Kornimate/medical-research-clean huggingface dataset:
booster vaccination study with a pneumococcal vaccine in children primed with the same vaccine

Conditions: Infections, Streptococcal

Summary: the purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine gsk1024850a when co-administered with hiberix at 12-18 months of age, in children primed with the same vaccines in primary study nct00680914.


Eligibility criteria:
inclusion criteria: * a male or female between, and including, 12-18 months of age at the time of booster vaccination. * subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol. * subjects who received three doses of pneumococcal conjugate vaccine in study nct00680914. * written informed consent obtained from the parent(s)/guardian(s) of the child/ward. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. * administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period. * administration of any pneumococcal and/or hib vaccine since the end of study nct00680914. * planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (visit 1) and up to the follow-up visit (visit 2) with the exception of vaccines included in the korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of reactions or allergic disease likely to be exacerbated by any component of the study vaccines. * known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * tympanic or axillary/ oral temperature \>= 37.5°c or rectal temperature \>= 38.0°c. a temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject. * acute disease at the time of enrolment.

Keywords: safety pneumococcal vaccine immunogenicity pneumococcal disease booster vaccination
study of the therapeutic effect of atorvastatin on the clinical outcomes in her2 negative breast cancer patients"

Conditions: Breast Cancer

Summary: statins, a major class of drugs for treatment of hypercholesterolemia, are widely used due to a notable prevention of cardiovascular disease, and accumulating evidence proposes a promising role of statins in breast cancer

statin has lipid independent effects include inhibition of inflammatory responses, immunomodulatory actions, apoptotic and antiproliferative effects, which might contribute to the suggested anti-tumoral effects of these agents. the epidemiological evidence projecting statins as anticancer agents is variable, depending on the particular type of cancer in question as well as the class of statin used

Eligibility criteria:
inclusion criteria: 1. confirmed breast cancer any stage confirmed by radiological and pathological or by clinical evaluation undergo surgery or receiving neo/adjuvant chemotherapy treatment 2. age above 18 years 3. her2 negative core biopsy 4. adequate renal function: the calculated creatinine clearance should be ≥50 ml/min 5. patients must be accessible for treatment and follow-up 6. performance status of eastern cooperative oncology group (ecog) ≤ 2 exclusion criteria: 1. known hypersensitivity reaction to the investigational compounds or incorporated substances 2. patients who are unlikely to comply with trial requirements (eg, confusion, psychological or mood disturbances ,alcoholism, cardiac arrhythmia)
transcutaneous direct current stimulation of the spinal cord for treatment of spasticity in multiple sclerosis

Conditions: Spastic Parapareses

Summary: the current research is aimed at using transcutaneous spinal direct current stimulation (tsdcs) as complementary therapeutic tool in the treatment of spasticity in multiple sclerosis. patients will be randomized into two groups (tsdcs-anode vs. tsdcs-sham) according to the detailed protocol. main outcome will be measured by the change in walking speed using the timed 25-foot walk (t25fw). a total of 40 patients ought to be enrolled as specified in methodology. secondary outcomes will assess functional improvement through multiple sclerosis walking scale (msws) short form - 36 (sf-36), expanded disability status scale (edss) and ashworth scale.

spasticity is experienced in around 80 % of patients with multiple sclerosis resulting in quality of life impairment. transcranial direct current stimulation has been proven effective for the treatment of spasticity in patients with chronic stroke or cerebral palsy. the effect of transcutaneous spinal direct current stimulation (tsdcs) has been applied in spasticity but not in patients with spasticity due to multiple sclerosis. the study aims to assess the efficacy of anodal tsdcs on spasticity in multiple sclerosis patients through several assessment tools. the investigators hypothesize that anodal tsdcs will reduce spasticity in multiple sclerosis patients. the study will be double blind sham-controlled crossover. the patients will be examined by the described assessment tools (t25fw, msws, sf-36, ashworth, edss) before receiving tsdcs. the sessions of tsdcs will be applied 1 session per day in 5 consecutive days. assessment using the scales and questionnaires will be performed at the end of the 5 days of stimulation, 1 week after the last day of first block of sessions and 2 weeks later. the group will be crossed and another block of 5 consecutive days of stimulation will follow. assessment will take place again on first day and last day of the stimulations followed as well by assessment 1 week after the last day of second block of stimulation and 2 weeks after.

Eligibility criteria:
inclusion criteria: -patients diagnosed with multiple sclerosis according to the 2010 mc donald criteria with spasticity in the lower extremities exclusion criteria: * cardiac pacemakers * patients with prior exposure to tdcs * metallic hardware in the spine * eczema or skin abrasion at the intended site of stimulation * currently pregnant or plan for pregnancy in the next 6 months * heart or respiratory failure resulting in activity impairment * walking impairment due to orthopaedics condition such as deformity or recent fracture.
badalona major depressive disorder database study

Conditions: Major Depressive Disorder

Summary: a retrospective study using a data base of anonymized medical records. the purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (mdd) and suboptimal response to antidepressant drugs in primary care

therapeutic strategies for the management of patients with major depressive disorder (mdd) and suboptimal response to antidepressant drugs in primary care: the badalona database study

Eligibility criteria:
inclusion criteria: * an international classification of primary care (icpc-2) or dsm-iv-tr diagnosis for major depressive disorder (mdd) * at least 8 weeks of antidepressant treatment during the identification period of 01 january 2008 - 31 december 2009 * 18 months of enrollment with medical and pharmacy records after index episode date

Keywords: major depressive disorder primary care real-world evidence database
rotational stability of v4c toric implantable contact lenses after on axis implantation measured with opd scan 3

Conditions: Myopic Astigmatism

Summary: the recently introduced toric v4c toric icl (staar surgical company, monrovia, ca, usa) has been designed with a 360-µm central hole to allow aqueous humor to flow without the need for an iridotomy. as far as the investigators certain, there have been not well-established prospective studies on the role of the v4c toric icl for myopic astigmatism correction. therefore, the present study aimed to investigate the clinical outcomes and rotational stability and to analyze factors that influence the rotational stability in v4c toric icl implanted eyes prospectively.


Eligibility criteria:
inclusion criteria: * age 19-45 years * presence of myopia with a manifest refraction spherical equivalent between -5.00 and -20.00 diopters (d) * astigmatism between -0.75 and -5.00 d exclusion criteria: * previous ocular or intraocular surgery (other than icl implant) * anterior chamber depth from the endothelium \< 2.8 mm * corneal endothelial cell density \< 2000 cells/mm2 * evidence of acute or chronic corneal infection, corneal inflammation * glaucoma, amblyopia, retinal detachment, diabetic retinopathy, macular degeneration, or neuro-ophthalmic disease
burch colposuspension or transobturatuar tape (tot)

Conditions: Incontinence

Summary: stress urinary incontinence surgery combined with hysterectomy can often be applied to patients in the same session. the aim of this study was to determine which urinary incontinence surgery would be a better option for patients who would have hysterectomy. the aim of this study was to retrospectively review the data of 69 patients between the ages of 2014 and 2017 who underwent total laparoscopic hysterectomy and anti-incontinence surgery (tot and burch) for benign indications (uterine pathology) and stress urinary incontinence (sui). in addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. in addition, fsi test results of women with sexual activity were compared with iciq-ui and udi-6 interrogations related to urinary incontinence.


Eligibility criteria:
inclusion criteria: * tlh operation with benign reasons and planned, * concurrent stress describing urinary incontinence, * women between the ages of 40-65 exclusion criteria: * planned operation with malignant causes, * urinary tract infection, * medication area for incontinence

Keywords: hysterectomy anti-incontinence surgery burch tot stress incontinence
financial incentives for maintenance of weight loss

Conditions: Obesity

Summary: this study aims to evaluate the effectiveness of financial incentives in improving and maintaining weight loss.

study participants will be obese volunteers recruited from a major community-based weight loss program (weight watchers), who have lost at least 5kg during the 4-6 months prior to enrolling in the study. among these participants, the following will be assessed: 1. the effectiveness of a daily lottery-based financial incentive, relative to the control group, on weight loss and weight maintenance; 2. the effectiveness of a direct payment incentive, relative to the control group, on maintenance of weight loss; 3. assess the comparative effectiveness of lottery-based and direct payment financial incentives on weight loss and maintenance; 4. the degree to which weight loss is maintained in the intervention groups relative to usual care during the 6 months following cessation of the intervention will also be determined. during phase i, incentives will be provided to some study participants (direct payment and lottery arm) for the first 6 months and subjects will be followed for 6 more months to examine effects following cessation of incentives.

Eligibility criteria:
inclusion criteria: * adults age 30-80 * bmi between 30 and 45 prior to starting weight watchers * have a documented weight loss of at least 5kg in the past 4-6 months before enrolling * stable health exclusion criteria: * substance abuse * bulimia nervosa or related behaviors * pregnancy or breast feeding * medical contraindications to counseling about diet, physical activity, or weight reduction * unstable mental illness * screen positive for pathological gambling on the basis of the 10 item dsm-iv criteria (excluded if meets 5 or more criteria) * individuals unable to read consent forms or fill out surveys in english
hydroxychloroquine with or without azithromycin for virologic cure of covid-19

Conditions: Covid19

Summary: q-protect is a placebo controlled randomized trial (rct) to ascertain the efficacy of hydroxychloroquine (hc) alone or, in combination with azithromycin (az), in reducing viral load in patients with covid 19.

reducing viral load is potentially key to reducing viral transmission between humans. observational data suggests hc and az may reduce the viral load. in this study we will randomise ambulatory patients with covid 19 (confirmed by pcr in combination with clinical symptoms) to receive hc/az or hc/placebo or placebo for 7 days. on days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ecg recorded and physical examination performed. on days 15-20, participants will be reviewed by telephone using a semi structured questionnaire. on day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for pcr analysis. participants will be followed for 6 months via their medical records.

Eligibility criteria:
inclusion criteria: * patient is in hmc facility for low-acuity, covid-positive patients being quarantined. * positive covid test on qualitative assay used during routine care (i.e. not as part of q-protect) * age at least 18 exclusion criteria: * treating physician judges patient not appropriate for study participation for any reason * age \<18 * breastfeeding or pregnancy (patient-reported pregnancy status is sufficient) * hypersensitivity to chloroquine or hc or az * history of or known qt prolongation * ekg required before study entry and on each visit during the subject's first seven days on pro-tocol, during the time period hc is being taken * baseline qtc \>480 if qrs width normal; qtc \>510 if qrs \>120 * known g6pd deficiency, porphyria, or retinopathy (eye exam prior to study entry) * known hepatic or renal disease (or abnormality on liver or renal function testing at study day 1) * low magnesium or low potassium (by testing on day 1) * current (pre-study) therapy with antimalarial or dapsone * current (pre-study) therapy with antiviral agents (e.g. oseltamivir) * tisdale36 score exceeding 6 as tallied below (based on acc recommendations)\* * 1 point each: age\>67, female sex, or being on loop diuretic * 2 points each: serum potassium \ 449, acute myocardial infarction * 3 points each: sepsis, heart failure, qt-prolonging drugs

Keywords: covid19 qatar coronavirus hydroxychloroquine respiratory disease pandemic azithromycin viral load emergency department sars-cov-2
heart rate variability & fatty acid status: haemodialysis patients

Conditions: Chronic Kidney Disease

Summary: studies suggest that dietary omega-3 fatty acids influence the extent to which the time interval between each heart beat varies (heart rate variability; hrv). low hrv is associated with increased risk of sudden cardiac death (scd). the purpose of this research is to investigate the relationship between 24 hour parameters of hrv and blood omega-3 fatty acid levels in patients who have recently commenced haemodialysis.


Eligibility criteria:
inclusion criteria: * ckd stage 5 commencing haemodialysis, * male or female, * aged 40-80 y, * written informed consent exclusion criteria: * history of chronic liver disease or neuropathy, infection or antibiotics within the last month.

Keywords: haemodialysis heart rate variability n-3 pufa
sonographic measurement of bladder wall thickness in patients with neurogenic bladder dysfunction

Conditions: Spinal Cord Injury

Summary: video-urodynamic investigations are regarded as the current standard diagnostics for neurogenic bladder dysfunction in patients with spinal cord injury. this examination is exact, but time consuming, costly and associated with the risk of urinary tract infection. in patients with lower urinary tract symptoms due to benign prostate hyperplasia, sonographic measurement of bladder wall thickness has been demonstrated to be able to replace urodynamic testing for the diagnosis of infravesical obstruction. hypothesis: measurement of bladder wall thickness in patients with neurogenic bladder dysfunction due to spinal cord injury is closely related to the known risk factors for upper urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group of patients and can therefore replace urodynamic examination in selected cases.


Eligibility criteria:
inclusion criteria: * neurogenic bladder dysfunction due to spinal cord injury * ability to understand german language * willingness and capability to undergo urodynamic testing * age \> or = 18 years exclusion criteria: * acute urinary infection at the time of examination * known bladder tumor or bladder stone * age \< 18 years * not capable to understand aim and purpose of the examination

Keywords: spinal cord injury urodynamics ultrasound neurogenic bladder dysfunction
adherence in patients receiving pegintron/rebetol for hepatitis c in conjunction with a psychotherapy support program (study p04252)

Conditions: Hepatitis C, Chronic; Hepacivirus

Summary: several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with pegintron plus rebetol may prompt patients to discontinue their treatment early. the goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

enrollment of participants will occur in a sequential order of treatment initiation.

Eligibility criteria:
inclusion criteria: * adult patients with hepatitis c exclusion criteria: * according to the products' labeling
novel approaches to target mecom/evi1 in aml

Conditions: AML, Adult

Summary: this is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by aml with mecom or atypical 3q26 rearrangements.

this is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by aml with mecom or atypical 3q26 rearrangements. to this end, bm samples and formalin fixed/paraffin-embedded bm biopsies will be collected at enrolment, before and after treatment, at relapse.

Eligibility criteria:
inclusion criteria: * aml with mecom or atypical 3q26 rearrangements. * age ≥18. * signed written informed consent according to ich/eu/gcp and national local laws. exclusion criteria: * none
safety and efficacy of bk1310 intramuscular injection in healthy infants

Conditions: Immunization

Summary: the purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of bk1310 in healthy infants.


Eligibility criteria:
inclusion criteria: * healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months). those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. infants who developed fever within 2 days after any previous vaccination. infants with history of convulsions. * written informed consent is obtained from a legal guardian (parent) exclusion criteria: * with past diagnosis of immunodeficiency or currently under immunosuppressive treatment * have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency * possibility of anaphylaxis due to food or pharmaceuticals * with diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents. * with experience of hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis * with experience of hib, diphteria, pertussis, tetanus or polio vaccination. * administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination * administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation * administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) * participated in other studies within 12 weeks before obtaining consent * with the gestational age \<37 weeks or weighed less than 2500 grams at birth. * considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.

Keywords: haemophilus influenza type b adsorbed diphtheria-purified pertussis-tetanus-inactivate poliovirus combined vaccine hib dpt-ipv intramuscular
health-related quality of life in patients undergoing surgery for pectus carinatum

Conditions: Pectus Carinatum; Quality of Life; Pain, Postoperative; Somatosensory Disorders

Summary: the purpose of the study is to assess changes in health-related quality of life in patients undergoing surgical correction of pectus carinatum. in addition, the study assessed long-term effects of surgical intervention in relation to the development of persistent postoperative pain and / or sensory disturbances in the surgical field.


Eligibility criteria:
inclusion criteria: * all patients undergoing surgery for pectus carinatum exclusion criteria: * patients without pectus carinatum

Keywords: pectus carinatum quality of life pain, postoperative somatosensory disorders