Kornimate/medical-research-clean huggingface dataset:
effectiveness of stellate ganglion block in patients diagnosed with parkinson's disease

Conditions: Parkinson Disease

Summary: the goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with parkinson's disease. the main question it aims to answer are: • can stellate ganglion block improve the dysphagia and activities of daily living in patients with parkinson's disease. participants will be divided into the the control group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. the swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

dysphagia, or swallowing difficulty, is a common symptom associated with parkinson's disease. it is characterized by weakened chewing and throat muscles, leading to difficulties in eating, coughing, and a sensation of choking in individuals with parkinson's disease. the goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with parkinson's disease. the main question it aims to answer are: • can stellate ganglion block improve the dysphagia and activities of daily living in patients with parkinson's disease. participants will be divided into the the control group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. the swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility criteria:
inclusion criteria: * age \>18 years. * meeting the diagnostic criteria for parkinson's disease developed by the neurology branch of the chinese medical association in 2006. * diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. * stable vital signs, conscious, able to cooperate with assessment and treatment. exclusion criteria: * dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. * history of mental diseases or use of antipsychotics. * complicated with cognitive impairment or consciousness dysfunction. * simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
long-term innohep® treatment versus a vitamin k antagonist (warfarin) for the treatment of venous thromboembolism (vte) in cancer

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to assess the efficacy and safety of innohep® in preventing the recurrence of vte in patients with active cancer who have had an acute vte episode.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of active cancer. * symptomatic and objectively confirmed vte. * ≥ 18 years of age or above the legal age of consent as per country specific regulations. * patients with eastern co-operative oncology group (ecog) performance status of 0, 1 or 2. * signed informed consent. exclusion criteria: * life expectancy \< 6 months. * patients with basal cell carcinoma or non-melanoma skin cancer. * creatinine clearance ≤ 20 ml/min. * contra-indications to anticoagulation. * known hypersensitivity to the investigational product (innohep®) or the reference product (warfarin). * history of heparin-induced thrombocytopenia (hit). * pre-randomisation therapeutic anticoagulant treatment for acute vte administered for more than 72 hours prior to randomisation. * patients unlikely to comply with the protocol. * participation in another interventional study. * pregnant or breast-feeding women. * women of childbearing potential.
validation of patient e-tool to measure systemic lupus activity

Conditions: Lupus Erythematosus, Systemic

Summary: validation of a self-questionnaire (sledai-p/lupin) completed by the patient to measure the activity of the systemic lupus, in order to improve the patient's empowerment.

systemic lupus erythematosus (sle) is a rare and chronic autoimmune disease. disease activity (da) is marked by remissions, spontaneous relapses or induced by therapeutic modifications. sle exposes to serious complications requiring close medical follow-up, but flares cannot be predicted and often do not coincide with medical consultations. sle da is measured during a consultation using the sledai tool, but cannot be completed by patients. there is therefore high at stake to develop tools allowing patients to measure da, predict flares and subsequently tailor the medical follow-u to each patient. using the same framework as a previous nationwide study related to covid-19 impact (epicure survey), we aim to develop and validate, in collaboration with the french national lupus reference centers and hometrix health, a patient-tailored tool (sledai-p/lupin). sledai-p/lupin was designed by expert lupulogist and patients. it is available as a paper questionnaire and a smartphone app. it consists of simple patient-oriented questions allowing numerical score calculation. in order to validate the sledai-p/lupin, we will recruit 500 sle patients who satisfy the 2019 acr/eular classification criteria. all patients will complete the self-questionnaire and have a follow-up consultation with a clinician within 7 days. the validity of the sledai-p self-questionnaire will be assessed by calculating the correlation between sledai-p/lupin and the clinical sledai-2k provided by the clinician (blindly of the sledai-p/lupin results). we will also collect information about the quality of life via the sf-36 questionnaire to evaluate if the sledai-p/lupin predicts patient-reported outcome measures. the results of this survey will permit the validation of the sledai-p/lupin as a self-questionnaire carried by the patient. the development of self-administrated disease activity questionnaires such as the sledai-p/lupin may allow to better tailor the treatment and follow-up of sle patients, and empower sle patients for the control and management of their disease.

Eligibility criteria:
inclusion criteria: clinical diagnosis of systemic lupus patient residing in metropolitan france or in the french ultra-marine departments and territories patient who has both completed the sledai-p/lupin, sf-12 and been assessed by a specialist via the sledai-2k within 15 days exclusion criteria : non-lupus patient/participant patient residing outside france patient who has not completed the sledai-p/lupin or has not been assessed by a specialist via the sledai-2k within 15 days

Keywords: patient-reported outcomes disease activity sledai patient empowerment lupus erythematosus systemic sledai-p lupin
ldx and functional magnetic resonance imaging (fmri in menopausal women

Conditions: Menopause; Brain Activity; Cognition

Summary: this study seeks to assess the effects of lisdexamfetamine (trademark name: vyvanse; ldx) on executive function and prefrontal cortex activation in menopausal women ages 45-57, who report subjective cognitive difficulties. this protocol will recruit women from dr. epperson's ongoing study, protocol #812470, to examine the impact of ldx on brain activation during performance of cognitive tasks specifically probing prefrontal cortex function.


Eligibility criteria:
inclusion criteria: 1. have no previous or present history of a dsm-iv psychiatric or substance dependence disorder within the previous year, according to the structured clinical interview for diagnosis- dsm-iv (scid)-non-patient version; 2. are within 5 years of last menstrual period (lmp); 3. have a follicular stimulating hormone level (fsh) of 20 iu/ml; 4. are able to give written informed consent; 5. must have clear urine toxicology screen upon recruitment; 6. are fluent in written and spoken english; 7. are right-handed; 8. negative urine pregnancy test if still menstruating. exclusion criteria: 1. mini-mental status exam score of less than or equal to 24; 2. presence of a psychiatric disorder within previous year or a life time history of adhd or psychotic disorder including bipolar disorder, schizoaffective disorder, and schizophrenia; 3. lifetime history of drug addiction or abuse, except nicotine; 4. regular use of other psychotropic medication; 5. regular use (more than once a week) of alcohol that is less than 3 drinks/day; 6. presence of a contraindication to treatment with stimulant medication unless the condition is controlled with medication; this would include the presence of uncontrolled hypertension, coronary disease, atrial fibrillation, and arrhythmia; 7. history of seizures; 8. history of cardiac disease including known cardiac defect or conduction abnormality; 9. abnormal electrocardiogram during screening; 10. use of estrogen therapy within previous 2 months; 11. current pregnancy or planning to become pregnant; 12. metallic implant; 13. claustrophobia.

Keywords: menopause fmri vyvanse
evaluation and follow-up of people with tick-borne diseases

Conditions: Lyme Disease; Tick-Borne Disease

Summary: background: lyme disease is the most common tick-borne disease in the united states, but other diseases transmitted by ticks have also been on the rise in recent years. early symptoms of a tickborne disease include fever, headache, fatigue and possible rash. researchers want to collect information and samples from people with lyme disease and other tick-borne illnesses to better understand and diagnose these diseases. objective: to evaluate and follow people with tick-borne diseases to help researchers learn more about these infections. eligibility: people ages 18 and older who have or are suspected of having a tick-borne infection. design: participants will have an initial visit, and visits about 1, 6, and 12 months later. the visits can include a physical exam, blood tests, collection of blood, urine and saliva samples for research, and filling out health-related questionnaires. participants who have the rash of lyme disease may be invited to have up to 3 skin punch biopsies of the rash for research.

lyme disease is a multisystem illness caused by the spirochete borrelia burgdorferi and it is the most common vector-borne illness in the united states. tick-borne disease cases reported to the center for disease control and prevention (cdc) have been on the rise with over 59,000 cases reported in 2017. this protocol is designed to collaborate with university of maryland school of medicine for the purpose of recruiting and enrolling patients with lyme disease and other tickborne illnesses. this is a natural history study which has the objective of developing a rigorously defined population of patients with lyme disease and other tick-borne illnesses, per cdc case definitions, to serve as the basis for research in multiple aspects of the infections. these research sub-projects have emphasis in exploring the biological markers of tick-borne infections, developing new diagnostic tests for these infections, assessing the clinical course and outcome of patients with these tick-borne infections, and defining the immunological response to the pathogens.

Eligibility criteria:
* inclusion criteria: * clinical diagnosis of suspected, confirmed, or probable lb or other tbd per cdc case definitions. * has not received antibiotic therapy for tick-borne disease for more than 2 weeks. * age \>=18 years. * able to provide informed consent. * subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other disorders. exclusion criteria: * post-treatment lyme disease syndrome * women who report they are pregnant. * any other condition or history of unacceptably poor compliance that, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in and completing the study.

Keywords: lyme borrelia anaplasma rickkettsia lone star natural history
clinical trial of group acyw135 meningococcal polysaccharide vaccine 001

Conditions: Meningitis

Summary: the clinical trial was designed to evaluate the safety against group acyw135 meningococcal polysaccharide vaccine of hualan administered on subjects 2 years of age and older.

complying with requirements of the approval letter of clinical trial issued by sfda (approval letter no.: 2006l01017), hualan conducted phase i clinical trial of group acyw135 meningococcal polysaccharide vaccine. the safety end points were the presence of any systemic, local and adverse reaction.

Eligibility criteria:
inclusion criteria: * healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent; * healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product; * be able to comply with the requirements of clinical trial protocol and immunogenicity examination; * have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks; * axillary temperature ≤37.0℃. exclusion criteria: * any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.; * allergic to vaccines or drugs (history of allergy to any vaccine in the past); * history of neurologic symptom or signs; * known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, hiv infection or related disease, etc.; * history of meningitis infection or vaccination of meningococcal vaccine within the past 3 months; * history of receiving other vaccines or immunoglobulin injection or any research drugs; * any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week; * history of fever within the past 3 days (axillary temperature ≥38.0℃); * participating in another clinical trial; * history of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease; * thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection; * acute chronic disease (such as down syndrome, diabetes, sickle cell anemia or neurologic disease, guillain-barre syndrome); * known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, sbav infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.; * pregnancy; * any condition that, in the judgment of investigator, may affect trial assessment.

Keywords: group acyw135 meningococcal polysaccharide vaccine
gsh supplementation on cold/flu symptoms in older healthy adults

Conditions: Improvement in Immune Cell Function in Elderly Humans

Summary: a randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. participants will receive a supplement capsule containing placebo (crystalline cellulose) or 500mg of setria® glutathione to eat for 120 days. glutathione is hypothesized to replenish the body's reserves that may be depleted through natural aging process, poor diet, or due to the detoxification process for drugs. the primary end point is the number of healthy days experienced during cold and flu season. secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.

the long term goal of this investigation is to understand how food components improve immune function, both in its ability to respond to pathogens and its ability to turn off when the response is no longer needed. the goal of this application is to examine mechanisms by which glutathione improves immune cells after consumption. the central hypothesis is that glutathione improves redox status within the cell, thereby improving cell function and increasing the number of healthy days experienced by the participants. after obtaining informed consent, human participants will receive 500 mg/day of setria® glutathione or placebo for 120 days. peripheral blood mononuclear cells (pbmc), neutrophils and serum will be obtained from blood draws before and after the 120 days. a daily diary of illness will be kept by each participant and will record any incidence of illness, the number of symptoms per incidence, and the number of days in which symptoms are present. this study is powered on the basis that over 120 days, the glutathione-supplemented group would experience 3% more healthy days compared to the placebo group. the analysis indicated 60 people per group. timeline should be between mid-january to may because the center for disease control and prevention indicates that this is the cold and flu season (http://www.cdc.gov/flu/weekly/fluactivity.htm) in the southwest part of the country.

Eligibility criteria:
inclusion criteria: * generally healthy * must have had at least one cold during the previous year * age 50-75 * must discontinue other dietary supplement use exclusion criteria: * on arthritis medication * on hypertension medication * severe allergies * compromised immune system * high cholesterol, heart failure, angina, etc. * diagnoses of diabetes or metabolic syndrome
effectiveness of exercise cardiac rehabilitation

Conditions: Cost-effectiveness of Exercise-based Rehabilitation Program

Summary: the objective of this multidisciplinary study is to employ health-economic evaluation in determining the health benefits achieved with exercise-based cardiac rehabilitation and the costs derived from it compared with conventional post-acute care of cardiac patients in the finnish health care system.

the cost-effectiveness of exercise-based cardiac rehabilitation has not been systematically studied earlier in finland, and it is not justifiable to directly apply the results of studies done in other countries to circumstances in finland due to differences in the health care and social security systems between the countries. the research will utilize top finnish expertise spanning clinical cardiology, health economics, and physical education. the hypothesis is that a quality-adjusted life year of a cardiac patient (cost/qaly) is 20 % less costly in a rehabilitation group than in a conventional post-acute care group. the participants in the study will be recruited from oulu university hospital patients from the oulu region (n = 300) who have suffered acute coronary syndrome (angiographically diagnosed coronary artery disease). of these patients, 130 will be randomized to exercise-based cardiac rehabilitation (verve) and 170 to a control group. dropping out of the intervention will be mini-mized by means of careful definition of the inclusion criteria and close follow-up. the rehabilitation will seek to implement the most recent international recommendations for health-enhancing physical activity (% of those who achieved the exercise target). instructions for a progressive training model will be compiled. the amount of exercise will be monitored objectively with a wrist-worn device based on wellness technology. subjective loading of both the training and health-enhancing physical activity will be monitored using self-evaluation. the study will last one year for each patient, after which cost-effectiveness will be analyzed (university of eastern finland). the results of the research will facilitate decision making and choices in finnish health care when arranging rehabilitation for cardiac patients and planning the optimal utilization of health care resources.

Eligibility criteria:
inclusion criteria: * the patients undergo coronary angiography and are diagnosed with coronary artery disease. exclusion criteria: * new york heart association (nyha) class iv * heart failure * unstable chest pain (angina pectoris) at the time of randomization * severe peripheral atherosclerosis (intermittent claudication) * severe retinopathy or neuropathy related to diabetes.

Keywords: acute coronary syndrome cost-effectiveness cardiac rehabilitation exercise physical activity home monitoring
a phase i dose escalation study of cgm097 in adult patients with selected advanced solid tumors

Conditions: Solid Tumor With p53 Wild Type Status

Summary: this is a first in human phase i study of single agent cgm097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. the tumor must be characterized by p53wt status. the study consists of a dose escalation part where patients will receive escalating doses of cgm097, and a dose expansion part in which patients are given cgm097 at the maximum tolerated dose (mtd) or recommended phase 2 dose (rp2d). each dose escalation step will be decided based on the recommendation from an adaptive bayesian logistic regression model (blrm).

this is a multi-center, open-label, dose finding, phase i study of single agent cgm097, administered in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. patients' tumors must be characterized by p53wt status. the study consists of a dose escalation part, where cohorts of three to six newly enrolled patients will receive escalating doses of cgm097, and a dose expansion part, in which patients are given cgm097 the maximum tolerated dose (mtd) or recommended phase 2 dose (rp2d). novartis and the site investigators will jointly decide on each dose escalation step based on the recommendation from an adaptive bayesian logistic regression model (blrm). if safety data should indicate a lower increment than suggested by the blrm, the next dose level (dl) will be adjusted accordingly.

Eligibility criteria:
inclusion criteria: * patient has advanced solid malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists * tumor of the patient is p53wt * evaluable disease as determined by recist 1.1 * who performance status 0-2 exclusion criteria: * prior treatment with cgm097 or other p53/hdm2-interaction inhibitor * patient with symptomatic or growing cns metastatic lesions * concurrent other malignancy * clinically significant cardiac disease as defined in the protocol * diagnosis of acute or chronic pancreatitis * concomitant therapy that precludes enrollment, as defined in the protocol * women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation * pregnant or nursing women other protocol-defined inclusion/exclusion criteria may apply.

Keywords: p53, solid tumor