Kornimate/medical-research-clean huggingface dataset:
asthma and obesity: pilot study

Conditions: Asthma; Obesity

Summary: develop and pilot test four theory-based educational modules that integrate counseling for asthma and obesity to promote greater physical activity among people with asthma.

of the 400 obese and non-obese adult asthmatics in new york city and denver during the 18-month observational phase of this study, the study team will randomize 80 participants (40 in nyc and 40 in denver) into a 4-week group session pilot study focused on beliefs and behaviors associated with asthma and obesity self-management behaviors (smb). eligibility will be determined based on asthma control questionnaire (acq) score and body mass index (bmi) at their 12-month visit. participants will be randomized into an intervention or an active control arm after completing their 18-month visit. participants will be consented into the pilot study during or after their 18-month visit. participants will be put into groups of 7-10 for the pilot. once formed, groups will have four 1-hour weekly visits. a person will be allowed to make up one missed session. the make-up session will be conducted on the phone or in-person depending on scheduling availability of both participant and care coach. participants will be given accelerometers at sessions 1 and 4 that they will be asked to wear for seven days and return along with an activity diary. a follow-up survey will be administered about 30 days after the last pilot session in order to reassess the patient's asthma, obesity, exercise and medication beliefs and their adherence to asthma smb. at the time of the follow-up survey, participants will also be given accelerometers that they will be asked to wear for seven days and return along with an activity diary.

Eligibility criteria:
inclusion criteria: * 21-64 years of age * bmi ≥ 30 * asthma diagnosis made by a health care provider * poor asthma control (acq score ≥ 0.75) * english speaking exclusion criteria: * bmi \< 30 * good asthma control (acq score \<0.75) * diagnosis of dementia * diagnosis of chronic obstructive pulmonary disease (copd) or other chronic respiratory illness * smoking history of ≥15 pack-years owing to possible undiagnosed copd

Keywords: asthma obesity self-management behaviors
dose escalation study in patients with relapsed or refractory dlbcl and myd88 l265p mutation

Conditions: Diffuse Large B Cell Lymphoma

Summary: recent reports have identified a specific oncogenic mutation l265p of the myd88 gene in approximately 30% of the patients with the activated b-cell (abc) type of diffuse large b cell lymphoma (dlbcl). myd88 is an initial adapter linker protein in the signaling pathway of the toll like receptors (tlrs), including the endosomal tlrs 7, 8, and 9, for which the ligands are nucleic acids. imo-8400 is an oligonucleotide specifically designed to inhibit ligand activation of tlrs 7,8, and 9. recent studies indicate that in the presence of l265p mutation ligand activation of those tlrs results in markedly increased signaling with subsequent increased cell activation, cell survival, and cell proliferation. the scientific rationale for assessing the use of imo-8400 to treat patients with dlbcl and the l265p mutation is based on laboratory observations that imo-8400 inhibits ligand-based activation of cells with the mutation and decreases the survival and proliferation of the cell populations responsible for the propagation of the disease.

eligible subjects will be enrolled and assigned to one of five dose cohorts. treatment will be administered by subcutaneous injection until progression or intolerable toxicity.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of diffuse large b cell lymphoma (dlbcl) of non-gcb subtype, established according to the world health organization (who) criteria that has been tested for the myd88 l265p mutation. * in addition to the above, key inclusion and exclusion criteria are listed below. 1. be at least 18 years of age 2. agree to use contraception exclusion criteria: 1. is nursing or pregnant 2. dlbcl of gcb subtype 3. has bmi \> 34.9 kg/m2 4. has a positive test for human immunodeficiency virus (hiv-1 or -2) hepatitis c virus (hcv) or hepatitis b surface antigen (hbsag) 5. receiving chronic systemic corticosteroid therapy \> 20 mg of prednisone daily 6. being treated with other anti-cancer therapies (approved or investigational) 7. has an active infection requiring systemic antibiotics 8. has had surgery requiring general anesthesia within 4 weeks of starting the study 9. has heart failure of class iii or iv

Keywords: dlbcl myd88 l265p lymphoma diffuse large b cell lymphoma idera imo 8400
effects of nevirapine on the steady state pharmacokinetics of fluconazole in hiv positive patients

Conditions: HIV Infections

Summary: the purpose of this study was to determine the effects of nevirapine on the steady state pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of nevirapine when given in combination with fluconazole.


Eligibility criteria:
inclusion criteria: * male or female patients between the ages of 18 and 65 years who are seropositive for hiv-1 antibody by an elisa test and confirmed by an alternative method, e.g. western blot * cd4 + cell count ≥ 100 cells/mm3 * patients who meet the following laboratory parameters * granulocyte count \> 1000 cells/mm3 * hemoglobin \> 9.0 g/dl (men and women) * platelet count \> 75,000 cells/mm3 * alkaline phosphatase \< 3.0 times the upper limit of normal * aspartame transaminase (ast) and alanine transaminase (alt) \< 3.0 times the upper limit of normal * total bilirubin \< 1.5 times the upper limit of normal * female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved from of barrier contraception * patients able to provide written informed consent and comply with study requirements exclusion criteria: * female patients who are pregnant or breast-feeding * seated systolic blood pressure below 100 mmhg, or greater than 160 mmhg, and/or heart rate less than 50 or greater than 100 beats/min * history of drug allergy or known drug hypersensitivity * patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication * patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 28 days of study entry (study day 1). such substances in these categories include: macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (e.g. itraconazole), rifabutin and phenytoin * patients requiring systemic treatment with cyp3a4 (cytochrome p450 3a4) substrates such as terfenadine, astemizole, cisapride, triazolam and midazolam during the course of the trial * use of protease inhibitors or non-nucleoside reverse transcriptase inhibitors within 28 days of study day 1 or during the trial * patients with a current history of intravenous drug abuse, alcohol or substance abuse (within the last year) * history of any clinically important disease including hepatic, renal, cardiovascular or gastrointestinal disease * patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
the prevalence of healthcare-associated infection in medical intensive care units in tunisia

Conditions: Cross Infection; Prevalence; Epidemiology; Critical Care

Summary: we aimed to determine the prevalence of hai in medical tunisian icus. secondary endpoints were to identify the predominant infecting microorganisms and evaluate independent risk factors of hais.

in tunisia, there is no national or regional monitoring system of hai. it is worth noting that hcais in intensive care unit (icu) are more common and life threatening than in general ward because of the frequent use of invasive procedures and multiple therapies. controlling this fatal scourge should begin with greater awareness of hai frequency and icu ecology. that is why conducting multi-center tunisian studies is necessary to guide control measurements against hai and to improve surveillance and infection-control practices. nosorea1 study (tunis med. 2018 oct-nov;96(10-11):731-736) was conducted in 2017 and showed that hai prevalence within tunisian icus was 25.2% ci 95% \[15-35\]. five years later, it is high time to update our finding.

Eligibility criteria:
inclusion criteria: * all patients occupying an icu bed over a 48-hour period * age \>=18 years exclusion criteria: * no criteria

Keywords: iatrogenic disease cross infection intensive care units prevalence risk factors critical care
cohort of patients with nsclc treated with nivolumab under the atu program

Conditions: Non-small Cell Lung Cancer; Nivolumab; Long-term Adverse Effects

Summary: our study sought to examine nivolumab efficacy and safety in advanced nsclc patients treated under the temporary authorization for use (atu, compassionate use) setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. the profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.

although the oncogene addiction concept has led to effective targeted treatments for certain histological non-small cell lung cancer (nsclc) types, most patients with advanced tumors are still treated with first-line chemotherapy. in 2015, several studiess demonstrated the efficacy of nivolumab, an immunotherapy targeting immune checkpoints. in france, besides the clinical trials, this molecule has been made available in january 2015 under a temporary authorization for use (atu, compassionate use). our study sought to examine nivolumab efficacy and safety in advanced nsclc patients treated under the atu setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. the profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.

Eligibility criteria:
inclusion criteria: * all patients with advanced nsclc, non-eligible for thoracic radiation therapy, having received nivolumab (at least one injection), under nominative or cohort atu, between 23-jan-2015 and 31-aug-2015 (end of atu). exclusion criteria: * patients included in a biomedical research trial with nivolumab * patients \<18 years old * patients included under atu to receive nivolumab administration, but never did * patients with a psychiatric history that hinders the comprehension of the information leaflet * patients refusing their data being collected

Keywords: nivolumab real-world study ifct
re-engaging patients with hepatitis c into care

Conditions: Hepatitis C, Chronic

Summary: aims: to evaluate the impact of a letter, phone call and incentive in re-engaging patients with hepatitis c care. outcomes of interest: primary outcome of interest: - attendance for assessment of liver disease within 4 months of being sent invitation letter. secondary outcomes of interest: - commencing treatment within 6 months of being sent invitation letter. methods: patient identification: the local copy of the scottish hepatitis c database holds data regarding patients referred to secondary care for treatment of their hepatitis c, and holds ethics approval for research on treatment and patient outcomes. this will be used to identify patients with hepatitis c infection that is untreated, treatment has been unsuccessful, or the patient has been treated but the outcome is unknown (due to non attendance for blood tests). the database has been cross checked with virus lab results, to ensure infection status is up to date. finally, the patient data has been checked by nhs gg\&c information team, to exclude patients who are deceased, or whom are no longer resident in nhs greater glasgow and clyde based on updated details obtained from scistore. inclusion criteria: patients (16 years and over) who have previously engaged with hepatitis c services in glasgow but who are either untreated, have been treated unsuccessfully, or have been treated but have not attended for blood tests to check for treatment success. exclusion criteria: patients with hiv. patients no longer resident within nhs greater glasgow and clyde area. allocation to contact groups: patients will be randomly distributed into 3 groups: 1. letter: will be sent letter 1 (appendix) 2. letter plus telephone call: will be sent letter 2 (appendix) and be followed up with a telephone call from the treatment centre if no contact has been received after 4 weeks 3. letter plus incentive: will be sent letter 3 (appendix) process: patient letters will be sent out by gg\&c public health. for all 3 groups the letter will be sent with the small hepatitis c scotland booklet "hepatitis c treatments have changed". letters will identify include the telephone number for the identified treatment centre which will be either, the last known treatment centre or a more local treatment centre were appropriate based on current residence. primary and secondary outcomes measures will be collected via the scottish hepatitis c database. lay summary: this study will test whether a letter alone, a letter plus follow up phone call or a letter with offer of incentive, will be most effective in re-engaging patients who are known to have hepatitis c but not yet received treatment.


Eligibility criteria:
inclusion criteria: * age 16 years or older * known hepatitis c infection which is either: * untreated * treated but the outcome of treatment unknown exclusion criteria: * known hiv infection * no longer resident within nhs greater glasgow and clyde area
an observational pilot study to test a smartwatch-based ema method during exercise with breast cancer survivors

Conditions: Breast Cancer

Summary: the goal of this pilot study is to evaluate the feasibility and acceptability of collecting ecological momentary assessment data regarding feeling states during physical activity among a cohort of breast cancer survivors, using a novel smartwatch app created by the study team called "phitbit."


Eligibility criteria:
inclusion criteria: * within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for stage 0-iii breast cancer. * own an android or iphone smartphone and willing to use the smartphone to complete app-based surveys during the assessment period. * willing to wear the actigraph monitor during the assessment period. * willing to wear the study issued fitbit versa 3 smartwatch during the assessment period. * access to internet to complete redcap survey assessments. exclusion criteria: * non-english speaking/not able to read english. * evidence of major contraindications for exercise per the 2020 physical activity readiness-questionnaire (par-q)+. * currently pregnant. * history of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium). * evidence of moderate-severe depressive symptoms (indicated by a score ≥ 10 on patient health questionnaire-8). -evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6- item cognitive screener). * evidence of clinically significant substance use as indicated by a score of ≥ 2 on the cage-aid screener.
a pilot investigational study: treatment of anxiety with non-needle electro-acupuncture

Conditions: Anxiety, Mild to Moderate

Summary: the purpose of this study is to determine the effects of non-needle electro-acupuncture on mild to moderate anxiety. the hypothesis is that this style of treatment will reduce state anxiety and not trait anxiety as measured by the spielberger stai test.

persistent and unrelenting stress is defined as anxiety. anxiety disorders are among the most common mental disorders in society. the nih estimates that nearly 200 million americans suffer from anxiety. anxiety disorders are associated with a lower quality of life, functional impairment and disability, and are also associated with co-morbid physical illness. acupuncture, one form of complementary and alternative medicine, has been used to treat anxiety. non-needle acupuncture is one of the safest methods, with none to rare side effects. this method has been studied in china (han 1986) and america (ulett 1998) pre-intervention testing, then three treatments within one week, will be followed by post intervention testing.

Eligibility criteria:
inclusion criteria: normally healthy persons with mild to moderate anxiety - exclusion criteria: severe anxiety, depression, pregnancy, and previous experience with hans non-needle electro-acupuncture treatment -
complex decongestive applications in patients with lipedema

Conditions: Lipedema

Summary: lipedema is a rare condition which almost exclusively affects women. the disease is characterized with bilateral, symmetric abnormal accumulation of subcutaneous fat and is often mistaken for simple obesity. in most patients, the hips, buttocks, thighs, knees, and lower legs are affected. upper extremity involvement has been reported to be present in 80% patients. the hands and feet are never affected. the accumulation of subcutaneous fat and edema results in tenderness, sensitivity to touch and pressure and also pain. patients also tend to bruise easily even after a minimal trauma. it has been reported that the complaint of pain increases with aging.there is no known cure for lipedema. however, conservative treatment with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy is used worldwide as a standard treatment regimen . the aim of this study is to investigate the effect of complex decongestive applications on lower extremity limb circumference and volume in patients with lipedema.

all participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy each patient received; 1. 45 minutes of manual lymph drainage on both lower extremities, 2. moisturisation of the lower extremities, 3. bandage application alongside this routine, the patients were advised to exercise (walk) regularly every day. this treatment routine was continued until the patients were discharged from the clinic.

Eligibility criteria:
inclusion criteria: * being willing to participate in the study * being 18-65 years old * having a diagnosis of lower extremity lipedema exclusion criteria: - having edematous disease in the lower extremity such as lymphedema or chronic venous insufficiency

Keywords: lipedema manual lymph drainage complex decongestive physiotherapy
impact of tomotherapy on xerostomia and quality of life of patients with cancer of the upper aero-digestive tract

Conditions: Head and Neck Cancer; Radiotherapy by Tomotherapy Exclusive; With or Without Concurrent Chemotherapy

Summary: this is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.


Eligibility criteria:
inclusion criteria: * patient (e) old (e) over 18 years * patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven. * patient targeted for head and neck radiotherapy by tomotherapy exclusive with or without concurrent chemotherapy (containing platinum) * indication of head and neck radiotherapy bilateral * all of the tnm stage except metastatic * patient has signed informed consent for participation in the study * mastery of the french language exclusion criteria: * history of head and neck radiotherapy * indication of head and neck radiotherapy unilateral * personal history of malignant tumors uncontrolled over the past 5 years * history of oral sicca syndrome * surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland) * concomitant treatment with amifostine * concomitant treatment with cetuximab * primary tumor of the salivary glands * head and neck hyperfractionated radiotherapy and / or accelerated * head and neck radiotherapy hypofractionated * metastatic disease * patient deprived of liberty, under guardianship * any medical condition or psychological associate that could compromise the patient's ability to participate in the study * refusal of the patient.

Keywords: tomotherapy xerostomy head and neck squamous cell carcinoma
ventricular tachycardia in ischemic cardiomyopathy; a combined endo-epicardial ablation within the first procedure versus a stepwise approach

Conditions: Ventricular Tachycardia; Ischemic Cardiomyopathy

Summary: rationale: nowadays ventricular tachycardia (vt) ablation in structural heart disease is performed primarily by early referral; while at the same time we still struggle with the limited longterm ablation success of endocardial vt ablation. an underestimated number of vts from ischemic substrate have an epicardial exit. however, one cannot accurately predict who is in need of epicardial ablation. the investigators hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up. objective: to show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on vt recurrence. study design: multicenter prospective open randomized controlled trial. study population: all patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation. intervention: one group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach. main study parameters/endpoints: the main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator (icd) interrogation - between the two ablation groups; secondary endpoints are procedure success and safety.


Eligibility criteria:
inclusion criteria: 1. clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers 2. history of ischemic heart disease 3. icd carrier or icd implantation planned after the ablation 4. informed written consent exclusion criteria: 1. current unstable angina as defined by current european guidelines 2. ami \< 30 days or in case of incessant vt \< 14 days 3. absence of visualisation of the coronary anatomy (coronary angiogram /ct-angiogram) 4. significant coronary stenosis approachable and clinically relevant for intervention 5. presence of a mobile left ventricle thrombus seen on (contrast) echocardiography or mri 6. previous pericarditis 7. presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions 8. previous thoracic radiation therapy 9. contra-indication for general anaesthesia 10. age below 18 years

Keywords: epicardial catheter ablation