Kornimate/medical-research-clean huggingface dataset:
effects of an active coping program in patients with persistent post-covid pain.

Conditions: Long COVID; Pain

Summary: justification: among the sequelae of covid-19 in clinical practice we frequently find persistent neuromusculoskeletal pain. previous studies carried out by this research group and in the scientific literature have shown that "pain neuroscience education" (pne) and therapeutic exercise (te) constitute an effective care strategy in the treatment of persistent pain. therefore, with this research we will try to respond with a treatment proposal from primary care (pc). objective: to determine whether an pne and te program is effective in patients presenting long covid pain (lcp). method: randomized clinical trial. a sample of 80 subjects will be recruited. the intervention group will receive a program of te and pne, of 12 weeks duration: 5 weeks of pne, of 1 weekly session of 90 minutes, and 7 weeks of te, with a total of 19 sessions of 60 minutes duration. the control group will receive the usual treatment. an assessment will be made at the beginning and after the end of the intervention, where the following variables will be measured: quality of life, intensity, distribution and expansion of pain, healthy physical condition and blood test values. these will be evaluated by means of physical examination, questionnaires and laboratory tests. applicability of the expected results: the proposed intervention is simple and reproducible. it requires few resources, and can produce changes in pain perception, functionality and quality of life in patients with lcp.


Eligibility criteria:
inclusion criteria: * patients who have had covid-19, with a confirmatory pcr+ test or positive antigen test and recorded in their primary care medical record. * subjects between 18-70 years old. * musculoskeletal pain of more than 12 weeks of evolution since the beginning of the infection. * agree to participate in the study and sign the informed consent form. exclusion criteria: * history of chronic musculoskeletal pain of more than 12 weeks of evolution prior to covid-19. * history of diagnosed major depression. * having a diagnosis of fibromyalgia prior to covid-19 infection. * pregnancy. * pain of oncologic origin. * fracture or surgical intervention on the spine in the last year. * cognitive neurological impairment that prevents understanding of pne contents (in case of doubt, assessment with minimental state examination). * bladder or bowel incontinence. * saddle anesthesia. * patients with other clinical conditions that may aggravate chronic spine pain (chronic fatigue syndrome, fibromyalgia and complex regional pain syndrome). * patients with associated pathologies that make it impossible for them to perform te. * patients undergoing treatment with alternative therapies.

Keywords: intervention long covid pain pain neuroscience education exercise
optimized treatment of peginterferon alfa 2a in treatment experienced patients with hbv related liver fibrosis

Conditions: Hepatitis B; Liver Fibrosis

Summary: compared to tdf, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis b surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. we design this study to compare the effectiveness and safety between the combination therapy of tdf and peg-ifn with tdf alone in nas experienced patients with hbv related liver fibrosis. especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.

compared to tdf, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis b surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. we design this study to compare the effectiveness and safety between the combination therapy of tdf and peg-ifn with tdf alone in nas experienced patients with hbv related liver fibrosis. especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc. main purpose: comparing the improvement rate of liver fibrosis. secondary purpose: comparing the incidence of adverse events. comparing the incidence of cirrhosis, hepatocellular carcinoma, and liver failure. comparing the rates of hbsag and hbeag serological conversion.

Eligibility criteria:
inclusion criteria: 1. positive hepatitis b surface antigen or hepatitis b virus dna \> 0.5 year; 2. receiving treatment of nucleoside/nucleotide analogues at least one year before recruited; 3. age from 18 to 55 years old; 4. normal liver function(alt\<uln,ast\<uln and tbil\<uln). 5. undetectable hepatitis b virus dna or less than 100iu/ml. 6. lsm between 6 and 12 kpa measured by fibroscan; 7. liver ultrasound: normal or echo thickening, and portal vein diameter ≤ 12mm. exclusion criteria: 1. decompensated cirrhosis, hepatocellular carcinoma or other malignancy; 2. pregnancy, lactation or female has plan of pregnancy within 18 months; 3. accompanied with other active liver diseases(hav, hcv, hdv, hev, autoimmune liver disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver disease, etc.)； 4. accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases; 5. accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions; 6. patients who fail to comply with this research arrangement and sign an informed consent form 7. patients can not follow-up; 8. investigator considering inappropriate.

Keywords: hepatitis b virus liver fibrosis peg interferon alfa-2a tenofovir disoproxil fumarate
effectiveness and safety of dysport® (abobotulinumtoxina) in paediatric lower limb spasticity

Conditions: Lower Limb Spasticity

Summary: the purpose of this study is to assess the longitudinal attainment of subject centred and functional related goals (cumulated goal attainment scale total (gas t) score) after abobotulinumtoxina injection (including following repeated injection cycles where they occur) alongside spasticity management used in real life settings over a period of 18 months (and a maximum of six injection cycles).


Eligibility criteria:
inclusion criteria: * female or male subjects aged 2 to 17 years inclusive * decision to prescribe abobotulinumtoxina, to be made prior to and independently from the decision to enroll in the study * primary diagnosis of paediatric lower limb (pll) spasticity and either: previously untreated with bont (naïve to bont), or previously treated with a bont (i.e. non naïve to bont), and for those who were previously treated with bont-a, they should have responded to bont-a treatment according to the investigator's criteria * for non naïve bont subjects, a minimum interval of 12 weeks since the last bont injection and in the presence of spasticity exclusion criteria: * known resistance to any bont or experienced serious safety issues with previous use of bont * concomitant treatment with other bont * known hypersensitivity to abobotulinumtoxina or related compounds, or any component in the study drug formulation * subjects with any clinical (or subclinical) evidence of marked defective neuromuscular transmission (e.g. lambert eaton syndrome or myasthenia gravis) or persistent clinically significant neuromuscular disorders
adaptive planning in bladder cancer

Conditions: Bladder Cancer

Summary: to demonstrate that radiotherapy treatments for bladder cancer can be delivered with greater accuracy using a new planning method and that this method can be used simply and effectively by those delivering treatment.

this study integrates a novel adaptive planning methodology, adaptive-planning organ localisation (a-polo), with optimised margins and cone beam ct technology for improving the accuracy of radiotherapy treatment delivery. the previous study (ccr2873, rec 07/q0801/13) evaluated the use of cone beam ct in radiotherapy for bladder cancer. a larger than expected number of bladder radiotherapy treatments were seen to have been delivered with some element of geographic miss. using the novel adaptive planning method these fractions of radiotherapy could have been correctly treated. the feasibility of this method has been proven in the previous study, particularly it has been shown that this method is appropriate and provides a simple solution to the problem. it can be carried out by the radiographers at the treatment unit without adding extra time to the treatment.

Eligibility criteria:
inclusion criteria: * age \> 18 * histologically confirmed invasive carcinoma of the bladder * patient planned to receive hypofractionated radiotherapy to the bladder. * no previous pelvic radiotherapy * written informed consent given according to ich/gcp and national/local regulations. exclusion criteria: * urinary catheter in situ: the presence of a urinary catheter degrades cone beam image quality and thus images would not be evaluable. patients with a urinary catheter would not be expected to show variation in bladder filling.

Keywords: radiotherapy bladder cancer adaptive planning
anecortave acetate in subfoveal choroidal neovascularization (cnv) due to wet age-related macular degeneration (amd)

Conditions: Macular Degeneration; Maculopathy, Age-Related; Age-Related Maculopathies; Age-Related Maculopathy; Maculopathies, Age-Related

Summary: the purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (cnv) due to exudative age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * diagnosis of exudative amd and a primary or recurrent subfoveal cnv lesion in the study eye. * other protocol-defined inclusion criteria may apply. exclusion criteria: * under 50 years. * other protocol-defined exclusion criteria may apply.

Keywords: amd anecortave acetate wet amd age-related macular degeneration macular degeneration maculopathy, age-related age-related maculopathies age-related maculopathy maculopathies, age-related
crisaborole ointment 2% skin biomarker biopsy study in atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: this study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (ad) lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate ad. two identified ad skin lesions for each subject will be treated for the first 15 days, one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for biomarker analysis will be performed on the lesions. following completion of the blinded treatment period, subjects will start the 28 day open label period during which all ad affected skin lesions will be treated with crisaborole ointment 2% twice daily.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of active atopic dermatitis (ad) with at least 6 month history prior to screening and that has been clinically stable for 1 month. * investigator's static global assessment (isga) of 2 (mild) or 3 (moderate) at baseline. * body surface area (bsa) covered with ad of at least 0.5% and no more than 10% at baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back of the hands, and soles. * two lesions of ad at least 3 cm x 3 cm in size and at least 5 cm apart, with identical lesion isga score of greater than/equal to 3. exclusion criteria: * clinically infected ad or requires high potency topical corticosteroids or systemic (oral/injectable) corticosteroids to manage ad. * history of angioedema or anaphylaxis to topical products or known sensitivity to components of crisaborole ointment 2%. * history of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the skin). * previous treatment with any topical or systemic pde4 inhibitor unless stopped for the reason of lack of efficacy.

Keywords: atopic dermatitis atopic eczema eczema topical treatment skin diseases phosphodiesterase-4 inhibitor pde-4 inhibitor crisaborole
a feasibility study designed to assess the efficacy of the actilady device in adult female subjects with dysmenorrhea

Conditions: Dysmenorrhea

Summary: actilady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).


Eligibility criteria:
inclusion criteria: 1. women aged 18-35 years 2. regular menstrual cycles (26-35 days); average duration of menstruation ≥5 days for the 4 months preceding the beginning of the trial. 3. dysmenorrhea pain score \>50mm on a 100mm visual analog scale (vas) for the maximum abdominal pain 4. analgesic use during every menstrual cycle 5. non-pregnant, with no intentions to get pregnant during the clinical trial 6. agrees not to use oral contraceptives or an intrauterine device (iud) during the trial period 7. agrees not to use analgesics, except during permitted period (16:00-04:00 the next day, daily) 8. consents to the use of pads or other vaginal devices throughout the trial period 9. subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study 10. signed written informed consent form (icf) to participate in the study exclusion criteria: 1. pregnant or lactating women 2. used hormonal and/or oral contraceptives in the preceding 4 months 3. use of an iud in the preceding 4 months 4. previous diagnosis of secondary dysmenorrhea 5. urinary incontinence 6. duration of menstruation is \<5 days 7. subjects with a known sensitivity to mechanical vibrations and/or silicone 8. participation in current or recent clinical trial within 30 days prior to baseline visit
clinical accuracy and reliability of infrared tympanic thermometer in an adult emergency department

Conditions: Fever

Summary: the primary aim of this study was to determine the accuracy of an infrared thermometer compared to the gold standard, mercury-in-glass thermometer. the secondary aim was to compare tympanic and axillary temperature measurements by evaluating agreement and correlation to determine whether an infrared tympanic thermometer can replace an axillary mercury thermometer in the emergency department.


Eligibility criteria:
inclusion criteria: * above 37.5°c measured by axillary mercury thermometer exclusion criteria: 1. otitis external/media 2. soft-tissue infection over the axillary fossa and forehead 3. complete occlusion by earwax 4. severe illness 5. trauma

Keywords: infrared tympanic thermometer axillary thermometer mercury glass thermometer adult emergency department
expanded access - autologous human schwann cells in peripheral nerve repair

Conditions: Peripheral Nerve Injuries

Summary: emergency expanded access for a single patient was granted to receive autologous human schwann cell (ahsc) augmentation of nerve autograft repair after severe peripheral nerve injury (pni).


Eligibility criteria:
inclusion criteria: * persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year; * peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings; exclusion criteria: * persons unable to safely undergo an mri (may include persons with an implanted device or metallic fragments which may interfere with mri safety); * persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve); * persons with severe peripheral nerve injury gap length \> 10 cm in length; * persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve; * pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation; * presence of disease that might interfere with participant
pk/pd study of gan & lee insulin aspart injection vs. us & eu novolog®/novorapid® in healthy males

Conditions: Diabetes Mellitus, Type 1

Summary: primary objective: to demonstrate pharmacokinetic (pk) and pharmacodynamic (pd) equivalence of gan \& lee insulin aspart injection with both eu-approved novorapid® and us-licensed novolog® (reference products) in healthy male subjects secondary objectives: to compare the pk and pd parameters of the three insulin aspart preparations to evaluate the single dose safety and local tolerability of the three insulin aspart preparations


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent obtained before any trial-related activities. trial-related activities are any procedures that would not have been done during normal management of the subject 2. healthy male subjects 3. age between 18 and 64 years, both inclusive 4. body mass index (bmi) between 18.5 and 29.0 kg/m\^2, both inclusive 5. fasting plasma glucose concentration \<= 5.50 mmol/l (100 mg/dl) at screening 6. considered generally healthy upon completion of medical history, physical examination, vital signs, ecg and analysis of laboratory safety variables, as judged by the investigator exclusion criteria: 1. known or suspected hypersensitivity to investigational medicinal products (imps) or related product 2. previous participation in this trial. participation is defined as randomized 3. use of other investigational drugs within five half-lives for enrolment or receipt of any medicinal product in clinical development within 30 days before randomization in this trial, whichever is longer 4. history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 5. clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the investigator 6. increased risk of thrombosis, e.g subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator 7. a positive result in the alcohol and/or urine drug screen at the screening visit 8. positive to the screening test for hepatitis bs antigen or hepatitis c antibodies and/or a positive result to the test for hiv-1/2 antibodies or hiv-1 antigen 9. blood donation or blood loss of m ore than 500 ml within the last 3 months

Keywords: diabetes insulin diabetes mellitus basal bolus
levo phencynonate hydrochloride for the prevention of seasickness

Conditions: Motion Sickness

Summary: a double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅱclinical superiority study.

the trial is composed by 3 parts: 1) on-boat screening period for seasickness and safety tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the impact of voyage experience. 3) on-boat drug testing period. the subjects will be administered the drug before voyage. the seasickness symptoms will be evaluated during voyage. the safety test will be conducted before and after one day of on-boat testing.

Eligibility criteria:
inclusion criteria: * subjects fulfilling the diagnostic criteria for motion sickness * have medical history for motion sickness * during screening, the severity of sea sickness is assessed as moderate or above according to sea sickness severity scale. * adults for 18-55 years, male or female. * agree to participate the study and can sign the icf independently. exclusion criteria: * be allergic to the study drug or be allergic constitution * alt, ast≥ 1.5 times of uln, scr\>uln, or other clinical significant lab values. * abnormal ecg which is clinical significant judged by investigators, including: qtc\>normal range * have medical history for urination disorder * have headache, vertigo, dizziness or nsomnia caused by other diseases than motion sickness. * have active gastrointestinal diseases or overweight (bmi≥24kg/m2 ) * have internal ear disease which may disturb the evaluation of motion sickness. * have glaucoma or posterior circulation ischemia * have anxiety, depression or other mental disease that investigator considering inadaptable to participate the study. * participated in other studies within the past 3 months.

Keywords: motion sickness
platelet activity in vascular surgery and cardiovascular events

Conditions: Cardiovascular Disease; Peripheral Artery Disease; Critical Limb Ischemia

Summary: pathological and clinical studies have consistently demonstrated that abnormalities in thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and atherothrombosis. screening for abnormalities in thrombosis and hemostasis by measuring platelet activity, thrombin generation, and markers of coagulation have been proposed to identify individuals at high-risk for cardiovascular events, however, it remains a research tool not ready for implementation in standard care. the proposed study will add to the growing understanding of platelet activity and markers of coagulation in cardiovascular disease; examine a comprehensive battery of platelet activity markers, thrombin generation, markers of coagulation, and inflammatory biomarkers in subjects undergoing vascular surgery; and will provide important data on the mechanism of increased platelet activity using micro rna, rna and dna expression profiling. the study design is prospective and the main outcome measure is platelet activity measurements associated with short-term cardiovascular events in pad patients

the main aim is to determine whether preoperative platelet activity measurements are independently associated with short-term cardiovascular events in peripheral artery disease (pad) patients undergoing open non-emergent lower extremity vascular surgery. we will characterize the platelet phenotype in 350 pad patients before vascular surgery and use cox proportional hazard models to determine the independent association of the platelet phenotype with risk of cardiovascular events in the first 30 days after surgery. blood collection at three different time points (before surgery, following surgery while still in the hospital, and at the subjects' first return visit to the vascular surgeon following surgery) will allow us to assess the dynamic change in platelet activity, coagulation and inflammation during the perioperative period. we believe that markers of clotting and bleeding will change during the course of surgery, and that some of these markers may be used to help predict the likelihood of developing a clotting or bleeding event following surgery. the long-term goal is to develop a clinically useful assessment of platelet activity, thrombin generation, coagulation and inflammation for risk stratification that may ultimately serve as a target for therapeutic intervention.

Eligibility criteria:
inclusion criteria: 1. subjects undergoing non emergent lower extremity revascularization 2. use of aspirin within 48 hours prior to surgery 3. age \> 21 years of age 4. able and willing to provide written informed consent for the study exclusion criteria: 1. use of any therapeutic anticoagulant 2. use of any nonsteroidal antiinflammatory drug (ibuprofen, naproxen, etc.) within 72 hours 3. thrombocytopenia (platelet count\ 500) 4. anemia (hemoglobin\<9) 5. any known hemorrhagic diathesis

Keywords: vascular surgery