Kornimate/medical-research-clean huggingface dataset:
brain computer interface（bci） system for stroke rehabilitation

Conditions: Stroke

Summary: a bci system for stroke subjects will be designed in an attempt to train the motor-related areas in their brains responsible for hand open/close function. a robot hand will be used and controlled by the system in real time based on eeg pattern for identification of motion intention for hand movements in the motor cortex. a randomized controlled trial study design will be adopted. all subjects will be assessed by clinical assessments including fma and neuroimaging assessments using multimodal mr techniques before and after the training to evaluate training effectiveness.


Eligibility criteria:
inclusion criteria: 1. sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment; 2. subcortical ischemic lesion within the territory of the middle cerebral artery; 3. have moderate to severe motor disability at the paretic upper limb (assessed by fugl-meter assessment (fma), modified ashworth score of fingers (mas), and action research arm test(arat)). 4. hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection. exclusion criteria: 1. severe hand spasticity, open hand wound or hand deformity; 2. visual field deficits; 3. aphasia, neglect, and apraxia, 4. participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up. 5. history of alcohol, drug abuse or epilepsy, 6. bilateral infracts, 7. uncontrolled medical problems, 8. serious cognitive deficits, 9. other mri contraindications
impact of a physical exercise program on the self-care capacity of people hospitalized for heart failure

Conditions: Heart Failure

Summary: the objective of the study is to evaluate the effectiveness of a self-care program that integrates physical exercise with components of aerobic and muscular strength training in improving functional capacity and muscular strength in people hospitalized for decompensated heart failure, in a clinical stabilization phase the main question it aims to answer is: is the self-care program that integrates physical exercise with aerobic and muscular strength training components effective in improving the capacity for self-care in people hospitalized for decompensated hf, in the clinical stabilization phase? in this randomized clinical trial, the self-care program will be applied in the experimental group. the eric-hf program will be applied in the control group. the eric-hf is a program of exercise only with an aerobic component. participants will complete these programs during their hospital stay and various assessment instruments (quality of life, functional capacity, capacity for self-care, muscle strength) will be applied at admission, at discharge and one month after discharge.


Eligibility criteria:
inclusion criteria: * participants: clinical diagnosis of decompensated hf, regardless of etiology or ventricular function; * participants: be over 18 years old; * participants: be able to provide informed consent. exclusion criteria (participants): * osteoarticular pathology that causes physical limitations that prevent the performance of physical exercise; * existence of intravenous inotropic medication; * uncontrolled auricular or ventricular arrhythmias; * chest pain in the last 8 hours; * heart rate greater than 120; * dyspnea at rest; * uncontrolled blood pressure - systolic blood pressure greater than 180mmhg or diastolic blood pressure greater than 110mmhg; * 2nd or 3rd degree atrioventricular block; * oxygen need at a rate greater than 3l/min; * glycemic decompensation in the last 12 hours.

Keywords: self-care heart failure rehabilitation nursing exercise
non-interventional observational study of pramipexole in restless legs syndrome: impact on quality of life

Conditions: Restless Legs Syndrome

Summary: in this german non-interventional observational study 1980 patients diagnosed with restless legs syndrome (rls) will be investigated by 990 general practitioners across all federal states in germany. both moderate to severe rls patients, with or without previous rls treatment, suffering from rls symptoms like a desire to move the extremities usually associated with some discomfort, motor restlessness and worsening of symptoms at rest with at least temporary relief by activity, worsening of symptoms later in the day or at night, are eligible for this study, if it is planned to initiate therapy with pramipexole or to add pramipexole to a previously given, insufficient therapy. three visits are planned to be documented in this pms study, one baseline visit, visit two after the end of pramipexole titration and visit three after 12 weeks of treatment. evaluations and visits are to be carried out and documented only if part of routine medical practice. the main goal of observational studies is to determine how pramipexole treatment works when applied in actual practice and thus maximise external validity. in actual practice patients who have been excluded in the clinical registration trials of ppx in moderate to severe primary rls (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will be treated with ppx. thus in addition during this observational study information on the efficacy and safety of ppx in those patients will be obtained. the objectives of this pms study are: * to evaluate the treatment effect of pramipexole on rls severity and general improvement as measured by irls and cgi-i. * to evaluate quality of life of rls patients as measured by the restless legs syndrome quality of life questionnaire (rls-qol). * to evaluate the safety profile of ppx in a natural study population.


Eligibility criteria:
inclusion criteria: 1. diagnosis of primary rls 2. indication for rls treatment with sifrol® (pramipexole) 3. male or female patients aged at least 18 years. exclusion criteria: 1. any contraindications according to the summary of product characteristics (spc): hypersensitivity to pramipexole or to any of the excipients. 2. ongoing treatment with sifrol® (pramipexole).
effects of hmb supplementation on recovery following acl surgery

Conditions: ACL Injury

Summary: the anterior cruciate ligament (acl) is a primary stabilizer of the knee, and thus when acl injury occurs participation in physical activity is compromised. reconstructive surgery is often necessary to repair the damage which is then followed by a regimen of physical therapy in order to regain full activity. nutritional intervention after the surgery could help the patient maintain muscle mass during recovery, thus allowing for a quicker return to normal activity.

beta-hydroxy-beta-methylbutyrate (hmb) is a nutritional supplement shown to improve muscle mass with exercise, and also in muscle loss conditions caused by a decrease in physical activity. participants will be recruited who will undergo reconstructive surgery for a complete acl tear and will then enter a standard physical therapy program during a six week recovery period. subjects will receive either hmb or a placebo supplement during the recovery period. muscle mass will be measured two weeks prior to the surgery and again after the recovery period using an inbody 720 body composition analyzer. additionally, the knee injury and osteoarthritis outcome score (koos) questionnaire will be administered as a measure of recovery and activity level during the study.

Eligibility criteria:
inclusion criteria: * complete anterior cruciate ligament (acl) tear * will benefit from acl reconstructive surgery * are able to participate in the physical therapy program * no previous major knee injuries or surgeries * no health conditions affecting muscle mass exclusion criteria: * incomplete acl tear * have multiple or bilateral ligament tears * are unable to participate in the physical therapy program * have had previous major knee injuries or surgeries * have health conditions affecting muscle mass

Keywords: hmb beta-hydroxy-beta-methylbutyrate acl surgery muscle mass
the pharmacokinetic study of saquinavir new tablet formulation in hiv-infected pregnant women.

Conditions: HIV Infections

Summary: pharmacokinetic study of saquinavir and ritonavir in hiv-infected pregnant women

it is generally accepted that hiv-infected pregnant women should receive treatment to prevent the transmission of hiv from mother-to-child.the (relative) contra-indications for the nnrtis during pregnancy make a pi based regimen the most rational choice. based on several experiences and investigations it is expected that saquinavir will play a role as a component of tripe drug regimens for hiv-infected pregnant women. since the bid dose regimen of 1,000mg saquinavir and 100mg ritonavir is approved by the regulatory authorities and with the availability of a new 500mg tablet formulation of saquinavir,there is a need for a well-designed pharmacokinetic trial using the new 500mg saquinavir tablet formulation in the above mentioned dose.

Eligibility criteria:
inclusion criteria: * hiv infected woman * 18 - 40 years of age * able and willing to sign informed consent * pregnant for a maximum of 31 weeks exclusion criteria: * history of sensitivity/idiosyncrasy to the drug * relevant history of interference with drug metabolism * inability to understand trial procedures * abnormal specific serum levels * use of specific concomitant medications * active hepatobiliary or hepatic disease * previous failure of saquinavir/ritonavir regimen

Keywords: hiv
effects of comorbid personality disorder on the treatment of bipolar i disorder

Conditions: Bipolar I Disorder; Borderline Personality Disorder

Summary: this study will examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar i disorder.

the major aim of this proposal is to examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar i disorder. the specific aims are to create a research and supervisory team and to identify potential moderators of treatment response and mediators of outcome over the course of treatment. members of the team will meet weekly to begin a treatment development process for enhancing interpersonal social rhythm therapy (ipsrt) for these patients. additional assessment measures will be utilized to examine the proposed mediators and moderators of treatment.

Eligibility criteria:
inclusion criteria: * bipolar i disorder with comorbid borderline personality disorder, currently manic or depressed exclusion criteria: * unstable medical illness
modified barium swallow in measuring swallowing function after surgery in patients with oropharyngeal cancer

Conditions: Oropharyngeal Cancer

Summary: this pilot clinical trial studies the modified barium swallow in measuring swallowing function after surgery in patients with oropharyngeal cancer who have undergone surgery. new diagnostic procedures, such as the modified barium swallow, may be effective in studying the side effects of cancer therapy in patients who received treatment for oropharyngeal cancer

primary objectives: i. to compare aspiration in oropharyngeal carcinoma patients that underwent transoral robotic surgery (tors) vs. chemoradiotherapy (crt) via an objective instrument, the modified barium swallow (mbs). secondary objectives: i. to compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent tors vs. crt via a subjective instrument, the m.d. anderson dysphagia inventory (mdadi) using the total mdadi score. ii. to compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent tors vs. crt via a second subjective instrument, the eating assessment tool (eat-10) using the total eat-10 score. iii. to estimate the correlation between the maximum penetration aspiration scale (pas) score and mdadi total score in tors or crt oropharyngeal carcinoma patients regardless of treatment modality. iv. to estimate the correlation between the maximum pas score and eat-10 total score in tors or crt oropharyngeal carcinoma patients regardless of treatment modality. v. to estimate the correlation between mdadi total score and eat-10 total score in tors or crt oropharyngeal carcinoma patients regardless of treatment modality. vi. to estimate cervical esophageal stricture diameters after tors vs. crt via an objective instrument, the mbs. outline: patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging.

Eligibility criteria:
inclusion criteria: * patient must have undergone tors or crt for oropharyngeal carcinoma 6-24 months prior at wake forest university baptist hospital (wfubh) * in crt treated participants, crt had to be delivered as a primary modality with curative intent * in tors treated participants, tors had to be done as a primary modality with curative intent * written informed consent * no evidence of recurrent disease or second primary tumors on physical examination exclusion criteria: * previous head and neck surgery, radiation, or chemotherapy preceding tors * previous head and neck surgery preceding crt * if crt patient, candidacy for tors is not met * known neurologic dysfunction affecting swallowing * evidence of recurrent or second primary cancers on examination * patient pregnancy (due to radiation exposure risk to unborn fetus) * inability to grant informed consent
efficacy an safety of volinanserin on sleep maintenance insomnia with a sub-study on stable type ii diabetes mellitus

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. the objective of the substudy is to assess glycemic control in the subgroup of patients with type ii diabetes mellitus.


Eligibility criteria:
inclusion criteria: * diagnosis of primary insomnia based on diagnostic and statistical manual of mental disorders (fourth edition) criteria * disturbances of sleep maintenance criteria based on participant's information related to sleep pattern during the preceding month sub-study : * participants will be included if they have an established medical diagnosis of type ii diabetes mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the screening visit (with stable regimen for at least one month prior to screening) exclusion criteria: * females who are lactating or who are pregnant * night shift workers, and individuals who nap 3 or more times per week over the preceding month * consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day * participation in another trial having received study medication within 1 month before the screening visit * body mass index ≥ 33 * use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, st. john's wort, alluna or prescription sleep medication * use of any substance with psychotropic effects or properties know to affect sleep/wake * history of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia * clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder * positive qualitative urine drug screen (opiates, cocaine, amphetamine...) the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: sleep problems insomnia sleeplessness primary insomnia insomnia disorder
study adding multikinase inhibitor sorafenib to existing endocrine therapy in patients with advanced breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.

a pilot phase ii study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted. primary end point was response by response evaluation criteria in solid tumors (recist) after 3 months of sorafenib. secondary end points included safety, time to progression and biomarker modulation. the study closed early owing to slow accrual.

Eligibility criteria:
inclusion criteria: * all subjects must be female. * age ≥ 18 years old. * histologically proven carcinoma of the breast. * estrogen receptor and/or progesterone positive disease. * metastatic or locally advanced disease. * patients on a preexisting endocrine agent for at least 3 months before enrollment. * have residual measurable disease after 1. maximal response to endocrine therapy or 2. no response to endocrine therapy or 3. progressive non-visceral disease on endocrine therapy. * must be able to provide a tumor block from either the primary or metastatic site, if available. * eastern cooperative oncology group (ecog) performance status 0-2. * adequate organ function. exclusion criteria: * patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy. * other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ. * prior use of anti-angiogenic agents. * as judged by the investigator, uncontrolled intercurrent illness. * known brain metastasis. patients with neurological symptoms must undergo a ct scan/mri of the brain to exclude brain metastasis. * treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment. * concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or st john's wort. * known or suspected allergy to sorafenib or any agent given in the course of this trial. * a serious non-healing wound or ulcer. * evidence or history of bleeding diathesis or coagulopathy. * major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug. * pulmonary hemorrhage/bleeding event ≥ common toxicity criteria for adverse effects (ctcae) grade 2 within the 4 weeks prior to the first dose of study drug. * pregnancy * any condition that impairs patient's ability to swallow whole pills. * documented malabsorption problem.

Keywords: breast cancer sorafenib nexavar endocrine therapy
human papillomavirus infection and related anal lesions in hiv-positive men who have sex with men

Conditions: Hiv Infection

Summary: multicentric epidemiological non-comparative study in france characterising evolution of anal human papillomavirus (hpv) infection and related lesions and evaluating markers associated with the observed evolution. estimated enrolment: 500 principal outcomes * detection of high-grade cytological and histological anal lesions by high resolution anoscopy * spontaneous regression of high-grade anal lesions * detection of anal hpv infection intervention (procedure): * patient medical interview (initial inclusion visit, month 12 and month 24 follow-up visits and if applicable month 6 and month 18 control visits) * standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, month 12 and month 24 follow-up visits and if applicable month 6 and month 18 control visits) * high resolution anoscopy (initial inclusion visit, month 12 and month 24 follow-up visits and if applicable month 6 and month 18 control visits) only if lesion suggestive of anal intraepithelial neoplasia (ain) detected during high resolution anoscopy (hra): - anal biopsy(ies) during hra only if high-grade lesion: - hra biannually

intervention (procedure): * patient medical interview (initial inclusion visit, month 12 and month 24 follow-up visits and if applicable month 6 and month 18 control visits) * standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, month 12 and month 24 follow-up visits and if applicable month 6 and month 18 control visits) * high resolution anoscopy (initial inclusion visit, month 12 and month 24 follow-up visits and if applicable month 6 and month 18 control visits) only if lesion suggestive of anal intraepithelial neoplasia (ain) detected during high resolution anoscopy (hra): - anal biopsy(ies) during hra only if high-grade lesion (atypical squamous cells-cannot exclude high-grade squamous intraepithelial lesion (asc-h), high grade superficial intra-epithelial lesion (hsil) or ain2/3): - hra biannually

Eligibility criteria:
inclusion criteria: * men who have sex with men * at least 35 years old * hiv-positive (documented search of hiv infection, with hiv status determined according to has algorithm) * signed informed consent * affiliated to or beneficiary of french social security * all severity criteria and evolution of hiv disease are accepted (including aids stage and co-infections) exclusion criteria: * contraindication to biopsy * history of anal cancer or pelvic radiotherapy * ain2/3 treated during previous year * current anticancer chemotherapy or within 24 months before inclusion * difficulty in evaluation (anus reshaped and/or scarred) * individual placed under judicial protection * foreseen absence which may hamper participation; insufficient motivation; associated pathology with priority for care
trial of a chikungunya vaccine, pxvx0317 chikv-vlp, in healthy adults

Conditions: Chikungunya Virus Infection

Summary: the goal of this phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of pxvx0317 in healthy adults. primary objective: to assess the immune response to the vaccine secondary objectives: to assess the kinetics of the immune response to different doses/formulations/schedules to assess the persistence of immune responses to different doses/formulations/schedules to assess the effect of a booster dose of the vaccine safety objective: to assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine

the trial will explore 8 formulation/schedule combinations of chikv vlp vaccine with or without alhydrogel adjuvant, and will also explore different dose schedules of day 1 and 15 or day 1 and 29 or day 29 only.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age 18 to 45 years old (inclusive) 3. using an acceptable method of contraception (if female of childbearing potential). 4. able and willing to provide informed consent for study participation. exclusion criteria: 1. current acute febrile illness. 2. clinically significant cardiac, respiratory, or rheumatologic disease, in the opinion of the investigator. 3. pregnant or breast-feeding. 4. laboratory evidence of infection with hepatitis b/c or hiv. 5. history of chikungunya virus infection. 6. travel to a world health organization-designated chikungunya-endemic region within 30 days prior to day 1. 7. history of allergic reaction to any component of chikv-vlp vaccine, diluent, or alhydrogel®. 8. inability to discontinue systemic immunomodulatory or immunosuppressive medications 30 days prior to day 1. 9. received or plans to receive any licensed vaccine from 30 days prior to day 1 through day 57. 10. received or plans to receive an investigational agent from 30 days prior to day 1 through the duration of study participation. 11. any other condition that, in the opinion of the investigator, creates an unacceptable risk to the subject. 12. any other condition that, in the opinion of the investigator, may interfere with the conduct of the study or the validity of the data. 13. any other condition that, in the opinion of the investigator, creates an unacceptable safety risk for apheresis (group 9 \& 10 only). 14. restricted venous access that would prevent the collection of pbmcs, plasma, and lymphocytes necessary for participation (group 9 \& 10 only). 15. weight \< 110 pounds (group 9 \& 10 only)