Kornimate/medical-research-clean huggingface dataset:
treat-to-target strategy with etanercept for ankylosing spondylitis

Conditions: Spondylitis, Ankylosing

Summary: evaluate the disease activity guided tapering and discontinuation strategies of etanercept (etn) in patients with ankylosing spondylitis (as) in 48 weeks.

ankylosing spondylitis (as), a subset of axial spondyloarthritis (axspa), is a chronic inflammatory disorder characterized by inflammatory back pain and predominant involvement of sacroiliac joints and spine, leading to bony fusion of vertebrae and eventually disability in some patients. nonsteroidal anti-inflammatory drugs (nsaids) are recognized as a first-line therapy for as, but the overall response rates to nsaids are considerably unsatisfactory. with the advent of biologics, the outcomes of as patients have been greatly improved. biologics including tumor necrosis factor α (tnfα) inhibitors (tnfi) have been included in many recommendations for the treatment of as. etanercept, a recombinant human tnfα receptor, is capable of binding to tnfα and blocking its biological activities. it is effective in relieving symptoms, improving physical function, and reducing disease activity in patients with as, and generally no severe adverse effects have been reported. however, the high expense of biologics restricts their long-term use, which urges a viable strategy to reduce the dosage of biologics while maintaining an optimal therapeutic efficacy. to investigate the stepwise tapering and discontinuation of tnfi based on disease activity in patients with as, a 48-week, prospective, randomized, multicentric study was conducted. an etanercept biosimilar, rhtnfr:fc (recombinant tnf receptor: fc fusion protein, yisaipu), which is one of the most widely used biosimilars in china, was used in this study.

Eligibility criteria:
inclusion criteria: * aged between 18 years old and 65 years old with as, according to 1984-revised new york classification criteria. * an active disease of asdas with c reactive protein (asdas-crp) ≥2.1. * a disease duration of 6 months to 30 years. * no exposure to biologics in recent 6 months before recruitment. concomitant medications with nsaids, conventional disease modifying anti-rheumatic drugs (cdmards), or prednisone or a prednisone equivalent (≤10mg/day), were allowed to continue if they were maintained at a stable dose for 4 weeks or more from baseline. exclusion criteria: * late-stage patients with spinal fusion. * patients with severe cardiac, hepatic, renal, hematologic or endocrine diseases. * patients with a history of multiple sclerosis, current or past malignancy. * patients who were pregnant, or planning to become pregnant, or breastfeeding. * patients with active or recurrent infections, or those who required oral antibiotics 2 weeks or intravenous antibiotics 4 weeks before screening. * patients with current or past or potential tuberculosis.
a phase 1, open-label trial of belzupacap sarotalocan (au-011) in bladder cancer

Conditions: Non-muscle-invasive Bladder Cancer; Muscle-Invasive Bladder Carcinoma

Summary: the main objectives of this study are to determine the feasibility and safety of au-011 treatment of bladder cancer utilizing intratumoral injection with or without intramural injection and with or without laser application.

aura is conducting a phase 1, 'window of opportunity', open-label trial of belzupacap sarotalocan (au-011) to determine the feasibility and safety of intratumoral injection with or without intramural injection and with or without laser application in subjects with bladder cancer.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis urothelial carcinoma of the bladder (recurrence of prior nmibc biopsy or pathology must be obtained within 12 months prior to enrollment. first time nmibc biopsy within 6 months of screening. mibc allowed if demonstrated pathologically) 2. have no evidence of metastatic disease 3. adequate bone marrow, renal, and hepatic function exclusion criteria: 1. any additional malignancy that requires active treatment. exceptions include: 1. basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy with evidence of remission for at least 1 year. 2. in situ cervical cancer treated and with at least 1 year without recurrence. 3. any other subject felt appropriate by the investigator upon discussion with trial's medical monitor. 2. used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of visit 1 or be concurrently enrolled in another investigational trial. 3. active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents. 4. chronic active hepatitis b or c and hiv.

Keywords: nmibc cystectomy turbt intramural au-011 belzupacap sarotalocan intratumoral mibc
comparison of electric heating pad versus forced-air warming to prevent inadvertent perioperative hypothermia

Conditions: Temperature Change, Body; Hypothermia; Anesthesia

Summary: compare core body temperature after laparoscopic surgery using the forced air heating system versus the warmtac® (a carbon fiber electric blanket).

in order to prevent perioperative hypothermia, we will compare two different heating sistems, one of them is an electric pad made with carbon fiber and the other system is a forced-air blanket. both of them will be situated under the patient during all the laparoscopic surgey.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age at the time of the preoperative visit. * patients who will undergo elective laparoscopic surgery * patients who sign the informed consent indicating that they have been informed of all relevant aspects of the trial. exclusion criteria: * axillary temperature\> 37.5ºc * active infection * dysfunction of the autonomic system
the value of adding group education (desmond method) to the standard primary care education practices in changing glycemic control and self-care practices in adults with type ii diabetes mellitus: a randomized controlled intervention study.

Conditions: Diabetes Mellitus, Type 2

Summary: the goal of this clinical trial is to assess the outcome of delivering the health education in a group format using the desmond program compared to the standard health education in newly diagnosed adults with type 2 diabetes mellitus . the main questions it aims to answer is: does adding group education (desmond method) to the standard primary care education practices is effective in changing glycemic control and self-care practices in adults with type ii diabetes mellitus . the enrolled study participants will be randomized to receive either the standard personal health care or group health education (desmond) session. questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of hba1c. these measurements will be repeated after 3 and 6 months of the intervention for both study groups.

1. objectives: this pilot, single primary healthcare center study is designed to assess the effect of delivering the group health education desmond program as an add-on to the standard health education in type 2 diabetic patients. 2. design: this is an analytic randomized controlled intervention study for adult patients who are newly diagnosed type ii diabetes mellitus. the enrolled study participants will be randomized to receive either the standard personal health care (routine diabetes health education services) or a standard group health education (desmond) session. a standard questionnaire form measuring diabetes self-care will be administered at baseline together with measurement of hba1c. these measurements will be repeated after 3 and 6 months of the intervention for both study groups. 3. setting :the family medicine clinics in airport health center in primary care, qatar. 4. participants: newly diagnosed type ii diabetes mellitus aged more than 18 years. 5. intervention: a six-hour structured group education program to be delivered by one certified desmond health educator compared with the standard care. 6. main outcome measures : blood hba1c % at baseline (before starting the diabetes management protocol of phcc), after 3, and 6 months of follow up. in addition, the diabetes self-management score (dsmq) after 3 and 6 months of receiving both the standard personal health education sessions and the tested group education (desmond) method.

Eligibility criteria:
inclusion criteria: 1. adult more than 18 years, newly diagnosed type ii diabetes mellitus (within 4 - 6 weeks of diagnosis) attending the airport health care center. 2. not yet receiving any form of standard health education in phcc. exclusion criteria: 1. using diuretics or cancer therapy. 2. had enduring mental health problem. 3. participants in another research study. 4. inability to communicate in arabic or english language

Keywords: diabetes self management desmond effect of diabetes self management on glycemic control
prevalence and impact of covid-19 on maternal and infant health in african populations

Conditions: SARS-CoV2 Infection; COVID-19

Summary: there is growing evidence that covid-19 threatens maternal and perinatal health. pregnant women are at higher risk of severe complications (severe pneumonia, hospitalizations, intensive care unit admission, invasive mechanical ventilation, extracorporeal membrane oxygenation) and death compared to age-matched non-pregnant women. on the other hand, the number of confirmed covid-19 cases reported in sub-saharan africa (ssa) continues to increase, where the highest maternal mortality rates in the world are registered. the world health organization (who) estimates that this region alone accounted for roughly two-thirds (196 000) of all maternal deaths in 2017, which among other reasons is explained by the inequalities in access to quality antenatal care (anc) services and the low numbers of skilled health workers in the region. the spread of sars-cov-2 in ssa is threatening the already fragile health services, affecting mainly the most vulnerable populations such as pregnant women. this project aims to describe the burden and effects of sars-cov-2 infection during pregnancy in women living in malaria endemic areas and high prevalence of hiv infection. pregnant women attending anc clinics in selected sites from libreville and lambaréné (gabon) and manhiça (mozambique) will be enrolled in a cohort study to determine the frequency of sars-cov-2 infection and covid-19 during pregnancy and its effects on maternal and neonatal health. participants will be tested for sars-cov-2 infection whenever reporting respiratory symptoms suggestive of covid-19 during routine anc follow-up and six weeks after the end of pregnancy. the presence of antibodies (igg/igm) against sars cov-2 in blood samples will be determined. the clinical presentation of covid-19 in pregnancy will be also characterised, and the incidence of infection during pregnancy and the risk factors of maternal and neonatal morbidity and mortality associated with sars-cov-2 infection and the frequency of mother- to- child transmission of sars-cov-2 will be assessed. the findings of this project will contribute to the understanding of the impact of sars-cov-2 and covid-19 among pregnant women living in ssa countries where malaria and hiv infections are highly prevalent.


Eligibility criteria:
inclusion criteria: * permanent resident in the study area * agreement to deliver in the study site's maternity(ies) wards exclusion criteria: * planning to move out the study area in the following 7 months from enrolment

Keywords: sars-cov-2 covid-19 pregnancy perinatal sub-saharan africa
a study observing everyday effectiveness and safety of the drug elafibranor in participants with primary biliary cholangitis who are receiving ongoing treatment

Conditions: Primary Biliary Cholangitis

Summary: this study will collect information from participants with primary biliary cholangitis (pbc) as they use the drug elafibranor in real world setting. pbc is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. the liver damage in pbc may lead to scarring (cirrhosis). pbc may also be associated with multiple symptoms. many participants with pbc may require liver transplant or may die if the disease progresses and a liver transplant is not done. in this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with pbc who are receiving treatment in real world setting. the total study duration for each participants will be 24 months.


Eligibility criteria:
inclusion criteria: * participant has provided written informed consent and agrees to comply with the study protocol. * participant with pbc diagnosis. * participant naïve to elafibranor, for whom the treating physician has decided to start treatment with elafibranor. * if a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected. exclusion criteria: * participant who started elafibranor treatment before baseline visit. * participant is currently participating in, plans to participate in or has participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives of the drug/active substance, whichever is longer, prior to baseline visit. * participant with known hypersensitivity to the product or to any of its excipients. * participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
sofosbuvir, ribavirin, for the treatment of chronic hepatitis c virus genotype 1 in hiv-coinfected patients receiving fixed dose co-formulation emtricitabine/ tenofovir/cobicistat/elvitegravir: a pilot study

Conditions: Hepatitis C Infection; HIV Infection

Summary: the protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.

the objective of this study is to evaluate the safety, efficacy and pharmacokinetics of sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in hiv-infected patients on fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (stribild).

Eligibility criteria:
inclusion criteria: * 18 years of age or older * chronic hcv genotype 1 infection * receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks. * cd4 count \>200 cells/mm3 at screening and no cd4 count \<200 in previous 12 weeks * hiv rna pcr \ 200 copies/ml in previous 12 weeks exclusion criteria: * history of integrase inhibitor resistance * history of integrase inhibitor failure * absolute neutrophil counts under 1500/mm3 ( black/ african americans \<1200/mm3 * patients with cirrhosis * platelet count under 90,000 per cubic millimeter * hemoglobin levels \<11 gm/dl in women or \<12 gm/dl in men * previous treatment with a daa * hepatocellular carcinoma * afp\>100 ng/ml * hepatitis b virus (hbsag positive) * evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy

Keywords: hiv hcv daa
study to assess pk/pd character, safety/tolerability of ckd-519 new formulation in healthy male subject.

Conditions: Dyslipidemia

Summary: study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to ckd-519 new formulation in healthy male subjects.

open-label, randomized, 3-period, 6-sequence, crossover study

Eligibility criteria:
inclusion criteria: 1. between 20 aged and 45 aged in healthy male adult 2. body weight ≥ 50kg and in the range of calculated bmi(body mass index) 18\~29kg/m2 3. subject who sign on an informed consent form willingly 4. necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products exclusion criteria: 1. clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system 2. have a acute disease within 28 days before the beginning of study treatment 3. have a disease history that can effect drug absorption, distribution, metabolism, excretion 4. have a clinically significant chronic disease 5. systolic blood pressure \ 140mmhg, diastolic blood pressure\ 90mmhg 6. positive for serology test (hbsag, anti-hcv ab, anti-hiv ab, vdrl(venereal disease research laboratories)) 7. subject treated ethical drug within 14 days before the beginning of study treatment 8. subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment 9. have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs) 10. cannot take standard meal 11. whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing 12. blood transfusion within 30 days 13. taking drugs have received any other investigational drug within 90 days prior to the first dosing 14. continuously taking caffeine(\>5 cups/day), drinking alcohol(\>30g/day), smoking excessive cigarettes(\>10cigarettes/day) 15. impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner) 16. subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
efficacy and safety of three doses of florence oral suspension in adults with eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: the purpose of this study is to evaluate the efficacy of three doses of florence oral suspension on changes of eosinophilic infiltration in esophageal biopsies.


Eligibility criteria:
inclusion criteria: * signed consent; * participants aged 18 years or more; * participants diagnosed with eosinophilic esophagitis, defined as: 1. presence of symptoms of esophageal dysfunction intermittently or continuously during previous week to the screening visit; 2. eosinophilic esophageal inflammation with ≥ 15 eosinophils/high-power field, in the screening endoscopy; 3. exclusion of other causes of esophageal eosinophilia. exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * participants with a stricture on endoscopy that prevents passage of the endoscope; * history of alcohol abuse or drug use; * use of concomitant therapies for any reason that may affect the assessment; * history of gastroesophageal surgery; * history of the abnormal gastrointestinal disorder; * another disorder that causes esophageal eosinophilia; * pregnancy or risk of pregnancy and lactating patients; * participants with known allergy, contraindication or hypersensitivity to the components of the medicine used in the clinical trial; * participation in clinical trial in the year prior to this study.
salivary cortisol as a biomarker in patients with temporomandibular disorder

Conditions: Temporomandibular Joint Disorder

Summary: t is recognized that cortisol, a hormone produced by the adrenal glands, is a marker that is elevated in patients with psychological disorders, particularly anxiety. on the other hand, temporomandibular disorders (tmd) are a condition with a multifactorial etiology, in which emotional disturbances play a crucial role. therefore, the aim of this study is to evaluate whether patients with tmd have higher levels of salivary cortisol compared to the general population. initially, an assessment will be conducted using the diagnostic criteria for temporomandibular disorders (dc/tmd) protocol to determine whether the patient suffer of any kind of temporomandibular disorder. based on the results, individuals will be classified into two groups: the study group, consisting of patients with tmd, and the control group, composed of individuals without the disorder. those who agree to participate will be required to sign an informed consent form. subsequently, a saliva sample will be collected for analysis.


Eligibility criteria:
inclusion criteria: * patients who attend the dental clinic of the faculty of medicine of university of coimbra exclusion criteria: * pregnant women, minors and non-autonomous individuals

Keywords: temporomandibular disorders tmd cortisol
radioactive iodine in treating patients who have undergone surgery for liver cancer

Conditions: Liver Cancer

Summary: rationale: radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. it is not yet known if radioactive iodine is more effective than no further treatment after surgery. purpose: randomized phase iii trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.

objectives: * compare the effect of adjuvant hepatic intra-arterial iodine i 131 lipiodol vs observation in terms of rate of recurrence and overall survival of patients with curatively resected hepatocellular carcinoma. outline: this is a randomized, multicenter study. patients are stratified according to participating center. patients are randomized to 1 of 2 treatment arms. * arm i: within 4-6 weeks after prior resection, patients receive adjuvant hepatic intra-arterial iodine i 131 lipiodol once. * arm ii: after prior resection, patients undergo observation. patients are followed monthly for 1 year and then every 3 months thereafter. projected accrual: a minimum of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed primary hepatocellular carcinoma (hcc) * completely resected disease with clear margins * no residual disease by postoperative ct scan * no metastatic disease patient characteristics: age: * 17 and over performance status: * karnofsky 60-100% life expectancy: * not specified hematopoietic: * wbc greater than 1,500/mm\^3 * platelet count greater than 50,000/mm\^3 hepatic: * bilirubin less than 2.92 mg/dl * pt less than 4 seconds over control renal: * creatinine less than 2.26 mg/dl other: * no contraindication to contrast or radioactive iodine * no uncontrolled thyrotoxicosis * no other prior or concurrent malignancy * not pregnant or nursing prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * see disease characteristics * recovered from prior surgery other * no other prior treatment for hcc

Keywords: localized resectable adult primary liver cancer adult primary hepatocellular carcinoma