Kornimate/medical-research-clean huggingface dataset:
post acute cardiac event smoking (paces) study

Conditions: Acute Coronary Syndrome; Tobacco Use

Summary: summary of the project : quitting smoking following acute coronary syndrome (acs) can reduce mortality up to 50%. however, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. behavioral activation (ba) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. the investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing ba based mood management techniques for post-acs smokers; behavioral activation treatment for cardiac smokers (bat-cs). objective: for this r01 the investigators will evaluate the efficacy of using a single, integrated treatment that targets both depressed mood and smoking (bat-cs).

this project will implement a fully powered efficacy trial enrolling 324 smokers with acs and randomize them to 12 weeks of either behavioral activation treatment for cardiac smokers (bat-cs) or control condition (including contact match). bat-cs interventions will focus on smoking cessation and mood management, while the control condition will focus on smoking cessation and general health education. both groups will be offered the nicotine patch if medically safe. follow-up assessments will be conducted at end-of-treatment (12 weeks post-discharge for index event), and 6, 9, and 12 months after hospital discharge. the occurrence of major adverse cardiac events and all-cause mortality will be tracked for up to 60 months post discharge.

Eligibility criteria:
inclusion criteria: * hospital inpatients with an acs diagnosis documented in medical record within the past 30 days * smoked equal or greater than 1 cigarette per day before being hospitalized * age of 18-75 years * english fluency * willing to consider quitting smoking at discharge * has a telephone or is willing to use a study issued cell phone * willing to consent to all study procedures. exclusion criteria: * limited mental competency * presence of severe mental illness that would interfere with participation or suicidality * expected discharge to hospice or greater than 50% chance of 6 month mortality per risk calculator * currently attending counseling for depression or smoking cessation.

Keywords: smoking depression behavioral activation mood management secondary prevention
immunogenicity of influenza vaccine in long term care

Conditions: Influenza

Summary: the study is designed to evaluated if adjuvanted vaccine elicits higher t cell and b cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.

summary: study investigators will recruit residents of nursing homes that are administering a licensed influenza vaccine as their standard or care, either the trivalent influenza vaccine (fluvirin) or the adjuvanted trivalent influenza vaccine (fluad). eligible residents are those or their legally authorized representatives who give written, informed consent for three blood draws over one month's time and permission to review their nursing home medical and administrative records, including information required to be submitted to medicare including quality performance data (the minimum dataset or mds) and medicare claims data for demographic and underlying disease comparisons between our participating populations between nursing homes. the investigators propose to study up to 230 subjects in one season at a 1:1 ratio of adjuvanted vs. and non-adjuvanted vaccine. background: influenza is the most common clinically important viral infection of older adults. influenza vaccination is associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. the adjuvanted vaccine was shown in the past to elicit higher antibody titers than non-adjuvanted tiv. this included the elderly population as well. there are far more limited data about cell-mediated immunity (cmi) and use of the adjuvanted vaccine. there are data that support that cmi is important beyond the helper function to b cells. cmi helps mitigate influenza disease if the antibodies alone are not adequately protective. objectives: to determine if adjuvanted vaccine elicits higher t cell and b cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.

Eligibility criteria:
inclusion criteria: * resident of medicare certified facility (so they have to report minimum data set (mds) data) * residence in a long-term care facility administering a seqirus influenza vaccine as the standard-of-care. * agreed to receive the vaccine that the nh plans to give to them * \>= 65 years old * able to obtain consent from subject or legally authorized representative (lar) and assent from subject * able to participate throughout the study period * resident for at least 45 days prior to enrollment exclusion criteria: * recent illness (within 30 days) severe enough to require hospitalization or physician-directed outpatient pharmacotherapy * receiving chemotherapy for an active cancer

Keywords: influenza vaccine nursing home influenza vaccination immunity cell-mediated immunity humoral immunity
a phase 3 study of barzolvolimab in participants with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: the purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with chronic spontaneous urticaria (csu) inadequately controlled by non-sedating second generation h1-antihistamines in comparison to placebo.

this is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with chronic spontaneous urticaria (csu) who are symptomatic despite treatment with non-sedating second generation h1-antihistamines at 1-4 times the locally approved dose. there is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

Eligibility criteria:
key inclusion criteria: 1. males and females, \>/= 18 years of age. 2. chronic spontaneous urticaria (csu) \>/= 6 months prior to screening (visit 1). 3. csu despite the use of a stable regimen of second generation non-sedating h1-antihistamine as defined by: 1. the presence of hives for \>/= 6 weeks at any time prior to visit 1 despite the use of non-sedating h1-antihistamines. 2. must be on a stable regimen of second generation non-sedating h1-antihistamine for \>/= 4 weeks prior to study treatment. 3. uas7 of \>/= 16 and iss7 of \>/= 8 during the 7 days prior to study treatment. 4. normal blood counts and liver function tests. 5. both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment. 6. willing and able to complete a daily symptom electronic diary and comply with study visits. 7. participants with and without prior biologic experience are eligible. key exclusion criteria: 1. women who are pregnant or nursing. 2. chronic urticaria whose predominant manifestation is due to cindu. 3. other diseases associated with urticaria. 4. active pruritic skin condition in addition to csu. 5. medical condition that would cause additional risk or interfere with study procedures. 6. known hiv, hepatitis b or hepatitis c infection. 7. vaccination of a live vaccine within 30 days prior to screening (visit 1) (subjects must agree to avoid live vaccinations during the study). inactivated vaccines are allowed such as seasonal influenza injection or authorized covid-19 vaccine. 8. history of anaphylaxis. 9. prior treatment with barzolvolimab. there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Keywords: cdx-0159 barzolvolimab chronic spontaneous urticaria csu urticaria activity score itch severity score hives severity score
feasibility study of cvc diagnosis via ultrasound in children

Conditions: Ultrasound for Diagnosis of CVC Position in Children

Summary: after the placement of a central venous catheter in children, a routine chest x-ray will be performed in order to examine the correct position of the catheter. in this feasibility study the investigators intend to evaluate whether the ultrasound is as sufficient as the chest x-ray to verify the correct position of the central venous catheter in children with the purpose to prevent radiation on children in the future.

for punctures of a central vein in very small children, ultrasound is an useful tool which allows for exact examination of the relevant anatomy in order to visualize the target vessel, so as to facilitate the puncture in real-time. however, to ascertain the correct position of the central venous catheter (cvc), a chest x-ray is still the gold standard. the main disadvantage of the x-ray is the children's exposure to radiation. that's why the investigators intend to perform this study whether the ultrasound is as sufficient as the chest x-ray to verify the correct position of a central venous catheter in children.

Eligibility criteria:
inclusion criteria: * infants and children aged between 0 and 8 years requiring a central venous catheter. the planned sample size is 20 subjects. the indication for a cvc, will be determined by the attending physician. inclusion criteria: * infants (inclusive early and late preterm) and children aged between 0 and 8 years * necessity of a central venous catheter * written informed consent given by parents after being provided with detailed information about the nature, risks, and scope of the catheterization * no legal incapacity and/or other circumstances rendering the parents unable to understand the nature, scope and possible consequences of the catheterization exclusion criteria: * parents refusal

Keywords: children, ultrasound, central catheter
reveal linq™ evaluation of fluid

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to investigate the use of subcutaneous impedance measured with an implanted medtronic reveal linq™ insertable cardiac monitor for use as a fluid status monitor in hemodialysis patients. the study will measure the changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. subcutaneous impedance trends will also be evaluated between dialysis sessions.


Eligibility criteria:
inclusion criteria: * patients who currently undergo in-clinic hemodialysis treatment prescribed 2 or 3 times per week * patients willing to be implanted with the reveal linq™ device * patients greater than 21 years of age * patients willing and able to comply with the study procedures including giving informed consent exclusion criteria: * patient has an active implanted cardiac medical device (e.g. ipg, icd, crt, etc) * patients who currently undergo home dialysis treatment * patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a medtronic study manager. * patient with a recent infection defined as 1) bacteremia within 60 days or 2) (nonbacteremic) infection within 14 days * patient not suitable for reveal linq™ implantation (e.g., severe cachexia, dermatologic conditions of the skin, or major medical or social conditions expected to reduce survival to \< 6 months), in the opinion of the investigator
evaluation of outcomes related to cerebrospinal fluid drain placement

Conditions: Cerebrospinal Fluid Drainage

Summary: the purpose of this study is to compare the rate and severity of complications associated with csfd placement either with or without fluoroscopic guidance.

patients undergoing thoracoabdominal aortic aneurysm (taaa) repair are at risk of suffering devastating spinal cord injury (sci), rendering them with a permanent neurologic deficit, paraplegia, or paraparesis. despite huge success over the last several decades with the introduction of innovative protective maneuvers, such as the use of cerebrospinal fluid drains (csfds), the rate of these complications remains around 5%. spinal cord perfusion can be compromised during aortic surgery and the intrathecal decompression achieved by csfds functions to increase the pressure gradient of blood flow, thereby optimizing spinal cord perfusion during aortic surgery. there are two methods commonly used to place cerebrospinal fluid drains: blind placement and with fluoroscopic guidance. prior to 2016, csfds at unc hospital were primarily placed without image guidance. however, hospital policy then transitioned to having all csfds placed using fluoroscopic guidance. to the investigators' knowledge, there are no reported studies directly comparing clinical outcomes of csfds placed by these methods. given the increased cost and radiation exposure associated with the use of fluoroscopy, a better understanding of comparative outcomes has great potential clinical value. therefore, the investigators propose to compare the rate and severity of complications associated with csfd placement either with or without fluoroscopic guidance.

Eligibility criteria:
inclusion criteria: * csf drain placed from 2010 to present prior to undergoing aortic surgery exclusion criteria: * patients under 18 years of age * patients undergoing emergency procedures
incretin secretion in women with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: the incretin hormones are secreted from the gastrointestinal tract in response to nutrient ingestion, and are responsible for 70 % of insulin secretion in response to glucose. the incretin response is attenuated in subjects with type 2 diabetes and other conditions associated with insulin resistance. polycystic ovary syndrome (pcos) is characterised by irregular periods and increased androgen levels. it is the most common endocrine disorder amongst young women at fertile age, and the most common cause of female infertility. insulin resistance plays an important role in the development of the disease, and women with pcos are at increased risk of developing tyoe 2 diabetes. the incretin hormones have not previously been investigated in women with pcos, and the purpose of the present study was to investigate the secretion of the two most important incretin hormones glucose-like peptide-1 (glp-1) and glucose dependent insulinotropic peptide (gip) during a three hour oral glucose tolerance test.


Eligibility criteria:
inclusion criteria: * subjects who fulfill the rotterdam criteria for pcos. age 18-38 exclusion criteria: * other endocrine diseases or diseases known to influence glucose/insulin/fat metabolism * oral contraceptive administration within three months of study start
prehospital resuscitation intranasal cooling effectiveness survival study 2

Conditions: Out-Of-Hospital Cardiac Arrest; Hypothermia; Ventricular Fibrillation

Summary: the aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. the study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm. the main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia. participants will be randomized to two groups. one group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by ems personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. the other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).


Eligibility criteria:
inclusion criteria: patients ≥18 years that meet all of the following inclusion criteria: 1. adult out-of-hospital cardiac arrest patients with initial shockable rhythm 2. unconsciousness defined as glasgow coma scale \< 8 3. inclusion within 20 minutes from ems arrival exclusion criteria: patients are not eligible if they meet one or more of the following criteria: 1. age ≥ 80 years 2. obvious non-cardiac causes to cardiac arrest 3. obvious already hypothermic 4. obvious barrier to placing intra nasal catheters 5. have a known do not attempt to resuscitate (dnar) order or other limitations in care 6. have a known terminal disease 7. known or clinically apparent pregnancy

Keywords: therapeutic hypothermia transnasal cooling neurologic outcome ultrafast hypothermia prehospital ecpr
comparative study of psychology and glaucoma knowledge in glaucoma day-ward patients inpatients

Conditions: Glaucoma

Summary: this study will compare the glaucoma day-ward patients' efficacy with inpatients by evaluating the glaucoma knowledge and psychology , and will analysis the reasons of the differences. half of participants will receive treatment in day-ward, while the other half will receive treatment in hospital.

ophthalmic surgery has short operative time, quick recovery, and small anesthesia risk, making day case surgery the main management mode of ophthalmic surgery. this study will explore the differences of psychology and glaucoma knowledge between glaucoma day-ward patients and the inpatients. the data will be collected by scale on admission and discharge.

Eligibility criteria:
inclusion criteria: 1. patient is diagnosed with glaucoma; 2. will receive glaucoma surgery; 3. voluntary participation in this study; 4. have enough language comprehension ability; 5. best corrected visual acuity reach 0.1 or better; 6. patient or his legal representative has sign the informed consent. exclusion criteria: 1. patient with mental disorder; 2. there are important viscera function failure or other serious disease, including clinical related coronary artery disease, cardiovascular disease or myocardial infarction into the group of the first six months; serious neurological or psychiatric illness; serious infections; coagulant function abnormality; general active infectious diseases; malignant tumor; serious immune diseases; 3. patient with monocular blindness; 4. axial length≤20 mm; 5. with other serious eye diseases; 6. neurologic diseases that could affect the visual field; 7. 3 months prior to research to participate in any clinical study; 8. researchers think not suitable to participate in this clinical trial subjects; 9. refused to sign the informed consent.

Keywords: knowledge psychology
study to evaluate the safety and effectiveness of microwave ablation in patients with hepatocellular carcinoma in korea

Conditions: Carcinoma, Hepatocellular; Hepatocellular Carcinoma; Hepatocellular Cancer; Cancer, Hepatocellular

Summary: this is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.

this prospective, single-arm single center study will provide clinical data for the neuwave medical microwave ablation system and accessories. individuals who undergo microwave ablation of liver tumors who meet study entry criteria, will be enrolled. the enrollment for the study will continue until 30 eligible subjects complete the 3-month visit after ablation for the primary effectiveness and safety analysis. the subjects will be followed for approximately up to 36 months after the ablation procedure for safety, oncologic and ablation outcomes.

Eligibility criteria:
inclusion criteria: 1. confirmed hepatocellular carcinoma, tumor size of more than 2 cm and up to 5cm, single location, barcelona clinic liver cancer (bclc) stage a based on imaging and biopsy confirmation 2. primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only; 3. scheduled for microwave ablation of the liver; 4. performance status 0-1 (eastern cooperative oncology group classification); 5. functional hepatic reserve based on the child-pugh score (class a or b); 6. american society of anesthesiologists (asa) score \< 3; 7. given voluntary, written informed consent to participate in this study and has authorized the transfer of his/her information to the sponsor, and willing to comply with study-related evaluation and treatment schedule; 8. at least 19 years of age exclusion criteria: 1. active bacterial infection or fungal infection; 2. systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure; 3. chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure; 4. subject with implantable pacemakers or other electronic implants; 5. planned/ scheduled liver surgery. 6. subject with a platelet count of less than 20,000/mm3; 7. subject with an inr greater than 1.5; 8. subject with renal failure on renal dialysis; 9. scheduled concurrent procedure other than microwave ablation in the liver; 10. pregnant or lactating; 11. physical or psychological condition which would impair study participation; 12. participation in any other clinical study concurrently or within the last 3 months; 13. the subject is judged unsuitable for study participation by the investigator for any other reason; 14. unable or unwilling to attend follow-up visits and examinations.

Keywords: hepatocellular carcinoma; liver cancer; cancer; liver
post-marketing surveillance of dehydrated human amnion/chorion membrane (dhacm) in non-ischemic chronic wounds

Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer

Summary: the purpose of this survey is to observe the efficacy and safety of epifix® dehydrated human amnion/chorion membrane (dhacm) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.

the study will enroll 75 subjects diagnosed with intractable diabetic foot ulcers or venous leg ulcers at 5 plastic surgery sites in japan. subjects will be treated with weekly applications of epifix for up to 12 weeks, followed by 6 months of follow-up.

Eligibility criteria:
inclusion criteria: patients with intractable diabetic foot ulcers or venous leg ulcers that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies, such as radical wound management (removal of necrotic tissue, infection control, wound cleansing, etc.), glycemic control for diabetic foot ulcers, compression therapy for venous stasis ulcers and moist therapy using wound dressing materials. exclusion criteria: 1. areas of active infection or latent infection. 2. patients with disorders that would cause an intolerable risk of postoperative complications. 3. ulcers that cannot be sufficiently debrided. 4. ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage. 5. wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed. 6. patients with hypersensitivity to the aminoglycoside antibiotics used during manufacturing.