Kornimate/medical-research-clean huggingface dataset:
registry to evaluate inomax in newborn babies with pulmonary hypertension

Conditions: Pulmonary Hypertension of Newborn

Summary: pulmonary hypertension is high blood pressure in the arteries to the lungs. it is a serious condition. it causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow. when this happens, the heart has to work harder to pump the blood through. some babies are born with pulmonary hypertension (ph). doctors might use inomax (a gas the baby breathes) to help newborn babies (neonates) with ph. this study will use information from the records of registered babies to see how effective and safe inomax is for treating premature and other newborn babies for up to 11 days after they are born.


Eligibility criteria:
inclusion criteria: 1. was either a p neonate born at least 27 weeks to less than 34 weeks of gestational age (ga) or a tnt neonate born at least 34 weeks but no more than 40 weeks of ga. 2. was administered inomax therapy after birth to 7 days of age via any route (invasive or noninvasive ventilation) for a minimum treatment period of at least 24 hours up to 96 ± 12 hours. the participants may receive inomax for a longer period. 3. had ph, as confirmed by echocardiogram or a differential saturation gradient of at least 10%. 4. received inomax administration as part of routine clinical practice in a level iii or higher neonatal intensive care unit in the united states. 5. has all variables required to calculate oi or soi (a baseline sample prior to treatment and 4 samples obtained during treatment). exclusion criteria: 1. was at risk of imminent death (death expected within 24 hours). 2. received extracorporeal membrane oxygenation (ecmo). 3. had a life-threatening abnormality (cranial, cardiac, thoracic), chromosomal abnormality, congenital diaphragmatic hernia, congenital heart defect (other than patent ductus arteriosus or small atrial septal defect). 4. had been resuscitated requiring chest compressions within 6 hours of receiving inomax. 5. had grade iv bilateral intraventricular hemorrhage or periventricular leukomalacia. 6. had active uncontrolled bleeding. 7. had disseminated intravascular coagulopathy. 8. had active seizures while receiving anticonvulsants. 9. experienced prolonged asphyxia with evidence of severe acidosis (ph \< 7.25). 10. received concomitant pulmonary vasodilator therapy (eg, prostacyclin or sildenafil) except when sildenafil was used to wean the participant from inomax therapy.

Keywords: premature and term-near-term neonates
high dose bupropion for smoking cessation - pilot study

Conditions: Smoking Cessation; Smoking, Tobacco; Smoking (Tobacco) Addiction; Cessation, Tobacco; Cigarette Smoking

Summary: this study aims to investigate the benefit of administering two differing doses of bupropion (bup) to smokers to assist with smoking cessation.

participants will be randomly assigned to either receive 300 mg of bup or 450 mg of bup for 8 weeks with an aim to quit smoking. in addition, participants will simultaneously receive counseling to set a quit date and stay motivated to quit. medication will be administered up to 4 weeks before and for 4 weeks after designated quit-date. post-treatment follow-up appointment will be scheduled for 8, 16, and 26 weeks post treatment to assess commitment to quitting and overall success of the study.

Eligibility criteria:
inclusion criteria: * smokes cigarettes daily for at least 1 year * breath co of 5 ppm or higher at baseline visit * age 21 - 65 exclusion criteria: * possible drug contraindications (panic disorder, bipolar disorder, bulimia, anorexia, insomnia, suicidal ideation, alcohol withdrawal, seizures, severe hypertension, renal/hepatic impairment, angle closure glaucoma) * unstable cardiovascular disorder or uncontrolled hypertension * severe renal/hepatic impairment based on serology evaluation * history of seizures, liver failure, central nervous system tumor, central nervous system infection, hypoglycemia, hyponatremia, hypoxia, stroke arteriovenous malformation, head injury * current use of other cessation medication or counseling * history of bupropion use * current anti-psychotic, anxiolytic, antidepressant, or psychostimulant medication use, other drugs that may lower seizure threshold, cyp2b6 inhibitors, cyp2b6 inducers, drug metabolized by cyp2d6 * sudden stoppage of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs * current (past 30 days) use of illicit or medical use of prescription stimulants * currently or plan to be pregnant or breastfeeding

Keywords: bupropion smokers smoking cessation cigarette smoking cigarette
l. casei dg® in patients with irritable bowel syndrome.

Conditions: IBS - Irritable Bowel Syndrome

Summary: to assess the effect of l. casei dg® (lactobacillus paracasei cncmi1572; enterolactis® plus) on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients with ibs (irritable bowel syndrome). patients will be randomized to receive l. casei dg® capsules, b.i.d. for 12 weeks the a 4 weeks follow up period will follow.


Eligibility criteria:
inclusion criteria: * age \> 18 years and ≤ 65 years * a positive diagnosis of non constipated ibs (i.e., ibs-d and ibs-m, both males and females), according to rome iv criteria. * a negative outcome of colonoscopy performed within 5 years before screening if patient is at least 50 years old, or if patient meet any of the following alarm features: 1. has a documented weight loss within the past 6 months; or 2. has nocturnal symptoms; or 3. has a familiar history of colon cancer; or 4. has blood mixed with their stool (excluding blood from hemorroids). * negative relevant additional screening or consultation whenever appropriate * ability to conform to the study protocol. exclusion criteria: * patients with ibs-c or ibs-u according to rome iv criteria * presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values, (i.e..liver or kidney functional levels 2-times greater than the upper reference values) * ascertained intestinal organic diseases, including celiac disease, food allergies or inflammatory bowel diseases (crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis). * previous major abdominal surgery. * active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable). * untreated food intolerance such as ascertained or suspected lactose intolerance, as defined by anamnestic evaluation or, if appropriate, lactose breath test. * use of probiotics or topical and/or systemic antibiotic therapy during the last month. * systematic/frequent use of contact laxatives. * pregnant females or females of childbearing potential in the absence of effective contraceptive methods. * inability to conform to protocol. * treatment with any investigational drug within the previous 30 days. * recent history or suspicion of alcohol abuse or drug addiction. * presence of red or white flags at the rome iv psychosocial alarm questionnaire for functional gastrointestinal disorders.
phase 4 study to evaluate efficacy and safety of entelon tab.150mg in patients with chronic venous disease(cvd)

Conditions: Chronic Venous Disease

Summary: this clinical trial is a multi-center, double-blind, randomized, active controlled , parallel design, non-inferiority phase 4 study to evaluate the efficacy and safety of entelon 150mg in 278 patients with chronic venous disease.

this study is to prove that entelon tab. 150mg is non-inferior in clinical efficacy and safety compared to venitol tab. for 8 weeks in patients suffering from chronic venous disease.

Eligibility criteria:
inclusion criteria: 1. 19 years ≤ age ≤ 80 years 2. those who are diagnosed as ceap classification class 1 \~ class 3 3. those who have the venous duplex ultrasonography result at least one of the following * reflux more than 1 second in femoral vein or popliteal vein * reflux more that 0.5 second in gsv or ssv or accessory saphenous vein or perforating vein or calf vein 4. those who have completed the washout period as following until the baseline, including the screening period * analgesic, corticosteroids, anti-inflammatory drugs: at least 2 weeks 5. those who provide written consent voluntarily to participate in this clinical trial exclusion criteria: 1. those who must wear compression stockings 2. those who have obstruction of the peripheral arteries of the lower extremities 3. those who have asymptomatic varicose veins 4. those who have acute deep vein thrombosis 5. those who have frequent lower extremity pain due to neuropathy 6. varicose vein surgery patient or prospective person (if surgery was done more than 1 year prior to the time of screening, recruitment is possible) 7. those who have systemic disease that causes edema or thrombosis 8. those who have a history of malignant tumors within 5 years prior to the time of screening 9. those who have severe renal dysfunction at the time of screening (serum creatinine ≥ 2 x upper limit of normal) 10. those who have severe liver dysfunction at the time of screening (ast or alt ≥ 3 x upper limit of normal) 11. those who are required to receive diuretics, analgesics, corticosteroids, anti-inflammatory drugs, or contraindications that may affect the outcome of this clinical trial during the clinical trial period 12. those who have a history of significant mental illness, alcohol abuse 13. patients who have an allergy to investigational product or any of its excipients 14. patients who participated in other clinical trials within 12 weeks prior to the date of screening 15. pregnant or lactating woman 16. those who do not agree to use an effective method of contraception 17. individual considered by the investigator to be ineligible for study participation
study of patients with drug-induced non-variceal upper gastrointestinal bleeding

Conditions: Upper Gastrointestinal Bleeding (UGIB)

Summary: * to study the association between non-variceal ugib and the use of nsaids, vkas, doacs and antiplatelet therapy. * to compare the severity of bleeding related to specified drugs. * to determine risk factors associated with non-variceal ugib.

upper gastrointestinal bleeding (ugib) carries a high mortality, especially in elderly patients having co-morbidities, and the incidence of non-variceal and variceal bleeding is reported to be 3.5% and 15%, respectively. atrial fibrillation, deep vein thrombosis, pulmonary embolism, and other conditions require anticoagulation, non-steroidal anti-inflammatory drugs (nsaids) and antiplatelet therapy putting the patients at high risk of hemorrhage. the latest american heart association (aha) report on cardiovascular diseases suggests a doubling of the prevalence of atrial fibrillation by 2030 compared to 2010. the need to institute anticoagulation for this condition, both as primary and secondary prevention, will automatically increase the number of ugib cases. an improvement in this regard has occurred with the advent of direct oral anticoagulants (doacs) which have been shown to be non-inferior to vitamin k antagonists (vkas). in the event of ugib, the rockall score is a valid prediction score, repeatedly confirmed to assess the risk of patients with non-variceal bleeding. the management of ugib is commonly adapted according to this score. identifying high-risk patients who may benefit from longer hospitalization is crucial.

Eligibility criteria:
inclusion criteria: * adult patients (aged 18 years and above) presented with signs and symptoms of ugib (hematemesis and/or melena) exclusion criteria: * variceal bleeding * age below 18 years * pregnant women * consent refusal
salbutamol use in ozone air pollution by people with asthma and/or exercise induced bronchoconstriction (eib)

Conditions: Asthma and/or Exercise Induced Bronchoconstriction; Ozone Air Pollution

Summary: salbutamol use is increased in areas with high levels of ozone pollution and the potential consequences of this are not well known. the purpose of this study is to examine the effect of salbutamol on lung function and inflammation in people with asthma and/or eib exercising in ozone air pollution. to examine this, we are planning a randomized cross over trial where people with asthma and/or eib complete sub maximal exercise in four conditions on four separate days. the four condition are: ozone + salbutamol, filtered air + salbutamol, ozone + placebo medication, and filtered air + placebo medication.


Eligibility criteria:
inclusion criteria: * have asthma and/or eib * able to perform maximal exercise * able to communicate sufficiently using the english language exclusion criteria: * allergic to salbutamol (also known as ventolin) * pregnant or potentially pregnant * have a history of smoking * had an upper respiratory tract infection within the last 4 weeks * have a chronic respiratory disease other than asthma or eib

Keywords: asthma exercise induced bronchoconstriction salbutamol ozone
how many patients suffering major trauma would be eligible for a pre-hospital transfusion

Conditions: Trauma Injury

Summary: the aim of the study is to measure the number of patients being cared for by a medical team for major trauma who could benefit from a transfusion labile blood products and thus provide a scientific argument in favour of supplying labile blood products to pre-hospital

in france, pre-hospital resuscitation of major trauma patients does not use labile blood products, except in exceptional circumstances. the physician staffed mobile intensive care unit (micu) are not equipped with this type of product. the first cause of death compatible with survival in the event of pre-hospital treatment identified in major trauma in war medicine is exsanguination. mortality in haemorrhagic shock occurs rapidly and appears to be significantly reduced if transfusions are performed early. early transfusion has proved its worth in the military context, leading the armed forces health service to recommend transfusion as a first-line treatment as quickly as possible, from the moment the patient is taken into care on the battlefield. more recently, in the north american civilian pre-hospital setting, the pamper study included 501 patients, 230 of whom were transfused with fresh frozen plasma (ffp - 2 units). the authors reported a significant reduction in mortality at d+30 in the ffp group (23.2% vs 33%; p=0.03). it therefore seems that transfusion as early as possible is associated with a reduction in mortality in the context of major trauma. the aim of the study is to measure the number of patients being cared for by a medical team for major trauma who could benefit from a transfusion labile blood products and thus provide a scientific argument in favour of supplying labile blood products to pre-hospital.

Eligibility criteria:
inclusion criteria : * patients over 18 * taken care of by a micu team from participating centres * victims of major trauma requiring transport to an emergency/recovery unit or declared dead during care * informed and did not object to the collection of his data for research purposes during his lifetime exclusion criteria : * traumatological reason for departure not confirmed in the emergency medical services report * patient care of by the micu for secondary transport (transport from one hospital to another) * patient died without resuscitation by a professional * patient with manifest isolated closed head injury * patient deprived of civil rights

Keywords: major trauma mobile intensive care unit (mciu) out of hospital emergency care blood transfusion
the clinical characteristics of the patients with choledocholithiasis without cholangitis

Conditions: Choledocholithiasis

Summary: laboratory change induced by common bile duct (cbd) stone is in general observed as the higher elevation of alkaline phosphatase (alp) and gamma-glutamyl transpeptideas (ɤ-gt), in comparison to those of aspartate aminotransferase (ast) and alanine aminotransferase (alt). however, some patients with cbd stone show the marked increased level of aminotransferase, which sometimes leads to misdiagnose those as liver disease caused by viral hepatitis, ischemia, and drug toxicity. the aim of this study is to investigate the clinicopathologic features of patients with cbd stones with the high level of aminotransferase in serum.


Eligibility criteria:
inclusion criteria: 1. patients were diagnosed with cbd stone under endoscopic retrograde cholangiopancreatography (ercp) 2. patients showing above 400 iu/l of aminotransferase when at the first admitted into hospital and the control groups is the patients displaying normal ast and alt. exclusion criteria: * 1. underlying hepatobiliary disease 2. alcoholics 3. cholangitis
improving polyp detection rate by artificial intelligence in colonoscopy

Conditions: Colonic Polyp

Summary: the aim of this study is to investigate if the use of artificial intelligence (ai) in colonoscopy improves the polyp detection rate, and if the use of ai has a learning effect.

the endoscopists will use gi genius from medtronic, a device that uses artificial intelligence (ai) based on machine learning to detect polyps in the colon in real time during colonoscopy. the device interprets the endoscopy pictures and superimposes possible polyps with frames. the patients will be included in regular outpatient clinics in western norway. the endoscopists will be divided into groups depending on their experience. the endoscopists will perform colonoscopies in three phases; (1) before the use of ai, (2) during the use of ai and (3) after the use of ai. the investigators will then evaluate the polyp detection rate (pdr) in the three phases to see if ai increases pdr, and if there is a learning effect on pdr after the use of ai. the investigators will also evaluate if there is a difference in the learning-effect from ai-use depending on if the endoscopist is experienced or inexperienced. the pdr's are registered as part of norway's national quality register of colonoscopy, gastronet. the data registered in gastronet can also help the investigators evaluate other outcomes such as withdrawal time, bowel preparation, patient reported pain, patient satisfaction and complications.

Eligibility criteria:
inclusion criteria: * patients coming to outpatient clinics to perform colonoscopies exclusion criteria: * total colectomy * reservation against registration in gastronet, the national quality register for colonoscopy in norway

Keywords: colonoscopy artificial intelligence polyp detection
study to assess steady-state trough concentrations, safety, and immunogenicity of abatacept after subcutaneous (sc) administration to subjects with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to study serum levels of abatacept after subcutaneous dosing in subjects with ra.


Eligibility criteria:
inclusion criteria: * meet ara criteria for diagnosis of ra with active disease. * ra diagnosis for at least 1 year. * \> = 6 swollen joints. * \> = 8 tender joints. * taking methotrexate (mtx) or mtx plus not more than 1 added oral dmard for \> = 3 months and stable for 28 days prior to dosing. exclusion criteria: * serious acute or bacterial infection in last 3 months. * chronic or recurrent bacterial infections. * history of tb within previous 3 years or old tb not adequately treated. * specific lab test abnormalities * history of cancer within 5 years. * exposure to ctla4ig (cytotoxic t-lymphocyte (t-cell)-associated antigen 4ig), belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic. * treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, d-penicillamine or calcineurin inhibitors. * exposure to live vaccines.
creating lasik flaps with the lensx femtosecond laser

Conditions: Myopia; Hyperopia

Summary: this will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo lasik surgery requiring an initial corneal flap. subjects will be screened for eligibility. subjects will undergo lasik surgery using the lensx laser to create the corneal flap prior to excimer laser treatment. subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. all patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.


Eligibility criteria:
inclusion criteria: 1. must have myopia or hyperopia eligible for femtosecond initiated lasik surgery 2. must be over 18 years of age 3. must have visual acuity correctable to at least 20/25 in both eyes 4. if subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses) 5. must be willing and able to return for scheduled follow up examinations through 3 months after surgery 6. must sign and be given a copy of the written informed consent form 7. postoperative refractive target is emmetropia exclusion criteria: 1. known sensitivity to planned study concomitant medications 2. participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation 3. presenting any contraindications to femtosecond initiated lasik 4. corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated 5. irregular astigmatism, based on investigator's judgment 6. undergoing monovision lasik 7. pregnant, lactating or plan to become pregnant during the course of this study 8. for bilateral second study eyes only: the surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.

Keywords: flap creation femtosecond laser corneal flap prior to lasik procedure