Kornimate/medical-research-clean huggingface dataset:
the efficacy of psb and recto-intercostal block combination on postoperative pain in patients undergoing cardiac surgery via sternotomy: case series

Conditions: Post Operative Pain

Summary: the aim of this study was to investigate the effectiveness of the combination of superficial parasternal block and recto-intercostal fascial plane block in patient groups undergoing cardiac surgery via sternotomy by evaluating postoperative pain scores and analgesic consumption.

ten patients received a combination of parasternal block and recto-intercostal fascial plane block as an intervention. patients received bilateral parasternal block and recto-intercostal fascial plane block with 0.25% bupivacaine (total volume 60 ml) in the operating room before surgery. all blocks will be performed after general anesthesia induction, before skin incision. all patients included in the study will be given 50 mg dexketoprofen and 1 g paracetamol intravenously (i.v.) 10 minutes before skin closure. all patients will be given 3x1 g iv paracetamol and 2x50 mg dexketoprofen within the first 24 hours postoperatively. numerical rating scale (nrs) was used to assess pain at the 1st, 6th, 12th, 18th and 24th hours after surgery. total morphine consumption was calculated using a patient-controlled analgesia (pca) device. tramadol was planned as rescue analgesic medication (maximum dose: 300 mg/day).

Eligibility criteria:
inclusion criteria: * adult patients over 18 years of age who will undergo cardiac surgery with sternotomy under general anesthesia and who are in classes i-ii-iii according to the american society of anesthesiologists (asa) risk classification. exclusion criteria: * patients who did not give consent, * patients with coagulopathy, * patients with signs of infection at the block application site, * patients using anticoagulants, * patients with local anesthetic drug allergies, * patients with unstable hemodynamics, * patients who could not cooperate during postoperative pain assessment

Keywords: sternotomy cardiac surgery parasternal block recto-intercostal fascial plane block postoperative pain regional anesthesia
the study of drotrecogin alfa (activated) in a subpopulation of adult patients with severe sepsis

Conditions: Sepsis

Summary: severe sepsis is defined as a systemic inflammatory response syndrome that results from infection and is associated with acute organ dysfunction. it usually results from bacterial infections, but it may occur in response to other pathogens, such as fungi, viruses, and parasites.

drotrecogin alfa (activated), a recombinant form of human activated protein c, is the first therapeutic intervention shown to reduce all-cause mortality in severe sepsis. in the phase 3 study (f1k-mc-evad; prowess), 1690 patients were randomly assigned to receive a 96-hour intravenous infusion of drotrecogin alfa (activated) 24 micrograms/kg/h or placebo (850 patients and 840 patients, respectively). overall, administration of drotrecogin alfa (activated) yielded a clinically significant reduction in 28-day all-cause mortality: 24.7% of drotrecogin alfa (activated) patients died versus 30.8% of placebo patients (19.4% relative risk reduction; p=0.005; bernard et al. 2001). the only safety concern noted in the phase 3 trial was an increased risk of serious bleeding among drotrecogin alfa (activated) patients (3.5% versus 2.0% of placebo patients). the difference between the two treatment groups in the number of patients who experienced a serious bleeding event was due to the greater number of drotrecogin alfa (activated) patients who experienced a serious bleeding event that was related to a procedure (for example, bleeding that resulted from the placement of a catheter or nephrostomy tube). the number of patients who experienced spontaneous serious bleeding events was similar between the two treatment groups. the regulatory authorities have approved the use of drotrecogin alfa (activated) in severe sepsis patients with a high level of disease severity and risk of death. thus, the regulatory authorities have requested a study evaluating drotrecogin alfa (activated) in a specific subpopulation of patients with severe sepsis and at lower risk of death.

Eligibility criteria:
inclusion criteria: * adult patients with severe sepsis. * presence of a suspected or proven infection. * one or more sepsis-associated organ failure. exclusion criteria: * are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country. * are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country. * platelet count \<30,000/mm3. * are receiving therapeutic heparin.
efficacy and safety of as012 in subjects with non-segmental vitiligo

Conditions: Non-segmental Vitiligo

Summary: this is a randomized, double blind, placebo-controlled, phase ii study. the study will be performed as a multicenter, multinational study.


Eligibility criteria:
inclusion criteria: 1. provide written informed consent. 2. male or female ≥ 18 years of age at time of screening 3. stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1 year) vitiligo 4. vasi of ≥ 4 at screening and baseline exclusion criteria: 1. segmental vitiligo, focal, or mixed vitiligo 2. subjects who have high risk of suicidality at the screening assessment based on investigator's judgment 3. history of alcohol or drug abuse in the previous 2 years 4. subjects who were submitted to melanocyte transfer -
surfactant administration via thin catheter using a specially adapted video laryngoscope

Conditions: Respiratory Distress Syndrome

Summary: in this study the investigators intend to assess the feasibility of surfactant administration via a thin catheter using a specially adapted video laryngoscope, with a groove designed to allow insertion of an endovascular catheter without the use of other instruments in the oral cavity (forceps ect.). the laryngoscope is of peak medic ltd, netania, israel.

a prospective study to assess the safety and efficacy of surfactant administration via thin catheter using a specially adapted vnscope, originally used for endotracheal intubation and adapted for the administration of surfactant without the placement of an endotracheal tube. once neonates present respiratory distress, the adapted scope will be used - clinical and outcome measures will be collected to asses the safety and efficacy of the use

Eligibility criteria:
inclusion criteria: 1. - premature infants with gestational age 30-36 weeks. 2. - diagnosis of respiratory distress syndrome 3. - treatment with antenatal steroids. 4. - spontaneously breathing with non-invasive positive pressure ventilation. 5. - maximal age 3 days. exclusion criteria: 1. - apgar score at 5 min \< 5 2. - need for chest compressions or medication upon delivery. 3. - evident major congenital malformation, metabolic or genetic disorders. 4. - clinical evidence of sepsis.

Keywords: video laryngoscope minimally invasive surfactant administration
uncover - a non-interventional study to investigate undiagnosed severe asthma

Conditions: Asthma

Summary: uncover is a non-interventional study to investigate the prevalence of difficult-to-treat and severe asthma eligible for treatment with biologics in a cohort of patients with suspected, so far undiagnosed severe asthma which were previously treated by general practitioners and office-based pulmonologists.


Eligibility criteria:
inclusion criteria: * 18 years of age or older at inclusion * written informed consent * currently diagnosed with asthma fulfilling at least one of the criteria of potential severe asthma * willing and able to complete the study questionnaire miniaqlq exclusion criteria: * biological treatment for asthma during the past 12 months * participation in a clinical trial within the last 3 months * patients who are not able to read or write, who do not understand the nature of the study or the icf or who are dependent from the investigator
optimization of treatment selection and follow up in oligometastatic colorectal cancer

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: a study investigating if analysis of circulating tumor dna (ctdna) can guide adjuvant treatment in patients with advanced colorectal cancer (crc)

an open label 1:1 randomized phase ii exploratory study investigating use of ctdna-guided adjuvant chemotherapy compared to standard of care (soc) after local treatment for metastatic colorectal cancer. patients are randomized 1:1 between soc and ctdna guided treatment and follow-up. escalation therapy comprises standard regimen of fluorouracil (5-fu), irinotecan and oxaliplatin (folfoxiri), de-escalation therapy of monotherapy capecitabine or observation only. soc is per institutional practice, based on national guidelines.

Eligibility criteria:
inclusion criteria: * radical intended treatment for metastatic spread from crc, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (crs) and hyperthermic intra-peritoneal chemotherapy (hipec) * no evidence of further disease based on pre-treatment work-up according to soc * age at least 18 years * eastern cooperative oncology group performance status 0-2 * clinically eligible for adjuvant triple ct at investigators decision. * adequate bone marrow, liver and renal function allowing systemic chemotherapy (absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 ml/min) * anticonception for fertile women and for male patients with a fertile partner. intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable * written and verbally informed consent exclusion criteria: * radiological evidence of distant metastasis, by ct- chest, abdomen, and pelvis * incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy * neuropathy national cancer institute common terminology criteria for adverse events (nci-ctcae) grade \> 1 * other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri * pregnant (positive pregnancy test) or breast feeding women * intolerance or allergy to 5fu, leucovorin, oxaliplatin, irinotecan or capecitabine

Keywords: circulating tumor dna adjuvant chemotherapy colorectal cancer metastatic
ventricular wall motion characterization

Conditions: Atrial Fibrillation; Tachycardia, Ventricular

Summary: the purpose of this study is to evaluate feasibility of using new technologies to characterize ventricular wall motion in patients indicated for mapping and ablation procedures. echo will be performed preoperatively and patients will receive a 1-month followup telephone call.


Eligibility criteria:
inclusion criteria: * be in sinus rhythm * have the ability to provide informed consent for study participation and be willing and able to comply with the clinical investigational plan described evaluations * be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (vt) or atrial fibrillation (af) according to hrs (heart rhythm society)/esc (european society of cardiology)/german national guidelines. the patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) symptomatic sustained monomorphic vt (smvt), or b) frequent pvcs, non-sustained vt, or vt that is presumed to cause ventricular dysfunction, or c) bundle branch reentrant or interfascicular vts, or d) symptomatic af with indication for ablation per current hrs/esc/german national guidelines in a patient who is either 1) refractory or intolerant to at least one class 1 or class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy exclusion criteria: * have permanent af * exhibit cheyne-stokes respiration * have a recent myocardial infarction within 40 days prior to enrollment * have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures * have had a recent cva or tia within 3 months prior to enrollment * be less than 18 years of age * be pregnant * be currently participating in any other clinical investigation
dose individualization of antineoplastic drugs and anti-infective drug in children with hematoplastic disease

Conditions: Hematological Neoplasms

Summary: the investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs in children with hematoplastic disease.

the investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs based on the opportunistic sampling strategy in children with confirmed or suspected hematological neoplasms.

Eligibility criteria:
inclusion criteria: * patients must be diagnosed with hematological neoplasms * antineoplastic drugs or anti-infective drugs used as part of regular treatment exclusion criteria: * expected survival time less than the treatment cycle; * patients with other factors that researcher considers unsuitable for inclusion.
pharmacokinetic assessment of simultaneous administration of clopidogrel and aspirin

Conditions: Coronary Artery Disease

Summary: this is a randomized, open-label, single-dose, two-sequence, two-period crossover study to investigate the pharmacokinetics between a tablet containing 75 mg of clopidogrel and 100 mg of aspirin and the simultaneous administration of the separate formulations of the two drugs in healthy male volunteers.

eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ecg) and clinical laboratory tests within 4 weeks before study drug administration. subjects suitable for this study will be admitted to the clinical trial center of ajou medical center on the day before dosing, and they will overnight-fasted from 10 p.m. of day -1. subjects will be dosed study drug (a tablet containing 75 mg of clopidogrel and 100 mg of aspirin, or the simultaneous administration of the separate formulations of the two drugs) orally with 240 ml of water around 8 a.m. of day 1. subjects will be performed scheduled pharmacokinetic sampling upto 24 hours. after 2 weeks of washout period, subjects will be dosed study drug by crossover manner, and will be performed scheduled pharmacokinetic sampling upto 24 hours. study participation will be ended on post-study visit (day 25).

Eligibility criteria:
inclusion criteria: * healthy male subjects aged 20 - 45 years * with in 20% of ideal body weight, {ideal body weight=\[height(cm)-100\]\*0.9} * agreement with written informed consent exclusion criteria: * clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (past history or present) * subject with symptoms of acute disease within 28 days of starting administration of investigational drug * subject with known for history which affect on the adme of drug clinically significant active chronic disease * inadequate result of laboratory test (especially, platelet count \ 350,000, ast/alt \> 1.25 x unl, total bilirubin \> 1.5 x unl) * positive reaction in the hbs ag, anti-hcv ab, anti-hiv ab, vdrl test * taking otc(over the counter)medicine including oriental medicine within 7 days * clinically significant allergic disease (except for mild allergic rhinitis and dermatitis seems to be not need for medication) * subject with known for hypersensitivity reaction to clopidogrel or aspirin analog * not able to taking the institutional standard meal * previously make whole blood donation within 60 days or component blood donation within 30 days * previously participated in other trial within 90 days * continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day) * an impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Keywords: healthy platelet aggregation inhibitors pharmacokinetics
a post market surveillance study of the hemovent extracorporeal cardiopulmonary support system:the mobybox trial

Conditions: Cardiac Failure; Respiratory Failure; Cardio-Respiratory Failure; Imminent Cardiorespiratory or Respiratory Failure

Summary: the purpose of this study is to evaluate prospectively the safety and performance of the mobybox system in the veno-arterial configuration in patients with cardiorespiratory failure or in the veno-venous configuration in patients with severe respiratory failure.


Eligibility criteria:
inclusion criteria: * diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent failure and 1 of the 5 following sets of findings: 1. a murray score ≥ 3.0 and/or severe hypoxemia with a pao2/fio2 \> 100 mm on 0.9 fio2; 2. uncompensated hypercapnia with ph \ 30 cm h20; 3. significant air leak/bronchopleural fistula; 4. need for intubation in a patient on lung transplant list; 5. immediate/risk of cardiac or respiratory collapse (pulmonary embolus, blocked airway, blocked blood flow, unresponsive to optimal care); * written consent of the patient or the legal guardian or external consulting physician as designated and approved by the ethics committee. exclusion criteria: * high pressure ventilation (fio2 \> 0.9 and pplateau \> 30 cm h2o) or high fio2 requirements for more than 7 days; * severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated * excessive weight (\> 180 kg) * severe irreversible brain injury (e.g., hypoxic brain injury) * inability to accept blood products; * any condition or organ dysfunction that would limit the likelihood of overall benefit from ecmo, such as severe, irreversible brain injury, hepatic and/or renal failure, or untreatable metastatic cancer; * immunosuppression with an absolute neutrophil count \< 400/mm3; * patient has been treated with ecmo ≤ 48 hours. * for veno-veno ecmo in the setting of respiratory failure the following exclusion criteria apply: * severe pulmonary hypertension (mpap \> 50 mm hg) * severe right or left sided heart failure (ef \< 25%) * for veno-arterial ecmo in the setting of cardiac insufficiency: * severe aortic regurgitation * aortic dissection. * the patient is moribund, or the patient has severe or deteriorating damage in critical body systems. * patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints. * any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
goal life-style change intervention to prevent type 2 diabetes

Conditions: Obesity; Type 2 Diabetes

Summary: life-style change achieved in controlled experimental condition has been shown to prevent type 2 diabetes. the purpose of this study is to evaluate to what extent the life-style change can be achieved in a routine health care setting.

the goal (good ageing in lahti region) program life-style change implementation trial to prevent type 2 diabetes was set to examine and enhance the effectiveness of life-style change counselling in the primary health care. in the intervention, specific nutritional, physical activity and weight loss objectives shown effective in diabetes prevention in an earlier randomised controlled trial are used as a benchmark, embedded in a structured group counselling model with an empowerment-oriented approach and adapted into the primary health care setting. in the trial, effectiveness and process are evaluated, the analyses including gender and socio-economic differences. participants were 361 middle-aged (50-65 yrs) adults at an increased risk for type 2 diabetes, recruited in 16 primary health care centres in paijat-hame, finland. intervention and data collection took place in year 2003.

Eligibility criteria:
inclusion criteria: * type 2 diabetes risk test score \> 11 (lindstrom \& tuomilehto, 2003) exclusion criteria: * mental health problem or substance abuse likely to interfere with participation * acute cancer * type 2 diabetes requiring pharmacological treatment * myocardial infarction during the past six months

Keywords: life-style counseling type 2 diabetes prediabetes physical activity diet cognitive-behavioral
traditional dietary advice versus reassurance-alone in postprandial functional dyspepsia

Conditions: Dyspepsia; Functional Gastrointestinal Disorders

Summary: functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (pds) variant. however, studies evaluating dietary modifications in pds are sparse. the investigators will perform a single-centre randomised trial evaluating traditional dietary advice (tda) in pds. 50 patients with pds will be randomly assigned to a leaflet explaining reassurance-alone +/- tda. the reassurance-alone group will be informed of the absence of organic disease and provided a diagnostic explanation of functional dyspepsia. the tda group will receive the same information but also be recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre. questionnaires are to be completed during the 4-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated leuven postprandial distress scale (lpds), gastrointestinal symptom rating scale, and napean dyspepsia quality of life index. the primary endpoint(s) to define clinical response will be evaluated over weeks 3-4 as, i) ≥50% adequate relief of dyspeptic symptoms, and ii) \>0.5-point reduction in the pds subscale of the lpds (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).


Eligibility criteria:
inclusion criteria: * fulfil rome iv symptoms criteria for functional dyspepsia * normal upper gastrointestinal endoscopy within last 3 years * online access * english literate exclusion criteria: * organic gastrointestinal diseases (e.g. inflammatory bowel disease, gi cancer, coeliac disease) * major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy) * documented h.pylori in the last 3 months * history of eating disorders * body mass index \<20 * current use of opioids or anti-inflammatory drugs * severe systemic disease (e.g. cardiac, renal, respiratory) necessitating frequent medical consultations * pregnant * diabetes mellitus * scleroderma * memory impairment * current dietary interventions