Kornimate/medical-research-clean huggingface dataset:
six month clinical trial assessing efficacy and safety of inhaled insulin in type 1 diabetes mellitus.

Conditions: Diabetes Mellitus, Type 1

Summary: to determine, in subjects with type 1 diabetes mellitus: 1. whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal inhaled insulin plus a single bedtime ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed regular/nph insulin injections per day. 2. the toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for more than 1 year * stable insulin regimen of at least 2 injections per day exclusion criteria: any smoking within the last 6 months. smoking is not permitted at any time during this study. * subjects on insulin pump during 2 months prior to screening. * subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
a study to assess dystrophin levels in participants with nonsense mutation duchenne muscular dystrophy (nmdmd) who have been treated with ataluren

Conditions: Duchenne Muscular Dystrophy

Summary: this study is designed to generate additional data on the effect of ataluren for producing dystrophin protein in nonsense mutation nmdmd participants. this study will evaluate dystrophin levels from participants with nmdmd who currently have been receiving ataluren for ≥9 months. the study will have a single visit (visit 1).


Eligibility criteria:
inclusion criteria: * evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial. * ambulatory (10 meters walk/run in less than \[\<\] 30 seconds) and functional grade on the brooke upper extremity scale of a 1 or a 2. * currently being treated with ataluren 10, 10, 20 mg/kg for \>=9 months, with no gap in treatment of greater than (\>) 1 month, in an ongoing ptc-sponsored nmdmd clinical trial prior to study entry. * phenotypic evidence of duchenne muscular dystrophy (dmd) based on the onset of characteristic clinical symptoms or signs (for example, proximal muscle weakness, waddling gait, and gowers' maneuver) by 6 years of age and an elevated serum creatine kinase (ck). medical documentation of phenotypic evidence of dmd needs to be provided upon request by the medical monitor. * willing to undergo muscle biopsy. exclusion criteria: * known contra-indication to muscle biopsy (such as bleeding or clotting disorders). * exposure to another investigational drug within 2 months prior to study enrollment or ongoing participation in any non-ataluren interventional clinical trial. * requirement for daytime ventilator assistance or any use of invasive mechanical ventilation via tracheostomy. note: evening non-invasive mechanical ventilation such as use of bilevel positive airway pressure (bi-pap) therapy is allowed. * prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder), medical history, physical findings or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
an open-label study of atomoxetine in adolescents with attention-deficit/hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: a single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12 through 17 years) with attention-deficit/hyperactivity disorder treated as outpatients in germany. an 8-week treatment phase is followed by a 16-week extension period.


Eligibility criteria:
inclusion criteria: * male or female outpatients who are at least 12 years of age and who will not have reached their 18th birthday * diagnosis of adhd * normal intelligence exclusion criteria: * weigh less than 30 kg or more than 85 kg at study entry * other relevant psychiatric diagnoses * are at serious suicidal risk as determined by the investigator * have a history of severe allergies * alcohol or drug abuse within the past 3 months * are female patients who are pregnant or breast-feeding. sexually active females must use a medically acceptable method of contraception.
chemotherapy plus gefitinib for advanced lung adenocarcinoma and sensitive egfr mutations: a randomized controlled trial

Conditions: Lung Adenocarcinoma

Summary: the purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.

the primary endpoints is to compare the progression-free survival (pfs) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma. in addition, the overall survival and safety index will be collected for analyses.

Eligibility criteria:
inclusion criteria: 1. patients had to voluntarily join the study and give written informed consent for the study; 2. histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage iiib or iv non-small cell lung cancer (nsclc); 3. a cytologic diagnosis is acceptable (fna or pleural fluid cytology) 4. sensitive egfr mutations (19del, 21l858r); 5. at least 1 unidimensionally measurable lesion meeting response evaluation criteria in solid tumours (recist) criteria; 6. patients did not receive systemic anti-cancer therapy previously; 7. able to comply with study and follow-up procedures; 8. age \>= 18 years, ecog ps: 0-1, estimated survival duration more than 3 months; exclusion criteria: 1. small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer); 2. evidence of small cell, carcinoid, or mixed small cell/non-small cell histology; 3. egfr wild-type patients, or patients with rare egfr mutations or complex egfr mutations; 4. previously (within 5 years) or presently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ta (noninvasive carcinoma), tis (carcinoma in situ) and t1 (invasion into lamina propria)\]; 5. symptomatic or untreated brain metastases; 6. unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible); 7. history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications; 8. gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (iv) alimentation, or prior surgical procedures affecting absorption; 9. pregnancy or lactation.

Keywords: adenocarcinoma, egfr, gefitinib, pemetrexed, carboplatin
spinal cord lesion detection in multiple sclerosis using novel mri sequences

Conditions: Multiple Sclerosis (MS)

Summary: this study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (amira) in spinal cord (sc) multiple sclerosis (ms) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

an averaged magnetization inversion recovery acquisitions (amira) sequence was proposed for sc mri. this mr-sequence delivers excellent contrast between the sc gray and white matter as well as between the sc and cerebrospinal fluid (csf) in clinically feasible-acquisition times. moreover, the high quality and in-plane resolution of amira images allows for segmentation of the sc gray and white matter with high accuracy and reproducibility. this study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (amira) in spinal cord (sc) multiple sclerosis (ms) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis according to established international criteria * steroid free period: \> 4 weeks * participation in the swiss ms cohort (smsc) study exclusion criteria: * . history of severe (other) neurological, internal or psychiatric disease with sc affection * mri-related exclusion criteria (questionnaire): 1. paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the sc) 2. pacemaker 3. claustrophobia 4. pregnancy, lactation 5. known hypersensitivity to gadolinium-based contrast media

Keywords: spinal cord (sc) pathology demyelinating lesions spinal cord mri averaged magnetization inversion recovery acquisitions (amira) sequence swiss ms cohort (smsc)
comparison of techniques for assessing cardiac output and preload in critically ill pediatric patients

Conditions: Cardiac Output

Summary: the ability to measure cardiac output (co) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. current techniques used in adults to measure co are not suitable for routine use with pediatric patients. a new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. the main aim of this study is to compare co measured by the new method with the clinician's estimate and implied co from the measurement of the arteriovenous oxygen content difference.


Eligibility criteria:
inclusion criteria: * patients with in situ central venous and arterial catheters * ability to draw blood from arterial and central venous catheters * presence of parent or guardian to provide consent exclusion criteria: * patients over 16 years of age.

Keywords: comparison of co by new method to clinician's estimate and implied co from the measurement of arteriovenous oxygen content difference.
coronary diet intervention with olive oil and cardiovascular prevention

Conditions: Myocardial Infarction; Unstable Angina; Malignancy; Cognitive Decline; Diabetes Mellitus; Metabolic Syndrome

Summary: the purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus mediterranean diet) on the incidence of cardiovascular events of persons with coronary disease.

randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; mediterranean diet 502 patients, low fat 500 patients) for 7 years. the two diets are: a)low fat diet: \ 35% fat (22% mufa; 6% pufa ; \<10% sat). primary objective: combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death). secondary objectives: those related in the outcome measures section of this webpage

Eligibility criteria:
inclusion criteria: * informed consent * clinical: unstable coronary disease with documented vessel/myocardial damage * acute myocardial infarction * revascularization exclusion criteria: * age \ 75 years (or life expectancy lower than 5 years). * patients already planned for revascularization. * patients submitted to revascularization in the last 6 months * grade ii-iv heart failure. * left ventricle dysfunction with ejection fraction lower than 35%. * patients unable to follow a protocol. * patients with severe uncontrol of diabetes mellitus, or those with renal insufficiency with plasma creatinine higher than 2mg/dl, or cerebral complications of diabetes mellitus. * other chronic diseases: * psychiatric diseases * renal insufficiency * chronic hepatopathy * active malignancy * chronic obstructive pulmonary disease * diseases of the digestive tract endocrine disorders * patients participating in other clinical trials (in the enrollment moment or 30 days prior).

Keywords: cardiovascular events blood pressure incidence of cancer cognitive decline mediterranean diet secondary prevention low fat diet
mfit: the mobile fitness project

Conditions: Overweight; Obese

Summary: background: the nascent field of mobile health (mhealth) is expanding with impressive speed. in march 2012, experts estimated that 40,000 health related smartphone applications were on the market but little is known about the effectiveness of these programs. to our knowledge, no studies have evaluated whether weight loss can be successfully achieved through use of a smartphone application or how these applications could be used in primary care practice. purpose: to evaluate the effectiveness of a popular, free smartphone application for weight loss and calorie counting in a primary care setting. methods: the first phase of this study involved a community based participatory approach to select the intervention. patient focus groups were conducted and analyzed to explore patients' preferences regarding various text-message versus smartphone programs. the second phase of this study, described here, will be a randomized controlled trial with overweight primary care patients exposed to one of two conditions for 6 months: (1) usual care; (2) usual care plus smartphone application, which includes instructing participants on how to use the application and encouraging them to use the applications' reminders and social networking features. the primary outcome of interest is weight change at 3 and 6 months. two-sample t-test or wilcoxon rank sum test will be used to compare weight change between groups, as appropriate. ancova models will be used to examine weight change after adjusting for covariates such as education, sex and age. repeated measures analysis will be carried out to compare weight change between the groups using baseline, 3 month and 6 month data. in addition to an intent-to-treat analysis, the investigators will also conduct a "treatment received" analysis, adjusting for the extent of application use in both the intervention and control arms. conclusions: this study will demonstrate whether a smartphone application introduced in primary care settings and incorporated into the visit can produce weight loss. study findings could inform a national discourse on the value of smartphone applications in routine clinical practice.


Eligibility criteria:
inclusion criteria: * primary care patient at ucla family health center or 16th street internal medicine * age 18 or older, * english speaking, * bmi \> 25, * interested in losing weight, * smartphone ownership, * valid email address. exclusion criteria: * current, planned or previous pregnancy within 6 months, * currently using a smartphone app for dieting, * hemodialysis, * terminal illness
post-operative haloperidol versus placebo for prevention of post-operative delirium after acute hip surgery

Conditions: Post-Operative Delirium; Hip Fracture

Summary: in this study the investigators want to determine if treatment with haloperidol direct post-operatively after acute hip surgery in high risk patients protects against developing a post-operative delirium.

a post-operative delirium is a serious and frequent (35-65%) complication with high morbidity and mortality in high risk patients. in this study we investigate whether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75 years of age and older. it's a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.

Eligibility criteria:
inclusion criteria: * hip fracture * 75 years and older exclusion criteria: * contra-indications for the use of haloperidol * pre-operative delirium * pre-operative use of haloperidol

Keywords: post-operative delirium hip fracture
ultrasound-guided ilioinguinal/iliohypogastric nerve block

Conditions: Inguinal Hernia Repair; Pain, Postoperative

Summary: abdominal wall hernias are common, with a prevalence of 1.7% for all ages and 4% for those aged over 45 years. inguinal hernias account for 75% of abdominal wall hernias, with a lifetime risk of 27% in men and 3% in women. repair of inguinal hernia is one of the most common operations in general surgery

the peripheral nerve block usage is increasing in popularity because it decreases pain as estimated by visual analogue scores/numerical rating pain scores postoperatively and decreases the need for postoperative analgesic usage thereby reducing opioid induced side effects like postoperative respiratory depression, nausea, vomiting, nsaid induced gastritis etc. nerve blocks also shorten post-anesthesia care unit stay time, and also increases patient satisfaction . ultrasound-guided peripheral nerve blocks including ilioinguinal/ iliohypogastric nerve block and transversus abdominis plane block have been widely used and considered as effective traditional techniques for postoperative analgesia in inguinal hernia repair . in recent years, the quadratus lumborum (ql) block is proposed to be an alternative regional block for both upper abdominal surgery and lower abdominal surgery. the blockade of ilioinguinal/iliohypogastric nerves in the anterior abdominal wall has improved postoperative analgesia after open inguinal hernia repair and many other procedures. the quadratus lumborum (ql) block is a regional anesthetic technique which described by anesthesiologist "dr rafael blanco" in 2007. quadratus lumborum block allows the local anesthetic agent to spread between the posterior aspect of the quadratus lumborum muscle and the middle layer of the thoracolumbar fascia, which is nearer to the thoracic paravertebral space. it has four approaches based on the point of drug deposition in relation to quadratus lumborum muscle. drug is deposited on the anterolateral, posterior, anterior to the quadratus lumborum muscle in the three approaches. in fourth approach drug is deposited intramuscularly. it provides postoperative analgesia for longer duration .

Eligibility criteria:
inclusion criteria: 1. all patients undergoing elective or emergent unilateral inguinal hernia repair 2. patients scheduled for unilateral inguinal hernia repair exclusion criteria: 1. patient refusal. 2. contraindication to neuraxial block. 3. neuromuscular diseases (as myopathies, myasthenia gravies). 4. hematological diseases, bleeding or coagulation abnormality. 5. uncontrolled psychiatric diseases, 6. local skin infection and sepsis at site of the block. 7. known intolerance to the study drugs. 8. body mass index \> 40 kg/m2, 9. unstable cardiovascular condition
improving breast cancer diagnostic by novel sonographictechniques study

Conditions: Breast Cancer

Summary: with the proposed project we seek to advance the detection and diagnosis of breast cancer in an outpatient breast clinic. novel sonographic approaches will be scrutinized. the first aim of this study will be to explore whether there is an advantage of ductosonography over conventional breast sonography in detecting and localizing breast lesions by comparing the diagnostic accuracy of ductosonography and conventional breast sonography in detecting suspicious and unclear sonographic lesions.in addition, reliability and time requirement of ductosonographic examination will be investigated. the second specific aim is to investigate the potential of tissue elasticity as a diagnostic marker in solid breast lesions (us-bi-rads 3, 4 and 5) by elastosonography. the study design allows investigating the reproducibility of the method.

the research project consists of mainly two parts that involve different methodological approaches: for the first part, different breast ultrasound techniques will be employed for the examination of an unselected population in a regular setting of a breast outpatient clinic. the second part includes measuring and characterizing tissue elasticity of breast lesions by elastosonography.

Eligibility criteria:
inclusion criteria:all women , who agree with the two examinations of the breast: conventional method and ductosonography exclusion criteria: a women, who have only the conventional examination of sonography

Keywords: elastosonography comparing conventional sonography with ductosonography
testing the effects of singapore's front-of-pack healthier choice symbol label with or without a physical activity equivalent label

Conditions: Obesity; Diabetes; Diet, Healthy

Summary: poor diets are known risk factors for chronic diseases, and in recent years, food labelling has been increasingly sought-after as a cost-effective intervention to help stem the rising trend in chronic diseases. in efforts to promote a healthy diet, the singapore health promotion board (hpb) supplements traditional nutrition labelling with the healthier choice symbol (hcs), which identifies food items within a specific category of foods as healthier choices. the original logos were enhanced to include additional information focusing on particular macronutrients, taking one of two themes; it either indicates that a product contains more of a healthier ingredient, or less of a less healthy ingredient. however, to date, no published studies have assessed the role of the original and enhanced hcs logos in influencing food choices. there is a lack of scientific evidence on the role of the existing symbols in assisting consumers make healthier food purchasing decisions. there are also concerns over the unintended consequences of health claims made based on a single aspect of nutrient content, without considering other aspects. that is the goal of this effort. specifically, the investigators propose to conduct the following: use a three arm randomized controlled trial (rct) and an experimental fully functional web-based grocery store to assess the causal effect of the new hcs logos on measures of diet quality either alone, or in combination with a complementary front-of-package (fop) label: physical activity equivalents (paes), which provides information on how long one would need to engage in a certain activity (e.g., jogging) to burn off one serving of the product. the investigators hypothesize that the greatest reduction in calories per serving (primary outcome) will occur in the hcs plus paes arm, followed by hcs only, and no logo control arm.


Eligibility criteria:
inclusion criteria: * singapore residents * 21 years of age and above * primary grocery shopper for the household exclusion criteria: * not residing in singapore * under 21 years of age * not the primary grocery shopper for the household

Keywords: nutrition front-of-pack label calories online grocery store singapore physical activity equivalent