Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, tolerability, and immunogenicity of v114 followed by pneumovax™23 in healthy adults 50 years of age or older (v114-016/pneu-path)

Conditions: Pneumococcal Infections

Summary: this study is designed 1) to evaluate the safety, tolerability, and immunogenicity of v114 and prevnar 13™, 2) to describe the safety of sequential administration of v114 or prevnar 13™ followed by pneumovax™23, and 3) to evaluate the immune responses to the 15 serotypes contained in v114 when pneumovax™23 is given approximately 12 months after receipt of either v114 or prevnar 13™ in healthy adults 50 years of age or older. there was no formal hypothesis testing.


Eligibility criteria:
inclusion criteria: * male or female in good health * female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last study vaccine. exclusion criteria * history of invasive pneumococcal disease * known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine. * known or suspected impairment of immune function * coagulation disorder contraindicating intramuscular vaccination * history of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * female participant: positive urine or serum pregnancy test * prior administration of any pneumococcal vaccine * received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry. * received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (note: topical, ophthalmic, intra-articular or soft-tissue \[e.g., bursa, tendon steroid injections\], and inhaled/nebulized steroids are permitted). * received immunosuppressive therapy * received a blood transfusion or blood products within 6 months of enrollment * participated in another clinical study of an investigational product within 2 months of enrollment * current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence.
a study of efficacy and safety of ax-8 in chronic cough

Conditions: Chronic Cough

Summary: this is a randomized, double-blind, placebo-controlled, crossover, multicenter study of ax-8 in participants with unexplained or refractory chronic cough designed to evaluate the effectiveness of ax-8 in reducing cough frequency.


Eligibility criteria:
inclusion criteria: * chest radiograph or computed tomography (ct) of the thorax approximately 12 months before screening not demonstrating any abnormality considered to be significantly contributing to the chronic cough * have a diagnosis of refractory chronic cough (rcc) or unexplained chronic cough (ucc) for at least one year * women of childbearing potential and their male partners must use 2 acceptable methods of contraception * male subjects and their female partners of childbearing potential must use 2 acceptable methods of contraception * have provided written informed consent exclusion criteria: * positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) * current smoker (including e-cigarettes), individuals who have given up smoking within the past 12 months, or individuals with a smoking history of 20 pack-years * treatment with an ace-inhibitor as the potential cause of a subject's cough or requiring treatment with an ace-inhibitor during the study or within 12 weeks prior to the baseline visit * history of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks * history of cystic fibrosis * positive test for any drug of abuse * history of malignancy within 5 years prior to the baseline visit * history of infection or known active infection with human immunodeficiency (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) * history of hypersensitivity or intolerance to ax-8 or other trpm8 agonists or any of the excipients
analgesic efficacy of capsaicin 8% patch (qutenza®) in coccygodygnia

Conditions: Coccyx Disorder

Summary: a retrospective study over a period of 6 years to explore analgesic efficacy of 8% capsaicin patch (qutenza®) in coccygodynic patients, as well as neuropathic predictive factors of therapeutic response.

coccygodynia corresponds to a localized pain in the coccyx region, aggravated or triggered by sitting and/or by getting up from a seat. even if there is no epidemiology of this pain in france, coccygodynia represents a frequent recourse to specialized consultations (rheumatology or algology). currently in france, there is no recommendation on the management of chronic disabling coccygodynia. treatments are proposed in accordance with known/presumed underlying pathophysiology. anti-inflammatory drugs and manual therapy (pressure relief cushions) are thus always offered as first-line treatments. but despite their common use/prescription, their efficacy is variable, with low level of evidence. more over, upstream of invasive coccygectomy, therapeutic arsenal is largely deficient, inviting to explore new approaches. considering frequent neuropathic expression in coccygodynic pain pattern (tingling, itching, pain cold sensation...), capsaïcine 8% patch (qutenza®) are often performed. and in the same way, no/few researches tried to measure real-life analgesic pain efficacy of qutenza® strategy. observational retrospective study (non-interventional anonymized data) capsacoxp aims to assess analgesic efficacy of capsaicin 8% patch (qutenza®) and explore possible neuropathic determinants of therapeutic response in coccygodynia.

Eligibility criteria:
inclusion criteria: * patients who received topical capsaicin 8% patch therapy for the treatment of their coccygodygnia between august 2016 and august 2022 exclusion criteria: * patients who have already received 8% capsaicin patch topical treatment in coccyx area.

Keywords: chronic coccygodynia neuropathic pain capsaicine 8%
tranexamic acid in clopidogrel exposure to decrease hemorrhage and transfusion

Conditions: Coronary Artery Disease

Summary: the use of platelet aggregation inhibitors, including aspirin and clopidogrel(cpdg), has become a standard management strategy for patients with acute coronary syndrome. on this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition. investigations on the effect of antiplatelet treatment on postoperative bleeding after cardiac surgery have shown that patients treated with antiplatelet agents until surgery have increased postoperative bleeding, and also an increased need for transfusions of blood products. as a result of the antiplatelet effect of clopidogrel, the frequency of serious bleeding complications has increased significantly, as seen in patients requiring coronary artery bypass grafting(cabg), especially when they received clopidogrel until surgery. tranexamic acid(ta) is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has seceded in 2007.the release of plasmin during cardiopulmonary bypass(cpb) activates fibrinolysis and may contribute to platelet dysfunction. pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after cpb and decrease postoperative bleeding. tranexamic acid prevents plasmin formation and inhibits fibrinolysis. concerning the cessation of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population. the purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion until surgery. the investigators working hypothesis was that tranexamic acid would lower postoperative blood loss and transfusion requirements in these patients and would attenuate bleeding complication of antiplatelet therapy.


Eligibility criteria:
inclusion criteria: * patients requiring primary and isolated coronary artery bypass grafting with cardiopulmonary bypass exclusion criteria: * history of cardiac surgery * hematocrit \<33% * platelet count \<100,000/ml * allergy to tranexamic acid * recruited in other studies

Keywords: clopidogrel tranexamic acid cardiac surgical procedures hemostasis
css-assessing the course of degenerative cervical spinal stenosis using functional outcomes

Conditions: Cervical Spinal Stenosis; Cervical Myelopathy

Summary: the study will consist of two parts: * in study a, objectively assessed physical activity, gait, balance, range of movement of specific joints during walking and neurophysiological findings between patients with cervical spine stenosis (css) without myelopathy who will be treated conservatively and patients with stenosis and signs of myelopathy who are candidates for surgical treatment will be compared. * in study b, the 6-month changes in the same outcomes in patients treated conservatively (from the first specialist consultation until 6 months later) and in patients treated surgically (preoperative day and 6-month post-operatively) will be quantified.

study a is a single centre cross-sectional study with two study groups, one that will be treated conservatively (stenosis) and one that will be treated surgically (stenosis and myelopathy). study b is a single centre longitudinal study where the same patient groups will be followed up during the course of their treatment. clinical, radiological, biomechanical (kinematic and electromyographic), neurological and neurophysiological data will be collected. differences in and the relationship between the clinical, radiological, biomechanical, neurological and neurophysiological data will be determined .

Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosis of degenerative cervical spine stenosis defined by mri (stenosis grade 2 or grade 3 * local clinical symptoms due to degenerative changes of the cervical vertebral column with or without clinically defined myelopathy exclusion criteria: * stenosis after trauma or neoplasm * prior decompressive surgery * previous spine or extremity surgery with a consequent sensorimotor impairment * other pathologies than cervical spine stenosis causing gait disturbance * bmi \> 35 kg/m2 * use of walking aids * inability to provide informed consent * contraindications for recording of motor evoked potentials (mep) * contraindications to safely undergo mri

Keywords: cervical spinal stenosis cervical myelopathy
webmap mobile self-management of adolescent chronic pain

Conditions: Chronic Pain

Summary: approximately 5-8% of children report severe chronic pain and disability. although evidence supports pain-self management as effective for reducing pain and disability, data show that most youth do not have access to this intervention. the investigative team's prior studies demonstrate that technology-delivered pain self-management (webmap program) can reduce barriers to care, is feasible, acceptable, and effective in reducing pain-related disability and improving anxiety and depression in youth with chronic pain. in this trial, the investigators propose an implementation project to address critical challenges in nationwide dissemination of the webmap pain self-management program. using a hybrid effectiveness-implementation trial design, 8 clinics from across the u.s. will participate in a pragmatic randomized controlled trial with a stepped wedge design to sequentially implement webmap in the clinics following randomized usual care periods. data will be collected from clinic records, web and app administrative tracking, and provider surveys to gather information on adoption and implementation following the reach, effectiveness, adoption, implementation, maintenance (re-aim) public health impact framework. individual patient-level pain outcomes will be collected from 140 patients to evaluate intervention effectiveness. the expected outcome of the project is to yield a strategic approach for a nationwide technology-delivered pain self-management intervention for youth with chronic pain that can be readily sustained in clinical settings.


Eligibility criteria:
inclusion criteria: 1. child age 10-17 years, 2. has chronic pain defined as pain present for at least 3 months, and 3. has access to a smartphone or web-enabled device (e.g., laptop, computer, ipad). exclusion criteria: 1. non-english speaking, 2. presently in a psychiatric crisis, 3. cognitive impairments or intellectual disabilities (has to be able to complete surveys independently), 4. does not have access to a smartphone, computer, or internet, and 5. is unable to read at the 5th grade level.

Keywords: adolescent cognitive behavioral therapy chronic pain smartphone application internet-delivered
compression therapy following truncal vein endothermal ablation and distal sclerotherapy

Conditions: Varicose Veins

Summary: study purpose is to research whether compression therapy is beneficial after truncal vein rf-ablation and distal sclerotherapy done in the same session when needed. patients will be randomised to either no compression group (group i) or compression group (group ii)

in this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. also post-procedural pain and need for painkillers are monitored. compliance and reasons for non-compliance is recorded in compression group. second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in aberdeen score between groups compared to pre-operative stage. study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.

Eligibility criteria:
inclusion criteria: * duplex ultrasound verified gsv and/or ssv incompetence (0.5 seconds or more) * comprehensive classification system for chronic venous disorders (ceap) rated from c2 to c4 * truncal vein insufficiency (gsv and/or ssv) treatable with radiofrequency ablation exclusion criteria: * history of pulmonary embolism or deep venous thrombosis * large (\>12mm) truncal vein diameter * ceap c5-c6 * patient unwilling to participate

Keywords: varicose veins compression stockings sclerotherapy radiofrequency ablation
a study of once-monthly subcutaneous mircera for the treatment of chronic renal anemia in pre-dialysis patients not currently treated with esa.

Conditions: Anemia

Summary: this single arm study will assess the efficacy and safety of subcutaneous mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with esa. eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic renal anemia; * no esa therapy during previous 3 months; * adequate iron status; * rapid chronic kidney disease progression. exclusion criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension requiring hospitalization in previous 6 months; * significant acute or chronic bleeding.
oxygen therapy in schizophrenia

Conditions: Chronic Schizophrenia

Summary: due to intense atp-consuming processes in the brain, a high level of brain energy supply is required. a popular hypothesis regarding the pathogenesis and pathophysiology of schizophrenia postulates hypofunction of neuronal circuits in the prefrontal and limbic-temporal areas. an emerging body of data suggests that impaired energy metabolism due to mitochondrial dysfunction plays a role in the pathophysiology of schizophrenia. under normal conditions cellular metabolic rate, i.e. oxygen and glucose consumption, increases proportionally with any increase in neuronal activity. the impaired energy metabolism due to mitochondrial dysfunction and frontal lobe hypofunction might be improved by increasing o2 supply to the brain. oxygen-enriched air inhalation has been shown to increase brain oxygen supply. hyperoxia therapy is a useful tool in the treatment of neurological and neurotrauma deficits. we therefore suggest a randomized double blind cross-over study of enriched inspired o2 partial pressure in schizophrenia. it is surprising given the numerous findings on reduced energy metabolism in schizophrenia that simple treatment with inspired enriched oxygen has not been studied.


Eligibility criteria:
inclusion criteria: * 18-45 years old * 2 years of illness * panss more than 60 exclusion criteria: * unstable or serious physical illness * suicidality * drug abuse * bmi above 30 * taking anti-hypertension medication

Keywords: schizophrenia oxygen therapy
real world evidence of the effectiveness and clinical practice use of glecaprevir plus pibrentasvir in patients with chronic hepatitis c in the russian federation

Conditions: Chronic Hepatitis C (CHC)

Summary: this study seeks to assess the effectiveness of glecaprevir plus pibrentasvir in participants with chronic hepatitis c in a real-life setting across clinical practice populations in the russian federation.


Eligibility criteria:
inclusion criteria: * treatment-naïve or - pegifn (or ifn), and/or ribavirin (rbv) and/or sofosbuvir (prs) experienced with confirmed chc, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral gle/pib regimen according to standard of care, international guidelines and in line with the current local label. * may be enrolled up to 4 weeks after treatment initiation. * patients must voluntarily sign and date informed consent form prior to inclusion into the study, * patient must not be participating or intending to participate in a concurrent interventional therapeutic trial. exclusion criteria: * none.

Keywords: chronic hepatitis c hepatitis c hepatitis glecaprevir pibrentasvir real world setting observational study
combined digital x-ray and ultrasound technique for improved detection and characterization of breast lesions

Conditions: Breast Cancer; Mass Cystic; Benign Mass

Summary: the study will evaluate and refine a breast screening and diagnosis device.

the device produces 3-d mammograms and ultrasound pictures of the breast at the same time and in the same position. this should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. the 3-d mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.

Eligibility criteria:
inclusion criteria: * to participate in this research study you must be a female over the age of 25 * have had a normal mammogram or are scheduled for a breast biopsy * have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy. exclusion criteria: * male * under the age of 25 * documented breast cancer
investigative headgear with cpap mask

Conditions: Obstructive Sleep Apnea

Summary: this investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a cpap mask for a duration of 2-4 weeks.

up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with osa and receiving cpap or bi-level pap for the treatment of their osa. these include current cpap mask users.

Eligibility criteria:
inclusion criteria: * ahi≥5 from the diagnostic night * ≥18 years of age * prescribed cpap or bilevel therapy for osa * existing cpap mask users exclusion criteria: * inability to give informed consent * patient intolerant to pap * anatomical or physiological conditions making pap therapy inappropriate * history of respiratory disease or co2 retention. * pregnant or think they may be pregnant * investigated by land transport safety authority
vascular boot warming program after acute deep vein thrombosis (dvt) ± pulmonary embolism (pe)

Conditions: Acute DVT of Lower Extremity

Summary: the researchers are studying whether a vascular boot warming program plus standard of care anticoagulation can be a safe and effective method to resolve deep vein thrombosis (dvt) ±pulmonary embolism (pe) earlier and prevent development of post-thrombotic syndrome (pts). additionally, to learn whether a more detailed imaging of the affected lower extremities will provide a more accurate and reliable method to guide treatment for this condition.

participants with diagnosis of acute lower extremity dvt (proximal and distal) and/or pulmonary embolism will be identified and approached for participation, when they are seen in the thrombophilia clinic or mayo hospital for management of the acute vte. if they match the preset inclusion and exclusion criteria, they would then be consented during this visit and scheduled for baseline studies at a later date. baseline tests include venous plethysmorgraphy, lower extremity ultrasound, and medical history, will be conducted and if eligible, participant will then be randomized to vascular boot plus standard anti coagulation program or standard anti coagulation using a randomization program. participants will be randomized into two groups and followed for 3 months. standard of care (soc) group (no vascular boot utilized): patients will receive standard anticoagulation (determined at discretion of the treating provider), baseline studies, and follow up at the end of treatment (3months). vascular boot (vb) group (includes vascular boot in addition to soc): patients will receive standard anticoagulation (determined at discretion of the treating provider), baseline studies and standardized vascular boot warming. all patients randomized to this group will wear the vascular boot for a minimum of 30 minutes per day for the first 10 days of participation. patients in this group may initially be enrolled at either the thrombophilia clinic or the hospital.

Eligibility criteria:
inclusion criteria: * able to tolerate wearing a vascular boot, if randomized to this group. * diagnosis of acute dvt±pe (within 24 - 48 hours) and received approximately 24 hours of anticoagulation prior to starting the study. exclusion criteria: * unable to tolerate wearing a vascular boot * unable to comply with keeping log of activity/ of wearing a vascular boot. * weight \> 300 pounds. (weight limit for the venous plethysmography chair) * previous history of dvt or pe. * on anticoagulation for another purpose (example stroke prevention with atrial fibrillation). * patients who do not accept to participate in research studies. * pregnant women will not be allowed to participate * patients less than 18 yrs

Keywords: deep pulmonary venous vascular post vein thrombosis embolism thromboembolism thrombotic syndrome