Kornimate/medical-research-clean huggingface dataset:
early immune responses to inactivated influenza vaccine: a pilot study

Conditions: Influenza Virus Vaccine

Summary: some people experience symptoms just after receiving the seasonal inactivated influenza vaccine. the cause of some of these symptoms is likely to be an immune response to the vaccine. the investigators would like to look at the earliest immune responses to the inactivated influenza vaccine. this pilot study will help us to determine at what time points we should look.


Eligibility criteria:
inclusion criteria: 1. age between 18-50 years. 2. good general health as a result of review of medical history and medications. 3. willingness to participate in the study as evidenced by signing informed consent document. 4. available for the duration of the trial. exclusion criteria: 1. known to be pregnant. 2. medical, behavioral, cognitive or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol. 3. severe allergy to eggs or any component of the influenza vaccine 4. previous receipt of the 2011-2012 season influenza vaccine 5. other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol. 6. history of receiving any investigational product within the past 30 days. 7. participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. 8. history of a severe allergic reaction or anaphylaxis. 9. pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, sjögren's syndrome, or autoimmune thrombocytopenia. 10. known immunodeficiency syndrome. 11. use of chronic (≥14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e. prednisone \>10 mg/ day) or immunosuppressive drugs within 30 days of starting this study. 12. receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study. 13. history of a surgical splenectomy. 14. receipt of blood products within the past 6 months. 15. refusal to allow storage of samples for future research.

Keywords: influenza vaccine cytokines chemokines symptoms
the safety and efficacy of naltrexone and scopolamine utilized in the treatment of major depression

Conditions: Depression

Summary: the purpose of this clinical trial is to determine the safety and efficacy of scopolamine utilized in conjunction with naltrexone for the treatment of major depression.

the study will be a double blinded, randomized controlled trial. the medications will be administered orally. the sample size will be 40 participants, 20 in the treatment group and 20 in the control group. the study period will be 4 weeks. eligible participants will have major depression by history for at least 8 weeks, between 18-65 years old, and in generally good health other than depression. the madrs questionaire will be utilized to determine the response to the medications.

Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 * in good health other than major depression for 8 weeks or more * negative pregnancy test * able to comply with instructions * able to provide informed consent exclusion criteria: * pregnant or lactating * danger to self or others * severe kidney or liver disease * schizophrenia * allergy to scopolamine or naltrexone * glaucoma * monoamine oxidase (mao) inhibitor use
a study to examine the safety, tolerability and pharmacokinetics of pf-02545920 in psychiatrically stable subjects with schizophrenia

Conditions: Schizophrenia

Summary: to evaluate the safety and tolerability of multiple doses of pf 02545920 administered orally to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/- other adjunctive medication.


Eligibility criteria:
inclusion criteria: * psychiatrically stable subjects with schizophrenia. * evidence of stable schizophrenia symptomatology greater than or equal to 3 months. * subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications. exclusion criteria: * history of seizures or of a condition with risk of seizures. * subjects who have had electroconvulsive therapy within the 6 months prior to randomization. * pregnant or nursing females, and females of child bearing potential.

Keywords: pf-02545920 safety schizophrenia
clinical effects of ganshuang combined tdf to treat chb and nafld

Conditions: Chronic Hepatitis B; Nonalcoholic Fatty Liver Disease

Summary: the changes in liver function, body mass index, controlled attenuation parameters, liver stiffness and hbv-dna at different time points in each group before and after treatment were counted to explore the clinical efficacy of ganshuang granules combined with tenofovir in the treatment of chb complicated with nafld.

92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. both groups of patients received conventional basic treatment such as liver protection. moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise. the control group was treated with silymarin glucosamine tablets (jiangsu zhongxing pharmaceutical co., ltd.; national medicine permission number: h32026233; production batch: 200304) and tenofovir (qilu pharmaceutical co., ltd.; national medicine permission number: h20173185; production batch: 1l0694df6). the use of silymarin glucosamine tablets was 0.2g/d, 3 times/d for 24 weeks; the use of tenofovir was 300mg/d, 1 time/d for 24 weeks. the treatment group was treated with ganshuang granules (baoding tianhao pharmaceutical co., ltd.; national medicine permission number: z20027671; production batch: 200326 ) combined with silibinin meglumine tablets and tenofovir. libribin meglumine tablets and tenofovir were used in the same way as in the control group, and ganshuang granules were used 3 g/time, 3 times/d, and the course of treatment was 24 weeks.

Eligibility criteria:
inclusion criteria: chronic hepatitis b patients not treated with antiviral drugs； fatty liver was diagnosed by b-ultrasound and imaging； no history of excessive drinking； good drug compliance and regular medication； exclusion criteria： non chronic hepatitis b patients； taking other drugs； liver failure, liver cancer and other diseases； patients who refused to sign informed consent；
comparative of sequential application of pulsed dye laser and potassium-titanyl-phosphate laser treatment for capillary malformations versus single application

Conditions: Port-Wine Stains (Capillary Malformations)

Summary: this prospective, non-randomized study aims to evaluate the efficacy and tolerability of treating port-wine stains (capillary malformations) using pulsed dye laser (pdl), potassium titanyl phosphate (ktp) laser, or a sequential combination of both. each participant will receive all three treatments on different areas of the lesion. the primary outcome is improvement measured using the investigator global assessment (iga) scale. secondary outcomes include pain (vas), local adverse events, and patient satisfaction.

port-wine stains (pws), also known as capillary malformations, are congenital vascular anomalies affecting approximately 0.3-0.5% of newborns. these lesions, often located on the face and neck, tend to darken and thicken over time, potentially leading to psychosocial distress and reduced quality of life. pulsed dye laser (pdl) therapy has long been the standard of care, utilizing selective photothermolysis to target dilated capillaries. despite its safety and effectiveness, complete clearance is achieved in only 10-20% of cases. recently, long-pulsed potassium titanyl phosphate (ktp) lasers operating at 532 nm have emerged as viable options for vascular lesions, offering greater spot sizes, variable pulse durations, and integrated cryogen cooling systems that allow deeper and more consistent energy delivery. clinical experience suggests that combining pdl and ktp treatments sequentially may enhance treatment outcomes, especially in resistant pws, yet no controlled study has directly compared this approach to either treatment in isolation. this prospective, single-center, non-randomized clinical trial aims to compare the efficacy, safety, and patient satisfaction of pdl (595 nm), ktp (532 nm), and sequential ktp followed by pdl in adults with pws. each lesion will be divided into three anatomically comparable areas, each receiving a different treatment modality. all treatments will be administered with cryogen spray cooling and without anesthesia, according to current clinical practice. the primary endpoint is improvement at 6 weeks based on the investigator global assessment (iga) scale, evaluated by three blinded dermatologists. secondary outcomes include pain during treatment (vas), adverse events at 48 hours, and patient satisfaction scores. a total of 30 patients will be enrolled to ensure adequate statistical power and account for potential dropouts. this study seeks to provide evidence supporting the optimal laser treatment strategy for pws, potentially improving clinical outcomes and guiding future protocols.

Eligibility criteria:
inclusion criteria: * age ≥18 * fitzpatrick skin types i-iv * presence of port-wine stain exclusion criteria: * open wounds in treatment area * pregnancy * nearby metal implants * photodermatoses

Keywords: port-wine stains capillar malformation laser pulsed dye laser ktp laser
dose response of dance 501 in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this will be a randomized, open-label, active-controlled, 6-period crossover study. target population will be subjects with type 2 diabetes mellitus (t2dm)

to assess the dose-response and dose-exposure of dance 501 (human insulin inhalation solution) administered with the dance 501 inhaler.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with t2dm. * bmi between 25.0 and 40.0 kg/m2. * treated with metformin and/or at least 1 daily injection of insulin for at least 6 months. * non-smoker for at least 5 years. * forced vital capacity and forced expiratory volume in one second is at least 75% normal. exclusion criteria: * any condition affecting pulmonary drug absorption. * history or presence of cancer except basal cell skin cancer or squamous cell skin cancer. * serious systemic infectious disease during four weeks prior to dosing. * clinically significant abnormal lab values. * proliferative retinopathy and/or severe neuropathy. * recurrent severe hypoglycemia. * current treatment with oral anti-diabetic drugs except metformin, glucagon-like peptide receptor agonists. * current treatment with mao inhibitors. * unstable thyroid hormones for at least 3 months. * insufficient glycemic control with significant fluctuations of blood glucose.

Keywords: inhaled insulin
tezacitabine with or without 5-fluorouracil (5-fu) for advanced esophageal cancer or gastric cancer

Conditions: Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-fu) to subjects who have advanced esophageal or gastric adenocarcinoma.


Eligibility criteria:
inclusion criteria: * males and females greater than or equal to 18 years of age. * histologically confirmed recurrent (inoperable) or metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or stomach. * at least one bidimensionally measurable lesion, not previously irradiated, with a diameter that meets recist criteria, that can be serially measured. intraluminal tumors, evaluable only by endoscopy, are not acceptable as target lesions. * karnofsky performance score greater than or equal to 70%. * subjects must be in the second line therapy setting, thus they must have experienced progression following treatment with one (and only one) prior chemotherapy regimen used for the treatment of unresectable locally advanced, recurrent, or metastatic disease. * recovery from any serious (grade 3 or higher) toxic effects of prior radiation therapy. * adequate hematologic profile: absolute neutrophil count greater than or equal to 1,500/mm3; hemoglobin greater than or equal to 9 g/dl; hematocrit greater than or equal to 30% (transfusion allowed); and platelet count greater than or equal to 100,000/mm3. * adequate hepatic function: bilirubin less than or equal to 1.5 mg/dl; ast and alt less that 2.5 x uln (5 x uln if liver involved with tumor); alkaline phosphatase less than 5 x uln * adequate renal function; serum creatinine less than or equal to 1.5 mg/dl or calculated creatinine clearance greater than 50 ml/min. * both male and female subjects of childbearing potential must be using a contraceptive method that is medically acceptable to the investigative center. * disease-free from a prior malignancy, other than non-melanoma skin cancer or carcinoma in-situ of the cervix, for greater than 5 years. exclusion criteria: * unstable angina or class iii or iv new york heart association heart disease. * cns metastases. * pregnant or breast-feeding. * uncontrolled seizure disorder. * ongoing (grade 3 or higher) stomatitis, esophagopharyngitis, or uncontrolled diarrhea. * impaired nutritional status as evidenced by a serum albumin of 2.7 mg/dl or less. * major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment. concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation.

Keywords: adenocarcinoma of the esophagus or stomach
resting full-cycle ratio in side branch

Conditions: Coronary Artery Disease

Summary: the goal of this observational study is to evaluate diagnostic performance of resting full-cycle rate (rfr) in side branch lesion. we aims to evaluate whether the diagnostic performance of rfr in the side branch lesion is non-inferior compared to that in the main vessel lesion rfr and ffr measurements will be performed to define functional significance in patients with side branch lesion with or without main vessel lesion

the presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. pressure-based functional assessment has been recommended to assess the presence of myocardial ischemia due to low accuracy of image-based assessment in intermediate coronary artery disease. selective revascularization for only ischemia-producing lesion with fractinal flow reserve(ffr) guidance proved to decrease adverse cardiac events and avoid unnecessary coronary stenting, compared to angiography-guided revascularization. therefore, current guidelines strongly recommend ffr measurement for the assessment of the functional severity of moderate stenosis of a culprit lesion in stable coronary artery disease, and non-culprit lesion in acute coronary syndrome. however, it's clinical adaption in a real world was still very low, because of the need of pressure wire and hyperemic agent. instantaneous flow ratio (ifr), which the ratio of distal coronary artery pressure to aortic pressure during wave-free period at rest, had a high diagnostic accuracy to define functional significance without need of adenosine. according to two large randomized trials, ifr-guided coronary revascularization proved to be non-inferior to ffr-guided revascularization with respect to one-year risk of major adverse cardiac events. recently, new adenosine-free index, called as a resting full-cycle ratio (rfr), which is completely independent of the ecg and irrespective of systole or diastole has been validated to detect myocardial ischemia. rfr is not limited by sensitive land marking of components of the pressure waveform unlike ifr, and is diagnostically equivalent to ifr. this novel physiologic index without need of adenosine have a potential to widely spread of functional assessment for coronary artery stenosis in daily clinical practice, and simplify procedure in complex coronary artery disease. therefore, we sought to investigate diagnostic performance of this novel physiologic index to define myocardial ischemia in coronary bifurcation lesion, which is one of complex lesion subset.

Eligibility criteria:
inclusion criteria: * patients with side branch lesion, who need functional evaluation exclusion criteria: * severe lv systolic dysfunction (lvef \<30%) * culprit vessel in acute coronary syndrome * donor vessel to supply chronic total occlusion lesion of non-target vessel * symptomatic valvular heart disease or cardiomyopathy * too much overlapping or severe tortuosity to disrupt quantitative coronary analysis * previous bypass surgery

Keywords: bifurcation lesion physiologic assessment
stannous fluoride and gingivitis

Conditions: Gingivitis

Summary: 8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). gingivitis index will be performed at bl, week 4 and week 8. a number of biological samples will be collected at each timepoint.


Eligibility criteria:
inclusion criteria: * be 18 years of age or older; * provide written informed consent and receive a signed copy of consent; * agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study; * agree not to participate in any other oral care studies for the duration of this study; * agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products; * agree to return for all scheduled visits and follow study procedures; * have at least 16 natural teeth; * be in good general health, as determined by the investigator/designee based on a review of the health history/update for participation in the study. for unhealthy group: * have at least 20 bleeding sites (sites with a score of 1 or 2 on the screening gbi exam); and * have a minimum of 3 sampling sites with bleeding and pocket depth \>/=3mm but not deeper than 4mm at the screening visit. for healthy group: * have a maximum of 3 bleeding sites (sites with a score of 1 or 2 on the screening gbi exam); and * no pockets deeper than 2mm. exclusion criteria: * self-reported pregnancy or the intent to become pregnant anytime during the course of the study; * inability to comply with study procedures; * rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment; * severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession; * fixed orthodontic appliances or attachments for aligner treatment; * having had a dental prophylaxis within 2 weeks of plaque sampling visits; * having taken antibiotics or used anti-gingivitis/anti-bacterial oral care products such as chlorhexidine or listerine within 2 weeks of plaque sampling visits; * needing an antibiotic prophylaxis prior to dental visits; * presenting with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or * having any condition or disease, as determined by the investigator/designee which could be expected to interfere with examination procedures or with the subject's safe completion of the study.
observational study of pertuzumab safety in participants with breast cancer

Conditions: Breast Cancer

Summary: this phase iv, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-human epidermal growth factor receptor 2 (her2) therapy for their metastatic disease with her2 positivity in korea. participants who are administered with pertuzumab according to medical opinions of the doctor in charge of surveillance will be registered for this study and treated with pertuzumab under the approval conditions of the product in korea.


Eligibility criteria:
inclusion criteria: * participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-her2 therapy for metastatic disease with her2 positivity * her2-positive, locally advanced, inflammatory, or early stage breast cancer (greater than \[\>\]2 centimeters \[cm\] in diameter) participants who have never received chemotherapy and surgery for breast cancer exclusion criteria: * hypersensitivity for pertuzumab (perjeta) or any of its excipients * contraindications to perjeta according to smpc * pregnancy and lactation
the safety and tolerability of budesonide foam in participants with active ulcerative proctitis or proctosigmoiditis

Conditions: Proctitis; Proctosigmoiditis

Summary: the purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (up) or ulcerative proctosigmoiditis (ups).

this is a phase 3, multicenter, open-label study in participants who previously participated in a salix-sponsored budesonide rectal foam study for the treatment of up or ups. approximately 300 participants were to be enrolled into the study and receive budesonide foam cyclically for 6 weeks (twice a day \[bid\] for 2 weeks and once daily \[qd\] for 4 weeks). the study was to continue until regulatory approval of budesonide foam occurred or the sponsor decided to terminate the study.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-breast-feeding females ≥18 years old. * participant was previously diagnosed with active mild to moderate up/ups and was currently experiencing symptoms of active up/ups disease after having completed participation in salix's bucf3001 (nct01008410) or bucf3002 (nct01008423) study. * willingness to undergo sigmoidoscopy. exclusion criteria: * active systemic, ocular, or cutaneous infection (for example, parasitic, fungal, amoebic, viral, or bacterial disease). * history of sclerosing cholangitis, cirrhosis, or hepatic impairment, including chronic hepatitis of any etiology. * participant took systemic, inhaled, oral, topical, or rectal corticosteroids (other than budesonide rectal foam) within 7 days of starting a treatment cycle. * participant took ketoconazole and other potent cyp3a4 inhibitors within 7 days of starting a treatment cycle. * participant took diuretics with cardiac glycosides. * unstable significant cardiovascular, hepatic, renal, endocrine, neurologic, or pulmonary disease.

Keywords: open-label proctitis proctosigmoiditis ulcerative salix budesonide foam budesonide rectal gastrointestinal colitis uc up ups additional relevant mesh terms: proctocolitis ulcer colitis, ulcerative gastroenteritis gastrointestinal diseases digestive system diseases rectal diseases intestinal diseases colonic diseases sigmoid diseases pathologic processes inflammatory bowel diseases bronchodilator agents autonomic agents peripheral nervous system agents physiological effects of drugs pharmacologic actions anti-asthmatic agents respiratory system agents therapeutic uses glucocorticoids hormones hormones, hormone substitutes and hormone antagonists anti-inflammatory agents