Kornimate/medical-research-clean huggingface dataset:
visual outcomes and the predictive factors in chinese patients with diabetic macular edema treated with ranibizumab

Conditions: Diabetic Macular Edema

Summary: the aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (dme).

the aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (dme). mean change of logarithm of the minimal angle of resolution (logmar) visual acuity (va), central foveal thickness (cft), as well as predictive factors including best-corrected visual acuity (bcva) were assessed.

Eligibility criteria:
inclusion criteria: * 1) patients (aged\>18 years) with dme who had a best-corrected visual acuity (bcva) between 20/32 and 20/200, and crt≥300μm; 2) clinically significant dme confirmed by both fundus fluorescein angiography (ffa) and optical coherence tomography (oct) (spectralis hra+oct; heidelberg engineering, germany); 3) decreased vision caused by foveal thickening from dme, which could not be explained by any other cause. exclusion criteria: * 1) previous anti-vegf or laser treatment; 2) proliferative diabetic retinopathy who required immediate panretinal photocoagulation; 3) active proliferative diabetic retinopathy; 4) other causes for macular edema, for example, branch retinal vein occlusion; 5) other causes of visual loss in the study; 6) unstable systemic conditions, for example, uncontrolled blood pressure, stroke, renal or kidney failure.

Keywords: macular edema ranibizumab mpredictive factor
type 1 diabetes impacts of semaglutide on cardiovascular outcomes

Conditions: Diabetes Mellitus, Type 1

Summary: this trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. this medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and bmi in adults with type 2 diabetes. this study aims to look at how well the medication works in people with type 1 diabetes. semaglutide is not approved by the fda to be used in this way. these procedures are considered to be experimental.


Eligibility criteria:
inclusion criteria: * age 18-49 years * 1) t1d diagnosis defined as positive t1d-associated antibody(ies) or 2) a clinical diagnosis of t1d plus insulin requirement since diagnosis * insulin pump or automated insulin delivery systems * estimated glomerular filtration rate (egfr) ≥ 45 ml/min/1.73m2 * stable doses of drugs altering cardiovascular and renal function (e.g., angiotensin-converting enzyme inhibitor (acei), angiotensin receptor blocker (arb), statins, diuretics) * bmi 20-45 kg/m2 * adequate contraceptive method for females exclusion criteria: * hba1c \>9%, recent diabetic ketoacidosis (dka) or hospitalization * major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy * history/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (men2), pancreatitis * current/planned pregnancy or nursing * uncontrolled thyroid disease or hypertension (htn) (≥ 160/100 mm hg despite optimal therapy) * use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months * use of atypical antipsychotics * significant systemic illness such as cancer * shellfish/iodine allergy (only exclusionary to iohexol clearance procedure) * mri or pah contraindications (only exclusionary to mri and pah procedures), glp-1ra allergy
hypothermia's impact on pharmacology

Conditions: Cardiac Arrest; Hypothermia

Summary: the purpose of the study will help us understand the complex interaction between hypothermia (cooling) and pharmacogenetics (how specific genes effect how drugs are handled), and their impact on how routinely given sedation drug are broken down and used by the body when given to children after cardiac arrest (when heart stops pumping blood) and are critically ill.

background: therapeutic hypothermia is used in the pediatric intensive care unit, and is being studied in the setting of pediatric cardiac arrest. following cardiac arrest, multiple organ dysfunction syndrome, especially renal and hepatic dysfunction, is common and affects the metabolism and excretion of drugs. in addition, very little is known about the impact of hypothermia on a child's ability to metabolize medications. dose adjustments may be required in the setting of hypothermia to avoid under-dosing and over-dosing of medications. improper dosing and drug accumulation of sedatives and opiates can worsen existing neurologic, circulatory and respiratory failure. the measurement of the actual drug and metabolite concentrations in the body (pharmacokinetics) provides information on how a child metabolizes medications. in addition, variability in these concentrations after the administration of equal doses to different children may result from genetically driven differences in drug metabolizing systems (pharmacogenetics). finally, these genetic differences may respond differently to hypothermia. our overarching hypothesis is that morphine and midazolam disposition will be affected by temperature management even when accounting for potentially confounding quantifiable factors of organ dysfunction and genetic differences. objectives: the objectives of this study, hypothermia's impact on pharmacology 2, are 1. to estimate the impact of hypothermia on the variability in morphine and midazolam pharmacokinetics in children after cardiac arrest and 2. to estimate the impact of genetic factors on the variability in morphine and midazolam pharmacokinetics, specifically in the setting of hypothermia. sophisticated modeling and simulation techniques will be utilized to examine the highly dynamic changes in physiology associated with critical illness, drug disposition, pharmacogenetics and temperature modulation. the models created using this approach will be implemented to optimize the prospective treatment of these critically ill children. study design: prospective pharmacokinetic study

Eligibility criteria:
inclusion criteria: * be greater than or equal to three (3) kg * receiving or have received morphine and/or midazolam as part of clinical care * receiving hypothermia after any cardiac arrest * provide informed consent exclusion criteria: * receiving renal replacement therapy \[example continuous veno-venous hemofiltration (cvvh), continuous veno-venous hemodialysis (cvvhd), and continuous veno-venous hemodiafiltration (cvvhdf)\] * receiving plasmapheresis

Keywords: pharmacokinetics midazolam morphine cardiac arrest hypothermia
study of mk-0476 in adult patients with acute asthma (0476-334)

Conditions: Asthma

Summary: the study estimates the efficacy and safety of mk0476 and aminophylline intravenous administration in adult participants with acute asthma.


Eligibility criteria:
inclusion criteria: * adult participants with acute asthma attacks exclusion criteria: * participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., copd, chronic heart failure, etc.). * participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years. * participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.
guided cartilage regeneration membrane

Conditions: Articular Cartilage Injury; Knee Ligament Injury

Summary: guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury

mri evaluation using guided cartilage regeneration membrane for articular cartilage injury repair 730 days (2 years) is the main indicator of this trial. in this experiment, we observe the improvement of lysholm score, vas score, ratio change of regenerated cartilage t2 value to normal cartilage t2 value, and ratio of regenerated cartilage △r1 value to normal cartilage △r1 value indicators such as value changes are secondary evaluation indicators.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old and ≤50 years old, regardless of gender 2. 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery 3. patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up exclusion criteria: 1. those who have participated in clinical trials of other drugs or medical devices in the last 6 months 2. those with stage iii or above degeneration of bone and joint 3. those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues 4. those who are sensitive to collagen, foreign protein or pig-derived materials 5. repair the damaged area\> 8 cm2 or \<2 cm2, lack of normal cartilage tissue around the injury 6. severe heart, liver and kidney insufficiency are defined as: heart function: nyha grade iii or above; alt, ast\> 2.5 times the upper limit of normal value; serum creatinine\> 1.5 times the upper limit of normal value; 7. people with systemic immune diseases or systemic or local infections 8. joint fibrosis, joint stiffness, and obviously restricted movement 9. those with moderate or severe osteoarthritis 10. people with contraindications for mri examination 11. patients with hemophilia 12. those who cannot tolerate surgery 13. women who are pregnant or plan to become pregnant and breastfeeding women 14. persons with mental abnormalities and incapacity to act autonomously 15. other conditions that the doctor judges cannot participate in the trial
exercise inhibit innate immune response and ameliorate chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: the goal of this observational study is to learn about the effects of different physical exercise on disease progression in patients with chronic pancreatitis. the main question it aims to answer is: can physical exercise alleviate the disease progression of chronic pancreatitis? currently, the investigators have followed up with participants through a telephone questionnaire for six months to investigate whether the participants have engaged in physical exercise and to assess the disease progression of chronic pancreatitis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic pancreatitis * must be adhere to the guidelines of the american gastroenterological association exclusion criteria: * autoimmune pancreatitis * pancreatic cancer diagnosed within 2 years after the onset of cp * use of drugs or toxins, or presence of viral infections
testing the influence of different sugary drink warning label designs

Conditions: Obesity; Weight Gain; Diabetes Type 2

Summary: the aim of this study is to compare different sugary drink labels to see which most influence knowledge, beliefs, purchase intentions and choices. parents of children ages 6-11 will shop in a virtual convenience store after being randomized to 1 of 4 conditions: 1) calorie labels; 2) text warning labels; 3) graphic sugar warning labels; or 4) graphic health warning. this study will provide data comparing the influence of sugary drink text warning labels and two kinds of graphic warning labels.


Eligibility criteria:
inclusion criteria: 1. a primary caregiver of a child 6-to-11 years old; 2. ≥18 years old; and 3. can read and speak english exclusion criteria: 1. not a primary caregiver of a child 6-to-11 years old; 2. \<18 years old; and 3. cannot read and/or speak english
perioperative chemotherapy in gastric cancer

Conditions: Gastric Cancer

Summary: patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. one group of the patients will receive 5-fluorouracil (5-fu), leucovorin, oxaliplatin and docetaxel (flot), the second group will receive oxaliplatin and capecitabin (xelox). primary endpoint of the study is the proportion of patients who complete all allocated treatment.

328 рatients with resectable (t1b-4 and/or n-/+, m0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. after staging laparocopy patients will be randomized to receive preoperatively 4 cycles flot or 4 cycles xelox followed by curative surgery. adjuvant chemotherapy will be given as 4 cycles of flot or 4 cycles xelox. the primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.

Eligibility criteria:
inclusion criteria: * ct1b-t4b (ct4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery) * cn0-3 * m0 * age: 18 - 80 * ecog: 0 - 1 * histological type: adenocarcinoma * differentiation grade: g0 - g4 * no previous surgery * no previous chemotherapy * no concomitant severe comorbidity * written informed consent exclusion criteria: * ct1a, ct4b (invasion in truncus, hepatic artery, proximal part of splenic artery) * presense of distant metastases * ecog: 2 - 5 * age: \ 80 * severe concomitant comorbidity

Keywords: perioperative chemotherapy pathological responce rate gastrectomy gastric cancer
a study to test the performance of the cogstate computerized neuropsychological battery in patients with alzheimer's disease (0000-086)(completed)

Conditions: Alzheimer's Disease

Summary: this study will evaluate the performance of the cogstate computerized neuropsychological battery, alzheimer's disease assessment scale-cognitive subscale (adas-cog) and alzheimer's disease cooperative study - activities of daily living (adcs-adl) in participants with mild-to-moderate alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * participant is ambulatory, male or female and 55 years of age or older * participant has reliable informant/caregiver who can communicate effectively with the study site and personnel exclusion criteria: * participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia * participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes
study of acetaminophen (ace) in post-operative dental pain

Conditions: Dental Pain

Summary: this is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ace) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (ibu) (400 mg), and placebo over a 6 hour period. subjects will undergo dental extraction of three or four third molars.


Eligibility criteria:
inclusion criteria: 1. are 17 to 50 years of age 2. weigh 100 lbs or greater and body mass index (bmi) 18 to 30 (inclusive) 3. dental extraction of three or four third-molars. 4. experience moderate to severe pain after extraction of third molars exclusion criteria: 1. currently pregnant (or planning to be pregnant) or nursing a baby 2. known allergy to acetaminophen (ace) or non-steroidal anti-inflammatory drugs (nsaids) 3. inability to swallow whole large tablets or capsules 4. have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

Keywords: molar,third; teeth,wisdom; pain, postoperative; dental surgery; third molar extraction
radiotherapy plus concurrent nimotuzumab or cisplatin in stage ii-iii nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Nasopharyngeal Diseases; Head and Neck Neoplasm

Summary: this is a phase iii trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (imrt) in treating patients with stage ii-iii nasopharyngeal carcinoma.

scheme: eligible stage ii and iii npc patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio. - arm cisplatin: cisplatin 40mg/m2/week in concurrent with imrt - arm nimotuzumab: nimotuzumab 200mg/week in concurrent with imrt

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including who ii or iii * histologically confirmed positive egfr expression * stage ii and iii npc patients（according to the 8th ajcc edition） * male and no pregnant female * age between 18-65 * adequate marrow: leucocyte count ≥4000/μl, hemoglobin ≥90g/l and platelet count ≥100000/μl * normal liver function test: alanine aminotransferase (alt)、aspartate aminotransferase (ast) \<2.0×upper limit of normal (uln) * adequate renal function: creatinine clearance ≥60 ml/min * satisfactory performance status: karnofsky scale (kps) \> 70 * without radiotherapy or chemotherapy * patients must give signed informed consent exclusion criteria: * evidence of relapse or distant metastasis * history of prior malignancy or previous treatment for npc * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×uln), and emotional disturbance. * pregnancy or lactation

Keywords: nimotuzumab
expiratory muscle strength training (emst) in neuromuscular disorders

Conditions: Oculopharyngeal Muscular Dystrophy; Muscular Dystrophies; Myopathy; Hereditary

Summary: the purpose of this study is to investigate the impact of expiratory muscle strength training (emst) on the swallowing, breathing, oral intake, quality of life and cough function of people with oculopharyngeal muscular dystrophy (opmd).

outline: twenty participants with opmd, with dysphagia, will be recruited from neuromuscular clinics within calgary. the investigators will enrol patients in a parallel group, sham-controlled, randomized clinical trial, with 10 participants in each group (active emst and sham emst). participants will have baseline measurements of: (i) global swallowing function via modified barium swallow study, (ii) maximum expiratory pressure, (iii) voluntary cough spirometry, (iv) forced vital capacity, (v) functional oral intake, (vi) patient report of self-perceived swallowing impairment (eat-10 questionnaire), and (vii) biomarker analyses. participants will undergo 5-weeks of emst (active or sham). all baseline measurements will be repeated after 5-weeks of emst and 10-weeks post-emst to measure durability of effect. outcomes: the end-goal of the current research is to obtain preliminary data for the benefit of emst in a new study population, and direct future studies that may provide evidence for a new standard of care in treating neuromuscular diagnoses.

Eligibility criteria:
inclusion criteria: * diagnosis of oculopharyngeal muscular dystrophy (opmd) * 18 years of age or older * must be capable of providing informed consent * must be able to undergo respiratory function testing and swallowing studies * must have a forced vital capacity (fvc) greater than 60% * a score of 3 or greater on the eating assessment tool-10 (eat-10; self-administered, symptom-specific outcome instrument for dysphagia. a score of 3 or greater indicates increased stress around eating) * a score of 26 or greater on the montreal cognitive assessment (moca; 30-point screening assessment used for detecting cognitive impairment. a score of 26 or greater is considered to be within functional limits.) exclusion criteria: * severe coronary artery disease * acute myocardial infarction * moderate to severe hypovolemia * acute neurological events * unstable cardiac status * recent hernia * severe chronic obstructive pulmonary disease (copd) * uncontrolled reflux issues * women who are pregnant, or who suspect they may be pregnant * cognitive impairment that would prevent comprehension of instructions and adherence to intervention guidelines (a score of less than 26 points on the moca)

Keywords: dysphagia myopathy muscular dystrophy
treatment for osgood schlatter patients with a physiotherapy program

Conditions: Osgood-Schlatter Disease

Summary: this study is to compare the effect of a physiotherapy program to usual care treatment in patients with osgood schlatter disease (osd). patients will be randomly assigned into two groups. group 1 will receive the physiotherapy program with myofascial massage, while group 2 (usual care group usc) will receive usual care treatment.


Eligibility criteria:
inclusion criteria: * uni- or bilateral osd * ability to follow instructions * sufficient knowledge of german * availability: can participate in two exercise sessions per week for a period of 8 weeks exclusion criteria: * any history of knee surgery * medication intake affecting the knee * unstable fractures * neurological disorders * systematic diseases * already in physiotherapeutic treatment because of the knee * not possible to do any physiotherapy sessions at the universitäts-kinderspital basel (ukbb)

Keywords: myofascial massage stretching home exercises strengthening koos-child-questionnaire
cortical visual impairment and visual attentiveness

Conditions: Cerebral Palsy; Cortical Visual Impairment

Summary: this study will investigate the effect of enhanced visual and cross-modal environments upon the visual attentiveness of multiply handicapped children diagnosed with cerebral palsy (cp) and cortical visual impairment (cvi). research hypothesis 1. adapted visual environments which present controlled auditory, tactile, proprioceptive or contrasting visual background stimulation will enhance the visual attentiveness to a given visual stimulus of children diagnosed with cp and cvi. 2. systematic, repetitive, visual stimulation over time, improves the visual attentiveness and/or visual-motor responses of cp-cvi children. 3. the analysis of additional behavioral responses to visual stimuli is a critical component in evaluating the perceptual development of visual attention in cp-cvi children. use of noldus: the observer, an advanced objective computerized observation program, will enable precise detection of the neurobehavioral responses of the participants. both overt and covert responses will be observed, analyzed and correlated to identify the level of attention of each participant.


Eligibility criteria:
inclusion criteria: * two to twelve years of age * diagnosis of: cp, mental retardation (mr) and cvi (control group participants without visual disability) exclusion criteria: * n/a