Kornimate/medical-research-clean huggingface dataset:
effects of combination medical therapy followed by bpa on right ventricular-pa coupling and hemodynamics in cteph

Conditions: CTEPH

Summary: the main goal of this study is to determine the effects of combination medical therapy (riociguat and macitentan) and balloon pulmonary angioplasty (bpa) on hemodynamics and right ventricular (rv) function (including advanced assessments of rv-pulmonary artery (pa) coupling from invasive hemodynamics) in participants with inoperable or post-pte residual cteph.

recent presented but unpublished results from trials of bpa vs riociguat for inoperable cteph (nct02634203) have demonstrated that bpa provides a more significant hemodynamic benefit than medical therapy. the investigators hypothesize that participants who are treated with upfront combination medical therapy followed by bpa will have significant improvements in their hemodynamics and rv-pa coupling that can be monitored over time.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. age ≥ 18 years' old 2. diagnosis of cteph 3. not a candidate for pte 4. candidate for bpa based on suitable anatomy and disease burden 5. treatment-naïve (no cteph or pulmonary arterial hypertension (pah)-specific medical therapies) with plans for initiation of cteph/pah-specific medical therapy and treatment with bpa. 6. willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed). exclusion criteria: * subjects presenting with any of the following will not be included in the trials: 1. moderate to severe heart disease (lvef \< 45% or severe lv hypertrophy) 2. sarcoidosis 3. active cancer 4. sickle cell anemia 5. liver disease (childs-pugh class c) 6. prisoners 7. pregnant, planning pregnancy or lactating 8. conditions that will prohibit mri scanning (metal in eye, claustrophobia, inability to lie supine) 9. contraindication to riociguat or macitentan 10. medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Keywords: inoperable post-pte
neurovascular reactions to aat in patients with doc

Conditions: Consciousness Disorder; Brain Injuries

Summary: there is practical evidence but no scientific investigations that persons with severe disorders of consciousness can profit from animal-assisted therapy regarding their level of awareness. the aim of this study is to investigate the effect of animal-assisted therapy on brain activity of inpatients at rehab basel with severe disorders of consciousness. to do so, the frontal brain activity of 20 the inpatients at rehab basel in a minimally conscious state is investigated via near-infrared spectroscopy (nirs). moreover, 20 healthy participants are included as control subjects.

each participant will be measured in 6 sessions. sessions take place three times a week for 2 weeks (leading up to a total of 3 experimental sessions and 3 control sessions), each lasting for about 15 minutes. each session consists of 5 phases, with an animal present in three of them. in the beginning, waiting (with no stimulus presented) serves as baseline measurement. second, an animal is watched, then the animal is placed on the patient's lap and in the fourth condition, the patient can stroke the animal with the help of the present therapist. after, there is again a waiting condition. control sessions are comparable sessions but with a fur pet instead of a live animal as stimulus. measurements are: brain activity (near-infrared spectroscopy, nirs), skin conductance (eda), heart rate and heart rate variability assessed via photoplethysmography (ppg) during the sessions and the bavesta score after each session. for further behavior analysis all sessions are videotaped.

Eligibility criteria:
inclusion criteria for patients: * informed consent as documented by signature (appendix informed consent form) * inpatients of rehab basel with severe disorder of consciousness: minimal conscious state defined via: glasgow coma scale (gcs) / coma recovery scale-revised (koma remissions skala, krs/krs-s) / bavesta score * minimum age of 18 years inclusion criteria for healthy participants: * informed consent as documented by signature (appendix informed consent form) * history of acquired brain-injury * minimum age of 18 years exclusion criteria: * enrolment of the investigator, his/her family members, employees and other dependent persons, * medical contraindications for contact with animals as allergy, phobia etc. * if the patient's medication changes radically during the time of data collection (only eligible for clinical participants)

Keywords: animal-assisted therapy
questionnaire study concerning artificial intelligence

Conditions: Gastro-Intestinal Disorders

Summary: this study aims to investigate the knowledge, experience, and opinion on ai among gastroenterology (gi) patients, gastroenterologists, and gi-fellows, particularly concerning implementation and application of ai (in assisting clinicians) in healthcare. the secondary aims are to investigate (dis)advantages of ai use in healthcare and the availability of technical facilities and infrastructures within endoscopy to implement and apply ai in dutch hospitals.

in recent years, important developments have been made in the field of artificial intelligence (ai). these developments have led to the large-scale application of ai in our everyday lives and ai-research within healthcare. a potentially promising application of ai lies in imaging analysis. for example, within gastroenterology this means the detection and classification of colorectal polyps and barrett's neoplasia, disease severity scoring of inflammatory bowel diseases, and differentiating pancreatic cancer from chronic pancreatitis. despite the investments in ai-research, there is a lack in knowledge concerning patients' and physicians' perspectives on ai in healthcare. this prospective questionnaire study investigates these perspectives, obtaining data from both gastroenterology (gi) patients and gi-physicians within the netherlands. the questionnaires focus on the knowledge, experience, and opinion of ai, particularly concerning the implementation of ai in (gastroenterology) healthcare. furthermore, the current (endoscopic) infrastructure within dutch hospitals will be investigated for its readnessy for ai.

Eligibility criteria:
inclusion criteria: * gastrointestinal (gi) patients with an outpatient appointment in the gastroenterology department for an endoscopic procedure in the context of the dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases (in one of the two participating hospitals); * gastroenterologists working in dutch hospitals; * gastroenterology fellows working in dutch hospitals; * minimal age of 18 years old. exclusion criteria: * no appropriate understanding of the dutch language; * not willing to sign informed consent; * objection to participate in medical scientific research, reported in the medical file.

Keywords: artificial intelligence patients' perspective physicians' perspective questionnaire
evaluating the accuracy of microvessel ultrasound imaging for detecting extent of disease in patients with angiosarcoma of the skin

Conditions: Skin Angiosarcoma

Summary: this study evaluates the accuracy of a new ultrasound technology called microvessel imaging for detecting the extent of disease among patients with angiosarcoma of the skin. microvessel ultrasound imaging uses high frequency waves to visualize vessels in the skin that are not easily seen using other imaging tests.

primary objective: i. to determine the accuracy of depicting extent of disease of cutaneous angiosarcoma before and after neoadjuvant treatment compared to clinical photographs, magnetic resonance imaging (mr) or positron emission tomography (pet)/computed tomography (ct) imaging and surgical pathology both on skin biopsies and surgical excision. outline: patients undergo microvessel ultrasound imaging on study.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * diagnosed with cutaneous angiosarcoma of the breast or scalp and scheduled for trimodality therapy * twenty one years of age or older exclusion criteria: * unwilling to consent to microvessel ultrasound imaging * younger than 21 years of age
clinical and radiographic evaluation of ultrasonic activated irrigation versus non activated irrigation in pulpectomy of necrotic primary molars : a randomized clinical trial

Conditions: Pulpectomy Agents

Summary: this is a clinical and radiographic evaluation of canal irrigation using ultrasonically activated vs. non-activated irrigants in pulpectomy of necrotic primary molars: a randomized clinical trial" this study aims to compare the effectiveness of using ultrasonically activated irrigant versus non-activated irrigant in terms of clinical and radiographic success rates in the pulpectomy of necrotic primary molars, through a randomized clinical trial.

primary teeth are considered of great importance to children allowing their normal, healthy development and growth while preserving function, eating, speech and normal development of occlusion while preserving the space for permanent dentition and guide their eruption. pulpectomy of primary molar teeth is considered as reasonable treatment approach to ensure either normal shedding or long term survival of 1ry teeth as fully functional component in dental arch. treatment of necrotic primary teeth is complex due to anatomical and physiological characteristics and high no. of bacterial species present in endodontic infection. treatment success depend on the elimination of root canal infection which can be done mechanically and chemically to ensure the complete removal of bacterial canal infection. irrigation is a key part of successful root canal treatment. it has several important functions, the most important one that it has a washing effect and an antimicrobial/antibiofilm effect. irrigation is also the only way to impact those areas of the root canal wall not touched by mechanical instrumentation. ultrasonic activation cause irrigant streaming and cavitation phenomena resulting in significantly improved debridement of canal spaces, disruption of biofilm and improved penetration of irrigant into dentinal tubules and reduces bacterial level improving prognosis and ability to seal. this study has been conducted by only few researchers, and there is limited evidence supporting the effect of ultrasonic activation on irrigation. so this study is conducted to compare the effect of ultrasonic activation of irrigation on success of pulpectomy versus that of non-activated irrigation

Eligibility criteria:
inclusion criteria: - clinical criteria: 1. children aged between 4 to 7 years' old 2. children with deep caries involving pulp in primary molars 3. history of abscess, swelling or pus 4. pain on percussion 5. mobility grade 1 radiographic criteria: 1. root resorption due to abscess less that ⅔ of root 2. periapical rl or furcation rl 3. widening in pdl space or loss of lamina dura continuity exclusion criteria: * clinical criteria: - 1. refusal of participation. 2. patient unable to attend to follow up 3. non-restorable tooth. 4. medically compromised patient. 5. uncooperative patient

Keywords: primary molars irrigation activation within the canal
the bronchiolitis follow-up intervention trial

Conditions: Bronchiolitis

Summary: this study evaluates the value of routine follow-up with a child's pediatrician after hospitalization for bronchiolitis. parents of half of participants will be instructed to follow-up with the child's pediatrician regardless of symptom resolution, while the other half will be instructed to follow-up on an as-needed basis (only if the child worsens, doesn't improve, or other concerns develop).

bronchiolitis is highly prevalent and burdensome among children less than 2 years of age. for this reason, many therapies have been tried by providers and studied by researchers. unfortunately, interventions have largely been shown to be ineffective, prompting campaigns to reduce use of ineffective therapies. one commonly prescribed but thus far unstudied intervention often provided to children discharged after hospitalization for bronchiolitis is routine follow up with their pediatrician. whether the costs and time spent for these visits are worthwhile depends on the extent to which the child and the child's parents benefit.

Eligibility criteria:
inclusion criteria: * children less than two years of age who are hospitalized with an attending physician diagnosis of bronchiolitis. exclusion criteria: * chronic lung disease * complex or hemodynamically significant heart disease * immunodeficiency * neuromuscular disease * discharged home with medication for withdrawal * inpatient team believes the child should follow up with their pcp

Keywords: office visits
performance of bioabsorbable vascular scaffolds (absorb) compared to xience stents - an optical coherence tomography study

Conditions: Bioresorbable Scaffolds

Summary: the biodegradable absorb scaffold is characterized by a greater strut thickness, but it has a greater flexibility compared to the xience stent. due to its fragility the inflating pressure of the absorb scaffold is limited and suitable lesions have to be well prepared. this study assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion and edge dissection after absorb implantation compared to the xience stent.


Eligibility criteria:
inclusion criteria for implanting an absorb scaffold: * age \< 55 years or * lesion length \> 24mm or * multiple lesions to be treated

Keywords: coronary vessels coronary stenosis percutaneous transluminal angioplasty stents drug-eluting stents bioresorbable scaffolds optical coherence tomography
effects of a rehabilitation program on immune activation and mood in heart failure patients

Conditions: Heart Failure; Depressive Symptoms

Summary: the aim of this descriptive study is to examine potential changes regarding inflammatory cytokine levels, depressive symptoms and quality of life over the course of the 4-week inpatient rehabilitation program which includes a cassette of modalities including counseling, psychosocial education and supervised exercise training as a main pillar, and to further investigate if there are correlations between changes in immune regulation, depressive symptoms and quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of heart failure with reduced ejection fraction (hfref) with an ef ≤ 45%, nyha (new york heart association) i - iii; acc/aha (american college of cariology/ american heart association) stage c, irrespective of etiology * clinically stable patients without deterioration or hospitalization due to heart failure within the last 4 weeks * neuro-hormonal medication according to the esc (european society of cardiology) guidelines for the treatment of chronic heart failure consisting of antagonists of the renin-angiotensin-aldosterone system (raas) and beta-blockers as indicated. * ability to fully understand all elements of and sign the written informed consent before initiation of the study exclusion criteria: * fluid retention of cardiac decompensation, necessitating i.v. diuretic therapy * myocardial infarction within the last 2 months * surgery including cardiovascular or valvular surgery within 3 months * uncontrolled proinflammatory comorbidities (e.g. diabetes mellitus hba1c \>9%, copd ( chronic obstructive pulmonary disease) \>ii, active rheumatic diseases and autoimmune disorders) * current infectious diseases ( e.g. pneumonia, copd exacerbations or urinary tract infections) * morbid obesity: bmi \> 40 * alcohol or drug abuse * psychiatric disorders
a study to evaluate the effect on body weight of leptin administered in conjunction with pramlintide in overweight and obese subjects

Conditions: Overweight; Obesity

Summary: this study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.


Eligibility criteria:
inclusion criteria: * is obese (body mass index \[bmi\]\>=30kg/m\^2 and \ =27kg/m\^2 and \ 102 cm if male, \*waist circumference \>88 cm if female * is a nonsmoker (has not smoked for at least 6 months prior to the study) * consumes a morning and evening meal each day exclusion criteria: * is diagnosed with type 2 diabetes * is currently enrolled or plans to enroll in a diet, weight loss, or exercise program with the specific intent of losing weight (subjects who have been following an exercise regimen resulting in stable weight maintenance for at least 2 months prior to enrollment are eligible for study inclusion) * has been treated over the past 2 months, is currently treated, or is expected to require or undergo treatment with any of the following medications: \*antiobesity agents (prescription or over-the-counter), \*antipsychotic agents, \*antiepileptic agents, \*antidepressant agents, \*drugs that directly affect gastrointestinal motility * has received any investigational drug within 30 days or within a period corresponding to 5 half-lives of that drug, whichever is greater, prior to this study starting * has previously received treatment with recombinant leptin or pramlintide

Keywords: overweight obesity pramlintide leptin amylin
a microdose evaluation study of aby-029 in recurrent glioma

Conditions: Glioma

Summary: the primary study objective is to determine if microdoses of aby-029 lead to detectable signals in sampled tissues with an egfr pathology score ≥ 1 based on histological staining. the secondary study objective is to assess diagnostic accuracy of aby-029 detection by ifi and intraoperative probe relative to histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake and concentration of aby-029 in resected specimens.

the investigators plan a sample size of 6-12 patients in this open label, single center, clinical trial of aby-029. administration will occur as a single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery. the protocol is not a safety study since no physiological effects are expected at microdose levels of aby-029. rather, doses have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of aby-029 as a tumor biomarker sufficient to guide surgical resection in the future. no diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.

Eligibility criteria:
inclusion criteria: 1. preoperative diagnosis of recurrent high-grade glioma having egfr positive tissue from prior surgery. 2. tumor judged to be suitable for open cranial resection based on preoperative imaging studies. 3. valid informed consent by subject. 4. age ≥ 18 years old. exclusion criteria: 1. pregnant women or women who are breast feeding. 2. patients on any experimental anti-egfr targeted therapies

Keywords: aby-029 affibody molecular fluorescence-guided surgery epidermal growth factor receptor (egfr)
hand acceleration time assessment with ultrasound doppler

Conditions: Upper Limb Ischemia; Vascular Disease

Summary: chronic upper limb ischemia syndrome is uncommon compared to lower limb ischemia, with several potential causes (e.g., arteriosclerosis, compressive syndromes, arteritis, connective tissue diseases, trauma, and thrombosis). many patients with upper limb ischemia remain asymptomatic due to arterial collateral vascularization. given the wide variety of potential causes for upper limb ischemia, the diagnosis may require different technical approaches. doppler ultrasound is a non-invasive, accessible, non-radiating technique that provides direct arterial imaging, yielding valuable information on arterial anatomy and hemodynamics. some authors have described the reliability of the arterial duplex ultrasound for lower limb assessment using the pedal acceleration time (pat). the pat provides real-time hemodynamic physiological information on the entire limb. the acceleration time (at) is an ultrasound parameter which measures the time elapsed (in milliseconds, ms) from the beginning of the arterial doppler waveform until the systolic peak, evaluating the morphology of the arterial waveform in real time. in a healthy individual, this time should be short (between 40 - 100 milliseconds), displaying a triphasic waveform with a systolic acceleration, a sudden diastolic fall, and a subsequent anterograde flow at the end of diastole. a more damped wave suggests proximal stenosis and the acceleration time has been correlated to different degrees of foot ischemia. notably, the at parameter has also been studied in other territories, such as the carotid and pulmonary arteries, coronary arteries, and the aorta. hand acceleration time (hat) has also been described very recently as a potential tool to assess hemodialysis access-induced ischemia, cardiogenic shock, and subclavian iatrogenic ischemic lesion. however, the hat has not yet been properly characterized or validated. our working hypothesis is that the hat is a useful diagnostic tool for chronic upper limb ischemia.


Eligibility criteria:
inclusion criteria (healthy volunteers): * healthy adult volunteers (≥ 18 years of age). * no evidence of upper limb arterial disease. * who sign the written informed consent. exclusion criteria (healthy volunteers): * healthy volunteers unable (at the investigator discretion) to understand or comply with any study-related procedure. * healthy volunteers who refuse to participate. * those presenting cardiovascular risk factors (e.g., hypertension, diabetes mellitus, dyslipidemia). inclusion criteria (upper limb ischemia patients): * adult patients (≥ 18 years of age) with a known diagnosis of chronic upper limb ischemia. * who sign the written informed consent. exclusion criteria (upper limb ischemia patients): * patients unable (at the investigator discretion) to understand or comply with any study-related procedure. * patients who refuse to participate.

Keywords: hand acceleration time upper limb ischemia vascular disease
text message reminders for hearing healthcare

Conditions: Hearing Loss

Summary: many individuals with hearing loss do not receive adequate hearing healthcare. given their close and long-term relationships with patients, primary care providers (pcps) could play a vital role in improving access to hearing healthcare. unfortunately, hearing loss is often underdiagnosed in primary care settings, because hearing screening is not a routine part of primary care visits, and the responsibility often falls on the patient or family to recognize and address the issue. the investigators propose to pilot test the use of text message reminders to encourage elderly patients to discuss hearing assessment with there pcps. the study objectives are to: 1) design an automated text-messaging reminder system; 2) assess the feasibility of deploying the intervention in a clinical trial setting; and 3) evaluate whether the intervention increases willingness to seek hearing healthcare.


Eligibility criteria:
inclusion criteria: * english-speaking adult patients aged 65 and older * have not audiometric testing within the past 5 years * has had at least one prior visit encounter with a stanford primary care provider the past 1 year * has a cell phone with a valid phone number exclusion criteria: * history of childhood hearing loss * hearing aid users * limited english proficiency

Keywords: hearing loss; elderly; primary care; text message