Kornimate/medical-research-clean huggingface dataset:
study on how fiasp® can influence blood sugar levels of type1 diabetic patients in their daily lives, with the help of the freestyle libre® device

Conditions: Diabetes; Diabetes Mellitus, Type 1 Diabetes

Summary: the purpose of this study is to collect information about fiasp® to evaluate how effective fiasp® is in treating elevated blood sugar in patients with type 1 diabetes, compared with the participant's previous insulin treatment. the study will also assess how satisfied the participants are with the treatment with fiasp® and the impact of the treatment on quality of life. the study has also been set up to learn more about how effective fiasp® is in controlling the glucose levels during the day and night. the duration of the study is expected to be approximately 2 years. the participation is expected to be approximately 6-8 months for each patient.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) * the decision to initiate treatment with commercially available fiasp® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study * male or female, age greater than or equal to 18 years at the time of signing informed consent * diagnosed with t1dm at least 1 year prior to inclusion in the study * stable treatment by mdi/csii for at least 6 months prior to inclusion in the study. stable treatment is defined as not changing the treatment method, with dose adjustments allowed * regular (defined as usage on a monthly basis) user of freestyle libre® flash glucose monitoring for at least 6 months as the only continuous glucose monitoring (cgm) system actively used and availability of a full 2 weeks sensor download as "csv" file with 80% completeness of the data (if more sensor data are available, the 2 week data closest to baseline visit will be used) * latest hba1c value measured in the 3 months prior to inclusion in the study between 7.5-9.5% exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * anti-diabetic treatment intensification during the last 3 months prior to inclusion in the study. treatment intensification is defined as adding new anti-diabetic medication to previous treatment regimen * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, certain intrauterine devices), or sexual abstinence or a vasectomised partner
assessing the efficacy of iv ibuprofen for treatment of pain in orthopedic trauma patients

Conditions: Pain

Summary: study objectives: 1. to evaluate the effectiveness of around the clock (otc) iv ibuprofen (8 doses) in decreasing pain in orthopedic trauma patients with fractures of the extremities, face, pelvis and/or ribs compared to patients not receiving the medication. 2. to evaluate the effectiveness of around the clock (otc) iv ibuprofen (8 doses) in decreasing the use of opioid analgesics among orthopedic trauma patients with fractures of the extremities, face, pelvis, and/or ribs compared to compared to patients not receiving the medication.

eligible patients were trauma patients between the ages of 18 and 75 years old with adequate iv access who were able to self-report and communicate pain severity and who were consecutively admitted to the trauma intensive care unit (icu) or trauma step-down units with a fracture of the ribs, face, extremities and/or pelvis. eligible patients who signed the informed consent were randomized to either iv ibuprofen (caldolor®) or placebo via a computer-generated randomization list. patients had pain measured using a numerical rating scale (nrs) that ranged from 0 (no pain) to 10 (worst possible pain)

Eligibility criteria:
inclusion criteria: 1. trauma patient admitted to trauma icu or trauma step-down units. 2. fracture of ribs, face, extremities and/or pelvis 3. age between 18 and 75 years old 4. adequate iv access 5. able to self report and communicate pain severity exclusion criteria: 1. history of allergy or hypersensitivity to any component of iv ibuprofen, aspirin (or aspirin related products) nsaids, or cox-2 inhibitors 2. any intracranial or spinal cord trauma 3. history of clinically significant bleeding disorders including itp, dic or platelet dysfunction 4. recent history of intracranial surgery or stroke (within past 30 days) 5. history of ulcers, gastritis or previous gi bleeding 6. renal impairment (creatinine \> 3.0 mg/dl) 7. pregnant or breastfeeding 8. otherwise unsuitable in the opinion of the treating physician at time of randomization.

Keywords: ibuprofen caldolor orthopedic trauma
usefulness of sterile adhesive dressing at the exit-site of peritoneal dialysis catheter

Conditions: Peritoneal Dialysis

Summary: infection of peritoneal dialysis fluid is a major complication in patients treated with peritoneal dialysis (pd). the aim of catheter emergence care is to reduce bacterial contamination of the peritoneum. the recommendations of the international society of peritoneal dialysis do not provide information on the frequency of care delivery or the usefulness of a sterile adhesive dressing. thus each treatment center applies a protocol of its own. dressing is common practice although its safety and interest are not demonstrated. the usefulness of dressing is still to be demonstrated. on the other hand, the efficacy of the application in prevention of a cream of mupirocin at emergence on the reduction of the risk of infection with staphylococcus aureus (sa), the most frequent germ found in peritonitis, has been demonstrated. a spanish study showed that during a peritoneal infection at sa the site most frequently colonized by a similar strain of sa was the emergence of the catheter. it can be considered that an infection of the dialysis liquid in pd is not only related to the quality of emergency care but also to manipulations during exchanges. given the number of patients involved in pd in france, it is difficult to obtain sufficient power to formally demonstrate the non-inferiority of the absence of dressing. therefore, the investigators propose a descriptive, exploratory study of events that may occur in pd when a dressing is not applied. this is a step prior to performing a multicenter randomized comparative study that will aim to show the non-inferiority of the absence of dressing compared to the application of a dressing on the incidence of fluid infection. peritoneal dialysis.


Eligibility criteria:
inclusion criteria: * patient who has been informed and has given free and informed consent * patient affiliated to a social security scheme exclusion criteria: * inclusion of the patient in another biomedical research protocol that influences the risk of infection * burial of the catheter before the initiation of dialysis treatment second attempt at treatment with peritoneal dialysis following catheter removal and resection * patient under curatorq * pregnant woman

Keywords: peritoneal dialysis dressing exit-site catheter infection
famotidine compared with pantoprazole to prevent recurrent aspirin-induced peptic ulcer/erosion

Conditions: Peptic Ulcer/Erosions

Summary: low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects. the position of h2-receptor antagonists as a step-down therapy after healing of peptic ulcer or erosions by proton pump inhibitor is unclear. the objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin

low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease . its use is frequently limited by gastrointestinal side effects, ranging from dyspepsia (31%) to life-threatening bleeding or perforation of gastroduodenal ulcers (3.1%) over a period of 4 years . the best approach for the secondary prevention of low-dose aspirin induced symptomatic peptic ulcer or erosions in patients who need to continue aspirin remain uncertain. at present, eradication of helicobacter pylori infection and long-term maintenance with proton pump inhibitor ppi appears to be the best options. the position of h2-receptor antagonists (h2ra) as a step-down therapy after healing of peptic ulcer or erosions is unclear. the objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin.

Eligibility criteria:
inclusion criteria: * upper gib or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg * endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum * they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks * 18 years old or older. exclusion criteria: * concurrent erosive or ulcerative esophagitis * pyloric stenosis * previous gastric or duodenal surgery other than oversewing of a perforation * thrombocytopenia * renal failure with estimated creatinine clearance less than 10 ml / min * active cancer * known allergic to aspirin, famotidine or pantoprazole * pregnancy, lactation, child-bearing potential in the absence of contraception * psychosomatic disorder * planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant * disorders that might modify the absorption of study drugs

Keywords: pantoprazole famotidine aspirin dyspepsia gastrointestinal bleeding peptic ulcer / erosion
combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis

Conditions: Non-Cystic Fibrosis Bronchiectasis

Summary: this is a multi-centered, randomized, controlled study to assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.

objective: to assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance. methods: patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive nebulized amikacin bid for 14 days in combination with standard treatment) or the control group (participants receive nebulized 0.9% saline bid for 14 days in combination with standard treatment). the primary endpoint was bacterial clearance rate of sputum. expected results: compared with the control group, bacterial clearance rate of sputum of the observer group will increase significantly.

Eligibility criteria:
inclusion criteria: * male or female study subjects ≥18 years of age and ≤80 years of age; * confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis; * confirmation of infection with pseudomonas aeruginosa at screening; * are sensitive to amikacin; * acute exacerbation of bronchiectasis. exclusion criteria: * bronchiectasis due to special causes; * smokers; * are associated with bronchial asthma; * have any serious or active medical or psychiatric illness; * be allergic to amikacin or not tolerant to nebulised amikacin(fev1 reduces ≥15% after inhaling amikacin.

Keywords: nebulized amikacin; non-cystic fibrosis bronchiectasis; bacterial clearance rate of sputum； acute exacerbation.
evaluation of upper abdomen imaging with low field mri scanner (0.4t)

Conditions: Abdominal Pain

Summary: the goal of this observational, cross-sectional, prospective study is to compare the quality of the image obtained on the upper abdomen organs with a low-field 0.4 t mri system with the one obtained with a high-field 1.5 t mri system, taken as a comparator and reference device. the study is conducted on 40 consecutive adults, not vulnerable, patients who are already scheduled for diagnostic imaging examinations on the upper abdominal organs with the reference device.

the primary endpoint of the study is to : a) compare the image quality of the upper abdominal organs obtained with 0.4 t systems and with 1.5 t systems; this will be assessed via a noninferiority study on image quality. the image quality will be assessed by two experienced radiologists (more than 5 years' experience) and a trainee radiologist (at least 2 years) via blinded independent readings of the diagnostic images acquired both on the low-field 0.4t mri device and on reference device e.g. the high-end 1.5t mri device secondary endpoints of this study are: 1. evaluate the accuracy of representation and measurement (diameters, volumes) of the gallbladder and bile and pancreatic ducts; 2. compare the exam comfort with 0.4 t systems and with 1.5 t systems by means of questionnaires on the exam comfort provided to the subjects

Eligibility criteria:
inclusion criteria: * all subjects (in-patients or out-patients) who go to the diagnostic clinical center with the indication of performing an upper abdomen mri examination with mri 1.5t * age :18 years old or higher * the subject must be capable and willing to fulfill all study requirements exclusion criteria: * pregnancy, * poor cooperation * claustrophobia (only for 1.5t mri)
combined dialectical behavior therapy and digital cognitive behavioral therapy for insomnia for adolescents at high risk for suicide

Conditions: Suicide and Self-harm

Summary: the proposed research addresses the urgent need to reduce suicide rates among teens. this will be the first study that the investigators know of that will examine the feasibility and preliminary effectiveness of augmenting a suicide-focused treatment (dialectical behavior therapy, \[dbt\]) with an evidence-based treatment protocol for insomnia (a digital version of cognitive behavioral therapy for insomnia \[cbt-i\]). the goal of this clinical trial is to learn providing insomnia treatment in conjunction with suicide-focused treatment leads to greater reductions in suicidality and self-harm than suicide-focused treatment alone. participants will be randomly assigned to receive 6 months of dbt plus cbt-i or to dbt alone and will complete research assessments measuring suicidal ideation, self-harm behavior and insomnia symptoms every four weeks over the course of the study, as well as one post-treatment follow-up assessment. participants will also wear a device on their wrist (like a fitbit or wristwatch) for 10 days following each assessment to collect data about their sleep.


Eligibility criteria:
inclusion criteria: 1. 12-18 years of age and not yet graduated from high school. 2. insomnia symptoms, defined as a total score of ≥ 8 on the insomnia severity index . 3. high suicide risk, defined as: \>1 lifetime suicide attempt, b) \> 3 lifetime sh episodes (with at least 1 in the 12 weeks before baseline screening) and c) elevated si (≥31 on the siq-jr.). 4. if taking medication for psychiatric disorders or sleep, must be on a stable dose (\>2 months). 5. youth and parent both speak english. 6. at least one family member or responsible adult agrees to participate in assessments and in the dbt multi-family skills group. 7. youth lives at home. exclusion criteria: 1. significant current mania or psychosis; life threatening anorexia, or other diagnosis of a severe mental or physical condition requiring treatment specific to that disorder and/or that interferes with participation in assessments or treatment. 2. a history of being diagnosed with an autism spectrum disorder. 3. has a comorbid untreated sleep apnea or a severe circadian sleep-wake disorder with a habitual bedtime after 3 am or habitual rise time after 11 am. 4. insomnia symptoms are significantly impacted by substance use or withdrawal of psychoactive medications. 5. has conditions that require caution when implementing cbti, such as bipolar and seizure disorders. 6. court-ordered to treatment.
registry to evaluate chinese real-world clinical outcomes in patients with af using the watchman left atrial appendage closure technology

Conditions: Non-valvular Atrial Fibrillation

Summary: the aim of the registry is to evaluate chinese real-world clinical outcomes in patients with af using the watchman left atrial appendage closure technology


Eligibility criteria:
inclusion criteria: 1. patient is 18 years of age or above; 2. patient is eligible for a watchman device according to current international and local guide-lines and per physician discretion; 3. patient is willing and capable of providing informed consent to participate in all procedures associated with receiving a watchman device at an approved clinical investigational center. exclusion criteria: 1. patient is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. 2. patient is a woman of childbearing potential who is, or plans on becoming, pregnant during the duration of follow-up assessments required as part of the watchman procedure. 3. patient is unable or not willing to complete follow-up visits and examination as required as part of the watchman procedure.

Keywords: atrial fibrillation
a sub-study of bms-986036 in subjects with non-alcoholic steatohepatitis (nash)

Conditions: Non-Alcoholic Steatohepatitis

Summary: the purpose of this sub-study of mb130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of bms-986036 20 mg qd in subjects with non-alcoholic steatohepatitis (nash)


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * male or female between 21 and 75 years old * body mass index (bmi) of 25 or more exclusion criteria: * chronic liver disease other than nash * uncontrolled diabetes * any major surgery within 6 weeks of screening * unable to self-administer under the skin injections * any bone trauma, fracture or bone surgery within 8 weeks of screening

Keywords: first line therapy nash
clinical study of abcd in the treatment of cryptococcal meningitis

Conditions: Cryptococcal Meningitis

Summary: to evaluate the efficacy and safety of abcd in the treatment of cryptococcal meningitis in non-hiv patients at week 4, the end of induction therapy, week 10 and the end of consolidation therapy.

this study is a multi-center, single-arm clinical study. the objective is to evaluate the efficacy and safety of abcd in the treatment of cryptococcal meningitis in non-hiv patients. qualified subjects shall receive cryptococcus induction therapy with abcd combined with flucytosine for at least 4 weeks, or termination of treatment early at the investigator's discretion. efficacy and safety are followed up at week 4 (day 28), the end of induction therapy, week 10 (day 70) and the end of consolidation therapy.

Eligibility criteria:
inclusion criteria: * ≥18 years old and ≤70 years old, no gender limitation; * diagnosis of cryptococcal meningitis (with or without other cryptococcal lesions) based on csf culture and/or csf ink staining smear and/or csf antigen testing; * the researcher believes that patients can benefit from participating in this study; * the subjects voluntarily participated in the study and signed the informed consent. exclusion criteria: * patients with other invasive fungal diseases; * hiv infected patients; * patients who received intravenous polyene treatment within the past 6 months; * allergic to amphotericin b colloidal dispersion or other ingredients in this product; * patients with abnormal liver function \[aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>＝5 times the upper limit of normal value (uln) without total bilirubin elevation, or alt or ast \>＝ 3 times uln with total bilirubin \>＝ 1.5 times\]; * patients with impaired renal function (renal function index blood creatinine (cr) is more than 2 times higher than uln, or 24-hour urine creatinine clearance rate （ccr） is less than 50ml/min), or patients requiring/undergoing hemodialysis or peritoneal dialysis; * pregnant women, breast-feeding women and women of childbearing age who were unable to take effective contraceptive measures during the study period; * conditions considered unsuitable for the study by the investigator, such as concomitancy of severe organ insufficiency, clinically significant laboratory abnormalities, comprehension or compliance problems, etc.

Keywords: cryptococcal meningitis amphotericin b colloidal dispersion non-hiv patients
a study to evaluate lebrikizumab (milr1444a) in adult patients with asthma who are not taking inhaled corticosteroids

Conditions: Asthma

Summary: this is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. the purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.


Eligibility criteria:
inclusion criteria: * body weight ≥ 50 kg and ≤ 150 kg at visit 1 * chest radiograph within 12 months of visit 1 without evidence of a clinically significant abnormality * stable asthma exclusion criteria: * asthma exacerbation during screening * known malignancy * known immunodeficiency * pre-existing lung disease other than asthma * uncontrolled clinically significant medical disease * current smoker * history of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator * prior allergic reaction to a monoclonal antibody * patients (men and women) of reproductive potential who are not willing to use contraception * pregnancy

Keywords: milr1444a
comparison of simultaneous laparoscopic and open operations for synchronous liver metastases with colorectal cancer

Conditions: Optimization of Treatment

Summary: retrospective analysis of medical records of patients with synchronous liver metastatic colorectal cancer, who underwent simultaneous operations on the intestine and on the liver, from january 2011 to november 2020 at the russian scientific center for roentgenoradiology. 2 groups of 21 patients each were formed: group 1 included a patient with simultaneous laparoscopic operations, group 2 included a patient with simultaneous open operations.


Eligibility criteria:
inclusion criteria: * patients with synchronous metastatic liver lesions with colorectal cancer exclusion criteria: -