Kornimate/medical-research-clean huggingface dataset:
musical dual task training to improve attention control for dementia

Conditions: Dementia

Summary: the purpose of this project is to determine if the musical dual task training program improves attention control that influences measures of gait performances under dual tasking, balance, fear of falling, and behavioral disturbance in patients with mild to moderate dementia. this musical dual task training protocol is structured with musical content and patients are required to do musical tasks including singing and playing instruments contingent on visual or auditory cues while walking. this paradigm is designed to include music making because it involves great demands on attention and memory that might elicit experience-dependent plasticity in the brain. musical dual task training is proposed to strengthen brain networking for attention control that consequently may improve the gait performances in patients with dementia, as indicated by reducing dual task cost on gait.


Eligibility criteria:
inclusion criteria: * a mild to moderate dementia diagnosis with clinical dementia rating (cdr) score: .5, 1, or 2 * ability to walk 10 meters independently without the use of a walker or cane, or the assistance by another person exclusion criteria: * other known neurologic disorders such as stroke or parkinson's disease * significant orthopedic, visual, and hearing impairment that hinders ambulation

Keywords: musical dual task training dementia attention control dual task cost gait stability
developement of questionnaire to evaluate a regularity of lifestyle in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: in order to manage of type 2 diabetic patients with irregular lifestyle, developement of an appropriate questionnaire to evaluate a regularity of lifestyle is necessary.

we have a plan to perform the seven day's records and the questionnaires which is necessary to type 2 diabetic patients for the initial step. next, we will revise a questionnaire with professional advices for several times. finally we will test a reliability with a final version as form of multisite based study and will confirm a questionnaire for a regularity of lifestyle in type 2 diabetes.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients exclusion criteria: * type 1 diabetic patients, gestational dm patients

Keywords: questionnaire developement regularity lifestyle type 2 diabetes
efficacy and safety of idelalisib in combination with bendamustine and rituximab in adults with previously untreated chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: the primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (cll) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. an increased rate of deaths and serious adverse events (saes) among participants with front-line cll and early-line indolent non-hodgkin lymphoma (inhl) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (dmc) during regular review of 3 gilead phase 3 studies. gilead reviewed the unblinded data and terminated this study in agreement with the dmc recommendation and in consultation with the us food and drug administration (fda).


Eligibility criteria:
key inclusion criteria: * documented diagnosis of b-cell cll, with diagnosis established according to international workshop on chronic lymphocytic leukemia (iwcll) * no prior therapy for cll other than corticosteroids for disease complications * cll that warrants treatment * presence of measurable lymphadenopathy * eastern cooperative oncology group (ecog) performance status of ≤ 2 key exclusion criteria: * known histological transformation from cll to an aggressive lymphoma (ie, richter transformation) * known presence of myelodysplastic syndrome * evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization * ongoing liver injury * history of non-infectious pneumonitis * ongoing inflammatory bowel disease * history of prior allogeneic bone marrow progenitor cell or solid organ transplantation * ongoing immunosuppressive therapy other than corticosteroids * received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization note: other protocol defined inclusion/exclusion criteria may apply.
effect of brief dietary intervention on ammonia levels

Conditions: Cirrhosis; Hepatic Encephalopathy

Summary: study the impact of differing meal contents on venous ammonia levels over time in patients with cirrhosis. patients will be given specific meals and venous ammonia analyzed over time after those meals. the subjects will also provide stool for microbiome and serum, urine and plasma for metabolomics during this one-time study. total duration=4 hours

patient will be instructed to collect stool for baseline assessments. after a fast (\>4h from last meal) a venous blood sample will be drawn for analysis of baseline laboratory tests and spot venous ammonia and blood and urine for metabolomics and blood microbiome. spot ammonia and blood for metabolomics and microbiome will be collected from repeat samples at 1h and 2 hrs after a standardized meals from the three groups of protein meals. urine will also be collected for metabolomics during the observation period. on the day of the study, patients will be asked to complete a standard food frequency questionnaire encompassing meals over 3 days prior to the study. subjects will be randomly assigned into 3 groups (meal types a, b and c) with the standardized meal that contains 20gm of protein. all subjects are expected to consume it in its entirety. subjects are not allowed to eat anything else until the end of the study. subjects will be observed in the unit for a total of 3 hours after the standardized meal to ensure no symptoms related to potential elevated ammonia emerge. any adverse events will be treated according to standard clinical routine.

Eligibility criteria:
inclusion criteria: 1. cirrhosis 2. able and willing to voluntarily complete the informed consent process 3. available for and agree to all study procedures 4. consistent non-vegetarian western dietary patterns for at least a month prior to the study assessed by dietary interview exclusion criteria: 1. meld score \> 23 2. unclear diagnosis of cirrhosis 3. history of liver transplant 4. body mass index \< 18.5 or ≥ 40 kg/m2 5. prior transjugular intrahepatic portosystemic shunt placement 6. treatment with systemic (e.g., oral or intravenous) antibiotic (apart from rifaximin) within 4 weeks prior to enrollment 7. for those with he: stable dose of medications (lactulose or rifaximin) without a recent (\<1 month episode of he) 8. current use of valproate, corticosteroids, or cytotoxic drugs. 9. apart from chronic liver disease, any acute or chronic medical, surgical, psychiatric, or social condition including history of cerebrovascular disease (stroke, transient ischemic attack) or dementia, that may increase the subject risk associated with study participation, compromise adherence to study procedures and requirements, confound interpretation of the results, and, in the judgment of the investigator, make the subject inappropriate for enrollment.
meningococcal quadrivalent crm-197 conjugate vaccine infant study

Conditions: Meningococcal Disease; Infections, Meningococcal

Summary: this safety surveillance study of glaxosmithkline's quadrivalent meningococcal acwy conjugate vaccine (meningococcal quadrivalent crm-197) among children 2 months through 23 months of age is a post-marketing study required by the united states food and drug administration. it is an observational study of children 2-23 months of age who receive at least one dose of menacwy-crm vaccine at a kaiser permanente southern california facility (kpsc) while enrolled as a kpsc health plan member. the objective of the infant study is to describe medical events that require emergency room visit or hospitalization in 6 months following menacwy-crm vaccination in children 2-23 months of age in a health maintenance organization in the united states. outcomes include medical events that require emergency room visits or hospitalizations in children 2-23 months of age following any dose of menacwy-crm vaccination. events with a history of the same diagnosis prior to the first dose of menacwy-crm vaccination will be excluded as a pre-existing condition.


Eligibility criteria:
inclusion criteria: * children 2-23 months of age at the time of menacwy-crm vaccination * hold kpsc membership at the time of menacwy-crm vaccination * vaccinated with menacwy-crm during the study period in kpsc exclusion criteria: * none

Keywords: safety of meningococcal quadrivalent crm-197 conjugate vaccine children 2-23 months of age
project choices efficacy study

Conditions: Risk for an Alcohol-Exposed Pregnancy; Hazardous Alcohol Use; Risk for Unintended Pregnancy

Summary: project choices efficacy study is a randomized controlled trial (rct) designed to evaluate the clinical efficacy of a brief motivational intervention aimed at reducing alcohol-exposed pregnancies(aep)in high-risk preconceptional women. the study is a multi-site collaborative study between the cdc and three universities. the hypothesis of the study is that a greater proportion of women will reduce thier risk of having an alcohol-exposed pregnancy after participating in the information plus counseling (ipc) intervention than do those in the information only(io) control group.

women at high risk for an aep are define as sexually active, fertile women who are drinking more than 7 drinks per week and/or 5 or more drinks on any one day, and are noy using effective measures to prevent pregnancy. participants will be recruited from community-based setting previously shown to have increased proportions of women at risk for aep. women in the intervention group (ipc) will receive 4 counselling sessions that include personal feedback on aep risk behaviors drawn from baseline information,consequences of alcohol use in pregnancy, assessing readiness to change risk behaviors, pros and cons of risk drinking and unprotected intercourse, goal setting to reduce risk behaviors, and a consultation visit with a family planning provider to discuss appropriate choices for pregnancy prevention based on clinical assessment. clients are counseled that there are two routes to reducing aep risk, alcohol reduction or pregnancy prevention, with the ideal being both. women in the control group (io) will receive an informational brochure that addresses healthy lifestyle behaviors, including alcohol use, and a list of referral sources for health care treatment and alcohol abuse treatment. both groups will be assessed at baseline using a full battery of measures that include alcohol and contraceptive use with follow-up measures at 3, 6, and 9 months after baseline.

Eligibility criteria:
inclusion criteria: women who: are not pregnant, are between the ages of 18 and 44 years, consume more than seven drinks per week and/or at least one binge episode (five or more drinks in one day) in the last 90 days (for the texas jail \& recovery center sites, this will be the 90 days before entering these facilities), are able to provide and do provide informed consent, are members of the special setting's population, and are available for follow-up through 9 months after recruitment. - exclusion criteria: women who: do not meet the inclusion criteria, cannot commit to provide information about how to be contacted for follow-up, or are unable to understand spoken english. -

Keywords: alcohol-exposed pregnancy binge drinking frequent drinking unintended pregnancy fetal alcohol syndrome
analysis of the aetiological factors of malnutrition

Conditions: Disease-related Malnutrition; Inflammation

Summary: disease-related malnutrition (drm) is a frequent syndrome in clinical practice, in which the mutual relationship between disease and malnutrition is observed. inflammation, anorexia, changes in body composition or in energy and protein requirements, contribute to the development of drm. the global leadership initiative on malnutrition (glim criteria) provides a diagnostic system of malnutrition that has been accepted by the main international scientific societies in the field of clinical nutrition. the glim criteria proposes an algorithm that includes phenotypic criteria (weight loss, underweight and low muscle mass), with their corresponding severity thresholds, and aetiological criteria (decreased oral intake, nutrient malabsorption and the presence of an inflammatory component). the diagnosis of malnutrition is established when an aetiological and a phenotypic criterion are met. the aim of the study is to determine the diagnostic and prognostic value of aetiological factors of malnutrition based on glim criteria, presence and degree of inflammation and dietary intake, in patients diagnosed with drm.


Eligibility criteria:
inclusion criteria: * diagnosis of drm based on glim criteria with the presence of the aetiological criterion of inflammatory component and candidate for medical nutritional treatment according to current regulations. * agreeing to voluntarily participate in the study and sign the informed consent form, after having read the participant information sheet. * presence of an inflammatory response (crp\>3 mg/dl) * having an adequate cultural level and understanding of the clinical study. exclusion criteria: * pregnant or breastfeeding women * patients with advanced liver cirrhosis or chronic hepatitis (child=c scale) * patients with advanced neoplastic disease with life expectancy \<6 months * patients with renal insufficiency with creatinine clearance less than 45 ml/min * severe infection in the last 3 weeks * taking antibiotic therapy at the time of inclusion, with the exception of prophylactic treatments * taking corticosteroids at the current time or one month prior to inclusion * treatment with biological therapies (antibodies) at the current time or one month in advance * taking non-steroidal anti-inflammatory drugs at the time of inclusion * taking omega 3 supplements for any concomitant pathology at the time of inclusion * undergoing surgery during the follow-up phase of the study * initiation of any drug during the study phase that may modify the patient's inflammatory pattern at the investigator's discretion * any criterion that, in the opinion of the principal investigator, could condition the conduct of the study.
weakness and atrophy: isokinetic with surface electromyography assessment in acl surgery

Conditions: Anterior Cruciate Ligament Injury; Muscle Weakness

Summary: an assessment of the effect of surgical anterior cruciate ligament (acl) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. however, if a large number of studies had rated surgical technics, giving high results level for acl reconstruction (aclr), muscle recovery is still conditioning functional success. furthermore there is no consensus about criteria in return to sport. the aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation of muscle thigh after acl surgery.

the aim of this study is to assess the qualitative and quantitative variations of the strength, work and fatigue of the thigh muscles after acl surgery. the reference is the preoperative assessment (v1), the variation is measured on v2 (measurements at 3 months) and v3 (measures at 9 months). each patient is his own control. in addition, a control group of healthy subjects is used to determine level of significance of each parameter.

Eligibility criteria:
inclusion criteria: aclr group : * men or woman * 18 to 45 years old * no injuries sequels on contralateral limb * no contraindication to magnetic resonance imaging control group : * men or woman * 18 to 45 years old * no limb injuries sequels * no contraindication to magnetic resonance imaging exclusion criteria: * age less than 18 years * limb injuries sequels * contraindication to magnetic resonance imaging

Keywords: knee muscle strength fatigue mri acl
evaluation of the muscular force in the upper limbs of patients presenting a thoracic outlet syndrome

Conditions: Thoracic Outlet Syndrome

Summary: the thoracic outlet syndrome is a rare but debilitating pathology, responsible for upper limb pain. its frequency is probably underestimated because of diagnostic difficulties. this syndrome encompasses several entities including compressions of neurological, venous or arterial origin. in addition to pain, the majority of patients report fatigability and loss of strength in the upper limbs. however, the quantification of this loss of strength and fatigability has hardly been studied. in addition, the rehabilitation treatment is the first-line treatment of this pathology. it most often includes a muscle building phase. in this project, we would like to evaluate the proximal and distal force of patients presenting a thoracic outlet syndrome by comparing them to a population free from any pathology in the upper limbs. this evaluation would involve an isokinetic strength analysis of shoulder rotators at the proximal level, using an isokinetic dynamometer. at the distal level, the evaluation would be done using force clamps.similarly, performing a 6-minute walk test will assess whether there is a difference between patients and controls, which may also impact endurance in addition to the pathology. in a second step, we will also be able to evaluate the effects of the reeducation on the strength and the muscular fatigability of the patients presenting a thoracic outlet syndrome.


Eligibility criteria:
inclusion criteria: * age\> 18 years * rehabilitative management of an thoracic outlet syndrome in the physical and rehabilitation department of nantes university hospital * having given their consent by non-oral opposition. * affiliated to a social security scheme exclusion criteria: * mineurs * majeurs under tutorship, curatorship or safeguard of justice * pregnant or lactating women, protected persons * patients with other pathology of the upper limb or shoulder (osteoarthritis, tendinopathies, amputation, ...). * patients with non-stabilized pathologies, heart, respiratory, metabolic or neurological conditions * associated pathology able to interfere with carrying out assessments
cer-001 atherosclerosis regression acs trial

Conditions: Acute Coronary Syndromes

Summary: the purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg cer 001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as measured by coronary ivus, when administered to subjects presenting with acute coronary syndrome (acs) with significant plaque volume.

subjects will be required to have at least one epicardial coronary artery suitable for ivus imaging. a suitable target artery for ivus imaging will be determined at baseline as having stenosis of up to 50% and meeting all angiographic inclusion criteria. subjects having met all eligibility criteria will be randomized to receive an intravenous infusion of cer 001 (3 mg/kg) or placebo within 14 days of event presentation. randomized subjects will then return at 7 day intervals for nine additional infusions. a follow up ivus will be conducted at 14 days after the last infusion. the total study duration from randomization to follow up ivus for a completed study can range from approximately 9 to 12 weeks.

Eligibility criteria:
inclusion criteria: * male or female greater than 18 years of age * acute coronary syndrome (myocardial infarction or unstable agina) * angiographic evidence of coronary artery disease with suitable "target" coronary artery for ivus evaluation exclusion criteria: * females of child-bearing potential * angiographic evidence of \>50% stenosis of the left main artery * uncontrolled diabetes (hba1c\>10%) * hypertriglyceridemia (\>500 mg/dl) * congestive heart failure (nyha class iii or iv) * ejection fraction \<35% * uncontrolled hypertension (sbp \>180 mm hg) * known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction

Keywords: acs ivus hdl
impact of metformin on immuno-virologic parameters in hiv

Conditions: HIV/AIDS

Summary: non-diabetic, aviremic hiv-infected individuals on antiretroviral therapy (art) will be randomized to metformin therapy or to observation for 72 weeks. primary objective is to assess change over 72 weeks in cd4 t cell negative checkpoint receptors (pd-1 and tigit). as secondary objectives the study will look at 72 week change in other immuno-virologic parameters (cd8 t cell negative checkpoint receptors, plasma indoleamine 2,3-dioxygenase (ido) levels and cd4 t cell and monocyte intracellular hiv dna and hiv rna. the study will also explore the 72 week impact of metformin on change in carotid intima-media thickness (cimt) as a surrogate marker of atherosclerosis, on neuropsychological (np) performance, strength, and change in body composition.


Eligibility criteria:
inclusion criteria: * hiv+ * on suppressive art stable for \> 1 year * plasma hiv rna \ 200 copies/ml within the past 6 months prior to entry * age \>40 years * ability and willingness to provide written informed consent exclusion criteria: * uncontrolled chronic medical condition or cancer * acute illness within 2 weeks of entry * diagnosis of diabetes by history, fasting blood glucose \>126, or by hgba1c \> 6.5 * chronic, uncontrolled diarrhea * known hypersensitivity or contraindication to metformin use * current presence of hepatitis c including currently on or intent to start therapy for hepatitis c within the 48 week duration of study. * serum b12 level below the reference normal range as listed by the commercial lab utilized for this study (diagnostic laboratory services) * pregnancy, or intent to become pregnant or nursing an infant * any immunomodulator, hiv vaccine, any other vaccine, or investigational therapy within 30 days of study entry. * current uncontrolled coronary artery disease or nyha class 3 or 4 congestive heart failure * history of liver cirrhosis * current use of zidovudine, stavudine or didanosine * the following lab values * hemoglobin \< 9.0 g/dl * absolute neutrophil count \< 1000/μl * platelet count \< 50,000/μl * ast (sgot) and alt (sgpt) \> 5x upper limit of normal (uln) * calculated creatinine clearance (cockcroft and gault) \< 50 ml/min * active or recent past history (within past 2 years) of illicit substance or alcohol use or abuse which, in the judgment of the investigator, will interfere with the patient's ability to comply with the protocol requirements * patients, who, in the opinion of the investigator, are unable to comply with the dosing schedule and protocol evaluation or for whom the study may not be advisable