Kornimate/medical-research-clean huggingface dataset:
gardasil immunogenicity with needle-free injection

Conditions: HIV

Summary: 1. compare rates of seroconversion and gmts generated following a 3-dose series of vaccine in women given low doses of vaccine by the id route with the nfi (group iii) to those women given standard doses by the im route with a needle and syringe (group i) at 1 month, 6 months and 18 months following completion of the vaccination series. 2. compare rates of seroconversion and gmts generated following a 3-dose series of vaccine in women given standard doses of vaccine by the im route with the nfi (group ii) to those women given standard doses by the im route with a needle and syringe (group i) at 1 month, 6 months and 18 months following completion of the vaccination series.

primary hypotheses: the primary goal of this study is to compare the vaccination groups. using gmts to measure immunogenicity of the 3 different vaccination regimens, we will test for non-inferiority between group i and group ii and between group i and group iii. our hypotheses are: 1. gmts of antibodies to all 4 hpv types (6, 11, 16 and 18) following a 3-dose series of vaccine in women given low doses of vaccine by the id route with the nfi (group iii) will be non-inferior to gmts in women given standard doses by the im route with a needle and syringe (group i). non-inferiority criteria will have been satisfied when the upper 95% confidence limit on the ratio of gmts (gi/giii) is less than 1.5 for all hpv types. 2. gmts of antibodies to all 4 hpv types (6, 11, 16 and 18) following a 3-dose series of vaccine in women given standard doses of vaccine by the im route with the nfi (group ii) will be non-inferior to gmts in women given standard doses by the im route with a needle and syringe (group i). non-inferiority criteria will have been satisfied when the upper 95% confidence limit on the ratio of gmts (gi/gii) is less than 1.5 for all hpv types. 3. the proportions of baseline-naïve vaccinees seroconverting to all 4 hpv types (6, 11, 16 and 18) following a 3-dose series of vaccine in women given low doses of vaccine by the id route (group iii) and standard doses of vaccine by the im route (group ii) with the nfi will be non-inferior to the seroconversion rates in women given standard doses by the im route with a needle and syringe (group i). non-inferiority criteria will have been satisfied when the upper 95% confidence limit on the difference in proportions is less than 10% for all hpv types.

Eligibility criteria:
inclusion criteria: 1. thai national 2. woman 3. age 18-26 years 4. has had no more than 5 lifetime sex partners 5. hiv-uninfected 6. able to complete all of the protocol visits and has signed the consent form exclusion criteria: 1. known contraindications to vaccination with gardasil

Keywords: hiv-uninfected
predictors of cardiovascular disease in the elderly

Conditions: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Cerebrovascular Accident; Coronary Disease; Hypertension

Summary: to evaluate factors associated with cardiovascular morbidity and mortality in a cohort of 795 men and women aged 75 years or older at the time of a comprehensive examination conducted between 1984 and 1987.

background: the study was needed because evidence in 1991 suggested that cardiovascular risk factors which had been identified by studies of middle-aged populations did not have the same predictive value in the elderly; especially the "oldest old" aged 75 and above. design narrative: the study analyzed data that had been collected over the years. at the time of the analysis, mortality follow-up was complete for over 99 percent of subjects, and incident morbidity information was available for myocardial infarction, coronary bypass surgery and stroke. the database included measurements which allowed: 1) prospective analyses of the effects of putative cardiovascular risk factors on disease incidence in the elderly, 2) prospective analyses of the impact of change in risk factors on events in the elderly, 3) exploration of risk factors not classically associated with cardiovascular events in younger populations but which may be important in the very old, and, 4) cross-sectional description of putative risk factors in an aged population. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a study to compare the efficacy and safety of 2 dosing regimens of iv infusions of azd9773 (cytofab™) with placebo in adult patients with severe sepsis and/or septic shock

Conditions: Severe Sepsis; Septic Shock

Summary: the primary purpose of this study to evaluate the effect of two different doses of azd9773 (cytofab™) versus placebo on ventilator free days (vfds) over the first 28 days after the start of dosing with azd9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.


Eligibility criteria:
inclusion criteria: * adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics. * at least 2 of 4 sirs criteria in the 24 hours before organ dysfunction (must include either fever or elevated white blood cells \[wbc\]) * cardiovascular or respiratory dysfunction. exclusion criteria: * immunocompromising comorbidities or concomitant medications: 1. advanced human immunodeficiency virus (hiv) infection (cd4 ≤50/mm3). 2. stage iii or iv cancer. 3. haemopoietic or lymphoreticular malignancies not in remission. 4. receiving radiation therapy or chemotherapy. 5. stem cell, organ or bone marrow transplant in the past 6 months. 6. absolute neutrophil count \<500 per μl. 7. high dose steroids or other immunocompromising drugs. * concomitant diseases: 1. deep seated fungal infection or active tuberculosis. 2. cirrhosis with portal hypertension or childs-pugh class c. 3. history of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease. 4. neuromuscular disorders that impact breathing/spontaneous ventilation. 5. quadriplegia. 6. cardiac arrest in the past 30 days. 7. new york heart association functional class iv due to heart failure or any disorder. 8. burns over \> 30% of body surface area. * medication and allergy disqualifications. 1. treatment with anti-tnf agents within the last 8 weeks. 2. previously received ovine derived products (crofab™, digifab™). 3. sheep product allergy or allergy to latex, papain, chymopapain.

Keywords: severe sepsis tnf neutralisation septic shock patients
investigating neural processing of social stimuli

Conditions: Healthy Adults

Summary: the primary goal of the present study is to test whether neural activity in brain regions associated with processing threat and social stimuli may underlie paranoid thinking.

paranoia is a prominent symptom of psychosis that occurs in several other diagnoses, as well as the general population, and that is associated with significant distress and impairment. previous research suggests that increased baseline activity of the amygdala and related neural circuits may serve as a mechanism for paranoid ideation. this exploratory study will use a paranoia induction procedure in healthy individuals who vary in pre-existing levels of paranoid ideation to test whether increases in self-reported paranoia are accompanied by increases in resting cerebral blood flow (cbf), decreased stimulus-driven neural activity in social processing networks, and increased behavioral perceptions of untrustworthiness. participants will be randomly assigned to participate in a paranoia induction procedure or a control condition and will then complete neuroimaging and behavioral assessments.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 55 exclusion criteria: * current psychiatric diagnosis * current use of psychotropic medications * history of head trauma with loss of consciousness for more than 15 minutes * presence of neurological or neurodegenerative disorder * sensory impairments that preclude assessment * presence of intellectual disability * contraindications for mri (e.g., metallic implants or pregnancy)
study to evaluate the safety and efficacy of a once-daily cls001 topical gel versus vehicle

Conditions: Rosacea

Summary: this study evaluates the safety and efficacy of once-daily application of cls001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.


Eligibility criteria:
inclusion criteria: 1. healthy, male and non-pregnant female subjects, 18 years of age or older. 2. a diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at baseline. subjects must have no more than 2 nodular lesions, at baseline. 3. subjects with the presence of telangiectasia at baseline. 4. subjects with an erythema score of at least 2 on the investigator assessment of erythema scale at baseline. 5. subjects with severe rosacea on the investigators global assessment scale at baseline. exclusion criteria: 1. subjects with steroid rosacea or subtype 3 (phymatous rosacea). 2. subjects with nodular rosacea. 3. standard exclusion criteria.
evaluation of efficacy and safety of vx-993 for pain associated with diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of vx-993 in participants with pain associated with diabetic peripheral neuropathy (dpn)


Eligibility criteria:
key inclusion criteria: * diagnosis of diabetes mellitus type 1 or type 2 with * glycosylated hemoglobin a1c (hba1c) less than or equal to (≤) 9% and * presence of bilateral pain in lower extremities due to dpn (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year key exclusion criteria: * painful neuropathy other than dpn * history of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) * history of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months other protocol defined inclusion/exclusion criteria may apply.
diet and exercise intervention in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine the effect of a worksite-based intensive lifestyle therapy intervention (weight loss with exercise training) on blood sugar control in people with obesity and type 2 diabetics.

the purpose of this study is to conduct a randomized, controlled trial in people with obesity and type 2 diabetes to determine the therapeutic effects of intensive lifestyle therapy conducted at the worksite compared to standard care on: i) the major factors involved in the pathogenesis of type 2 diabetes (insulin sensitivity, β-cell function and the metabolic response to glucose ingestion), ii) body composition; iii) physical function (cardiorespiratory fitness and muscle strength); iv) and the potential cellular mechanisms that can affect insulin action in muscle and adipose tissue (fat).

Eligibility criteria:
inclusion criteria: 1. age 25-68 yrs old 2. bmi 27.0-50.0 kg/m² 3. diagnosis of type 2 diabetes based on hba1c\>6.5% or results of an oral glucose tolerance test or current use of anti-diabetic medications 4. hba1c ≤9.5 %. 5. work at washington university in st. louis, barnes jewish hospital, st. louis children's hospital, shriners, st. louis college of pharmacy, central institute for the deaf, rehabilitation institute of st. louis, and/or any institutions affiliated with these. exclusion criteria: 1. any change in diabetes medication in previous 3 months 2. treated with \>0.5 units of insulin/kg body weight per day 3. unstable weight (\>2% change during the last 2 months before entering the study) 4. history or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or new york heart association class iii heart failure (patients with marked limitation of activity and who are comfortable only at rest) or iv heart failure (patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity). 5. evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program. 6. creatinine \>1.5 mg/dl 7. microalbuminuria; spot urine albumin:creatinine ratio \>50 (50 μg albumin/mg creatinine) 8. coagulation disorders 9. anemia (hemoglobin \<10.0 g/dl) 10. liver enzymes (alt and ast) ≥3 times the upper limit of normal 11. uncontrolled proliferative diabetic retinopathy 12. severe peripheral neuropathy diagnosed by monofilament testing 13. severe organ dysfunction 14. pregnant or breastfeeding 15. participating in regular exercise (\>1 h of structured exercise/week) 16. joint replacement within the last year 17. smokes tobacco 18. severe lactose intolerance 19. take any medication that might interfere with interpretation of the metabolic studies 20. unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.

Keywords: type 2 diabetes exercise weight loss
young women diagnosed with early stage ovarian cancer: a focus on fertility issues and sexual function

Conditions: Ovarian Cancer

Summary: the purpose of this study is to ask youn women diagnosed with ovarian cancer who have undergone surgery that will allow them to have children in the future, on issues such as: education about their options to keep their ability to have children, after-chemotherapy treatment decision making, and reproductive history. the second purpose is to determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.

* participants will be asked to complete a questionnaire either in the clinic or at home and return it to the research staff by mail or in person. * the study will involve being asked questions about the following: fertility history; sexual history after being diagnosed with cancer; decision to have surgery that will allow them to have children; education they may or may not have received about the surgery that saved their ability to have children. * answers to all questions will be kept confidential and participants will be identified by a number only.

Eligibility criteria:
inclusion criteria: * women diagnosed with stage i or ii invasive ovarian cancer, that underwent fertility sparing surgery * women who were premenopausal prior to diagnosis * 40 years of age or younger at the time of ovarian cancer diagnosis * completed therapy for early stage cancer * no evidence of recurrence * no history fo known infertility prior to diagnosis * no other significant medical conditions that would affect fertility

Keywords: fertility stage i ovarian cancer stage ii ovarian cancer fertility sparing
cocoa butter for prevention of stretch marks

Conditions: Striae Gravidarum; Pregnancy

Summary: this study will check to see if using cocoa butter lotion on the belly, breasts and thighs will help reduce the appearance of stretch marks in pregnancy. women entering the study will either receive a lotion containing cocoa butter with vitamin e or a lotion containing only vitamin e. after delivery, the study investigators will evaluate whether the women who used cocoa butter lotion were less likely to develop stretch marks.

primigravid women presenting for prenatal care in the first trimester will be recruited to participate in the study. they will be randomly assigned to receive the study lotion (a commercially available lotion containing cocoa butter with viatmin e), a placebo lotion (a lotion containing vitamin e but no cocoa butter). participants and investigators will be blinded to the lotion assignment. women will be asked to apply a thin layer of the lotion to their abdomen, breasts and thighs once daily until the date of delivery. participants will be recruited as early in their pregnancy as possible but will not be asked to start applying the lotion before 12 weeks of pregnancy. women presenting after 20 weeks of pregnancy will not be eligible to participate in the study. the cocoa butter and placebo lotions have been made up to look, smell and feel the same and will be provided to the participants in identical containers. women who have known hypersensitivity to cocoa butter or any of the components of the lotion will be excluded from the study. participants will be assessed at study entry for presence of stretch marks. baseline information will be collected at that time including pre-pregnancy weight, skin type, and history of stretch marks in the mother or siblings. women will then be followed up monthly by telephone to assess compliance with the regimen and ensure that they are not developing skin reactions. participants will be assessed for the development of stretch marks after delivery. women will also be asked to provide their own assessment of their skin condition in terms of presence/absence of stretch marks and their severity.

Eligibility criteria:
inclusion criteria: * primigravid women in first trimester of pregnancy exclusion criteria: * hypersensitivity of cocoa butter

Keywords: striae gravidarum stretch marks cocoa butter prevention
lung ultrasound score and weaning outcome

Conditions: Lung Ultrasound Score; Acute Respiratory Failure

Summary: objectives: failure of extubation of patients on mechanical ventilation is one of the common problems in the icu. aim of work: to evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress.

methods: a prospective observational study of 50 patients planned for extubation who passed a spontaneous breathing trial, lung ultrasound score and serum level of nt-pro bnp were done to all patients at end of spontaneous breathing trial, and all patients were followed after extubation and monitored for oxygenation, re-intubation rate, icu stay, and icu mortality.

Eligibility criteria:
inclusion criteria: - 1. patients age \> 18 years 2. patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation. exclusion criteria: * 1. patients \< or =18 years 2. patients with left ventricular failure 3. right ventricular failure 4. pulmonary hypertension 5. aortic valve disease 6. hyperthyroidism 7. tracheostomy
daytime bright light, circadian abnormalities, and delirium in medical icu patients

Conditions: Circadian Rhythm Disorders

Summary: to determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.

to determine if daytime bright light will promote circadian alignment and shorten or prevent delirium. the objective is to conduct a randomized controlled trial to determine if a circadian entrainment intervention, daytime bright light, will promote circadian alignment and reduce days of delirium

Eligibility criteria:
inclusion criteria: 1. hospital admission ≤30 hours at noon on enrollment day 2. expected to say in the medical intensive care unit (micu) ≥24 hours after enrollment 3. age ≥50 years exclusion criteria: 1. at significant risk for pre-existing circadian abnormalities: * severe chronic brain injury (injury greater than 30 days ago resulting in the inability to live independently) * acute brain injury of any severity (injury less than 30 days ago including acute intracranial bleed, traumatic brain injury, central nervous system infection, tumor) * documented circadian disorder or blind/disease of the optic nerve * current history of substance abuse including alcohol (use in last 30 days) 3. transferred from an outside hospital. 4. history of bipolar disease 5. paralyzed (due to injury, disease or medications) enrolled patients who do not stay in the micu through 13:00 of study day 2 will be excluded; patients transferred from the micu to the floor between 22:00 and 05:00 on subsequent study nights will continue in the study but be excluded from the primary analysis (estimated 10% of patients).

Keywords: circadian misalignment bright light entrainment zeitgeber critical illness delirium actigraphy
trial of steroids in pediatric acute lung injury/ards

Conditions: Acute Respiratory Distress Syndrome (ARDS); Acute Lung Injury (ALI)

Summary: acute lung injury (ali) and acute respiratory distress syndrome (ards) are devastating disorders associated with lung inflammation, low oxygen levels and respiratory failure in children. prevalence of ali ranges from 2.2 to 12 per 100,000 children per year. using these estimates, up to 9,000 children each year will develop ali/ards, which may cause upto 2,000 deaths per year. currently, there are no specific therapies directed against ards/ali in children. in adult patients, use of steroids early in the course of ards appears promising. there are no published clinical trials examining the use of steroids for the treatment of ali/ards in children. hypothesis: subjects with ali/ards receiving steroids early in the course of disease (within 72 hours) and longer than 7 days will have improved clinical outcomes as compared to placebo control group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly increased pao2/fio2 ratios.


Eligibility criteria:
inclusion criteria: 1. between 1 month and 18 years of age; and 2. admitted to the picu with a diagnosis of ali or ards, as defined by: 1. acute onset of the disease, 2. pao2/fio2 ratio \<300, 3. evidence of bilateral infiltrates on chest radiography, and 4. no evidence of cardiac dysfunction; and 3. intubated and mechanically ventilated. exclusion criteria: 1. underlying disease requiring steroids \>0.5mg/kg/day of methylprednisolone (eg. asthma) 2. hiv positive, or have any other congenital or acquired immunodeficiency; 3. terminally ill patients or patients on hospice care or if there is a lack of commitment to aggressive intensive care 4. cytotoxic therapy within the past 3 weeks 5. major gastrointestinal bleeding within last 1 month 6. extensive burns (\>20% total body surface area of full- or partial-thickness burns) 7. known or suspected adrenal insufficiency 8. vasculitis or diffuse alveolar hemorrhage 9. bone marrow or lung transplant 10. disseminated fungal infections 11. severe chronic liver disease 12. other conditions with estimated 6-month mortality of 50% or higher

Keywords: child infant lung injury inflammation pneumonia ventilator