Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of pegcetacoplan in patients with pnh

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: evaluation of the efficacy and safety of pegcetacoplan in patients with paroxysmal nocturnal hemoglobinuria .


Eligibility criteria:
inclusion criteria: * be at least 18 years old (inclusive). * have ldh ≥1.5 x uln at the screening visit. * have pnh diagnosis, confirmed by high sensitivity flow cytometry (granulocyte or monocyte clone \>10%). * have hb less than the lower limit of normal (lln) at the screening visit. * have ferritin greater than/equal to the lln, or total iron binding capacity (tibc) less than/equal to uln at the screening visit, based on central laboratory reference ranges. if a subject is receiving iron supplements at screening, the investigator must ensure that the subject's dose has been stable for 4 weeks prior to screening, and it must be maintained throughout the study. subjects not receiving iron at screening must not start iron supplementation during the course of the study. * body mass index (bmi) ≤ 35 kg/m2 at the screening visit. * have a platelet count of \>50,000/mm3 at the screening visit. * have an absolute neutrophil count \>500/mm3 at the screening visit. exclusion criteria: * treatment with any complement inhibitor (eg, eculizumab) within 3 months prior to screening. * hereditary complement deficiency. * history of bone marrow transplantation. * concomitant use of any of the following medications is prohibited if not on a stable regimen for the time period indicated below prior to screening: * erythropoietin or immunosuppressants for at least 8 weeks * systemic corticosteroids for at least 4 weeks * vitamin k antagonists (eg, warfarin) with a stable international normalized ratio (inr) for at least 4 weeks * iron supplements, vitamin b12, or folic acid for at least 4 weeks * low-molecular-weight heparin for at least 4 weeks
esomeprazole in ppi failures - improve

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to assess how ppi treated gerd patients with insufficient symptom control will benefit from a change in management by providing a more efficient acid secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to pre-study ppi treatment.


Eligibility criteria:
inclusion criteria: * provision of informed consent * male or female, aged 18-65 years * history of gerd symptoms during, at least, six months prior to enrolment * ppi as maintenance treatment during the last 30 days prior to enrolment * heartburn as predominant gerd symptom, as judged by the investigator * persisting gerd symptoms during the past 7 days prior to visit 1, judged by the patient as either: 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities) exclusion criteria: * any treatment with esomeprazole during 30 days prior to enrolment history of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer * current or historical evidence of the following diseases/conditions, as judged by the investigator:zollinger-ellison syndrome,primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm, * gastric or duodenal ulcers within the last three months, malabsorbtion * malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study * unstable diabetes mellitus. stable diabetes controlled by diet, oral agents or insulin is acceptable * patients with severe diseases or disorders which may interfere with the conduct of the study
the effect of education given according to meleıs' transitional theory to patients with pacemaker

Conditions: Educational Activities

Summary: this study will be carried out to determine the effect of training given according to meleis's transition theory to patients with pacemaker implantation on anxiety, depression and self-efficacy levels.

this study will be carried out to determine the effect of training given according to meleis's transition theory to patients with pacemaker implantation on anxiety, depression and self-efficacy levels. hypotheses of the research h01: training given to patients with pacemaker implantation according to meleis's transition theory does not affect the anxiety and depression levels of the patients. h11: training given according to meleis's transition theory to patients with pacemaker implants reduces the anxiety and depression levels of patients. h02: training given to patients with pacemaker implantation according to meleis's transition theory does not affect the self-efficacy level of the patients. h12: training given to patients with pacemakers according to meleis's transition theory increases the self-efficacy level of the patients.

Eligibility criteria:
inclusion criteria: * patients with pacemaker implantation, * ages 18 and over, * the one who is literate, * open to communication and collaboration, * patients who volunteer to participate in the study will be included in the study. exclusion criteria: * not oriented to person, place and time, * hearing loss, * cannot understand and speak turkish and * patients who do not want to continue the study will be excluded from the study.

Keywords: pacemaker, meleis transition theory, education, self-efficacy, anxiety, depression, nursing
hydroxyurea in young children with sickle cell anemia

Conditions: Sickle Cell Anemia

Summary: the purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea therapy in children with sickle cell anemia between ages 18 months and 5 years, with special emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.

previous studies have shown that hydroxyurea therapy in adults and older children with sca improves laboratory parameters and ameliorates the clinical severity of disease. little is known, however, about the effects of hydroxyurea on the chronic organ damage that occurs in patients with sca and leads to significant morbidity and mortality in young adults. the objectives of this study are to assess the safety and efficacy of hu in young children with sca and to determine whether hu preserves renal function, reduces transcranial doppler ultrasound (tcd) values, and prevents development of brain ischemia as evidenced by mri/mra imaging. in addition, we will evaluate the effects of hydroxyurea on quality of life

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sickle cell anemia (hb ss or hb s beta zero-thalassemia)

Keywords: sickle cell anemia hydroxyurea
carbon nanoparticles as lymph node tracer in rectal cancer after neoadjuvant radiochemotherapy

Conditions: Rectal Cancer

Summary: the purpose of this study is to evaluate whether injection of carbon nanoparticle as a lymph node tracer before neoadjuvant radiochemotherapy in rectal cancer can increase lymph node yield after surgery compared which do not inject.

this is the randomized controlled, multi-centers，and open-labeled study. the lymph node yield was significantly decreased in rectal cancer after neoadjuvant radiochemotherapy (nat), hard for pathologists to detect, and is difficult to meet the guideline that minimun of 12 lymph nodes should be retrived after surgery in colorectal cancer. carbon nanoparticle (cnp) is a specific lymph node tracer, which only dyeing the lymph node, and can keep the lymph node in dyeing state in at least half year. the inverstigator attempted to compare the amount of lymph node yield after surgery in locally advanced rectal caner between injection cnp before nat and no injection cnp before nat. in this study, the participants with clinical tnm stage t3+ or n+ will be recruited. the participants will be randomized (1:1 ratio) to a control and intervention arm. the participants in the control arm will not receive injection of any kind lymph node tracers. the participants in the intervention arm will receive injection of cnp before nat. and the specimen would be evaluated by the pathologist.

Eligibility criteria:
inclusion criteria: 1. age: 18-75 years old; 2. histologically confirmed adenocarcinoma; 3. the rectal adenocarcinoma 0-12cm from the anal margin; 4. clinical tnm stage: t3+ or n+; 5. untreated patients (who have not received treatment including radiotherapy, chemotherapy, and surgery); 6. good liver and kidney function, without contraindications for radiotherapy, chemotherapy or surgery; 7. able and willing to give informed consent to participate; exclusion criteria: 1. malignant tumor history or other malignant tumors; 2. emergency operations such as intestinal obstruction, perforation and hemorrhage; 3. pregnant or lactating women; 4. history of severe mental illness; 5. contraindications for radiotherapy, chemotherapy and surgery; 6. conditions that the researcher thinks it is not suitable for selection.

Keywords: locally advanced rectal cancer lymph node yeild lymph node tracer stage shift prognosis
evaluate the safety of agent-797 in participants with moderate to severe difficulty breathing secondary to sars-cov-2

Conditions: Respiratory Distress Syndrome, Adult

Summary: a phase 1/2 study of agent-797 to treat moderate to severe acute respiratory distress syndrome (ards) secondary to acute respiratory syndrome coronavirus 2 (sars-cov-2) or influenza.

this is a phase 1/2 study to evaluate the safety and potential efficacy of agent-797, an unmodified, allogeneic invariant natural killer t (inkt) cell therapy, in participants with moderate to severe ards secondary to sars-cov-2 or influenza, either with intubation or at high risk to be intubated, as determined using berlin definition(s). part 1 will employ a standard 3+3 dose escalation design of agent-797. all participants will receive a single infusion of agent-797. participants will also receive other treatments and supportive care per discretion of the investigator. once the maximum tolerated dose of agent-797 has been cleared in part 1, an expansion cohort will be opened. a safety monitoring committee will be established to assess safety and decide on escalation to next cohort and expansion dose, as well as any protocol modification to include less severe cases.

Eligibility criteria:
inclusion criteria: 1. voluntarily agree to participate and can provide informed consent or have a duly appointed health care proxy establish which/who has the authority to consent on behalf of the participant 2. inpatient hospitalization 3. evidence of sars-cov-2 infection with the diagnosis of moderate to severe ards secondary to sars-cov-2 or influenza per berlin definition (ards 2012) 4. participants, or study participant's duly appointed health care proxy with the authority to consent on behalf of the participant, must consent to placement of a central venous access line for the administration of agent-797 exclusion criteria: 1. currently participating and receiving study therapy of an investigational agent that is not registered for any other indication 2. clinically significant cardiomyopathy 3. pre-existing respiratory disease, such as significant chronic obstructive pulmonary disease requiring home oxygen, hospitalization, or systemic steroid use during the past year 4. "significant" pulmonary hypertension, defined as mean pulmonary artery pressure ≥ 20 millimeters of mercury and evidence of right ventricular dysfunction or enlargement 5. receipt of vaccines containing live virus within 4 weeks prior to first dose of study treatment 6. known hypersensitivity to donor-derived cell therapy or their preservation solution 7. active systemic bacterial or fungal infection or viral co-infection 8. pregnant or lactating women 9. presence of multiorgan dysfunction syndrome; no organ failure should be seen other than the organ of interest, which is the lung

Keywords: sars-cov-2 influenza
ophthalmological screening and follow-up of optic pathway gliomas in children with neurofibromatosis type 1.

Conditions: Neurofibromatosis Type 1

Summary: the goal of this project is to get more insight into the (neuro)ophthalmological characteristics of children with neurofibromatosis type 1. this way investigators would like to update the current guidelines for follow up and treatment of optic pathway gliomas. clinical findings will be compared with the results of optical coherence tomography (oct) and mri (magnetic resonance imaging).


Eligibility criteria:
inclusion criteria: * neurofibromatosis type 1 exclusion criteria: * no neurofibromatosis type 1

Keywords: optic pathway glioma ophthalmological screening
complementary therapies for the reduction of side effects during chemotherapy for breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine wether a complementary therapy consisting of a combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation concerning nutrition and physical activity can reduce side effects of a chemotherapy in breast cancer patients.

patients were randomized to receive: (a) individual nutrition consultation with recommendations for physical activity before or on the first day of chemotherapy together with daily oral medication consisting of selenium (sodium-selenit 100 microg/d), milk thistle (silibin 280 mg/d), goldenrod (solidago 1,680g/d) and pineapple enzyme (bromelaine 3.000 f.i.p. units/d) during the first three cycles till 3-5 weeks later, (b) individual nutrition consultation with recommendations for physical activity only and (c) a leaflet "5-a-day" for the control group. primary endpoint was the difference of the global health status from the eortc qlq-c30 before and 3-5 weeks after the third cycle of chemotherapy. secondary endpoints were the other subscales of the eortc qlq c3o and br 23 and anxiety and depression from the hads-d.

Eligibility criteria:
inclusion criteria: * indication for chemotherapy for breast cancer for at least 3 cycles exclusion criteria: * prior chemotherapy within 12 months * use of herbal or nutritional supplements or other complementary or alternative medications ≥ 7 days prior to start of chemotherapy and during the trial * allergy to study medication * selenium intoxication * current use of cumarins or other medication influencing the coagulation system * edema in case of impaired cardial or renal function * other severe medical condition * psychiatric or central neurological disorders * regular fluid intake \< 2000 ml per day

Keywords: breast cancer chemotherapy phytotherapy nutritional counseling
the impact of colorectal cancer screening on surgical outcomes

Conditions: Prognosis; Colorectal Cancer; Screening

Summary: this study aims to investigate the pathological characteristics and surgical outcomes of stage iii crc patients detected through screening. data extracted from the database included the following patient information: age at diagnosis, gender, tumor location, neoadjuvant therapy, surgical procedures, histologic type, differentiation, vascular invasion, perineural invasion, pathological t stage, pathological n stage, and survival outcomes.


Eligibility criteria:
inclusion criteria: * patients who underwent radical surgery for crc, had confirmed stage iii crc through postoperative pathology, had no prior history of cancer before surgery, and had clear cancer detection information.
evaluation of physician knowledge of safety and safe use information for aflibercept in canada

Conditions: Age-related Macular Degeneration (AMD); Central Retinal Vein Occlusion (CRVO); Diabetic Macular Edema (DME)

Summary: the primary objective of this study is to measure physician knowledge and understanding of the key safety information contained in the eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.

the source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. questionnaires for physicians will be developed and tested using best practices for instrument development. the questions will be tailored to the study aims and the information provided in the the vial preparation instruction card, the intravitreal injection procedure video, and the eylea product monograph. other questions will obtain information needed to assess potential differences across subgroups and identify any biases (e.g., demographics, experience with eylea). the questionnaire will be tested through cognitive interviews with physicians. questionnaires will be tested in local languages, to assure that the introductory material, consent forms, and questionnaire items (question stems and response choices) are culturally appropriate and easily and correctly understood by individuals similar to those who will participate

Eligibility criteria:
inclusion criteria: this study will be conducted with retinal specialists and ophthalmologists in canada who have prescribed and/or administered aflibercept to at least 1 patient in the past 6 months. exclusion criteria: * none applied
massage and cold water immersion on movement variability after fatigue in swimmers

Conditions: Movement Disorders; Muscle Tone; Perceived Exertion

Summary: the goal of this clinical trial is to investigate the effectiveness of post-exercise massage and cold-water immersion compared to control in young elite swimmers. the main questions it aims to answer are: * is post-exercise techniques effective for recovery of the movement variability, , myotonometric, ergometric and perceptive parameters after fatigue? * can neuromuscular fatigue protocols impair movement variability, myotonometric, ergometric and perceptive parameters? * what tests are reliable to assess different aspects of swimmers' recovery? researchers will compare massage and cold-water immersion to control and to each other to see if recovery is antecipated. they will also compare an in-water and an out-of-water fatigue protocol to see if they are effective and can be used in different settings. participants will: * perform test and retest sessions to assess movement variability, myotonometric, ergometric and perceptive parameters. * perform an in-water fatigue protocol consisting of 8x100m front-crawl sprints * receive three recovery strategies in a randomized order (massage, cold-water immersion and control (i.e. rest) * answer a questionnaire regarding ther beliefs and preferences for recovery.


Eligibility criteria:
inclusion criteria: * male and female athletes * between 15 and 30 years old * no injury over the last month (any complaint that prevented the athlete from training or compete at least once) exclusion criteria: * use of pain killers at least 24h before study participation

Keywords: swimming massage cryotherapy movement variability
a study in participants with diabetic kidney disease

Conditions: Diabetic Kidney Disease; Diabetic Nephropathy; Diabetic Glomerulosclerosis

Summary: the purpose of this study is to determine if ly2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes.

the primary objective is to determine if ly2382770, administered monthly for 1 year, is more effective than placebo at slowing the progression of diabetic kidney disease in participants treated with an angiotensin-converting enzyme inhibitor (acei) or an angiotensin ii receptor blocker (arb).

Eligibility criteria:
main inclusion criteria: * participants with chronic kidney disease presumed due to diabetes type 1 or type 2 * participants with certain levels of kidney function - serum creatinine (scr) 1.3 to 3.3 mg/dl (115 to 291 micromol/l) inclusive for women and 1.5 to 3.5 mg/dl (132 to 309 micromol/l) inclusive for men, or an estimated glomerular filtration rate (egfr) 20 to 60 ml/min/1.73 m² * participants with protein in the urine - 24-hour urine protein/creatinine ratio (pcr) greater than or equal to 800 mg/g (greater than or equal to 91 mg/mmol). * participants must be on a stable and acceptable dose of an ace (angiotensin-converting enzyme) inhibitor or an arb (angiotensin ii receptor blocker), or not able to tolerate these medications. main exclusion criteria: * female participants who can become pregnant, are pregnant or breastfeeding * participants who have any of the following medical conditions (the site research staff will discuss these criteria and determine a participant's ability to participate) * chronic inflammatory or autoimmune diseases * chronic kidney disease from causes other than diabetes * an organ transplant * too high a blood pressure * viral hepatitis b or c liver infection, liver cirrhosis, or significant liver disease * recent gastrointestinal bleeding * acute kidney injury within the 3 months before screening * major surgery within 3 months before screening or plan to have it during the study period * hiv infection- the virus that causes aids * heart disease that is not considered stable * cancer that is too recent or other condition which poses too high a risk for developing cancer * required to take drugs that change the immune system

Keywords: chronic kidney disease diabetic kidney disease end-stage renal disease transforming growth factor beta 1 monoclonal antibody type 1 diabetes type 2 diabetes
the metformin-fmd trial

Conditions: Ischemia Reperfusion Injury; Endothelial Function

Summary: in acute myocardial infarction early restoration of coronary blood flow is the most effective strategy to limit infarct-size. paradoxically, reperfusion itself also aggravates myocardial injury and contributes to final infarct size, a process termed 'reperfusion injury'. ischemia and reperfusion (ir)-induced endothelial dysfunction seems to play a pivotal role in this process, resulting in vasoconstriction and reduced blood flow to the already ischemic tissue. recently, it has been shown that the glucose-lowering drug metformin is able to limit ir-injury in murine models of myocardial infarction, probably by increased formation of the endogenous nucleoside adenosine. in the current research proposal, the investigators aim to translate this finding to the human in vivo situation, using flow-mediated dilation (fmd) of the brachial artery as a well-validated model of (endothelial) ir-injury.


Eligibility criteria:
inclusion criteria: * age 30-50 years * written informed consent exclusion criteria: * smoking * hypertension (in supine position: systolic bp \> 140 mmhg, diastolic bp \> 90 mmhg) * hyperlipidaemia (fasting total cholesterol \> 5.5 mmol/l or random \> 6.5 mmol/l) * diabetes mellitus (fasting glucose \> 7.0 mmol/l or random glucose \> 11.0 mmol/l) * history of any cardiovascular disease * concomitant use of medication * renal dysfunction (mdrd \< 60 ml/min) * professional athletes