Kornimate/medical-research-clean huggingface dataset:
zostavax(r) local registration trial (v211-019)

Conditions: Varicella Virus Infection

Summary: the purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of zostavax(r) in taiwanese adults.


Eligibility criteria:
inclusion criteria: * subject is older than 50 years of age on day of signing informed consent * all females must be postmenopausal or have a negative serum or urine pregnancy test * postmenopausal is defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (fsh) levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea * a subject who is of reproductive potential must agree to remain abstinent or use (or have her partner use) 2 acceptable methods of birth control for three months after vaccination * acceptable methods of birth control are: intrauterine device, diaphragm with spermicide, contraceptive sponge, oral contraceptive pills, condom, tubal ligation, and vasectomy * subject must sign informed consent prior to any study procedure * subject must be afebrile (\<38.3 °c oral) on day of vaccination * any underlying chronic illness must be in stable condition
continuing lamivudine vs switching to entecavir in patients with detectable hbv dna

Conditions: Hepatitis B, Chronic

Summary: this is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg qd from lamivudine versus maintaining lamivudine 100 mg qd treatment in hbv-infected subjects currently receiving lamivudine monotherapy.

entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than lamivudine in nucleoside-naïve chb patients. the prompt switch from lamivudine to entecavir in patients who have insufficient hepatitis b virus suppression (hbv dna ≥ 60 iu/ml by pcr) may lead to full viral suppression to undetectable level by pcr method. the prompt switch from lamivudine to entecavir in patients who have insufficient hepatitis b virus suppression (hbv dna ≥ 60 iu/ml) may preclude development of drug resistance. the results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from lam to etv.

Eligibility criteria:
inclusion criteria: * adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic hbv infection for at least 6 months with ≥ hbv dna 60 iu/ml level and hbeag positive at baseline. exclusion criteria: * all subjects will be tested for presence of m204v/i mutations in the ymdd motif at baseline. subjects with m204v/i mutations in the ymdd motif at baseline are not eligible for the study. * subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study. * subjects should have alt \< 10 x uln, and no evidence of hepatocellular carcinoma. * subjects should be without serological evidence of co-infection with hcv, hiv, or hdv. * subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Keywords: chronic hepatitis b lamivudine entecavir
caffeine reduction and overactive bladder symptoms

Conditions: Overactive Bladder

Summary: a. statement of objective: to conduct a randomized trial to evaluate the impact of caffeine restriction on overactive bladder(oab) symptoms including urinary frequency, nocturia, incontinence episodes, symptom severity and bother and quality of life. b. specific aims/hypothesis: 1. to determine if reduction in caffeine intake decreases urinary frequency, nocturia and incontinence episodes as measured on a 3-day voiding diary in women with overactive bladder (oab). we hypothesize that women with overactive bladder will report less frequent urination and decreased nocturia and incontinence episodes with caffeine reduction. 2. to determine whether caffeine reduction results in decreased symptom severity and bother and improved quality of life scores as measured by the questionnaire for incontinence severity index (isi), questionnaire for urinary incontinence diagnosis (quid), urogenital distress inventory (udi-6) and the incontinence impact questionnaire (iiq-7). we hypothesize that women with oab who reduce their intake of caffeine will report decreased symptom bother and improved quality of life as measured by the isi, udi-6 and the iiq-

objective: to evaluate the impact of caffeine reduction education on urinary frequency. methods: women with overactive bladder (oab) symptoms who scored a 6 on the questionnaire for urinary incontinence diagnosis and who consumed at least 200 mg of caffeine daily were recruited. after completing baseline 3-day bladder diaries including amount and type of caffeine consumption, as well as validated urinary symptom severity, bother and quality of life questionnaires, women were randomized to receive caffeine reduction education vs. a control group who reviewed their voiding diary with no counseling to reduce caffeine; both groups were asked to maintain total fluid intake. participants repeated the 3-day bladder diary and validated questionnaires following randomization. a total of 80 women were required to achieve 80% power with an alpha error of 0.05 to detect a difference of 1.3 in mean number of daily voids averaged over a 3-day voiding diary.

Eligibility criteria:
inclusion criteria: * only women 18 years and older with overactive bladder syndrome and who report that they consume an average of two cups of caffeinated beverages (approximately 200mg caffeine) daily will be included. exclusion criteria: * women presenting with stress predominate bladder symptoms as evaluated by the quid, urinary tract infection or hematuria as evaluated on urine dip analysis, currently pregnant or pregnant within the past six months or history of radiation to the pelvic floor will be excluded from participation
elastance: prospective physiological study of lung elastance in recruitment and derecruitment in early onset mechanically ventilated ards patients

Conditions: Acute Respiratory Distress Syndrome

Summary: the recruitment strategy in acute respiratory distress syndrome (ards) patients mechanically ventilated combines recruitment maneuvers and positive end expiratory pressure (peep). recruitment maneuvers promote alveolar recruitment leading to increased end-expiratory lung volume in order to prevent repetitive opening and closing of unstable lung units and reduce the strain induced by ventilation. in addition, recruitment is effective in improving oxygenation. variety of recruitment maneuver have been described, the most commonly used is the application of sustained continuous positive airway pressure at 40 cmh2o for 40 seconds. staircase recruitment maneuver (srm) is an alternative with good hemodynamic tolerance. staircase recruitment maneuver (srm) involves a progressive increase in positive end expiratory pressure (peep) (up to 40 cmh2o), in pressure control ventilation, in order to increase end-expiratory lung volume (eelv); then a decreasing peep trial is performed. the positive end expiratory pressure (peep) to prevent alveolar collapse depends on ratio between lung elastance and chest wall elastance. if chest wall elastance is high, the peep to obtain a positive end-expiratory transpulmonary pressure is high. the only way for the time being to know the transpulmonary pressure and the ratio between lung and chest wall elastance is the use of esophageal catheter. a non-invasive method for measuring the lung elastance by measuring volume recruited during a change of pressure (∆peep/∆eelv) could be used to avoid the use of esophageal catheter.


Eligibility criteria:
inclusion criteria: early onset (less than 24 hours)moderate or severe acute respiratory distress syndrome (ards) according to berlin definition mechanical ventilation for less than 72 hours exclusion criteria: bronchopleural fistula, emphysema, pneumothorax, antecedent of pneumothorax, increase intracranial pressure, pulmonary arterial hypertension with right heart failure, hemodynamic instability with mean arterial pressure \< 65 mmhg, pregnancy.

Keywords: acute respiratory distress syndrome (ards) positive end expiratory pressure (peep) staircase recruitment maneuver (srm) lung elastance chest wall elastance
cepheid rectal sample validation study

Conditions: Gonorrhea; Chlamydia; Trichomonas

Summary: the purpose of this study is to validate xpert ct/ng for the detection of ct and gc in rectal samples as part of the pa doh and clia requirements. the evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to ct and gc. a secondary objective will be to evaluate the prevalence of trichomonas vaginalis in vaginal and rectal samples using both the xpert system and ac2 to assess whether women positive for this pathogen rectally usually or always have vaginal infection due to this pathogen. the investigators hypothesis is that real-time pcr (polymerase chain reaction) amplification testing with the cepheid xpert ct/ng will have greater sensitivity than culture in detecting neisseria gonorrhoeae in rectal samples. the investigators also hypothesize that xpert ct/ng will be equivalent to the gen-probe aptima combo2 (ac2) in detecting chlamydia trachomatis and neisseria gonorrhoeae in rectal samples.

because of its high sensitivity and specificity, naat testing has largely replaced bacterial culture for the diagnosis of genital ct and gc in both males and females. naat assays have the greatest potential for detecting ct and gc in the rectum; however, no naat is currently cleared for use with extragenital specimens by the us food and drug administration. in order to comply with clia regulations, laboratories must perform in-house validations to use naats with rectal and pharyngeal specimens. there are multiple studies in the literature evaluating naat assays in diagnosing ct and gc in rectal and pharyngeal specimens using expanded reference standards, which includes positive culture result and secondary confirmatory naat assays. the proposed validation study is intended to provide data to support the use of naat for rectal and pharyngeal specimens.

Eligibility criteria:
inclusion criteria: 1. male and female participants aged 18 and older 2. women or men who have a history of engaging in receptive anal intercourse 3. willing to provide written informed consent for participation in this study exclusion criteria: 1. use of oral antibiotics in the past 7 days 2. use of rectal douche or other rectal product in the past 24 hours 3. if female, use of a vaginal douche or vaginal product in the past 24 hours

Keywords: gonorrhea chlamydia trichomonas
internal biodegradable stent versus non-stent in patients at high-risk of developing fistula after pancreatoduodenectomy

Conditions: Pancreatoduodenectomy; Clinically Relevant Postoperative Pancreatic Fistula; Internal Biodegradable Pancreatic Stent

Summary: the aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (pd), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (cr-popf). patients undergoing pd will be randomized into two arms: * arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis * arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis the rate of occurrence of cr-popf will be compared between the two arms.

clinically relevant postoperative pancreatic fistula (cr-popf) represents the most common complication that can occur after pancreatoduodenectomy (pd). cr-popf is the main cause of morbidity after pd, being associated with a risk of mortality up to 60%. the placement of external or internal pancreatic stents after pd have been investigated as possible strategies for preventing the development of cr-popf. however, device displacement has been reported as a common cause of pancreatic stents malfunction. recently, a novel biodegradable pancreatic stent (archimedes™) has been introduced. the device has been specifically designed to reduce the risk of displacement, thus offering a new valuable tool to decrease the rate of cr-popf after pd. in this randomised, controlled, single-center trial, researchers investigate the possible efficacy of biodegradable internal pancreatic stenting of pancreatic anastomosis in patient undergoing pd versus no stenting, focusing on a possible superiority association for preventing cr-popf. participants will be randomised into two arms (biodegradable stent vs non-stent) based on their intra-operative risk of developing popf according to the fistula risk score (frs). the rate of cr-popf will be compared between the two arms.

Eligibility criteria:
inclusion criteria: * age ≥18 * patients who undergo pancreatoduodenectomy (pd) * informed consent exclusion criteria: * previous distal pancreatectomy * patients with intra-operative negligible, intermediate or moderate risk of popf (fistula risk score \< 7)

Keywords: pancreatic surgery pancreatoduodenectomy cr-popf post operative complications archimedes™
a study of ly3437943 in participants who have obesity or are overweight

Conditions: Obesity; Overweight

Summary: this is a study of ly3437943 in participants who have obesity or are overweight. the main purpose is to learn more about how ly3437943 affects body weight loss. the study will last about 18 months and may include up to 18 visits.


Eligibility criteria:
inclusion criteria: * participants must have a body mass index (bmi) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and \<30 kg/m², with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease * participants must be willing to learn how to self-inject study drug or receive an injection from a trained individual if visually impaired or with physical limitations, and follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice (for example, dietary changes and physical activity plan), maintain a study drug administration log, and complete required questionnaires exclusion criteria: * participants must not have type 1 or type 2 diabetes mellitus * participants must not have had an increase or decrease in body weight \> more than 5 kg (11 pounds) within the past 3 months * participants must not have had surgery for obesity or plan to have such surgery during the study * participants must not be using medications that promote weight loss or cause weight gain * participants must not drink excessive amounts of alcohol (more than 14 units a week for women or more than 21 units a week for men) * participants must not have used marijuana within the last 3 months. * participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months * participants must not have active cancer within the last 5 years * participants must not have uncontrolled high blood pressure * participants must not have liver disease other than non-alcoholic fatty liver disease * participants must not have renal impairment with estimated glomerular filtration rate (egfr) \<45 ml/min/1.73 m2 * participants must not have a history of acute or chronic pancreatitis symptomatic gallbladder disease or documented human immunodeficiency virus infection * participants must not have a major problem with depression or other mental illness within the last 2 years * participants must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative) * female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Keywords: nutritional or metabolism disorder weight loss overnutrition incretins hormones physiological effects of drugs
ivim & olink in sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the hypoxia \> metastasis axis suggests that a dwi-based biomarker of hypoxia incorporating ivim may be able to predict metastasis in sts patients, ultimately enabling stratification for personalized treatments at the time of diagnostic (mr) imaging, without adding an excessive burden to the patient or clinical workflow (typical dwi/ivim sequences can be acquired acquired in approximately 5 minutes).

tumour hypoxia has been implicated as a major driver in sts metastatic dissemination. despite this, patients are not routinely assessed for hypoxia, largely due to the cost and difficulty involved. pet hypoxia imaging using fluorine-18-labelled nitroimidazole-based agents such as fluoroazomycin arabinoside (faza) provide non-invasive in vivo quantification of hypoxia \[5\], including in sts. the expense and unproven clinical value of these agents and the long times between their injection and pet scanning (typically, two hours) has limited the uptake of pet-hypoxia imaging as a routine screening modality. in contrast, magnetic resonance imaging (mri) is standard for diagnosis of sts and is a routine part of the radiation therapy workflow due to its superior contrast between tumour and surrounding normal tissue. in addition, diffusion-weighted magnetic resonance imaging (dwi) can quantify physiological tumour properties such as cellularity and perfusion that may provide information about tumour biology, including hypoxia. hypoxia results from the interplay between oxygen demand (oxygen consumption rate) and supply (perfusion). hypothesizing that oxygen consumption increases with increasing cellularity, hompland and colleagues demonstrated that a biomarker derived from ivim measurements could predict hypoxia in prostate, breast, and cervical cancer patients. an ongoing prospective imaging study of hypoxia in sts patients at princess margaret is investigating the capacity of faza to image hypoxia in sts and develop correlative dwi (ivim)-based biomarkers of hypoxia on a combined pet/mri scanner.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * ability to understand and the willingness to sign a written informed consent document * grade 2 or 3 soft tissue sarcoma greater than 5 cm in largest dimension exclusion criteria: * contraindication to mri scan as per current institutional guidelines (for patients requiring mri)
atlantis symbicort

Conditions: Asthma

Summary: the purpose of this study is to determine whether symbicort compared with advair, will be more effective in controlling asthma in adults and adolescents.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma * baseline lung function tests as determined by protocol * required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol exclusion criteria: * has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers * had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Keywords: asthma inhaled cortocisteroids symbicort budesonide/formoterol advair fluticasone/salmeterol
regulation of coagulation in orthopedic surgery to prevent deep vein thrombosis (dvt) and pulmonary embolism (pe). a study of bay 59-7939 in the prevention of vte in subjects undergoing elective total knee replacement.

Conditions: Prevention; Venous Thromboembolism

Summary: the purpose of this study is to assess if 10 mg bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.


Eligibility criteria:
inclusion criteria:- male and female patients aged 18 years or above- patients scheduled for elective total knee replacement exclusion criteria:- active bleeding or high risk of bleeding contraindicating treatment with lmwh- contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
perfusion and hypoxia evaluation in tumors using 18f-fdg pet/ct

Conditions: Perfusion and Hypoxia

Summary: investigators want to use 18f-fdg pet/ct imaging to reflect tumor perfusion and hypoxia.

perfusion and hypoxia were independent prognositic parameters for tumor patients. developing a method that can evaluate tumor perfusion and hypoxia noninvasively and conveniently was in urgent need. 18f-fdg pet/ct imaging could reflect tumor hypoxia in 60min balanced imaging was proved and accepted. moreover, fdg could diffuse out of the vasculature and through cell membranes passively and rapidly due to its lipophilicity, its regional uptake at initial times is expected to reflect tumor perfusion. so, investigators want to use 18f-fdg pet/ct imaging to evaluate tumor perfusion and hypoxia simutaniously，in order to guide the clinical diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * 1.solid tumor proved by pathology(d\>3.0cm); * 2.age\>18-year-old; * 3. karnofsky performance status \>70; * 4.sign the informed consent. exclusion criteria: * 1.there are obvious metal implants near the tumor; * 2.can not lie still for 15 minutes. * 3.pregnancy.

Keywords: fdg, perfusion, hypoxia, tumor, pet
expanded access protocol of verdiperstat in patients with multiple system atrophy (msa)

Conditions: Multiple System Atrophy (MSA)

Summary: the purpose of this expanded access program is to provide access to the investigational drug verdiperstat in patients with multiple system atrophy (msa). expanded access allows patients with a serious or a life-threatening disease or condition access to an investigational drug when no satisfactory approved treatment options are available.


Eligibility criteria:
inclusion criteria: 1. with a diagnosis of probable or possible msa documented by a physician according to consensus clinical criteria,5 including patients with msa of either subtype, msa-p or msa-c. 2. able to swallow whole tablets without crushing or chewing. 3. with established care with a physician at the specialized msa center involved in the protocol and will maintain this clinical care throughout the duration of the eap. 4. not eligible for an ongoing clinical study with verdiperstat and/or an ongoing eap for msa exclusion criteria: 1. based on the physician's judgement, any condition (including history of a clinically significant or unstable medical condition or lab abnormality) that would interfere with the patient's ability to comply with the eap instructions, visit schedule, requirements and/or procedures, place the patient at unacceptable risk, or confound/interfere with the adequate assessment/interpretation of data; including difficulty swallowing verdiperstat tablets or any other sound medical, psychiatric and/or social reason. 2. presence of clinically significant thyroid disease despite treatment and/or tsh \>10 miu/ l at screening/baseline, confirmed by repeat. 3. patient is known to have acute or chronic liver disease that is clinically significant in the prescriber's judgment 4. first or second dose of covid-19 vaccination within 7 days of first dose of verdiperstat.

Keywords: multiple system atrophy msa verdiperstat bhv3241 mpo inhibitor myeloperoxidase inhibitor msa-p msa-c