Kornimate/medical-research-clean huggingface dataset:
post-marketing clinical observation of an inactivated influenza split vaccine

Conditions: Human Influenza

Summary: phase iii clinical trial was carried out in jintan city, jiangsu province, china in may, 2006. trial results showed that the vaccine had proved safety and immunogenicity. influenza vaccine of hualanbio has obtained production permission and marketing authorization in may, 2008. in order to further investigate the safety and immunogenicity of the vaccine in the market, the clinical observation was planned to be conducted in mianyang city (yanting county), sichuan province, china.

dosage and administration route in this clinical trial: subjects age 3 years or older was vaccinated following a single 0.5ml dose immunization regime. the preferred site of injection was the at the skin near outboard deltoid muscle of the upper arm. the administration route is after the sanitization with 75% alcohol, intramuscularly inject the test vaccine or the control vaccines when the skin was slightly dried for those subjects complied with the inclusion requirements. safety indicators: * post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reaction within 30 minutes ; * post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reactions through 6 hours to the 29th day ; * summarize the adverse events/severe adverse events and the incidence levels from the inclusion of the subjects to the completion of the clinical trial. immunogenicity indicators: evaluate the post-vaccination immunogenicity of the test and the control influenza vaccines in persons age 3 years and older by its hi antibody level on day 28. take 1:10 serum dilution as the minimum dilutability. the seroconversion in this trial was defined as the post-vaccination hi antibody titer ≥ 1:40 when the hi antibody \< 1:10 before the vaccination or the post-vaccination hi antibody titer quadruply increased when hi antibody ≥ 1:10 before the vaccination. the immunogenicity criteria set for this clinical trial is the seroconversion shall be \> 40% after 14 days of the vaccination.

Eligibility criteria:
inclusion criteria: * healthy male or female age 3 and older, volunteers or their guardians are able to understand and sign the informed consent; * healthy male or female by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product; * be able to comply with the requirement of clinical trial protocol; * have no history of vaccination within the past 6 months and vaccination with other product within the latest 1 week; * axillary temperature \<37.1℃. exclusion criteria: * subject that was allergic to eggs and any component of the vaccine, or has history of other allergy; * fever, acute disease or acute onset of chronic disease and influenza; * guillain-barre syndrome

Keywords: respiratory tract infections; orthomyxoviridae infections
deep brain stimulation (dbs) for parkinson's disease international study

Conditions: Parkinson Disease

Summary: to gather data on dbs therapy effectiveness in different geographic populations.

the purpose of this prospective open label post market study of dbs for pd is to gather data on dbs therapy effectiveness as measured by clinician and patient reported health outcomes data through one year of follow-up in different geographic populations.

Eligibility criteria:
inclusion criteria: 1. indication of dbs for pd consistent with the country specific approved labeling. 2. levodopa-responsive parkinson's disease (updrs iii ≥ 30% improvement on levodopa challenge test). 3. symptoms treatable by medications but not adequately controlled with medications (with persistent disabling symptoms, such as motor fluctuations, dyskinesia). 4. at least 22 years old. 5. screening cranial mri, performed within 12 months of entry into the study, that is normal or with a non-significant abnormality that does not present any incremental risks or concerns for the patient as a result of the dbs procedure. 6. understand potential risk/benefit, consent to the study, study procedures, and agree to complete the study follow-up visits and comply with the study protocol requirements. exclusion criteria: 1. secondary parkinson's disease, atypical syndromes. 2. previous stereotactic functional neurosurgery or ablative therapy (e.g., pallidotomy, subthalamotomy), surgical contraindications related to dbs. 3. dementia (mattis dementia rating scale ≤ 130), major depression with suicidal thoughts (beck depression inventory ii \> 25), acute psychosis, active alcohol or drug abuse, terminal illness, and any major medical or psychological histories, diagnoses, conditions, or comorbidities that would interfere with participation in the study per the investigator's medical judgment. 4. electrical or electromagnetic implant (e.g., cochlear prosthesis, cardiac pacemaker). 5. surgical or medical contraindications to dbs surgery or therapy (e.g., uncontrolled hypertension, advanced coronary artery disease). 6. participation in a drug, device, or biologics trial within the preceding 30 days that may confound the study results. 7. pregnant female.

Keywords: parkinson's disease deep brain stimulation
evaluating dose regimen of intravenous unfractionated heparin and low molecular weight heparin in critical ill patients versus critical ill covid-19 patients using anti-xa levels.

Conditions: COVID-19; Deep Vein Thrombosis; Anticoagulants and Bleeding Disorders; Critical Illness

Summary: to see whether our increased dosing regimen of unfractionated heparin (uf) and low molecular weight heparin (lmwh) in covid-19 patients was effective at preventing thrombo-embolic complications. we did regular anti-xa tests to optimise the dose of our thromboprophylaxis. furthermore, we want to examine the time it takes to reach adequate anti-xa levels, to determine additional risk factors and do a subgroup analysis. lastly, we will study if there are possible complications of our thromboprophylactic therapy.

covid-19 took the world by storm with its fast spread, high number of infected patients and its potential to range from mild illness to very severe respiratory distress. this pandemic is currently the focus of a lot of research, however there are still a lot of unknowns regarding covid-19. current literature shows that covid-19 patients have an increased risk for thrombo-embolic events which is why patients at the ghent university hospital get increased dose of thrombo-prophylactic therapy. patients were also screened for presence of deep venous thrombosis using ultrasound. anti-xa is a test in which the we determine the activity of the antithrombine-heparine complex on factor xa. using this test allowed us to measure the effect of our uf of lwmh and adjust the dose if needed. at this moment it is still unclear how high the prevalence of thromboembolic events in this group of patients is and whether our thromboprophylaxic therapy prevents this. we also looked into the time it took for anti-xa to reach adequate levels in our dosing regimen. furthermore, current risk factors for thromboembolic complications in covid-19 patients are still unclear. we compared the results of the covid-19 patients to a group of critical ill patients without covid-19.

Eligibility criteria:
inclusion criteria: * 18 years or older * hospitalisation required * icu admission exclusion criteria: * coagulopathies prior to covid 19 infection (known thromboembolism in the last 6 months i.e. deep venous thrombosis, pulmonary embolism, ...) * therapeutic anticoagulation on moment of icu admission * major trauma * major bleeding * cerebro vascular accident or neuro trauma in the last month
efficacy of kinesiotape on treatment of nonspecific cardiac chest pain

Conditions: Nonspecific Cardiac Chest Pain

Summary: purpose of the study to investigate the effect of kinesio-tape on treatment of nonspecific cardiac chest pain

nonspecific musculoskeletal chest pain is a major health problem and is a very common and functionally limiting pain complaint. patients with this problem complain also of significant disability of daily living activities and lost productivity. the clinical symptom of anterior chest pain generally elicits a long list of diagnoses, when cardiac and pleural conditions are excluded, conditions that affect the musculoskeletal system become important considerations. the musculoskeletal structures of the thoracic wall and the neck are relatively common sources of chest pain, hypersensitive loci, named myofascial trigger points in the literature, are associated with the pathophysiology and clinical manifestation of myofascial pain, rhomboid muscle trigger point can be a distressing cause of chest pain which can be effectively taken care of by ischemic compression therapy. rhomboid muscle trigger points are one of the major causes of nonspecific cardiac chest pain that make the patient seek treatment in different medical health care, but still there is a lake of scientific evidence that supports a particular treatment. conducting the current study will find an additional solution for this problem. kinesio-taping a technique highly appropriate in patients with soft tissue involvement and plays a major role in the deactivation of trigger points, kt is theorized to have several functions: (1) restoring correct muscle function by supporting weakened muscles, (2) reducing congestion by improving the flow of blood and lymphatic fluid, (3) decreasing pain by stimulating neurological system, (4) correcting misaligned joints by retrieving muscle spasm, and (5) enhancing proprioception through increased stimulation to cutaneous mechanoreceptors

Eligibility criteria:
inclusion criteria: * 30 subjects from both sexes with nonspecific cardiac chest pain 2- rhomboid trigger point 3-all subjects range from 7 to 9 on vas. 4-age range from 20-35. 5- all subjects will complain from limited shoulder rom exclusion criteria: * acute coronary syndrome/ ischemic heart disease 2-pleurisy 3-pulmonary lessons like(copd) chronic obstructive pulmonary disease,( coad) chronic obstructive airway disease and bronchiectasis, 4-costochondritis, ' 5-teitze syndrome, 6-chest wall syndrome 7-rheumatologic conditions, 8-infections in the chest wall 9-gastro-intestinal problems and 10-neoplastic disorders
covid-19 vaccine immune response in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: coronavirus (covid-19) has affected millions of people worldwide. vaccines to prevent covid-19 infection have been offered to reduce the risk of infection. while these vaccines have been offered to people with multiple sclerosis (ms), they have not been tested in these individuals. it is uncertain whether people with ms will develop protective antibodies after a covid-19 vaccination and how long these antibodies will last. the investigators are planning to study the immune response to the full course of covid-19 vaccine in people with ms (study group) and compare this to people without ms or immune suppression (control group).


Eligibility criteria:
inclusion criteria (study group - ms patients): * aged 18 years and over * diagnosis of multiple sclerosis as per mcdonald's criteria 2017 * falls into one of following the disease modification treatment (dmt) groups: on ocrelizumab, on natalizumab, on alemtuzumab, on tecfidera, on fingolimod, on interferon, not on any dmt * has had a complete course of covid-19 vaccination including any boosters (standard dosing: prescribed as per the uk government guidelines) * willing and able to give fully informed consent * willing and able to comply with the study procedures exclusion criteria (study group - ms patients): * has declined or does not wish to have covid-19 vaccine * has switched dmt since the date of first dose of covid-19 vaccine * has any other immunological condition or on immune treatment causing immune suppression * has declined or does not wish to have covid-19 vaccine * ineligible\* for covid-19 vaccine (\*ineligible for health reasons and/or as per government prioritisation of vaccinations) * non-english speaker where translation facilities are insufficient to guarantee informed consent inclusion criteria (control group - healthy volunteers): * aged 18 years and over * has had a complete course of covid-19 vaccination (standard dosing: prescribed as per the uk government guidelines) * willing and able to give fully informed consent * willing and able to comply with the study procedures exclusion criteria (control group - healthy volunteers): * has declined or does not wish to have covid-19 vaccine * has ms or another long-term immunological condition * history of taking any immune treatment causing immune suppression in the last 5 years * history of any immune conditions or comorbidities known to result in immune suppression within the last 5 years; * ineligible\* for covid-19 vaccine (\*ineligible for health reasons and/or as per government prioritisation of vaccinations) * currently participating in one or more interventional trials involving immune suppression or immune agent * non-english speaker where translation facilities are insufficient to guarantee informed consent
fast track admittance of hip fracture patients

Conditions: Hip Fracture

Summary: the study examines time spent in the emergency room on admission of patients with hip fracture in a cohort with a traditional setup compared with a prospective cohort with a fast track admission schedule including nurse initiation of treatmnet, standardized analgesia, fluid and oxygen therapy and standardized logistics for x-ray and admission procedures.


Eligibility criteria:
inclusion criteria: * admission with a primary hip fracture exclusion criteria: * none
cryotherapy and laser therapy on muscle damage

Conditions: Myalgia [C05.651.542]

Summary: this study propose investigate the effect of cryotherapy and laser therapy in response to strenuous exercise-induced muscle damage on the biceps brachii muscle (muscle of the arms). all the individuals underwent to an strenuous exercise protocol (2 series of 10 contractions of non-dominant elbow flexors) and three assessments (pre, post and 48hr after the exercise), composed of pain sensation, measure of the strength and muscle activation.


Eligibility criteria:
inclusion criteria: * female sex * aged between 18 and 28 years * healthy, considered active according to the international physical activity questionnaire -short form (ipaq) * engaging in physical activity involving upper limbs at least 2 times a week * exhibiting shoulder joint, elbow and non-dominant hand integrity * not having a history of osteo-myoarticular injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments. * furthermore they could not be allergic to ice (verified by the ice cube test) or any absolute contraindication for the use of laser (cancer and pregnancy). exclusion criteria: * not understanding the commands given in the protocols and/or inadequate performance during assessments.

Keywords: cryotherapy laser therapy eccentric exercise delayed onset muscle soreness muscle damage dynamometry electromyography
tolerance and patients' satisfaction with ighy

Conditions: Secondary or Primary Immunodeficiency

Summary: primary immunodeficiencies (pid) represent more than 150 diseases affecting the immune system. more than 50% of pids are due to a lack or an insufficiency in antibody production. some of these immunodeficiencies as well as some secondary immune deficiency with deficient antibody production (especially in hematology and oncology) are responsible for repeated and/or severe infections, requiring long-term replacement therapy with intravenous polyclonal immunoglobulin. intravenous replacement therapy is administered every 21 or 28 days in hospital. subcutaneous administration (weekly or bi-weekly) can be initiated for patients who cannot tolerate intravenous infusions or who have difficult venous access. however, some patients experience a decrease in quality of life with these more frequent administration at home. a new treatment is available in france since 2017, which is a subcutaneous infusion of human immunoglobulin facilitated by recombinant human hyaluronidase (ighy), administered every 3 to 4 weeks in a single abdominal site, at home. no direct data are available in adults to evaluate tolerance and satisfaction with this treatment, but we know it is a preferred option in children and adolescents.

the objective of the study is to describe the continuation of the human immunoglobulin-assisted recombinant human hyaluronidase (ighy) therapy at 6 months from the start of treatment. the secondary objectives are to evaluate the quality of life of patients treated with human immunoglobulin-assisted recombinant human hyaluronidase (ighy) therapy.

Eligibility criteria:
inclusion criteria: * major (\> 18 years), * with primary or secondary immunodeficiency, * followed in the department of internal medicine, infectious diseases - clinical immunology chu reims. * benefiting from human immunoglobulin treatment facilitated by recombinant human hyaluronidase, * agreeing to participate in the study. exclusion criteria: * patients refusing to participate in the study * minors

Keywords: ivig pid home infusion hyaluronidase immunoglobulin secondary and primary immunodeficiency disease tolerance
asimadoline for the treatment of subjects with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

a randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with ibs.

Eligibility criteria:
inclusion criteria: * males and females aged 18-79 * must sign an icf * females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial * must have been diagnosed with ibs as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form * must demonstrate a willingness to comply with daily telephone diary entry exclusion criteria: * any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data * pregnant or breastfeeding females * refusal to discontinue prohibited concomitant medications * use of an investigational drug or participation in an investigational study within 30 days of screening * inability or unwillingness to use the touch-tone telephone data entry system

Keywords: irritable bowel syndrome asimadoline
pharmacokinetic profile and pharmacodynamic characteristics of a furosemide high dosage formulation in patients with chronic renal failure undergoing peritoneal dialysis

Conditions: Renal Failure

Summary: primary objective: * to determine the absolute bioavailability of furosemide 500 mg (lasix® special) oral formulation in patients with chronic renal failure undergoing peritoneal dialysis. secondary objectives: * to determine the pharmacokinetic profiles of furosemide 500 mg (lasix® special) oral formulation and 250 mg iv formulation * to compare the pharmacodynamic characteristics of furosemide 500 mg (lasix® special) oral formulation and 250 mg iv formulation

* screening: 7 to 10 days * treatment period: 14 days (period 1: 7 days; period 2: 7 days) * end of study: 7 days after the last dosing, * total duration from screening per subject: 22 to 25 days.

Eligibility criteria:
inclusion criteria : * male or female, 18 years old or older, with chronic renal failure undergoing peritoneal dialysis for at least 3 months. * women of childbearing age should have a negative pregnancy test before administration of the study drug exclusion criteria: * contra-indications to furosemide, including: * hypersensitivity to furosemide or to sulphonamide-derived drugs or to any ingredient in the formulation or component of the container. * glomerular filtration rate below 5 ml/min * glomerular filtration rate above 20 ml/min * severe liver disease * patients with renal failure accompanied by hepatic coma and precoma * renal failure due to poisoning with nephrotoxic or hepatotoxic substances * severe hyponatremia, hypokalemia, hypovolemia, dehydration or hypotension * nursing women * pregnancy * treatment with any diuretic, which cannot be discontinued with the required washout period before the first drug administration * existence of any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with absorption, distribution, metabolism or excretion of drugs. * psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance. * treatment with the following inhibitors of secretion at the renal level: clarithromycin, erythromycin, itraconazole, cyclosporin, ketoconazole, quinidine, and verapamil, which cannot be discontinued during the course of the study. interfering substance:subjects must abstain from alcohol and beverages containing stimulating xanthine derivates (e.g. coffee and tea) during the entire study period. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
long-term effects of endobronchial valve implantation on cardiac function and skeletal muscle function

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the goal of this type of study: clinical trial is to evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function in chronic obstructive pulmonary disease. the main question it aims to answer are:evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function. participants will undergo lung volume reduction surgery with endobronchial valve implantation.


Eligibility criteria:
inclusion criteria: * patients with chronic obstructive pulmonary disease * fev1 ≤ 45% pred and fev1/fvc\<70% * tlc\>100% pred and rv\>175% pred * cat score≥18 * emphysema damage\>50% * complete interlobar fissure \>95% based on quantitative analysis of ct measurement * no smoking\>6 months * sign the informed consent form exclusion criteria: * paco2\>8.0 kpa, or pao2\<6.0 kpa * 6-minute walk test\<160m * obvious chronic bronchitis, bronchiectasis or other infectious pulmonary diseases * more than 3 hospitalizations for pulmonary infection in the past 12 months before baseline assessment * previous lobectomy, lvrs or lung transplantation * lvef\ 50mmhg * anticoagulant therapy that cannot be stopped before surgery * patients with obvious immune deficiency * participated in other lung drug studies within the first 30 days of this study * pulmonary nodules requiring intervention * any disease or condition that interferes with the completion of the initial or subsequent assessment