusion criteria: * history of poor adherence to hd treatment * prolonged hospitalization or surgery in the past 3 months prior to recruitment * diagnosed with inflammatory diseases or malignancy * vegetarian * regular intake of ons

Keywords: hemodialysis protein energy wasting oral nutritional supplementation ultrasound imaging
prostate cancer evaluation of targets in genito urinary screening program

Conditions: Metastatic Castration Resistant Prostate Cancer Patients

Summary: toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells.


Eligibility criteria:
inclusion criteria: * prostate cancer patients * castration resistant * prostatic tissue available * metastasis which may be biopsied exclusion criteria:
metabolic interventions to resolve non-alcoholic steatohepatitis (nash) with fibrosis (mirna)

Conditions: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis With Liver Fibrosis

Summary: the study aims to evaluate two, orally administered, investigational agents - pf-06865571 (dgat2 inhibitor) and the coadministration of pf-06865571 with pf-05221304 (acc inhibitor). this study is specifically designed to evaluate the effect of a range of doses of dgat2i alone, and dgat2i + acci, on resolution of nash or improvement in liver fibrosis, as assessed histologically (via liver biopsy).


Eligibility criteria:
inclusion criteria: * biopsy proven nash with either f2 or f3 fibrosis, per nash crn definition * bmi \>/= 22.5kg/m2 exclusion criteria: * evidence of other causes of liver disease such as alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis * any condition possibly affecting drug absorption -unstable concomitant medical conditions, based on medical history or screening laboratory results including- * unstable liver function tests, recent cardiovascular event(s) significant malignancies,
high-tech acupuncture for treatment of chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome

Summary: 1. to study the relationship between chronic fatigue syndrome (cfs) and heart rate (hr) and its variability (hrv). 2. to compare the curative effects and the hr/hrv indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).


Eligibility criteria:
inclusion criteria: 1. the patients meeting criteria of cfs; 2. aged from 18-65; 3. with no skin lesions for the acupuncture area; 4. sign on the informed consent form; exclusion criteria: 1. patients who can't accept and are afraid of acupuncture in the acupuncture group. 2. patients suffering from heart and cerebrovascular diseases, serious lung disease, diabetes, neurological diseases, or severe primary diseases such as those of liver, kidney and the hematopoietic system. 3. persons suffering from a mental disease, alzheimer's disease or cancer. 4. persons who have taken qi-reinforcing chinese herbal medicine in the week preceding the investigation. 5. pregnant women and nursing mothers. 6. persons suffering from thrombocytopenia and abnormalities of blood coagulation function. 7. persons with alcohol and drug abuse history.
ethical deliberation in the intensive care unit, impact of formalized multidisciplinary team meetings, a pilot study

Conditions: Ethics, Narrative

Summary: most patients who die in the intensive care unit do so after a withholding or withdrawing of life sustaining treatments (wwlst) decision. the implementation of formalized interdisciplinary team meetings for ethical deliberation in the icu may improve nurses participation in wwlst decisions. the investigators decided to implement such team meetings in their icu. at this occasion, the investigators will measure job satisfaction, job related frustration and ethical decision making climate climate.

most patients who die in the intensive care unit do so after a withholding or withdrawing of life sustaining treatments (wwlst) decision. because those decisions are value-laden, guidelines as well as french regulations recommend that they should involve not only medical doctors but also nurses. despite that, nurses' involvement remains incomplete. poor collaboration between doctors and nurses on ethical decisions is associated with job dissatisfaction, burnout and desire to quit. the implementation of formalized interdisciplinary team meetings for ethical deliberation in the icu may improve nurses participation in wwlst decisions. for those reasons the investigators decided to implement such team meetings in their icu. at this occasion, the investigators will measure job satisfaction, job related frustration and ethical decision making climate climate.

Eligibility criteria:
inclusion criteria: * all patients admitted in the icu exclusion criteria: * age below 18

Keywords: end of life decisions in the icu multidisciplinary team meetings ethical decision making climate nurses job satisfaction
combination study of urelumab and rituximab in patients with b-cell non-hodgkins lymphoma

Conditions: B-Cell Malignancies

Summary: the purpose of the study is to determine the safety, tolerability and maximum tolerated dose of urelumab in combination with rituximab in patients with b-cell non-hodgkins lymphoma

intervention model: dose escalation (part 1) of study= sequential design; dose expansion (part 2) of study= parallel design

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * clinical diagnosis of relapsed/refractory b-cell malignancies (b-non-hodgkins lymphoma (nhl)) per international workshop group (iwg) * progressed or refractory to at least 1 prior line of standard therapy * subjects in expansion cohorts are restricted to relapsed/refractory diffuse large b-cell lymphoma (dlbcl) or follicular lymphoma (fl) subjects who are either relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens * follicular lymphoma (fl) must have at least 1 lesion that can be biopsied at screening and on treatment * eastern cooperative oncology group (ecog) of 0 to 1 exclusion criteria: * active or progressing brain metastases * other concomitant malignancies (with some exceptions per protocol) * active or history of autoimmune disease * positive test for human immunodeficiency virus (hiv) 1\&2 or known acquired immune deficiency syndrome (aids) * history of any hepatitis (a, b or c) * history of grade 3-4 drug-related hepatitis * known current drug or alcohol abuse * active tuberculosis (tb) * prior therapy with any antibody/drug that targets the t cell coregulatory proteins, including but not limited to, anti-cd137, anti cytotoxic t lymphocyte-associated antigen 4 (anti-ctla4) or anti-glucocorticoid-induced tumor necrosis factor receptor (anti-gitr). however, anti-programmed death-1 (anti-pd-1), anti-programmed death-ligand1 (anti-pd-l1) are permissible as prior therapy
repellents as added control measure to long lasting insecticidal nets

Conditions: Malaria

Summary: the scaling up of long lasting insecticidal nets (llin) and the expansion of indoor residual spraying (irs) has contributed to a significant decrease of malaria worldwide. however these control methods tackle only indoor and night biting vectors. the proportion of transmission occurring outdoors and before sleeping hours or so-called "residual transmission" is steadily increasing and may compromise the effort towards malaria elimination. the purpose of this study is to raise evidence on the effectiveness of mass use of topical repellents in addition to llins in controlling malaria infections. a multidisciplinary approach will be used to collect information on the most important factors that contribute to the successful reduction of "residual malaria transmission". in a first objective the epidemiological efficacy of repellents on prevalence of malaria carriers and malaria incidence will be assessed. to achieve this goal 98 communities will be randomly assigned to one of two treatment arms (llin and llin + repellent). within a community a cross sectional random sample of 65 people will be drawn at the beginning and the end of the malaria season to obtain an estimate of the malaria prevalence. the second objective will handle the entomological efficacy and persistence of the topical repellent on malaria vectors. and lastly the acceptability, adherence and adequacy of the topical repellents will be studied in a third objective.


Eligibility criteria:
inclusion criteria: * all household members volunteering from selected communities exclusion criteria: * infants less than 2 years

Keywords: outdoor malaria transmission anopheles topical repellent early biting vector long lasting insecticidal net (llin) cambodia
efficacy and safety of imvt-1402 in adult participants with primary sjogren's disease with moderate to severe systemic disease activity

Conditions: Primary Sjögren's Syndrome

Summary: this is a phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of imvt-1402 in adult participants with moderate to severe systemic primary sjogren's disease (sjd).

the primary objective is to evaluate the efficacy, safety, and tolerability of imvt-1402 compared to placebo, as measured by the change from baseline of clinical european league against rheumatism sjogren's syndrome disease activity index (cliniessdai) at week 24. the total duration of study participation is expected to be up to 57 weeks for an individual participant.

Eligibility criteria:
inclusion criteria: * participants with a diagnosis of primary sjd for at least 12 months prior to the screening visit and meet classification criteria for primary sjs according to the 2016 american college of rheumatology/ european league against rheumatism classification criteria for primary sjogren's syndrome at the time of screening. * participants with moderate to severe systemic disease activity as determined by a clinessdai total score ≥ 5 at the screening visit. * participants are seropositive for antibodies to sjogren's syndrome a (ssa)/anti-sjogren's syndrome a (ro) at the screening visit. * participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (ml/min) at the screening visit. additional inclusion criteria are defined in the protocol. exclusion criteria: * participants with a diagnosis of secondary sjd or an autoimmune disease other than primary sjd that constitutes the principal illness, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, pre-existing fibromyalgia or polymyositis, at the screening visit. * participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the screening visit. additional exclusion criteria are defined in the protocol.

Keywords: sjogren disease imvt-1402
ekiss: electronic kiosk intervention for safer-sex

Conditions: Reproductive Behavior; Contraception; Sexually Transmitted Diseases

Summary: this study is a randomized controlled trial to test acceptability, feasibility and preliminary efficacy of an interactive computer-based intervention with individualized feedback to promote sexual health in adolescents and young adults with assessment of behavioral and biomarker outcomes.

this study is a randomized controlled trial to test acceptability, feasibility and preliminary efficacy of an interactive computer-based intervention (icbi) with individualized feedback to promote sexual health in adolescents and young adults. the intervention uses physician avatars and uses elements of motivational interviewing to elicit sexual risk behaviors and motivation to change risky behavior. feedback includes instructive video modules. participants were asked to identify one behavior to change and were reassessed at 3-month follow-up for interim sexual behavior including condom and birth control use. participants were tested for chlamydia, gonorrhea, and pregnancy(females) at baseline and 3-month follow-up.

Eligibility criteria:
inclusion criteria: * english speaking and reading * report at least one episode of unprotected vaginal sex (no condom or no birth control) in the last 2 months * not currently pregnant or actively seeking pregnancy in self or partner exclusion criteria: * currently pregnant or actively seeking pregnancy in self or partner

Keywords: reproductive health, condoms, sexually transmitted diseases, contraception
study of the evaluation of patient education efficacy in pharmacy of national taiwan university hospital

Conditions: Infection

Summary: the primary purpose of this study is to evaluate the patient education efficacy of the pharmacists in national taiwan university hospital. we randomize patient family into one of the following three groups: 1. to read the package insert of the drug 2. to read the education information provided by pharmacy of ntuh 3. oral education provided by the pharmacist then we will evaluate the difference on patient knowledge of reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form between these three groups.

the primary purpose of this study is to evaluate the patient education efficacy of the pharmacists in national taiwan university hospital. we designed twelve questions about reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form in a questionnaire. we will recruit pediatric patients who are prescribed one of the two oral antibiotics powder for suspension, augmentin and zithromax. we will randomize the family of these patients into one of the following three groups: 1. to read the package insert of the drug 2. to read the education information provided by pharmacy of ntuh 3. oral education provided by the pharmacist then we will ask them the twelve questions in the questionnaire and record their answer. eventually, we will be able to compare the number of the correct answer, and to evaluate the difference on patient knowledge of reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form between these three groups.

Eligibility criteria:
inclusion criteria: * family of pediatric patient who is prescribed one of the two oral antibiotics granule for suspension, augmentin and zithromax, in ntuh exclusion criteria: * family of pediatric patient who can not read chinese

Keywords: pediatrics antibiotics patient education
ct follow-up of the simmetry sacroiliac joint fusion system

Conditions: Sacroiliitis

Summary: this study will evaluate long-term follow-up of subjects implanted with the simmetry sacroiliac (si) joint fusion system (simmetry).


Eligibility criteria:
inclusion criteria: * patient must have a simmetry device implanted. * patient is willing to comply with study procedures and provide informed consent. exclusion criteria: * patient is physically unable to return to the clinic for ct imaging.

Keywords: si joint fusion si joint pain si joint si joint treatment si joint disease sacroiliac joint simmetry
a u.s. registry of eosinophilic esophagitis adolescent and adult patients treated with dupixent® as standard of care

Conditions: Eosinophilic Esophagitis (EoE)

Summary: this observational research study is to better understand patients with eosinophilic esophagitis (eoe) who have recently been prescribed dupixent® (dupilumab). the purpose of this research study is to look at how dupixent is used in normal care of patients with eoe. possible benefits to others include a better understanding of eoe and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward. patient questionnaires will measure the following: * how eoe makes one feel * eoe symptoms * how eoe affects quality-of-life * how eoe impacts aspects of daily life * how difficult it is to swallow * how eoe symptoms have changed throughout the study


Eligibility criteria:
key inclusion criteria: 1. initiating treatment with dupixent® for eoe according to the uspi 2. able to understand and complete registry-related questionnaires (including adolescents) key exclusion criteria: 1. patients who have a contraindication to dupixent® according to the uspi 2. treatment with dupixent® within the 6 months prior to the screening assessment 3. participation in an ongoing interventional study on or within 6 months of the baseline assessment. once enrolled in registry, participation is allowed in other ongoing studies (at the discretion of the registry investigator) note: other protocol defined inclusion/exclusion criteria apply