Kornimate/medical-research-clean huggingface dataset:
evaluation of the benefit of traditional karate in heart failure for cardiac rehabilitation

Conditions: Heart Failure

Summary: cardiac rehabilitation is based on physical activity which, usually, associates combination of a cycle ergometer or treadmill completed by gymnastics. some studies have been done with complementary physical activities such as tai chi or yoga integrated into the strategy of non-drug therapies. the tai chi study showed a tendency to improve the peak of vo2 in the tai chi group but which was not significant but also a significant improvement on secondary objectives such as quality of life, the increase in the 6-minute walk test and a decrease in the level of natriuretic peptides. a study of the effects of yoga after coronary artery bypass surgery showed at one year an improvement of the ejection fraction, the lipid profile and the state of anxiety of the patients. this study showed that the addition of yoga to conventional cardiac rehabilitation could improve cardiovascular risk factors especially in patients with abnormalities such as low hdl. the physical activities offered in rehabilitation to improve physical performance are currently limited to cycling, treadmill or gymnastics. many patients do not like cycling or treadmill, which limits their adherence to a cardiac rehabilitation program. moreover, one of the main problems of rehabilitation is that after the rehabilitation cycle, a minority of patients continue the physical activity. strategies for implementing home exercises have been tested to increase the level of physical activity after rehabilitation. cardiac rehabilitation has several components: correction of risk factors, optimization of treatment, physical activity to improve the physical abilities to exertion that are directly correlated to mortality. our hypothesis is that the implementation of a program of physical activity based on traditional karate would improve the physical abilities to effort and the quality of life of patients, to give a better psychological confidence to patients who, after a cardiovascular event such as acute coronary syndrome, bypass surgery or valvular surgery, have marked anxiety or depression. rehabilitation, and especially physical activity, is one of the therapeutic means proposed. the interest of this study would be to be able to offer an additional activity for rehabilitation centers, to offer patients an activity in post-rehabilitation. in addition, interaction between patients could increase adherence to rehabilitation.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years * patient with heart failure * patient with impaired ejection fraction with left ventricular ejection fraction ≤ 40% * patient affiliated with a health insurance plan * patient giving free, informed and express consent exclusion criteria: * patient under tutorship or curatorship * patient deprived of liberty * non-french speaking patient
blood donor recruitment during epidemic of covid-19

Conditions: Blood Donation

Summary: in december 2019, an unknown pneumonia rapidly spread in wuhan, china, a new coronavirus, 2019 novel coronavirus (2019-ncov), aroused the attention of the entire world. on january 31, 2020, world health organization (who) announced the outbreak of coronavirus disease 2019 (covid-19) in china as a public health emergency of international concern. the number of volunteer non-remunerated blood donors decreased because of quarantine, caring for relatives, and fear of exposure to covid-19. due to the blood shortage, patient blood management and cessation of elective surgery are contributing to decreased demand, but sepsis may increase requirements and significant reductions will not be possible in areas such as trauma, cancer patients, hereditary haemolytic anaemias and childbirth. therefore, recruiting enough blood donors during the epidemic is vital for public health in china, and also worldwide. in order to assess the effects of a questionnaire on blood donor recruitment, the investigators designed two kinds of self-administered, standardized and structured questionnaires. in addition of the basic socio-demographic characteristics, one questionnaire includes the information of precautions of blood donation during epidemic, and the other dose not. the questionnaires were randomly sent to ever blood donors, and the same number of ever blood donors are coded as control.

in order to assess the effects of a questionnaire on blood donor recruitment, the investigators designed two kinds of self-administered, standardized and structured questionnaires. in addition of the basic socio-demographic characteristics, one questionnaire includes the information of precautions of blood donation during epidemic, and the other dose not. information of precautions of blood donation during epidemic included taking donor's temperature and enhancing hand disinfection before donation etc. the questionnaires were randomly sent to ever blood donors, and at the same day, equal number of ever blood donors as the ones who filled the questionnaire are coded as control.

Eligibility criteria:
inclusion criteria: * blood donors whose last donation were between 1 feb to 31 march, 2019. exclusion criteria: * blood donors whose blood test results were positive. blood donors who were aged above 60. blood donors whose cell phone number was obviously invalid.
impact of women's empowerment program for abused pregnant women

Conditions: Abuse Physical Battered Woman Syndrome

Summary: although domestic violence is recognized as major threat in pregnancy, there is no intervention has been developed or test to support women in india. to evaluate the effect of women's empowerment program administered to abused women in order to reduce domestic abuse, improving health status and safety behavior.


Eligibility criteria:
inclusion criteria: * at least 18 years of age, * victims of intimate partner violence, and * willing to participate exclusion criteria: * women whose abuser was not their intimate partner or * who were unable to consent
safety and efficacy of inhaled interferon gamma-1b in pulmonary mac infection

Conditions: Lung Infection

Summary: the purpose of this research study is to test the safety and effectiveness of inhaled interferon gamma-1b (ifn-g 1b), when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72 weeks for the treatment of a lung infection caused by a bacterium called mycobacterium avium complex . fda has not approved interferon gamma-1b for use in patients with mac infection of the lungs, which is the purpose of this study.interferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms.

laboratory research has shown that a mouse form of interferon gamma is effective in treating mice with infections caused by bacteria similar to mac as well as mac infection.

Eligibility criteria:
male and female patients, 18 years of age or older, with bacteriologically and radiographically confirmed pulmonary mac infection who have been treated for their infection for at least 6 months within the previous 2 years, as well as patients with moderate or severe pulmonary disease due to mac, not previously treated for this infection. patients with recurrent pulmonary mac infection after previous successful treatment for pulmonary mac disease are also eligible. in addition, various laboratory testing must confirm conditions. patients cannot be positive for hiv or have an extra-pulmonary (in general, outside of the lungs) infection of mac. other preconditions related to health or other conditions exist as factors for inclusion or exclusion from this study.

Keywords: pulmonary mycobacterium avium complex infection mac nontuberculous mycobacteria lung
study of spi-1620 in combination with docetaxel versus docetaxel alone for patients with non small-cell lung cancer (nsclc)

Conditions: Non Small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to estimate and compare the objective response rate of spi-1620 administered in combination with docetaxel in patients with nsclc and to determine the safety of spi-1620 when administered in combination with docetaxel.

this will be a two part study. in single arm part, patients will receive 11 μg/m2 of spi-1620 iv followed by docetaxel 75 mg/m2 iv. cycles will continue every 3 weeks until progression or intolerable toxicity. overall 27 patients will be enrolled in the single arm part. if 6 or more responses (cr/pr) are observed in this group then the randomized part will be initiated. in the randomized part approximately 200 patients (100 per arm) will be randomized to receive spi-1620 plus docetaxel or docetaxel alone. in the experimental arm, patients will receive 11 μg/m2 of spi-1620 iv followed by docetaxel 75 mg/m2 iv administered in 3-week cycles until progression or intolerable toxicity. in the control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or intolerable toxicity.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally advanced or metastatic nsclc that has failed one prior platinum-containing chemotherapy * measurable disease as per recist v. 1.1 * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * adequate bone marrow, liver and renal function exclusion criteria: * more than one prior chemotherapy regimen for metastatic nsclc * known, uncontrolled central nervous system (cns) metastases * significant circulatory disorders in the past 6 mo. * concomitant treatment with phosphodiesterase inhibitors * uncontrolled orthostatic hypotension, asthma or chronic obstructive pulmonary disease (copd)
direct-acting antivirals and hepatocellular carcinoma recurrence

Conditions: Hepatocellular Carcinoma; Hepatitis C; Direct Acting Antivirals

Summary: background and aims: arrival of direct-acting antiviral (daa) agents against hepatitis c virus (hcv) with high-sustained virological response (svr) rates and very few side effects has drastically changed the management of hcv infection. the impact of daa exposure on hepatocellular carcinoma (hcc) recurrence after a first remission in patients with advanced fibrosis remains to be clarified. methods: 68 consecutive hcv patients with a first hcc diagnosis and under remission, subsequently treated or not with a daa combination, were included. clinical, biological, and virological data were collected at first hcc diagnosis, at remission and during the surveillance period.


Eligibility criteria:
inclusion criteria: * first hcc diagnosed by invasive or non-invasive criteria following the american association for the study of liver diseases (aasld) guidelines during the study time horizon * complete remission after hepatocellular carcinoma treatment defined by the european association for the study of the liver (easl) criteria as absence of residual tumor/complete necrosis at imaging one month after the end of hepatocellular carcinoma treatment exclusion criteria: * prior history of hepatocellular carcinoma before january 2009 * liver transplantation before hepatocellular carcinoma diagnosis * presence of "non-characterized nodules" after hepatocellular carcinoma treatment at imaging * history of direct-acting antivirals treatment before the first hepatocellular carcinoma diagnosis * hepatic decompensation * human immunodeficiency virus (hiv) coinfection.
protein ingestion timing on body composition and biochemical markers in resistance-trained males

Conditions: Hypertrophy; Physical Performance

Summary: protein ingestion timing is an important component for muscle accretion. the investigators hypothesized that protein ingestion timing could affect muscular adaptations and performance in resistance-trained men.


Eligibility criteria:
inclusion criteria: * performing resistance training at least three times a week for 1 year prior to the start of the study * not taking any steroids or any illegal agents known to increase muscle size for at least 1 year prior to the start of the study * no known medical issues * sleeping for at least seven to eight hours during the 24-hour day exclusion criteria: * non-willingness to continue protein ingestion or exercise protocols * participation in exercise other than the prescribed resistance training program * consumption of dietary supplement (other than the protein intervention) during the study period * missing more than one resistance training session or protein ingestion throughout the study period
autonomy among physically frail older people in nursing homes

Conditions: Frailty

Summary: the purpose of this study is to assess the status of perceived autonomy and to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people living in nursing homes.

experiencing autonomy is recognised to promote health and well-being for all age groups. perceived lack of control has been found to be detrimental to physical and mental health. there is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings perceive autonomy. further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on individual wishes for daily activities. the purpose of this study was to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people in nursing homes.

Eligibility criteria:
inclusion criteria: * aged 65 years or older * all kinds of diseases leading to physical frailty * dependent on assistance in minimum one p-adl activity * able to understand verbal instructions * willing to participate * expected to live in the nursing home during the 24 weeks * both men and women exclusion criteria: * terminal stages of disease * mmse-score below 16

Keywords: autonomy older people physically frail nursing home intervention study
augmenting exposure therapy with self-distancing

Conditions: Anxiety

Summary: anxiety is prevalent, impairing, and costly in childhood. evidence-based treatments for pediatric anxiety exist; however, as many as 40-60% of youth do not demonstrate optimal response. by identifying psychological factors that potentiate symptom severity and treatment response, it may be possible to strengthen these factors to treat, or even prevent the development of youth emotional disorders. this study aims to examine whether the combination of exposure and self-distancing is a feasible, acceptable, and efficient intervention for increasing perseverance in the face of exposures. this will be measured by child and parent report of treatment acceptability, examination of attendance and dropout rates, as well as participant and therapist report of participant engagement during exposures.


Eligibility criteria:
inclusion criteria: * parent or guardian willing to give informed consent to participate * children who give written or oral assent * ages 7 and older to under 18 years old * has a historical anxiety diagnosis (diagnosed within the last year either within a clinical or clinical research setting) and have moderate or greater levels of current anxiety symptoms * current or past history of elevated symptoms of depression, obsessive-compulsive disorder and posttraumatic stress are allowable, but anxiety must be the chief complaint * no evidence of acute risk due to suicidal intentions or behaviors in the past 6 months. exclusion criteria: * currently receiving cognitive behavioral therapy or any other form of psychotherapy * have elevated symptoms of bipolar i/ii disorder, schizophrenia/schizoaffective disorder, schizophreniform disorder, psychosis not otherwise specified (nos), mental retardation, severe behavioral concerns, or autism * history of current substance/alcohol abuse/dependence (past history abuse is allowable if in remission for greater than 1 year)

Keywords: anxious anxiety
bioavailability and food effect study of tki258 (csf capsules vs. fmi capsules)in adult patients with advanced solid tumors

Conditions: Neoplasms; Cancer; Tumors

Summary: this study will evaluate the relative bioavailability of 2 oral formulations of tki258, and the effect of food on the bioavailability of tki258, in adult patients with advanced solid tumor


Eligibility criteria:
inclusion criteria: * patients with an advanced solid tumor, except breast cancer,which has progressed despite standard therapy, or for which no standard therapy exists * world health organization (who) performance status ≤ 2 * patient must meet protocol-specified laboratory values exclusion criteria: * patients with brain cancer * patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study * patients who have not recovered from previous anti-cancer therapies * female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control other protocol-defined inclusion/exclusion criteria may apply

Keywords: neoplasms cancer tumors administration, oral capsules chir258 chir-258 chir 258 tki258 tki-258 tki 258 bioavailability food
a study of obinutuzumab [ro5072759 (ga101)] in combination with chop chemotherapy in patients with previously untreated advanced diffuse large b-cell lymphoma (gather)

Conditions: Lymphoma, B-Cell

Summary: this open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[ro5072759 (ga101)\] in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy in patients with advanced diffuse large b-cell lymphoma. patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on day 1 of each 21-day cycle, during cycle 1 obinutuzumab will also be infused on days 8 and 15) in combination with chop chemotherapy on day 1 of cycles 1 to 6. a substudy will investigate the drug-drug interaction of obinutuzumab with chop chemotherapy agents. for the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.


Eligibility criteria:
inclusion criteria: * adult patients, ≥18 years of age * previously untreated cluster of differentiation antigen 20 (cd20)-positive diffuse large b-cell lymphoma * ann arbour stage iii/iv and bulky ii (mass \>10 cm) * at least one bi-dimensionally measurable lesion defined as \>1.5 cm in its largest dimension by ct scan * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * left ventricular ejection fraction ≥50% * adequate hematologic function exclusion criteria: * transformed lymphoma (follicular iiib) if previously treated with chemotherapy or immunotherapy * prior therapy for diffuse large b-cell lymphoma except for nodal biopsy or local irradiation * central nervous system (cns) lymphoma, primary mediastinal large cell lymphoma, primary cutaneous lymphoma, primary effusion lymphoma * patients who received cytotoxic drugs or rituximab as part of their treatment for another condition (e.g. rheumatoid arthritis) or prior use of an anti-cd20 antibody * chemotherapy or other investigational therapy within 28 days prior to the start of cycle 1 * contraindication to any of the individual components of chop, including prior receipt of anthracyclines * history of severe allergic or anaphylactic reactions to monoclonal antibody therapy * history of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or malignancy treated with or without curative intent and in remission without treatment for ≥2 years prior to enrolment * positive for hepatitis b, hepatitis c, human immunodeficiency virus (hiv) or human t-cell leukemia virus (htlv-1) infection * pregnant or lactating women
observational study of sifrol® in patients with primary restless legs syndrome (rls)

Conditions: Restless Legs Syndrome

Summary: the objectives of this post marketing surveillance (pms) are: * evaluation of the treatment effect of pramipexole on restless legs syndrome (rls) severity as measured by international restless legs syndrome scale (irls) and clinical global impression improvement scale (cgi- i) * evaluation of the time to reaching maintenance dose of pramipexole * evaluation of work productivity impairment associated with rls based on the work productivity and activity impairment questionnaire (wpai) questionnaire


Eligibility criteria:
inclusion criteria: * patients suffering from primary rls who are eligible for pramipexol (ppx) treatment could be included into the study * patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication * male of female patients of any age exclusion criteria: * the treating physicians are asked to consider the regulations described in the summary of product characteristics (smpc) for the treatment with pramipexole
clinical impact through ai-assisted ms care - a retrospective multi-center observational study.

Conditions: Multiple Sclerosis; NMO Spectrum Disorder; Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease; Radiologically Isolated Syndrome; Clinically Isolated Syndrome

Summary: the reclaim study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building ai-based models that will support diagnosis and prognosis of individual multiple sclerosis patient's disease course and treatment response in a real-world setting. additionally, the data will be used to generate further insights on multiple sclerosis progression as well as to develop the tools to monitor this progression.

there is a clear need for a data-driven and personalized treatment optimisation tool for people with multiple sclerosis (ms), in order to enable/support physicians to deploy appropriate therapeutic measures that will help to better slow down disease progression and eventually, progressive disability worsening. while early diagnosis and prognostic modelling is important to make data-driven recommendations for treatment optimisation, being able to disentangle and monitor the disability accumulation due to 'relapse associated worsening' or due to 'progression independent of relapse activity' will be key to optimizing treatment for the best possible long-term outcomes. the latter strongly depends on the availability of biomarkers that can detect and differentiate between these different forms of disease worsening. with the reclaim study, we focus on gathering a centralized and harmonized dataset, enabling the secondary use of data to support prognosis for people with ms, as well as treatment optimisation in a real-world setting. as such, reclaim aims to develop mri-based tools to better monitor disease progression in people with ms, as well as ai-based models that will support prognosis of individual disease course and treatment response, comprising: (i) a biomarker-based ms progression model, (ii) an mri-focused generative model to predict brain characteristic evolution, and (iii) an interventional model for treatment optimisation. additionally, the data will be used to generate further insights on multiple sclerosis progression as well as to develop the tools to monitor this progression.

Eligibility criteria:
inclusion criteria: * patients must have a confirmed diagnosis of ms, nmosd, mogad, cis or ris. * patient (or patient's legal representative) has previously signed and dated an informed consent form (icf) for the secondary use of their data, or assent form. alternatively, the secondary use of the patient's data is allowed following institutional review board (irb)/ethical committee (ec) approval in accordance with national and local subject privacy regulations. exclusion criteria: * patients under 18 years of age will be excluded. * other unspecified reasons that, in the opinion of the investigator or joint steering committee, make the patient unsuitable for participation in the study.

Keywords: multiple sclerosis prognosis progression ai models disease worsening