Kornimate/medical-research-clean huggingface dataset:
flublok v. standard dose vaccine effectiveness among kaiser permanente northern california adults 18-64 years

Conditions: Influenza; Pneumonia; Lower Respiratory Tract Infection; Acute Myocardial Infarction; Congestive Heart Failure; Stroke

Summary: the overall objective of this study is to describe the effectiveness of flublok quadrivalent vaccine compared to standard dose inactivated influenza vaccine (sd-iiv) in adults 18 through 64 years of age. during this study, flublok quadrivalent or sd-iiv will be administered according to the guidelines in the prescribing information materials and only to persons for whom it is indicated. the 2018-2019, 2019-2020, and 2020-2021 formulations of recombinant influenza vaccine (flublok quadrivalent vaccine) and sd-iiv will be evaluated for outcomes including all polymerase chain reaction (pcr)-confirmed influenza, pcr-confirmed hospitalized influenza, hospitalized community-acquired pneumonia and cardio-respiratory events.


Eligibility criteria:
inclusion criteria: * between the ages of ≥18 and \<65 years at the time of influenza vaccination * receive either flublok quadrivalent vaccine or standard dose inactivated influenza vaccine at a kaiser permanente northern california facility during the study period from august 2018 through april 2020 exclusion criteria: * children \<18 years old * adults ≥65 years old

Keywords: influenza vaccine effectiveness
evaluation of microinvasive glaucoma surgery: miniject® versus hydrus® microstent in combination with cataract surgery

Conditions: Glaucoma; Cataract

Summary: the study aims to investigate postoperative outcomes after two different migs implants (miniject or hydrus) in combination with cataract surgery for patients with glaucoma.

the study aims to investigate postoperative outcomes in terms of intraocular pressure as well as safety measures after two different migs implants (miniject® or hydrus®) in conjunction with cataract surgery (cs) for patients with chronic glaucoma. the patients will be followed up for 5 years after the date of their implantation. standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination and ocular imaging with oct (optical coherence tomography). assessment of life quality as well as adverse events will be performed.

Eligibility criteria:
inclusion criteria: * patients with glaucoma in which surgery is indicated to reach target intraocular pressure as well as lens opacities where cs is indicated * clinically eligible for both surgeries * subjects not anticipated to require any further surgery in the next 12 months * patients' age \> 18 years exclusion criteria: * patients who do not want to make follow-ups at the department * angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrome, axenfeld-rieger syndrome * prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation * allergy to any drugs or substances required for the protocol * pregnant women

Keywords: glaucoma open-angle glaucoma cataract minimally invasive glaucoma surgery (migs) intraocular pressure (iop) reduction
prospective registry trial for single port robot-assisted nipple sparing mastectomy (sprnsm)

Conditions: Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Ductal Carcinoma in Situ; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; BRCA1 Mutation; BRCA2 Mutation

Summary: this is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (sprnsm) utilitzing the sp da vinci surgical system.

robotic assisted nipple sparing mastectomies with multi-port robots, like the da vinci xi, have been described previously but pose significant hurdles due to the small area like the breast. the single-port da vinci sp (intuitive surgical), which was designed for application to small cavity surgery, may be more appropriately suited for this procedure. this is a prospective registry trial to study the outcomes of performing a single-port robot-assisted nipple sparing mastectomy. subjects who undergo rnsm and bilateral breast reconstruction of the affected breast via single site small hidden axillary scar technique will be offered participation in the prospective registry trial at their pre-operative visit in the ut southwestern breast clinic. the patient will then be seen at their regularly scheduled clinic appointments at 2 weeks, 1 month, 6 months, and 1 year post operatively at both breast and plastics and reconstructive surgery (prs) departments. outcomes will be tracked in a prospectively kept electronic registry.

Eligibility criteria:
inclusion criteria: 1. subjects age \>= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at utsw exclusion criteria: 1. subjects who are \<18 years of age 2. subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at utsw

Keywords: nipple sparing mastectomy robot-assisted nipple sparing mastectomy
withdrawal of colchicine in behçet syndrome

Conditions: Behçet's Syndrome

Summary: behçet's syndrome is a multisystem variable vessel vasculitis. clinical features include mucocutaneous manifestions such as oral ulcers, genital ulcers, papulopustular lesions and nodular lesions, musculoskeletal manifestations, uveitis, venous thrombosis, arterial aneurysms and thrombosis, central nervous system involvement and gastrointestinal involvement. management of behçet's syndrome depends on the type of organ involvement, disease severity, and prognostic factors. the main objective in patients with major organ involvement is to rapidly suppress the inflammation and prevent relapses in order to prevent organ damage. on the other hand, mucocutaneous and musculoskeletal manifestations do not cause damage and in patients with only mucocutaneous and joint involvement, the aim is to improve the quality of life. colchicine is usually the first-line systemic treatment in patients with only mucocutaneous and joint involvement. conflicting results were reported on the efficacy of colchicine on different mucocutaneous manifestations in randomized placebo-controlled trials. the relapsing and remitting nature of these manifestations in behçet's syndrome may cause challenges in disease assessment during clinical trials. another approach to evaluate the effectiveness of a medication is to evaluate whether the lesions recur or increase after discontinuation of the drug. the aim of this study is to assess mucocutaneous disease activity among behçet's syndrome patients after discontinuation of colchicine treatment and compare it to patients who continue to use colchicine.


Eligibility criteria:
inclusion criteria: fulfilling international study group criteria. being between the ages of 18 and 65 years. having mucocutaneous involvement. using colchicine at a stable dose (1-2 mg/day) for at least 3 months. showing no adverse events related to colchicine use. providing informed consent to participate in the study. - exclusion criteria: patients with active uveitis. patients with active venous involvement. patients with active arterial involvement. patients with active nervous system involvement. patients with active gastrointestinal involvement. -
a study of avastin (bevacizumab) in combination with herceptin (trastuzumab)/docetaxel in patients with her2 positive metastatic breast cancer.

Conditions: Breast Cancer

Summary: this 2 arm study will compare the efficacy and safety of avastin plus herceptin/docetaxel, versus herceptin/docetaxel alone, in patients with her2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. patients will be randomized 1:1 to receive either avastin (15mg/kg iv q3weeks) + herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or herceptin + docetaxel alone. the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * her2 positive breast cancer with locally recurrent or metastatic lesions; * eligible for chemotherapy; * baseline lvef \>=50%. exclusion criteria: * previous chemotherapy for metastatic or locally recurrent breast cancer; * previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief); * other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix; * clinically significant cardiovascular disease; * chronic daily treatment with aspirin (\>325mg/day) or clopidogrel (\>75mg/day).
efficacy and safety study of methylphenidate hydrochloride extended release in adults with childhood-onset attention deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit/Hyperactivity Disorder

Summary: this study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (adhd).


Eligibility criteria:
inclusion criteria: 1. diagnosis of attention deficit/hyperactivity disorder (adhd) which started in childhood 2. female patients of childbearing potential must be practicing an acceptable method of contraception. exclusion criteria: 1. patients with body mass index (bmi) less than 18.5 kg/m2 or more than 35 kg/m2 2. history of alcohol or substance abuse within the last six months. 3. history of seizures or use of anticonvulsant medication. 4. any psychiatric condition that requires medication or may interfere with study participation. 5. pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc. 6. significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder 7. diagnosis of glaucoma, hyperthyroidism, pheochromocytoma 8. diagnosis or family history of tourette's syndrome 9. pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke other protocol-defined inclusion/exclusion criteria may apply

Keywords: attention deficit /hyperactivity disorder, hyperactivity
repetitive transcranial magnetic stimulation as a treatment for tinnitus

Conditions: Tinnitus

Summary: efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus

repetitive transcranial magnetic stimulation (rtms) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rtms in improving tinnitus-related distress. the investigators aimed to investigate whether rtms of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic tinnitus * chronic subjective tinnitus for more than 6 months * subject is naive regarding rtms * other concurrent treatments: a four-week washout from any other tinnitus treatment or management program is required prior to entering this study * stable enough to complete this study per the opinion of the study physician * no restrictions, provided the dosages have been in place for at least 3 months * a three month washout from any other tinnitus treatment or management program is required prior to entering this study. exclusion criteria: * objective tinnitus or tinnitus with treatable cause * presence of intracranial or intraocular ferromagnetic materiel or particles * cardiac pacemaker or other electronic implants (including cochlear implant) serious heart disease or other unstable major medical condition * personal history of central nervous system disorder, head injury, stroke or seizures * familial history of epilepsy * concomitant medication with antidepressants and antipsychotics * pregnant women * others known contraindications to rtms or brain mri

Keywords: tinnitus
prevention and treatment of hemodialysis vascular access malfunction

Conditions: End-Stage Renal Disease

Summary: vascular access is considered the achilles heel of the dialysis patient. it constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the us of at least one billion dollars annually. currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses. it is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. moreover, once accesses at potential risk are identified, it is not well established which method of intervention, surgery vs. angioplasty vs. expectant management, is superior in terms of clinical and financial outcome. the proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.


Eligibility criteria:
inclusion criteria: 1. subjects with end stage renal disease on chronic maintenance hemodialysis 3 times per week 2. have an arteriovenous (polytetrafluoroethylene) graft as vascular access 3. have a venous stenosis between 30% and 70% as determined by angiogram exclusion criteria: 1. native arteriovenous fistula 2. known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries \>4 3. unwilling to participate 4. allergy to iodine 5. absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery) 6. known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization 7. known hypercoagulable state

Keywords: end stage renal disease esrd chronic maintenance hemodialysis
circulating tumor dna to monitor response to neoadjuvant chemotherapy in breast cancer

Conditions: Breast Cancer

Summary: investigators aim to investigate whether circulating tumor dna is a sensitive marker to evaluate patients' response to neoadjuvant chemotherapy

neoadjuvant chemotherapy(nac) is traditionally for locally advanced disease, converting an inoperable to a resectable tumor.in recent years, it has become an option for patients of lower tumor stage to increase the possibility of breast conserving therapy. an effective method to monitor the response to nac is important.

Eligibility criteria:
inclusion criteria: * female patients undergoing nac * age: 18-70 yrs * any menopausal status * any hormal receptor status exclusion criteria: * metastasis discovered during nac * lost more than 2 blood samples during nac and surgery

Keywords: circulating tumor dna
single patient protocol: a phase ii study using the administration of autologous t-cells genetically engineered to express t-cell receptors reactive against mutated neoantigens in a patient with metastatic cancer plus the administration of pembrolizumab


Summary: single patient expanded access

background: please refer to national cancer institute surgery branch (nci-sb) protocol 18-c-0049, amendment f. objective: under individual patient expanded access, to treat a patient with metastatic prostate cancer with autologous peripheral blood lymphocytes (pbl) that have been transduced with genes encoding t-cell receptors that recognize the mutated tp53 shared oncogene in the autologous cancer. eligibility: * must have measurable, metastatic disease as assessed per recist v1.1 criteria. * must sign the informed consent document. * willing to sign durable power of attorney form. * must have all regulatory approvals prior to start of treatment. design: * please refer to nci-sb protocol 18-c-0049, amendment f. * the patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced pbl and then high-dose aldesleukin. the patient will also receive pembrolizumab on day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.

Eligibility criteria:
inclusion criteria: * measurable (per recist v1.1 criteria), metastatic prostate cancer. * refractory to approved standard systemic therapy. * ability of subject to understand and the willingness to sign a written informed consent document. * willing to sign a durable power of attorney form. * willing to practice birth control from the time of enrollment on this study and for four months after treatment. * subject must be co-enrolled on protocol 03-c-0277. exclusion criteria: not applicable.
evaluation of extubation criteria in children with upper respiratory infection (uri)

Conditions: Upper Respiratory Tract Infections

Summary: the investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection.

the objectives of this study are to evaluate various extubation criteria and their predictive value for successful extubation in non-cardiac surgical procedures. to evaluate the predictive value of room air oxygen and an original preoperative uri questionnaire in pediatric patients with uri or uri symptoms.

Eligibility criteria:
inclusion criteria: * all study participants must be undergoing general anesthesia and surgery with an endotracheal tube * the uri group will be participants with a score of at least 3 on our pre-operative uri survey, with planned airway instrumentation with an endotracheal tube (ett) for their surgical procedure who are to be discharged same day or on postoperative day 1. * the non uri group will be participants undergoing elective procedures with no uri symptom or recent uri. defined as no uri or "allergy" symptom within the past 6 weeks and a score of 1 or less on the uri survey, with planned airway instrumentation with an ett for their surgical procedure who are to be discharged same day or on postoperative day 1. exclusion criteria: * history of home oxygen use or ventilator dependence, * patients undergoing emergent procedures. * patients with cyanotic congenital heart disease. * patients receiving a surgical procedure where the duration of post procedure * admission is anticipated to be greater or equal to 2 postoperative days. * patients undergoing anesthesia for imaging procedures alone. * patients who are extubated deep intentionally. * patients intended to be managed with supraglottic airway. * patients undergoing total iv anaesthesia (tiva).

Keywords: extubation criteria pediatric anesthesia outpatient surgery
acute hemostasis following the use of the aquabeam® system for the treatment of benign prostatic hyperplasia ii

Conditions: Benign Prostatic Hyperplasia

Summary: a single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis following prostate resection using the aquabeam for treatment of luts resulting from bph.

procept biorobotics has developed the aquabeam, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from luts due to bph. the aquabeam system is intended for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (luts).the primary objective of this study is to evaluate the safety and performance of obtaining hemostasis with catheters following prostate resection using aquabeam for the treatment of luts resulting from bph. up to 50 participants will be included in the trial at one clinical study site. all patients will be followed up for 30 days for safety assessment prior to study exit. the trial is a single-arm prospective, interventional clinical trial.

Eligibility criteria:
inclusion criteria: * male * bph symptoms exclusion criteria: * serious concurrent medical conditions

Keywords: image-guided bph aquablation aquabeam luts tissue resection robotics
ultrasound guided subclavian vein cannulation at emergency room

Conditions: Ultrasound Subclavian Cannulation

Summary: 1. to observe and report the success rate associated with the use of ultrasound for subclavian vein catheterization. 2. to observe and report the type and complications and any constrains associated with this technique.

central venous catheterisation is a commonly performed procedure in anaesthesia, critical care, acute and emergency medicine. 1 , the subclavian vein (scv) has been an important vessel for central venous cannulation.2 the scv cannulation offers several advantages when compared to the common alternative sites for central venous access. these advantages may include fewer cases of thrombosis, infectious complications, better patient comfort, and increased ability to remain patent in hypovolemic states.3-4 traditionally, subclavian venous catheterisation has been performed using the landmark technique and because of the complications associated with this technique, it is not commonly performed.1 the complications such as catheter malposition, arterial puncture, hematoma, pneumothorax, hemothorax, and nerve injury.

Eligibility criteria:
inclusion criteria: * all patient admitted to emergency room and indicated for central venous catheterization exclusion criteria: * 1. any contraindication for central vein cannulation as coagulopathy, hemorrhage from target vessel, suspected proximal vascular injury 2- age below 18 year
efficacy and safety of salmon calcitonin nasal spray in improving muscle strength and reducing pain after forearm fracture in postmenopausal women

Conditions: Forearm Fracture

Summary: calcitonin has been used for many years for treating osteoporosis in postmenopausal women, and it has been shown that calcitonin reduces pain after spine and hip fracture in women with osteoporosis. therefore, this study assesses the safety and efficacy of salmon calcitonin nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture healing in postmenopausal women.


Eligibility criteria:
inclusion criteria: * post-menopausal women, aged at least 60 years old * having a forearm fracture within the last 3-7 days before treatment * fracture is treated with either a plaster cast only, or a cast plus kirschner wires exclusion criteria: * multiple fractures, severe fractures, or the forearm fractured in more than one place * nerve damage in the forearm caused by the fracture * other conditions which would interfere with the grip strength measurements (e.g. swelling, paralysis, skin diseases or rheumatoid arthritis) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: forearm fracture postmenopausal women pain grip strength salmon calcitonin