Kornimate/medical-research-clean huggingface dataset:
a phase i multicenter trial to evaluate the safety and immunogenicity of hiv-1 recombinant envelope glycoprotein gp160

Conditions: HIV Infections

Summary: to evaluate the safety and immune response to 640 and 1280 mcg hiv-1 recombinant envelope glycoprotein gp160. to evaluate the duration of antibody response and its relationship to dose and frequency of inoculation. evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. a preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. a preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest. in the initial phase of the study, 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo. at least 30 days later, 20 additional volunteers receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo. injections are given on days 0, 30, 180, and 365.

Eligibility criteria:
inclusion criteria patients must have: * normal history and physical exam. * negative for hiv infection by elisa and western blot (i.e., no reactivity at gp160, gp120, gp41, or p24). * t4 count \>= 800 cells/mm3. * normal chest x-ray and urinalysis. * negative hepatitis b surface antigen. * negative hiv p24 antigen test. * normal skin reactivity by merieux test. exclusion criteria co-existing condition: subjects with the following symptoms or conditions are excluded: * positive ppd. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease). subjects with the following prior conditions are excluded: * history of immunodeficiency, chronic illness, or use of immunosuppressive medications. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. prior treatment: excluded: * prior blood transfusions or cryoprecipitates within the past 6 months. identifiable high-risk behavior for hiv infection (as determined by prescreening questions designed to identify risk factors for hiv infection), including: * any history of iv drug use. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. * more than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Keywords: vaccines, synthetic vaccinia virus hiv-1 hiv envelope protein gp160 aids vaccines hiv seronegativity hiv preventive vaccine
comparison of the clinical efficacy of naproxen, associated or not with esomeprazol, in lower third molar removal

Conditions: Pain; Other Surgical Procedures; Impacted Third Molar Tooth

Summary: the present clinical trial randomized compared the clinical efficacy of the naproxen associated or not with esomeprazol, for the removal of lower third molars. onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. for this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 4% (1:200,000 adrenaline) in a doubleblind, randomized and crossed manner.

the control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal antiinflammatory drugs (nsaids). studies have shown that nsaids exert their therapeutic effect by the inhibition of cyclooxigenases (cox) 1 and 2, which determines the inhibition of prostaglandins production whose effects potentiate the action of many inflammatory mediators. the present study aims to evaluate in a double blind, randomized and cross over manner the clinical efficacy of naproxen (500 mg) and naproxen in association with esomeprazol (500 mg and 20 mg), both administered by oral route every 12 h during 4 days, in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. the following parameters will be analyzed: 1) subjective postoperative pain evaluation, with the aid of a visual analogue scale, 2) mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal), 3) beginning and duration of the surgery after anesthetic administration, 4) incidence, type and severity of adverse reactions, 5) total amount of rescue analgesic medication (paracetamol), 6) facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery). the comparative analyses of the data along with the application of the adequate statistical tests will provide the basis for an evaluation of the clinical efficacy of both nsaids.

Eligibility criteria:
inclusion criteria: * need of lower third molar surgeries in similar positions exclusion criteria: * presence of systemic diseases; * presence of local inflammation and/or infection; * any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration; * cardiovascular, kidney or hepatic diseases; * patients who are making use of antidepressants, diuretics or anticoagulants; * asthma and allergy to aspirin, naproxen or any other nonsteroidal antiinflammatory drug; * regular use of any nonsteroidal antiinflammatory drug, * pregnancy or * breast feeding.

Keywords: naproxen lower third molar oral surgery esomeprazole
homework in retrograde intrarenal surgery

Conditions: Retrograde Intrarenal Surgery; Stone, Kidney

Summary: to evaluate the effectiveness of this homework on stone clearance rates after retrograde intrarenal surgery (rirs) by instructing the patient in the home environment and suggesting percussion and movement/position changes to assist in spontaneous stone passage.


Eligibility criteria:
inclusion criteria: * patients with an indication for rirc exclusion criteria: * patients with anatomic abnormalities such as horseshoe kidney, fragments in the calyx diverticulum, infundibular stenosis, pelvi-ureteral junction obstruction or ureteral stenosis. * patients with morbid obesity, uncontrolled hypertension, previous cerebrovascular accident, skeletal deformity such as significant coronary artery disease or symptomatic gastro-esophageal reflux disease. * patients with lumbar disc herniation who have undergone spinal surgery and are unable to undergo behavioral therapy.
assessing the role of a fermented soy extract in inflammation and the human microbiome

Conditions: Obesity

Summary: the consumption of fermented soy foods can alter the human microbiome and may confer health benefits. researchers propose a line of inquiry to assess the effects of q-can plus ("qc") fermented soy beverage in humans, assessing immunological, microbiological, and clinical parameters.

the study will start with a detailed testing of the microorganisms present in the qc fermented soy liquid, using deep sequencing. subsequently, the researchers will determine the effect of the qc fermented soy product on the microbiome and inflammation in lean and obese individuals, as obese individuals are known to have dysbiosis. the work on inflammatory changes will be supplemented by studies to investigate the cellular and molecular mechanistic pathways responsible for the biological action of qc fermented soy liquid.

Eligibility criteria:
inclusion criteria: * adults (aged between 18 and 70) that are obese (bmi 32-37) (n=10) * adults (aged between 18 and 70) that are lean (bmi 21-25) (n=10) exclusion criteria: * allergy to soy or soy derivatives. * patients will be excluded if they had abdominal surgeries (excluding cholecystectomy, appendectomy, hysterectomy, and hernia repair). * history of inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease) and/or gastrointestinal bleeding. * medications: antibiotics, probiotics, or systemic corticosteroids (within 6 months of enrollment). * radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function. * patients will be excluded if using medications which are known to be affected by modest dietary changes. this will include, but is not limited to, warfarin and immunosuppressives such as cyclosporin. * alcohol use disorder, anorexia nervosa, autoimmune disease, bulimia, celiac disease, chronic infections, and illicit drug use. * major changes in dietary habits in past six months. * pregnancy or intent to get pregnant during study period * use of tobacco, including cigarettes, smokeless tobacco, cigars, and pipes within 30 days of enrollment.
er niacin/laropiprant impact on cardiovascular markers and atheroprogression in hiv-infected individuals on cart

Conditions: HIV; Atherosclerosis

Summary: hiv-infected patients are at increased risk for cardiovascular disease. large investigations support an inverse correlation between hdl-c levels and coronary heart disease. therefore a treatment lowering hdl-c such as niacin could reduce the risk of atheroprogression not only through its benefit in terms of lipid profile, but also by reducing atherosclerotic inflammation. the study aims at showing that a therapy targeting hdl-c increase in hiv-infected patients on suppressive cart has the potential for reducing subclinical atherosclerotic inflammation associated with hiv itself in hiv-individuals on cart. nilach is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to test the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness (imt) in 90 subjects. * regimen 1: er niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5 to the end of the study (the titration aims to reduce adverse reactions) * regimen 2: er niacin/laropiprant placebo p.m. the primary end point is the change in mean common carotid intima-media thickness from baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group. the proposed in vivo experiments should provide insights on the potential benefits of niacin treatment of cardiovascular disease in hiv patients. in addition, we will be able to further clarify the role of systemic inflammatory mediators in the development of early atherosclerosis of hiv-infected patients on antiretroviral therapy. detection and treatment of non-infectious co-morbidities such as cardiovascular diseases have become essential for hiv-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere management of opportunistic infections or virologic suppression.


Eligibility criteria:
inclusion criteria: * adult patients \> 40 years; * women of childbearing potential must use two reliable contraceptive methods during the entire trial, from day 1 to one month after the end of the trial. * signing the study consent form; * stable cart since at least 3 months (ie no recent drug change); * hiv-rna below 100 copies for at least 6 months; * hdl-cholesterol \<1.29 mmol/l for men; \<1.42 mmol/l for women exclusion criteria: * pregnancy or lactation; * congestive heart failure; * malignant hypertension; * acute or chronic coronary artery diseases; * any known cardiac arrhythmias; * diabetes; * concomitant cancer, rheumatologic disease or inflammatory bowel diseases; * concomitant renal or hepatic disease: * creatinine above 150 micromol/l * transaminases above 5 times upper normal limit * prothrombin time (quick) value below 50%; * prior intolerance to niacin therapy (reported in a medical report); * cyclosporine, anti-inflammatory drugs (other than aspirin) or cytokine therapy in concomitant intake; * abnormal thyroid function; * excessive consumption of alcohol; * known severe lactose intolerance.

Keywords: hiv atherosclerosis niacin/laropiprant hdl
dopamine transporter scintigraphy imaging (dat-imaging) in patients with lewy body dementia

Conditions: Lewy Body Dementia; Non-DLB Dementia; Alzheimer's; Vascular Dementia

Summary: the study is designed to determine the diagnostic efficacy of the visual assessment of spect scans in differentiating between probable dementia with lewy bodies (dlb) and non-dlb dementia subjects determined by the clinical diagnosis of an independent expert consensus panel used as the standard of truth.

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Eligibility criteria:
inclusion criteria: * subjects must be adults between 55 to 90 years of age with an established diagnosis for dementia in accordance with dsm-iv criteria and have to fulfil at least one of the following: the icc criteria for probable and possible dlb, the national institute of neurological and communicative disorders and stroke and alzheimer disease and related disorders association (nincds-adrda) for alzheimer's disease (ad), or the national institute of neurological and communicative disorders and association internationale pour la recherche et l'enseignement en neurosciences (nincs-airen) for vascular dementia (vad). exclusion criteria: * subjects are not eligible if they have a mini mental state examination (mmse) score of \<10 and use medication known or suspected to interact with the striatal uptake datscan to the dopamine transporter. * furthermore subjects are not eligible if they were diagnosed with idiopathic parkinson's disease (pd), with persistent severe depression, normal pressure hydrocephalus, multiple system atrophy, cortico-basal degeneration or huntington's chorea disease.

Keywords: lewy body dementia non-dlb dementia dopamine transporter striatal uptake
prospective study for the evaluation of the cementless anatomic femoral stem minimax -launay

Conditions: Primary Osteoarthritis; Secondary Osteoarthritis; Traumatic Arthritis; Rheumatoid Arthritis; Congenital Hip Dysplasia; Avascular Necrosis; Fracture; Femur, Head

Summary: this is a post-marketing surveillance on minimax stem


Eligibility criteria:
inclusion criteria: 1. patient with a clinical condition requiring tha 2. patient receiving a minimax® stem 3. patient aged more than 18 years 4. patient having a social insurance or a similar protection regime 5. patient eligible for an amis procedure 6. patient able to follow the study requirements 7. patients who are willing to give informed written consent exclusion criteria: 1. patient with local or systemic infection 2. participation to biomedical research 3. patient whose bmi exceeds 40 4. patient with less than 18 years 5. protected adults 6. vulnerable person according to article l1121-6 of the code de la santè publique. 7. pregnant or lactating woman 8. patient unable to express his/ her opinion about the participation to the study
cardiovascular responses to exercise in people living with hiv/aids: effects of exercise training

Conditions: HIV Infections

Summary: patients living with hiv (plwhiv) have compromised muscle metaboreflex, which can cause exercise intolerance. this randomized controlled clinical trial will verify the effects of regular exercise on autonomic and hemodynamic responses to muscle ergoreflex activation in these patients. plwhiv without regular physical exercise will be randomly assigned into an exercise training or a control group. the exercise training group will undergo regular physical exercise during 12 weeks (60-min session performed 3 times/wk with moderate intensity), while the control group will keep inactive. another group consisted of inactive hiv-uninfected group will be included. the primary endpoints will be blood pressure and autonomic markers in response to the stroop color-word test and the activation of muscle ergoreflex, by means of the post-exercise circulatory arrest (peca), which will be performed with and without the topical application of a capsaicin-based analgesic balm. secondary endpoints will include heart rate, peripheral vascular resistance, stroke volume, cardiac output, blood lactate concentration, anthropometrics, and handgrip strength. the active and inactive plwhiv groups will be evaluated before and after the exercise training, while the healthy group only at baseline.

hiv-infection is associated to a reduced maximal cardiac output and blunted pressor reflex response to static handgrip exercise, which are suggestive of impaired ergoreflex activation. an abnormal ergoreflex activation may lead to exercise intolerance and increases in cardiovascular risk. despite the importance of therapeutic strategies in reducing the cardiovascular risk among patients living with hiv, exercise-related effects on ergoreflex sensitivity in these population have not been previously investigated.

Eligibility criteria:
inclusion criteria for people living with hiv: * diagnosis of hiv infection for at least 5 years; * use of combined antiretroviral therapy for at least 3 years; * asymptomatic and free from opportunistic diseases at enrollment. exclusion criteria: * regular physical exercise; * malnutrition; * presence of coronary artery disease, ischemic diseases, pulmonary disease, diabetes, chagas disease, tuberculosis, heart failure, hypertension; * using pacemakers and/or antidepressant, antiarrhythmic or antihypertensive medication, especially beta-blockers.
the effect of eyelid surgery on dry eye - a prospective study

Conditions: Dry Eye Syndrome; Ptosis; Dermatochalasis

Summary: the investigators aim to assess the effect of blepharoplasty with or without muller muscle resection on the symptoms of dry eye syndrome. this will be an observational study in which patients undergoing the aforementioned surgeries will be followed up and monitored for dry eye symptoms.

patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in the investigators institution, will be offered to participate in the study. after filling and informed consent form, patients recruited will fill in a questionnaire about dry eye symptoms, and will be examined by an ophthalmologist for visual acuity, intra ocular pressure, anterior segment examination using a slit lamp biomicroscopy, schirmer test, tear break up time assessment and tear osmolarity. these are all standard examination in ophthalmology. the surgical procedure planned to correct the eyelid pathology will not be affected by the results of these examinations. the same combination of ophthalmic examination will by done on postoperative follow-up examination 1 week, 1 month and 3 months after the surgery. dry eye questionnaire will be filled in by the patients on postoperative follow-up examination 1 month and 3 months after the surgery. this data will help us assess the effect of these common surgical procedures on dry eye symptoms.

Eligibility criteria:
inclusion criteria: * patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution * no other ophthalmic procedures planned for the patient in study period * ability to undergo full ophthalmic examination as stated in the study protocol * ability to complete the dry eye questionnaire * ability to sign an informed consent form exclusion criteria: * previous eyelid surgery * other orbital or lacrimal gland disease * concurrent use of contact lenses * concurrent use of restasis * previous glaucoma surgery * use of punctual plugs * pregnant or nursing women

Keywords: dry eye syndrome blepharoplasty muller muscle resection surgery
efficacy and safety of intramuscular midazolam compared to buccal midazolam in pediatric seizures

Conditions: Seizures

Summary: the goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.

both buccal and intramuscular midazolam have been used to control seizures with variable succuss rates and side effects. in this study the investigators are going to assign patient randomly to receive either buccal or intramuscular midazolam. then will compare both efficacy and side effect in both groups.

Eligibility criteria:
inclusion criteria: * children 6 month to 14 years who will be presented to the pediatric emergency or attended by emergency medical service who have active seizure and had no intravenous access would be eligible for the study. exclusion criteria: * cardiac arrest * head trauma * drowning * congenital heart disease * inborn errors of metabolism * electrolyte imbalance (hypocalcaemia, hyponatremia and hypoglycemia) * hemodynamic instability * allergy to benzodiazepines * focal seizures with preserved level of consciousness
chlorhexidine vs. iodine for vaginal preparation in urogynecologic procedures

Conditions: Pelvic Organ Prolapse; Urinary Incontinence; Pelvic Floor Disorders; Gynecologic Disease; Post-Op Infection; Surgical Site Infection; Urinary Tract Infections

Summary: this is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.

the purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. the first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the centers for disease control). the second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.

Eligibility criteria:
inclusion criteria: * female subjects \>18 years of age * english or spanish speaking/reading * must be able to provide informed consent * undergoing urogynecologic procedures or surgery exclusion criteria: * pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient. * inability to return for follow-up visits * no concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation * lack of telephone * known allergy to either antiseptic agent * prisoners will not be eligible to participate in this study

Keywords: urogynecology surgery antiseptic preparation