Kornimate/medical-research-clean huggingface dataset:
open-label extension study to evaluate the safety of sd-101 cream in participants with epidermolysis bullosa

Conditions: Epidermolysis Bullosa

Summary: the purpose of this study was to assess the continued safety of topical use of sd-101 cream (6%) in participants with epidermolysis bullosa (eb). funding source: fda office of orphan products development

this was an open-label extension study to assess the continued safety of topically applied sd-101 dermal cream (6%) in participants with simplex, recessive dystrophic, and junctional non-herlitz eb. sd-101 dermal cream (6%) was applied topically, once a day to the entire body for the duration of the study. participants who successfully completed the entire sd-003 study (nct02014376) had the option to roll over into the sd-004 study (nct02090283). the baseline visit occurred at the final visit date for the sd-003 study. the body surface area (bsa) coverage of blisters and lesions assessment made at the final sd-003 study visit were used as the baseline information at the baseline visit for the sd-004 study. participants returned to the study site for the following 13 visits (36 months) to have bsa assessed. bsa was assessed at all subsequent scheduled study center visits. scheduled study center visits occurred every 6 months after month 36 (month 42, 48, and so on). after completion of month 36, the next participant visit (month 39) was a phone call from the site to the participant. telephone visits occurred every 6 months thereafter (month 45, 51, and so on) and included assessment of adverse events and concomitant medications only. for female participants of childbearing potential, a urine pregnancy test was performed at month 6 and every 6 months up to and including the final study visit.

Eligibility criteria:
inclusion criteria: * informed consent form signed by the participant or participant's legal representative; if the participant is under the age of 18 but capable of providing assent, signed assent from the participant. * participant (or caretaker) must be willing to comply with all protocol requirements. * participant must have successfully completed the sd-003 study. exclusion criteria: * participants who do not meet the inclusion criteria. * pregnancy or breastfeeding during the study. a urine pregnancy test will be performed at the final visit for sd-003 for female participants of childbearing potential. * females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception.

Keywords: amicus therapeutics scioderm, inc. recessive dystrophic junctional non-herlitz epidermolysis bullosa simplex sd-101 6% sd-101-6.0 allantoin 6% zorblisa
noninvasive evaluation for carotid artery stenosis: the carotid stenotic scan

Conditions: Carotid Stenosis

Summary: the purpose of this study is to determine the accuracy of a new non-invasive device, the carotid stenotic scan (css), to check for stenosis of the internal carotid artery (ica) as compared to a carotid duplex ultrasound study.

currently, carotid duplex ultrasound is the primary diagnostic tool for the evaluation for ica stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. this test is not considered suitable for screening for disease. it would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ica disease in an office based setting. however, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation. this study will evaluate a new technology called the carotid stenotic scan (css) developed by cvr medical. the css instrument uses sensitive transducers to detect low frequency pressure fluctuations associated with flow disturbances downstream from areas of arterial narrowing. subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. subjects will have a noninvasive css assessment either before or after the carotid duplex ultrasound.

Eligibility criteria:
inclusion criteria: * patients age ≥ 65 years scheduled for a diagnostic carotid artery duplex ultrasound study and with one or more of the following: * hypertension * hyperlipidemia * diabetes * tobacco usage - current or past * known cad/pad * family history of early onset of atherosclerotic disease exclusion criteria: * unable / unwilling to provide informed consent * prior carotid endarterectomy or carotid artery stent * aortic stenosis * congestive heart failure * bmi \> 35

Keywords: carotid stenosis noninvasive
clinical performance of a vaginal pessary (phyph) in bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: this is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of gedea pessary in 24 adult women with confirmed bv according to fulfillment of at least 3 of the 4 amsel criteria. on day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. patients will be examined after 7 days with respect to 3 amsel criteria (the criterion: "ph of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), and if not cured, will receive prolonged treatment for one additional week. patients will be followed-up by telephone up to 29 days after last treatment. vaginal samples will be used for confirming diagnosis and microbiome analyzes. patient questionnaires will be used for assessing bv symptoms, usability, and adverse events (aes).


Eligibility criteria:
inclusion criteria: adult, post-menarchal, pre-menopausal women aged 18 years or older * diagnosis of bv according to amsel's criteria, defined as having at least 3 of the 4 following criteria: 1. thin, white, yellow, homogenous discharge 2. clue cells on microscopy (more than 20 percent of epithelial cells) 3. ph of vaginal fluid above 4.5 4. release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[koh\] solution) is added * having decisional capacity and providing written informed consent * negative urine pregnancy test at screening * refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period * refrain from sexual intercourse or use a condom until day 7 * signed informed consent and willing and able to comply with all study requirements exclusion criteria: patients with known or apparent signs of other infectious causes of bv (vulvovaginal candidiasis, trichomonas vaginalis, neisseria gonorrhoeae, chlamydia trachomatis, herpes simplex, or human papillomavirus) at screening * anticipated menstruation during the treatment period (day 0 till day 7) * patients who are pregnant or breastfeeding * patients who were treated for bv within the past 14 days * patients who are currently receiving antibiotic therapy unrelated to bv or have received antibiotic therapy within the past 14 days * patients who have used ph-modifying vaginal products within the last 14 days * patients who have received an investigational drug in a clinical investigation within 30 days prior to screening * known/previous allergy or hypersensitivity to any product constituent * any medical condition that in the investigator's judgments would make the patient unsuitable for inclusion

Keywords: vaginitis vaginal disease vulvovaginitis genital disease, female vaginitis, bacterial
evaluation of the causes and disease processes of chronic lung disease

Conditions: Pulmonary Disease

Summary: chronic lung diseases are disorders associated with abnormalities in any of the structures involved in the process of breathing and bringing oxygen into the lungs and blood. this includes abnormalities in the airways, lungs, blood vessels in and around the lungs, and the tissue covering the lungs (pleura). the purpose of this research study is to evaluate patients referred to the cardiovascular and pulmonary branch of the national heart, lung, and blood institute (nhlbi) in order to; 1. develop a better understanding of the causes and disease processes involved in disorders of the lungs 2. identify patients eligible to participate in other p-ccmb research studies

the chronic lung diseases are those disorders associated with functional and/or structural derangement to the alveolar structures, airways, pulmonary blood vessels, pleura and/or mediastinum. the purpose of this project is to permit the comprehensive evaluation of patients referred to the pulmonary branch of the national heart, lung, and blood institute (nhlbi) in order to: (1) develop an understanding of the etiology and pathogenesis of these disorders; and (2) identify individuals who will be suitable candidates for other nhlbi protocols. testing and procedures will only be performed when medically indicated for the purposes of making a diagnosis or obtaining information likely to be useful in the management of the subjects' disease or condition.

Eligibility criteria:
* inclusion criteria: symptoms consistent with pulmonary disease. may have family history of lung disease. patients with diseases of organs with known association with lung disease. ranging in age from 7 to 90 years old. pregnant and nursing women may participate in minimal risk procedures exclusion criteria: persons with no clinical evidence of lung disease.

Keywords: computed tomography fiberoptic bronchoscopy pulmonary function testing cardiopulmonary exercise testing allergen skin testing
evaluation of bacterial flora among operation theatre staff at a tertiary care hospital

Conditions: Microbial Colonization

Summary: health care associated infection (hcai) is a serious health hazard as it leads to increased morbidity and mortality of patients, length of hospital stay and costs associated with increased hospital stay. a total of 361 subjects divided into four groups were included in this study. the first group comprised of 179 doctors, the second had 31 nurses, third group had 110 ot technicians and the fourth group included 41 subjects which included housekeeping staff and cleaners. swabs were collected from ot staff at the time of entry and at exit from the ot. places of swabs taken were: a) web space, b) ot dress and c) anterior nares.

introduction: health care associated infection (hcai) is a serious health hazard as it leads to increased morbidity and mortality of patients, length of hospital stay and costs associated with increased hospital stay. infections from ot is well known and is well established which are often referred to as "hot zones" for emergence \& spread of microbial resistance. contamination in an operation theatre is an important cause of hcais and is the third leading cause of hcais. this was a prospective observational study conducted in the operation theatre of a tertiary hospital once a month randomly from april 2014 - april 2016. all operation theatre (ot) staff were included in the study. all the patients in ot and samples from the ot air \& equipment were excluded from the study. a total of 361 subjects divided into four groups were included in this study. the first group comprised of 179 doctors, the second had 31 nurses, third group had 110 ot technicians and the fourth group included 41 subjects which included housekeeping staff and cleaners. swabs were collected from ot staff at the time of entry and at exit from the ot. places of swabs taken were: a) web space, b) ot dress and c) anterior nares.

Eligibility criteria:
inclusion criteria: all operation theatre staff - exclusion criteria: patients in operation theatre, operating room air \& equipment -

Keywords: operation theatre bacterial contamination web-space ot dress anterior nares
randomised placebo-controlled trial of modafinil for cocaine dependence

Conditions: Cocaine Dependence

Summary: the study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of cocaine dependence.

modafinil is a novel wake promoting agent approved in australia for the treatment of narcolepsy. preliminary studies have suggested that modafinil may have value in the treatment of psychostimulant dependence through positive effects on mood, sleep patterns, concentration, fatigue and drug craving. it appears to be well tolerated with a low abuse liability. thirty dependent cocaine users will be randomised to 2 equal groups. the experimental group will receive modafinil 200 mg/day for 10 weeks and a tailored cognitive behavioural therapy program. the control group will receive placebo under equivalent conditions. primary outcome will be a between group comparison of cocaine negative urine samples collected over the 10 week study period. adverse events, side effects, compliance, retention, self reported health, psychosocial and drug use outcomes will also be compared between the groups.

Eligibility criteria:
inclusion criteria: * dsm-iv cocaine dependence diagnosis * cocaine positive urine sample at intake * regular current cocaine use (2-3 days per week) * aged 18 years or older exclusion criteria: * pregnant or nursing females * concurrent uncontrolled physical or mental illness

Keywords: modafinil cocaine dependence randomised placebo-controlled trial
effect of lactobacillus reuteri in cystic fibrosis

Conditions: CYSTIC FIBROSIS

Summary: the purpose of this study is to evaluate in patients with cystic fibrosis the effect of lactobacillus reuteri (lr) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.

the hallmarks of cystic fibrosis (cf) are recurrent severe and destructive pulmonary inflammation and infection, beginning in early childhood and leading to morbidity and mortality due to respiratory failure. during the disease, most children become colonized with pseudomonas aeruginosa (pa) and undergo progressive impairment of respiratory function. therefore, patients colonized with pseudomonas are at increased risk for pulmonary infections and persistent inflammation and have a decrease in survival rate. in an attempt to reduce the rate and severity of pulmonary exacerbations, children with cf are put on heavy load of antibiotics. intestinal inflammation is another typical finding in cf patients and gut bacterial overgrowth may be present. probiotics are live bacteria administered orally, successfully used in children with acute gastroenteritis, as well as in preventing and treating atopic diseases in children. in addition, probiotics have been used as adjuvant therapy in patients with pouchitis and inflammatory bowel diseases. interestingly, probiotic supplementation is able to reduce the incidence of fever, child care absences, antibiotic prescription and to prevent nosocomial gastrointestinal and respiratory infections. the effect of probiotics may be through improvement of intestinal barrier function and modulation of immune response. the latter mechanism could well explain the clinical effects of probiotics observed in extraintestinal diseases.

Eligibility criteria:
inclusion criteria: * forced expiratory volume in the 1st second (fev1) \> 70%. * no inhaled or systemic steroids. * no anti-inflammatory drugs, antileukotrienes and mast cell membrane stabilizers. * no serious organ involvement. exclusion criteria: * history of pulmonary exacerbation or upper respiratory infection in the previous two months. * changes in medications in the past two months. * history of hemoptysis in the past two months.

Keywords: cystic fibrosis probiotics lactobacillus reuteri
the effect of aerobic exercise, on fitness and functional muscle strength, in patients with muscular dystrophy

Conditions: Bethlem Myopathy

Summary: muscular dystrophy is a group of disorders that are characterized by progressive muscle weakening and loss of muscle mass, caused by defects in muscle proteins. muscular dystrophy is almost always inherited disorders, and so far, no curative treatments exist. previous studies have shown that endurance training significantly improves fitness and self-assessed muscle function in a variety of muscular dystrophies. in this study, we wish to investigate whether patients with bethlem myopathy (a specific form of muscular dystrophy) also benefit from endurance training. the study consists of two test days, a 10-week training period and five blood tests. patients will be required to train, three times per week, for 10 weeks, on a bike ergometer with a specific training intensity, under pulse rate monitoring. the training period will be flanked by two test days, where we will determine, and compare the patients' muscle strength and fitness level, from before to after the training program. the patients conditioning level will be determined from a 15 minute cycle ergometer test and patients will undergo three functional tests to determine their functional muscle strength. we will as a safety measure analyze blood tests before, during and after the training program for the muscle enzyme creatine kinase (an indicator of muscle damage) and through adverse effects as reported by patients during weekly telephone-consultations with the principal investigator. we anticipate, that bethlem myopathy patients will have a similar rise in fitness level and functional muscle strength, as that seen in patients with other forms of muscular dystrophy, who undertake a similar training program.


Eligibility criteria:
inclusion criteria: * patients with bethlem myopathy exclusion criteria: * patients with disorders that would confound the interpretation of the effect from training (cardiomyopathy, pregnant women, etc.) * patients who are deemed mentally unfit for cooperation with the training program

Keywords: aerobic training vo2max bethlem myopathy
cognitive function in older women with stage i, stage ii, or stage iii breast cancer receiving hormone therapy

Conditions: Breast Cancer

Summary: rationale: gathering information about cognitive function over time in postmenopausal women with breast cancer may help doctors learn about the long-term effects of aromatase inhibitor therapy and plan the best treatment. purpose: this clinical trial is studying cognitive function in older postmenopausal women with stage i, stage ii, or stage iii breast cancer receiving hormone therapy and in healthy volunteers.

objectives: * explore the impact of treatment with an aromatase inhibitor on the cognitive function of postmenopausal women with stage i-iii breast cancer vs in cancer-free, age-matched healthy volunteers. outline: patients receive adjuvant anastrozole or letrozole in the absence of disease progression or unacceptable toxicity. patients and healthy volunteers undergo cognitive function testing consisting of neuropsychological battery tests and complete self-reported questionnaires (e.g., squire memory self-rating questionnaire, and fact-b quality of life measure) regarding cognitive ability, quality of life, fatigue, and psychosocial status. patients and healthy volunteers also undergo geriatric assessment at baseline and after 6 months of initiation with aromatase inhibitor therapy.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * patient diagnosed with breast cancer * stage i-iii disease * estrogen receptor- and/or progesterone receptor-positive * planning to start treatment with anastrozole or letrozole * age-matched healthy volunteer (control) * no history of breast cancer * not receiving adjuvant aromatase inhibitor therapy patient characteristics: * postmenopausal * able to converse, write, and read english * no claustrophobia (patients participating in the pet scan correlative study) prior concurrent therapy: * see disease characteristics * no prior hormonal therapy, including estrogen replacement therapy * no previous treatment with cns radiation

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer
allopregnanolone for the treatment of traumatic brain injury

Conditions: Traumatic Brain Injury; Posttraumatic Epilepsy

Summary: this study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.

this is a double-blind, placebo-controlled, randomized, dose-finding, two-stage adaptive, clinical trial study comparing allopregnanolone to placebo when administered intravenously for 5 days beginning within 8 hours after injury. test products to be administered are low and high dose allopregnanolone (products l and h, respectively) and placebo (product p) intravenous solutions. the products are administered during a 4-day treatment period followed by a 1-day dose de-escalation period. stage 1 of the study will assess safety and confirm that dosing with products l and h achieve the target steady-state plasma concentrations set for each of these products. dosing will be adjusted in stage 1, if necessary. stage 2 will initially allocate subjects equally to products l, h and p but will then use adaptive randomization to allocate subjects between products l and h to optimized the probability of yielding a better 3-month glasgow outcome score extended (gos-e) score.

Eligibility criteria:
inclusion criteria: * english or spanish speaking person * moderate to severe closed or blunt traumatic brain injury \[post resuscitation glasgow coma score (gcs) 3-12 with abnormal head ct scan if gcs is 9-12\] * less than 8 hours from injury to study initiation * able to participate for the full term of the study exclusion criteria: * subjects with life expectancy of less than 24 hours * isolated epidural hematoma * hypoxia (pulse oximetry saturation ≤90% for 15 or more minutes before enrollment) * hypotension (systolic blood pressure ≤90 mm hg on 2 or more reliable measurements before enrollment) * cardiopulmonary arrest prior to randomization * spinal cord injury with motor deficits * bilateral non-reactive pupils with glasgow coma scale 3 * body weight \>120 kg * pregnancy * active breast or reproductive organ cancer * allergy to progesterone * history of thromboembolic events * receipt of activated factor vii before enrollment * any disease that is unstable or which could jeopardize the safety of the subject including severe renal impairment (creatinine clearance \<50 ml/min) * prisoner/ward of the state * known treatment with another investigational drug therapy or procedure within 30 days of injury

Keywords: brain injuries pregnanolone epilepsy