Kornimate/medical-research-clean huggingface dataset:
emotional awareness and expression therapy for patients with persistent physical symptoms in routine psychiatric care: a pilot study

Conditions: Persistent Physical Symptoms (PPS); Functional Somatic Disorder; Functional Somatic Syndromes; Somatic Symptom Disorder (DSM-5)

Summary: emotional awareness and expression therapy (eaet) has emerged as a promising approach for addressing persistent physical symptoms (pps). investigating eaet within the context of routine psychiatric care is crucial for several reasons: many patients with pps experience significant distress and functional impairment, yet traditional medical treatments often fail to provide adequate relief. integrating eaet into routine care could offer a valuable therapeutic option for this population. preliminary studies suggest that eaet can lead to significant reductions in pain and other somatic symptoms. investigating its effectiveness in routine care settings could enhance treatment outcomes for patients who have not responded to conventional therapies. there is often a disconnect between mental health and physical health treatment in routine care. investigating eaet can help bridge this gap, fostering collaboration between mental health professionals and primary care providers to address the complexities of patients\&#39; health issues.


Eligibility criteria:
inclusion criteria: * the participant certifies that they have undergone a medical assessment for their physical symptoms (see separate certificate). * the participant rates either moderate distress from physical symptoms on the phq-15 questionnaire (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom). * the participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile. * any prescribed medications must have been stable for at least one month. exclusion criteria: * participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.). * participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines). * participants are involved in other psychological treatments focused on physical symptoms. however, other psychological treatments are permitted as long as the supportive therapy does not occur more than once a month. * participants do not have sufficient proficiency in the swedish language. please note that it is the chief physician of each respective research sponsor who, based on collected anamnesis and self-assessment information, makes the final decision regarding whether a participant should be included or excluded from the research project.

Keywords: emotional awareness and expression therapy group psychotherapy routine care
development of software to provide the speechvive device via the internet

Conditions: Parkinson Disease

Summary: telehealth, increasingly recognized in the neurology field as a solution to access issues for people with parkinson's disease, improves access to speech therapy, particularly those living in rural areas or with travel barriers. the speechvive device, developed by speechvive, inc., is a treatment solution that is easy to use and effective. in an nih funded study, the speechvive device improved communication in 90% of individuals with pd by improving volume, articulation, and speech rate. the investigators propose to eliminate the one drawback of the speechvive device, namely that it currently must be programmed by a speech-language pathologist for each patient in person. the overall goal of this project is to develop a telehealth platform for the speechvive device that will enable video conferencing for treatment and remote programming of the speechvive device for each patient. once the platform has been developed, the investigators will conduct a study to examine effectiveness and the patient and caregiver satisfaction with telepractice using the speechvive device.


Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease * difficulty communicating * is currently being seen, or agrees to be seen, by a speech pathologist who fits the speechvive device and also has agreed to participate in the study * has a regular caregiver living with him/her exclusion criteria: * neurological diagnoses (except parkinson's disease) * bilateral hearing aids (since one free ear is required for use of the speechvive device)

Keywords: speech problems
identification of microbial properties predicting a worsening course of fatty liver disease

Conditions: Patients With Fatty Liver Disease

Summary: this study investigates the relation between the gastrointestinal tract bacteria and the progression of fatty liver disease .

in the gastrointestinal (gi) tract live wide spectrum of bacteria, in this study we are trying to find if there is a relation between the gi tract bacteria and the development of non alcoholic fatty liver disease, the results of the this study may help us identify the stage of liver disease in noninvasive means and enables us to adopt methods to reduce morbodity.

Eligibility criteria:
inclusion criteria: * patients with non alcoholic fatty liver disese. * patients who give approval to participate in the study exclusion criteria: * liver failure * acute or chronic kidney failure * heart failure ( nyha 3-4) * active cancer * fatty liver due to non alcoholic etiology. * patients who consume drugs from the estrogen/methotrexate family, or chloroquine. * history of hypothyrodism or cushing. * patients who used tpa in the last 6 months . * pathients with chronic liver disease like a1at, hemochromatosis, wilson, toxic damage and autoimmunity . * special population like - children, pregnant women and patients who lack the ability to make judgment. * infectious liver disease - viral hepatitis or hiv. * inflammatory bowel disease. * patients who underwent surgery of the gastrointestinal trant.
ketamine and changes of the short portable mental status questionnaire

Conditions: Postoperative Cognitive Dysfunction

Summary: - cognitive changes are related to aging, affecting the performance of older patients in the solution of problems and the execution of tasks. this phenomenon has been observed as a decline of neurophysiological domains, especially memory, and the velocity of thought. * anesthesia and surgery performed contributes to its development then, is named post-operative cognitive dysfunction (pocd). the incidence varies due to conditions of: 1. anesthesia and surgery. 2. the time elapsed after surgery. 3. the population studied, and the type of cognitive test employed. * the aim of this study is to evaluate the changes around the short portable mental status questionnaire (spmsq-e) after ketamine administration on ophthalmic surgery on the common conditions of geriatric patients, -comorbid and settings as minor surgery-.

participants will be patients programmed for a vitrectomy or cataract surgery involving a retrobulbar block, to be carried out with a local anesthesia. - administration of ketamine will be suspended during the study for any cause considered as a risk to the patient according to the judgment of the researchers.

Eligibility criteria:
inclusion criteria: * patients be over 60 years and older. * intraocular pressure less than 20 millimeter of mercury. * american society of anaesthesiologists (asa) physical status classification, i-iii. exclusion criteria: * history of psychosis or schizophrenia. * nephropathy. * difficult to control hypertension. * uncontrolled hepatic disorders. * allergy to ketamine. * moderate to severe depression. * post-operative delirium. * needed to use medications other than those contemplated in the study.

Keywords: ketamine acute cognitive dysfunction geriatric patients
endothelial function in patients with scleroderma or cirrhosis with and without pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: pulmonary arterial hypertension (pah) is a condition characterized by an increased pulmonary vascular resistance that can lead to right heart failure and death. several diseases are known etiologies of pah including scleroderma and cirrhosis. the presence of pah in the context of systemic sclerosis or cirrhosis has a dramatic impact on prognosis and survival of the connective tissue or liver disease. despite advances in the diagnosis of pah, echocardiography remains a necessary test for screening pah in patients with scleroderma or cirrhosis. however, echocardiography is less than ideal for diagnosing pah and predicting treatment response. thus, there is a pressing need to identify methodologies that can accurately and non-invasively recognize the presence of pah in patients with scleroderma and cirrhosis. hypothesis: 1. to measure endothelial function and exhaled gases in patients with scleroderma and cirrhosis. to assess whether they correlate with the presence or the development of pah. 2. the degree of local (forearm) capillary vasodilation during treprostinil iontophoresis identifies patients who will develop pah and in those already diagnosed pah predicts response to pah-specific therapies.

patients with scleroderma are known to have endothelial dysfunction and limited data suggested an association between the degree of endothelial function in scleroderma and the presence of pah. however, these data is preliminary and has not been used to predict response to pah-specific therapy or the development of pah. we will test patients with cirrhosis because they tend to have pah in the context of a hyperdynamic instead of a hypodynamic state as observed in scleroderma and pah. aims: 1. to measure endothelial function and exhaled gases in patients with scleroderma or cirrhosis to assess whether they correlate with the presence or the development of pah. 2. to evaluate the degree of endothelial response to local treprostinil iontophoresis and determine if this test can predict the development of pulmonary hypertension or response to pah-specific therapies.

Eligibility criteria:
inclusion criteria: * patients with scleroderma or cirrhosis. exclusion criteria: * exclusion criteria include individuals younger than 16, etiologies of pah other than scleroderma or cirrhosis.

Keywords: scleroderma cirrhosis
isometric handgrip exercise -mri in children and adolescents

Conditions: Type 1 Diabetes Mellitus; Coronary Artery Disease

Summary: this project aims to assess coronary vessel response to isometric handgrip exercise (ihe) during magnetic resonance imaging (mri) in children with t1d children and healthy controls. the investigators will compare the groups in terms of surrogate markers of intima media alteration and arterial stiffness, i.e. carotid intima media thickness (cimt) and aortic pulse wave velocity (pwv).

background type 1 diabetes mellitus (t1d) in children and adolescents is associated with significant cardiovascular morbidity and mortality. early detection of vascular dysfunction is key to management yet assessment is invasive - which is particularly challenging when considering pediatric patient populations. recently, a novel approach using isometric handgrip exercise (ihe) during magnetic resonance imaging (mri) has been developed to evaluate coronary endothelial function in adults. this project aims to assess coronary vessel response to ihe using mri in children with t1d children and healthy controls. in addition, the investigators will compare the groups in terms of surrogate markers of intima media alteration and arterial stiffness, i.e. carotid intima media thickness (cimt) and aortic pulse wave velocity (pwv). community-dwelling healthy volunteers (\<18 years-old) and children with type 1 diabetes mellitus (disease duration ≥ 5 years) are recruited. ihe-mri studies are conducted and measurements are recorded at rest (baseline) and under stress (ihe at 30% maximal effort). carotic ultrasound and sphygmocor cpv system are used to assess cimt and pwv respectively. student's t-tests are used to compare results between groups.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus or * healthy community-dwelling children on no medications exclusion criteria: * smoking * obesity (bmi \>97th percentile) * systolic or diastolic hypertension (\>90th percentile) * inflammatory process.

Keywords: type 1 diabetes mellitus mri isometric handgrip exercise children adolescents
metacognitive beliefs in obese patients

Conditions: Obesity

Summary: the study aims to investigate the presence of metacognitive beliefs, emotional regulation, and emotional eating in obese patients and their possible relationships.


Eligibility criteria:
inclusion criteria: * age: between 18 and 65 years * italian nationality * body mass index ≥ 35 kg/m2 exclusion criteria: * psychiatric pathologies * severe cognitive deficits that could compromise the completion of the questionnaires * absence of signed informed consent

Keywords: metabeliefs metacognition rumination dysfunctional lifestyle rehabilitation
phase i safety and immunogenicity study of vax102 [flagellin.hum2e] influenza vaccine in healthy adults

Conditions: Influenza Infection

Summary: this study will evaluate the safety and immunogenicity of vax102 \[flagellin.hum2e\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

vax102 is a cross-protective influenza a vaccine based on a recombinant protein expressed in e. coli. the protein comprises salmonella typhimurium flagellin type 2 (stf2; tlr5 ligand) fused to human m2e. the active component of the vax102 vaccine is manufactured by a standard fermentation process. unlike the ha and na viral proteins, the amino acid sequence of m2e has remained remarkably stable in all human influenza a virus isolates. thus an influenza vaccine based on the m2e antigen could elicit cross-protective immunity against most human influenza a virus strains. vax102 vaccine relies on a single cross-reactive influenza a virus antigen manufactured by a recombinant protein fermentation-production process.

Eligibility criteria:
inclusion criteria: * healthy adults aged 18-49 years inclusive who provide written informed consent to participate. * comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits. exclusion criteria: * presence of significant acute or chronic, uncontrolled medical or psychiatric illness * documented influenza infection in the 6 months prior to study entry. * presently receiving or history of receiving any medications or treatments that affects the immune system * acute disease within 72 hours prior to vaccinations investigational product (test article) administrations will occur on days 0 and 28 (± 3). * in-clinic safety evaluations will be performed at screening, before each test article dose, and at days 1, 7 (± 2), 14 (± 2), 29, 35 (± 2), 42 (± 2), 60 (± 2), 120 (± 7), and 180 (± 7). * completion of a memory aid for seven days following each vaccine dose will be requested of subjects for use in accurate recall of local and systemic reactions.

Keywords: influenza vaccines m2e
a phase 1/1b study of medi3726 in adults subjects with metastatic castration resistant prostate cancer

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: the purpose of this study is to assess the safety and tolerability, describe the dose-limiting toxicities (dlts), and determine the maximum tolerated dose (mtd) or maximum administered dose (mad \[in the absence of establishing the mtd\]) for single agent medi3726 in subjects with mcrpc who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mcrpc setting.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at the time of screening. * histologically confirmed diagnosis of metastatic castration-resistant prostate adenocarcinoma (mcrpc). * documented pd in subjects with mcrpc as assessed by the investigator and defined by at least one of the following according to the pcwg3 criteria: 1. radiographic progression. 2. psa progression. * prior exposure to abiraterone or enzalutamide of at least 12 weeks in the mcrpc setting. note: subjects who have received both abiraterone and enzalutamide in the mcrpc setting are eligible. * in dose escalation: prior taxane-based chemotherapy in the mcrpc setting is: 1. required for arm a. 2. excluded for arm b. 3. optional for arm c. exclusion criteria: * subjects with neuroendocrine, neuroendocrine differentiation and/or small cell prostate cancer. * the subject has received any conventional or investigational anti-cancer treatment within 21 days before the first dose of investigational product, with the following modifications: 1. at least 14 days before the first dose of investigational product since completion of treatment with abiraterone or enzalutamide 2. at least 14 days before the first dose of investigational product since completion of prior taxane-based chemotherapy 3. at least 28 days before the first dose of investigational product since completion of treatment with radium-223. 4. at least 42 days before the first dose of investigational product since completion of prior bicalutamide and nilutamide treatment. note: an lhrh agonist or antagonist required for ongoing testosterone suppression will be permitted if inclusion criterion is satisfied. * prior exposure to psma-directed therapies. * subjects with previous radiotherapy for the treatment of unresectable, locally advanced or metastatic prostate cancer are excluded if: 1. more than 25% of marrow-bearing bone has been irradiated. 2. the last fraction of radiotherapy has been administered within approximately 2 weeks prior to the first dose of investigational product. * brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to the first dose of investigational product. * subjects with known history of peripheral vasculopathies including, but not limited to, macro and microangiopathies secondary to diabetes, peripheral arteriopathy of any cause, intermittent claudication, repeated and/or non-healing ulcers of any cause.

Keywords: metastatic, prostate cancer
short term follow-up of patient implanted with the proximal interphalangeal implant

Conditions: Hammer Toe; Claw Toe; Shortening 2nd Toe; Revision of Arthrodesis or Arthroplasty Failure

Summary: hammertoe and clawtoe are ones of the most common foot deformities. the second toe is the most frequently affected, but the other small toes may also be involved. when nonoperative treatment fails, surgery often is recommended. one surgical option is the arthrodesis of the proximal interphalangeal (pip) joint. this arthrodesis is technically demanding, its needs: * internal fixation; * interphalangeal compression; * anatomic pip joint plantar flexion angle. the implant ipp-on has been developed for this specific arthrodesis. the objective of this study is to evaluate the efficacy and safety of the proximal interphalangeal implant: ipp-on at short term follow up. the safety of the ipp-on will be described in terms of rate of device related complications. the efficacy of the ipp-on will be described in terms of fusion rate at 6 months.


Eligibility criteria:
inclusion criteria: * any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal interphalangeal implant ipp-on be implanted * age \>= 18 years * have willingness to give his/her data transfer authorization exclusion criteria: * contraindication of the implantation of the ipp-on the implant should not be used in a patient who has currently, or who has a history of: • active local or systemic infection * severe peripheral vascular disease * severe longitudinal deformity * insufficient quantity or quality of bone to permit stabilization of the arthrodesis * conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process * suspected or documented metal allergy or intolerance. * history of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol

Keywords: arthrodesis pip joint
methotrexate therapy effects in the physical capacity of patients with ischemic heart failure (metis trial)

Conditions: Heart Failure; Myocardial Ischemia

Summary: the aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure.

recent studies have showed the importance of proinflammatory mediators in the heart failure. however, there is a lack of benefit of therapies that tried to neutralize these mediators. methotrexate has adenosine-mediated anti-inflammatory effects in rheumatoid arthritis and psoriasis. methotrexate limits infarct size via this adenosine-dependent mechanisms in heart of dogs (j cardiovasc pharmacol. 2004 apr;43(4):574-9). a recent trial showed that this drug reduced proinflammatory mediators in patients with heart failure (am heart j. 2006 jan;151(1):62-8). these data suggest that methotrexate may improve physical capacity in patients ischemic heart failure reducing inflammation, but a randomized clinical trial is necessary to prove it.

Eligibility criteria:
inclusion criteria: * heart failure functional class measured using the new york heart association classification class ii, iii or iv * left ventricular fraction \<0.45 at the ventriculography * angiographic coronary lesions higher than 50% or coronary lesion revascularized (coronary artery bypass or percutaneous transluminal coronary angioplasty) exclusion criteria: * myocardial infarction in the past four months * coronary artery bypass or percutaneous transluminal coronary angioplasty in the past four months * left ventricular disfunction diagnosed during a acute coronary syndrome * those who require revascularization in the following 12 weeks * hepatic disease (alt and ast higher than the upper limit of the reference value) * renal failure (plasma creatinine higher than 2.0mg/dl) * alcoholism (20 doses per week or more) * illegal drug use * rheumatoid arthritis or other inflammatory diseases * infectious disease * neoplasm * anemia (hematocrit lower than 30%) * currently on any anti-inflammatory drugs * difficulty in walking * unable to understand/complete the 36-item short form health survey (sf-36) * those who do not give informed consent

Keywords: heart failure myocardial ischemia methotrexate inflammation anti-inflammatory agents inflammation mediators