Kornimate/medical-research-clean huggingface dataset:
evaluation of multisensor data in heart failure patients with implanted devices

Conditions: Heart Failure

Summary: the goal of the multisense study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.

the purpose of multisense study is to collect data about patient events during worsening heart failure, determine how sensor measurements vary during patient daily activities and during the development and recovery from events of worsening heart failure, develop algorithms capable of detecting the onset of worsening heart failure prior to the overt presentation of patient symptoms using reference measurements: thoracic impedance, heart sounds, physiologic responses to activities and respiration.

Eligibility criteria:
inclusion criteria: * age 18 or above, or of legal age to give informed consent specific to state and national law * willing and capable of returning for all follow-up visits and emergency care at the investigational center as medically appropriate * willing to participate in all testing associated with this clinical investigation at an approved clinical investigational center * currently implanted with a cognis device (model n119 or n120, p107, p108) * classified as nyha class ii, iii or iv within the last six months exclusion criteria: * inability or refusal to sign the subject informed consent * inability of refusal to comply with the follow-up schedule * documented as pacemaker dependent * unable to rest comfortably in a semi-recumbent position for up to 20 minutes * implanted with active medtronic fidelis lead models: 6930, 6931, 6948 or 6949 * currently implanted with unipolar ra, rv, or lv leads * lv sensitivity programmed to less than 0.7 mv agc * history of appropriate tachycardia therapy (external or implanted) for rates \< 165 bpm within 1 week prior to enrollment * device battery status indicates approximate time to explant \< 2 years * likely to undergo lead or pg revision during the course of the study as determined by the investigator * receiving regularly scheduled intravenous (iv) inotropic therapy as part of their drug regimen * have received heart or lung transplant * receiving mechanical circulatory support * patients who have been referred or admitted for hospice care * a life expectancy of less than 12 months per physician discretion * enrolled in any concurrent study without boston scientific written approval * devices previously converted to the srd-1 and withdrawn from the study * received a sub-pectoral cognis implant prior to february 1, 2011 with a dash number listed in appendix k of the study protocol * known pregnancy or plan to become pregnant within the course of the study * lv offset is programmed to a value greater than zero

Keywords: heart failure decompensation cardiac resynchronization therapy
nola (neuwave observational liver ablation) registry

Conditions: Cancer of the Liver; Liver Cancer; Neoplasms, Liver

Summary: this is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the neuwave microwave ablation system.

this is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the neuwave microwave ablation system. the data gathered from participating sites will be available to be analyzed to develop ablation parameter guidance for ablation approaches under varying patient liver tissue conditions and liver lesions. this is an "umbrella registry," which was included as an optional component in other neuwave studies; hence, data from consenting patients who are or will be enrolled in other neuwave soft tissue liver lesion ablation studies will be included in this registry. all other patients will be enrolled and followed prospectively, enrolled retrospectively with prospective, longitudinal follow up, or enrolled retrospectively with all retrospective follow up. enrollment for this study will include up to 1,500 patients throughout the world who underwent or are scheduled to undergo microwave ablation of one or more soft tissue liver lesions using the neuwave microwave ablation system or the neuwave microwave ablation system with ablation confirmation.

Eligibility criteria:
inclusion criteria: 1. patients who underwent or are scheduled to undergo a microwave ablation of one or more liver lesions with the neuwave microwave ablation system per the device's instructions for use (ifu). 2. patients with signed informed consent (or waiver approved by irb/ec) who are willing to comply with the assessment schedule, and willing to have data included in the database. 3. patients greater than or equal to 22 years old at the time of informed consent (or waiver approved by irb/ec). exclusion criteria: 1. patients with a life expectancy of less than 1 year, in the opinion of the treating physician. 2. use of microwave ablation purely as a transection tool, rather than focused liver lesion ablation. 3. patient is currently participating, or planning to participate, in another neuwave/ethicon-funded clinical trial or registry studying microwave ablation in the liver. note: roll-over patients from previous neuwave trials are permitted.
a korean cohort study of tdf rescue therapy for difficult-to-treat chb patients: a comparison between tdf monotherapy and tdf-based combination therapy

Conditions: The Difficult-to-treat Chronic Hepatitis B

Summary: antiviral resistance remains an important issue for long-term na therapy. for lamivudine (lam), the rtm204v/i and rtl180m mutations occur in more than 70% after 5 years of therapy. in korea, primarily owing to limited subsidization policy in the health insurance system, many patients with lmv-resistance had been treated with either rescue adv or etv 1.0 mg monotherapy, ultimately leading to the higher prevalence of mdr strain. for those patients, rescue therapies of combining adv with either etv or lam had been tried, but frequently with suboptimal responses. rescue tdf monotherapy or tdf-based combination therapy are available in korea for patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures. however, which is the better has not been evaluated yet. a long-term efficacy and safety of tdf-based rescue therapies in real practice for those patients should be necessary to revise the korean guideline for the treatment of chronic hepatitis b in near future.


Eligibility criteria:
inclusion criteria: * more than 20 years old adults * chronic hepatitis b * the patients treated by tenofovir alone or tenofovir based combination therapy because of the previous treatment failure * the patients who agree and singed on the consent form exclusion criteria: * co-infected patients with hcv, hdv or hiv * pregnancy or breast feeding woman or female patients who are planning to be pregnant * past history with hepatocellular carcinoma * combined with other liver disease including wilson, alcoholic, nash, alpha-1 antitrypsin deficiency liver disease. * patients with hypersensitivity for drugs * patients who were enrolled in other clinical study within 60 days * patients who were eligible for the clinical study according to the investor
sayed issa's hybrid shoulder arthroscopic-open surgical management (hssm)

Conditions: Shoulder Impingement Syndrome; Adhesive Capsulitis; Rotator Cuff Tear; Hill-Sachs Lesion; Frozen Shoulder; Tendinopathy

Summary: sayed issa's hybrid shoulder arthroscopic-open surgical management (hssm) is a limited lateral approach to the shoulder arthroscopically guided. which achieves less surgical trauma and smaller surgical incision than even in mini lateral shoulder approach (mlsa).

after making a full clinical, x-rays and mri examinations of the shoulder, and finding shoulder impingement syndrome, adhesive capsulitis, rotator cuff tear, or hill-sachs lesion, we decide to manage the problem surgically we can survey the shoulder from the inside and determine the shape, size and the exact position of the defect by shoulder arthroscopy. the patient is operated on under general anesthesia; shoulder arthroscopy can be performed in the lateral decubitus or beach chair position which is the basic shoulder arthroscopy (beach chair patient positioning). after identifying the full characteristics of the lesion, we go for mini lateral shoulder approach (mlsa), as known as second sayed issa's approach.

Eligibility criteria:
inclusion criteria: * patients presented with shoulder impingement syndrome refractory to conservative treatment and local steroid injection * patients presented with adhesive capsulitis and frozen shoulder syndrome refractory to conservative treatment and local steroid injection * patients without femur head immigration on x-ray * patients with injury for one month to six months maximum exclusion criteria: * patients with femur head immigration on x-ray * patients with injury for more than six months * uncontrolled diabetes mellitus type 1 and 2 * patients with non controlled vascular hypertension * significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. * myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization

Keywords: shoulder shoulder approach lateral shoulder approach shoulder impingement syndrome rotator cuff tendinopathy adhesive capsulitis frozen shoulder syndrome mlsa shoulder arthroscopy mini lateral shoulder approach second sayed issa's approach hill-sachs lesion mini-incision release tendinopathy arthroscopy tendon injuries
a pilot study to evaluate zadaxin's® (thymalfasin) ability to enhance immune response to the h1n1sw influenza vaccine

Conditions: END STAGE RENAL DISEASE

Summary: the purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived h1n1sw monovalent influenza vaccine in hemodialysis patients. the final aim is that of gathering information needed for planning a following confirmatory study on the efficacy and safety of thymosin alpha 1 in the same indication.

the emergence and spread of the novel influenza a (h1n1) virus has been of great concern globally. uremic patients are especially vulnerable to infections and it is generally recommended to vaccinate patients with chronic renal insufficiency yearly against influenza. in patients on haemodialysis (hd) the vaccination response has been considered suboptimal. decreased antibody response to t-cell dependent antigens may be one factor that accounts for insufficient efficacy of certain vaccination programs (eg, influenza). diminished antibody responses have also been reported in patients with end-stage renal disease. the evidence for impairment of cell-mediated immunity in hemodialysis patients has been attributed to incompetence in t-cell-mediated immune responses. since zadaxin can enhance t-cell-dependent specific antibody production, the addition of zadaxin (thymosin alpha 1)to vaccination programs for immunocompromised individuals should be effective.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. age \> 18 . 3. chronic dialysis for esrd . 4. life expectancy of at least 6 months. exclusion criteria: 1. they have any serious disease 2. they are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine. 3. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine. 4. within the past 3 days, they have experienced fever (i.e., axillary temperature _ 38°c). 5. they have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.

Keywords: esrd
prospective evaluation of focal brachytherapy using cesium-131 for patients with low risk prostate cancer

Conditions: Prostate Cancer

Summary: the standard options for men with very low risk prostate cancer include active surveillance and the standard treatment options for low risk disease, i.e. radical prostatectomy, external beam radiotherapy, and whole gland prostate brachytherapy. the present study seeks to evaluate focal brachytherapy using the isotope cesium 131 to treat patients with low risk prostate cancer. the goals of the study are to determine the biochemical disease free survival at five years in these patients, as well as to determine the acute and late urinary, bowel, and sexual toxicity associated with focal prostate brachytherapy using cesium 131. patients eligible for the study will be men with histologically confirmed adenocarcinoma of the prostate with clinical stage t1c-t2an0m0, gleason score ≤3+3=6, prostate specific antigen(psa) \<10 ng/ml or a psa density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum of 12 cores sampled. additionally, patients must have a single, dominant index lesion on mri. the study is a phase ii study. patients will be followed prospectively. dosimetry will be evaluated post-procedure, and psas will be obtained every three months in year one and every six months from year two through year five. urinary, bowel, and sexual morbidity will be assessed by patient survey prior to treatment , two weeks, after treatment, at three month intervals in year one and at six month intervals in years two through five.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * clinical stage t1c-t2an0m0 * gleason score \<= 3+3=6 * prostate specific antigen (psa) \<10 ng/ml * \<= 2 cores positive out of a minimum of 12 cores sampled
the efficacy of adductor-canal-block (acb) in patients after anterior cruciate ligament (acl) reconstruction

Conditions: Anterior Cruciate Ligament Reconstruction

Summary: the purpose of this study is to determine whether adductor-canal-block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.


Eligibility criteria:
inclusion criteria: * 18-70 years * reconstruction of anterior cruciate ligament * written consent * asa i-ii * bmi 19-35 exclusion criteria: * unable to communicate in danish * allergic reactions toward drugs used in the trial * pregnancy * abuse of alcohol/drugs * daily opioid intake * infection at injection site * can not be mobilised to 5 meters of walk; pre-surgery

Keywords: adductor canal block (acb) anterior cruciate ligament (acl) reconstruction saphenous nerve pain ultrasound block
2d versus 3d radiographs in the localization of upper impacted canines

Conditions: Impacted Canines

Summary: seventeen patients diagnosed with the extraction-based treatment of impacted maxillary canines will be included in this study. each patient will undergo conventional 2d radiography including panoramic, and lateral cephalometric, in addition to 3d imaging by cone beam computed tomography (cbct) images. a set of variables will be evaluated on 2d and 3d images by a panel of assessors and then these results will be compared with the gold standard which will be established based on surgical detection and direct visualization of the impacted canine.

after taking the radiographic records, the impacted maxillary canines will be surgically exposed under local anesthesia where a full-thickness flap will be elevated from the buccal or palatal according to the initial radiographic diagnosis. after cleaning the work yard to achieve good visibility, the pre-extraction parameters will be recorded which will be included labiopalatal position, mesiodistal position, and vertical position of the canine cusp, in addition to ankyloses of the impacted maxillary canine, proximity to the adjacent teeth, resorption of the adjacent incisors induced by the impacted maxillary canine, and bony coverage of the canine crown. this will be followed by the extraction of the upper impacted canine and the recording of the post-extraction parameters, which will include the shape and the root apex development of the extracted canine. the pre- and post-extraction readings will be deemed the gold standard which will be compared to the 2d- and 3d-based assessments of the assessors. assessment sessions will be divided into two sessions with a one-week break in between. the first session will be devoted to the evaluation of the 2d image sets, while the second one will be to the evaluation of the 3d images. before beginning the assessment, the assessors will be subjected to a set of instructions and clarifications, including a set of graphs that help each assessor to accurately identify each variable, in addition to an oral explanation of some points so that the assessor will not fall into doubt when evaluating the radiographs.

Eligibility criteria:
inclusion criteria: 1. patients from both gender (male and female), age range: 14-27 years. 2. unilateral impaction of the maxillary canines requiring surgical extraction. 3. non-syndromic patients without any pathology of the maxillofacial region (benign or malignant tumor, cleft lip or cleft palate, trauma) 4. patients with a set of panoramic and lateral cephalometric images, in addition to cbct radiograph (cbct is indicated for treatment planning) 5. the time period between taking the radiological records and undergoing the surgical intervention does not exceed four weeks exclusion criteria: 1. patients who had a systemic disorder, cleft lip/cleft palate, craniofacial syndrome, traumatic injury, and congenital number anomaly. 2. patients had previous orthodontic treatment.
the physical effects of pain catastrophizing in labor

Conditions: Pregnancy

Summary: the purpose of this study is to determine whether labor self-efficacy (as determined by scores for the lederman pseq ii (self-efficacy scores) impacts the second stage 2 length (nromal vs. prolonged) as determined by quartile ranges for our sample. other studies have shown that women who experience intense pain in the earliest stages of labor have a higher risk of complications. the investigators want to know if negative thoughts can predict this outcome.

subjects will complete questionnaires at three timepoints: during the prenatal period, within 24-48 hours of giving birth, and 4-8 weeks postpartum. the questionnaires will measure pain catastrophizing, depression, maternal support, support and control in birth, and childbirth satisfaction. chart review following delivery will record data such as length of labor, medication used, need for augmentation or surgical delivery, complications.

Eligibility criteria:
inclusion criteria: * at least 20 weeks of pregnancy * nulliparous * singleton pregnancy * low risk pregnancy exclusion criteria: * primiparous and multiparous women * women who request cesarean delivery * women who are pregnant with twins * women who plan induction * women who deliver before 37 weeks * women enrolled in the "centering pregnancy" program at the family birth center * high risk pregnancies * severe mental illness that impairs cognition or function * suicidal ideation * women who do not speak english or spanish

Keywords: pregnancy birth labor labor pain catastrophizing
tlr4 polymorphisms and risk of skin cancer

Conditions: Skin Cancer

Summary: toll-like receptors (tlrs) play a key role in the innate immune system. toll-like receptor-4 (tlr4) in particular, appears to play a role in susceptibility to cancer. of 44 identified snps (small nucleotide polymorphisms) in tlr4, the most common is an a-g substitution at nucleotide position +896, downstream of the cdna start codon, a missense mutation which leads to an amino acid substitution asp299gly in the third exon of the tlr4 gene. pre-clinical studies from our laboratory have shown an association of tlr4 with ultraviolet radiation induced skin cancer. hence, in this study we will assess the pattern of tlr4 polymorphisms and susceptibility to skin cancer.

toll-like receptors (tlrs) play a key role in the innate immune system. toll-like receptors generally, and tlr4 in particular, appear to play a role in cancer susceptibility as well as tumor immunosuppression and stromal invasion. of 44 identified snps (small nucleotide polymorphisms) in tlr4, the most common is an a-g substitution at nucleotide position +896, downstream of the cdna start codon, a missense mutation which leads to an amino acid substitution asp299gly in the third exon of the tlr4 gene, and which was later shown to co-segregate with snp thr399ile-also in the third exon of tlr4.1 this snp, present in 10% of the general population, has been found associated with gastric cancer, prostate cancer, and nasopharyngeal cancer.2-4 pre-clinical studies from our laboratory have shown an association of tlr4 with ultraviolet radiation induced skin cancer. hence, in this study we will assess the pattern of tlr4 polymorphisms and susceptibility to skin cancer.

Eligibility criteria:
inclusion criteria: * male or female over the age of 50 * fitzpatrick skin type i-iv exclusion criteria: * tumor types other than basal cell carcinoma, squamous cell carcinoma and melanoma * chronic immunosuppression due to transplant antirejection regimen or hiv/aids * nevoid basal cell carcinoma syndrome, cowden's syndrome, xeroderma pigmentosum or other syndrome with skin-cancer predisposition * known exposure to arsenic or ionizing radiation

Keywords: single nucleotide polymorphisms toll-like receptor-4
intraperitoneal dexamethasone vs dexamethasone plus magnesium sulphate for pain relief in laparoscopic cholecystectomy

Conditions: Pain, Postoperative

Summary: laparoscopic cholecystectomy has become a standard technique for gall bladder surgery. benefits in comparison to conventional laparotomy are shorter lived effects on pulmonary function and less postoperative pain . however, patients often suffer from considerable pain during the first 24 postoperative hours. pain can prolong hospital stay and lead to increased morbidity, which is particularly important now that many centers are performing this operation as a day-case procedure. administration of intraperitoneal local anesthetic, either during or after surgery, is used by as a method of reducing postoperative pain. although a number of studies have reported a significant reduction in postoperative pain after the use of intraperitoneal analgesia, others have reported no benefit. several investigations have been conducted in order to find the cause of this pain. according to some of these investigations, the pain is attributed to peritoneal inflammation due to carbon dioxide pneumoperitoneum. since steroids have been used for reducing inflammation, they may be considered as alternatives for relieving pain. dexamethasone is a strong long acting glucocorticoid and it is widely used after surgery. it has been established that steroids are effective in relieving postoperative pain in laparoscopic cholecystectomy. also, administration of magnesium sulphate has been shown to have a potential to prevent postoperative pain and to reduce intra operative anesthetic and analgesic requirements being an antagonist of n-methyl-d-aspartate (nmda) receptors and its associated ion channels. some studies showed reduction of pain scores if magnesium sulphate was injected intra-articular and intraperitoneal with no serious adverse effects. in this study the investigators will use intraperitoneal dexamethasone vs dexamethasone plus magnesium sulphate to study their analgesic efficacy after laparoscopic cholecystectomy as the investigators assume that the combination of both drugs will provide stronger analgesia than dexamethasone alone


Eligibility criteria:
inclusion criteria: 1. age group and gender: between 18 to 60 years both males and females 2. american society of anesthesiologists (asa) physical status i-ii exclusion criteria: 1. age \ 60 years 2. asa physical status iii or iv 3. patients with diabetes 4. patient refusal to participate in the study 5. chronic respiratory disease 6. advanced renal or hepatic diseases 7. use of opioids, tranquilizers or steroids 8. confusion or psychiatric illness 9. acute cholecystectomy 10. patients with peritoneal drain after surgery