Kornimate/medical-research-clean huggingface dataset:
a comparison trial between pca and epidural analgesia for pectus excavatum repair

Conditions: Pectus Excavatum

Summary: the aim of this study is to compare the efficacy of epidural and iv analgesia in controlling pain in patients undergoing nuss repair of pectus excavatum. the primary end point will be the mean pain score during postoperative days 0-4.

pectus excavatum is a cartilaginous deformity that is the most common congenital anterior chest wall defect in children \[1\]. children with this disease process often complain of dyspnea, decreased exercise tolerance, and shortness of breath implying a restrictive pulmonary deficit \[2\]. besides the reported physical limitations, patients can also exhibit manifestations of psychological disturbances (poor body image and depression). surgical repair has been correlated with enhanced quality of life and improvement in body image\[3\] with recent studies showing improved pulmonary function and cardiac output \[4, 5\]. surgery initially introduced by sauerbruch involved rib cartilage resection and sternal osteotomy. this open procedure was further modified and became \[6\] known as the ravitch procedure. this was the mainstay for repair for over 40 years until the introduction of minimally invasive surgery without rib resection by nuss and colleagues in 1987 \[7\]. the nuss repair involves placing an intrathoracic brace through small lateral chest wall incisions aided by thoracoscopy. similar to bracing the teeth, the nuss procedure avoids osteotomy or rib cartilage resection \[8\]. the nuss procedure is the most common minimally invasive procedure in use today to correct this condition and is the current standard of surgical practice. complications from nuss repair can range anywhere from 7% to 25% \[9\] and can occur for as long as the bar is in place. pain control remains a major issue in the perioperative period as patients may require weeks to months of oral narcotics before becoming pain-free after correction of the pectus. a prospective multicenter study reported peak pain scores of 8 on a 0-10 scale in the postoperative period and a mean score of 3 at discharge \[4\]. postoperative pain after pectus repair has been managed with iv opioids administered by patient controlled analgesia (pca) devices and by thoracic epidural infusions of combinations of local anesthetics and opioids. it is unclear from published data which method is superior and different tertiary care centers in the usa have a preference for different methods.

Eligibility criteria:
inclusion criteria: * patients age 8- 18 years 2) patients undergoing minimally invasive pectus excavatum repair via nuss procedure 3) american society of anesthesiology status i-iii exclusion criteria: * 1) refusal of epidural catheter 2) pregnancy 3) bleeding history 4) inability to understand how to use the pca device 5) medication interfering with blood coagulation 6) patients allergic to local anesthetics 7) patient refusal to participate in study 8) developmental delay
perioperative lidocaine infusions for the management of pain from burn injury

Conditions: Pain Management; Burn Injury; Lidocaine

Summary: the purpose of this study is to find out if iv lidocaine infusion decreases the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use in burn injury participants undergoing wound debridement in the operating room. participants will: * be randomized to receive either an iv lidocaine treatment or an iv saline placebo during their surgery. the iv treatment continues for 48 hours after surgery. * be asked about their pain and how they're feeling at 4 timepoints during the 48 hours. * be asked about their pain 2 weeks after surgery. the participant and medical care providers will both be blinded to what iv treatment is being received. researchers will compare the 2 groups to see if iv lidocaine helps decrease the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use (this includes opioid tolerance, opioid dependence, and opioid induced hyper-sensitivity to pain).


Eligibility criteria:
inclusion criteria: * acute burn patients * 18 years or older * \<20% total body surface area * wound debridement surgery scheduled at harborview medical center exclusion criteria: * history of polysubstance use * chronic opioid use (med\>40mg for more than 6 weeks) * cases where the known clinical standard care would be to keep patient intubated postoperatively * cases where the known clinical standard care would avoid iv lidocaine infusion * allergy to amide local anesthetics * any elevated risk for local anesthetic systemic toxicity as determined by the study team * cardiac arrythmias or cardiovascular instability (e.g. shock) * severe renal or hepatic impairment * pregnancy * local anesthesia will be given by another route (e.g. nerve block) * prisoners * non-english speaking/reading
mechanisms for laser-induced rejuvenation

Conditions: Skin Cancer

Summary: it has shown that laser wounding of geriatric skin protects it against skin cancer. the purpose of this study is to determine the origin of cells called fibroblasts which are present after treatment with fractionated laser resurfacing (flr). these cells restore a youth-like ultraviolet b (uvb) response, but where they come from is currently unknown. the study recruits subjects who are scheduled to undergo abdominoplasties to investigate the origin of those cells stimulated by laser treatment.


Eligibility criteria:
inclusion criteria: * adult males and females 18 and older * able to comprehend procedures and risks * planning to undergo abdominoplasty surgery * minimum amount of skin to be removed is 50 x 20cm exclusion criteria: * medical history of not well-controlled diabetes. this is defined as a subject who needs high doses of insulin, recent history of hospitalization for diabetes-related complications, or poor wound health as evidenced by diabetic ulcers. subjects who have been deemed healthy enough for abdominoplasty surgery would tend to suggest that their diabetes should not be an issue. however, if the subjects have diabetic complications as outlined above, they could affect the wound healing which is the object of this protocol so they would be excluded. * pregnant or nursing * history of pathologically abnormal wound healing such as keloidal scars * existing tattoos on the abdomen that are so extensive that they could interfere with the study
quartet lead and resynchronization therapy options iii (quarto_iii)

Conditions: Heart Failure

Summary: the purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a cardiac resynchronization therapy (crt-d) device and a quartet left ventricular (lv) quadripolar lead and with the multipoint pacing (mpp) feature activated.

the primary endpoint of the study is to measure prospectively at 6 months the percentage of responder\* patients implanted with a quartet lv quadripolar lead and with the multipoint pacing feature activated compared with no pacing at baseline. \*a positive crt response is defined as an improvement of more than 15 % in left ventricular end systolic volume (lvesv) at 6 months post-implant, measured by echocardiography.

Eligibility criteria:
inclusion criteria: * patient that will be implanted with a cardiac resynchronization therapy (crt-d) with the multipoint pacing (mpp) feature under the current guidelines indications for crt-d implant (including upgrades from single or dual chamber defibrillator or pacemaker). * patient that will be implanted with a quartet left ventricular (lv) quadripolar lead. * in sinus rhythm at baseline visit. * patients with left bundle branch block (lbbb) * must be willing and able to comply with study requirements. * older than 18 years * must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form. exclusion criteria: * already has a crt device implanted. * myocardial infarction or unstable angina within 40 days prior the enrollment. * new york heart association (nyha) class iv * recent cardiac revascularization in the 4 weeks prior to enrollment. * cerebrovascular accident (cva) or transient ischemic attack (tia) in the 3 months prior the enrollment. * classification of status 1 for cardiac transplantation or consideration for transplantation over the next 12 months. * primary valvular disease requiring surgical intervention. * atrial fibrillation (af): * persistent af at the time of enrollment or 30 days prior the enrollment * permanent af not treated with atrio-ventricular node ablation within 2 weeks after the crt-d implant * history or incidence of paroxysmal or persistent af within 30 days prior the enrollment * patient for whom suitable transthoracic echocardiographic images for determining the cardiac output (co) and lv volumes cannot be obtained. * undergone a cardiac transplantation or being waiting for it * life expectancy \< 6 months * pregnancy or planning to become pregnant * unable to comply with the follow up schedule * currently participating in any other clinical investigation.-

Keywords: heart failure cardiac resynchronization therapy quadripolar left ventricular lead multipoint pacing hemodynamic response
an alternative way to deliver oxygen to people

Conditions: Hypoxia

Summary: the availability of oxygen is a crucial prognostic indicator for outcomes pertinent to many chronic diseases. accordingly, interventions that might increase oxygen availability have obvious beneficial clinical application. in this regard, respirogen micro-oxygen (rmo) technology holds considerable promise. data from experimental animal models of lung injury suggest administration of rmo is a feasible method to deliver oxygen in a manner independent of pulmonary function. our ultimate long-term goal is to provide a product that can be used to deliver oxygen to humans experiencing respiratory distress and pulmonary dysfunction in this first exploratory study, our goal is to begin to understand the physiological responses to enteral (rectal) delivery of rmo in low-oxygen environments in healthy adults at rest.


Eligibility criteria:
inclusion criteria: * age between 18-40 years, * body mass index between 19 and 30 kg/m\^2, * resident at a similar altitude for a minimum of 1-year, * no travel to/from areas varying by \~2000 feet of elevation within 4-weeks of initiation of study participation. exclusion criteria: * identification of overt chronic disease (including cardio-pulmonary disorders), * prior diagnosis of asthma, cystic fibrosis, chronic obstructive pulmonary disease, or ventilator therapy * anemia, * pregnancy, * habitual use of tobacco/nicotine products, * known allergy to sodium phosphate (or other common laxatives), * habitual use of recreational drugs that require inhalation, * history of seizures, kidney problems, stomach or bowel problems, ulcerative colitis, problems with swallowing or gastric reflux, gout, and and/or low blood sodium. * irritable bowel * acute respiratory illness such as bronchitis, pneumonia, upper respiratory infection or acute gi issues such as gastroenteritis. * anemia (as measurement of hemoglobin and/or hematocrit) . * sickle cell disease. * history of altitude sickness
a study evaluating cpi-1205 in patients with b-cell lymphomas

Conditions: B-Cell Lymphoma

Summary: first in human, open-label, sequential dose escalation and expansion study of cpi-1205 in patients with progressive b-cell lymphomas. cpi-1205 is a small molecule inhibitor of ezh2.


Eligibility criteria:
inclusion criteria: adults (aged ≥ 18 years) histologically confirmed diagnosis of a b-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available eastern cooperative oncology group (ecog) performance status ≤ 2 adequate hematological, renal, hepatic, and coagulation laboratory assessments must give written informed consent to participate in this study before the performance of any study-related procedure exclusion criteria: a primary lymphoma of the central nervous system (cns) or known lymphomatous involvement of the cns impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of cpi-1205, including any unresolved nausea, vomiting, or diarrhea that is ctcae grade \>1 treatment with proton pump inhibitors, h2 antagonists, or antacids achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures) impaired cardiac function or clinically significant cardiac diseases, including any of the following: * acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug * new york heart association class iii or iv congestive heart failure * qtcf \> 470 msec on the screening ecg uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded) a past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen) any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection) systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of cpi 1205 radioimmunotherapy (e.g., 131i-tositumomab, 90y-ibritumomab tiuxetan) less than 6 weeks before the first dose of cpi-1205 treatment with an investigational small molecule less than 2 weeks before the first dose of cpi-1205. treatment with a therapeutic antibody less than 4 weeks before the first dose of cpi-1205. treatment with medications that are strong inhibitors of cyp3a4 treatment with medications that are inducers of cyp3a4 enzymes treatment with medications that are known to carry a risk of torsades de pointes pregnant or lactating women women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter patients unwilling or unable to comply with this study protocol

Keywords: b-cell lymphoma ezh2 inhibitor phase 1
52 week, international, multi-center, randomized, double-blind, double-dummy, parallel-group clinical trial to compare retention on treatment, safety, tolerability & efficacy of lumiracoxib 100 mg od, lumiracoxib 100 mg bid & celecoxib 200 mg od in pts with primary oa of hip, knee, hand or spine

Conditions: Osteoarthritis

Summary: this trial will compare the retention on treatment (based on the rate of patients staying on treatment for 1 year) of patients suffering from primary osteoarthritis using two different doses of lumiracoxib (100 mg od or 100 mg bid) or using celecoxib (200 mg od)


Eligibility criteria:
inclusion criteria: * primary osteoarthritis in the hip, knee, hand, or spine * requiring nsaid therapy exclusion criteria: * secondary oa with history and/ or any evidence of the following diseases: rheumatoid arthritis, uncontrolled gout, inflammatory joint disease, ochronosis, acromegaly, hemochromatosis, wilson's disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility), collagen gene mutations, primary fibromyalgia (secondary fibromyalgia is allowed if in the opinion of the investigator it will not interfere with the patient's oa pain assessment), and systemic lupus erythematosus * history and/ or any evidence of the following diseases in the target joint: septic arthritis, gout, recurrent episodes of pseudogout, paget's disease of the bone, and articular fracture. if the patient has history of these conditions, then patient should only be excluded if the target joint is affected. * history of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: osteoarthritis, lumiracoxib, retention on treatment, efficacy, safety
time to perform lung function test in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: time to perform lung function test after chest physiotherapy in cystic fibrosis. the investigators study fev1(forced expiratory volume in one second) and fvc (forced vital capacity).

the patients perform spirometry before, direct after, 30 minutes, 1 hour, 2 hours, and 3 hours after physiotherapist. the investigators want to study the fev1 and fvc.

Eligibility criteria:
inclusion criteria: * patients with cystic fibrosis exclusion criteria: * patients with cystic fibrosis who could not stay at the clinic for more than 4 hrs.

Keywords: lung function physiotherapy
evaluation of safety and effectiveness of 2 lower dose combined pde5i's versus single maximal dose pde5i treatment

Conditions: Erectile Dysfunction

Summary: clinical effectiveness is of the finest tools to evaluate treatment success and is combined of 3 elements: treatment effectivity, side effect profile and patient compliance. since the 3 main pde5i's differ in their molecular structure, therapeutic profile and pharmacokinetics, it seems logical to assume that combining 2 different pde5i's at lower dosage each may be beneficial in comparison to a single pde5i maximal dose therapy. the aim of this study is to compare the clinical effectiveness of combination therapy (2 lower-dose pde5i's) versus single maximal dose pde5i therapy.

this will be a prospective, randomized, 3-arm parallel trial on 60 males with erectile dysfunction (ed) that have never been exposed to pde5i therapy (naïve patients) will be enrolled. in each group, every patient will receive three treatment regimes (viagra®50mg \& cialis®10mg, viagra®100mg, cialis®20mg), in different sequences of administration.

Eligibility criteria:
inclusion criteria: * age ranging between 35-75 years. * sexually active * iief ed domain score 22 and below exclusion criteria: * subjects with premature ejaculation as their main sexual complaint. * subjects with severe cardiovascular disease * subjects with contraindications to pde5i therapy. namely patients receiving treatment with nitrate based medication or patients that for various reasons cannot take pde5 inhibitors (i.e severe coronary disease, liver or renal failure, concomitant medications, etc.).

Keywords: erectile dysfunction combination therapy sildenafil tadalafil pde5i no conditions
monitoring of symptoms and cognitive function using telehealth

Conditions: End Stage Liver Disease

Summary: end-stage liver disease (esld) is one of the ten leading causes of death in us. it is marked by episodic acute exacerbations of the underlying liver disease which often leads to severe symptoms, poor quality of life, mental deterioration and repeated hospitalizations. the overall purpose of this project is to introduce a telehealth based intervention (involving remote monitoring of symptoms and cognitive function initiated at the time of discharge of esld patients. this will support enhanced clinical care and improve self-management in esld population. in addition, it will reduce healthcare utilization, improve medication adherence and overall health outcomes

this is a single arm study to assess the effectiveness of an experimental telehealth intervention within the treatment of esld, and compare it with a historic cohort. all inpatients with advanced liver disease and at least 1 complication will be eligible to participate. the study group receives the telehealth intervention and will be given an ipad preloaded with the instruments used for symptom monitoring and cognitive function assessment during the hospital admission.

Eligibility criteria:
inclusion criteria: * end stage liver disease with at least 1 or more complications (hepatorenal syndrome, portal hypertension, ascites, hepatic encephalopathy) exclusion criteria: * cognitive impairment * current psychosis

Keywords: telehealth quality of life
effects of intra-articular stromal vascular fraction injection on clinical symptoms and cartilage health in osteoarthritic knees

Conditions: Osteoarthritis, Knee

Summary: background: osteoarthritis (oa) is a prevalent form of arthritis worldwide. intra-articular stromal vascular fraction (svf) injections are a potential therapeutic option for patients with oa. this study aims to assess the effects of intra-articular svf injections on knee oa. methods: ten patients with knee oa participated in this study. after being administered intra-articular svf injections, their outcomes were evaluated using various questionnaires. mri t2 mapping was conducted and compared before the intervention and 6 months after. all data underwent analysis using various tests.


Eligibility criteria:
inclusion criteria: * aged ≥ 35 years. * patients with degenerative knee oa confirmed via x-ray and classified according to the kellgren lawrence grading scale 2\~4. * persistent knee pain after nonsurgical treatment. exclusion criteria: * arthritis caused by other systemic or local immune diseases. * patients who have undergone total knee replacement surgery. * patients who have been administered platelet-rich plasma or hyaluronic acid injections within the past three months. * patients with symptoms related to degenerative arthritis in the ankle, which affected the assessment of pain. * patients with severe heart problems and coagulation disorders. * patients who have taken glucosamine within the previous month. * mri exclusion conditions, including patients with a heart rhythm regulator who have received vascular surgery with a hemostatic clip and artificial heart valves.
virtual reality for anxiolysis during laceration repair in the pediatric emergency room

Conditions: Procedural Anxiety; Laceration of Skin

Summary: the investigators propose a pilot study to examine the feasibility of utilizing immersive virtual reality to reduce procedural anxiety in children undergoing non-facial laceration repair in the pediatric emergency department. the investigators hypothesize that virtual reality will be well-received by patients and their caregivers, and that the anxiety provoked by laceration repair will be mitigated by the immersive virtual reality experience.


Eligibility criteria:
inclusion criteria: * children 5-13 years of age * present to ed during the study period with non-facial lacerations * patient to undergo wound closure with sutures exclusion criteria: * patients with lacerations on the head/face * patients with lacerations sustained in conjunction with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma * patients who sustained a laceration in conjunction with an open fracture * patients with open skin, lice, scabies, or other infectious skin conditions on the head/face * patients with a history of or current symptoms of vertigo * patients who are blind * patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver * patients on whom the vr headset does not fit appropriately * non-english speaking patients will be excluded from this study (we do not have funds available to translate the study documents into other languages)

Keywords: procedural anxiety virtual reality anxiolysis laceration repair pediatric