Kornimate/medical-research-clean huggingface dataset:
treatment of depression and/or anxiety - the tree theme method® (ttm) as an intervention

Conditions: Depression; Anxiety

Summary: depression and anxiety are among our most common diseases and the prevalence is increasing. when suffering from depression or anxiety, the individual's ability to cope with everyday life occupations is decreased, as well as the ability to relate to others. the tree theme method® (ttm) is a treatment method. the purpose is to enhance the ability to develop strategies for occupations in everyday life and relationships with others. the method involves using creative activities to create a life story focusing on everyday occupations and to create an imagination of future possibilities/goals. the ttm is a short-term therapy with five sessions. the treatment also implies that the patient is asked to identify various homework tasks to perform between the sessions. the aim of the project is to investigate the effects of the ttm compared to a control group for people with depression and anxiety diagnosis. the intention is to examine the effect on outcome measures regarding psychological symptoms, everyday occupations and health. the study has been approved by the regional ethical review board. the project is a randomized multicenter study with an intervention group and a control group. a total of 130 patients will be included. inclusion criteria are patients with depression and/or anxiety in the age of 18-65 years and who have problems with their everyday occupations. exclusion criteria are individuals with a severe somatic illness or psychosis and/or who have difficulties to understand and fill out self-rating questionnaires. the project implies that doctors will refer appropriate patients to the occupational therapist. after informed consent each patient will be drawn to the ttm or control. before and after the treatment, as well as 3 and 12 months after finished treatment the patient will meet a project assistant in order to respond to questionnaires regarding psychological symptoms, everyday occupations and health. the study is a collaborative project involving the region skåne, kronoberg county council, and jönköping county council. doctors will recruit patients and occupational therapists will perform the treatment. the research team comprise of researchers from kronoberg county council (b gunnarsson and k hedin), lund university (c håkansson) and school of health sciences in jönköping (p wagman).


Eligibility criteria:
inclusion criteria: * depression and/or anxiety in age of 18-65 years and problems with everyday occupations. exclusion criteria: * severe somatic illness or psychosis and/or difficulties to understand and fill out self-rating questionnaires
resiliency among older adults receiving lung cancer treatment

Conditions: Advanced Lung Carcinoma; Extensive Stage Lung Small Cell Carcinoma; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Unresectable Lung Carcinoma; Unresectable Lung Non-Small Cell Carcinoma

Summary: this trial studies how well physical therapy and progressive muscle relaxation works in improving physical performance and mood in older patients with stage iiia-b or iv lung cancer who are undergoing treatment. improving physical performance and mood may help older patients maintain an independent lifestyle by helping to improve their resilience, the ability to bounce back to normal functioning after a stressor or intervening health event such as treatment or disease progression. giving physical therapy and progressive muscle relaxation may work in improving symptoms and quality of life in patients with lung cancer.

primary objectives: i. to assess the feasibility of a novel, weekly supervised virtual health-assisted physical therapy plus relaxation intervention delivered to older adults with advanced thoracic malignancy (n=20). outline: patients participate physical therapy sessions consisting of cardiovascular and resistance training exercises in person or online and also undergo progressive muscle relaxation sessions once weekly for up to 12 weeks. after completion of study therapy, patients are followed up at 24 weeks, and then periodically for up to 24 months.

Eligibility criteria:
inclusion criteria: * diagnosed with advanced lung cancer: unresectable stage iiia, iiib, or stage iv non-small cell lung cancer (nsclc) or extensive stage small cell lung cancer (sclc). * intent to receive treatment from the ohio state university comprehensive cancer center (osuccc) thoracic oncology clinic. * willingness to participate and adhere to the study intervention program. * ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means). exclusion criteria: * prisoners are excluded from participation. * there is no exclusion criteria pertaining to eastern cooperative oncology group (ecog) performance status, laboratory values, prior cancer diagnoses, presence of comorbidities or brain metastases.
evaluating the effectiveness of a pneumococcal immunisation campaign in a camp for internally displaced people

Conditions: Pneumococcal Infections

Summary: pneumococcal conjugate vaccine (pcv) is used routinely worldwide as part of infant immunisations to prevent acquisition of s. pneumoniae, the aetiologic agent responsible for a large proportion of early childhood pneumonia and invasive disease. however, pcv has seen minimal uptake in populations affected by forced displacement and humanitarian crises, where the burden of pneumococcal disease is plausibly elevated. this study seeks to generate evidence on appropriate vaccination strategies for crisis-affected populations. the investigators plan to exhaustively vaccinate children aged between six months and four years in a camp for displaced persons outside hargeisa, the capital of somaliland. the study will deliver pcv in a campaign modality, so as to achieve both short- and long-term herd immunity effects that, the investigators hypothesise, will reduce population-wide nasopharyngeal s. pneumoniae transmission and thereby protect young children from pneumococcal disease. the study will adopt a quasi-experimental design, with baseline and post-intervention surveys to evaluate changes in pneumococcal carriage, complemented by safety assessment in children aged over 2 years, who fall outside of the who prequalification age range for the vaccine that will be used in this study (i.e. pneumosil) and for whom pcv safety data are scarce. in addition, we the study will also collect longitudinal data on incidence of pneumonia and antibiotic prescriptions in the camp.


Eligibility criteria:
inclusion criteria: 1. resident in digaale camp 2. voluntary written/thumb-printed informed consent has been provided by a parent or caregiver 3. subject's parent/caregiver must be able to comprehend and comply with study requirements and procedures 4. subject's parents/caregivers must have a readily identifiable place of residence in the study area exclusion criteria: 1. known hypersensitivity to any component of any of the epi vaccines, including diphtheria toxoid, in the child or any sibling 2. history of allergic disease or history of a serious reaction to any prior vaccination in the child or any sibling 3. history of anaphylactic shock, regardless of cause 4. history of long-term treatment (defined as 14 or more consecutive days) with immunosuppressants or other immune modifying drugs, including glucocorticoids, but excluding topical and inhaled glucocorticoids

Keywords: pneumococcal conjugate vaccine humanitarian crisis forced displacement mass vaccination quasi-experimental
eliminating hcv infection among pwud

Conditions: Hepatitis C, Chronic; Drug Use

Summary: identify 300 pwud with chronic, viremic hcv infection and engage them in a multidisciplinary, generalizable model of care and initiate hcv treatment


Eligibility criteria:
inclusion criteria: 1. ability to review, sign and date the irb/iec approved informed consent form 2. age ≥19 years 3. documented hcv rna positive for 6 months or more, with any hcv genotype 4. active pwud (ongoing drug use or documented use within the previous 6 months) or active enrolment in an opiate substitution program exclusion criteria: 1. previous daa-based hcv treatment 2. pregnant or breast-feeding 3. indications of decompensated liver disease 4. diagnosis of active hepatocellular carcinoma 5. positive test at the time of screening for hepatitis b surface antigen (hbsag) 6. frequent injecting drug use that is judged by the treating physician to compromise subsequent hcv treatment safety 7. inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of hcv treatment
conventional ultrasound versus remote ultraportable ultrasound in the context of viral hepatitis

Conditions: Hepatitis; Teleradiology

Summary: comparison of abdominal us exam in patients with viral hepatitis between ultraportable us with teleradiology capacities (tup) versus conventional ultrasound (cus)

primary objective the investigation seeks primarily to determine the performance of abdominal us examinations realized with tup and cus based on defined imaging criteria secondary objectives evaluate satisfaction and comfort and reproducibility of use of the ultraportable us

Eligibility criteria:
inclusion criteria: * informed consent signed by the subject * all adult patients with viral hepatitis for which an ultrasound is planned exclusion criteria: * known or suspected non-compliance * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * previous enrollment into the current study
desmoteplase in acute ischemic stroke (dias)

Conditions: Stroke

Summary: the dias study (part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on mri within a time window of 3 to 9 h after stroke-symptom onset. in addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.

acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability. the outcome can be improved by early treatment with thrombolysis. alteplase (r-tpa) is the only approved thrombolytic drug in the indication of acute ischemic stroke. however, the use of alteplase is currently restricted by the need to administer it within 3 hours of symptom onset. as the risk of transforming a cerebral infarct into haemorrhage probably rises as the time elapsed increases, a thrombolytic drug that carries a lower risk of haemorrhage than alteplase may offer a wider time-to-treatment window and improve the safety profile.desmoteplase (dspa) with its high fibrin specificity, lack of neurotoxicity, potential neuroprotective effect, non-activation by ß-amyloid, and long terminal half-life may account for an improved safety and efficacy profile within the first 9 hours after onset of symptoms.

Eligibility criteria:
inclusion criteria: * scoring 4 to 20 on the national institute of health stroke scale (nihss) * showing a perfusion-diffusion mismatch on mri of 20 % * enrolment within a 3 h to 9 h time window after symptom onset. * 18-85 years of age exclusion criteria: * participation in any interventional trial in the previous 30 days. * women in the childbearing age. * any history of intracranial hemorrhage, subarachnoid hemorrhage, neoplasm, arteriovenous malformation or aneurysm. * conditions that, according to the judgment of the investigator, might impose an additional risk to any individual stroke patient when receiving study medication (this applied to patients on platelet-function inhibitors as well). * mri exclusion criteria: evidence of ich, evidence of sah, signs of extensive early infarction on dwi assessed by evidence of involvement of \>1/3 of the middle cerebral artery (mca) territory. no perfusion deficit, internal carotid artery (ica) occlusion ipsilateral to stroke lesion without additional ipsilateral mca, anterior cerebral artery (aca) or posterior cerebral artery (pca) occlusion. any intracranial pathology that would interfere with the mri assessment of acute ischemic stroke.

Keywords: acute ischemic stroke
treatment of chronic hip pain by application of conventional radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerve

Conditions: Hip Pain Chronic

Summary: the estimated prevalence of hip joint pain is 7% in men and 10% in women over the age of 45 years.although physical therapy and weight loss, use of walking aids (such as walking sticks) and analgesic agents are used as conservative treatment methods, these methods usually provide short-term and partial benefits.the anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve. denervation of the articular branches of the femoral and obturator nerves with the radiofrequency thermocoagulation (rft) method is a method used in chronic hip pain. in this study, we aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent hip rft.

hip pain is a common medical condition with increasing age.the effectiveness of conservative methods used in hip pain is limited.since the lifespan of prostheses used in hip surgery is limited, new methods are needed in the treatment of pain.the anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve. denervation of the articular branches of the femoral and obturator nerves with the radiofrequency thermocoagulation (rft) method is a method used in chronic hip pain.in previous studies with small groups, it was shown that radiofrequency thermocoagulation procedure caused 50% reduction in hip pain between 1-11 months.hip joint radiofrequency thermocoagulation is a procedure applied in our clinic. in this study, we aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent hip rft.

Eligibility criteria:
inclusion criteria: 1. be over 18 years old 2. written consent has been obtained 3. those with chronic hip pain for more than 3 weeks exclusion criteria: 1. major psychiatric illness 2. the patient has lumbar compression pain or referred pain 3. patients using anticoagulant agents 4. patients with infection in the area to be treated 5. those who are allergic to local anesthetics 6. those who are allergic to betamethasone 7. pregnancy

Keywords: chronic hip pain radiofrequency thermocoagulation algology femoral and obturatuar nerve
research on optimal immunization strategy of hepatitis b vaccine in chronic kidney disease population

Conditions: Hepatitis B Vaccine

Summary: at present, chronic kidney disease population are vaccinated with hepatitis b vaccine according to the standard three-dose schedule immunization program, and the effect of preventing hbv infection is not ideal. this is a randomized, controlled trial. the study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis b vaccine with three or four injections at months 0, 1, and 6 or 0, 1, 2, and 6 in chronic kidney disease population.

participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis b vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis b vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis b vaccine group at months 0, 1, 2, and 6. hbsag and anti-hbs will be tested during the study period. adverse reactions will be recorded after vaccination.

Eligibility criteria:
inclusion criteria: * aged between 18 and 70 years at the enrolment * serologically negative for hepatitis b surface antigen (hbsag), hepatitis b surface antibody (anti-hbs) and hepatitis b core antibody (anti-hbc) at enrollment * sign informed consent, willing to participate in this study exclusion criteria: * being pregnant * intolerance or allergy to any component of the vaccine * any vaccination during the month preceding enrollment * patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever * patients with hepatitis b virus associated glomerulone nephritis or hbv dna positive

Keywords: hepatitis b vaccine randomized controlled trial chronic kidney disease population immunogenicity long-term immune response
siderophore-profile in allergic and non-allergic subjects

Conditions: Allergy; Healthy; Allergic Sensitisation

Summary: this study aims to profile the siderophore-content in the human gut from allergic and non-allergic subjects and to assess their contribution in iron homeostasis.

iron is an essential nutrient for the majority of commensal bacteria, which commonly secrete siderophores to liberate iron from their surroundings. in several studies, a misbalanced microbiota has been demonstrated in allergics suggesting that also their siderophore profile is severely attenuated. there are currently no data and very limited knowledge present on the composition of bacterial surviving factors in humans, or on their impact on the human immune system. as such, 1) the iron status, 2) the microbial biota composition and the 3) siderophore-profile in allergics and non-allergics will be assessed.

Eligibility criteria:
inclusion criteria: * allergic and non-allergic volunteers exclusion criteria: * patients will not be considered for the study if they have co-morbidities such as diabetes mellitus, disorders of the liver including hemochromatosis or kidney, autoimmune or metabolic diseases and malignancy or if they use of medications (e.g. antibiotics, ppis) that influence the iron, inflammatory or microbial status. further exclusion criteria are pregnancy, lactation; veganism, zinc, and iron supplementation and smoking. volunteers will be asked to cease blood donation for at least three months' before recruitment and to cease other supplements for at least two weeks, e.g. vitamins, fish oil or minerals (other than zinc and iron).

Keywords: iron siderophores allergy allergic sensitisation trace elements
reminiscence, anxiety and early alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study seeks to establish the acceptability and evaluate the limited efficacy of simple reminiscence (sr), a home-delivered non-pharmacological intervention designed to relieve stress, improve affect, and prevent or quell disruptive or maladaptive behaviors in community-residing individuals diagnosed with early alzheimer's disease (ead). unmanaged episodes of anxiety can be antecedents of maladaptive behaviors, including agitation, anger, and sometimes even violence. sr is a dyadic strategy; both the person with ead and the caregiver engaged the patient's memory to interrupt a current episode of anxiety.

through the intervention, family caregivers are trained to collaborate with and guide patients to access positive memories as a way to manage or move past the anxiety that plagues individuals with ead - often arising when confronted by common complex tasks they previously were able to perform. during the project's first six months (phase 1), the investigators will develop a series of 4 video-vignettes illustrating dyads (including one member with ead) managing a variety of anxiety provoking scenarios associated with ead (e.g., trouble reconciling a checkbook) through the use of sr. during the second phase of the project, a research assistant will administer sr at four home visits. the sr intervention has three components: 1. a didactic component using the sr manual that the couple retains (15 minutes); 2. viewing one of the brief video-vignettes illustrating the application of reminiscence techniques (5 minutes; a different video-vignette will be viewed at each visit; and 3. facilitation of caregiver practice in applying the techniques, using a recent example of anxiety-linked experience of the person with ead (10 minutes). the caregiver is encouraged to learn and practice the techniques in order to cue and coach the person with ead in their use. the attention control treatment, a social visit, is a 30-minute activity in which the person with ead, the caregiver and the research assistant (ra) review and discuss the day's newspaper headlines. the ra will use communication techniques specifically designed to keep the conversation present focused. both members of the dyad will collect saliva to evaluate diurnal cortisol secretion.

Eligibility criteria:
inclusion criteria: * live in the community * reside with a primary caregiver who must be willing to participate in all study activities (the primary caregiver must have a familial or marital relationship with the person with ead of sufficient length to support reminiscence activity \[i.e., an adult child, a long-term spouse or committed partner\]) * have received a diagnosis of early alzheimer's disease from a primary care provider * achieve a score on the mini-mental state examination (mmse) between 19 and 25 exclusion criteria: * unable to give consent * mmse score lower than 19 or greater than 25.

Keywords: caregivers anxiety depression
betaeval global - the new betaconnect auto-injector : adherence and evaluation of multiple sclerosis patients treated with betaferon

Conditions: Multiple Sclerosis, Relapsing Remitting

Summary: considering the significance of an early and consequent multiple sclerosis (ms) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. the data storage capabilities of the betaconnect device, including the automated recording of injections, will facilitate the collection of reliable data on patient's injection behavior and adherence, which should be unaffected by recall bias or reporting bias. to better understand the utilities of the new betaconnect device and characterize its contribution to adherence, we plan to prospectively follow-up ms patients using this device for 24 weeks. the study will take place in a real-life setting in neurology centers across europe.


Eligibility criteria:
inclusion criteria: * patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome. * patients must be on treatment with betaferon or the decision to treat a patient with betaferon has been made by the attending physician. * patient and attending physicians must have agreed on the usage of the betaconnect auto-injector device. * written informed consent must be obtained. exclusion criteria: * patients receiving any other disease modifying drug. * contraindications of betaferon described in the summary of product characteristics.