Kornimate/medical-research-clean huggingface dataset:
robotic therapy and brain stimulation in the early phase after stroke

Conditions: Stroke

Summary: stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential intervention to enhance effects of other rehabilitation strategies on improvement of motor performance of the paretic upper limb. in this proof-of-concept study we will evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere associated with robotic therapy on improvement of motor performance of the paretic upper limb in the early phase post-stroke.

the main goal of this study is to test the proof of concept of benefits of inhibition of the motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics of motor performance, in patients with upper limb paresis in the early phase post-stroke. for this purpose, patients will be randomized to receive real or sham transcranial direct current stimulation before a session of robotic therapy. data will be collected by kinematic assessment performed automatically by the robot at baseline, immediately after and 24h after the intervention. the working hypothesis is that one session of upper limb motor training will lead to improvement of performance in metrics of kinematics, and this improvement will be maintained up to 24h after the end of the training.

Eligibility criteria:
inclusion criteria: ischemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed tomography or magnetic resonance imaging. motor impairment of an upper limb, defined as a score between 1 - 3 in the medical research council scale, for at lest one the following movements: elbow extension, shoulder flexion, or shoulder extension. ability to provide written informed consent. ability to comply with the schedule of interventions and evaluations in the protocol. exclusion criteria: severe spasticity at the paretic elbow, wrist or fingers, defined as a score of \> 3 in the modified ashworth spasticity scale. no active shoulder and elbow movements uncontrolled medical problems such as end-stage cancer or renal disease pregnancy potential contraindications to transcranial direct current stimulation: history of seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery, use of drugs that interfere on cortical excitability (such as antiepileptic drugs, benzodiazepines) other neurological disorders such as parkinson's disease psychiatric illness aphasia or severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent. hemineglect cerebellar lesions or on cerebellar pathways contact precautions

Keywords: stroke robotic therapy transcranial direct current stimulation
assessment of midodrine in the prevention of vasovagal syncope: the prevention of syncope trial iv

Conditions: Vasovagal Syncope

Summary: about 20% of adults faint recurrently. these patients are often highly symptomatic, have problems with employment and driving and have reduced quality of life. there are no therapies that have withstood the test of adequately designed and conducted randomized clinical trials. midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist that increases venous return to the heart and raises blood pressure. there is considerable lower level evidence that it might prevent vasovagal syncope. the investigators will test the hypothesis that midodrine prevents recurrences of syncope in patients with moderate to severe vasovagal syncope.


Eligibility criteria:
inclusion criteria: * patients will be eligible if they have: * ≥2 syncopal spells in the year preceding enrolment, and * ≥ -2 points on the syncope symptom score for structurally normal hearts, and * age ≥ 18 years with informed consent. exclusion criteria: * patients will be excluded if they have: * other causes of syncope, such as ventricular tachycardia, complete heart block, postural hypotension or hypersensitive carotid sinus syndrome, * an inability to give informed consent, * important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia, * hypertrophic cardiomyopathy, * a permanent pacemaker, * a seizure disorder, * urinary retention, * hypertension defined as \>140/90 mm hg, * hepatic disease, * glaucoma or * a 5-minute stand test resulting in diagnoses of postural orthostatic tachycardia syndrome or orthostatic hypotension.

Keywords: reflex fainting vasovagal syncope midodrine
pds versus prolene as suture material for vaginal sacrospinous hysteropexy

Conditions: Pelvic Organ Prolapse; Prolapse

Summary: introduction: pelvic organ prolapse is a common gynecological disease, which about 50% of women develop in the course of their lives. there are many different options for surgical care, e.g. the uterus-preserving sacrospinal fixation (= sacrospinal hysteropexy = sshp). this technique has been increasingly used in recent years. however, there is still no data on whether the fixation sutures should be performed with absorbable or non-absorbable threads. internationally, both types of threads are routinely used and both types of threads are described in publications. so far, there is no comparative data on the effectiveness and subjective results. the aim of this study is to compare subjective symptom improvement materials \& methods: this is a randomized, single-center superiority study. the sacrospinal fixation is performed according to a standardized method and two different types of threads (absorbable pds sutures vs. non-absorbable prolene sutures) are used for the fixation suture. patients are randomized to either the absorbable pds sutures group or the non-absorbable prolene sutures group. the primary outcome of interest is the subjective symptom improvement 12 months after surgery (evaluated using the german version of the pelvic floor questionnaire). secondary outcome variables are anatomical outcomes, condition-specific quality of life, and adverse events. 52 patients will be included in the study. the results of the study will be published in peer-reviewed journals and the results will be presented at scientific meetings.


Eligibility criteria:
inclusion criteria: * anterior vaginal wall prolapse beyond the hymen (pop-q-point aa or ba \>0) with central defect * prolapse of the apical vaginal vault beyond the hymen (pop-q point c \>0) with central defect * symptoms of a vaginal bulge * a primary reconstructive operation using sacrospinous hysteropexy is planned exclusion criteria: * recurrent prolapse * history of hysterectomy * a primary reconstructive operation with mesh or obliterative surgery is planned * an operation with hysterectomy is planned * known pelvic malignancy * known inflammatory disease * current systemic treatment with glucocorticoids or immunosuppressants * the subject cannot or does not want to participate
the prophylactic effect of stilamin on post-endoscopic retrograde cholangiopancreatography pancreatitis

Conditions: Post-ERCP Acute Pancreatitis

Summary: pancreatitis are one of the most common complications of post-ercp (endoscopic retrograde cholangiopancreatography), the incidence rate is 5\&-10%, how to prevent pep and hyperamylasemia is an important issue, somatostatin is widely used in the field of pancreas treatment. in order to explore the effects of somatostatin on prevent pep(post-ercp pancreatitis), 908 subjects will be enrolled in two group in the study, one group is given common treatment, the other uses somatostatin in the base of common treatment.

a prospective, multi-center, investigator sponsored, randomized controlled trial, 15 sites join in in china, 908 subjects will be enrolled. a descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. a two proportion equality test will be conducted to explore whether incidence rates are different. descriptive statistics including number (n), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. frequency tables of number (n) and percentage of subjects will be produced for all categorical variables.

Eligibility criteria:
inclusion criteria: * males and females, age \> 18 years. * normal amylase level before undergoing ercp. * signed inform consent form and agreed to follow-up on time. exclusion criteria: * pregnancy or history of allergy to somatostatin. * renal insufficiency (scr\>177umol/l). * acute myocardial infarction within 3 months of the procedure. * history of subtotal gastrectomy (billroth ii method). * symptom of shock before undergoing ercp, such as hypotension (systolic blood pressure \ 120 bpm). * medical or psychological condition that would not permit the patient to complete the study or sign the informed consent . * patients involved in other study within 60 days. * patients unfitted for the study by investigators. * all contraindications to stilamin.
sepse: critical analysis of new sepse definitions and retrospective evaluation of sepse protocol at a tertiary hospital in brazil

Conditions: Sepsis

Summary: research in the databases lilacs, bireme, scielo by the terms: systemic inflammatory response syndrome (sirs), sepsis, severe sepsis and septic shock and their equivalents in the english language. selection of the main articles of the last five years to study and contextualize the reality presented since the implantation of the huvr sepsis protocol. statistical analysis of data since the implementation of the sepsis protocol in the huvr, in july 2014 until june 2016.


Eligibility criteria:
inclusion criteria: all individuals who had a confirmed or suspected sepsis diagnosis and had a sepsis protocol completed during the study period. - exclusion criteria: individuals with confirmed or suspected sepsis in the study period who did not complete the protocol. individuals under the age of 18 -
study and role of inflammasome in platelet activation during bacterial and/or viral sepsis

Conditions: Bacterial Sepsis

Summary: : sepsis, now defined as life-threatening organ dysfunction due to a dysregulated host response to infection, is an important global health problem representing about a fifth of all global deaths. it can be associated, in some cases, with multiple organ failure and cytokine storm. the main objective of this study is to estimate and to compare the activation rate of the nucleotide-binding domain leucine rich repeat containing protein 3 (nlrp3) inflammasome in platelets between five groups of patients suffering from bacterial and/or viral sepsis, with different severity levels according to sequential organ failure assessment (sofa) score to precise the platelets' implication in this cytokine storm.

patients with bacterial or vial sepsis have been shown to exhibit very high levels of pro-inflammatory cytokines (il1, il6, ifn, ip10 and mcp1) that may activate the t-helper-1 lymphocytic response (th1). these cytokines can be produced by several cell types, including blood platelets. il1 is an important pro-inflammatory cytokine whose expression is increased in various pro-inflammatory contexts, including dengue infection. it induces an increase in endothelial permeability and a pro-thrombotic state, as described in patients infected with covid-19. it is synthesized as a protein precursor that is cleaved by the nlrp3 (nucleotide-binding domain leucine repeat rich containing protein 3). close associations between the deregulation of inflammasome activity and hereditary or acquired diseases suggest an important role of nlrp3 inflammasome in regulating immune responses. the activation of the nlrp3 inflammasome increases caspase 1 activity and induces the production of bioactive il1 as well as other pro-inflammatory cytokines such as il18. the major role of nlrp3 platelet inflammasome in the "cytokine storm" has been highlighted in the case of dengue virus infection. we hypothesize that blood platelets may play an important role in the inflammatory response observed during sepsis through the activation of nlrp3 inflammasome, particularly during its exacerbation. * five groups of patients will be constituted: patients with leptospirosis, patients with bacterial infections including in-hospital-acquired-infections, patients with viral infection, patients non infected (control group), patients with viral infection sars-cov2 +. * only one blood collection will be realized

Eligibility criteria:
inclusion criteria: * for all groups: patients older than 18 years at inclusion and acceptation of participation by the patient, his relative or his legal representative (depending on the situation) * for groups 1, 2, 3 and 5: patient with a confirmed sepsis (microbiological confirmation) * for group 4 : patient non infected exclusion criteria: * refusal of participation by the patient, his relative or his legal representative (depending on the situation) * patients subject to a safeguard measure of justice * patients younger than 18 years at inclusion

Keywords: sepsis platelet nlrp3 btk il-1β
to investigate safety, reactogenicity and immunogenicity of vir-1388 compared with placebo in participants without hiv

Conditions: HIV I Infection

Summary: the purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of vir 1388 in adults in good health without hiv.

this is a phase 1, randomized, double-blind, placebo-controlled, multicenter study in adults aged 18 to 55 years in overall good health and without hiv. participants will be enrolled concurrently into 1 of 3 dose levels of vir-1388 or placebo. the overall study design includes 2 study parts, part a and part b. part a will be a lead-in phase enrolling a limited number of hcmv seropositive persons of non-childbearing potential (poncbp) with a frequent safety monitoring schedule. part b will expand enrollment into a broader population of hcmv-seropositive participants, including persons of childbearing potential required to use 2 forms of contraception and maintains a similar overall safety monitoring schedule as part a . there is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.

Eligibility criteria:
inclusion criteria: * in overall good health as determined by medical history, physical exam, and laboratory values * hiv uninfected * cmv seropositive * willing to use condoms during intercourse for the duration of the study * assessed by clinic staff as being low risk for hiv infection and committed to maintaining behavior consistent with low risk of hiv exposure through the last protocol visit * childbearing status * part a: only participants of non-childbearing potential * part b: participants of childbearing potential must be on 2 forms of contraception and not planning on becoming pregnant for the duration of the study exclusion criteria: * participant is immunocompromised * participant has an autoimmune disorder * participants having intimate contact with immunocompromised individuals * participants having intimate contact with a pregnant partner or partner planning to become pregnant * participants who are breastfeeding

Keywords: hiv vaccine cmv cytomegalovirus
extension study of participants from spg302-alz-101

Conditions: Alzheimer's Disease

Summary: this study will evaluate the long-term safety and efficacy of participants enrolled in spg302-alz-101 with mild to moderate alzheimer's disease (ad)

this is an open-label extension study of spg302-alz-101 to investigate the long-term safety, tolerability, and efficacy of spg302 administered orally in participants with mild-to-moderate ad. enrolled participants will continue at the dose they received at the end of the first trial, and will self-administer spg302 orally every day for up to 52 weeks. participants will have an in-person clinic visit every 3 months (± 3 days) and a monthly phone visit. an end of treatment visit will occur within 7 days of the last dose of spg302. a final visit to collect safety data will be conducted up to 1 month (± 3 days) post last dose.

Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate ad * clinical laboratory values within normal range or \< 1.5 times uln * life expectancy of \>2 years * able and willing to provide written informed consent * must have participated in all study activities of spg302-alz-101, the parent study exclusion criteria: any physical or psychological condition that prohibits study completion * known cardiac disease * active or history of malignancy in the past 5 years * serious infection that will not be resolved by first day of study intervention. * history of clinically significant cns event or diagnosis in the past 5 years. * acute illness within 30 days of day 1 * history of suicidal behavior or suicidal ideation * history of chronic alcohol use or substance abuse in the last 5 years * hiv, hepatitis b and/or hepatitis c positive * vaccines within 14 days * receipt of investigational products within 30 days * blood donation within 30 days * pregnant or breastfeeding

Keywords: alzheimer's disease synapse neural connectivity
a study of the safety and preliminary efficacy of oral midostaurin (pkc412) in relapsed or refractory pediatric leukemia

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Summary: this is a phase i/ii pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients \<18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including mll-rearranged all and flt3 positive aml.


Eligibility criteria:
inclusion criteria: * mixed-lineage leukemia (mll) gene rearranged acute lymphoblastic leukemia (all), that does not respond to treatment or has relapsed from prior treatment; or flt3 mutated acute myeloid leukemia (aml) that does not respond to a second treatment or has relapsed from 2 prior treatments * normal organ function, and chest x-ray * expected survival greater than 8 weeks * can care for most of personal needs and perform at least minimum activity exclusion criteria: * patients with symptomatic leukemic central nervous system involvement or isolated extramedullary leukemia * patients must not have received other treatments for leukemia within a predefined time period, 72 hours for medications, 2 months for transplants * patients with heart function that is not normal * patients with hiv or hepatitis * patients with another severe disease or medical condition besides leukemia other protocol-defined inclusion/exclusion criteria may apply

Keywords: acute myeloid leukemia aml acute lymphoblastic leukemia all midostaurin pkc412 pediatric relapsed or refractory flt3 positive acute myeloid leukemia pediatric relapsed or refractory mixed-lineage leukemia gene rearranged acute lymphoblastic leukemia
safety and tolerability of pf-06649751 in parkinson's disease patients with motor fluctuations

Conditions: Parkinson's Disease With Motor Fluctuations

Summary: the purpose of this study is to evaluate the long term safety and tolerability of pf-06649751 in parkinson's disease patients who experience motor-fluctuations.

this is an open label study evaluating the long term safety and tolerability of pf-06649751 in parkinson's disease patients who experience motor-fluctuations. subjects who completed ph2 study b7601003 will be randomized to one of 4 treatment groups (15 mg qd, 7 mg qd, 3 mg qd, or 1 mg qd group) depending on the treatment received in b7601003 and titrated up to 15 mg qd over a 3 week period, as appropriate. all subjects who were blindly down-titrated during the b7601003 study will remain at/or be titrated to 7 mg qd only and remain at that dose for the rest of the b7601017 study in order to protect the blind for the prior study. subjects who successfully titrate to 15 mg qd will enter the adjustment period at that dose. subjects who cannot tolerate 15 mg qd at any time during the study will be allowed to down-titrate to 7 mg qd (but not lower) and will stay at that dose for the rest of the study. subjects who cannot remain at a stable dose (7 mg or 15 mg qd) will be discontinued.

Eligibility criteria:
inclusion criteria: * having successfully completed parent study b7601003. * clinical diagnosis of parkinson's disease. * able to refrain from any parkinson's disease medication not permitted by the protocol. exclusion criteria: * female of childbearing potential. * severe acute or chronic medical or psychiatric condition or laboratory abnormality. * participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.

Keywords: parkinson's disease motor fluctuations d1 partial agonist
self-management interventions for advanced breast cancer

Conditions: Advanced Breast Cancer Stage IV

Summary: the purpose of this research study is to evaluate whether self-management discussion groups are helpful for women with advanced breast cancer who are experiencing pain. the study is looking at the usefulness of two different types of discussion groups, one of which also includes gentle exercise.


Eligibility criteria:
inclusion criteria: * diagnosis of stage iv breast cancer or recurrent metatastic breast cancer * receiving care at duke cancer institute, * life expectancy ≥9 months as estimated by the treating oncologist, * speak and read english, * be at least age 18 * be able to travel to the duke cancer institute exclusion criteria: * cognitive impairment as assessed by the 6-item mini-mental status exam, * karnofsky performance rating of \<60 as rated by the oncology provider, an ecog rating of 0-2 * treatment for serious psychiatric illness (e.g., schizophrenia, severe depression) in the past 6 months, * currently engaged in yoga practice ≥ 1 day per week
a phase 3 study of khk4827 in patients with systemic sclerosis

Conditions: Moderate to Severe Systemic Sclerosis

Summary: to evaluate the efficacy and safety of khk4827 in patients with systemic sclerosis who have moderate to severe skin thickening


Eligibility criteria:
inclusion criteria: * subject meets the criteria for diagnosis of the diagnostic criteria, severity classification, and clinical practice guidelines for systemic sclerosis （japanese dermatological association 2016） at the pre-examination * subject presented the first symptoms of sclerosis other than raynaud's phenomenon within 60 months before enrollment * subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mrss of 10 to \<30 at the pre-examination and who has progressing skin thickening exclusion criteria: 1. any of the following significant concomitant diseases: * type 1 diabetes * poorly controlled type 2 diabetes (hba1c \> 8.5%) * congestive heart failure (class ii to iv of the new york heart association functional classification) * myocartial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product * poorly controlled hypertension (systolic pressure \> 150 mm hg or diastolic pressure \> 90 mg hg at screening) * severe chronic lung disease (%fvc \< 60% and %dlco \< 40%, calculated according to the reference values for spirometry, including viral capacity, in japanese adults calcluated with the lms method and compared with previous values \[japanese respiratory society\]) * major chronic inflammatory diseases or connective tissue diseases other than scleroderma 2. patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion 3. patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the columbia-suicide severity rating scale (c-ssrs) at enrollment 4. patient has severe depression based on a total score of ≥ 15 on the patient health questionnaire-8 (phq-8) at enrollment

Keywords: systemic sclerosis brodalumab khk4827