Kornimate/medical-research-clean huggingface dataset:
accelerated resolution therapy for complicated grief

Conditions: Grief; Depressive Symptoms; Trauma, Psychological

Summary: this study will examine whether accelerated resolution therapy (art) is effective for the treatment of prolonged and complicated grief and associated psychological trauma among older adult hospice caregivers who have experienced the death of an immediate family member at least 12 months ago.

art is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers. mental health professionals are delivering art in clinical practice to assist with grief; however, there is a need for formal research evaluation of the effects of art on complicated grief and psychological distress.

Eligibility criteria:
inclusion criteria: * adult age 60 years of age or older * previous primary caregiver of immediate family member who died after enrollment in hospice with the death occurring at least 12 months prior to enrollment * current symptoms indicative of proposed diagnostic criteria for complicated grief disorder, as proposed by shear et al. (2011) * current score of \>25 on the 19-item inventory of complicated grief * current symptoms indicative of significant psychological trauma, as documented by score \>33on the 20-item dsm-5 ptsd checklist (pcl-5)26 or score \>4 on the pdsq ptsd subscale * denial of suicidal ideation or intent, with no evidence of psychotic behavior exclusion criteria: * engaged in another psychotherapy regimen that could also influence symptoms of pcg - - major psychiatric disorder (e.g. bipolar disorder) deemed likely to interfere with treatment delivery * current substance abuse dependence (alcohol and/or drug) treatment anticipated to interfere with treatment delivery.
efficacy and safety of subcutaneous secukinumab (ain457) for moderate to severe chronic plaque-type psoriasis assessing different doses and dose regimens

Conditions: Moderate to Severe Plaque-type Psoriasis

Summary: this study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.


Eligibility criteria:
inclusion criteria: * moderate and severe plaque-type psoriasis diagnosed for at least 6 months. severity of disease meeting all of the following three criteria: * pasi score of 12 or greater, * investigator's global assessment (iga) score of 3 or greater * total body surface area (bsa) affected of 10% or greater. * inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy. exclusion criteria: * current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate). * current drug-induced psoriasis. * previous use of secukinumab or any drug that targets il-17 or il-17 receptor. * significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject. * hematological abnormalities. * history of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis. * history of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years. * pregnant or nursing (lactating) women. * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: psoriasis plaque inflammatory skin disease scaly patches ain457 secukinumab moderate to severe plaque-type psoriasis
blood-flow restriction exercise following a knee replacement

Conditions: Knee Injuries; Knee Osteoarthritis; Knee Arthritis

Summary: this study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (b-free) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (tkr).

this study aims to determine the safety and efficacy of using b-free to overcome persistent quadriceps muscle weakness that occurs following a tkr. we hypothesize that b-free can provide a safe training stimulus and offer a home-based program to restore quadriceps muscle strength and improve functional mobility. specifically, subjects that have a tkr will perform b-free at home (light weights with resistance bands and walking) 3x/wk for 10 weeks. quadriceps muscle strength, balance, and functional mobility will be assessed before and after the program. changes in these variables will be compared to healthy age-matched uninjured controls.

Eligibility criteria:
inclusion criteria * 40-75 years of age * have had a unilateral tka \> 6 months prior to participation (arm 1) * no previous history of knee injury/surgery (arm 2) exclusion criteria * are a smoker * have diabetes * have suffered a heart attack or stroke * have any cardiopulmonary disorders (hypertension discussed below) * have been diagnosed with any neurological disorders * have any implanted devices such as but not limited to a pacemaker or pain pump * uncontrolled (not medicated) stage 1 hypertension or stage 2 hypertension
real-world data collection of the gore® viabahn® vbx balloon expandable endoprosthesis when used as a bridging stent with branched and fenestrated endografts in the treatment of aortic aneurysms involving the renal-mesenteric arteries

Conditions: Abdominal Aortic Aneurysm; Thoracic Aortic Aneurysm

Summary: multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of gore® viabahn® vbx balloon expandable endoprosthesis when used as a bridging stent with branched and fenestrated endografts in the treatment of aortic aneurysms involving the renal-mesenteric arteries.

up to 15 sites in europe will be required to enroll a minimum of 220 patients that have had treatment with gore® viabahn® vbx balloon expandable endoprosthesis when used as a bridging stent with branched and fenestrated endografts in the treatment of aortic aneurysms involving the renal-mesenteric arteries. the registry procedures consist of two phases, retrospective phase and prospective phase. the retrospective phase consists only of the collection of retrospective data (baseline, treatment and fu data) from the source documents available at the site from the time of the treatment until the enrollment date (icf signature). the prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. the fu data collected prospectively can change from subject to subject depending on the index procedure date. diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards.

Eligibility criteria:
inclusion criteria: 1. patients treated with the gore® viabahn® vbx balloon expandable endoprosthesis as a bridging stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair from 31 december 2021 until 01 january 2017 2. age ≥18 years at the time of implant 3. provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according to local regulations. exclusion criteria: 1. patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure 2. patient treated for acute or sub-acute dissection, \<90 days from onset of symptoms 3. patient treated using physician-modified endovascular grafts 4. patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan 5. at the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment 6. patient was pregnant at the time of treatment. 7. participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints. 8. patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.
icanquit smoking cessation among hispanic adults

Conditions: Cigarette Smoking-Related Carcinoma

Summary: this phase iii trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among hispanic adults who would like to quit smoking. the icanquit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.

outline: participants are randomized to 1 of 2 arms. arm i: participants receive access to the icanquit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. arm ii: participants receive access to the icanquit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. participants also receive nrt patch(es) and gum or lozenges to use per the usage instructions tailored to the participants' baseline smoking levels. in addition, participants receive daily push notifications with nrt dosage and refill reminders for 12 months. after completion of study intervention, patients may be followed up at 12 months.

Eligibility criteria:
inclusion criteria: * self-identify as hispanic ethnicity * age 18 and older * smoking at least one cigarette per day in the past 30 days * want to quit smoking within 30 days * interest in learning skills to quit smoking * willing to be randomly assigned * united states (us) or puerto rico (pr) residency for the next twelve months * have daily access to their own android or iphone smartphone * ability to download a smartphone application (app) * proficiency in english or spanish * not currently (i.e., within past 30 days) using other smoking cessation interventions * willing to consider using nrt * no previous use of icanquit * no household or family member participating * willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups * providing email, phone number(s), and mailing address exclusion criteria: * nrt contraindication: heart attack in the last 2 months * nrt contraindication: stroke in the last 6 months * nrt contraindication: diagnosed arrhythmia or tachycardia * nrt contraindication: uncontrolled hypertension * nrt contraindication: currently using warfarin * nrt contraindication: pregnant or breastfeeding, or plans to become pregnant during the next 6 months
pilot study of the comparison of the upper airway dynamics of oronasal vs nasal masks with pap treatment

Conditions: Obstructive Sleep Apnea (OSA)

Summary: our group has recently found that the choice of positive airway pressure mask can significantly affect the pressure required to adequately treat sleep disordered breathing. the goal of this study is to visualize the upper airway in the retropalatal and retroglossal region while using both oronasal and nasal masks with cpap in order to investigate differences in upper airway dynamics that may occur between these two mask types.

it is known that oronasal masks are not as effective at opening the upper airway compared to nasal only continuous positive airway pressure (cpap) masks in patients with sleep-disordered breathing. however, the physiological mechanism for this difference in efficacy is not known; although, it has been hypothesized to involve the retroglossal and/or retropalatal region of the upper airway. the objective of this study was to investigate differences in retroglossal and retropalatal anterior-posterior space with the use of oronasal vs. nasal cpap masks using real-time cine magnetic resonance imaging (cmri).

Eligibility criteria:
inclusion criteria: * ahi\> 30/hr * 18-75 years of age exclusion criteria: * history of claustrophobia * history of pacemaker, nerve stimulator, or any other metal implanted device
specific blockage of angiotensine 2 and podocyturia in glomerular nephropathies with hypertension and proteinuria

Conditions: Proteinuria; Hypertension; End Stage Renal Disease

Summary: chronic glomerular diseases are one of the main causes leading to end stage renal disease (esrd). hypertension and proteinuria are two modifiable factors promoting the progression of esrd. podocyte are terminally differentiated epithelial cells and play a central role in the progression of chronic kidney disease and in the development of glomerulosclerosis. the presence of podocyte in urines (podocyturia) has been documented by several teams with continuous and regular podocyturia during glomerular disease. this facts suggests that podocyturia could become a marker of podocyte loss and glomerular damage. in our university hospital, we developed a technique to evaluate the number of microparticles (cellular fragments) in different biologic samples. the podocytary origin of microparticles will be determinated thanks to specific antibodies. the aim of the present study is: i) to quantify podocyturia during glomerular nephropathies by dosing podocyte microparticles ii) to study the relationship between podocyturia and other biologic markers such as proteinuria iii) to evaluate the effect of angiotensine 2 blockage on podocyturia. this is an open-labelled randomized monocenter cross-over study. twenty subjects with hypertension and glomerular nephropathy characterized by proteinuria and a normal or slightly altered renal function will be included. patients will be treated successively by an angiotensin receptor blocker (arb), losartan and by a thiazide, hydrochlorothiazide, (after a wash out period). we will study the impact of these two therapies on podocyturia. results will be compared with others markers like proteinuria (and its selectivity). we may finally dispose of a non invasive urinary marker of podocyte lesions responsible for glomerulosclerosis and for esrd progression. moreover mechanism of nephroprotection of the arb may be more comprehensive.


Eligibility criteria:
* hypertension (tas \> 130, tad \> 80mmhg or under antihypertensive treatment) * glomerular nephropathy, proteinuria \> 1 g/day, serum creatinin \< 200 µmol/l ; * informed consent given ; * no contraindication for arb and hydrochlorothiazide ; * efficient contraception for women

Keywords: podocyte - podocyturia - microparticles - angiotensin receptor antagonist - glomerulosclerosis patients presenting with stable glomerular nephropathy with proteinuria, normal or slightly altered renal function, with hypertension
adherence in upper extremity home-based rehabilitation

Conditions: Stroke

Summary: the objective of the proposal is to determine the feasibility of implementing ecological momentary assessment (ema) and motivational interviewing (mi) methods to enhance adherence for a 4-week self-initiated arm training protocol. a non-randomized feasibility study using a 4-week ue training protocol will be conducted in 15 individuals within the first 12 months post-stroke living in the community. ema data will be collected using a mobile app to automate real-time collection of adherence data on a daily basis. mi will be used to produce self-generated training plans (training goals, training schedule), guided by the therapist before the start of training.

using a mixed methods design, the study will collect quantitative data before, during, and after training. qualitative data will be collected after the training period and analyzed to explain the quantitative findings in depth, within the context of everyday life. study aim 1 is to evaluate the feasibility of using ema to measure adherence and of applying the mi approach. quantitative data will include four indicators of adherence and accuracy. interview responses will be used as qualitative data to elucidate participants' acceptance of the mi approach and feedback on using the ema app. study aim 2 is to explore to what extent ue outcomes change after the 4-week self-initiated home-based rehabilitation program. outcomes will include ue use in real-world environments and self-perceived changes in ue use.

Eligibility criteria:
inclusion criteria: * adults (\> 18 years old) diagnosed with stroke at least 6 months ago at the time of screening * living in the community * have presence of ue motor impairment on the affected side (fugl-meyer assessment scores \< 66) * availability of mobile technology (tablet or smartphone) with internet connection to use phone app and zoom videochat) * be medically stable * able to provide written consent exclusion criteria: * currently receiving active occupational or physical therapy for the treatment of the affected ue * presence of severe cognitive impairment (mini mental status exam \<24) * self-reported moderate to severe pain of the affected ue with use * presence of unilateral spatial neglect (star cancellation task scores \< 44) * presence of neurological diagnosis other than stroke.

Keywords: stroke upper extremity motivational interviewing shared decision making ecological momentary assessments self-initiated training
effect of gut microbiota and fecal inflammatory marker on childhood gastroenteritis

Conditions: Clinical Infection; Microbial Colonization; Gastroenteritis; Inflammatory Response; Probiotics

Summary: childhood gastroenteritis establishes gastrointestinal disease and increase the economic burden, and the pediatric population is especially vulnerable to these gastrointestinal infections. the aim of this study is to evaluate the role of intestinal microbiota and their relationship with childhood gastroenteritis.

childhood gastroenteritis establishes gastrointestinal disease and increase the economic burden, and the pediatric population is especially vulnerable to these gastrointestinal infections. according to a world health organization report in 2003, the median incidence of diarrhea for all children age under 5 years was 3.2 episodes per child-year, and this number has not changed significantly since 1980s. in taiwan, the enteric pathogens associated mortality is low, but the social burden and economic costs are substantial because of the high incidence. intestinal microflora are able to use the substances consumed in the diet: bacteria can transform complex polysaccharides and monosaccharides in short-chain fatty acids. short-chain fatty acids are a source of energy for colonocytes and directly affect the storage of lipids and the absorption and metabolism of food, creating the so-called 'second meal effect'. qualitative and quantitative alterations of commensal flora may result in various gastrointestinal and extraintestinal diseases. one of the first interactions these bacteria have when interacting with the intestinal epithelial cells lining the gi tact. the first aim of this study is to evaluate the role of intestinal microbiota and their relationship with childhood gastroenteritis. the second aim of this study is determining the inflammatory markers (such as fecal tnf-α, interleukin -6, calprotectin, lactoferrin) on the host of childhood gastroenteritis. the investigators try to seek to gain an advanced understanding effect of intestinal microbiota and fecal inflammatory marker in the childhood gastroenteritis.

Eligibility criteria:
inclusion criteria: * children with or without diarrhea less than three days exclusion criteria: * diabetes * chronic liver disease
efficacy and safety of lectranal® in treatment of seasonal allergic rhinitis symptoms

Conditions: Seasonal Allergic Rhinitis

Summary: the purpose of the study is to determine weather lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

patients allergic to the specific pollen are divided into two groups randomly. one group is being administered lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. methods used for evaluation are: sars questionnaire(seasonal allergic rhinitis symptoms), mini rqlq (mini rhinoconjunctivitis quality of life questionnaire) skin prick test, specific ige and igg, eosinophilia in nasal secretion. methods used for follow up safety include side effects report, physical examination and vital signs.

Eligibility criteria:
inclusion criteria: * history of seasonal allergic rhinitis symptoms to pollen * positive skin prick test to pollen * negative history of seasonal allergic asthma * male or female older than 18 * female participants must use appropriate contraception * able to comply to study procedures exclusion criteria: * pregnancy * alcohol or drug abuse * subject receiving antihistamines , immunotherapy or on hyposensibilisation

Keywords: seasonal allergic rhinitis lectranal allergy
pacing of the atria in sick sinus syndrome trial preventive strategies for atrial fibrillation

Conditions: Sick Sinus Syndrome

Summary: the purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with sick sinus syndrome in order to avoid development of atrial fibrillation.

the incidence of atrial fibrillation (af) in sick sinus syndrome patients treated with pacing is quite high. as af can cause dizziness, fatigue, thromboembolism and ischemic stroke it is clinically relevant. due to earlier publications pacing modes and lead placement seem to influence the incidence of af. in this study the incidence of af will be compared between 4 different atrial lead positions: 1. free atrial wall 2. right atrial appendage 3. coronary sinus-os 4. dual site right atrial pacing: b) plus c). the following primary parameters will be evaluated during the study period of 2 years after implantation: 1. amounts of af episodes with a duration of \> 48 hours 2. amounts of af episodes with a duration of \> 30 minutes 3. consultations of physicians due to af secondarily, af burden, incidence of af in total, quality of life, implant duration and complications will be evaluated.

Eligibility criteria:
inclusion criteria: * sick sinus syndrome * symptomatic sinus bradycardia * symptomatic sa block * bradycardia-tachycardia-syndrom * binodal diseases, sinus node syndrome and high degree av-block * in case of antiarrhythmic drug therapy: patient must be on a stable dose for at least 3 months before enrollment exclusion criteria: * permanent atrial tachycardia that cannot be transferred into sinus rhythm by drugs or electric cardioversion * decompensated heart failure * dilatative cardiomyopathy with an ejection fraction \< 35% * hypertrophic obstructive cardiomyopathy * symptomatic hypo- or hyperthyreosis * myocardial infarction less than 6 months ago * planned cardiac surgery intervention * pregnant woman * patients under 18 years of age * patients involved in other studies * patients, already implanted with other (cardiac) leads * patients with reduced expectancy of life due to other diseases * patients who are not able to agree in participation of the study * patients, who cannot attend follow-up visits due to their place of residence

Keywords: cardiac pacing, artificial atrial fibrillation pacemaker leads lead positions