Kornimate/medical-research-clean huggingface dataset:
the effects of music listening on anxiety and agitation in people with mild and moderate cognitive impairment

Conditions: Anxiety; Agitated Depression

Summary: advancing age is associated with an increased risk of developing dementia which can lead to a rapid acceleration in both the healthcare costs and caregiver burden. there is a need to develop non-pharmacological and easily accessible modalities of support for the well-being and enhancing quality of life for individuals with dementia. there is evidence that music listening is associated with stress and anxiety reduction in older adults. here, the investigators aim to assess the effects of music listening as provided by a novel digital music-based intervention (developed by lucid) on mood, anxiety, and quality of life in individuals at the early stages of dementia. lucid uses reinforcement learning machine learning to curate and personalize the musical playlist while incorporating monoaural theta auditory beat stimulation (abs) into the music. the study will be conducted remotely with study hardware (tablets and bluetooth speakers) being delivered to caregivers/participants. the study will take place over an 8- week period, with participants completing four 30 mins music or audiobook listening sessions per week. pre and post-intervention assessments will be done via zoom with the presence of a research staff member. the control condition consists of a randomized list of short audiobooks. the experimental condition consists of music and monoaural abs curated by lucid's ai system. the investigators hypothesize that the lucid ai music curation system, compared to audiobooks, will be correlated with a greater reduction in measures of anxiety and agitation and an enhancement of mood and quality of life.


Eligibility criteria:
inclusion criteria: * mild to moderate cognitive impairment (mild: moca scores (18-25); moderate: moca scores (10-17)) * aged 65-85. exclusion criteria: * unmanaged hearing loss (defined as the average pure-tone average threshold of 35 db hl or greater without the use of hearing instruments or personal sound amplification product) - self-report * severe tinnitus * hyperacusis * current (but not prior) severe psychiatric disorder, an unstable or serious medical condition that may limit participation in the assessments.
cardiac rehab for advanced heart failure-lvad candidates

Conditions: Heart Failure

Summary: this study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (nyha class iii-iv), who are being considered for lvad therapy.

frailty in patients with advanced heart failure is not thoroughly described, but in those studies that assessed frailty, it was a common phenomenon. furthermore, some data suggest an association between pre-lvad implant frailty and post-implant complications and survival. interventions for frailty have been utilized in various populations, including the elderly frail and the frail from cardiovascular causes. these interventions target physical strengthening and endurance and have been shown on occasion to improve functional outcomes. the current study, a pilot study, seeks to assess frailty in a prospective cohort of patients being evaluated in heart failure clinic for consideration of lvad implantation due to nyha class iii-iv dyspnea and enroll these patients in a six-week focused cardiac rehabilitation protocol aimed at improving frailty and functional independence. the primary endpoint of the study is improvement in frailty markers at the end (gait speed, handgrip strength), and secondary endpoints include improvement in the indices of quality of life and symptomatology via validated questionnaires.

Eligibility criteria:
inclusion criteria: * candidate for a left ventricular assist device (lvad) * advanced heart failure as determined by new york heart association classification iii or iv exclusion criteria: * unable to perform physical activities required by protocol due to anatomic or musculoskeletal comorbidities * physical activity is contraindicated

Keywords: advanced heart failure nyha class iii-iv frailty cardiac rehabilitation
cabergoline as an adjuvant to clomiphene citrate for management of unexplained infertility

Conditions: Infertility

Summary: infertility refers to an inability to conceive after having regular unprotected sex. infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. in many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse


Eligibility criteria:
inclusion criteria: * unexplained infertility, primary or secondary. * absence of galactorrhoea. * normal serum prolactin. * normal hysterosalpingography. * normal spermogram. exclusion criteria: * women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen. * known hypersensitivity for cabergoline or clomiphene citrate. * other factors of infertility as tubal factor, uterine factor or male factor.
a study to evaluate the feasibility of screening relatives of patients affected by non-syndromic thoracic aortic diseases

Conditions: Screening; Aortic Aneurysm and Dissection; Genetic Disease

Summary: the primary hypothesis is that a tailored programme of genetic and imaging screening of first- and second-degree relatives of patients affected by non-syndromic forms of thoracic aortic diseases will identify individuals at risk of death from these conditions. these individuals would constitute specific population of patients, requiring dedicated imaging surveillance and/or earlier prophylactic aortic surgery.

diseases involving the thoracic aorta (the major artery in the body) are a major health problem affecting an increasing number of people worldwide. in particular, a group of these conditions termed non-syndromic aortic diseases (ns-tad), can develop without any obvious symptoms or external features which prevents early identification. unfortunately, if not treated, the aorta may enlarge and lead to dissection, a life-threatening medical emergency. for this reason, the investigators believe it might be helpful to investigate relatives of patients undergoing surgery for thoracic aortic disease to understand if there are tests that could help identify and treat this condition at the right time. therefore the investigators propose to conduct a feasibility study to identify the practical issues and challenges that would need to be overcome in order to perform a successful tailored genetic (by collecting a small blood sample) and imaging (with exams such as echocardiography and mri) screening in such population of individuals. moreover, all participants will receive two questionnaires to ask their opinion about the study and to measure their levels of anxiety and depression, to judge whether and how this study has affected their emotional status. the study will be carried out at the department of cardiovascular sciences glenfield hospital, university hospitals of leicester nhs trust.

Eligibility criteria:
inclusion criteria: 1. ns-tad probands operated on (n=16). 2. fdr and sdr, aged 16 and above: 1. at least two relatives willing to participate in the screening programme. 2. relatives able to understand english. exclusion criteria: 1. probands with syndromic aortopathies, including marfan syndrome, loeys-dietz syndrome, ehlers-danlos syndrome, shprintzen-goldberg syndrome, aneurysm-osteoarthritis syndrome, arterial tortuosity syndrome, and cutis laxa syndrome. 2. probands with aortic lesions associated with trauma and infections. 3. probands/relatives unable to give informed consent

Keywords: screening, aortic disease, mortality, genetic testing, imaging
a research study in italy to understand how the dose check app used with xultophy® works in the treatment of people living with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study will look at how a mobile based app called 'dose check' used along with xultophy® helps the treatment in participants with type 2 diabetes mellitus (t2dm). participants will get xultophy® as prescribed by study doctor or will continue already prescribed treatment with xultophy®. participants will also be prescribed to use dose check app by study doctor. participants will be asked to install the dose check app in their mobile phone, which will be supported with the correct dose of xultophy®. the study will last for about 6 to 8 months.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * male or female, age above or equal to 21 years at the time of signing informed consent. * diagnosed with t2dm \>=12 weeks prior to signing consent. * the decision to initiate treatment with commercially available dose check app as a part of treatment along with xultophy® as per the local label has been made by the patient and the treating physician before and independently from the decision to include the participant in this study. * participants who are insulin naive (including the following situations: i. already on treatment with xultophy® at v1 for less than or equal to (\<=) 12 months and for \<= 15 dose steps and ii. short-term insulin use for acute illness for a total of \<14 days) * available hba1c value \<=12 weeks prior to the 'informed consent and initiation of dose check app visit' (v1) or hba1c measurement taken in relation with the 'informed consent and initiation of dose check app visit' (v1), if in line with local clinical practice. * willingness to continue using the dose check app on a compatible smartphone according to the intended use for the entire duration of the study. exclusion criteria: * previous participation in this study. participation is defined as having signed informed consent in this study. * women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study. * treatment with any investigational drug or software as a medical device (samd) within 30 days prior to enrolment into the study. * diagnosed with type 1 diabetes mellitus. * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * hypersensitivity to the active substance or any of the excipients as specified in the xultophy® local label.
accuracy of needle placement into the subacromial space of the shoulder

Conditions: Rotator Cuff Tendonitis

Summary: this study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. typically, in medical practice, one of the routes of injection is used. it has not been determined if one route is superior, or if all routes are equal in delivering medication into the subacromial bursa, which sits on top of the rotator cuff tendons.

patients with a diagnosis of rotator cuff tendonitis, having failed other non-operative measures, are offered an injection of steroid and local anesthetic to relieve their pain. this is standard treatment. in this study, patients are prospectively randomized to receive their injection by one of the three commonly used routes: anterior, posterior, or lateral. accuracy of the injection is determined by including a small amount of contrast dye in the injection which will make the injection visible on post-injection radiographs.

Eligibility criteria:
inclusion criteria: * rotator cuff tendinitis exclusion criteria: * diabetes * allergy to contrast dye * renal disease * pregnancy * frozen shoulder

Keywords: tendonitis rotator cuff shoulder injection
pdo/pdo-til/pdots for drug screen

Conditions: Liver Cancer; Metastatic Liver Cancer

Summary: this clinical trial aims to use the patient-derived organoid (pdo), patient-derived organoids-tumor-infiltrating lymphocyte coculture system (pdo-til) and patient-derived organotypic tissue spheroids (pdots) to simulate the tumor microenvironment in cancer patients. the culture system can be used for pre-clinical validation of drugs and screening of drugs to treat sensitive people and provide individualized treatment for patients with liver cancer. this model is used to explore the molecular mechanism of drug resistance and to find intervention strategies to further improve the response rate of drugs. this study is expected to provide an ideal platform for drug screening and drug resistance research in liver cancer patients, which can replace experimental animal models, and guide personalized medication for liver cancer patients, so as to improve the overall prognosis of patients.


Eligibility criteria:
inclusion criteria: 1. ≥18 years old, male or female. 2. liver cancer or metastatic liver cancer diagnosed clinically or pathologically, at least one measurable lesion. 3. eastern cooperative oncology group (ecog) performance status 0-1. 4. patient has given written informed consent. 5. the function of important organs meets the requirements. 6. non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period. exclusion criteria: 1. the patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included). 2. the patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \> 10 mg/day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment. 3. have clinical symptoms or diseases that are not well controlled. 4. significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization. 5. arterial/venous thrombosis in the first 6 months of randomization. 6. according to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.
a primary-secondary care partnership to prevent adverse outcomes in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: chronic kidney disease (ckd) is a major public health problem with a uk prevalence of 8-10%. the study hypothesis is to ascertain if intensive primary care led disease management programmes for ckd, supported by input from secondary care specialists will slow progression of ckd, improve blood pressure control and reduce cardiovascular events in patients on ckd registers. the investigators have partnered with nene commissioning, a practice based commissioning group representing approximately 80 gp practices in northamptonshire, to run this study. this will be a cluster randomised trial of an intensive, secondary care supported, ckd management programme in primary care vs normal ckd care. randomisation will be at the level of the individual general practice. all general practices associated with nene commissioning will be invited to participate. randomisation of practices will be performed by the university of leicester clinical trials unit and the study will adhere to guidelines for undertaking randomised cluster trials. the aims of the study are: 1. to determine whether reinforcement of best practice in the management of key aspects of ckd care by clinical nurse specialists based in primary care, but with close links to colleagues from secondary care, improves clinical outcomes. 2. to foster excellence in ckd care 3. to improve coding of ckd and prevalence on chronic disease registers. 4. to increase interest in, and capacity for primary care research in northamptonshire. 5. to implement and evaluate a new model of partnership working between primary and secondary care. the primary outcome measures will be changes in estimated glomerular filtration rate (egfr). secondary outcome measures will be blood pressure control, proteinuria, incidence of cardiovascular events,other biochemical parameters, referrals to secondary care and hospitalisations and mortality.

see above

Eligibility criteria:
inclusion criteria: * measurement of serum creatinine * egfr \< 60 ml/min/1.73m2

Keywords: ckd
hypnosis for pain and itch following burn injuries

Conditions: Burns

Summary: the purpose of this study is to determine whether hypnosis will decrease the intensity of either pain or itch in patients who have sustained a burn injury. primary hypothesis: hypnosis will provide more effective relief from post-burn itch and pain than a control intervention at 1-month, 3-months, 6-months and 1-year post-burn injury. secondary hypothesis 1: subjects treated with hypnosis will report better sleep quality and fewer symptoms of post traumatic stress disorder (ptsd). secondary hypothesis 2: subjects treated with hypnosis will require less escalation of the gabapentin doses and have lower average pain scores than those in the control group. exploratory hypothesis: subjects who will randomize to the hypnosis treatment group early after injury will report lower rates of neuropathic pain and itch than subjects who will be enrolled in the study and receive hypnosis later in the healing process.

this is a randomized, controlled study comparing two groups of subjects, those in the control (standard care) group and those in the experimental group (hypnosis). control subjects will receive treatment as usual, which consists of a standardized protocol for treating post-burn itch. this protocol is based on past research and combines medications in a stepped approach that establishes therapeutic decisions based on clearly defined criteria. subjects randomized to the experimental group will undergo four sessions of live hypnosis completed over a two month period. they will be provided with a compact disk (cd) of each session and instructed to listen to it daily. post-hypnotic suggestions will address uncomfortable sensations, with additional suggestions for improved sleep and well-being. subjects may be inpatient or outpatients.

Eligibility criteria:
inclusion criteria: * 18-65 years old * ability to provide informed consent for study participation * ability to read and understand english * undergoing pharmacologic therapy for burn related itch according to the standard itch protocol * scoring of 4 out of 10 on the numerical rating scale for average itch or pain exclusion criteria: * age less than 18 or greater than 65 * inability to provide informed consent * inability to read or understand english * delirium * history of mania, paranoia, dissociation and current suicidal ideation

Keywords: burn injuries
comparison of daily nocturnal hemodialysis with daily hemodialysis

Conditions: Kidney Failure, Chronic

Summary: hemodialysis remains associated with a high mortality (approximately 22% per year) and many complications despite improvements over the last twenty years. several nephrologists have suggested that increasing the frequency and amount of dialysis will result in improved outcomes. in fact, various forms of daily dialysis have been performed in over 300 patients in the last 30 years with improvements in blood pressure, quality-of-life, bone disease, and other complications of renal failure. whether this form of treatment can be expanded to the 220,000 americans on hemodialysis is unknown. the primary outcome of this study is to determine the effectiveness of nocturnal dialysis in hemodialysis patients in st. louis. if the pilot study is effective, then participation in a larger, multicenter trial is expected. the endpoints measured are use of antihypertensive medications, improvement in secondary hyperparathyroidism and use of phosphorus binders, quality-of-life measured by sf-36 surveys, and improvement in physical function as measured by maximal oxygen uptake.


Eligibility criteria:
adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years

Keywords: renal dialysis
clinical trial to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (7.5μg/0.25ml)

Conditions: Seasonal Influenza

Summary: the purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.

the study includes open-labelled phase i and randomized, double-blind, controlled phase iii clinical trial. in the phase i, 20 healthy chinese children aged 6-35 months were administered with two doses of qiv (7.5μg/0.25ml). in the phase ⅲ clinical trial, 2320 children were assigned to qiv group, tiv (b/victoria) group and tiv (b/yamagata) group in a 2:1:1 ratio. all vaccines were manufactured by sinovac biotech co., ltd.

Eligibility criteria:
inclusion criteria: * healthy volunteer between 6 - 35 months old; term birth; birth weight \>2500g; * proven legal identity; * written consent of the guardian(s) of the volunteer; exclusion criteria: * received seasonal influenza vaccine in the current year; * suffering from seasonal influenza in the past 6 moths; * axillaty temperature \> 37.0 °c; * history of allergy to any vaccine or vaccine ingredient; * history of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc; * autoimmune disease or immunodeficiency; * congenital malformation, developmental disorders; * severe malnutrition; * diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; * history of epilepsy (except febrile seizures occurred \< 2 years of age or pure epilepsy occurred within the past 3 years that does not need treatment) * chronic diseases (e.g., viral hepatitis, tuberculosis, diabetes, blood diseases, or neurological disorders) * acute disease or acute stage of chronic disease; * receipt of any of the following products: 1. any subunit vaccine or inactivated vaccine (e.g., pneumococcal vaccine) or treatment of allergy within 14 days prior to study entry; 2. any live attenuated vaccine within 30 days prior to study entry; 3. any other investigational medicine(s) or vaccine within 30 days prior to study entry; 4. blood product within 3 months prior to study entry; 5. any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry; * participate or will participate in other clinical trial(s) during this study; * based on the judgment of investigator(s) or the ethic committee, there was any condition indicating that the subject should be excluded;

Keywords: influenza vaccine quadrivalent trivalent children