Kornimate/medical-research-clean huggingface dataset:
palliative outcome evaluation muenster i

Conditions: Cancer; Chronic Heart Failure; COPD Exacerbation; Palliative Care

Summary: for patients with an advanced disease and their families an excellent and compassionate care is essential. however, in hospitals optimal end-of-life care is not yet fully realized and patient's needs are often not met. palliative care is able to increase patients' quality of life and to carefully meet their and their families' needs. to improve the awareness of unmet needs patient-reported outcome measurement has been the pivot of latest palliative care research. besides the improvement of care outcome measurement allows the evaluation of the quality of palliative care and comparisons on a national and international level. the aim of the present study is to evaluate the quality of palliative care in different settings (palliative care unit, inpatient and outpatient consultation teams) using the integrated palliative care outcome scale (ipos). the ipos has been lately developed as improved follow-up version of the palliative care outcome scale (pos) integrating most important questions and simultaneously being brief and comprehensive. the study is planned as a multi-centric observational study. primary endpoint is the reduction of symptom burden of patients. the clinical study hypothesis bases on the assumption that palliative care can change the symptom burden, measured by a change in the ipos overall profile score, and that there might be a difference in the size of the effect depending on the caring setting.

after the enrolment and consent of participation the patient receive a questionnaire consisting of three independent assessments: to assess the symptom burden and specific palliative care needs the integrated palliative outcome scale (ipos) is used. to measure the generic health-related quality of life the patient has to answer the euroqol group 5-dimension 5-level self report questionnaire (eq-5d-5l). to get an opinion of the general condition the patient is to complete the nccn distress thermometer which includes a visual analogue scale (with values from 0 to 10). meanwhile, a professional palliative caregiver completes a questionnaire about the main demographic aspects of the patients and assess the palliative care needs and the symptom burden using the ipos. after one week both, patient and professional palliative caregiver, will receive the same questionnaires again to assess the change from baseline.

Eligibility criteria:
inclusion criteria: * indication for palliative care due to any advanced life-limiting and progressive disease * 18 years and older exclusion criteria: * age under 18 years * pregnant or breastfeeding women * inability to understand information for participation * refusal of participation
effects of sedentary behaviour on metabolic parameters

Conditions: Sedentary Lifestyle; Type 2 Diabetes

Summary: the rates of sedentary activity are increasing. studies have shown that time spent on doing sedentary activities is an independent risk factor for cardiovascular disease. prior studies have shown that interrupting inactivity improved the body's handling of blood glucose and gene expression. the investigators plan to explore this further by examining the effects of interrupting 4 hours of inactivity with 2 minutes of moderate intensity exercise every 20 minutes on the following metabolic parameters: blood pressure, cortisol, c-reactive protein, glucose and insulin levels.

there is a current trend towards increasing time spent in sedentary behaviour. more jobs are being automated, and more time is spent in front of a computer, playing video games and watching television.current studies suggest that sedentary behaviour is an independent risk factor for cardiovascular disease. increasing time spent in sedentary behaviour has been linked to all-cause mortality, markers of cardiovascular disease and metabolic syndrome. however, the data is mainly from cross-sectional studies and based on self-recall, limiting the ability to draw definitive conclusions. current exercise guidelines recommend at least 150 minutes of moderate to vigorous intensity exercise per week. it may be difficult for some elderly people to meet these guidelines. older adults with diabetes are already at a higher risk fo conditions that are affected by sedentary behaviour and may stand to benefit the most from intervention. this study proposes to study the effects of breaking up sedentary activity with moderate intensity exercise on multiple metabolic parameters in older adults with diabetes.

Eligibility criteria:
inclusion criteria: * 65 years of age or older * type 2 diabetes managed with diet or oral hypoglycemic agents exclusion criteria: * using insulin to manage diabetes * baseline of pre-session blood glucose reading equal to or greater than 10 mmol/l * any medical condition that would limit the ability to perform activity portion of the study * people not comfortable exercising on a stationary bicycle * subject answers yes to one of more of the questions in the physical activity readiness questionnaire

Keywords: exercise sedentary behaviour type 2 diabetes older adults
effectiveness of board game on improving elementary school students' infection control

Conditions: Knowledge of Infection Control; Attitude of Infection Control; Behavioral Intentions of Infection Control

Summary: the goal of this clinical trial is to learn if board game can improve elementary school students' infection control intentions. the investigators use the theory of planned behavior (tpb), which includes three main factors: attitude, subjective norm, and perceived behavioral control. the main questions it aims to answer are: 1. exploring the factors influencing children's behavioral intentions of infection control through theory of planned behavior? 2. the effectiveness of board game on improving children's knowledge and behavioral intentions of infection control? researchers will compare gamified instruction to conventional lesson lecture to see if the former has better results. students who participated in filled out the questionnaire three times, each time taking about 15 to 20 minutes: before the intervention, after the intervention, and after a one-month delay. the students' legal representatives filled out a basic demographic questionnaire before intervention, which took about 5 minutes. after a one-month delay, two groups of students were asked to filled out the post-test questionnaire again. then, students in the control group were invited to participate in a board game and asked which teaching method they preferred (gamified instruction or conventional lesson lecture).


Eligibility criteria:
inclusion criteria: * students in fifth to sixth grade of the elementary school (10 to 13 years old) and their legal representatives must fill in the informed consent form. exclusion criteria: * n/a

Keywords: gamification child communicable diseases theory of planned behavior
memantine for spasticity in ms patients

Conditions: Multiple Sclerosis

Summary: participants (n=20) will be identified at routine care visits performed at the rochester multiple sclerosis center. eligible participants will have ms by mcdonald criteria,7 and will have a modified ashworth spasticity rating8 of two or higher in at least one lower extremity muscle group. participants will be seen at screening, one, and three months, and will be evaluated using the modified ashworth scale,8 pendulum test,9 toe tapping test,10 manual muscle testing,11 timed 25 foot walk,12 and multiple sclerosis functional composite.13 the type and severity of any adverse events will be recorded using standard definitions. participants will be instructed to call between visits to inform the investigators regarding any adverse events they experience. follow-up will continue until all adverse events resolve or stabilize.

this is a randomized, placebo controlled, double-blind, parallel group trial of memantine in patients with ms and spasticity. participants will be identified at routine care visits at the rochester multiple sclerosis center. after obtaining informed consent, patients will undergo screening, which will include a physical/neurologic exam and an assessment of the expanded disability status scale, spasticity, and functional abilities. eligible patients will return for a baseline evaluation, will initiate their randomly assigned study medication, and will return after one and three months for re-evaluation. the type and severity of any adverse events will be recorded using standard definitions. participants will be instructed to call between visits to inform the investigators regarding any adverse events they experience. follow-up will continue until all adverse events resolve or stabilize.

Eligibility criteria:
inclusion criteria: 1. multiple sclerosis by mcdonald criteria. 2. spasticity. a minimum score of two on the ashworth spasticity scale in at least one lower extremity muscle group and a total score of at least four in the lower extremity muscles tested. 3. age 18-70. 4. normal renal function (estimated crcl \> 50 ml/min). 5. women of childbearing potential (i.e., those not postmenopausal or surgically sterile) may participate provided that they are using adequate birth control methods (including barrier methods, iud, and oral contraceptives) for the duration of the study. 6. willing and able to perform all procedures related to the clinical trial and to provide informed consent. exclusion criteria: 1. evidence of clinically significant thyroid, gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, neoplastic, endocrine (including diabetes mellitus), neurologic (other than ms), or other medical or psychiatric disorder at screening. 2. women must not be pregnant or lactating. serum or urine pregnancy tests will be required prior to randomization for women of childbearing potential unless the last menstrual period started less than 28 days prior to randomization.

Keywords: multiple sclerosis
safety and efficacy study of oc000459 dosed twice daily for 28 days in asthmatic subjects

Conditions: Asthma

Summary: the purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of oc000459 in comparison to placebo on clinic lung function (fev1) in mild to moderate asthmatics with an fev1 of 60-80% of predicted and requiring only short acting inhaled b2-adrenergic agonists for symptomatic control.


Eligibility criteria:
inclusion criteria at screening: * male or female asthmatics, any racial group. females of childbearing potential must practise two forms of contraception * non smokers * mild to moderate asthmatics according to gina guidelines for at least 12 months. * history of asthma symptoms increasing in response to external allergens. * testing positive on skin prick test to an allergen associated with the subject's asthma exclusion criteria: * use of inhaled or local corticosteroids in the period from 28 days prior to screening. * receipt of prescribed or over the counter medication within 14 days of the first study day.
w-suds for covid-19

Conditions: Substance Use Disorders; Alcohol Use Disorder

Summary: the purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the covid-19 pandemic. this study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during covid-19.


Eligibility criteria:
inclusion criteria: * all genders aged 18-65 years * access to a smartphone * available and committed to engage with app and complete assessments * be willing to provide email address (as this is how assessment incentives will be distributed), * literate in english (as w-suds conversational and video materials will be in english). exclusion criteria: * pregnancy (as w-suds will not be specifically developed to address the unique needs of this population) * history of severe drug/alcohol use * history of opioid misuse without medication-assisted treatment * suicide attempt within the past year * opioid overdose within the past year
smallest significant value in osteodensitomery in an obese population

Conditions: Obesity

Summary: the aim of this study is to determined the smallest significant value in osteodensitometry in obese population. the study population will be divided in 3 groups according to their bmi. bone mineral density will be measured twice in osteodensitometry, then the smallest significant value will be determined. our hypothesis is that the smallest significant value that we use in an non-obese population can be different in an obese population.

the aim of this study is to determined the smallest significant value in osteodensitometry in obese population. there will be at least 120 patient included. the study population will be divided in 3 groups according to their bmi : the first group has a bmi between 30 and 35 kg/cm² ; the second group has a bmi between 35 et 40 kg/cm² ; and the third group has a bmi over 40 kg/cm². patients will be referred by their doctors (rheumatologist and others) to evaluate their bone mineral density in osteodensitometry at chu of reims. patients will be informed of the aim of the study by the prescriptor of the osteodensitometry. the osteodensitometry will be executed by a nurse. patients will have to complete a questionnaire about their medical history and their medications. bone mineral density will be measured twice in osteodensitometry, at the lumbar spine, the hip and the femur. this exam lasts approximately 40 minutes. then the smallest significant value will be determined by comparing each measure for every patients.

Eligibility criteria:
inclusion criteria : * major patients * patients referred to the chu of reims to make an osteodensitometric evaluation of their bone mineral density * bmi \> 30 kg/cm² * patient affiliated to a health insurance plan * patients who have signed informed consent exclusion criteria : * minor patients * pregnant women * patients protected by the law

Keywords: bone density osteoporosis osteopenia obesity osteodensitometry
cognitive behavioural therapy in dissociative seizures

Conditions: Dissociative Seizures

Summary: the purpose of this study is to determine whether adults with disoociative (psychogenic non-epileptic) seizures receiving cognitive behavioural therapy (cbt) show a greater reduction in seizures and health service use and greater improvement in employment status and overall psychosocial functioning than patients who receive standard care.

preliminary results from a pilot study demonstrated that cognitive behavioural therapy (cbt) is associated with a significant benefit for patients with dissociative seizures. the current study aims to extend these findings by conducting a randomised controlled trial comparing cbt with standard outpatient medical care. standard outpatient care has been chosen as the comparison treatment as it most closely resembles what is currently offered to this group of patients by the national health service. the primary outcome measure will be seizure frequency. secondary outcome measures will be work and social adjustment and health service use. our hypothesis is that cbt will be superior to standard outpatient care for patients with dissociative seizures as determined by the above measures.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of dissociative seizures * diagnosis confirmed by video eeg telemetry where practicable * aged 16 - 70 exclusion criteria: * co existent diagnosis (past or present) of epilepsy * seizure frequency of less than 2 seizures per month * current alcohol or drug abuse * benzodiazepine use exceeding the equivalent of 10mg diazepam per day.

Keywords: non epileptic seizures cognitive behavioural therapy dissociative disorders seizure disorders randomised controlled trial
impact of physician directed education on patient compliance with hepatitis c therapy

Conditions: Chronic Hepatitis C; Genotype 1

Summary: the purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis c patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.

the new treatment paradigm for hcv in the era of protease inhibitors will add a level of complexity that was previously not seen with pegylated interferon and ribavirin. in addition to new concepts such as utilization of a lead-in period, compliance with a tid dosing regimen of a third agent, development of resistance, and futility rules and decision points have yet to be assessed in a real life practice setting. the optimal trial is designed to evaluate the impact of an education program for community sites participating in a cldf study treating chronic hcv genotype 1 patients. group a will be comprised of approximately 30 cldf designated hepatology centers of educational expertise (hcee) and group b will be comprised of approximately 60 community sites. group a will also deliver the educational program regarding the use of hcv protease inhibitors, and the overall treatment of hcv to approximately two (2) community sites in it's geographic region. group b will be comprised of community sites that have no previous clinical trial experience with boceprevir or an hcv protease inhibitor. for the purpose of this study, each community site in group b will be assigned to an hcee.

Eligibility criteria:
inclusion criteria: * chronic hepatitis c (hcv) genotype 1 * detectable hcv-rna within 180 days of screening * age ≥ 18 years * weight \> 40 kg * patient and partner(s) must agree to use acceptable methods of contraception * written informed consent exclusion criteria: * known co-infection with hiv or hbv * previous interferon or ribavirin regimen requiring discontinuation for an adverse event considered related to ribavirin and/or interferon * currently taking or planning on taking any prohibited medications * evidence of decompensated liver disease including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy * diabetes and/or hypertension with clinically significant ocular examination findings * pre-existing psychiatric condition(s) * history of severe and uncontrolled psychiatric disorders * active alcohol or drug abuse (not including marijuana) * pre-existing medical condition that could interfere with the patient's participation in the study * chronic obstructive pulmonary disease * abnormal lab values

Keywords: hcv genotype1 naive partial responder relapser
long-term follow-up study for subjects treated with p-bcma-101

Conditions: Multiple Myeloma

Summary: subjects are enrolled in this study following completion or early discontinuation from a poseida sponsored or supported study of p-bcma-101 t cells and will be followed for a total of 15 years post treatment from the last p-bcma-101 treatment. subjects will be monitored for safety and efficacy to assess the risk of delayed adverse events (aes) and assess long-term efficacy, and pk and quantification of p-bcma-101 t cells. rimiducid may be administered as indicated.

per health authorities guidelines for gene therapy medicinal products that utilize integrating vectors (fda, 2006; guidance for industry, gene therapy clinical trials-observing subjects for delayed adverse events), long term safety and efficacy follow up of treated subjects is required. subjects are enrolled in this study following completion or early discontinuation from a poseida sponsored or supported study of p-bcma-101 t cells and will be followed for a total of 15 years post treatment from the last p-bcma-101 treatment. subjects will be monitored for safety and efficacy to assess the risk of delayed adverse events (aes) and assess long-term efficacy, and pk and quantification of p-bcma-101 t cells. rimiducid may be administered as indicated. study visits subjects will only enter this protocol after completing or discontinuing from their primary p-bcma-101 protocol. once enrolled in this protocol a subject will return for regular follow-up depending on when they last received p-bcma-101 on their primary protocol: * every 3 months until the end of the first year after p-bcma-101 treatment * every 6 months until the end of the third year after p-bcma-101 treatment * then yearly until the end of the 15th year after p-bcma-101 treatment (ie. if a subject discontinues from their primary protocol 2 years after receiving p-bcma-101, they will be entering this study at the beginning of the 3rd year, and will remain on this study for 13 years). subjects will undergo serial assessment of safety, chemistry, hematology, and disease response as specified in the schedule of events. subjects will further undergo a physical exam and medical history, and anti-myeloma medications, related aes, new malignancies, new or exacerbated clinically significant neurologic, hematologic, rheumatologic or other autoimmune disorders will be recorded. after progressive disease (pd) has been confirmed for a subject after p-bcma-101 administration, visits may be performed remotely (aes collected by telephone and laboratory studies completed at a local facility).

Eligibility criteria:
inclusion criteria: * subjects who have received p-bcma-101 and completed or discontinued early from a poseida sponsored treatment protocol. * subject has provided informed consent. exclusion criteria: * none

Keywords: car-t cells
the prospective segeberg registry for rotational atherectomy in coronary lesion/s

Conditions: Coronary Artery Disease

Summary: a prospective follow-up assessment in bad segeberg with patients undergoing a rotational atherectomy in coronary lesion/s

a prospective single center registry including all patients treated with rotational atherectomy in coronary lesion/s at the heart center, bad segeberg, germany. patients undergo a routine clinical follow-up schedule, including a long-term follow-up.

Eligibility criteria:
inclusion criteria: * all patients undergoing a rotational atherectomy of coronary lesion/s exclusion criteria: * none

Keywords: calcified coronary artery lesions
effects of breezy candy on halitosis

Conditions: Halitosis

Summary: users of breezy candy will utilize the candy's abrasiveness to scrape tongue surface. the scraping action together with the release of compounds contained inside the abrasive microcapsules will result in significant reduction of oral halitosis.


Eligibility criteria:
inclusion criteria: * adult * healthy * male * female * bad breath exclusion criteria: * subject suffering from diabetes * subject suffering from renal disease * pregnant women * cigarette smokers * any illness of oral cavity for the last 3 months * subjects undergoing chemotherapy * treatment by antibiotic * treatment by anti-inflammatory

Keywords: halitosis