Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of gpo seasonal trivalent inactivated influenza vaccine in healthy thai adults

Conditions: Influenza

Summary: the study is aim to evaluate the safety and immunogenicity of one dose (15 μg ha per strain per dose) of the gpo seasonal trivalent inactivated split virion influenza vaccine (tri fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.

this is a double blind randomized study consisting of two phases - phase i and phase ii. the same vaccine, a seasonal trivalent inactivated split virion influenza vaccine \[a/california/7/2009, reassortant virus nymc x-181 (h1n1), a/victoria/210/2009, reassortant virus nymc x-187 (h3n2), and b/brisbane/60/2008, reassortant virus nymc bx-35 virus strains\] will be given in both phase i and phase ii of the study. the vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. after vaccination volunteers will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization. total follow-up is 90 days. blood specimens will be collected on day 0 prior to vaccination, day 21, day 60, and day 90.

Eligibility criteria:
inclusion criteria: * healthy * age 18-49 years old * having thai id card or equivalent * all hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination) * able to read and write and sign written informed consent form or assent form. exclusion criteria: * known history of egg allergy * having had recently influenza infection confirmed as h1n1, h3n2, or flu b within 3 months preceding enrolment to the trial * vaccination against influenza in the past 6 months preceding enrolment to the trial * history of bronchial asthma, chronic lung diseases, chronic rhinitis * history of immunodeficiency state * history of immunosuppression \< 6 months prior to immunization * history of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. gentamicin or thimerosal) * acute infectious with fever \> 38 degree celsius and noninfectious diseases (within 72 hours) preceding enrollment in the trial * the volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the experiment * participation in other research study * pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding * current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures * any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine

Keywords: gpo tri fluvac vaccine tri fluvac vaccine
intrapartum maternal glycemic control using insulin pump versus insulin drip - cohort observational trial

Conditions: Pregestational Diabetes

Summary: the purpose of this study is to compare intrapartum glycemic control using insulin pump versus intravenous (iv) insulin administration.

intrapartum maternal glycemic control in women suffering from pregestational diabetes mellitus type 1 will be evaluated and compared in the 3 study groups. maternal and neonatal capillary blood glucose will be measured. all women suffering from diabetes mellitus and all neonates to hyperglycemic mothers are being tested for their blood glucose in our institute. measurements' data will be collected. the primary outcome of the study is the number of neonatal hypoglycemic events (neonatal blood glucose \< 40mg/dl). all women participating in the study will be treated according to the standard accepted protocol for "the treatment of pregestational diabetes during labor" in our institute. the research will not include new treatments or equipment. the study is a cohort prospective and retrospective observational study in the tertiary center - sheba medical center.

Eligibility criteria:
inclusion criteria: * pregnant women suffering from pregestational diabetes mellitus type-1, * women are being treated for a minimum of 3 months in the high risk pregnancy clinic in sheba medical center * women are being treated with either insulin pump or sc insulin (basal-bolus) exclusion criteria: * women not compliant to treatment * women not planning their delivery in our institute

Keywords: maternal intrapartum glycemic control pregestational diabetes
mdr - m/l taper with kinectiv technology stems and necks

Conditions: Hip Disease; Hip Fractures; Hip Injuries; Hip Arthritis; Hip Pain Chronic

Summary: the objective of this consecutive series pmcf study is to collect data confirming safety, performance and clinical benefits of the m/l taper with kinectiv technology stems and necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up\*. ml taper with kinectiv technology has been on the market since 2008, but has insufficient long term clinical data. therefore, a prospective aspect to the study will be necessary to reach the 10-year time point.

the objective of this consecutive series pmcf study is to collect data confirming safety, performance and clinical benefits of the m/l taper with kinectiv technology stems and necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up\*. ml taper with kinectiv technology has been on the market since 2008, but has insufficient long term clinical data. therefore, a prospective aspect to the study will be necessary to reach the 10-year time point. the primary objective is to confirm safety of the study products. this will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. relationship of the events to either implant or instrumentation should be specified. the secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (proms). \*follow-up with the patient at the 10 year time point will be collected by the site prospectively and the 1, 2 and 5 year time point data will be collected by the sponsor retrospectively from an existing database including ml taper with kinectiv technology patients from a zimmer biomet hip registry.

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older * rheumatoid arthritis * osteoarthritis * traumatic arthritis * polyarthritis * collagen disorders * avascular necrosis of the femoral head * nonunion of previous fractures of the femur * acute femoral neck fractures * congenital hip dysplasia * protrusio acetabuli * previously failed endoprostheses * patient must be willing and able to sign irb/ec approved informed consent. exclusion criteria: * skeletal immaturity * loss of abductor musculature in the affected limb * poor bone stock (e.g., steroid-induced metabolic bone disease) * poor skin coverage around the hip joint * neuromuscular disease (e.g., charcot's joint) in the affected limb * local and/or overt systemic infection * patient with a stove-pipe femur * stem implanted using cement fixation. * off-label use * uncooperative patient or patient with neurologic disorders who are incapable of following directions * patient is known to be pregnant or nursing * patient is a prisoner * patient is a known alcohol or drug abuser * patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent patient is unwilling to sign the informed consent
efficacy study of vaginal mifepristone to treat uterine fibroids

Conditions: Uterine Fibroid; Vaginal Bleeding.

Summary: the purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.

uterine fibroids are benign tumors of the uterus made up of smooth muscle and the extracellular matrix proteins collagen and elastin. they are exceptionally common; the cumulative incidence of a diagnosis of fibroids in women aged 25 to 45 is approximately 30 percent. uterine fibroids can cause abnormal uterine bleeding, dysmenorrhea, lower back pain and non-cyclic pelvic pain. they also can contribute to symptoms related to an enlarging pelvic mass (e.g., urinary frequency or constipation). uterine fibroids are also associated with an increased risk of complications of pregnancy, and with infertility, although it is unclear whether this association is causative. symptoms associated with uterine fibroids can have a significant impact on quality of life, with scores on standard measures that are comparable to those for other major chronic diseases

Eligibility criteria:
inclusion criteria: * uninterested in fertility during the study. * premenopausal status. * active symptoms related to uterine fibroids. * subjects will be obligated to use non hormonal contraceptives during the study. exclusion criteria: * abnormal liver and renal function * participants with significant increase in uterine fibroids size during a short time. * exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect. * current use of steroids, anticoagulants, herbals, or botanicals with possible hormonal effects.

Keywords: oral mifepristone vaginal tablets
high dose insulin therapy to improve liver function

Conditions: Hepatitis C Virus

Summary: insulin resistance is one of the key factors in defining a progressive course of chronic hepatitis c virus (hcv) infection and hepatic fibrosis. multiple trials have targeted insulin resistance as an adjuvant way to manage hepatitis c liver disease with promising results. long term therapy using high dose insulin was shown to significantly reduce insulin resistance in obese patients. in cardiac and critically ill patients, long term insulin was shown to produce better outcomes mainly by reducing the overt inflammatory response. furthermore, initial results of ongoing trials are revealing more benefits of insulin therapy. using the (hyperinsulinimic normoglycemic clamp) for eight hours on patients undergoing major liver resection was able to maximize their liver function post-operatively. this trial also demonstrated inhibition of the inflammatory response, improvement in liver glycogen, inhibition of apoptosis and stimulation of liver regeneration. putting in mind the potential ability of the liver to regenerate and regain better function. the anti-inflammatory properties of insulin therapy along with its ability to reduce insulin resistance over time has led us to see the potential benefits of using insulin therapy on patients with chronic hepatitis c virus liver cirrhosis. insulin will target the pathophysiology of the disease at a cellular and a molecular level. the investigators theorize that long-term high insulin therapy would be able to promote better liver function and slow down fibrosis and injury in this population of patients.


Eligibility criteria:
inclusion criteria: * hepatitis c positive adult patients (serum hcv antibody positive) * meld score 6-15 at the time of inclusion * viral genotype "non-3" * not on antiviral therapy exclusion criteria: * hbv or hiv co-infection * evidence of hepatocellular carcinoma at the start of the trial either by imaging and or afp levels above 400 * undetectable hcv viral load (using hcv pcr test) * recent infection or bleeding (in the last 3 months)
vec-162 study in adult patients with primary insomnia

Conditions: Primary Insomnia

Summary: the purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of vec-162 as compared to placebo in male and female patients with primary insomnia.


Eligibility criteria:
inclusion criteria: * males and females with a diagnosis of primary insomnia as defined in dsm-iv. * habitual bedtime between 9:00 pm and 1:00 am. * no history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea. * patients must sign a written consent form. exclusion criteria: * history of drug or alcohol abuse as defined in dsm-iv. * history of psychiatric disorders, including major depressive disorder, generalized anxiety disorder and delirium. * history of chronic obstructive pulmonary disease (copd), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia. * recent history of shift work or jet lag.
safety and efficacy of sublingual immunotherapy (slit) tablets in grass pollen rhinoconjunctivitis

Conditions: Allergy

Summary: to evaluate the safety and efficacy of slit compared with placebo for reduction of symptoms and rescue medication usage


Eligibility criteria:
inclusion criteria: * written consent * grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons. * sensitised to grass pollen (positive spt and rast level of at least class 2). * total symptom score of the rrtss during the previous pollen season greater than or equal to 12. * safety laboratory resuts within the references ranges exclusion criteria: * pregnancy, breast-feeding/lactation * had received desensitisation treatment for grass pollen * treatment by immunotherapy with another allergen within the previous 5 years * usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies * treated with beta-blockers or under continuous corticotherapy

Keywords: sublingual immunotherapy grass pollen tablet allergic rhinoconjunctivitis
appendicitis in adults and children in france-a prospective study by the french surgical association multicenter cohort

Conditions: Appendicitis Acute; Peritonitis

Summary: acute appendicitis still represents a surgical challenge, despite profound changes in practice in recent decades. the objective of this study was comprehensively document current surgical practices aimed at improving the management and follow-up of pediatrics and adults patients presenting with appendicitis in france.

the appea series is a national multicentric prospective cohort that included children and adults in france with acute appendicitis presenting between march 1st and june 30th, 2016. data included demographic characteristics, medical history, symptoms, biology, radiology, treatments given during hospitalization, the modalities of the intervention, and any complications during a follow-up period of 6 months.

Eligibility criteria:
inclusion criteria: * patients admitted for appendicitis in participating centers * informed exclusion criteria: * patient's (or parent's for children) opposition

Keywords: laparoscopic surgery
64cu-sar-bispsma positron emission tomography of patients with known or suspected prostate cancer

Conditions: Prostate Cancer

Summary: this research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.

this is a prospective, non-randomized, single arm, single center, open-label study of 64cu-sar-bispsma pet in patients with known or suspected prostate cancer (pc). patients will be screened during a 28-day period and assessed against the inclusion and exclusion criteria. during screening the investigator will determine the patient's disease status (for patients with suspected prostate cancer) or stage of disease (for patients with known prostate cancer) and management plan based on the available standard of care test results (including available imaging, histopathology, biochemical markers, clinical and symptoms history, etc.). eligible patients will receive a single administration of 64cu-sar-bispsma and complete a pet scan at an early time (1-4 hours) and a late time (24-72 hours). the patient's status will only be assessed in patients with suspected disease at study entry and will be characterized as suspected or known prostate cancer during the follow up. staging will only be assessed in patients with known prostate cancer at study entry and will be characterized according to the tnm system and as localized, regional or distant (nodes/visceral/bone).

Eligibility criteria:
inclusion criteria: 1. signed an informed consent. 2. \>18 years of age. 3. known diagnosis of prostate adenocarcinoma confirmed by histopathology or patients with suspicion of prostate cancer based on elevated psa but negative standard of care imaging and/or negative biopsy. 4. the eastern cooperative oncology (ecog) performance status 0-2. 5. adequate recovery from acute toxic effects of any prior therapy. 6. adequate renal function (egfr of 30 ml/min/1.73m2 or higher) exclusion criteria: 1. participants must not receive other investigational agents within 28 days prior to 64cu-sar-bispsma administration. 2. patients administered any high energy (\>300 kev) gamma-emitting radioisotope within 5 physical half-lives prior to 64cu-sar-bispsma administration. 3. known or expected hypersensitivity to 64cu-sar-bispsma or any of its components. 4. any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
quartet lead and resynchronization therapy options

Conditions: Heart Failure

Summary: the purpose of this clinical trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead. furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.

this is a prospective, non-randomised, multi-centre, national, interventional clinical trial of a medical device. this trial involves two visits: one at the beginning of the study, which will be undertaken in the seven days following implant, and another visit at 6 months after enrollment. it is recommended that the enrollment visit is undertaken as soon as possible after implantation, although the time window allows the timing to be adapted to each centre's standard practice. resynchronization therapy in those patients suitable for participation in this trial is expected to begin once this enrollment visit has been completed. once data collection at enrollment visit has been completed, final device programming will be based on each investigator's criteria and will be undertaken following the standard practice of each centre.

Eligibility criteria:
inclusion criteria: 1. patients with a cardiac resynchronization therapy defibrillator device (crt-d) and a quartet® quadripolar electrode from st jude medical (used in "single site pacing" mode) implanted in the left ventricle. 2. patients who have provided written informed consent 3. patients who are in sinus rhythm. 4. patients older than 18 years of age. exclusion criteria: 1. patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit. 2. patients with valvular disease. 3. patients in functional class new york heart association (nyha) iv 4. patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained. 5. patients whose device has been changed/upgraded. 6. pregnant patients. 7. patients who do not fulfill all the inclusion criteria. 8. patients who are unable to provide written informed consent
a trial of shr-a2102 for treatment of advanced gynecological malignancy

Conditions: Advanced Gynecological Malignancy

Summary: the main objective of this study is to evaluate the effectiveness and safety of shr-a2102 for participants with advanced gynaecological cancer.


Eligibility criteria:
inclusion criteria: 1. participate in the study voluntarily, sign the informed consent form. 2. recurrent or metastatic gynecological malignancies that had failed standard treatments. 3. at least one measurable lesion (recist version 1.1). 4. ecog 0\~ 1. 5. with adequate organ functions. 6. female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of shr-a2102，female participants' hcg must be negative within 72 hours prior to enrollment and must be non-lactating. exclusion criteria 1. with untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression. 2. previous or contemporaneous malignancies, unless these malignancies reached complete remission at least 5 years prior before screening and did not require or are not expected to require other treatment during the study period. such as cutaneous squamous cell carcinoma, cervical carcinoma in situ etc. 3. had previously received antibody drug conjugates containing topoisomerase i inhibitors. 4. had undergone major surgery other than a diagnosis or biopsy within 28 days prior to the first administration; undergone minor traumatic surgery within 7 days prior to first administration. 5. known to be human immunodeficiency virus positive, active hepatitis b virus, or active hepatitis c virus. 6. had active pulmonary tuberculosis within 1 year prior to enrolment. 7. known to be allergic to any of the components of shr-a2102. 8. were not fit to participate in this study by investigator's judgment.
mometasone furoate and oxymetazoline in the treatment of adenoid hypertrophy

Conditions: Adenoidal Hypertrophy

Summary: the purpose of this study is to determine the effect of mf/oxy in the treatment of adenoid hypertrophy children with severe allergic rhinitis.

the investigators performed a two stages, parallel, randomized, double-blind, double-dummy, clinical trial in 240 ah children concomitant with perennial allergic rhinitis. in the first treatment stage, the 240 children were assigned to mf (50μg, 1 puff in each nostril every evening) or control group (normal saline) after two week's run-in period. after 6 week's treatment, the children in mf group were evaluated and grouped as responders and non-responders according to subjective symptoms and objective performance. responders were followed up for six months and reassessed. non-responders underwent 2-week washout period and were randomly assigned to 4 groups receiving the following treatments: placebo, oxy (0.05%, 1 puff in each nostril every evening) or mf (50μg, 1 puff in each nostril every evening). all participants received 8 weeks' mf or its placebo plus one week's oxy or its placebo for every second week. after that, the patients were followed for six months and the evaluation was done at different time points.

Eligibility criteria:
inclusion criteria: * adenoid occluding at least 75% of the nasopharynx at nasal endoscopy * age between 5 and 11 years * chronic obstructive nasal symptoms no less than 12 months * moderate-to-severe ar exclusion criteria: * tonsillar hypertrophy * upper respiratory infection within the last 2 weeks * sinonasal anatomic anomalies or diseases * craniofacial malformations * genetic diseases (i.e., down's syndrome) * neurologic or cardiovascular diseases * immunodeficiency * history of epistaxis * asthma * hypersensitivity to mf or oxy * undergoing intranasal, topical, or systemic steroid or antibiotic treatment within the past 4 weeks