Kornimate/medical-research-clean huggingface dataset:
clinical trial to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (15µg/0.5ml)

Conditions: Seasonal Influenza

Summary: the purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years

this study is a phase i\& iii clinical trial. phase i is open-labelled, and phase iii is randomized, double-blind, active-controlled. the purpose of this study is to evaluate the safety and immunogenicity of the quadrivalent influenza vaccine (qiv) (experimental vaccine) manufactured by sinovac biotech co., ltd in subjects aged over 3 years. in phase i, 60 volunteers received single dose qiv (15µg/0.5ml). in phase iii, 2320 volunteers were assigned to receive single dose qiv (15µg/0.5ml) or two commercial trivalent influenza vaccines (tivs) (15µg/0.5ml) in a ratio of 2:1:1. the commercial tivs were also manufactured by sinovac biotech co., ltd.

Eligibility criteria:
inclusion criteria: * healthy volunteers aged ≥3 years; * proven legal identity; * participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment; exclusion criteria: * prior vaccination with influenza vaccine of the current year; * history of influenza within 6 months prior to study entry; * axillary temperature \> 37.0 °c; * history of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.; * serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.; * severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness; * autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry; * history of asthma, thyroidectomy, angioedema, diabetes or malignancy; * no spleen, or functional no spleen, or splenectomy.

Keywords: influenza vaccine quadrivalent trivalent
piloting visual chat in internet obesity treatment

Conditions: Obesity

Summary: chat is an internet-based weight loss research program designed for women with overweight or obesity who want to lose weight through dietary change and increased physical activity. participants will be randomized into a group-based online program who meet via a text chat or a video chat.

the overall goal of this project is to determine whether weight losses can be improved if visual chat and electronic smart scales are added to an established 6-month online weight loss program. the primary aim is to assess weight change differences between subjects randomized to receive an internet program alone (with text chat; internet) vs. an internet program with visual chat and electronic scales (video internet). a secondary aim is to evaluate differences in social support experienced by subjects in both conditions. overweight and obese adults (n=40) at two study sites (uvm and the university of south carolina) will be randomly assigned to internet (n=20) or video internet (n=20). all participants will receive the same 24 week web-based group weight control program which features synchronous facilitated chats and online behavioral tools. the only difference will be the delivery of the chat (text vs. visual) and the electronic smart scales given to the video internet group. assessments will be conducted at 0, 2 and 6 months and will include measures of body weight, treatment engagement (e.g., attendance, self-monitoring, website utilization), social support and treatment satisfaction.

Eligibility criteria:
inclusion criteria: * 18 years old * bmi between 25 and 55 * free of medical problems that would preclude participation in a behavioral weight reduction program containing an exercise component * not currently pregnant or pregnant in the previous 6 months or breastfeeding * must have a computer at home or work with access to the internet * only one member of a household is eligible to participate * must successfully complete a self-monitoring diary of foods consumed for 3 days * must be willing to share access to self monitoring information collected via my fitness pal by friending the chat research team * not currently on medication that might affect weight loss * not enrolled in another weight loss program exclusion criteria: * bmi less than 25 or more than 55 * lost 10 pounds or more in the last 6 months * had a heart attack or stroke in the past 6 months * ever had weight loss surgery * currently taking medications for weight loss * persons required by their doctor to follow a special diet (other than low fat) * plans to move from the area in the upcoming 9 months * schedules that make it likely someone would have difficulty attending the scheduled chat groups

Keywords: internet behavioral weight loss obesity
local drug delivery of aloe vera gel in chronic periodontitis

Conditions: Periodontitis

Summary: background: aloe vera is considered to be the most promising and high-ranking agent as an all-purpose herbal plant amongst herbal agents used in dentistry. this study was designed to evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

background: aloe vera is considered to be the most promising and high-ranking agent as an all-purpose herbal plant amongst herbal agents used in dentistry. this study was designed to evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis. methods: twelve subjects diagnosed with chronic generalized periodontitis were selected and randomly divided into two groups: test group which received scaling and root planning (srp) followed by application of aloe vera gel as a local drug delivery agent in the deepest periodontal pocket and control group which received srp alone. clinical evaluation was undertaken using plaque index (pi), gingival index (gi), probing pocket depth (ppd), relative attachment level (ral) and gingival marginal level (gml) and microbiologic counts (total colony count/ml) were assessed at baseline, 6 weeks and 3 months.

Eligibility criteria:
inclusion criteria: * inclusion in this study was based on the following criteria: 1. patients with age group between 30 - 60 years from both sexes. 2. chronic periodontitis patients with at least 1 pair of periodontal pocket ≥ 5mm in contra-lateral quadrants. exclusion criteria: * exclusion criteria were: 1. subjects who have received antibiotic treatment in the preceding 6 months. 2. patients with history of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any herbal products.
serum ykl-40 level and platelets indices among patients with diabetic erectile dysfunction

Conditions: Erectile Dysfunction; Erectile Dysfunction With Diabetes Mellitus

Summary: the aim of this current study is to estimate serum level of ykl-40, serum total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3 months.


Eligibility criteria:
inclusion criteria: * diabetic patients with ed. exclusion criteria: * patients with history of pelvic trauma. * patients with major pelvic surgical intervention. * patients with hypogonadism and hyperprolactinemia. * patients with chronic liver disease. * patients with cardio vascular system diseases. * history of chronic intake of central nervous system, anti androgen drugs or other drugs as tramadol. * smokers patients. * patients with non-vasculogenic erectile dysfunction.
study on disease characteristics and treatment in locally advanced or recurrent / metastatic cervical cancer in italy

Conditions: Cervical Cancer; Locally Advanced Cervical Cancer; Recurrent Cervical Cancer; Metastatic Cervical Cancer

Summary: multicenter, observational, retrospective charts review. observational study with descriptive purpose only. retrospective data capture in consecutive patients diagnosed with cc who attended the oncologic clinics from jan 2018 to dec 2021 (using medical records, either electronic or not), inserted in ecrf and analyzed.

this is a multicenter, observational, retrospective study. the primary aim of this trial is to describe patients and disease characteristics, as well as treatment pattern of locally advanced and recurrent/metastatic cervical cancer (r/m and lacc) in italy, through a retrospective data capture, from january 2018 to december 2021. eligible cervical cancer patients will be identified by reviewing medical records and physician notes (paper or electronic). disease will be defined as follow: * locally advanced cervical cancer: a large tumour within the cervix (more than 4cm) or it has grown into the tissues around the cervix, but the cancer has not spread to other organs; usually includes stage 2b, 3 and 4a (figo staging) * recurrent cervical cancer: local tumour regrowth or development of distant metastasis discovered 6 months or more after complete regression of the treatment (26) * metastatic cervical cancer: cancer spreads beyond the pelvis to other parts of the body; usually defined as stage 4b (figo staging) moreover, the patients' characteristics will be stratified as low risk and high risk for locally advanced cervical cancer and differences between their treatment partners will be reported.

Eligibility criteria:
inclusion criteria: * patient (or their legally acceptable representatives) must have signed and dated the informed consent \& privacy form (icf) * age ≥18 years * diagnosis of a cervical cancer * locally advanced stage (not suitable for curative surgery) or recurrent or metastatic disease * any treatment received between january 2018 and december 2021 for advanced disease exclusion criteria: * patients participating in a pharmacological clinical trial for the treatment of advanced disease * patients who participated in a clinical trial * patients who were administered with pembrolizumab, olaparib or levantinib or medications from these class of drugs
a 16 week study to evaluate the efficacy and safety of pf-06882961 in adults with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (pk) of multiple dose levels of pf-06882961 in adults with type 2 diabetes mellitus (t2dm) inadequately controlled on metformin and/or diet and exercise. in addition, the study is intended to enable selection of efficacious doses for future clinical development of pf-06882961.


Eligibility criteria:
inclusion criteria: * patients with t2dm who are treated with metformin and/or diet and exercise * hba1c greater than or equal to 7% and less than or equal to 10.5% * total body weight \>50 kg (110 lb) with bmi 24.5 to 45.4 kg/m\^2 exclusion criteria: * any condition possibly affecting drug absorption * diagnosis of type 1 diabetes * history of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening * any malignancy not considered cured * personal or family history of mtc or men2, or participants with suspected mtc * acute pancreatitis or history of chronic pancreatitis * symptomatic gallbladder disease * known medical history of active proliferative retinopathy and/or macular edema * known medical history of active liver disease, including chronic active hepatitis b or c, or primary biliary cirrhosis * known history of hiv * supine blood pressure greater than or equal to 160 mmhg (systolic) or greater than or equal to 100 mmhg (diastolic) * clinically relevant ecg abnormalities * positive urine drug test
endostar continued pumping into vein combining with gemcitabine-carboplatin to treat non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine whether endostar with gemcitabine-carboplatin are more effective than gemcitabine-carboplatin alone in the treatment of non-small cell lung cancer (nsclc),and about endostar ,compared with intravenous, continued vein-pumping maby is a more effective way.

endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. this study was designed to evaluate the safety and efficacy of endostar continued vein-pumping combining with gemcitabine-carboplatin (gc)chemotherapy in patients with nsclc,and seeking for more effective injection. methods: in this randomized, open label, 90 patients are planned to be enrolled at random into 3 arms(1:1:1): experimental: endostar -continued pumping into+gemcitabine-carboplatin(gc),active comparator: endostar -injecting into +gemcitabine-carboplatin(gc),active comparator: gemcitabine-carboplatin(gc),

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically diagnosed nsclc; 2. primary treatment,inoperable stage iii/iv nsclc; 3. age of 18-70years; gender not required; 4. adequate hematologic, renal, and hepatic function ,specific index as follows: liver function: s-bilirubin ≤1.5 uln ; transaminase≤2 uln. renal function: s-creatinine ≤1.2 uln; blood urea nitrogen ≤1.2 uln . uln: upper normal limit. marrow hemopoietic function: wbc≥4.0×10\^9/l, anc≥2.0×10\^9/l platelet count ≥100×10\^9/l, hb≥100 g/l; 5. ecog ps 0-2,life expectancy ≥ 3 months; endure more than two cycle chemotherapy; 6. the patients have explicit lung tumor lesions and the lesions were measurable; (according to the standard of recist1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral ct, mri); 7. no history of serious drug allergy; 8. informed consent should be obtained before treatment. exclusion criteria: 1. symptomatic brain metastases with cognitive disorder,bone metastases with complications; 2. major organ dysfunction and serious heart disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and resistant hypertension,); 3. serious complications and investigator consider it is unsuited enrolling; 4. pregnant or lactating women; 5. allergic to research drug; 6. participating in other experimental trials and receive the treatment in four weeks; 7. the position that is for observing curative effect have a radiotherapy.

Keywords: non-small cell lung cancer endostar continued pumping into gemcitabine carboplatin
high-field mr imaging in migraine, visual snow and epilepsy

Conditions: Migraine; Epilepsy; Visual Snow Syndrome

Summary: in this project, the aim is to recruit patients with drug resistant epilepsy and those suffering from migraine. interestingly, patients suffering from epilepsy are also more often reporting to suffer from migraine. the pathobiology is understudied, but it is believed that both etiologies results from brain networks changes. a clinical certified 7t terra siemens scanner will be employed to assess in all participants (including healthy controls) how the microstructure differs in disease specific areas. patients will further be clinically assessed as well as undergo questionnaires. migraine is also a common comorbidity to visual snow syndrom and has been shown to impact similar brain regions. however, the pathophysiology is still understudied and a better understanding of the two diseases is needed.


Eligibility criteria:
inclusion criteria: patients: * patient must be able to read and sign the informed consent form * stable prophylactic medication for 2 months prior to mri * at leat one of the two criteria applies: * patients diagnosed with migraine (with or without aura, episodic or chronic). diagnosis is ensured by clinical interview (at least 8 weeks prior to mri). also, patients complete a migraine questionnaire (hardship) (at least 8 weeks before mri). migraine frequency ≥ 2 migraine attacks/month. * patients with drug resistent epilepsy accroding to ilae crtieria * patients with diagnoses of visual snow syndrome healthy participants; * no migraine (validated by questionnaire) or epilepsy * participants must be able to read and sign the informed consent form exclusion criteria: * treatment of migraine disease with botox within \< 4 months before baseline and during the study period * pregnant or breastfeeding women * intention during the course of the trial to become pregnant * women with bilateral ovariectomy, with or without hysterectomy, and postmenopausal women (\>2 years of age) are not considered childbearing. * other clinically significant comorbidities (e.g., renal insufficiency, hepatic dysfunction, cardiovascular disease, etc.), * known or suspected noncompliance with the protocol, drug or alcohol abuse, * patient's inability to follow trial procedures, e.g., due to language problems, mental illness, dementia, etc., * prior participation in the clinical trial * enrolment of the investigator, his/ her family members, employees and other dependent persons of the test personnel * metallic objects in the body (e.g., splinters, mr incompatible implants). * pacemaker * claustrophobia * obesity (body mass index \> 35 kg/m2)
study of gemcitabine and concurrent radiation followed by adjuvant hysterectomy in bulky stage ib and iia cervical carcinoma

Conditions: Uterine Cervical Cancer

Summary: the purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. in addition, the investigators want to determine the side effects and the effectiveness of this combination. the investigators will also study several markers to try to identify markers or tests that will predict which patients will benefit more from this treatment.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed bulky stage ib or stage iia cervical cancer. bulky stage ib disease is defined as tumor mass greater than 4 cms in diameter. * cervical lesion which is measurable by physical examination. * no prior therapy for invasive cervical cancer. * gog performance status 0-2 * signed informed consent * patients must have adequate: * bone marrow function: absolute granulocyte count \> or = to 1500, platelet count \> 100,000. * renal function: creatinine \< or = to 1.8 mg/dl * hepatic function: bilirubin \< or = to 1.5 x normal, sgot and alkaline phosphatase \< or = to 3 x normal exclusion criteria: * patients with a history of prior malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or other cancer for which the patient has been disease free for at least five years. * pregnant or lactating women. women of reproductive age may not participate unless they have agreed to use an effective method of birth control. * patients with uncontrolled infection. * patients who are hiv positive * patients with psychiatric or social conditions that would interfere with consent or follow-up. * patients with any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Keywords: cervical carcinoma
ketoprofen lysine salt as mouthwash in acute phlogosis of the pharyngeal cavity versus benzidamine hydrochloride

Conditions: Pharyngitis

Summary: a study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis


Eligibility criteria:
inclusion criteria: * male and female outpatients, aged 18 to 70 years, suffering from acute pharyngitis, pharyngolaryngitis * moderately or severely intense pain in the pharyngeal region (score ≥ 70 mm) from the "visual analogue scale" (vas) * at least 1 of the 2 inflammation signs (edema and hyperemia) to be moderately or severely intense (score ≥ 2) from the scoring scale from 0 to 3 * release of written informed consent by the patient exclusion criteria: * patients suffering from a microbial infection requiring specific antimicrobial treatment * patients who have taken the trial drugs during the week before enrolment * patients who have taken corticosteroids or antibiotics during the week before enrolment * ascertained or suspected hypersensitivity to trial drugs or to chemically correlated drugs or to other non-steroidal anti-inflammatory drugs or to mouthwashes in general * patients who are unable to properly fill in the diary every day as provided for by the protocol * ascertained or presumed pregnant or lactating women * inclusion in any other clinical trial during the study
trial evaluating the efficacy of a chlorhexidine-impregnated sponge (biopatch®) to reduce catheter-related bloodstream infections in hemodialysis patients

Conditions: Catheter Related Bloodstream Infection

Summary: there are currently no published data on the efficacy of the chlorhexidine-impregnated foam dressing to reduce catheter-related bloodstream infections (bsi) in hemodialysis patients. the researchers perfomed a cross-over intervention trial on patients who were dialyzed through central venous catheters at two outpatient dialysis centers were enrolled. the use of a chlorhexidine-impregnated foam dressing was incorporated into the catheter care protocol during the intervention period. a nested cohort study of all patients who received the foam dressing was also conducted to determine independent risk factors for development of bsi. the primary outcomes were the catheter-related bloodstream infection rates in the intervention and control groups. secondary outcomes include the clinical sepsis rates between the two groups and risk factors for development of bloodstream infection despite the use of the foam dressing.


Eligibility criteria:
inclusion criteria: * all patients who were dialyzed through a central venous catheter during the time period exclusion criteria: * patients who were allergic to chlorhexidine

Keywords: bloodstream infections hemodialysis catheter