Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of the vitasiro solo™ respiratory assay

Conditions: SARS-CoV-2; COVID-19; RSV; Influenza

Summary: the purpose of this clinical trial is to demonstrate the clinical performance of the vitasiro solo™ sars-cov-2/flu/rsv assay in detecting sars-cov-2, flu a, flu b and rsv in symptomatic population. the primary aim is to determine the ppa/npa against a comparator assay. the secondary aim is to determine the diagnostic sensitivity, specificity, ppv and npv against the standard-of-care test. each subjects will be asked to provide both nasal swab (ns) and nasopharyngeal swab (nps) for testing purposes.

the study is designed as a multisite, observational, prospective study. subjects will be prospectively recruited from the target population, specifically individuals displaying signs and/or symptoms of respiratory tract infections. consent for participation will be obtained prior to any eligibility confirmation or sample collection. subsequently, both nasal swab (ns) and nasopharyngeal swab (nps) specimens will be collected from each subject. these specimens will be tested using both the vitasiro solo™ sars-cov-2/flu/rsv assay and the cepheid xpert xpress cov-2/flu/rsv plus assay (comparator) to determine the positive percent agreement (ppa) and negative percent agreement (npa). subjects will be recruited across up to 20 sites, targeting the following intended user groups: trained laboratory professionals in a central laboratory setting trained healthcare practitioners in a point-of-care (poc) setting under clia moderate and high complexity. if a standard-of-care (soc) diagnosis is available, the sensitivity, specificity, positive predictive value (ppv), and negative predictive value (npv) will also be calculated.

Eligibility criteria:
inclusion criteria: * subject displaying one or more of the following signs and/or symptoms of a respiratory tract infection: 1. fever 2. cough 3. nasal congestion 4. shortness of breath 5. difficulty in breathing 6. runny nose 7. sore throat 8. muscle pain 9. headache 10. chills 11. nausea 12. diarrhoea 13. vomiting 14. new loss of taste/smell * if age 18 or over, subject is willing and capable of providing written informed consent. if under the age of 18, parent or legal guardian is willing to and capable of providing consent/assent. assent should be obtained from minor subjects of appropriate intellectual age as defined by the irb. exclusion criteria: * subject is unable to provide consent and assent (as appropriate) or parental/legal guardian consent permission and assent (as appropriate) cannot be obtained. * pi determines that specimen collection represents an unacceptable risk. * subjects who have already been enrolled in the study previously.

Keywords: respiratory sars-cov-2 covid-19 influenza rsv poct
randomized safety, tolerability and pilot efficacy of an-1792 in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: a multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular an-1792 in patients with mild to moderate alzheimer's disease.

the study will enroll approximately 375 patients with mild to moderate alzheimer's disease at investigational sites in the united states and europe. patients will receive either an-1792 or placebo, and they will be evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of alzheimer's disease pathology. the goal of the study is to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the a-beta peptide in patients with alzheimer's disease.

Eligibility criteria:
mild to moderate alzheimer's disease. ability to cooperate with mri scanning and neuropsychological testing. live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.

Keywords: alzheimer's an-1792 aip-001
pretreatment with valproate prior to immunotherapy targeting cluster of differentiation antigen 20 in chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: this trial includes patients with chronic lymphocytic leukemia, the most common kind of malignant lymphoma. monoclonal antibodies directed against cluster of differentiation antigen 20 have improved treatment results in different forms of lymphomas; however in chronic lymphocytic leukemia treatment with monoclonal antibodies is less effective, and it has been suggested that this is depending on a lower expression of the cluster of differentiation antigen 20 protein on the chronic lymphocytic leukemia cells. valproate, an anticonvulsant drug, has been shown to increase the cluster of differentiation antigen 20 expression, and the rationale in this study is that an increasement of cluster of differentiation antigen 20 would make treatment with monoclonal antibodies in patients with chronic lymphocytic leukemia more effective.


Eligibility criteria:
inclusion criteria: * age 18-80 years * histologically confirmed chronic lymphocytic leukemia * leucocyte count more than 20 x 10 9/l * no other simultaneous treatment for lymphoma * no treatment indicated for chronic lymphocytic leukemia * who performance status 0-2 * hiv negativity * negativity for hepatitis c virus , hbsag, anti-hepatitis b core antigen, or other active infection uncontrolled by treatment * agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy * agree not to share study medication with another person and to return all unused study drug to the investigator * written informed concent exclusion criteria: * psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study * neurological or neuropsychiatric disorder, interfering with the requirements of the study * hearing impairment over grade 2 * porphyria * history of acute or chronic hepatitis * family history of severe drug-induced hepatitis * pregnancy and lactation

Keywords: chronic lymphocytic leukemia valproate cluster of differentiation antigen 20 lymphomas b-cell lymphomas translational research monoclonal antibodies
study to assess the performance of magnetos flex matrix compared to cellular allograft

Conditions: Degenerative Disc Disease

Summary: the purpose of this study is to demonstrate the performance of magnetos flex matrix in patients with leg pain and/or back pain.

this is a prospective, randomized, multi-center study that intends to demonstrate the performance of magnetos flex matrix compared to cellular allograft in patients with leg pain and/or back pain requiring up to four-level instrumented plf surgery.

Eligibility criteria:
inclusion criteria: 1. patient is able to read/be read, understand, and provide written informed consent and has signed the irb approved informed consent. 2. male or female patient ≥ 18 years old. 3. patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (t11 - s1). 4. failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment. exclusion criteria: 1. requires greater than four-level fusion or expected to need secondary intervention within one year following surgery. 2. had prior plf fusion or attempted plf fusion at the involved levels. 3. had previous decompression at the involved levels. 4. women who are or intend to become pregnant within the next 12 months. 5. to treat conditions in which general bone grafting is not advisable. 6. in conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible). 7. in case of significant vascular impairment proximal to the graft site. 8. in case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or paget's disease) that affect bone or wound healing. 9. in case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis). 10. when intraoperative soft tissue coverage is not planned or possible. 11. undergoing any procedure that allows magnetos to come in direct contact with the articular space. 12. receiving treatment with medication interfering with calcium metabolism. 13. has leg pain, and/or back pain related to benign or malignant tumor. 14. has history or presence of active malignancy. 15. has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements. 16. is involved in active litigation relating to his/her spinal condition. 17. has participated in an investigational study within 30 days prior to surgery for study devices
study on the dynamic changes of metabolic biomarkers and their prognostic relationship in ovarian cancer

Conditions: Ovarian Cancer

Summary: ovarian cancer is a highly lethal gynecological malignancy, often diagnosed at an advanced stage, with high rates of recurrence within 1-2 years after frontline treatment. current guidelines recommend monitoring tumor markers ca125 and he4 for disease progression, but these markers may not detect recurrence or disease progression when their levels are below the detection limit. therefore, there is a need to identify new prognostic biomarkers and monitor their dynamic changes for effective risk stratification and personalized treatment in patients with ovarian cancer

ovarian cancer is the deadliest gynecological malignancy, with over 70% of patients being diagnosed at advanced stages, and more than 70% experiencing recurrence within 1-2 years after frontline treatment. the recommended tumor biomarkers for monitoring ovarian cancer progression, ca125 and he4, still pose the risk of recurrence and disease progression when their levels are below the detection limit. therefore, it is of paramount importance to search for new prognostic monitoring biomarkers for ovarian cancer in order to stratify the prognosis and implement personalized treatment, ultimately improving patient outcomes. previous research and literature have indicated that metabolic biomarkers can directly reflect the biochemical changes, physiological status, and disease progression in cancer patients. in comparison to studying the relationship between metabolite expression levels at a single time point and disease prognosis, the dynamic changes in metabolite trajectories with multiple time points can better reflect the dynamic patterns of disease progression throughout the entire cancer cycle, providing more prognostic information for patients with ovarian cancer.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years; * pathological diagnosis of high-grade serous ovarian cancer; * newly diagnosed ovarian cancer case without prior neoadjuvant therapy. exclusion criteria: * non-primary (recurrent) patients; * ovarian cancer patients who have not undergone surgical treatment; * patients with a history of other malignancies.
gdf-15 levels in risk stratification in acute pulmonary embolism

Conditions: Pulmonary Embolism

Summary: prospective observational study evaluating serum gdf-15 levels in patients with acute pulmonary embolism.

prospective observational study evaluating serum gdf-15 levels in patients with acute pulmonary embolism (ape). in ape right ventricle failure developing due to ischemia and myocarditis is considered the primary cause of death, however, its pathomechanism has not been fully established yet. growth differentiation factor 15 (gdf-15) is a chemokine secreted by activated macrophages in response to oxidative stress. it has now been shown that ischemic injury, mechanical stretch, and pro-inflammatory cytokines also stimulate the expression of gdf-15 in cardiac myocytes. the objective of this project is to describe the role of gdf-15 in the pathomechanism of acute right ventricle failure in the setting of acute pulmonary embolism and to verify the hypothesis that higher serum concentrations of gdf-15 are associated with more advanced right ventricle dysfunction and failure.

Eligibility criteria:
inclusion criteria: * adult patients with ape hospitalized who give written consent. exclusion criteria: * lack of informed consent * ape with symptoms lasting above 14 days before the admission * acute coronary syndrome, diagnosed pulmonary hypertension * severe valve disease * sepsis * active malignancy * diagnosed mitochondrial diseases * chronic kidney disease at least stage 4 (kdigo) * pregnancy.
effect of spironolactone and vitamin e in patients with nonalcoholic fatty liver disease

Conditions: Fatty Liver; Steatohepatitis

Summary: the primary aim of the study is the effect of spironolactone and vitamin e versus vitamin e on serum levels of adipokines 52 weeks post-treatment.

unlike other chronic liver diseases (e.g., hepatitis c), there are no effective treatment strategy for nafld. currently, the management of nafld includes modification of underlying risk factors, detection of patients that have progressed to cirrhosis, management of cirrhosis-related morbidity and transplantation in patients with end-stage liver disease. diet, exercise, bariatric surgery and pharmacologic treatment, including weight loss agents, insulin sensitizers, lipid-lowering agents, ursodeoxycholic acid and vitamin e have been investigated with some promising results. the renin-angiotensin-aldosterone system (raas) has been implicated in the pathogenesis of insulin resistance (ir) and nonalcoholic fatty liver disease (nafld). recently, low-dose (25-50 mg/day) aldosterone antagonists in patients with heart failure diminish mortality, possibly by reducing cardiac and vascular fibrosis. moreover, the beneficial effect of spironolactone in a mouse model with diet-induced diabetes and nafld has been reported. however, to our knowledge, the role of spironolactone in nafld patients has not been investigated yet. the primary aim of the study is the effect of spironolactone and vitamin e versus vitamin e on serum levels of adipokines 52 weeks post-treatment.

Eligibility criteria:
inclusion criteria: * bright liver on ultrasound imaging and increased liver function tests for at least 6 months before liver biopsy * biopsy-proven nafld (either nafl or nash) according to nafld activity score (nas) exclusion criteria: * ethanol consumption more than 20 g/day * known intolerance to spironolactone or vitamin e * history of liver disease (chronic viral hepatitis, autoimmune hepatitis, drug-induced liver disease, primary biliary cirrhosis, hemochromatosis, wilson's disease and α1-antitrypsin deficiency) * previous exposure to hepatotoxic drugs * spironolactone or vitamin e administration within one year before screening * type i diabetes mellitus * pancreatitis * uncontrolled hypothyroidism or hyperthyroidism * adrenal insufficiency * renal failure * cancer * pregnancy exclusion criteria were generally the same as those proposed for pivens trial design with two modifications: a) known intolerance to spironolactone as an exclusion criterion and b) the inclusion of patients with t2dm not receiving thiazolidinediones or insulin.

Keywords: nonalcoholic fatty liver disease nonalcoholic steatohepatitis adipokines spironolactone vitamin e adiponectin visfatin leptin resistin tnf-alpha il-6 il-1
a multiple dose study of ertugliflozin (pf-04971729, mk-8835) in otherwise healthy overweight and obese volunteers (mk-8835-037)

Conditions: Healthy Volunteer

Summary: ertugliflozin (pf-04971729, mk-8835) is under development for the treatment of type 2 diabetes. the primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.

to evaluate the safety and tolerability, pharmacokinetics (pk), and pharmacodynamics, of multiple oral doses of ertugliflozin.

Eligibility criteria:
inclusion criteria: healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. body mass index (bmi) of 26.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). evidence of glycosuria, as defined by a positive urine dipstick test; fasting (at least 10 hours) serum triglyceride \>300 mg/dl; fasting (at least 10 hours) ldl-cholesterol \>190 mg/dl; fasting (at least 10 hours) serum 25-oh vitamin d concentration \<20 ng/ml
long term diabetes improvement after cancer gastrectomy and colectomy

Conditions: Diabetes Mellitus; Prediabetes; Morbid Obesity; Gastric Cancer; Colorectal Cancer

Summary: there is evidence that gastrointestinal operations for non weight-losing purposes are beneficial for diabetes mellitus. aiming to analyze such hypothesis, patients submitted to gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for colo-rectal cancer will be compared. the end point will be changes in fasting blood glucose and hemoglobin a1c concentration.

in a prospective protocol with retrospective information, patients (n=240) undergoing bariatric roux-en-y gastric bypass (n=80), cancer subtotal or total gastrectomy (n=80) and right colectomy or rectosigmoidectomy (n=80) with follow-up \>3 years free of disease, with or without previously impaired fasting blood glucose, will be recruited. patients will be submitted to a questionnaire involving diet, diagnosis of diabetes and glucose-lowering drugs, body weight and other clinical items. preoperative information available in the hospital system will be completed and current findings will be updated, including body mass index and biochemical measurements. using the outcomes of the bariatric population as benchmark, both concerning diabetics that were ameliorated and nondiabetics that progressed to new-onset diabetes,results in the other groups will be compared. the study should answer whether gastric and colorectal surgery for cancer 1) are beneficial for established diabetes; 2) attenuate the conversion of normal patients to diabetes, both within a follow-up period of 3- 12 years;

Eligibility criteria:
inclusion criteria: * follow-up period \> 3 years, * weight stable in the last year exclusion criteria: * reoperation or take-down of original operation, * consumptive diseases, * protein-calorie malnutrition, * organ failures, * pancreatic surgery, * cell or organ transplantation, * type 1 diabetes, * cognitive impairment or alzheimer disease, * refusal to participate in the protocol

Keywords: diabetes mellitus prediabetes fasting blood glucose hba1c roux en y gastric bypass cancer gastrectomy cancer colorectal surgery
a phase 1 dose escalation study of vx-993 in healthy participants

Conditions: Pain

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of vx-993 at different doses in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight of more than (\>) 50 kg * participants of non-childbearing potential * nonsmoker or ex-smoker for at least 3 months before screening key exclusion criteria: * history of febrile illness or other acute illness within 14 days before the first dose of study drug * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
study to evaluate the efficacy and safety of ckd-350

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to compare the efficacy and safety of ckd-350 in patients with dry eye syndrome

active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of ckd-350 eye drops in patients with dry eye syndrome

Eligibility criteria:
inclusion criteria: 1. more than the age of 19 years old 2. subjects with dry eye symptoms for at least 3 month prior to screening 3. subjects who have following values 1) ≥ 2 point of corneal staining score 2) ≤ 10 seconds of tear break-up time 3) ≤10mm/5min of schirmer i test 4. subjects who have a visual acuity equal to or better than 0.2 in both eyes 5. subjects who sign on an informed consent form willingly exclusion criteria: 1. subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora 2. subjects who have medical history following 1) abnormal eyelids function including abnormality of eyelid or eyelash 2) ophthalmology operation within 1 year 3) active ocular infection at present or treatment of allergic eye diseases 4) herpetic keratopathy, conjunctiva scar from cicatricial keratoconjunctivitis(alkali injuries, stevens-johnson syndrome, ocular cicatricial pemphigoid), pterygium, congenital lacrimal gland absence, neural keratitis, keratoconus 3. subjects who have received occlusion therapy with lacrimal or punctal plugs within 3 months or have a surgery plan in clinical trial 4. subjects who wore contact lenses within 3 months or need to wear contact lenses during the study 5. subjects who take steroidal or immunosuppressive drug within 1 month 6. over 22mmhg iop(intraocular pressure) 7. subjects who have malignant tumor within 5 years 8. subjects with known hypersensitivity to investigational product 9. women who are nursing, pregnant or planning pregnancy during the study 10. subjects who have received any other investigational product within 1 month prior to the first dosing 11. impossible subjects who participate in clinical trial by investigator's decision

Keywords: dry eye syndrome sodium hyaluronate ckd-350