Kornimate/medical-research-clean huggingface dataset:
effects of group music therapy interventions on alzheimer's disease patients: a three-arm randomized controlled blind study.

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine what type of music therapy (active versus passive) approach has higher effects on clinical symptoms in advanced alzheimer's disease patients

ninety ad patients from six nursing homes participated in the study. nursing homes were randomly and blindly assigned to receive for three months either active music intervention, passive music listening or usual care. effects on cognition, behaviour, daily living activities and motor function were assessed after the intervention.

Eligibility criteria:
inclusion criteria: * nursing-home dwelling * diagnosis of probable alzheimer's disease * mild or moderate stage (clinical classification of the dementia) exclusion criteria: * aphasia * hearing impairment that may affect participation in the activities.

Keywords: alzheimer's disease cognition. behaviour function motor function active music therapy passive music therapy
a study of ly3025876 in participants with diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the main purpose of this study is to assess the safety and tolerability of ly3025876 given alone (part a) and in combination with liraglutide (part b) in participants with type 2 diabetes mellitus (t2dm).

this study will also evaluate how much of the study drug enters the blood stream and how long it takes for the body to remove the study drug. information about any side effects that may occur will also be collected. participants will continue their usual diet and exercise program and may remain on their physician-prescribed dose of metformin. each part of the study is expected to last 10 to 12 weeks on average, not including screening. participants may only enroll in one part.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus (t2dm) as determined by the investigator, controlled with diet or exercise alone or on a stable dose of metformin for at least 30 days * have a body mass index (bmi) greater than or equal to 23 and less than or equal to 45 kilograms per square meter (kg/m\^2) at screening * have a supine blood pressure reading at screening of between 90-160 millimeter of mercury (mmhg) (systolic) and 40-95 mmhg (diastolic) * women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause exclusion criteria: * have taken ly3025876 or investigational drugs like it (for example, other fibroblast growth factor-21 \[fgf21\]-related drugs) or have known allergies to these drugs * history or presence of bone disease (including osteoporosis or unhealed fractures) * current active treatment of periodontal disease * have had a significant change in weight, defined as a gain or loss of at least 4 kilogram (kg) (9 pounds) in the last 3 months * have had greater than 1 episode of severe hypoglycemia within 6 months of screening that required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions or had a seizure or coma * have known allergies or a history of intolerance to liraglutide, glucagon-like peptide 1 (glp-1) analogues, or other related compounds * have a history of acute or chronic pancreatitis * have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
whole-body mri for the detection of metastasis

Conditions: Breast Cancer; Metastases

Summary: develop and optimize protocols for whole body mri for detection of metastases. evaluate diagnostic accuracy through application of optimized protocols for screening of cancer patients.


Eligibility criteria:
inclusion criteria: - cancer patient exclusion criteria: * poor general condition * pacemaker or other mri contraindications

Keywords: magnetic resonance imaging data accuracy reproducibility of results diagnosis
socknleg compression stocking kit: physical properties

Conditions: Venous Insufficiency of Leg

Summary: this study evaluates physical properties of a innovative leg compression stocking compared to a standard compression stocking of the same compression strength in patients with chronic venous insufficiency clinical stadium c3 and above, according to the ceap classification for chronic venous insufficiency. the physical properties can be measured through a series of measurements. the hypothesis is that the innovative compression stocking, although changed in design to be more easily donned, will perform as good as the standard compression stocking. in each participant the examinations will be conducted with both stockings. a computer generated list will allocate each participant to either one of the stockings, with which the examinations will be conducted first.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * male or post-menopausal women over the age of 65 * diagnosed chronic venous insufficiency stage c3-c6 (according to ceap classification) * indication of a compression therapy by medical compression stocking exclusion criteria: * peripheral artery disease (pad) or calcinosis (ankle-brachial-index \ 1.3 * suspected polyneuropathy with ≤4 sensible test areas measured with the semmes- weinstein-monofilament-test * advanced heart insufficiency (nyha iii-iv) * contraindications to compression therapy * known allergies to any components of the stocking material * inability to follow the procedures of the study
impact of moderate preterm birth on vocabulary acquisition

Conditions: Premature Birth

Summary: children born prematurely may present a neurodevelopmental disorder with a language delay diagnosed as early as 2-3 years of age. this situation is not uncommon: each year in france, approximately 35,000 children are born between 32 and 36 weeks of amenorrhea. in our most recent work, we have shown that moderate premature infants show an attenuated cortical response to a vowel change, suggesting a deficit in the cortical encoding of vowels. this work needs to be continued in order to better understand syllable encoding and identify the neuroplasticity mechanisms underlying early speech encoding. the identification of markers to predict language development is essential for the screening of these children at risk of language delay. these children could thus benefit from early adapted care even before the appearance of language deficits.


Eligibility criteria:
inclusion criteria: * infants born prematurely (32-36 weeks gestational age, ga) or at term (40-2 weeks gestational age, ga) * birth weight appropriate to gestational age determined by who growth charts (weight, height, head circumference) * normal clinical examination at inclusion. * written informed consent obtained from both parents (or single parent if single parent) * infant with at least one parent who speaks and understands fluent french * infant is affiliated with the social security system * infant whose parents reside in marseille exclusion criteria: * neonatal distress (apgar score \< 7) * hypoxic and ischemic encephalopathy * perinatal acidosis * intrauterine growth retardation * brain injury (such as intraventricular or periventricular hemorrhage, periventricular leukomalacia) * cerebral congenital malformations * neonatal epilepsy * any condition that in the opinion of the investigator would not be compatible with the conduct of this study * abnormal hearing test performed as part of the child's routine care at birth,

Keywords: speech acquisition prematurity sounds processing eeg
donepezil hcl & cognitive deficits in autism

Conditions: Autistic Disorder

Summary: this 11-week study will examine the safety and effectiveness of the medication donepezil (aricept®) compared to placebo for treating cognitive deficits in children and adolescents with autism spectrum disorder.

children with autism spectrum disorder (asd) often have impaired communication, problems with social interaction, and repetitive and stereotyped patterns of behavior. while most research has attempted to treat the behavioral deficits commonly associated with asd, few studies have attempted to improve the core features of this disorder. a recent study found that donepezil hcl helped to improve speech production, attention span, and ability to express emotions in a group of children with autism. this study will provide an opportunity to conduct further testing of the effects of donepezil hcl on the cognitive deficits presumed to underlie the core features of asd. this study begins at week 1 with a baseline assessment. participants are then randomly assigned to either donepezil hcl or placebo. participants will start with either a 5mg/day dose of donepezil hcl or placebo followed by a cognitive assessment after 4 weeks on this dose. participants will then have their dose increased to 10mg/day. another cognitive assessment will be given after 4 weeks on this dose.

Eligibility criteria:
inclusion criteria: * autism spectrum disorder (asd) * asperger's disorder * iq of 75 or above * baseline assessment tests within the acceptable range exclusion criteria: * bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder * seizure disorder requiring the use of anticonvulsant medications * congenital rubella, cytomegalovirus, or tuberous sclerosis * certain medications prescribed for management of behavior (please contact the investigator for a complete list) * medications/preparations that are known to interact with donepezil hcl * significant medical illness, endocrinopathies, cardiovascular disease, or severe chronic malnutrition * pregnancy or sexually active females not using a reliable method of contraception
a systematic review of studies of the effect of influenza vaccine against mismatched strains

Conditions: Influenza

Summary: the purpose of this study is to consolidate the cross-protection offered by influenza vaccines against circulating influenza a or b viruses that are not antigenically well-matched to vaccine strains and to determine the degree of cross-protection separately for influenza a and influenza b, through a systematic review of the literature.

the research question of this project is: "what is the cross-protection afforded by vaccination (using an laiv, tiv, or other type of vaccine) against influenza a or b and their subtypes and lineages?" the preferred reporting items for systematic reviews and meta-analyses (prisma) statement will be used to guide the reporting of this review. studies reporting cross-protection data after vaccination with approved formulations of influenza vaccines with influenza a or b will be included. inclusion will not be limited by publication status, or year of dissemination but will be limited to randomized clinical trials (rcts) and quasi-rcts comparing influenza vaccine(s) with placebo. only rcts written in english will be included. a meta-analysis will be conducted if there is sufficient data.

Eligibility criteria:
inclusion criteria: * healthy children, adults or the elderly will be included that participated in randomized clinical trials (rcts) and quasi-rcts comparing influenza vaccine(s) with placebo. * placebo-controlled randomized clinical trials (rcts) reporting laboratory-confirmed influenza among healthy participants vaccinated with antigens of influenza strains that differed from those circulating. * all influenza vaccines will be included, and will be categorized as tiv, laiv, and others (that is, non-tiv or non-laiv). * only rcts written in english will be included. exclusion criteria: * rcts which are not providing any data will be excluded. * studies using rapid influenza diagnostic tests will not be included, as their sensitivity is low (especially during flu season) and false positives are common during low activity seasons. * laboratory-confirmed influenza through antibody assay as part of the primary outcome will not be included, as this is a less sensitive test than pcr and viral culture.

Keywords: influenza systematic review meta-analysis mismatched strains cross-protection
edg004 treatment of adult patients with generalized anxiety disorder (gad)

Conditions: Generalized Anxiety Disorder (GAD)

Summary: to evaluate the efficacy of edg004 compared to placebo for the treatment of adult patients with gad, diagnosed by diagnostic and statistical manual of mental disorders, 5th ed. (dsm-5) and confirmed by the mini international neuropsychiatric interview (mini 7.0). efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated hamilton rating scale for anxiety (ham-a) for the edg004 treatment group compared to placebo.


Eligibility criteria:
inclusion criteria: * men and women between the ages of 18-65 years and * diagnosed with gad and * no other psychiatric conditions, and are otherwise medically healthy. exclusion criteria: * women who are pregnant or lactating.
the gabaergic inhibitory system in drug resistant epilepsy

Conditions: Drug Resistant Epilepsy; Temporal Lobe Epilepsy

Summary: this study aims to investigate the effect of lovastatin on neurotransmission and neuroinflammation in patients with temporal lobe onset drug resistant epilepsy. structure: (1) visit 1: 3 consecutive days of physiologically probing drug/placebo intake, (2) visit 2: outcome measures and additional evaluations in the day after the last drug/placebo intake, (3) washout period of 4 weeks, (4) 3 consecutive days of drug/placebo intake, (5) visit 3: outcome measures and additional evaluations in the day after the last placebo/drug intake.

this study investigates the potential therapeutic effects of lovastatin, a drug known for its anti-inflammatory and neuroprotective properties, in patients with temporal lobe drug-resistant epilepsy (dre). emerging evidence suggests that inflammation plays a significant role in epileptogenesis, and preclinical models of epilepsy have demonstrated the efficacy of statins in reducing seizure susceptibility. this pilot, double-blinded, placebo-controlled crossover study included five participants with focal-onset dre. the primary objectives were to evaluate the impact of lovastatin on cortical inhibition, oxidative stress, and seizure activity. participants received 60 mg/day of lovastatin or placebo for a specified period, with treatment phases separated by a washout period. key assessments included magnetic resonance spectroscopy (mrs) to measure brain metabolites such as gaba, glutamate, and glutathione in the occipital cortex. event-related potentials (erp) were recorded during a facial recognition task to examine visual evoked potentials, while resting eeg was used to analyze interictal epileptiform discharges (ieds).

Eligibility criteria:
inclusion criteria: * diagnosis of pharmacoresistant epilepsy as defined by the international league against epilepsy, * focal temporal lobe onset * nonpregnant and nonlactating in women exclusion criteria: * history of cardiovascular or cerebrovascular disease, * history of dyslipidemia, previous use of statins or a previously documented adverse reaction to statins, * having any metal inside the head but outside the mouth, * implanted devices such as cardiac pacemakers or cochlear implants, * having a vagal nerve stimulation device and the presence of other comorbid neurologic conditions
impact of the relaxation response resiliency program on patients with atrial fibrillation

Conditions: Atrial Fibrillation; Stress; Quality of Life; Anxiety; Depression; Hostility

Summary: the purpose of this study is to determine if an eight week multimodal relaxation response resiliency program (3rp) intervention can effectively improve symptom severity, frequency and quality of life (q.o.l) in atrial fibrillation (af) patients. this will be measured by a reduction in af symptom score, perceived stress, anxiety, hostility and depression.

atrial fibrillation (af) is a very common cardiovascular disease. symptoms include dizziness, palpitations, lightheadedness, shortness of breath, fatigue and exercise intolerance. af is also associated with a high risk of complications like thrombo-embolism and stroke, heart failure, dementia. the presence and severity of these symptoms and complications adversely affect a patient's health related quality of life. improvement in quality of life (qol) is an important measure for evaluating response to treatment in af patients. depression and anxiety are significant part of the psychosocial burden faced by approximately one-third of af patients, and are important components that effect qol in these patients. in this study the investigators will apply the 3rp (relaxation response resiliency program - developed at the benson henry institute at massachusetts general hospital) intervention among af patients to assess the reduction in their stress, anxiety and depression levels and the reduction in af symptom burden and severity.

Eligibility criteria:
inclusion criteria: 1. age: 18-90 years 2. diagnosed with documented recurrent symptomatic paroxysmal atrial fibrillation 3. currently on stable medical therapy for af and willing to continue on the same treatment regimen for 8 weeks while participating in the study. 4. no current or prior practice of yoga, meditation, guided imagery or other techniques that elicit relaxation response (rr). 5. able to provide informed consent and to understand written and spoken english. exclusion criteria: 1. end stage renal failure or heart failure, severe unstable medical or psychiatric disease 2. patients deemed unable to complete protocol due to cognitive or other reasons. 3. patients on psychoactive medications will have eligibility determined by the pi or md co-investigator on a case-by-case basis, and will be admitted to the study if medication is deemed stable

Keywords: atrial fibrillation relaxation response resiliency program intervention af symptom severity and burden stress, anxiety, depression and hostility quality of life af qol 3rp
a study to measure the effect of tolterodine extended release on the thickness of the bladder wall in patients with overactive bladder

Conditions: Urinary Incontinence

Summary: the main aim of the study is to investigate whether taking tolterodine for overactive bladder symptoms can reduce the thickness of the bladder wall, as measured by intra-vaginal ultrasound. this will help doctors to understand whether there is a link between changes in the thickness of the bladder wall and progression of symptoms.


Eligibility criteria:
inclusion criteria: * symptoms of overactive bladder (described as urinary urgency, with or without urge incontinence, usually with frequency and nocturia for more than 6 months * bladder wall thickness of 5mm or more exclusion criteria: * treatment in the previous four weeks with an anticholinergic drug or any drug for the treatment of overactive bladder. * significant stress incontinence - urinary tract infection or a history of intermittent urinary tract infections (more than four episodes in the last two years). * conditions considered significant by the investigator (e.g. cystocoele, significant bladder prolapse, bladder stone, indwelling catheter etc)
visceral obesity and colorectal surgery

Conditions: Visceral Obesity; Colorectal Surgery; Risk Factor

Summary: while perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value as independent parameter in predicting postoperative complications after colorectal resection remains poorly investigated. the investigators want to test the value of perirenal fat as surrogate of visceral obesity as risk factor for morbidity in colorectal surgery and to compare it to the effect of body mass index (bmi) and waist- hip ratio (whr).


Eligibility criteria:
inclusion criteria: * elective colorectal resection exclusion criteria: * age under 18 * emergency condition * immunosuppression
a phase 1, open-label, multicenter, dose escalation study of ibi363 (pd1-il2m) in subjects with advanced solid malignancies or lymphomas

Conditions: Solid Malignancies or Lymphomas

Summary: this is a phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and dlts to establish the maximum tolerated dose (mtd) or maximum administered dose (mad), and the rp2d of sequential doses of ibi363 (study drug) in subjects with advanced, refractory solid malignancies or lymphomas.


Eligibility criteria:
inclusion criteria: 1. male or female subjects, ≥ 18 years 2. subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; subjects with documented lymphomas 3. subjects with a malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor 4. subjects who are refractory to or intolerant to existing therapy(ies) known to provide clinical benefit note: subjects may have received and failed prior therapy with a pd-1/pd-l1 inhibitor and be considered eligible for this trial. 5. subjects with measurable or non-measurable disease according to recist v1.1 or standard criteria for lymphoma (lugano 2014) 6. subjects, both male and female, who are either not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug 7. subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol exclusion criteria: 1. women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. women of childbearing potential (wocbp) or fertile men with wocbp partner(s), not using and not willing to use a highly effective method of contraception. 2. subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. 3. subjects with: * active thrombosis, or a history of deep vein thrombosis (dvt) or pulmonary embolism (pe) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the investigator to be stable. * active uncontrolled bleeding or a known bleeding diathesis.
effects of lumbar spinal manipulation in subjects with chronic low back pain

Conditions: Low Back Pain

Summary: this study aims to measure the effects of spinal manipulation on chronic spinal pain by assessing muscle mechanical properties (mmps) using myotonpro®, mechanical perception threshold (mpt) using von frey monofilaments, and pressure pain threshold (ppt) using an algometer. participants will be randomly assigned to either spinal manipulation or placebo groups to compare effects on mmps, mpt, and ppt. assessments will occur at three time points: baseline, immediately post-intervention (real or simulated), and 24 hours post-intervention. this research targets individuals with chronic spinal pain, providing insights into the potential benefits of spinal manipulation in managing this condition.


Eligibility criteria:
inclusion criteria: * subject with chronic low back pain exclusion criteria: * spinal trauma or surgery history. * spinal congenital deformities. * inflammatory or autoimmune disease * herniated disc in the segment l5. * pregnant women. * body mass index \&gt; 30kg/m2 * subjects that have received treatment for low back pain in the seven days prior to the study.

Keywords: manipulation, spinal muscle mechanical properties pain threshold perception threshold