Kornimate/medical-research-clean huggingface dataset:
studying the effects of copaxone on retinal health using optical tomography over 24 months

Conditions: Multiple Sclerosis

Summary: this is a prospective, observational, single-blinded, longitudinal, 24-month oct study of the evolution of axonal loss, as evidenced by loss of rnflt and tmv, in rrms patients treated with ga and in healthy controls.

the primary aim of this study is to explore whether treatment with copaxone may decrease accumulation of axonal loss, as measured by retinal nerve fiber layer thickness (rnflt) on optical coherence tomography (oct) in patients with rrms over 24 months and compared to a reference population of healthy controls. the secondary objective of this study is to investigate the effect of ga on total macular volume (tmv) on oct in patients with rrms over 24 months. we will also explore how the 24-month changes of rnflt and tmv on oct relate to progression of disability, as measured by expanded disability status scale (edss).

Eligibility criteria:
inclusion criteria: * ms patients diagnosed with clinically definite ms according to the mcdonald criteria (polman et al., 2005) * starting ga monotherapy (20mg/day sc) at the time of the oct scan * having baseline clinical oct scan that included rnflt and tmv assessment at the start of the ga * having baseline clinical oct scan that included rnflt and tmv assessment (healthy controls) * ms patients having a rr disease course (lublin and reingold, 1996) * age 18-65 (healthy controls will be matched to ms patients for age and sex) * signed informed consent at the 24-month follow-up * none of the exclusion criteria exclusion criteria: * patients who had a relapse within 30 days prior to oct scan date * patients who received steroid treatment within 30 days prior to oct scan date * women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study * ms patients who used other imunomodulatory or immunosuppressant treatment other than ga during the follow-up (e.g., ifn-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, ivig, cellcept, natalizumab, etc.)

Keywords: oct copaxone multiple sclerosis relapsing-remitting
wearable blood pressure devices to identify masked uncontrolled hypertension.

Conditions: Hypertension,Essential; Hypertension, Masked

Summary: uncontrolled out-of-office blood pressure (bp), measured by either home bp monitoring (hbpm) or ambulatory bp monitoring, has been shown to predict higher cardiovascular risk. however, hbpm could not identify daytime bp surge, which leads to underestimation of future risk among treated hypertensive individuals. heartguide provides validated out-of-office bp measurements, along with activity/sleep recordings. the present study is designed to examine whether bp monitoring with the heartguide could identify masked uncontrolled hypertension in controlled hypertensive patients based on office bp. we will enroll hypertensive patients with controlled office bp according to their cardiovascular risk profile. we will also examine prevalence of post-prandial bp changes and bp variability using heartguide.

recent hypertension guidelines stressed the importance of out-of-office bp monitoring. ambulatory bp (abpm) and home bp monitoring (hbpm) both predict future cardiovascular events better than office bp. masked hypertension is an important issue. as revealed by recent studies, daytime bp surge can result in greater target organ damage for high-risk hypertensive individuals. previous trials such as tasminh2 and tasminh-sr study showed positive effects of hbpm on bp control in hypertensive patients. however, several issues preclude perfect applications of hbpm. for example, hbpm could not provide bp recordings during activity or at night-time. in addition, the currently recommended time schedule for hbpm may be insufficient for detecting daytime surge especially among high-risk individuals. wearable bp devices seem to fill in this gap as a novel approach of out-of-office monitoring. heartguide, the new watch bp monitor, was recently validated to provide accurate bp measurements. it could provide incremental knowledge with potentially larger numbers of recordings. the primary objective of this study is to unveil uncontrolled masked hypertension with heartguide, particularly for those undetected with current office bp and hbpm. a second objective is to assess diurnal bp trends and bp variability.

Eligibility criteria:
inclusion criteria: * willing to sign informed consent form * currently taking anti-hypertensive therapy for more than 3 months * drugs are unchanged during the study period * office bp below 140/90 mmhg at least one visit exclusion criteria: * diagnosed with terminal illness * end-stage renal disease requiring lifelong dialysis treatment * patients with impaired performance status (ecog \>= 2) * women undergoing or expecting pregnancy during the study period * resistant hypertension (taking more than 4 kinds of anti-hypertensive drugs) * known atrial or ventricular arrhythmia * wrist circumference out-of range between 13.5 to 21.5 cm

Keywords: home blood pressure monitoring wearable blood pressure device masked uncontrolled hypertension
evaluation of ciprofloxacin for inhalation to cystic fibrosis patients with p. aeruginosa

Conditions: Cystic Fibrosis

Summary: this is a phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of ciprofloxacin for inhalation (cfi) in patients with cystic fibrosis who have a history of chronic p. aeruginosa lung infection.

this is a phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of ciprofloxacin for inhalation (cfi) in patients with cystic fibrosis who have a history of chronic p. aeruginosa lung infection. patients will be enrolled and followed in this study for 1 month. this study will consist of a screening phase, a treatment phase consisting of a 14 days, and a follow up phase consisting of a 14 days off-treatment period.

Eligibility criteria:
inclusion criteria: * 6 to 17 years of age (inclusive) at visit 1. * positive sputum culture for p. aeruginosa * clinical diagnosis of cf * fev1 greater than or equal to 40% predicted normal lung function * able to perform spirometry testing reproducibly according to ats guidelines. exclusion criteria: * use of an investigational agent within 30 days prior to visit 1 (first dosing visit). * history of sputum culture or deep-throat cough swab (or bal) culture yielding burkholderia cepacia (b. cepacia), within 2 years prior to screening and/or sputum culture yielding b. cepacia at the screening visit; * use of any nebulized or systemic antibiotics within 14 days prior to visit 1, other than maintenance oral macrolides that has been consistently used for at least 28 days prior to visit 1. * history of intolerance or hypersensitivity to quinolone or fluoroquinolone class antibiotics * history of lung transplantation. * ast, alt or total bilirubin \> 3 x upper limit of normal at screening. * history of hemoptysis \> 30 cc per episode during the 28 days prior to visit 1. * other present conditions, abnormality in screening laboratory tests or physical examination findings, that in the opinion of the investigator or medical monitor would compromise the safety of the patient or the quality of the data.
effect of tiotropium (spiriva) on exercise tolerance in copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to investigate whether tiotropium (spiriva) improves exercise endurance in patients with copd


Eligibility criteria:
inclusion criteria: male or female patients with a clinical diagnosis of chronic obstructive pulmonary disease (copd) based on american thoracic society (ats) guidelines with: * relatively stable, moderate to severe airway obstruction with an forced expiratory volume in one second (fev1) less than or equal to 65% of predicted normal (determined at visit 1). * presence of lung hyperinflation as demonstrated by functional residual capacity determined by body plethysmography (tgv(frc)) greater than or equal to 120% of predicted normal (determined at visit 1). * age greater or equal to 40 years and less than or equal to 75 years. * a cigarette smoking history of more than ten pack-years. a pack-year was defined as the equivalent of smoking one pack of cigarettes per day for a year. * able to perform all specified procedures and able to maintain all necessary records during the study period as required in the protocol. * able to inhale the trial medication from the handihaler device. exclusion criteria: * patients with a significant disease other than copd. a significant disease was defined as a disease which, in the opinion of the investigator, may have put the patient at risk because of participation in the trial or may have influenced the results of the trial or the patient's ability to participate in the trial. * patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis. if the abnormality defined a disease listed as an exclusion criterion, the patient was excluded. * patients with serum glutamic oxaloacetic transaminase (sgot) ≥1.5 x uln (upper limit of normal range), serum glutamic pyruvic transaminase (sgpt) ≥1.5 x uln bilirubin ≥1.5 x uln or creatinine ≥1.5 x uln were excluded regardless of the clinical condition. * patients with a recent history (i.e., 1 year or less) of myocardial infarction. * patients with a recent history (i.e., 3 years or less) of heart failure, pulmonary edema, or patients with cardiac arrhythmia (with or without symptoms) or any contraindication to exercise. * patients requiring the regular use of daytime oxygen therapy. * patients with known active tuberculosis. * patients with a history of cancer within the last 5 years. patients with treated basal cell carcinoma were eligible. * patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis. * patients who had undergone thoracotomy with pulmonary resection. patients with a history of thoracotomy for other reasons were evaluated as per the first exclusion criterion (i.e., significant disease other than copd). * patients with an upper respiratory tract infection in the 6 weeks prior to the screening visit (visit 1) or during the run-in period. * further exclusion criteria apply.
fsrt in breast cancer patients with brain metastases

Conditions: Breast Cancer; Brain Metastases

Summary: brain metastasis accounted for 10-15% of all breast cancer patients and even higher in patients with triple negative and her2 overexpressed subtype. stereotactic radiation is the standard option for patients with 1-4 brain metastases. among patients with 1-4 brain metastases, many studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. also, several studies had demonstrated that 5-10 lesions had similar overall survival by using whole brain radiotherapy or stereotactic radiotherapy. fractionated stereotactic radiotherapy(fsrt) is increasingly administered in the brain metastatic patients and retrospective studies had shown that fsrt had better local control and lower brain radiation necrosis than single fraction stereotactic radiation. therefore, in this study, we explore to treat 1-10 brain metastasis lesion in breast cancer patients with fsrt.

breast cancer patients with 1-10 brain metastasis will be treated with fsrt for brain metastasis. 3 to 5 fractions and 8gy per fraction will be used for these patients based on the lesion number and volume.

Eligibility criteria:
inclusion criteria: * histologically confirmed her2 positive advanced breast cancer * age\>18 years. * 1 to 10 brain metastases confirmed by enhanced brain mri * kps≥70 * life expectancy of more than 12 weeks * prior therapy of oral dexamethasone not exceeding 16mg/d * time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1. * maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain mri(2-3mm) * prior endocrine therapy were allowed * anti-her2 targeted treatment were allowed * screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration): absolute neutrophil count (anc) ≥ 1.5 x 109/l, platelets≥ 90 x 109/l, hemoglobin ≥ 90 g/l aspartate aminotransferase/alanine aminotransferase (ast/alt) ≤2.5 x uln without liver metastasis,≤ 5 x uln with liver metastases serum bun and creatinine ≤ 1.5 x upper limit of normal (uln) * time interval from chemotherapy was more than 2 weeks, endocrine therapy and anti-her2 targeted treatment are allowed to be used concurrently with fsrt * signed the informed consent form prior to patient entry exclusion criteria: * leptomeningeal or hemorrhagic metastases * uncontrolled epilepsy * severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc. * pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures. * inability to complete enhanced mri * patients who are difficult or unable to be followed-up * not suitable for inclusion for specific reasons judged by sponsor * patients who are receiving cytotoxic drug concomitantly * have received prior radiotherapy for brain metastasis
determinants of coronary disease in high risk families

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to define factors contributing to coronary heart disease (chd) in high risk families.

design narrative: the study followed healthy siblings of patients diagnosed with chd before age 60. all siblings underwent comprehensive risk factor screening and exercise thallium tomography to identify occult chd. follow-up was performed from 6-15 years after entry (mean 8.7 years) to determine the incidence of (1) acute coronary events (sudden death, myocardial infarction, and unstable angina) and (2) progression of occult chd (repeat exercise thallium tomography). blood was obtained for genomic dna, which was tested for polymorphisms of candidate genes which may be associated with premature thrombotic chd events (platelet proteins gpiib/iiia\[pla1/a2 and baka/b\] and gpibb, endothelial nitric oxide synthase, angiotensin converting enzyme, angiotensinogen, d-fibrinogen, plasminogen activator-1, and methylenetetrahydrofolate reductase). plasma levels of proteins implicated in the pathogenesis of atherosclerosis and thrombotic chd events were measured (fibrinogen, plasminogen activator inhibitor-1, tissue plasminogen activator, homocysteine, lipoprotein (a), and apo(a) isoform size). dna was also obtained from living probands and affected siblings to use for genetic linkage studies using affected and unaffectedsibling pairs. statistical analyses examined (1) whether selected genetic polymorphisms were linked to the occurrence of acute chd events, and (2) to what extent traditional sociodemographic and biological coronary risk factors or new genetic polymorphisms explained the progression of occult chd, or the transition from occult to symptomatic chd events in families with premature chd. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
asthma (antibiotics to help manage asthma) pilot study

Conditions: Asthma

Summary: the asthma pilot study is a randomized, controlled, parallel group clinical trial of 6 weekly doses of azithromycin (cumulative dose 4800 mg) or placebo as adjunctive treatment in addition to usual care for adults with stable persistent asthma, with final follow up at 3 months after completion of study medication. the hypothesis to be tested is that antibiotic treatment will improve asthma at followup, and that this improvement will be limited to patients with evidence of c. pneumoniae infection. the secondary hypothesis is that randomized, controlled treatment trials can be carried out successfully in a geographically dispersed practice-based research network.

asthma is a chronic inflammatory bronchial condition of unknown etiology. decades ago many clinicians believed that infection played a major role in asthma etiology, but current expert opinion favors the view that asthma is a noninfectious condition whose root cause is inflammation. therefore chronic antiinflammatory therapy, mainly inhaled corticosteroids, is currently advocated as primary anti-asthma treatment. it is important to recognize, however, that antiinflammatory therapy is palliative, not curative. a growing body of evidence implicates chronic bronchial infection with chlamydia pneumoniae in the pathogenesis of asthma in both adults and children. organism identification studies (culture and pcr) suggest that up to one-half of children with asthma may be chronically infected by c. pneumoniae, and seroepidemiologic studies in adults are consistent with chronic c. pneumoniae infection in the majority of adult-onset asthmatics. furthermore, case reports and uncontrolled trials have provided provocative but inconclusive evidence that treatment of c. pneumoniae infection in both children and adults with asthma can favorably affect the natural history of this disorder. we propose a randomized, placebo-controlled, triple-blinded study of antichlamydial antimicrobial therapy in adult-onset asthma. results will help to determine whether antimicrobial therapy is effective in treating some adult asthma syndromes. positive results would have significant public health implications. methodologies developed for use in this trial may expedite future studies in practice-based research networks.

Eligibility criteria:
inclusion criteria: * adults with stable persistent asthma and evidence for reversible airway obstruction exclusion criteria: * macrolide allergy, pregnancy or lactation, specified comorbidities or medications

Keywords: asthma chlamydia pneumoniae chlamydophila pneumoniae azithromycin
blind and ultrasound guided injection in morton neuroma

Conditions: Morton Neuroma

Summary: the aim of this work trial is to compare the effectiveness of blind and ultrasound guided injection for morton neuroma in order to determine which is more appropriate as the initial procedure in conservative treatment

this is a evaluator-blinded randomized trial. the final sample size has been calculated to be 100 patients. 50 of group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. 50 of group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance. the inclusion criteria are clinical suspicion of morton neuroma confirmed in ultrasound scan. included patients are assessed clinically by vas score, the manchester foot pain and disability schedule (mfpds), and a generic quality-of-life instrument, the eq-5d. injection includes 1 cc of 2% mepivacaine and 40 mg of triamcinolone in each web space with morton neuroma. according evolution until 4 injections were allowed the first 2 months of follow-up, follow up was performed by phone calls and/or scheduled consultations at 15 days, 1 month, 45 days, 2 months, 3 months, 6 months and 1 year. statistical analysis was performed by unpaired student's t test

Eligibility criteria:
inclusion criteria: * clinical suspicion of morton neuroma confirmed in ultrasound scan * symptoms present more than six months * the thickness of the nerve must be at least 2 mm in short axis and at least 5 mm in the longitudinal axis. exclusion criteria: * contraindication for the use of corticosteroids or local anesthetics * presence of inflammatory arthropathy or neuropathy * skin lesions in the area * diabetes mellitus * infiltration or previous surgery in the area * refusal to participate in the study
radiotherapy with fdg-pet guided dose-painting for primary head and neck

Conditions: Head and Neck Cancer

Summary: dose-painting may increase the chance of cure at minimised radiation-induced toxicity in volumetric-arc radiotherapy (vmat) for head and neck cancer. this trial (radpaint) investigates the safety of fdg-pet guided radiotherapy using vmat dose-painting by contours for patients with head and neck cancer of poor prognosis.

in this study, radiotherapy is planned using 18f-fdg pet/ct (18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose positron emission tomography) making one experimental "dose-painting by contours" sib (simultaneous integrated boost) plan with a maximum point dose of 83 gy. the participants will be given 73 gy and 78 gy minimum doses to two gtvs (gross tumor volumes inside the conventional gtv (68 gy). gtv_73gy and gtv_78gy are determined from the suv (standardized uptake values) from the 18f-fdg pet/ct according to the formula proposed by the ghent group (van der straeten et al, r\&o -06). it is expected to keep the level of normal tissue side-effects within or slightly above the level of conventional radiotherapy (i.e. maximum dose of 68 gy). in addition to the routine follow-up, the participants will be examined with 18f-fdg pet/ct (3 months after treatment and toxicity scoring at 6 weeks, 3 months, 6 months, 1 year, 1.5 years and 3 years after radiotherapy (in addition to the routine follow-up).

Eligibility criteria:
inclusion criteria: histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; sinonasal, oral cavity, hypopharynx cancer, larynx cancer, hpv-unrelated (p16 negative and/or hpv dna negative) oropharyngeal cancer and tnm (primary tumor, regional nodes, metastasis) stage t4 any n m0 hpv-related (p16 positive and/or hpv dna positive) oropharyngeal cancer. patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with or without nimorazole hypoxic cell radiosensitizer) planned treatment at the oslo university hospital age \> 18 years who (world health organization) performance status 0-2 exclusion criteria: tnm (primary tumor, regional nodes, metastasis) stage ct1 cn0-n1 cm0 glottic cancer ct1-t2 cn0 cm0 hpv-related oropharyngeal carcinoma ct1-t3 (any n) cancer in the soft palate diabetes mellitus use of anticoagulant (or platelet inhibitor) active smoking and/or alcohol abuse

Keywords: dose painting 18f-fdg positron emission tomography radiotherapy