Kornimate/medical-research-clean huggingface dataset:
development of scalable new model(s) focused on care co-ordination and care provision for medically complex, co-morbid chronic disease patient segments focusing on heart failure

Conditions: Heart Failure

Summary: the goal is to define a set of clinical pathways for heart failure patients, reflecting the period from prior to admission to the post-discharge period following hospitalisation, under the current system that exists at the two clinical sites \[as mentioned previously, the main site is at st vincent's university hospital in dublin, but to ensure generalizability the project team will also carry out similar work portsmouth hospital, united kingdom\]. these pathways have been drawn up using the experience of the clinical investigators, using an interactive workshop approach and a pilot study. 1. pre-admission pathway 2. emergency department pathway 3. in-hospital management pathway 4. pre-discharge pathway 5. post-discharge pathway during identification of these pathways, the research team identified the settings/personnel that require study to more fully comprehend the methods, strengths and weaknesses of the present processes. study activities are focused on two aspects of the patient journey, immediately before discharge and three months post discharge during the outpatient phase.

heart failure is a significant public health issue with a prevalence of over 2%, and is among the leading causes of hospital admission worldwide, particularly in those over-65 years. patients with heart failure frequently require acute hospitalisation and are at increased risk of mortality (more than half of heart failure patients will die within five years of initial diagnosis, american heart association). the high hospital admission rate and readmission reduce quality of life and significantly drive up the costs of health care provision for these patients. moreover, there is a high variability in the reported readmission rates across institutions and countries, indicating that the structure of health care delivery is variable and of significant importance to outcome in this population. this study sets out to investigate the most clinically effective and cost- efficient method of delivering care to patients with heart failure focusing on the phase immediately before hospital admission, the hospital stay and the immediate discharge period, through analysis of the current standards of practice in both ireland and the united kingdom.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and above. * with or without an established community diagnosis of heart failure. * admitted to the hospital through the emergency department or directly to the cardiology wards, for management of a primary problem/complaint of acute decompensated heart failure. * able and willing to provide written, informed consent. exclusion criteria: * patients who present with primary non-heart failure presentation who may/may not have a secondary problem with heart failure, or stable heart failure not contributing to the present illness will be excluded. * also excluded will be those who cannot provide informed consent.
effects of a rehabilitation treatment on balance in pd evaluated with a stabilometric platform

Conditions: Parkinson Disease

Summary: pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in parkinson's disease, whereas previous reports of physical interventions have suggested promising results. the investigators want to study the effects of the multidisciplinary intensive rehabilitation treatment (mirt) on balance disorders in parkinson disease (pd).

pharmacotherapy with dopaminergic medications and deep brain stimulation cannot provide significant improvements in postural instability in parkinson's disease, whereas previous reports of physical interventions have suggested promising results. the investigators want to study the effects of our multidisciplinary intensive rehabilitation treatment (mirt) on balance disorders in pd. pd patients in stage 3 of hoen \& yahr will undergo clinical and instrumental evaluations at the beginning (t0) and at the end (t1) of the mirt. berg balance scale (bbs) will be performed to assess static and dynamic balance abilities. in order to determine some variables as index of postural stability, the investigators will use a stabilometric platform. with respect to the average centre of gravity the standard deviation (sd) of trunk sway will be calculated: total, in antero-posterior (ap) and in medio-lateral (ml) direction. the investigators can obtain a statokinesigram, that is the layout of a line connecting the successive positions of the center of pressure during the recording, and the area of the ellipse containing 90% of the sampled positions of the center of pressure. these measurements will be calculated with open eyes (oe), and while the patient was performing a cognitive task (open eyes counting \[oec\]).

Eligibility criteria:
inclusion criteria: * patients diagnosed with pd in stage 3 of hoen \& yahr according to the united kingdom brain bank criteria. exclusion criteria: atypical parkinsonisms, patients with osteoarticular and muscular pathologies, pd patients with mini mental state examination \< 26, patients with other disorders of balance.

Keywords: stabilometric platform rehabilitation balance disorders falls
dose escalation trial of nitroglycerin, 5-flourouracil and rad therapy for rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to determine whether topical nitroglycerin in addition to 5-flourouracil and radiation therapy are effective in the treatment of operable rectal cancer.

this is an open label, non-randomized, multi-cohort, dose escalation trial to evaluate the safety, tolerability, feasibility and maximum tolerated dose (mtd) of topical nitroglycerin in addition to 5-flourouracil and radiation therapy for neo-adjuvant treatment of, t3-t4 or clinically node positive, operable rectal cancer. patients that would otherwise be eligible for concurrent neo-adjuvant chemotherapy with continuous infusion 5-fu, for locally advanced operable rectal cancer, will be assigned to 4 sequential cohorts of 3 different dose levels of nitro glycerin patches (0.2; 0.4; and 0.6 mg/hr). each cohort will consist of 3 patients. all patients will receive radiation therapy, 45-50 gy in 25-28 fractions to the pelvis along with continuous infusion 5-fu 225mg/m2 for the duration of the radiation therapy. the radiation therapy will be planned and delivered as per institutional standard of care for the dallas vamc radiation oncology department.

Eligibility criteria:
inclusion criteria: * biopsy proven rectal adenocarcinoma * histological diagnosis of operable t3-4, or t1-4 node positive, m0 rectal adenocarcinoma using endorectal ultrasound and/or mri in addition to computed tomography (ct) of the chest, abdomen and pelvis for pre-study staging acceptable alternatives for systemic staging instead of ct chest , abdomen, pelvis are ct abdomen and pelvis plus a chest x-ray or a pet/ct * ability to give informed consent and willingness to adhere to study protocol * age ≥ 18 years and otherwise eligible to receive medical care at the dallas va medical center. * eastern cooperative oncology group (ecog) performance status of 0-2 * adequate hematological, hepatic and renal function defined as in protocol. exclusion criteria: * any condition that would hamper informed consent or ability to comply with the study protocol * significant history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, decompensated congestive-heart failure, myocardial infarction within the last six months or ventricular arrhythmias requiring medication. * pregnant and lactating women. * patients taking phosphodiesterase - 5 inhibitors (e.g. sildenafil, vardenafil or tadalafil) and is unable to stop for the duration of the chemoradiotherapy.

Keywords: nitroglycerin 5-flourouracil radiation therapy neo-adjuvant treatment
vahelva respimat regulatory post-marketing surveillance in korean patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to monitor the safety profile and effectiveness of vahelva respimat in korean patients with copd in a routine clinical practice setting

study design: regulatory pms study

Eligibility criteria:
inclusion criteria: * patients who have been started on vahelva respimat in accordance with the approved label in korea * age \>= 18 years at enrolment * patients who have signed on the data release consent form exclusion criteria: * patients with hypersensitivity to vahelva respimat or to any of the excipients. * patients with a history of hypersensitivity to atropine or its derivatives(e.g. ipratropium, oxitropium, glycopyrronium, clidinium, umeclidinium) * patients with asthma * current participation in other clinical trials
influence of an innovative telemetric smartphone application on re-hospitalization

Conditions: Paroxysmal Atrial Fibrillation

Summary: a randomized, open, mono-centric pilot study to investigate the influence of an innovative telemetric smartphone application on re-hospitalization and quality of life after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

the telemetric smartphone application includes a digitized medical record, a mobile ecg device and a 24-hour on call service by a cardiologist. the hypothesis is that the use of a telemetric smartphone application can reduce re-hospitalization in patients after cryoballoon pulmonary vein isolation. secondary endpoints are quality of life measurements, health care cost calculations and recurrences of atrial fibrillation after ablation. all patients will undergo ablation and will be randomized into two groups: 1) conventional follow up with outpatient visits 6 and 12 months after ablation compared to 2) a structured follow up with the smartphone application, a mobile ecg device (patients will be able to send in as many ecgs as wanted), up to three phone calls with a cardiologist (24-hour on call service) as well as outpatient visits 6 and 12 months after cryo-ablation.

Eligibility criteria:
inclusion criteria: * age \> 18 years * written informed consent * symptomatic paroxysmal atrial fibrillation (at least two episodes within 3 months prior to ablation) * cryoballoon pulmonary vein isolation * possession of a compatible smartphone exclusion criteria: * age \< 18 years * persistent or permanent atrial fibrillation (af) * prior catheter or surgical ablation of af * pregnant females * contraindication for oral anticoagulation * manifest hyper-/hypothyroidism * no intention to cooperate * alcoholism

Keywords: paroxysmal atrial fibrillation pulmonary vein isolation telemetry monitoring cryoballoon ablation
manual therapy dosage factorial study

Conditions: Whiplash Injuries

Summary: this study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology. subjects with acute whiplash associated disorders (wad) ii and iii with a symptom duration of less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive different doses of mobilization. the dosage treatment groups will differ in the number of sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks). a zero treatment/week option is included to insure that the impact of any mobilization is included and because previous studies suggest a single mobilization may have a treatment effect. all patient participants will receive a core standard treatment of education, advice to stay active, and neck/postural stretching and strengthening exercise. all patient participants will receive supervised exercise and advice for the full 12 weeks. all patients will be provided with an instructional cd and exercise brochure to reinforce the whole program. follow-up assessments will consist of quantitative sensory testing (vibration threshold; current perception threshold), the neck walk index (nwi), the upper cyclical reach and grasp task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography), range of motion, head flexion endurance, and self-report symptoms and disability (visual analogue scale; neck disability index; disabilities of the arm, shoulder, hand; pain threshold and tolerance algometry; and perceived self-efficacy; sf-36). hypothesis: during recovery, patient are expected to transition from an acute painful state to one where they can resume normal activity and add intensive strengthening exercises.


Eligibility criteria:
inclusion criteria: * acute whiplash associated disorders (wad) ii and iii (113) with a symptom duration of less than 30 days or subacute (30 to 90 days) * pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache * pain intensity must be at or above 30 mm on a 100 mm visual analogue scale * must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months. exclusion criteria: * arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy * conditions that make the provision of neck exercise unsafe

Keywords: wad ii wad iii mobilization dosage acute whiplash associated disorders (wad) ii and iii (113) with a symptom duration of less than 30 days neck pain
predictive questionnaires for risk of acute copd (chronic obstructive pulmonary disease) exacerbations

Conditions: COPD

Summary: copd patients frequently suffer intermittent exacerbations of their disease characterised by acute deterioration of symptoms. acute exacerbations of copd (aecopd) are associated with significant impairment of health status, use of health care resources, poor prognosis and increased mortality. the development of simple and practical predictive tools would help to identify copd patients at greater risk of suffering exacerbations, which is important since those patients would need more intense and early treatment. this one-year prospective cohort non-drug study will evaluate several copd-specific questionnaires as predictive tools and the presence of cardiovascular comorbidities as risk factors, for the composite events in study cohorts. the trial duration consists of a screening period (4-6 weeks) and a follow-up period (12 months), 4 visits in total along the study.


Eligibility criteria:
inclusion criteria: * signed informed consent * age ≥ 40 years * patients fulfilling criteria for copd according to the global initiative for chronic obstructive pulmonary disease (gold) stage i or higher * smokers or ex-smokers of at least 10 pack-years * patients suffering an aecopd either: 1. admitted to hospital due to aecopd (severe exacerbation) or 2. confirmed aecopd at gp (general practitioner) setting (moderate exacerbation) definition aecopd: increase in respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both. exclusion criteria: * patients who have never smoked * patients with active long-term respiratory disease (e.g. bronchial asthma, cystic fibrosis, severe bronchiectasis, malignancy, restrictive lung diseases etc.) * exacerbation of copd due to other causes such as pneumothorax and acute decompensated congestive heart failure * difficulties in communication (cognitive deterioration, sensorial disability, language barriers) * severe disease with poor vital prognosis (life length expectancy less than one year)

Keywords: copd
impact of virtual reality on pre-procedural anxiety prior to heart catheterization - vr-theia

Conditions: Preprocedure Anxiety

Summary: the primary aim of this study is to test the hypothesis that use of vr combined with standard procedural education will result in less pre-procedural anxiety than standard procedural education alone among patients undergoing first-time cardiac catheterization. the vr technology being evaluated in this study will allow patients to experience a 3-d simulation of certain aspects of their upcoming procedure prior to the actual procedure date.


Eligibility criteria:
inclusion criteria: * scheduled to undergo a left-heart catheterization procedure at the meijer heart center * 18-75 years of age * signed study consent form exclusion criteria: * history of cardiac procedure(s) in a cardiac catheterization laboratory * history of seizures, migraine headaches or severe susceptibility to motion sickness * currently taking psychotropic drugs or on long-term psychotropic treatment * unable to read and speak english * visually impaired * unable to provide written consent

Keywords: preprocedure anxiety cardiac catheterization
efficacy and safety of panitumumab combined with docetaxel and cisplatin as a first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma

Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Summary: the clinical hypothesis of this study is that the addition of panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma.


Eligibility criteria:
inclusion criteria: * written informed consent inclusion: * age ≥ 18 years * histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with advanced unresectable or metastatic disease. * measurable disease per the revised recist (response evaluation criteria in solid tumor) guidelines * ecog performance score of 0 - 2 * within seven days prior to initiating study treatment:haematology:neutrophils ≥ 1.5x109, platelets ≥ 100x10/ l, hemoglobin ≥ 9g/dl. hepatic functions: total bilirubin ≤ 1.5 time the upper normal limit (unl),asat ≤ 2.5xunl in absence of liver metastases, or ≤5xunl in presence of liver metastases,alat ≤ 2.5xunl in absence of liver metastases, or ≤5xunl in presence of liver metastases. renal function: creatinine clearance ≥50 ml/min. metabolic function: magnesium ≥ lower limit of normal, calcium ≥ lower limit of normal. exclusion criteria: * prior chemotherapy or other anticancer therapy for advanced unresectable or metastatic disease (1st line) * prior anti-egfr antibody therapy (e.g. cetuximab) or treatment with small molecule egfr inhibitors (e.g. erlotinib). * her2-positive tumor (centrally assessed) * past or current history (within the last 5 years prior to treatment start) of other malignancies except gastric cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible) * current or prior history of central nervous system metastases * evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study * known hypersensitivity to any of the study drugs * clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment * history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest ct scan. * subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. * subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
the effect of a brief intervention for problem gamblers

Conditions: Gambling Problem

Summary: a pragmatic randomized pilot trial primarily examining the feasibility of a brief therapist guided online self-help program based on cognitive behavioral therapy (cbt). participants will be randomized to either a treatment as usual condition (tau) or to tau plus cbt.

the current study is a pragmatic randomized pilot trial examining the feasibility and effects of a brief therapist guided online self-help program based on cognitive behavioral therapy (cbt) . participants will be randomized to either a treatment as usual condition (tau) or to tau plus cbt. participants will be recruited via the swedish national gambling helpline. after assessment for eligibility participants will be randomized, using block randomization to ensure balanced groups, to either tau or tau+cbt. the participants will be measured; at baseline, weekly during the intervention (6 weeks), immediately after the intervention and at 6 weeks after treatment termination. informed consent will be collected prior any data collection.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * experiencing gambling problems (pgsi ≥ 3 p) * good enough knowledge in swedish * access to a smart phone or computer with internet connection exclusion criteria: * being involved in another treatment study the previous 3 months * other concurrent treatment for gambling problems * being on a non-stable pharmacological treatment for any psychiatric condition * severe depression defined as a phq-9 score of 20 points or more
a research for combination of prostate health index (phi) and mpmri pi-rads in the diagnosis of prostate cancer

Conditions: Prostate Cancer

Summary: before prostate puncture, the patient's serum was collected for phi detection, and multi-parameter mri was performed to obtain the pi-rads score. the sensitivity and specificity of phi combined with pi-rads score in the diagnosis of clinically significant prostate cancer were explored.

this study is a multi-center prospective study. patients who meet the indications for prostate puncture and whose psa is in the gray area (4.0\~10.0 ng/ml) undergo standard prostate biopsy. the patient's serum was collected for phi detection before puncture, and multi-parameter mri was performed before puncture. to explore the sensitivity and specificity of phi combined with pi-rads score in the diagnosis of clinically meaningful prostate cancer. assess the benefit of combining phi and mpmri before biopsy compared with phi or mpmri alone. formulate clinical recommendations for phi and mpmri.

Eligibility criteria:
inclusion criteria: * patients with suspected prostate cancer * patients can perform standardized prostate biopsy exclusion criteria: * have a history of prostate cancer * use of drugs that affect psa before blood sampling
the effect of music on postoperative anxiety

Conditions: Anxiety Postoperative; Quality of Recovery

Summary: in this study, it is planned to learned the effect of listening to the music preferred by the patient on postoperative anxiety.

preoperative anxiety can be detected via structured and standardized screening by the state-trait anxiety inventory (stai) i and ii. 80 patients scheduled for total knee arthroplasty surgery for will be included in our study. preoperative stai i and ii score (anxiety questionnaire) will be applied to each patient. the patients will be divided into two groups as listening patient preferential music, and control. the patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones.secondary aim is to assess the effect of listening patient preferred music on quality of recovery, postoperative pain, mcid (minimal clinically important diffirence), patient and surgeon satisfaction.

Eligibility criteria:
inclusion criteria: * undergo total knee arthroplasty under spinal anesthesia exclusion criteria: * poor vision * significant hearing loss * dementia * active opioid use * regular use of anxiolytics or discontinuation of them on the day of surgery * unwillingness to participate in the study * unwillingness to listening to music