Kornimate/medical-research-clean huggingface dataset:
collection of samples for the clinical evaluation of the aptima hbv (hepatitis b virus) quant (quantification) assay

Conditions: Hepatitis B, Chronic

Summary: this non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic hbv infection who are initiating antiviral therapy. these samples will be used to estimate clinical utility endpoints for the aptima hbv quant assay, which is used as an aid in the management of hbv-infected patients undergoing hbv antiviral therapy.


Eligibility criteria:
inclusion criteria: * the subject is chronically infected with hbv.the subject is treatment naïve and is initiating hbv antiviral therapy with either entecavir or tenofovir as indicated in the fda approved label * the subject will be considered treatment naïve if he/she had \<12 weeks of oral antiviral therapy with any nucleoside or nucleotide therapy * the subject is at least 18 years of age at the time of enrollment * adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria * the subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s) exclusion criteria: * subject is in one of the following patient populations: * acute hbv infection * patients who are hbv immune tolerant * human immunodeficiency virus (hiv) and/or hepatitis c virus (hcv) co-infection * solid organ or bone marrow transplant recipients * renal failure or dialysis * evidence or history of hepatic decompensation * evidence or history of hepatocellular carcinoma * underlying liver disease other than hbv * receiving chemotherapy, immunosuppressive agents * subject is unsuitable for study participation based on the investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication) * participating in another investigational study that the investigator believes might interfere with the subject's participation in this study
global study to evaluate the long-term safety and efficacy of elagolix in women with moderate to severe endometriosis-associated pain

Conditions: Endometriosis

Summary: a randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis associated pain in adult pre-menopausal women who completed 6 months treatment in pivotal study m12-671 (nct01931670).

the study consists of 2 periods: a 6 month treatment period and a post treatment follow-up period of up to 12 months. participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg once daily (qd) or elagolix 200 mg twice daily (bid) for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg qd or elagolix 200 mg bid for up to 6 months. an electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.

Eligibility criteria:
inclusion criteria: * subject has completed the 6-month treatment period in pivotal study m12-671. * agrees to use required birth control methods during the study through month 6 of the post-treatment follow-up period exclusion criteria: * clinically significant gynecological condition * bone mineral density (bmd) loss greater than or equal to 8 percent in the spine, femoral neck or total hip * plans to become pregnant in the next 18 months

Keywords: endometriosis-associated pain elagolix gonadotropin-releasing hormone antagonist dysmenorrhea (dys) non-menstrual pelvic pain (nmpp) dyspareunia
tab08 in patients with systemic lupus erythematosus (sle), not adequately controlled with current treatment

Conditions: Lupus Erythematosus, Systemic

Summary: the purpose of this study is to assess whether tab08 may be beneficial compared to placebo in patients with active systemic lupus erythematosus, not adequately controlled with current concomitant treatment. secondary purpose is to assess efficacy, safety, pharmacokinetic and pharmacodynamic parameters in this study population.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of lupus erythematosus according to american college of rheumatology (acr) criteria (4 of 11) * active sle (sle disease activity index ≥ 6) * skin or joint sle manifestations exclusion criteria: * lupus-nephritis and/or central nervous system affection (neuro-lupus) * prohibited treatment * pregnant or nursing women * concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization
this research study examines the effects of cannabidiol-infused candy on reducing the bacteria causing tooth decay, when comparing it to a sugar free candy on adults.

Conditions: Tooth Decay

Summary: the goal of this clinical trial is to compare the effect of cbd candy versus sugar free candy on reducing the number of bacteria causing tooth decay, in adults the main question is to see whether cbd have any effect on reducing the number of streptococcus mutans, in the oral cavity the main bacteria causing tooth decay. participants will be randomly placed in a group, and assigned to take either cbd-infused lozenge (if in the experimental group) or a sugar-free candy (if in the control group) once a day for 15 days. a sample of saliva will be collected and analyzed in a lab before and after consumption of the candy to see whether either product could reduce the harmful bacteria in the mouth.


Eligibility criteria:
inclusion criteria: adults aged 18 years or older, that were not taking any antibiotics, using prescribed toothpaste or mouthwash, who were not experiencing any tooth ache or mouth sores, have not visited the dentist within the past 48 hours, who willingly signed a consent form agreed to participate and be available on specific dates set by investigators and followed the recommended regimen for 15 days were included in the study. the suggested regimen involved consuming one candy in the evening at approximately the same time, allowing it to dissolve in the mouth without crushing it. furthermore, individuals who could abstain from alcohol consumption for at least 12 hours before saliva collection on day 1 and day 15 and refrain from food or drink (except water) for preferably 2 hours were also eligible to participate in this clinical trial. exclusion criteria: encompassed individuals taking or recently completing an antibiotic regimen within two weeks before participation. participants with allergies to specific substances, such as propriety broad spectrum nano hemp extract, isomalt, organic stevia, natural or artificial cherry flavoring, natural coloring, maltitol syrup, or citric acid, were also excluded. further exclusion criteria included participants using professional-strength anti-cavity or anti-gingivitis products, individuals experiencing toothache or mouth sores, and those who had visited a dentist within the last 48 hours. in addition, participants who did not meet the saliva collection guideline protocols were excluded from the study.

Keywords: cbd, streptococcus mutans
study of epratuzumab in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: epratuzumab is an investigational antibody designed to help treat systemic lupus erythematosus (sle). the purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of epratuzumab.

due to the logistical considerations, ucb has decided to consolidate the phase ii and phase iii open-label extension trials. subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in phase iii open-label extension study sl0012 (nct01408576).

Eligibility criteria:
inclusion criteria: * must have participated in sl0003 or sl0004 and benefitted from participation in those studies exclusion criteria: * development of toxicity to epratuzumab * significant protocol deviations during the sl0003 or sl0004 studies * evidence of significant infection

Keywords: lupus antibody b-cell immunotherapy
observational pharmacokinetic study of gw679769 in subjects with renal impairment

Conditions: Vomiting

Summary: the purpose of the study is to evaluate how subjects with mild or moderate kidney problems process or breakdown the study drug gw679769 in their bodies as compared to healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy or have mild or moderate renal impairment. * females must be of non-childbearing potential(hysterectomy, bilateral oophorectomy, post-menopausal) or childbearing and must have a negative pregnancy test and meet/comply with one of the following: abstinence, double-barrier contraception, vasectomized partner). * be negative for hepatitis b and c. * have negative results on drug, alcohol and hiv tests. * have stable renal function. exclusion criteria: * have a peptic ulcer. * abuse drugs or alcohol. * are pregnant or lactating. * have heart failure. * have uncontrolled emesis. * have an infection. * have taken or received inducers or inhibitors of cyp3a4 or cyp3a5 within 14 days of study start. * active peptic ulcer disease. * digoxin use. * laboratory results that show low iron or pepsinogen levels, ast and ck level \>1,5 uln, or that show stool is positive for occult blood.

Keywords: emesis renal impairment gw679769 kidney problems
preoperative ca 19.9 level predicts lymph node metastasis in resectable adenocarcinoma of the head of the pancreas.

Conditions: Pancreas Cancer

Summary: in our multicenter retrospective study, preoperative ca 19.9 levels predicts the presence of lymph node metastasis at final histology in patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma .

a retrospective analysis have been conducted on more than 2.000 patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma radiologically resectable at the preoperative staging. preoperatory levels of ca 19.9 were measured in order to identify a relation with nodal involvement at the pathological staging.

Eligibility criteria:
inclusion criteria: * all patients undergone pancreatoduodenectomy * no preoperative radiological suspicion of lymph node metastases. exclusion criteria: - age \< 18

Keywords: ca 19.9 pancreatic adenocarcinoma pancreatoduodenectomy
correlation research of thioredoxin reductase in lung cancer

Conditions: Non-small Cell Lung Cancer; Benign Neoplasm of Lung

Summary: in pre-clinical study the investigators found that the thioredoxin reductase activity of serum harbours huge difference between cancer patients and non-cancer patients, the enzyme activity elevated remarkably among cancer patients, so the investigators hypothesis that this is due to tumor cells loading of the patients, the enzyme activity may harbours huge difference between carcinoma tissues and para-carcinoma tissues in early staged non-small cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level because of removing of tumor.

this is a cooperative research project in thoracic surgery department and medical oncology department of affiliated cancer hospital of xiangya school of medicine central south university, and the state key laboratory for natural medicine and biomimetic drugs perking university. the primary objective is to measure the thioredoxin reductase activity using blood and lung cancer tissue and measure thioredoxin reductase messenger ribonucleic acid (mrna) and protein expression using lung cancer and pericarcinomatous tissue in early staged(ⅰ\~ⅲa) non-small lung cancers, to study the correlations of thioredoxin reductase between blood and tissue. the secondary objectives are to measure the thioredoxin reductase activity between non small lung cancers and lung benign lesion patients to identify the difference between tumor and lung benign mass.

Eligibility criteria:
inclusion criteria: * pathologically proven staged(ⅰ\~ⅲa) non-small cell lung cancer or ct scan shows resectable lung mass * receive surgery in thoracic oncology department hunan tumor hospital without contraindication of surgery * malignant tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before） * signed informed consent about providing blood and tissue for study exclusion criteria: * patients have received antitumor treatment * patients with contraindication of surgery or patients who need adjuvant chemotherapy with contraindication of chemotherapy * pregnant or breast feeding women

Keywords: thioredoxin reductase non-small cell lung cancer
a first-in-human study evaluating aga2115 in adult healthy volunteers

Conditions: Osteogenesis Imperfecta

Summary: to understand if aga2115 is safe and well tolerated in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * healthy men and women ≥18 to ≤65 years old. * vitamin d sufficiency (≥20 ng/ml (50 nmol/l) and agree to taking calcium and vitamin d supplements during the trial. exclusion criteria: * history of myocardial infarction or stroke (or other cardiovascular associated event deemed significant by investigator) within 12 months prior to day 1. * malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinoma that have been excised with no recurrence within the last 5 years is allowed). * hyper- or hypocalcemia. * known sensitivity to mammalian-derived drug preparations and/or any biologics. * pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
hbv-associated liver transplant(lt) patients by iv injecting gc1102

Conditions: Hepatitis B Infection

Summary: this is a clinical study for gc1102 to demonstrate preventing the recurrence of hepatitis b virus (hbv) infection following liver transplantation and a dose-finding study to determine its optional dose.

gc1102 is a new recombinant hepatitis b immunoglobulin (hbig) from chinese hamster ovary (cho) cells. it is a monoclonal antibody and has high affinity and avidity to hepatitis b surface antigen and several advantages compared to hbig derived from blood plasma of human donors. volunteers will participate in the study, receive 24-week treatment with 80,000/100,000 iu of gc1102 or i.v hbig and be followed up till 28 weeks.

Eligibility criteria:
inclusion criteria: 1. subject who was informed of, and fully understood, all aspects of the study and has provided voluntary written consent for participation in the study 2. subject aged over 19 years at the time of consent provided 3. subject with planned liver transplantation due to hbv-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure 4. subject with hbsag(+) exclusion criteria: 1. subject with planned reoperation following liver transplantation 2. subject with hemophilia 3. subject with a history of venous or arterial thrombosis 4. subject with hav, hcv or hiv infection 5. subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation 6. subject with hemolytic or blood loss anemia 7. subject with iga deficiency 8. subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer 9. subject with moderate to severe kidney disease (serum creatinine \> 20mg/dl or anuria, kidney failure or dialysis) 10. subject with a history of transient ischemic attack(tia), myocardial infarction(mi), unstable angina, cerebral infarction, cerebral hemorrhage, percutaneous transluminal angioplasty(pta) or coronary artery bypass graft(cabg) within the last 6 months prior to the screening 11. subject with severe heart failure(nyha class iii\~iv), arrythmia requiring treatment 12. subject with known hypersensitivity (anaphylaxis) to any component of the study drug 13. subject who had received other immunoglobulin product within the last 3 months prior to the study entry 14. subject who had received live parenteral vaccine (mmr, cholera and varicella) within the last 3 months prior to the study entry 15. subject who had received estrogen or hormone alternative medicine 16. pregnant or breast-feeding women 17. woman of childbearing potential with positive pregnancy test confirmed by serum beta-human chorionic gonadotropin(b-hcg) test within 28 days prior to dosing by urine pregnancy or subject who refused to use a reliable method of contraception 18. alcohol or drug abuse within 6 months 19. subject who has participated in any other clinical trial within 30 days 20. subject who has any clinically meaningful disease investigator's judgement to prevent participating in this study

Keywords: hbv-related liver transplantation hepatitis b immunoglobulin
reverse or nothing for complex proximal humeral fractures

Conditions: Humeral Fractures

Summary: reverse shoulder prosthesis has recently emerged as an acute treatment for complex proximal humeral fractures. promising functional results have been reported in observational papers. however, no clinical trials have yet been reported when comparing the conservative treatment to surgical treatment through the use of reverse shoulder arthroplasty.

introduction the proximal humeral fractures are frequent in the investigator's environment. among them, about 20% are considered as complex features. conservative treatment has traditionally offered an extensive range of results. the reverse shoulder prosthesis as a treatment for acute fractures of the proximal humeral in the elderly population has changed the therapeutic approach of this acute pathology. however, high-level evidence-based studies are still not available, when comparing the conservative treatment with the treatment with reverse shoulder prosthesis. objective to compare the functional results and complications of elderly patients presenting acute complex fractures of the proximal humerus through two types of treatments; conservative treatment and treatment with reverse shoulder prosthesis. methodology a prospective, multicentre and randomized study comparing conservative treatment with the surgical treatment at two years followup by the use of functional shoulder assessment (constant scale), complications and re-interventions associated with each treatment. the quality of life will also be analyzed through the sf-36 health questionnaire expected results the null hypothesis of the work is based on the appearance of non-significant differences between the two groups of the study (conservative vs. surgical treatment), concerning functional status, complications, and re-interventions

Eligibility criteria:
inclusion criteria: * patients with mental conditions available for rehabilitation protocols * patients presenting a 3 or 4 part proximal humeral fracture exclusion criteria: * extremely displaced fractures with no bony contact or less than 1 cm. * cognitive impairment (pfeiffer test \>3) * shoulder dislocations * unable to sign informed consent or unable to respond to questionnaires * trauma or previous surgery of the extremity * open or pathological fracture * vascular or neurological injury associated * unable to collaborate with rehabilitation * patients with serious comorbidities that discourage surgery

Keywords: conservative treatment reverse shoulder arthroplasty proximal humeral fractures
hepatitis b virus prevalence and risk factors in belgium

Conditions: Hepatitis B

Summary: the aim of this study was to evaluate the current prevalence and risk factors of hepatitis b virus (hbv) infection in a multi-ethnic neighbourhood situated in middle limburg, belgium. additionally, the investigators will determine linkage of care in hepatitis b surface antigen (hbsag) positive subjects.

although the hbv prevalence is generally low in western countries, such as belgium, pockets of higher hbv prevalence exist in areas with large immigrant populations. therefore national prevalence figures can underestimate the burden of hbv infection. the prevalence of chronic hbv in the population-based study in 2003 is believed to be an underestimate due to under-representation of the non-belgian population. moreover, by this time there are no data regarding the risk factors for hbv infection in the general population of belgium. even in low-prevalence areas such as belgium, hbv prevention and control is a public health priority, particularly since safe and effective vaccines are available. the aim of this study was to evaluate the current prevalence and risk factors of hbv infection in a multi-ethnic neighbourhood situated in middle limburg, belgium. additionally, the investigators will determine linkage of care in hepatitis b surface antigen (hbsag) positive subjects.

Eligibility criteria:
inclusion criteria: * age between 18 and 70 * males and females exclusion criteria: /

Keywords: belgium prevalence risk factor ethnicity linkage of care