Kornimate/medical-research-clean huggingface dataset:
regulatory post-marketing surveillance study for hepatitis a vaccine (avaxim 160u)

Conditions: Hepatitis A

Summary: this safety surveillance study is being conducted in accordance with korea food and drug administration (kfda) "basic standard for reexamination of new drug". primary objective: * to assess the safety of avaxim 160u (hepatitis a vaccine) administered under the routine practice, according to korea food and drug administration "basic standard for reexamination of new drug" based on the pharmaceutical law in korea.

the study will be conducted under the real clinical practices in accordance with korea food and drug administration "basic standard for reexamination of new drug". no vaccine will be provided and/or administered as part of this protocol, however only participants that has received avaxim 160u vaccine administered under the routine practice according to summary of product characteristics will be part of the surveillance.

Eligibility criteria:
inclusion criteria: * subjects aged 16 years and older * informed consent signed by the subject and by parent or legal representative for subject aged 16 to 19 years * informed consent sign by subject for subject aged of 20 year of age and older * receipt of avaxim 160u according to summary of product characteristics (smpc). exclusion criteria: * contraindications to vaccination according to avaxim 160u summary of product characteristics (smpc) * subject is known to be pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence for at least 4 weeks prior to the vaccination until at least 4 weeks after)

Keywords: hepatitis a hepatitis a vaccine avaxim 160u
core cerebrospinal fluid biomarker profile in anti-leucine rich glioma inactivated 1 (anti-lgi1) encephalitis

Conditions: Encephalitis; LGI1 Antibody Associated Encephalitis

Summary: limbic encephalitis associated with anti leucine-rich glioma inactivated-1 lgi1 antibody (anti-lgi1) usually presents with seizures and progressive disturbance of memory and behavior. but anti-lgi1 associated encephalitis (lgi1-e) could present with a variety of features including an elective cognitive form of the disease, which mimicks a neurodegenerative condition such as creutzfeld jakob disease or rapidly progressive alzheimer disease. in these patients, the appropriate diagnosis could be challenging. the primary aim of this study is to describe cerebrospinal fluid biomarkers in a cohort of lgi1-e patients as results of these markers are currently not described in lgi1-e. moreover, patients with lgi1-e often present seizures. at this point, the impact on cerebrospinal fluid biomarkers has not been described in this condition. the secondary aims of this study are to compare cerebrospinal fluid (csf) biomarkers in lgi1-e patients to these in other neurodegenerative conditions ( e.g. creutzfeld jakob disease, alzheimer disease), which are considered as a possible differential diagnosis in these patients. the last aim of this study is to look for correlations between cerebrospinal fluid biomarkers in lgi1-e and clinical data in these patients, especially seizure.


Eligibility criteria:
inclusion criteria: * presence of well characterized leucine rich glioma inactivated 1 (lgi1) antibody in serum or cerebrospinal fluid (csf); * lgi1 antibody associated encephalitis diagnosis according to the international guidelines; * at least one core csf biomarkers sample (t-tau, p-tau, ab-1-42) available after disease onset; * age at least 18 years old. exclusion criteria: * absence of clinical data

Keywords: lgi1 encephalitis biomarkers cerebrospinal fluid (csf) neurology
study of metastatic ocular melanoma

Conditions: Ocular Melanoma

Summary: this study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.

treatment of patients with metastatic ocular melanoma with combination chemotherapy gemcitabine and treosulfan versus monotherapy with treosulfan as first-line chemotherapy.

Eligibility criteria:
inclusion criteria: * metastatic ocular melanoma exclusion criteria: * prior treatment with chemotherapy * active 2nd malignancy * cerebral metastasis

Keywords: metastatic ocular melanoma
energy expenditure in patients with crohn's disease

Conditions: Crohn's Disease

Summary: the objective of this study is to investigate the changes in crohn on resting energy expenditure.


Eligibility criteria:
inclusion criteria: * patients with crohn's disease
penicillin and metronidazole in treatment of peritonsillar abscess

Conditions: Peritonsillar Abscess

Summary: treatment of peritonsillar abscess varies. to study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. recovery and recurrence are analyzed.


Eligibility criteria:
inclusion criteria: * referring doctor suspects peritonsillar abscess * patient is voluntary * patient has daily access to his/her e-mail * patient speaks and understands finnish of swedish * female patients have adequate birth-control method * patient has peritonsillar abscess exclusion criteria: * allergy to penicillin * allergy to metronidazole * use of metronidazole in preceding one month * pregnancy * breast-feeding * renal insufficiency * liver insufficiency * alcoholism (drunk at least once a week) * participant in another clinical trial at the moment * treatment of peritonsillar abscess requires in-patient care * tonsillectomy during the next 30 days * army recruit

Keywords: peritonsillar abscess quinsy penicillin metronidazole recurrence
efficacy, safety, and tolerability of avp-786 for the treatment of residual schizophrenia

Conditions: Schizophrenia

Summary: the objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of avp-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.


Eligibility criteria:
inclusion criteria: * patients who meet dsm-iv-tr diagnostic criteria for schizophrenia using the m.i.n.i. version 6.0. * patients must meet panss criteria * patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose exclusion criteria: * patients with current major depressive disorder (mdd) * patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication * patients currently using anticholinergic medications * recent in-patient hospitalization

Keywords: negative symptoms schizophrenia avp-786
evaluation of photodynamic treatment fotosan® efficacy in periodontology

Conditions: Periodontitis

Summary: periodontitis are infectious and inflammatory diseases of gum and tooth supporting tissues leading to tooth loss and oral disability. twenty to 30 percents of patients treated for periodontal diseases display more or less pronounced persistence of periodontal tissue infection, inflammation, and destruction. the therapeutic additional value of photodynamic anti-infectious treatment remains controversial. the objective of this study is to evaluate the mid-term effect of the photodynamic device fotosan®630 on severe periodontitis treatment outcomes and to define its specific therapeutic indications.


Eligibility criteria:
inclusion criteria: * aged 40 years * signed informed consent * generalized severe chronic periodontitis * patient with at least 24 teeth * more than 30% of sites with clinical attachment loss \>5mm- at least 5 sites with pocket depth \>4mm per quadrant- at least one molar per quadrant- evidenced bone loss on radiographs- bleeding on probing ≥30% exclusion criteria: * aggressive periodontitis * smoking more than 10cig/day * patient with endocarditis risk or need of antibiotic prophylaxis * pregnant women * patient included in other trials * patient under guardianship * patient treated with antibiotics, anti-inflammatory, and other drugs (inhibitors of calcium channels...) influencing periodontal status within 6 months before examination * patient suffering from diseases influencing periodontal status (diabetes...) * patient periodontally treated with root planing or periodontal surgery within 1 year before examination * patient with scheduled extensive prosthetic treatment * patient with a high haemorrhagic risk (inr\>4) * impossible patient cooperation

Keywords: periodontitis, treatment, photodynamic, mid-term, bacteria
comparison of morphine with nalbuphine in a multimodal approach for pain relief in patients undergoing gynecological procedures: randomized controlled double blind clinical trial

Conditions: Pain, Acute

Summary: this study was conducted in the aga khan university hospital, karachi. pakistan is developing country and overall shortage of morphine in developing country. rationalizing, in multimodal analgesia, nalbuphine is equivalent to morphine in open abdominal hysterectomy

a large number of patients undergoing major surgical procedures need gold standard analgesic like morphine for adequate pain control. shortage of morphine results in inadequate pain relief leading to delayed recovery, prolonged hospitalization and persistent post-surgical pain syndrome. for better surgical outcome, there is a strong need to find an alternative to morphine in a multi modal analgesia that help optimize pain relief with less opioids in patients undergoing gynecological procedures

Eligibility criteria:
inclusion criteria: * all asa i and asa ii women, age b/w 18-59 scheduled for elective open moderate to major gynecological procedures at aga khan university hospital exclusion criteria: * patient is unwilling to participate or provide informed consent history of chronic pain or pain syndrome with concurrent opioid medication use fibromyalgia patient has received opioids and/or tramadol in the past 4 hours history of adverse reaction to morphine, ketamine and nalbuphine presence of oxygen dependent pulmonary disease, liver cirrhosis or renal disease requiring dialysis. presence of ischemic heart disease presence of intracranial mass or vascular lesion. presence of psychosis or hallucinations weight greater than 115kg or less than 45 kg
intestinal microflora in lung cancer after chemotherapy

Conditions: Lung Cancer; Effects of Chemotherapy; Tumor Immunity; Malnutrition

Summary: probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.

chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications. probiotics may restore the intestinal immunity, mucosal barrier and nutrient absorption.

Eligibility criteria:
inclusion criteria: * patients scheduled for chemotherapy of lung cancer exclusion criteria: * antibiotic, probiotic or prebiotic usage within 1month * other malignancy * history of abdominal surgery * pregnant or breast-feeding (for females) * impaired liver or renal function * diabetes, thyroid disorder, coagulopathy or bleeding disorders, mental disorder

Keywords: gut microflora lung cancer chemotherapy immunity nutrition
the clinical comparison of narafilcon a and stenfilcon a contact lenses

Conditions: Myopia

Summary: this study aims to compare the clinical performance and subjective acceptance of the narafilcon a lens with the stenfilcon a lens when used on a daily wear, daily disposable basis.

this will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. seventy subjects will use each lens type for a week in a random sequence. follow-up visits for each lens will be performed after one week of wear. lenses will be worn on a daily wear, daily disposable wear schedule.

Eligibility criteria:
inclusion criteria: * subjects will only be eligible for the study if: 1. they are of legal age (18) and capacity to volunteer. 2. they understand their rights as a research subject and are willing and able to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they agree not to participate in other clinical research for the duration of this study. 5. they have a contact lens spherical prescription between -1.00 to - 6.00d (diopters) (inclusive) 6. they have a spectacle cylindrical correction of -0.75d or less in each eye. 7. they can be satisfactorily fitted with the study lens types. 8. at dispensing, they can attain at least 0.10 logmar distance high contrast visual acuity in each eye with the study lenses within the available power range. 9. they currently use soft contact lenses or have done so in the previous six months. 10. they are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day). 11. they own a wearable pair of spectacles. exclusion criteria: * subjects will not be eligible to take part in the study if: 1. they have an ocular disorder which would normally contra-indicate contact lens wear. 2. they have a systemic disorder which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment. 4. they have had cataract surgery. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. they are pregnant or breast-feeding. 8. they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 9. they have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. hiv), or a history of anaphylaxis or severe allergic reaction. 10. they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study. 11. they currently wear either the stenfilcon a lens or narafilcon a lens.
a study to evaluate the reactogenicity, safety, and immunogenicity of the third generation hepatitis b vaccine

Conditions: Healthy

Summary: a single center, randomized, double blinded phase i/iia exploratory study to evaluate reactogenicity, safety, immunogenicity and dose-response of a new hepatitis b vaccine in human adult

* objectives: to explore the most effective dose of the third generation hepatitis b vaccine through the evaluation of reactogenicity, safety, and immunogenicity. * subjects: adults having anti-hbs antibody titers less than 10 miu/ml after 3 previous injections of the conventional hepatitis b vaccine. * study hypothesis: the third generation hepatitis b vaccine, containing pres antigens in addition to s antigen, has an ability to elicit faster protection and higher antibody titers than the second generation hepatitis b vaccine in the subjects.

Eligibility criteria:
inclusion criteria: 1. adults between 20 and 50 years of age 2. anti-hbs titers \< 10 miu/ml 3. subject is able to provide written informed consent by oneself or legal representative exclusion criteria: 1. hepatitis b core antibodies positive patient 2. patient has abnormal results in liver-function test 3. patient has active microbial, viral, or fungal infections in need of systemic treatment 4. patient has history of serious heart disease (nyha functional class iii or iv heart failure, myocardial infarction within 6 months, treatment required ventricular tachyarrhythmias, or unstable angina etc.) 5. patient has seizure disorder required anticonvulsants treatment 6. serious chronic obstructive pulmonary disease patient accompanied hypoxemia 7. uncontrollable diabetic patient 8. uncontrollable hypertension patient 9. patient with known history of hiv, hbv, or hcv infection 10. subject had experience of participating other clinical study or clinical treatment within 30 days before screening 11. subject has hypersensitivity or anaphylactic reaction for hbv vaccine components 12. patient being treated for prolonged immunosuppressive therapy (including steroids) 13. hemodialysis patient 14. subject has continuous drinking (\>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol 15. subject is pregnant or breastfeeding or intending to become pregnant during the study 16. subject has any other significant findings unacceptable in this study under the opinion of the investigator
evaluation of the reproducibility of jumping mechanography

Conditions: Sarcopenia

Summary: sarcopenia, the age-related decline in muscle mass and function (widely recognized as "frailty"), is increasingly being appreciated, primarily in the research environment. interventions to prevent or treat sarcopenia can be anticipated to reduce falls, fractures and thereby to facilitate independence and improve quality of life for older adults. unfortunately, there is no current consensus definition of sarcopenia, thereby impeding clinical recognition and treatment. it has been advocated that low appendicular (arm and leg) lean mass, as measured by dxa, be utilized as a clinical diagnostic tool to define sarcopenia. while such an approach is possible, however, muscle strength loss is more rapid than mass loss, indicating deterioration of muscle "quality." muscle quality may be affected by changes at the neuromuscular, cellular or subcellular levels; parameters not detected by measuring mass alone. clearly, tools evaluating muscle performance, not simply mass, are needed to optimally identify, and subsequently monitor, treatment of older adults with sarcopenia. while current tests of muscle power/function (e.g., chair-rising, self-selected gait velocity, etc.) do correlate with functional limitation in older adults, these existing tests have limitations in that they cannot be performed in all people, may have "yes/no" results rather than a continuous scale and may not be highly precise. thus, improved muscle function assessment tools are needed, both clinically and in research venues. jumping mechanography is very likely one such methodology.


Eligibility criteria:
inclusion criteria: * ambulatory, community dwelling men and women age ≥ 70 years * able and willing to sign informed consent * able to stand without assistance exclusion criteria: * abnormalities on screening laboratory assessment deemed to be clinically significant by the study investigators * history of myocardial infarction within the prior six months or ongoing angina * history of injury or surgery within the prior six months which limits the ability to ambulate * history of severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study * history of malignancy with metastasis to the musculoskeletal system * neuromuscular disease impairing balance to the degree of not being able to stand without assistance * bmd t-score of less than -3.5 at any measured site and a prior hip or vertebral fracture
a study of the use of high-dose proton pump inhibitor for the treatment of gastro-oesophageal reflux related non-cardiac chest pain - a randomized double-blind placebo-controlled study

Conditions: Chest Pain

Summary: non-cardiac chest pain accounts for 2-5% of all emergency presentations. in the united states, it has been estimated approximately that us$8 billion was spent annually for the initial care of patients suspected to have an acute coronary syndrome, but who were subsequently found not to have coronary artery disease (1). the most common cause of non-cardiac chest pain is gastro-oesophageal reflux disease (2). two randomized, double-blind, placebo-controlled trials on the use of omeprazole versus placebo for the treatment of nccp have been published in the western population and reported an efficacy of 62% to 80% (3,4). high-dose omeprazole was used in the previous trials (3,4). recently, it has been shown that rabeprazole, which is a newly developed benzimidazole proton pump inhibitor, is a more potent and rapid inhibitor of h+,k+-atpase and acid secretion than omeprazole, lansoprazole and pantoprazole (5,6). whether the above findings applied to chinese population is unknown. thus we would like to propose a randomized double-blind placebo-controlled trial to study the effects of high-dose proton pump inhibitor for the treatment of non-cardiac chest pain in chinese population. the aim of this study is to evaluate the efficacy of high-dose proton pump inhibitor for the treatment of gastro-oesophageal reflux related non-cardiac chest pain.


Eligibility criteria:
inclusion criteria: * ambulatory patients with age over 18 years old * patients with chest pain for at least 12 weeks, in the preceding 12 months who are evaluated by cardiac catheterization or exercise radionuclide scan / persantin radionuclide scan will be assessed for suitability to enter the study. patients will be included if the results of the cardiac investigation are normal. exclusion criteria: * patients with history of significant cardiac, renal, pulmonary or hepatic diseases. * patients with history of gastrointestinal surgery or peptic ulcer diseases. * intake of h2 receptor blockers, bismuth or proton pump inhibitors or drugs affecting gastrointestinal motility in the preceding four weeks. * patients who are pregnant or lactating. * patients who are suffering from costochrondritis. * patients who are known to be sensitive to proton pump inhibitor. * patients with glaucoma and benign prostatic hypertrophy.

Keywords: non-cardiac chest pain
ketamine versus fentanyl for induction of anesthesia in septic shock

Conditions: Septic Shock

Summary: the aim of this work is to compare two protocols (ketamine-midazolam versus fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find the most safe protocol with regards to hemodynamic status of patients

induction of anesthesia in hemodynamically compromised patients is a challenge for every anesthetist. most of the intravenous induction agents have a negative effect on arterial blood pressure and cardiac output. theoretically, the "ideal" emergency induction intravenous anesthetic should achieve rapid hypnosis and maintain the hemodynamic stability. ketamine has been reported as an induction anesthetic with a sympathomimetic activity. in patients with intact autonomic nervous system ketamine increases heart rate, cardiac output, and arterial blood pressure (abp). despite its sympathomimetic activity in hemodynamically stable patients, the hemodynamic response to ketamine in unstable cardiovascular conditions is not clear. no studies to the best of our knowledge compared ketamine-based and opioid-based protocols in rapid sequence induction of anesthesia in hemodynamically unstable patients. in this study, patients with severe sepsis or septic shock scheduled for surgery will be assigned to receive either ketamine or fentanyl for induction of anesthesia. after induction of anesthesia, endotracheal tube will be inserted aided by succinyl choline. invasive blood pressure will be monitored through a transducer connected to arterial catheter. electrical velocimetry (cardiometry) device will be used for non-invasive monitoring of cardiac output and stroke volume.

Eligibility criteria:
inclusion criteria: * sepsis patients * with shock index (heart rate divided by systolic blood pressure) \>0.7. or sepsis patients with norepinephrine infusion. exclusion criteria: * traumatic brain injury * cerebrovascular disorders