Kornimate/medical-research-clean huggingface dataset:
n-acetyl-cysteine (nac) for healing of amputation stumps in the setting of diabetes

Conditions: Diabetes Mellitus; Critical Limb Ischemia; Lower Limb Amputation Knee; Peripheral Arterial Disease

Summary: in this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (cli) who undergo a major (above-knee or below-knee) lower extremity amputation. by exploring the primary endpoints we aim to determine whether nac can affect amputation stump perfusion and healing. based on preclinical data, the investigators hypothesize that nac will augment both amputation stump perfusion as well as healing. the investigators will utilize the data from this trial to determine the true effect size that is necessary for a larger clinical trial to determine the clinical efficacy of nac is healing surgical sites such as major lower extremity amputation stumps.

in this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial, in 50 participants with cli who have undergone a major (above-knee or below-knee) lower extremity amputation. 25 participants will receive nac 1200mg intravenously twice a day for 6 consecutive days following amputation. 25 participants will receive placebo saline intravenous infusion twice a day for 6 days following amputation. post-amputation participants will be monitored for specific anthropometric parameters and stump perfusion assessments (using laser-assisted fluorescent angiography and transcutaneous oxygen pressure measurement). the primary study endpoints are to determine if lower extremity stump healing and perfusion are affected by perioperative nac administration. a secondary endpoint will be to determine the effect size that would be necessary to power a larger clinical trial to determine whether nac treatment can affect tissue perfusion and healing at major lower extremity amputation stumps in participants with cli.

Eligibility criteria:
inclusion criteria: * subject undergoing elective major (above-knee or below-knee) lower extremity amputation for cli * both male and female patients * all ethnic groups * between of the ages of 30-90 years old * adequate nutritional status - defined as bmi \> 19 exclusion criteria: * pregnant women, and women who are breastfeeding * known history of end-stage liver disease * severe asthma * heavy alcohol consumption (male \> 2 drinks per day and women \> 1 drink per day) * individuals actively receiving chemotherapy. * anticipated enrollment in another study that investigates another drug agent within 30 days from enrollment in this study. * patients receiving carbamazepine. * severe anemia (hct \< 22). * allergy to either nac or indocyanine green (icg). * patients with open wound(s) from a prior amputation on the ipsilateral limb (excluding patients who had prior partial foot amputation, who are now requiring a below-knee or above-knee amputation).
pbp vs traditional training: the t-rec trial

Conditions: Educational Problems

Summary: this randomized controlled trial aims to compare the effectiveness of traditional training approach to training with the proficiency-based progression (pbp) approach for teaching the technical skills (ts) and non-technical skills (nts) for surgeons in the context of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery.

in a prospective, randomized and blinded study surgical residents (n = 48) from belgium university (i.e. the katholieke universiteit \[ku\] leuven and university of gent residency training programs) will be enrolled and randomized to traditional type training proficiency-based progression (pbp) training to learn how to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model. specifically, this study will include four independent arms, each employing different training methodologies for technical skills (ts) and non-technical skills (nts). group 1 will receive standard training for both ts and nts. group 2 will receive pbp training for ts and standard training for nts. group 3 will receive standard training for ts and pbp training for nts. group 4 will receive pbp training for both ts and nts. all four group will receive the same e-learning on ts and nts (on an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery on a dry lab model). the pbp trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., for the e-learning, ts and nts). the traditional trained group will train in the same laboratory for a case-matched period of time as the pbp group, with the same level of supervising faculty proctors and using the same training resources but with no proficiency benchmarks. investigators will be trained in pairs to assess performance from a pre-defined set of explicitly defined binary metric events reliably (inter-rater reliability \> 0.8). they will also be blinded as to the identity of the trainee performing the procedure, how they were trained (i.e., group) and procedure order. h1 it is hypothesized that implementation of pbp training in teaching ts and nts for surgeons in the context of an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery, leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to traditional training.

Eligibility criteria:
inclusion criteria: * recently accepted, form first to last year residents' gynecology and obstetrics, urology and general surgery. * ability to perform a laparotomy exclusion criteria: * any robotic experience with emergency undocking.

Keywords: training robotic surgery proficiency based progression emergency undocking
heart failure treatment pattern analysis of hf patients in hf centers and non-hf centers in china

Conditions: Heart Failure

Summary: this is a retrospective, researcher-initiated, database-based study that will retrospectively observe the treatment and medication patterns of about 22,500 patients with heart failure from 25 heart failure centers and 25 non-heart failure centers in the database of heart failure center. the proportion of patients with heart failure treatment drugs reaching the target dose recommended in the guidelines and discontinuation rate will be observed at 1 month, 3 months and 12 months follow up time point. the purpose of this study is to illustrate the current hf treatment status in hf center hospitals and non-hf center hospitals, which may provide insights for improving the clinical practice of heart failure treatment in china, and promote the standardization of heart failure treatment in china.


Eligibility criteria:
inclusion criteria: * an index hf diagnosis date in the records * age ≥ 18 years old at initial diagnosis date * hf patients baseline characteristic record
chronic subdural hematoma - reduction of recurrence by treatment with angiotensin converting enzyme inhibitors

Conditions: Hematoma, Subdural, Chronic

Summary: the project aims at investigating if treatment with the angiotensin converting enzyme inhibitor coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.

previous studies have indicated that treatment with ace inhibitors can reduce the risk of recurrence of csdh after surgical evacuation. this randomized clinical trial was designed to investigate this

Eligibility criteria:
inclusion criteria: 1. patients with chronic subdural hematoma that needs surgical evacuation 2. age \> 18 year exclusion criteria: 1. lack of compliance 2. kidney artery stenosis 3. stenosis of the aorta 4. severely decreased kidney function 5. allergy or intolerance/contraindications toward ace inhibitors 6. already in ace inhibitor treatment 7. coagulopathies 8. malignant disorders 9. fertile women 10. other neurological disorders 11. treatment with pharmaceuticals contraindicating treatment with ace inhibitors
extubation readiness and neuroventilatory efficiency after acute respiratory failure

Conditions: Respiratory Failure

Summary: the aim of this study was to compare the indices of rapid shallow breathing, neuromechanical efficiency (nme), and neuroventilatory efficiency (nve) between patients being successfully extubated and those who failed weaning.

patients, mechanically ventilated for \> 24 h, were included when they met criteria for their first spontaneous breathing trial (sbt) on continuous positive airway pressure (cpap) (5-6 cmh2o) for 30 minutes. patients who did not fulfill the criteria for successful sbt, or required assist, or deceased within 48h post-extubation were considered extubation failure (f). patients who completed the sbt and remained extubated \> 48 h were considered successfully extubated (s). before and during the sbt, arterial blood gases, heart, rate, blood pressure, and eadi, flow, vt, f, and, airway pressure (paw) were measured. at 0, 5, 10, 15 and 30 minutes of the sbt, f/vt, diaphragm electrical activity (eadi), nme, and nve were calculated. nme was calculated as paw/eadi during inspiratory occlusion. nve was calculated as vt/eadi during unassisted inspirations.arterial blood gases, heart rate, and blood pressure were measured. the receiver operating characteristic (roc) curve was calculated to evaluate the predictive performance of each index.

Eligibility criteria:
inclusion criteria: * we chose a number of eligible patients which were admitted to icu of the zhong-da hospital and required mechanical ventilation for more than 24 h. exclusion criteria: (1) age \ 85 years, (2) tracheostomy, (3) treatment abandonment, (4) history of esophageal varices, (5) gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days, (6) coagulation disorders (inr ratio\>1.5 and aptt\>44 s), (7) history of acute central or peripheral nervous system disorder or severe neuromuscular disease, (8) history of leukemia, severe chronic liver or chronic cardiac disease, (9) solid organ transplantation, (10) malignant tumor

Keywords: neuromechanical efficiency neuroventilatory efficiency weaning respiration, artificial
bases trial: basel starch evaluation in sepsis

Conditions: Sepsis; Severe Sepsis; Septic Shock

Summary: background: in patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality. standard infusion therapy consists of crystalloid infusions. the role of modern, low molecular weight, starch preparations and their influence on the course of disease is not determined yet. hypothesis: the purpose of this study is to determine wether initial infusion therapy with hydroxyethylstarch and ringer's lactate reduces in septic patients reduces intensive care unit and hospital length of stay without impairment of renal function design: double-blind, randomized, controlled monocentric study setting: intensive care units of a university hospital patients: 240 consecutive patients with sepsis, severe sepsis and septic shock intervention: volume therapy with ringer's lactate and saline or hydroxy-ethyl starch (mw 130, substitution 0.4) in the first five days of intensive care treatment. parameter: * intensive care length of stay * hospital length of stay * mortality * kidney function statistics: mann-whitney test for non-parametric data like intensive care length of stay. unpaired t-test for kidney function parameters. study withdrawal: significant impairment of kidney function parameters in the hydroxy-ethyl starch group


Eligibility criteria:
inclusion criteria: * patients with suspected or proven infection and 2 of the following 6 criteria: * body temperature \ 38.3° celsius * heart rate \> 90 beats/min * tachypnea \> 20/min or a arterial pco2 below 4.25 kpa * white blood cell count higher than 12.000 or below 4.000 or more than 10% immature forms * systolic blood pressure \<90 mmhg or mean arterial pressure \< 65 mmhg * altered mental state or oliguria exclusion criteria: * pregnancy * age below 18 * allergy against hydroxyethyl starch * chronic renal insufficiency

Keywords: hydroxyethyl starch shock, septic infusion, intravenous mortality
the atrial high rate episodes in pacemaker patients

Conditions: Arrhythmia; Atrial Fibrillation; Atrioventricular Block; Bradycardia; Sick Sinus Syndrome

Summary: prospective study assessing the incidence of atrial high rate episodes (ahre) in pacemaker patients with and without previously diagnosed at.

the purpose of this study is to assess the incidence of fast heart rates that originate in the upper chamber of the heart (atrial tachyarrhythmias) in pacemaker patients that have not been previously diagnosed with this condition. the study will also look at how the diagnostic feature in the pacemaker that detects atrial tachyarrhythmias helps physicians with the medical management of patients' heart rhythm.

Eligibility criteria:
inclusion criteria: * patients undergoing a medtronic kappa dr 700 or medtronic kappa 900 dr implant, for approved indications * no previous history of pacemaker implantation * patients 50 years of age or older exclusion criteria: * patients with a history of atrial tachyarrhythmias (primary arm of study) * patients with medical conditions that would limit study participation * patients inaccessible for follow-up at the study center * patients incapable of providing informed consent * patients with nyha classification of iv * patients with a history of neurocardiogenic syncope, long qt syndrome, or hypertrophic obstructive cardiomyopathy (hocm) * patients taking sotalol or amiodorone * patients with a history of a prior icd or pacemaker implantation.

Keywords: physiologic pacing dual chamber pacing atrioventricular block bradycardia sick sinus syndrome
pilot study to assess number of patients for main trial

Conditions: Wound Healing

Summary: the objective of the study was to investigate the efficacy of bepanthen® wound healing ointment compared to placebo in a superficial abrasive wound model. the primary objective was the re-epithelization at day 5. the secondary objectives were re-epithelization at days 2, 3, 4, 6, 7, 8, 9, 10 and 15, assessment of cosmetic outcome/acceptance at day 15 (investigator only) and at day 36 (investigator and subject), and documentation and analysis of safety parameters.


Eligibility criteria:
inclusion criteria: * healthy caucasian subjects of both genders, 18 to 45 years of age, fitzpatrick skin type i to iv exclusion criteria: * active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring * history of keloids and hypertrophic scars * history of plaster sensitivity * intake of drugs interfering with the immune system within 30 days before day 1 as well as during the study * concomitant therapy with substances affecting blood coagulation within up to 14 days prior to the start of the study as well as during the study * any condition or treatment which might influence the study * change of hormonal contraception within 3 months prior to enrolment and during the study * application of any topical treatment at the test areas during the conduct of the study * intensive ultraviolet-light exposure within two weeks before the beginning as well as during the study * removal of axillary lymph nodes * allergy to the ingredients of the test product * pregnancy or lactation * any illness on account of which the subject should not participate in the study in the opinion of the investigator * psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing * any history of drug addiction or alcoholism in the past 3 years * infectious diseases (e.g. hepatitis or aids)
recurrence and distant metastases in hepatocellular carcinoma treated by transcatheter arterial chemoembolization

Conditions: Hepatocellular Carcinoma

Summary: this project will include at least 40 patients with hepatocellular carcinoma (hcc) who will receive transcatheter arterial chemoembolization (tace) as a sole method for the management. the serum is collected before and at the 3rd and 7th day after tace. the serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin l are determined. all patients will be evaluated according to the tnm system for the cancer staging before and 3 months after each session of treatment. the vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded. these data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.

transcatheter arterial chemoembolization (tace) is the traditional method for the palliative management of patients with hepatocellular carcinoma (hcc). this method will cause tissue hypoxia in area of embolization. several proangiogenic factors will be induced by the condition of hypoxia. this may have the possibility to promote the proliferation of the residual cancer cells. however, there is no study to clarify this issue. this project will determine the serial changes of serum proangiogenic factors (vascular endothelial growth factor, angiopoietin 2), antiangiogenic factor (endostatin) and cathepsin l before and after tace. these data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients. this project will include at least 40 patients with hcc who will receive tace as a sole method for the management. the serum is collected before and at the 3rd and 7th day after tace. the serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin l are determined. all patients will be evaluated according to the tnm system for the cancer staging before and 3 months after each session of treatment. the vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded.

Eligibility criteria:
inclusion criteria: * patients with hepatocellular carcinoma treated by transcatheter arterial chemoembolization exclusion criteria: * patients with hepatocellular carcinoma unable to be treated by transcatheter arterial chemoembolization

Keywords: hepatocellular carcinoma vascular endothelial growth factor angiopoietin cathepsin
does perioperative pregabalin reduce postoperative pain after arthroscopic anterior cruciate ligament reconstruction surgery under spinal anesthesia?

Conditions: Anterior Cruciate Ligament (ACL) Reconstruction

Summary: the investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (acl) reconstruction . patients are randomly assign to 1 of 2 groups. the placebo group receive placebo capsules 1 hour before surgery and 12 hours after initial dose. the pregabalin group receive pregabalin 150 mg, respectively at the same points.


Eligibility criteria:
inclusion criteria: * age between 20-65 years * physical condition type i or ii in asa (american society of anesthesiology) exclusion criteria: * patients of asa classification 3 or more * with a history of cardiovascular or respiratory disease * dizziness or frequent headache * active alcohol or drug usage, * intake of any analgesics daily or 48 hours before surgery * impaired renal and/or hepatic function
association between lipid profiles and cardiovascular events

Conditions: Dyslipidemias; Cardiovascular Diseases

Summary: korlipid (study on the association between lipid profiles and cardiovascular events) registry enrolled 4234339 subjects who underwent general health check-ups provided by national health insurance service in 2009.

subjects who underwent general health check-ups provided by national health insurance service in 2009 were included in korlipid study. demographic data, anthropometric data and medical information from general health check-ups were collected. in addition, medical records in national health insurance service between 2002 and 2018 were also collected.

Eligibility criteria:
inclusion criteria: * subjects who underwent general health check-ups in 2009 exclusion criteria: * age less than 30 years * age 75 years or more
a rct comparing dronabinol to a placebo for post-operative pain in total joint arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (tka).

subjects enrolled will be randomized into one of two groups either receiving the study drug or a placebo and will be followed for the first 6 weeks with regards to outcomes data.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent from * stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study. * male or female * age 21-75 * unilateral total knee arthroplasty at colorado joint replacement * all individuals will be screened for drug use (including cannabis) at their preoperative appointment * ability to take oral medication and be willing to adhere to the dronabinol regimen * for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. * for males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. exclusion criteria: * narcotic use in the past 6 weeks * regular cannabis use in the past 3 months * major depression or anxiety disorders * documented psychiatric illness (e.g. bipolar, schizophrenia) * seizure disorder * current or previous history of drug and alcohol abuse * known allergic reactions to components of dronabinol * tobacco use in the past 90 days * treatment with another investigational drug * patients that cannot receive spinal anesthesia * patients that cannot receive the standardized multimodal pain medications (i.e. tylenol, gabapentin and meloxicam) * patients that are not able to go home after leaving the hospital and require a short term rehabilitation facility