Kornimate/medical-research-clean huggingface dataset:
safety of and immune system response to an hiv vaccine (ep hiv-1090) in hiv infected patients

Conditions: HIV Infections

Summary: hiv-1-infected patients who have been treated with anti-hiv drugs for a long time may have weakened immune responses to hiv. the dna-based vaccine in this study is designed to boost the immune system's responses against many hiv-1 proteins. the main purposes of this study are to test the safety of this hiv vaccine (ep hiv-1090) and to test whether the vaccine can stimulate immune system responses in people who have hiv-1 infection.

significant data support the hypothesis that hiv-specific cytotoxic t lymphocyte (ctl) responses contribute to the control and potential clearance of the virus. vaccines designed specifically to induce ctl responses are likely to be well suited for treatment of hiv infection. the conceptual basis of the ep hiv-1090 vaccine is the use of highly defined ctl epitopes as the vaccine immunogen. the vaccine is formulated with a water-soluble polymer that stabilizes and protects the dna and facilitates uptake by cells. preclinical studies have shown that the vaccine induces strong ctl responses in animal models. this study will evaluate the safety and tolerability of the vaccine and the immune response to the vaccine in hiv-1-infected individuals who are being treated with highly active antiretroviral therapy (haart) and have a cd4 count of 350 cells/mm3 or more and fully suppressed viral replication on stable haart. each patient will receive a total of four immunizations to be given at day 0 and at weeks 4, 8, and 16. participants will be randomly assigned to receive either vaccine or placebo. ten patients will be assigned to each dose group; eight will receive active vaccine and two will receive placebo. the injections will be delivered intramuscularly into the deltoid muscle. in addition to undergoing standard safety exams, patients will have blood drawn for use in evaluating the immunogenicity of the vaccine. the treatment duration will be 16 weeks and patient will be followed for safety and immune responses for an additional 24 weeks after they complete vaccination; the total study is estimated to take 18 months.

Eligibility criteria:
inclusion criteria * documented hiv-1 infection * taking haart for 6 months or longer and on stable haart for at least 4 weeks * plasma hiv-1 viral load of less than 400 copies/ml for at least 6 months prior to study entry * cd4 count of 350 cells/mm3 or more within 30 days of entry exclusion criteria * immunomodulatory agents * prior receipt of experimental hiv vaccines in the 5 years prior to study entry * hepatitis b surface antigen or hepatitis c virus antibody positive

Keywords: hiv therapeutic vaccine ctl epitope treatment experienced
gastric volume in patients on glp-1 medications

Conditions: Diabetes

Summary: evaluating gastric volume in patients on glp-1 ra medications

glucagon like peptide 1 (glp-1) receptor agonist (ra) medications have in recent years been approved for use in children with type 2 diabetes mellitis (dm) and obesity. the side effects of these medications include nausea and vomiting, and in the adult literature, delayed gastric emptying has been described. due to the likelihood of delayed enteric motility, standard nil per os (npo) guidelines may not be sufficient to minimize the chance of aspiration of gastric contents before anesthesia and surgery in patients receiving glp-1 ra medications. investigators seek to measure the gastric volume of children on glp-1 ra medications who are appropriately npo (greater than/equal to 8 hours for solids and greater than/equal to 1 hour for clear liquids) using standard institutional npo guidelines. the secondary objective is to measure the gastric volume of children not on glp-1 ra medications, but with type 2 diabetes mellitis or obesity and/or type 1 dm. the only study intervention is the addition of a gastric ultrasound. the gastric ultrasound is a non-invasive mode of imaging using sound waves with no known safety risks. the ultrasound will be performed while the subject is awake and will take less than 5 minutes.

Eligibility criteria:
inclusion criteria: fasting diabetic on glp-1 ra exclusion criteria: prior surgery that affects gastric anatomy
creation health readmission risk assessment tool

Conditions: Heart Failure; COPD; Myocardial Infarction; Coronary Artery Bypass Graft; Pneumonia; Total Knee Replacement; Total Hip Replacement; Stroke

Summary: this study occurs in two phases. phase 1 involves initial item development and measurement validation of a new tool for identifying hospitalized patients at high risk for preventable readmission. primary tasks include item construction and content validation, data collection, analysis, and instrument refinement. phase 2 involves administering the refined instrument to a new group of patients to determine final item content for the instrument, its factor structure, and its predictive validity.

participants will complete the instrument on an electronic device provided by research staff in the hospital room. if an individual is unable to complete the instrument, the participant may have another individual input answers on the electronic device. hospitalized patients (n = 1240: 620 in phase 1 and 620 in phase 2) with a variety of chronic diseases will be recruited into the study. study coordinators will recruit participants with the following diagnoses: heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, coronary artery bypass graft, pneumonia, total knee or hip replacement, and stroke. these diagnoses were chosen because of the frequency with which patients are readmitted after discharge.

Eligibility criteria:
inclusion criteria: * primary or secondary admission diagnosis of heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, coronary artery bypass graft, pneumonia, total knee or hip replacement, or stroke. * age 21 and over * able to provide informed consent * able to speak and read english * able to complete an electronic survey or relay answers to questions to another party who may complete the survey for the participant * resides in central florida and anticipates continued residence in central florida for the next 120 days * planned discharge to a non-hospital or residential care environment exclusion criteria: * under age 21 * does not speak or read english * permanent residence is outside central florida * not of cognitive capacity to provide valid responses * dementia or cognitive impairment that renders subject unable to provide informed consent * prescribed a known psychoactive medication that might reasonably affect the ability of the participant to provide valid responses
polyurethane foam on the sacrum for prevention

Conditions: Hip Fracture; Pressure Ulcer

Summary: the aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (msp) in addition to standard care reduces the rate of pressure sores (pu) and their severity especially in the elderly population admitted for fragility hip fractures.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 65 years with hip fragility fracture without national pressure ulcers advisory panel scale (npuap) scale grade ≥ ii pu * patients or legal guardians who give their consent to take part in the study exclusion criteria * patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products * patients with peri-prosthetic or pathological fractures * patients with diaphyseal or distal femoral fractures
improving antibiotic prescribing practices in mexican primary care clinics

Conditions: Acute Respiratory Tract Infections

Summary: the purpose of this study is to improve antibiotic prescribing practices of mexican primary care physicians for patients seeking care for acute respiratory tract infections (aris). the investigators will employ a combination of qualitative and quantitative methods to develop and evaluate a patient education and physician decision-support intervention. hypothesis 1: the investigators will identify barriers and facilitators of appropriate antibiotic use for aris that can be addressed through patient education and physician decision-support. hypothesis 2: the proportion of patients who report desire for antibiotics as a "very important" reason for seeking care will decrease from 50% to 30% following exposure to the educational intervention; and 90% (95% confidence interval: 80% to 100%) of patients will report that they trust the information provided by the computer. hypothesis 3: antibiotic prescribing for adults with uncomplicated acute bronchitis will decrease from 80 percent to 40 percent following the introduction of a real-time clinical decision support tool.


Eligibility criteria:
inclusion criteria: * adults age 18 years or greater exclusion criteria: * mental disability; severe illness
the effect of applying multidisciplinary bundle intervention on the delirium incidence in critically ill patients

Conditions: Delirium

Summary: the patients will exposed to different intervention through three nights (ear plug, eye mask). 50 patients in the age range 18- 60 years admitted to icu of assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).

the multicomponent bundle of interventions is designed to be multidisciplinary, and included measures taken to reduce noise, light and iatrogenic sleep disturbance, as well as attempts to modify risk factors for delirium. the patients will exposed to different intervention through three nights (ear plug, eye mask) grouping of nursing activity to be delivered before the 23:00 or delay their completion until after 08:00 where possible. orientate patients regarding time, place and date every eight hours.

Eligibility criteria:
inclusion criteria: * age \>18 years old. * no hearing problems. * no eye disease. exclusion criteria: * head injury. * psychiatric disease. * shocked patients
the effects of soy protein and isoflavones on glycemic control, insulin sensitivity and cardiovascular risk factors

Conditions: Diabetes; Cardiovascular Risk

Summary: the investigators propose to perform a double-blind, randomized placebo-controlled trial to examine the hypothesis that soy protein with isoflavones could improve glycemic control, insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with prediabetes.


Eligibility criteria:
inclusion criteria: * hong kong chinese menopausal women aged 46-70 years with prediabetes or early untreated diabetes exclusion criteria: * women with breast, ovary or other cancers in recent 5-year * severe renal or liver dysfunction * women with androgen excess * smokers * current use or recent (3-month)use of any drug or treatment for glycemic control, lipid improvement, weight reduction; subjects with known soy or milk allergy.
evaluation of objective perimetry using pupillometer

Conditions: Retinitis Pigmentosa; Glaucoma; Visual Field

Summary: objective perimetry can better monitor visual field defects in rp and glaucoma patients than conventional subjective perimetry.the plr ( pupil light reflex ) of the short and long wave ratio should be significantly higher in areas of visual field defects in rp and glaucoma patients.

pupil light reflex will be measured by a pupillometer in response to short and long wavelength light small spot stimulus in different area of the visual field. the prl will be measured in four quadrant, central, 10, 20, and 30 degree from the visual axis. stimulus duration will be 1000 ms (1 sec), with intervals of 890 ms between stimuli. the stimuli size v with light intensity of 39.8 cd-s/m2 for both short wavelength stimuli (peak 485 nm) and long wavelength stimuli (peak 620nm).

Eligibility criteria:
inclusion criteria: 1. age 18-75 2. sign on informed consent 3. papillary response to light. 4. groups of : normal , glaucoma patients with early glaucoma damage on hvf (nasal step ect. ), glaucoma patients with advanced glaucoma damage on hvf (arcuate , tubular vision ) and rp patients (early vf damage , ring scotoma ) . 5. refractive correction up to -3.5 d. exclusion criteria: 1. cloudy corneas. 2. surgical intraocular ophthalmic procedure within the past 30 days. 3. nonreactive pupils. 4. synechia of the iris to the lens after surgery or inflammation . 5. neovascularization. 6. iris coloboma. 7. sphincter damage due to ischemia or trauma (tears of sphincter or diffuse damage to muscle). 8. sphincter damage due to high intraocular pressure . 9. iris tumor or cyst . 10. ectropion uvea . 11. adie's pupil . 12. optic neuropathy with the potential for producing a positive rapd (relative afferent pupillary defect ). 13. chronic use of myotics or mydriatics. 14. systemic medication which affect on papillary response . 15. any condition preventing accurate measurement or examination of the pupils.

Keywords: pupillometer retinitis pigmentosa glaucoma objective perimetry
preschool cgm use and glucose variability in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (cgm) use on glucose variability (gv) in preschool children with t1d treated with csii. downloads from cgm and csii saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in slovenia. glucose variability and other glycemic parameters will be analyzed separately for periods when cgm was used (cgm and smbg data) and compared to periods when cgm was not used (smbg only data).


Eligibility criteria:
inclusion criteria: 1. subject with type 1 diabetes (\&gt; 6 months since diagnosis) 2. insulin infusion pump csii therapy for at least 3 months 3. age ≤ 7 years 4. hba1c at inclusion ≥ 6.5 and \< 10 5. bmi sds - below the 95th percentile for age exclusion criteria: 1. concomitant diseases that influence metabolic control 2. participation in any other interventional study 3. known or suspected allergy to trial products
subcuticular suture versus synthetic glue in thyroidectomy incision

Conditions: Goiter; Thyroid Neoplasms; Parathyroid Pathologies

Summary: the aim of this study is to compare aesthetic results of two different type of sutures (subcuticular versus synthetic glue) in post-thyroidectomy incisions. it is a randomized clinical trial (single blinded) designed as a superiority study, since in the authors' hypotheses glue can give better results compared with subcuticular suture in this particular district. secondary objective is to investigate if other factors (like the use of cold/warm blade, the sex, the presence of diabetes, the lenght of incision) can influence aesthetic results.


Eligibility criteria:
inclusion criteria: * patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy exclusion criteria: * former neck operations with external incisions * post-operative bleeding * cervical nodes involvement (with the necessity of widened incisions)

Keywords: thyroidectomy surgery synthetic glue subcuticular suture
minocycline for the prevention of post-operative intercostal neuralgia

Conditions: Post-operative Intercostal Neuralgia

Summary: in about half the patients who have an open chest surgery there is persistent severe pain in the chest. the investigators are examining whether minocycline, a commonly used antibiotic, will prevent pain. minocycline blocks the activity of immune cells which the investigators believe are responsible for prolonging the pain.

the study is of double-blind placebo controlled parallel groups design in up to 116 patients undergoing elective open thoracotomy. minocycline 200mg twice daily or matching placebo are given three days before surgery.

Eligibility criteria:
inclusion criteria: * male or female * aged 18 years or older * undertaking elective, open thoracotomy with ample time pre-operatively to provide informed consent and undertake dosing * sufficient fluency in english language to read and understand consent form, fulfil study requirements and communicate with research staff * negative pregnancy test at screening for women of child bearing potential * females of child bearing potential must agree to use a medically acceptable method of contraception other than oral contraceptives from time of first dosing until one week post-operatively. acceptable methods include abstinence, contraceptive patches, nuvaring (etonogestrel/ethinyl oestradiol vaginal ring), diaphragm with vaginal spermicide, intrauterine device, condom and vaginal spermicide, progestin implant or injection * avoid prolonged, direct sunlight or ultra-violet light exposure during dosing period * refrain from strenuous activities and avoid changes to regular exercise patterns throughout trial period exclusion criteria: * pregnant or breast feeding * known allergy to minocycline and other tetracycline antibiotics * pre-existing neuralgic pain condition in area designated for operation * physical abnormality in area designated for operation * taking disallowed concomitant medication * renal insufficiency as determined by a calculated creatinine clearance of \< 60ml/min * hepatic dysfunction as determined by alanine transaminase and/or aspartate transaminase in excess of three times upper normal limits * diagnosis of systemic lupus erythematosus * recent diagnosis of enterocolitis or colitis * participation in another trial of an investigational product within 30 days of commencing dosing or are scheduled to commence trial of an investigational product during study period * patients who, in an investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason * history of major psychiatric disorder not medically controlled

Keywords: neuropathic pain minocycline
evaluation of therapeutic strategies for treatment of ectopic pregnancies (ep) and evaluation of subsequent fertility

Conditions: Tubal Pregnancy

Summary: three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. there are no data about subsequent fertility except in a cohort study. the investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.

the first group includes non active ectopic pregnancies defined by score or algorithm. in this case, we propose a randomized controlled trial between medical and conservative surgery. in all others clinical situations, we proposed surgery treatment. in a randomized controlled trial we compare conservative versus radical treatment. the patients are followed-up during 2 years with phone contact every 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis by ultra sound of ectopic pregnancy (ep) * patients aged \> 18 years old * desire of future pregnancy exclusion criteria: * ep by failure of contraception * ep associated with in vitro fertilization (ivf)

Keywords: ectopic pregnancy surgical treatment medical treatment fertility
wearable vibration device to prevent bone loss in postmenopausal women--aim 2

Conditions: Osteopenia

Summary: the wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities. we propose that demonstrating higher rates of compliance and consistent delivery of optimal force, with accelerometer feedback, will provide a superior alternative to whole body vibration and is plausibly more effective at preventing bone loss in postmenopausal women than vibration platforms in the home setting.

the goal of this study is to demonstrate that postmenopausal women will tolerate our device, have high rates of compliance with the study protocol, receive consistently therapeutic levels of vibration and see significant effects on bone turnover based on plasma markers of bone anabolism and catabolism. the anticipated outcomes from serum draws are an improvement in two bone turnover markers after a 30 minute treatment with the wvd.

Eligibility criteria:
inclusion criteria: 1. female 2. last menstrual period at least one year prior and not more than eight years prior. 3. 19 years of age and older. 4. bmd t-score at or above -2.49 at the total hip and l1-l4 spine skeletal sites as measured by dxa. 5. ambulatory (can walk or stand without an assistive device for a minimum of 30 minutes). 6. able to understand spoken and written english. 7. capable and willing to follow all study-related procedures. exclusion criteria: 1. bmd t-score at or below -2.5 at the total hip and l1-l4 spine skeletal sites as measured by dxa. 2. a 10-year probability of hip fracture of \> 3% or major fracture of \> 20% based on results of dxa using the frax tool (see attached). 3. weight \> 300 lbs. 4. are currently taking or have taken bisphosphonates within the past 12 months, estrogen replacement therapy, or drugs affecting bone such as tamoxifen or aromatase inhibitors within the past 6 months. 5. active cancer or cancer treatment. 6. any change in exercise in the past 3 months. 7. fractures or major surgery within the past 6 months. 8. medical implants (excluding dental implants). 9. diagnosed with paget's disease, heart disease, uncontrolled hypertension, renal disease, chronic fatigue syndrome, herniated disc, severe peripheral neuropathy, severe osteoarthritis. 10. any bleeding disorder or treatment with a blood thinning medication within the last 2 years. 11. hip circumference is greater than 42 inches
coronary and structural interventions ulm - coronary chronic total occlusions

Conditions: Coronary Artery Disease; Ischemic Heart Disease; Stable Angina

Summary: to evaluate the long-term results after recanalization of coronary chronic total occlusions.

patients with successful recanalization of coronary chronic total occlusions are followed during a period of 5 years to demonstrate safety and efficacy.

Eligibility criteria:
inclusion criteria: * coronary artery disease * chronic total occlusion exclusion criteria: * no written informed consent
text messaging to promote walking among latino adults at risk for peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to learn about the impact of text messaging on physical activity in persons with risk factors for peripheral arterial disease (pad).

thirty-five million latinos live in the u.s. and nearly 14% have peripheral arterial disease (pad) defined as a build-up of plaque in the arteries that supply blood to the legs. approximately 40% have at least one risk for pad (i.e., aged 70 years and older, diabetes, high blood pressure, high blood cholesterol, or smoking). persons with at least one risk factor and who are physically inactive are more likely to suffer from severe pad. physical inactivity is highly prevalent in latinos and a major risk factor for pad. physical inactivity affects 50% of latinos aged 60 years and older. participation in this study will last for about 3 months. participants will be randomized to one of two groups. one group will receive text messages, brief telephone calls, and a handout. the other group will only receive the handout. the study will be looking at how the different groups respond to the different interventions used in the study.

Eligibility criteria:
inclusion criteria: * latino adults * english or spanish speaking * have one or more of the following: diabetes mellitus, smoking, hypertension, or hyperlipidemia. * adults age 70 years or older, regardless of having one or more the above noted risk factors for pad, will also be eligible for enrollment. exclusion criteria: * pregnancy * prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers) * use of supplemental oxygen * myocardial infarction within preceding 3 months

Keywords: physical activity physical inactivity pad diabetes high blood pressure high cholesterol smoking