Kornimate/medical-research-clean huggingface dataset:
study to evaluate the response rate to the licensed pneumovax 23™ in elderly population.

Conditions: Streptococcus Pneumoniae Vaccines

Summary: streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of humans. however, these bacteria can also cause severe infectious diseases such as pneumonia, septicemia and meningitis. elderly subjects are especially vulnerable to these infections, and the diseases can result in death. the currently available licensed streptococcus pneumoniae vaccine is recommended for prevention of pneumococcal diseases in individuals over the age of 65. however, the antibody level elicited by this vaccine, is not always satisfactory in elderly people. to overcome the problem, glaxosmithkline biologicals is currently developing candidate vaccines that are hoped to work better than the currently available vaccines. as a first step in this development, the present study is being conducted in order to evaluate the immune response to the currently marketed vaccine.

since influenza vaccination is recommended in the age range of the study population, fluarix™ (glaxosmithkline biologicals) vaccine will be offered free of charge for the study period (3 consecutive years), to be used by investigators according to national vaccination schedule/practice. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007

Eligibility criteria:
inclusion criteria * subjects who the investigator believes will comply with the requirements of the protocol. * a male or female \>= 65 years at the time of the first vaccination. * written informed consent obtained from the subject. exclusion criteria * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study. * previous vaccination against streptococcus pneumoniae. * history of administration of an experimental vaccine containing mpl or qs21. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * planned administration of a vaccine not foreseen by the study protocol within 2 weeks before and after first dose of vaccines, excluding influenza vaccine which can be administered at any time, including co-administration with pneumovax23™. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * current serious neurologic or mental disorders. * inflammatory processes such as known chronic active infections (e.g.hep b, c). * all malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. * acute disease at the time of enrolment. * chronic disease that might preclude participation to the whole study.

Keywords: prophylaxis invasive pneumococcal diseases and pneumonia
evaluation of salivary gal-7, gal-10 and mmp-9 levels of individuals with different periodontal diseases

Conditions: Periodontal Diseases

Summary: the aim of this study is; detection of galectin-10, galectin-7, mmp-9 levels in saliva samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. materials and methods: samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (p, n=20), gingivitis(g, n=20) and healthy periodontium (s, n=20). full-mouth clinical periodontal measurements including probing depth (pd), clinical attachment level (cal), bleeding on probing (bop), gingival index (gi) and plaque index (pi) were also recorded. enzyme-linked immunosorbent assay (elisa) was used to determine galectin-10, galectin-7 and mmp-9 levels in the biological samples.


Eligibility criteria:
inclusion criteria: * systemically healthy (the determination of healthy volunteers will be based on the statements of the patients in the anamnesis. no additional examinations will be made.) * at least twenty permanent teeth in the mouth * non-smoker * no medication for continuous use * those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months. * not in pregnancy or lactation period. * for the periodontitis group that has not received periodontal treatment in the last 6 months * for the periodontitis group; according to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss * for the gingivitis group; according to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss * for healthy group; according to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study. exclusion criteria: * any oral or systemic disease * regularly using a systemic medication * during pregnancy or lactation * received periodontal treatment within the last 6 months. * those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months * smokers are not included in the study
a clinical trial to evaluate the efficacy and safety of co-administration of dwc202206 and dwc202207 in patients with concomitant hypertension and hyperlipidemia

Conditions: Hypertension; Hyperlipidemias

Summary: this study aims to evaluate the efficacy and safety of co-administration of dwc202206 and dwc202207 in patients with concomitant hypertension and hyperlipidemia.

the study design is a randomized, double-blind, multicenter clinical trial. the patients were randomly assigned to each group. primary endpoint was the change of mssbp based on baseline between treatment arm and control 1 arm and the change of ldl-c based on baseline between arm and control 2 arm.

Eligibility criteria:
inclusion criteria: * age 19 to 80 years * patients with hypertension and hyperlipidemias exclusion criteria: * orthostatic hypotension * history of ventricular tachycardia, atrial fibrillation * uncontrolled diabetes mellitus
probiotics for the prevention of antibiotics associated diarrhoea and clostridium difficile associated diarrhoea

Conditions: Diarrhoea

Summary: the investigators aim to investigate whether the routine use of the probiotic formulation vsl#3 co-prescribed with antibiotics reduces the incidence of both antibiotic associated diarrhoea and clostridium difficile associated diarrhoea.

the investigators aim to find out whether vsl#3 can prevent antibiotic associated diarrhoea and clostridium difficile associated diarrhoea when vsl#3 is giving during a course of systemic antibiotics. patients will be randomized in a 1:1 proportion to receive either one sachet of vsl#3 or a similar looking placebo twice a day. this will be given for the length of the antibiotic course and another week thereafter. follow-up will last until 28 days after the last antibiotic dose. patient restarted on antibiotics during follow-up will be restarted on the trial medication and the 28 day follow-up will be recommenced. this trial has 2 co-primary outcome measures.

Eligibility criteria:
inclusion criteria: * adults aged 18 or older * hospital inpatients * on systemic antibiotics for an infection * antibiotics started within last 48 hours exclusion criteria: * diarrhoea at screening * unable to take enteral meds * patients on intensive care units * severe immunosuppression (neutropenia, aids, congenital immunoparesis, chemotherapy) * risk of endocarditis (artificial heart valves, history of rheumatic heart disease or infective endocarditis) * regular consumption of probiotics until 1 week prior to admission * acute severe pancreatitis persistent vomiting (two days or more)

Keywords: clostridium difficile associated diarrhoea antibiotic associated diarrhoea
use of a reinforced injectable calcium phosphate bone cement in the treatment of tibial plateau fractures

Conditions: Tibial Fractures

Summary: case series of tibial plateau fractures using norian drillable.

this study is a multi-center, non-randomized prospective case series of tibial plateau fractures using norian drillable to fill bone voids, to evaluate or time, blood loss, complications, ease of use, fracture stabilization and patient function and pain over time.

Eligibility criteria:
inclusion criteria: * subjects with closed tibial plateau fractures classified as ota b2, b3 or c3 resulting in a bone void. * at least 18 years of age. * psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms. * signed informed consent. exclusion criteria: * critically ill * mentally ill or mentally disordered * wards of the state * prisoners * refugees * in an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates * active or suspected infection - systemic or local * gustillo classification of 2 or 3 * bilateral tibial plateau fractures when both fracture patterns extend into the joint * have an existing calcium metabolism disorder (e.g. hypercalcemia) * chronic renal disease/renal failure * insulin dependent diabetes * taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids). * rheumatoid arthritis or other autoimmune disease. * systemic disease including aids, hiv, hepatitis. * active malignancy: a patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years. * subjects involved in other studies within the last month, prior to screening. * pregnant or interested in becoming pregnant in the next 18 months. females of child-bearing potential must use an acceptable method of contraception during trial participation.

Keywords: tibial plateau fracture orthopaedic trauma association (ota) b2 b3 c3 bone void
hairmax lasercomb open label study to treat seborrheic dermatitis

Conditions: Seborrheic Dermatitis

Summary: the purpose of this study is to test whether the stimulation of vascularization and cellular metabolism on the scalp by use of the hairmax lasercomb will produce improvement in the condition of scalp seborrheic dermatitis.

this is an open label pilot study to evaluate the effects of the low-level laser light on seborrheic dermatitis of the scalp. dandruff assessment scores for scalps with seborrheic dermatitis will be assessed at baseline with monthly evaluations during treatment, until final assessment at end of treatment at week 12. the trial will involve 10 patients aged 18 years and older with a diagnosis of seborrheic dermatitis. patients will use the lasercomb device three times per week on non-consecutive days for 12 weeks. no other seborrheic dermatitis products will be used during treatment. the investigator will conduct measurements of dandruff at each study visit, as a measure of efficacy. the trial consists of 4-5 study visits (screening/baseline, week 4, week 8 and week 12). dandruff evaluation and adverse event assessments will be performed at each visit. safety analysis will be assessed based on the reports of adverse events during the study.

Eligibility criteria:
inclusion criteria: * diagnosis of seborrheic dermatitis of the scalp * pga of 2 (mild) or greater at baseline * tdss score at baseline of 2 or greater, for both scaling and inflammation * must agree to use of non-medicated shampoos during study period; must refrain from use of other medicated scalp products during the trial exclusion criteria: * use of any topical or oral products that would affect assessment of the scalp sd condition, in the opinion of the primary investigator, within the following periods prior to baseline: * medicated shampoos within 2 weeks of baseline * topical scalp medications within 2 weeks of baseline * oral medications affecting the scalp within 4 weeks of baseline * other medications determined by the investigator to potentially affect the assessment of sd = washout to be determined by the investigator, as appropriate to the known medication properties * any current or past medical condition, including active dermatitis or any other dermatological condition, which might interfere with assessment of dandruff * patients using any medications that may increase photosensitivity, and thus pose a risk when undergoing lasercomb therapy * patients with known adverse reactions, allergy or hypersensitivity to laser light components/light sensitivity conditions * patients who have received any investigational drug within 30 days prior to study entry.

Keywords: seborrheic dermatitis
continuation of metformin to improve and keep peri-operative glycemic control

Conditions: Diabetes Mellitus Type 2

Summary: type ii diabetes mellitus patients having surgery who adhere to their regular scheduled metformin dosing and take this medication on the morning of surgery will have better glycemic control peri-operatively and potentially suffer less morbidity compared to individuals taking a placebo.

peri-operative hyperglycemia has been linked to numerous negative adverse consequences, including wound infection, impaired wound healing, endothelial dysfunction, neurocognitive dysfunction, sepsis, prolonged hospital stay and increased mortality. this has been shown in numerous studies as outlined in our detailed research proposal. the peri-operative period includes a timeframe ranging from 12 to 72 hours around the time of surgery according to definition. our study is examining glycemic control in the peri-operative period which we are defining as approximately 48 hours around the time of surgery. the majority of the patients with type ii diabetes take oral medications, such as metformin, to control their blood sugar. these patients have historically held their doses on the day of the surgery to avoid possible low blood sugar and lactic acidosis while fasting. however, numerous recent studies have shown that individuals who are fasting without renal, heart and liver failure are safe to take metformin. the most recent guidelines from the american diabetes association suggest that patients should take their dose of metformin on the day of surgery. despite these recommendations most anesthesiologists continue to withhold metformin on the day of surgery, as no studies exist to show the benefit of continuing metformin. if we are able to show that patients taken metformin have better glycemic control during this time we can extrapolate that result mean they may have a lower incidence of the consequences linked to poor glycemic control.

Eligibility criteria:
inclusion criteria: * ages 18 - 75, using metformin for control of type ii diabetes mellitus, american society of anesthesiologists(asa) i, ii and iii, informed consent, surgery in which less than 1000 ml of blood loss is expected. exclusion criteria: * renal failure, liver failure, congestive heart failure (chf), previous episodes of hypoglycemia, conditions which mask symptoms of hypoglycemia (autonomic neuropathy or chronic high dose beta-blocker usage), low capillary blood sugar (cbg) (≤4.0 mmol/l) at pre-operative appointment date, same day surgery, any patient who received contrast dye within 2 days of the planned surgery or requires intra-operative contrast dye and same day surgery.

Keywords: type 2 diabetes mellitus, metformin, peri-operative
the safety and efficacy of topical idp-108 versus vehicle in patients with onychomycosis

Conditions: Onychomycosis

Summary: the purpose of this study is to evaluate the safety and efficacy of topical application of idp-108 versus vehicle in treating patients with onychomycosis.


Eligibility criteria:
inclusion criteria: * clinically diagnosed onychomycosis of the target nail * presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected * has a positive koh examination from the target nail * has a positive dermatophyte culture from the target nail exclusion criteria: * presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug * use of any systemic antifungal therapy within 4 weeks prior to the screening visit or non-responsive to systemic antifungal therapy for onychomycosis * use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the screening visit * woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
safety, tolerability and pk/pd of jmt103 in patients with bone metastases from tumors

Conditions: Bone Metastases

Summary: jmt103 is a novel, full human igg4 monoclonal antibody targeting rankl. in preclinical studies, jmt103 demonstrated strong activity through blocking rankl receptor, rank on the surface of osteoclasts, leading to inhibit osteoclast differentiation, activation, and maturation and reduce bone resorption. this first-in-human study is conducted to assess the maximum tolerated dose (mtd) and dose-limiting toxicity (dlt) ,to evaluate the safety, pharmacokinetics and preliminary efficacy (bone turnover markers) of recombinant fully human anti-rankl monoclonal antibody (jmt103) in patients with bone metastases from tumors at single doses and multiple doses. about 36 cases patients are to be recruited.

this is a phase i, first-in-human, multi-center, open-label dose escalation clinical study of recombinant fully human anti-rankl monoclonal antibody (jmt103) administered subcutaneously to patients with bone metastases from tumors. the study includes two phases: dose escalation study and expansion study. the dose-escalation stage is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and following repeat doses of jmt103 given every 4 weeks (q4w) for three times. the expansion study stage is designed to evaluate the safety, tolerability, and pharmacokinetics of repeat doses of jmt103 given every 4 weeks (q4w) for three times.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed malignant solid tumors; * imaging examination shows at least one site with bone metastases from tumors; * ecog performance status of score 0 or 1; * expected survival time ≥ 7.5 months. exclusion criteria: * previous or present osteomyelitis or osteonecrosis of the jaw; unhealed dental or oral surgery wounds; acute disease of the tooth or jaw requiring oral surgery; and invasive dental surgery planned to be received during the study; * it is planned to perform therapeutic radiotherapy or orthopedic surgery for patients during the study; * known active brain metastases or leptomeningeal metastases. the subjects with neurological symptoms should receive brain ct/mri to ensure that there have no metastases; * patients with bone metabolic diseases (paget's disease, cushing syndrome and hyperprolactinemia), rheumatoid arthritis, and current hyperparathyroidism or parathyroid dysfunction; * uncontrolled complications * active bacterial or fungal infections requiring systematic treatment within 7 days before the screening; * patients with hiv infections or active hepatitis; * pregnancy (positive serum β-hcg result) or lactation;

Keywords: jmt103 in patients with bone metastases from tumors
efficacy and safety of coenzyme q10 in the treatment of statin-associated myalgia

Conditions: Statin-associated Myalgia

Summary: statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. overall, statins are well tolerated. approximately 10% to 15% of patients report muscle aches/pain while taking statins. in a very small percentage of patients (\<0.01%; less than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle damage. in these patients, statins must be discontinued. in some reports, patients taking statins have reduced blood levels of coenzyme q10. coenzyme q10 is an essential protein which is present in all human cells needed for normal cell function. coenzyme q10 has been tested in patients with heart failure where it has been shown to be safe and effective. many patients with heart conditions take coenzyme q10, but the risks and benefits of supplementation with this product is unknown. coenzyme q10 is considered a dietary supplement and is not approved by the food and drug administration (fda) for any medical condition. coenzyme q10 has very few, if any, side effects. upset stomach (gastritis), headache, body ache, and low blood pressure have been reported. the objectives of this project are to test the efficacy and safety of coenzyme q10 in treating muscle aches/pain in patients already taking statins who develop these symptoms.


Eligibility criteria:
inclusion criteria: * patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level exclusion criteria: * women of childbearing potential * patients currently taking coenzyme q10 (or have taken in the previous 30 days) * patients receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that effect cholesterol levels or interact with statins * patients with a history of alcoholism or malnutrition * patients who have had acute coronary syndrome or muscle trauma in the prior 7 days * patients with a history of chronic muscle/joint pain, fibromyalgia, or degenerative disk disease.

Keywords: coenzyme q10 statin myalgia
liver fibrosis in patients transplanted for hepatitis c receiving either cyclosporine microemulsion or tacrolimus

Conditions: Liver Transplant; Hepatitis C

Summary: following a transplant for hepatitis c cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver. the aim of this study was to see if the frequency of liver fibrosis was different with cyclosporine microemulsion than tacrolimus


Eligibility criteria:
inclusion criteria * reason for transplant is end-stage liver disease due to hepatitis c cirrhosis * patients receiving a first liver transplant from a deceased or living donor * patients in whom biopsies will be possible exclusion criteria * recipients of a liver from an hepatitis c virus positive (hcv+), human immunodeficiency virus positive (hiv+) or hepatitis b virus positive (hbv+) donor * patients with any severe coexisting disease or suffering any unstable medical condition or co-infected with hbv or hiv * patients with co-existing alcoholic disease who have not been abstinent for at least 6 months * transplanted for liver cancer exceeding a pre-defined size * pregnant or nursing women other protocol-defined inclusion/exclusion criteria may apply

Keywords: liver transplant, adults, hepatitis c, liver fibrosis, cyclosporine microemulsion, tacrolimus