Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of heplisav™ a hepatitis b virus vaccine in adults on hemodialysis

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to compare the immune response to heplisav™ booster injection with the immune response to engerix-b® and fendrix® booster vaccinations among patients with end stage renal disease (esrd) on hemodialysis.

the immune response of heplisav compared with engerix-b and fendrix and measured by seroprotection rate (spr) at 4 weeks after the booster injection

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * has loss of renal function and is receiving hemodialysis treatments * is not seroprotected against hepatitis b (has anti-hbs \< 10 miu/ml) * in the opinion of the investigator, is clinically stable * be serum negative for hbsag, anti-hepatitis b core antigen (hbc), hepatitis c virus (hcv), and hiv * is not scheduled to undergo a kidney transplant during the study period * if female, and of childbearing potential, subject must be: surgically sterile or neither pregnant nor breast-feeding, consistently using a highly effective method of birth control for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study. exclusion criteria: * if female, is pregnant, breastfeeding, or planning a pregnancy; * has a history of or is at high risk for recent exposure to hbv, hcv, or hiv; * has known history of autoimmune disease; * has history of sensitivity to any component of study vaccines; * has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results; * is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin; * has uncontrolled diabetes; * has received a kidney transplant previously that is still functioning and requires anti-rejection medication; * has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period; * has received the following prior to the study injection: 3 days: intravenous iron; 21 days: any inactivated virus or bacterial vaccine; 28 days: any live virus or bacterial vaccine; systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids; granulocyte colony stimulating factor (g-csf) or granulocyte-macrophage colony stimulating factor (gm-csf); any other investigational medicinal agent; * at any time: an injection of deoxyribonucleic acid (dna) plasmids or oligonucleotides; investigational or intradermal hepatitis b vaccine.

Keywords: end stage renal failure renal failure kidney failure kidney failure, chronic chronic kidney failure hepatitis b virus (hbv) vaccine hepatitis b vaccine hepatitis b hepatitis hbv prevention and control dialysis
liposomal bupivacaine vs dexamethasone isb

Conditions: Shoulder Pain

Summary: in this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. patients will be followed up with to determine postoperative pain and block duration.


Eligibility criteria:
inclusion criteria: * asa i-iii * age 18 years or older * scheduled for elective outpatient arthroscopic shoulder surgery exclusion criteria: * history of allergy to local anesthetic, or one of the study medications * pre-existing neurological deficits * psychiatric or cognitive disorders that prohibit patients from following study protocol * history of drug or alcohol abuse * chronic opioid use (longer than 3 months) * chronic pain syndromes * infection at the site of injection * patients with severe pulmonary disease * herniated cervical disc, cervical myelopathy * contraindication for general anesthesia and/or interscalene nerve block * pregnancy * open shoulder arthrotomies. * non english speakers
outcomes data of adipose stem cells to treat parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (svf), has on the quality of life of people with parkinson's disease (pd). svf contains components with "regenerative" properties, including stem cells that may be capable of ameliorating specific disease conditions. this study is designed to evaluate quality of life changes in individuals with pd for up to 12 months following svf treatment.


Eligibility criteria:
inclusion criteria: * subjects scheduled for a stem cell/svf treatment * subjects diagnosed with idiopathic parkinson's disease * subjects ages 18 years and older * subjects willing and able to sign informed consent * subjects willing and able to perform follow up interviews and surveys exclusion criteria: * subjects with additional major health diagnoses * subjects that are pregnant or breastfeeding
prostate cancer radiotherapy - bowel quality of life (procar-bq)

Conditions: Prostate Cancer; Radiotherapy Side Effect; Bowel Dysfunction; Quality of Life

Summary: this is a prospective pilot study to evaluate the mean increase of bowel symptoms after pelvic radiotherapy (rt) in prostate cancer (pca) patient using the validated \& newly translated eortc-qlq prt20 module.

questionnaires (qlq-c30 and prt20 modules) will be held to patients at the beginning and at the end of rt (4 weeks) to evaluate the mean increase of lower gi symptoms and decrease in overall qol after pelvic rt. for exploratory objectives, glim (global leadership initiative on malnutrition) criteria for malnutrition diagnosis, a 24h recall and dqi-i calculation will be assessed by the pi before the start of rt. ct sim \& dosimetry will be analyse by the pi before treatment to evaluation the body composition and the max and mean dose received by the bowel, the sigmoid and the rectum. a polar watches will be loaned to the patient by the pi at the ct sim appointment to record patient's daily movement for two weeks (usual waiting time between ct and treatment) and recovered on the first day of treatment.

Eligibility criteria:
inclusion criteria: * men with pca which are candidate for pelvic radiotherapy (rt) with or without previous surgery, with or without concomitant hormonotherapy (ht), performance status (ps) 0-2 (all patient able to undergo rt treatment), of all age, elderly included. exclusion criteria: * previous rt to the pelvis * diagnosed inflammatory bowel disease (ibd), celiac disease * severe gi symptoms before the beginning of rt (grade \> 2 according to ctcae grading system) * obvious cognitive impairment, * inability to understand french/english and no contact person able to accompany and translate.

Keywords: prostate cancer radiotherapy side effect radiation toxicity bowel dysfunction pelvic radiation disease diarrhea radiation proctitis radiation enteritis quality of life malnutrition sarcopenia diet physical activity
goal-directed vs. empirical tranexamic acid administrationin cardiovascular surgery

Conditions: Heart Diseases; Vascular Diseases; Transfusion Related Complication; Coagulation Disorder, Blood; Fibrinolysis; Hemorrhage

Summary: the present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. the study's primary objective is to compare the amounts of postoperative bleeding using two different txa administration strategies: empirical txa administration vs. viscoelastic test-based goal-directed txa administration in cardiovascular surgery. the secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. researchers assumed that goal-directed tranexamic acid (txa) administration using viscoelastic field tests would not be inferior to the empirical txa administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. it also would be beneficial in lowering txa-induced thromboembolic complications and seizures.

the present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. this study's primary objective is to compare the amounts of postoperative bleeding during postoperative 24 hours through chest tube drainage using two different tranexamic acid (txa) administration strategies: empirical txa administration vs. viscoelastic test-based goal-directed txa administration in cardiovascular surgery. the secondary objectives include determining the inter-group differences in hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. researchers hypothesized that goal-directed txa administration using viscoelastic field tests would not be inferior to the empirical txa administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. researchers also expect that goal-directed txa administration would be beneficial in lowering txa-induced thromboembolic complications and seizure risks.

Eligibility criteria:
inclusion criteria: * patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass * patients who provide written informed consent exclusion criteria: * pregnancy * refusal of allogenic blood transfusion * taking thrombin * history of thromboembolic and familial hypercoagulability disease * recent history of myocardial infarction or ischemic cerebral infarction (within 90 days) * hypersensitive to txa * histroy of convulsion or epilepsy * taking hemodialysis * history of heparin-induced thrombocytopenia
deep learning for intelligent identification of arrhythmias

Conditions: Arrhythmia

Summary: this study aims to design and train a deep learning model for the diagnosis of different arrhythmias.

this study aims to retrospectively and prospectively collect routine clinical data such as electrocardiograms from patients with arrhythmias who meet the inclusion and exclusion criteria. then we will design and train a deep learning model to analyse the electrocardiographic features of the arrhythmias, and identify the types of arrhythmias and evaluate the value of the model for the diagnosis of different arrhythmias.

Eligibility criteria:
inclusion criteria: * for retrospective study: 1.patients with arrhythmia diagnosed by routine surface 12-lead electrocardiogram or holter; 2.the type of arrhythmia is diagnosed by intracardiac electrophysiological examination. * for prospective study: 1.patients with arrhythmia diagnosed by routine surface 12-lead electrocardiogram or holter; 2.intracardiac electrophysiological examination is planned. exclusion criteria: * lack of routine surface 12-lead electrocardiogram or holter data; * lack of intracardiac electrophysiological examination; * patients refused to sign informed consent and refused to participate in the study.

Keywords: arrhythmia
exercise prehabilitation for locoregional esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of the study is to examine the feasibility and acceptability of exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal).


Eligibility criteria:
inclusion criteria: * biopsy-proven locoregional esophageal cancer (lec) * eastern cooperative oncology group (ecog) performance status 0-2 * treatment plan including neoadjuvant chemoradiation therapy and surgical resection * ability to read and speak english exclusion criteria: * regular engagement in resistance training (2x/week targeting all major muscle groups) * screen failure for exercise safety based on par-q * underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease * recent fracture or acute musculoskeletal injury that precludes ability to participate in resistance training safely * numeric pain rating scale of 7 or more out of 10 * myopathic or rheumatologic disease that impacts physical function
a study to evaluate the use of stavudine (d4t) to treat aids dementia complex

Conditions: AIDS Dementia Complex; HIV Infections

Summary: the purpose of this study is to see if adding stavudine (d4t) to anti-hiv drug regimens (with or without zidovudine, zdv) can improve symptoms of aids dementia complex (adc, problems involving the brain or spinal cord) in hiv-positive patients.

in this open-label, multicenter, multinational study, zdv is replaced with d4t in zdv-containing regimens, or d4t is added to non-zdv-containing regimens in 20 patients experiencing adc. patients are defined as having failed treatment if they progress by one adc stage on the msk (memorial sloan kettering) rating scale on study (i.e., from stage 1 to 2 or stage 2 to 3). patients are evaluated on a weekly basis until the dementia deterioration is confirmed to be caused by hiv-1. the effect of d4t-containing regimens is assessed for the following parameters: neurological status, survival, aids-defining conditions, csf (cerebrospinal fluid) and plasma viral load, csf and blood immunological markers, blood cd4 cell counts, and viral resistance. this study also assesses the pharmacokinetics of d4t in the csf and in the blood.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * are at least 13 years old (need consent if under 18). * have aids dementia complex. * have been on a stable anti-hiv drug regimen for at least 8 weeks prior to study entry. * agree to use effective methods of birth control during the study. * are available for at least 16 weeks of study. exclusion criteria you will not be eligible for this study if you: * have ever taken d4t. * have a neurological (brain/spinal cord) disease, such as chronic seizures or head injury, or certain other conditions that would interfere with your ability to complete the study. * are pregnant or breast-feeding. * abuse alcohol or drugs. * have peripheral neuropathy or a newly diagnosed aids-defining infection that requires treatment at the time of study enrollment. * have received certain medications. * cannot take medications by mouth. * have severe diarrhea for at least 7 days in a row within 30 days prior to study entry.

Keywords: aids dementia complex zidovudine stavudine reverse transcriptase inhibitors
cannabis use and relapse after one week of contingency management therapy

Conditions: Cannabis Dependence

Summary: the purpose of this study is to examine the effects of a seven-day combined contingency management (cm) with two sessions of brief motivation interviewing (mi) followed by standardized individual drug counseling on cannabis use and relapse in the following 90-day period in individuals with moderate to severe cannabis use disorder (dsm-5).

the primary aim of this study is to examine cannabis use and rates of abstinence and relapse in individuals with moderate to severe cannabis use disorder (cud) after intensive 7-day contingency management (cm) procedure to reinforce abstinence from cannabis use. in addition, this study will evaluate the effect of cm with two sessions of brief mi on the severity of cannabis withdrawal signs during the first 7-days of cm treatment and then during the following month. the study will also focus on prospectively monitoring the sustenance of abstinence and time to lapse and relapse to cannabis use over a 90-day period, using ecological momentary assessment (ema) via a smartphone-based application. an additional aim will be to evaluate changes in symptoms of cud during the period following the 7-day using the diagnostic criteria of the dsm-5.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) less than 32; * good health as verified by screening examination; * able to read english and complete study evaluations; * able to provide informed written and verbal consent; * cud sample must meet dsm-5 criteria for cud as assessed using scid-i and have positive cannabis urine toxicology screens on admission to study, with weekly 3 or more days of self-reported cannabis use. exclusion criteria: * meet current dsm-5 criteria for dependence on another psychoactive substance or alcohol, excluding nicotine and mild alcohol use disorder * current use of opiates or history of opiate abuse/dependence; * regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, other antihypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, ssri's, naltrexone, antabuse; * psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania); * significant underlying medical conditions such as a history of seizure disorder, cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude subjects from fully cooperating or be of potential harm during the study; a known history of hepatitis b, c, or hiv infection; * any psychotic disorder or current axis i psychiatric symptoms (excluding anxiety disorders) requiring specific attention, including need for psychiatric medications * women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy urine test during initial intake appointment; and * traumatic brain injury or extended loss of consciousness.
amodiaquine+artesunate vs. artemether-lumefantrine for uncomplicated malaria in ghanaian children

Conditions: Uncomplicated Malaria

Summary: artemisinin combination therapies (act) are currently recommended for malaria treatment. artemether-lumefantrine(a-l) and artesunate+amodiaquine (a+a) have been the most commonly adopted of the recommended act regimens. in ghana, a+a is the current first-line antimalarial treatment in ghana, but there has been 1 efficacy report of this regimen in ghana till date. moreover, the safety of repeated treatments with act has been little studied. this study aims to evaluate the efficacy of a+a vs. a-l, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.


Eligibility criteria:
inclusion criteria: * microscopically confirmed acute uncomplicated falciparum malaria; * temperature at screening 37.50c or more or history of fever 24 preceding enrollment; * willingness to comply with follow up schedule; * written informed consent by accompanying parent or guardian exclusion criteria: * features of severe malaria or danger signs of malaria * known intolerance or allergy to any of the study medications * known treatment with any of the study medications in the month preceding enrollment * serious underlying disease that may mask outcome assessment
inferior vena cava indexes in positive pressure supports

Conditions: Positive-Pressure Respirations; Respiratory Failure

Summary: collapsibility (ci-ivc), distensibility (divc) and delta (δivc) indices, which are dynamic measures of inferior vena cava (ivc) diameter, are used to assess the intravascular volume status in critically ill patients. positive pressure support (ps) has been shown to induce ivc diameter distention by increasing intrathoracic pressure, and high positive expiratory pressure (peep) decreases the ci-ivc percentage (4). during triggered positive pressure support it is necessary to clarify which ivc index is valid for measuring the volume status.it is aimed to compare the ivc indexes (ci-ivc, divc, δivc), positive rate of change with pressure, correlation with central venous pressure and accurate prediction of volume status in patients with different positive pressure support.

the ivc diameters at different pressure supports were measured by the same clinician after obtaining a clear image of where the us and ivc measurements were made and the probe stabilization was achieved. he performed the procedure of changing the pressure supports, a blind independent intensive care physician without working, and recorded the applied pressure supports respectively. the different pressure supports applied are as follows: 1. ps 10 mmhg-peep 5 mmhg, 2. ps 0 mmhg- peep 5 mmhg 3. ps 10 mmhg- peep 0 mmhg. 4. t-tube (ps 0 mmhg-peep 0 mmhg)

Eligibility criteria:
inclusion criteria: * age\>18 years * current use of mechanical ventilation through an endotracheal tube. exclusion criteria: * profound hypoxia defined as a fraction of inspired oxygen requirement \>90% or a peep \>10 mmhg * patient-ventilator desynchrony or active agitation * unstable o2 requirement * cardiovascular instability * current peep requirements of \>10 mmhg * current oxygen saturation (spo2) of \<88%. * high intra abdominal pressure * right cardiac failure * morbid obesity

Keywords: ultrasound,inferior vena cava, positive pressure
evaluation of immunosuppression in septic shock: biomarkers and pharmacological restoration (immunosepsis)

Conditions: Immunology of Septic Shock

Summary: septic syndromes (systemic inflammatory response associated with infection) remain a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units. while it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immunologic response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. as a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. this is illustrated in those patients by reactivation of dormant viruses (cmv or hsv) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. these alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. both arms of immunity (innate and adaptive) are indeed markedly suppressed (including enhanced leukocyte apoptosis, lymphocyte anergy and deactivated monocyte functions). new promising therapeutic avenues are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. the prerequisite for immunostimulation administration (ifng, gm-csf, il-7) however relies on the investigators capacity in identifying the patients who could benefit from it, as there is no clinical sign of immune dysfunctions. the main objectives are: 1. to identify the best biomarkers for sepsis-induced immunosuppression and 2. to evaluate ex vivo whether drugs could rejuvenate immune functions.


Eligibility criteria:
inclusion criteria: * septic shock is defined by an identifiable site of infection, persisting hypotension despite fluid resuscitation requiring vasopressor therapy, and evidence of a systemic inflammatory response exclusion criteria: * age \< 18 * immunosuppressive disease (hiv, cancer, primary immune deficiency) * immunosuppressive treatment or corticoid treatment (dosage \> 10mg/day or cumulative dose \>700 mg equivalent prednisolone) * aplasia as defined by number of circulating neutrophils \< 500 cells / mm3 * extracorporeal circulation during the month prior icu admission

Keywords: sepsis septic shock immunosuppression hla-dr lymphopenia