Kornimate/medical-research-clean huggingface dataset:
safety and feasibility study of dapivirine (tmc120) vaginal ring in belgium

Conditions: HIV Infections

Summary: this phase i trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (tmc120) for 7 days. the study population will consist of 13 healthy, sexually abstinent women. safety and tolerability will be assessed through clinical and laboratory assessments. feasibility of drug delivery will be assessed by measuring dapivirine (tmc120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.


Eligibility criteria:
inclusion criteria: * female, age 18-50 years * willing and able to provide written informed consent * hiv-uninfected and otherwise healthy * willing to abstain from sexual activity and from use of vaginal products while participating in the study * currently using oral contraceptives for pregnancy prevention * willing to use oral contraceptives as needed to avoid menstruation while taking part in this study exclusion criteria: * history of allergy to tmc120 or to the constituents of the vaginal ring * history of diagnosis of and/or treatment for a sexually transmitted disease within the last three months * history of genital tract surgery within the last month * currently pregnant or breastfeeding, or within two months of last pregnancy outcome * currently or within one month of participating in any other clinical research study * current vulvar or vaginal symptoms / abnormalities that could influence the study results * current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption * current diagnosis of any genital infection * smoking more than 10 cigarettes / day

Keywords: hiv seronegativity
head and intraocular trauma tool for the identification of mild traumatic brain injury

Conditions: Brain Injuries, Traumatic

Summary: rebion has developed a device, the rebion trauma tool (referred to as the head and intraocular trauma tool, or "hitt"), that detects ocular fixation and alignment using a binocular retinal scan. preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (tbi) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. this study seeks to evaluate the ability of the rebion trauma tool to assess perturbations in eye movements resulting from tbi. the study will enroll 100 tbi patients and 100 controls.


Eligibility criteria:
inclusion criteria: 1. age 13-45 years 2. presents to the facility within 2 weeks of head trauma 3. able to provide informed consent • if minor, then able to provide parental consent and minor assent 4. able to participate in the examination, including the ability to follow simple instructions 5. fluency in english or spanish exclusion criteria: 1. glasgow coma scale score of equal to or less than 13 at the time of study enrollment 2. under the influence of alcohol or drugs 3. previous eye surgery 4. visual acuity known to be 20/200 or less in either eye 5. known strabismus, amblyopia (lazy eye), or double vision 6. known eye movement disorder, including nystagmus 7. known optic nerve disease, including papilledema or optic neuropathy 8. known retinal disease, including macular degeneration or retinal degeneration 9. known cataract 10. history of neurosurgery 11. history of stroke/brain hemorrhage, brain tumor, or epilepsy 12. any head trauma requiring medical attention from a physician within the last 6 months 13. diagnosed dementia or cognitive impairment requiring assistance for daily living 14. other condition(s) under the care of a neurologist 15. psychiatric hospitalization in the last 90 days 16. subject considered unsuitable for participation in this clinical trial by pi, treating clinician, or study research staff 17. any minor brain injury regardless of loss of consciousness
ultrasound for confirmation of gastric tube placement in critically ill patients under invasive mechanical ventilation

Conditions: Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation

Summary: introduction: data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology. aim: find the best strategy to confirm gastric tube placement to avoid immediate complication. method: a randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. the study will be conducted in one medical icu with 59 beds at a medical center. the primary outcome is the correct rate as comparing with the chest radiography in each group. total 190 patients is needed with estimated 10% drop-out rate.


Eligibility criteria:
inclusion criteria: * clinical indication of nasogastric tube placement * age than 20 years old. exclusion criteria: * facial trauma or head-base fractures * esophageal or gastric resection * esophageal strictures or alkaline injury * open wound in the area to prevent ultrasonography

Keywords: point-of-care ultrasound,ultrasound
effect of 15% eflornithine hydrochloride cream on african-american males with pseudofolliculitis barbae

Conditions: Pseudofolliculitis Barbae

Summary: this trial is designed to gain insight into the mechanism of action of eflornithine hydrochloride in men and to aid in determining if this compound is deserving of further development for a pseudofolliculitis barbae indication. this study will also provide knowledge which will be useful in designing future pfb trials in this indication is pursued.

the proposed mechanism of action of eflornithine hydrochloride for treatment of hair growth is that it reduces the rate of cell growth within the hair follicle by inhibition of the enzyme ornithine decarboxylase (odc). in preclinical studies eflornithine hydrochloride was shown to inhibit odc and decrease hair mass. in sheep, systemic inhibition of odc by eflornithine hydrochloride markedly altered not only the length and diameter of hair fibers, but also the portion of the hair fiber cross-section occupied by paracortical cells, which are primarily found in straight hairs. in a phase ii study evaluating the effect of the drug in the treatment of female hirsutism, it was anecdotally noted that those who also had pfb showed an improvement in this condition.

Eligibility criteria:
inclusion criteria: * males age 18 or older of african american descent. * history of pfb localized to the beard area of at least 2 years duration confirmed by a dermatologist. * pfb grade 3 (ingrown hairs and 20 or more papules of 2mm or greater in diameter with inflammation with minimal pustules) or greater involving the beard area of the face. * customary frequency of removal of facial hair by wet shaving at least once per week. exclusion criteria: * use of topical medications on the face within 2 weeks prior to treatment. * use of systemic steroids, antibiotics, lithium or isotretinoin within 2 months prior to pretreatment. use of etretinate or acitretin within one year prior to pretreatment. * use of systemic antiandrogens, spironolactone, growth hormone, immunostimulants. immunosuppressants, 5-alpha reductase inhibitors. minoxidil dehydroepiandrosterone (dhea) or other medications considered to have an effect on hair growth within 6 months prior to pretreatment. * use of physical hair removal techniques (laser, electrolysis, epilation) or chemical removal products (depilatories, waxing, sugaring) within 4 weeks prior to pretreatment. * presence of bacterial infections in the beard area including abscesses (3 or more) covering greater than 10% of the face and/or severe inflammatory acne.
safety, tolerability, and efficacy of anti-spike (s) sars-cov-2 monoclonal antibodies for hospitalized adult patients with covid-19

Conditions: COVID-19

Summary: the primary objectives are: pooled phase 3 (cohort 1) and phase 2 (cohort 1a) * to evaluate the virologic efficacy of regn10933+regn10987 compared to placebo in reducing viral load of sars-cov-2 * to evaluate the clinical efficacy of regn10933+regn10987 compared to placebo, as measured by death or mechanical ventilation phase 1/2 (cohort 1) * to exclude futility of regn10933+regn10987 compared to placebo, as measured by death or mechanical ventilation * to evaluate the safety and tolerability of regn10933+regn10987 compared to placebo


Eligibility criteria:
key inclusion criteria: * has sars-cov-2-positive antigen or molecular diagnostic test (by validated sars-cov-2 antigen, rt-pcr, or other molecular diagnostic assay, using an appropriate sample such as np, nasal, oropharyngeal \[op\], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. a historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable. * has symptoms consistent with covid-19, as determined by investigator, with onset ≤10 days before randomization * hospitalized for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category: 1. cohort 1a: with covid-19 symptoms but not requiring supplemental oxygen 2. cohort 1: maintains o2 saturation \>93% on low-flow oxygen as defined in the protocol 3. cohort 2: high-intensity oxygen therapy without mechanical ventilation as defined in the protocol 4. cohort 3: on mechanical ventilation key exclusion criteria: * phase 1 only: patients maintaining o2 saturation \>94% on room air * in the opinion of the investigator, unlikely to survive for \>48 hours from screening * receiving extracorporeal membrane oxygenation (ecmo) * has new-onset stroke or seizure disorder during hospitalization * initiated on renal replacement therapy due to covid-19 note: other protocol defined inclusion / exclusion criteria apply

Keywords: coronavirus disease 2019 (covid-19) severe acute respiratory syndrome coronavirus 2 (sars-cov-2) coronavirus acute respiratory distress syndrome
femoral bone metastases

Conditions: Cancer; Metastatic Malignant Neoplasm to Femur; Risk of Fracture

Summary: bone is a common site of metastasis for a range of malignancies. bone metastases have the potential to cause significant morbidity including pain, impairment of ambulation and reduced functional independence. previous research has shown that pathological fractures are observed in 9 to 29 percent of patients with long bone metastases, and a high proportion of these require surgical intervention to relieve pain and restore function. the goal of this study is to describe the clinical outcomes of patients with femoral metastases at high risk of pathological fracture. patients referred for treatment of femoral metastases at high risk of fracture will be followed prospectively after undergoing with surgery (± post-operative radiotherapy), or radiotherapy alone. patient and disease characteristics, ambulatory status and limb function will be documented before treatment. these clinical outcomes of participants in each treatment group will be measured 6 weeks after treatment, and 3- and 6 months after enrolment, with particular reference to patient-reported outcomes relating to pain, ambulatory status, limb function and quality of life.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of malignancy other than lymphoma * presence of femoral metastases at high risk of pathologic fracture (mirels' score 8 or more) * at least 18 years of age * able to provide written informed consent * able to participate in follow-up exclusion criteria: * surgical consultation for the purpose of obtaining a tissue/histological diagnosis only, not for treatment * histological diagnosis of lymphoma

Keywords: bone metastases femoral metastases
behavioral plant-based dietary intervention in latinos

Conditions: Obesity; Metabolic Disease

Summary: the aims of this study are 1) to develop a traditional plant-based diet that is palatable and acceptable to the latino population and which contains the appropriate calorie and macronutrient composition needed to lose weight and improve metabolic function and; 2) to develop a culturally sensitive \[based on previous literature and stakeholder input\] lifestyle intervention program, that will be delivered by community health workers \[chws\], that focuses on consuming a traditional plant-based diet and overcoming the barriers to incorporating this dietary therapy as part of the family lifestyle but with a focus on the adult participant with obesity. ultimately, in aim 3 the investigators will conduct a 16-week randomized controlled trial (rct) in 40 latino adults with obesity \[20 control, 20 treatment\] to evaluate the intervention's: i) clinical efficacy; ii) fidelity of the implementation by chws; and iii) acceptance by chws and study participants.


Eligibility criteria:
inclusion criteria: * self-reported hispanic and/or latino heritage * body mass index (bmi) 30-42 kg/m² * hba1c ≤ 6.4% exclusion criteria: * previous diagnosis of diabetes * unstable weight (≥4% during the last 2 months prior to study enrollment) * severe cardiovascular disease within the 6 months prior to study enrollment * severe organ system dysfunction * active substance abuse with alcohol or drugs * severe anemia * pregnant or breastfeeding * use of medications that are known to affect the study outcome measures * persons who are not able to grant voluntary informed consent

Keywords: latinos obesity plant-based diet
study assessing effects of jzp-110 on driving performance in the treatment of excessive sleepiness in osa

Conditions: Obstructive Sleep Apnea; Excessive Sleepiness

Summary: this trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of jzp-110 on driving performance in subjects with excessive sleepiness due to obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: 1. male or female, age 21 to 65 years inclusive 2. diagnosis of obstructive sleep apnea (osa) per international classification of sleep disorders (icsd-3) 3. bmi 18 to \<40 kg/m2 4. willing and able to provide written informed consent exclusion criteria: 1. female subjects who are pregnant, nursing, or lactating 2. any other clinically relevant medical, behavioral, or psychiatric disorder other than osa that is associated with excessive sleepiness 3. history or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to diagnostic and statistical manual of mental disorders 5th edition (dsm-5) criteria 4. history or presence of any unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy and/or safety assessments per the judgment of the investigator 5. history of bariatric surgery within the past year or a history of any gastric bypass procedure 6. presence or history of significant cardiovascular disease 7. unable to washout or refrain from taking any over-the-counter (otc) or prescription medications that could affect sleep-wake function

Keywords: driving
impact of ketone bodies and epigallocatechin gallate in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: based on the fact that the fundamental pathogenic mechanism of the multiple sclerosis (ms) disease is neuroinflammation, related in turn to cellular oxidation and mitochondrial alterations, this project aims to assess the impact of a nutritional intervention on the evolution of ms patients in their different slopes. to this end, the administration of medium-chain triglycerides, whose metabolism produces the increase of ketone bodies in the blood, will be carried out; and another of the antioxidant polyphenol epigallocatechin gallate. this procedure will be applied over 6 months, based on a isocaloric mediterranean diet, with a population for the study of 80 patients with different variants of the disease. the assessment of the intervention will be carried out every two months, at motor-functional, anthropometric, cognitive and emotional, inflammatory, and oxidation levels.


Eligibility criteria:
inclusion criteria: * multiple sclerosis patients older than 19 years ans under 65 who sign informed consent of the study exclusion criteria: * patients with coconut oil intolerance or other chronic metabolic pathologies
influencing factors of coronary heart disease in young people

Conditions: Coronary Heart Disease

Summary: the incidence of coronary heart disease in young people is not uncommon and the investigators will explore the factors contributing to this outcome

through the multi-center clinical research conducted by several units in nantong city, the risk factors and aggregation of the incidence of chd among young people in nantong city were obtained, so as to fill in the blank of domestic multi-center research and reduce the incidence of chd among young people.the investigators will conduct a long-term follow-up study on the young patients with chd to screen the factors contributing to the poor prognosis of chd in young patients.the investigators will fill this gap and intervene early to improve patients' quality of life and prolong their survival

Eligibility criteria:
inclusion criteria: * diagnosed coronary heart disease * confirmed by coronary angiography * diagnosed myocardial infarction * willing to sign an inform consent exclusion criteria: * patients won't sign an inform consent or will not comply with the follow up.

Keywords: coronary heart disease inflammatory cytokines lifestyle familial inheritance myocardial infarction
vitamin b complex improved exercise performance and anti-fatigue

Conditions: Exercise Performance; Fatigue

Summary: the aim of the present study was to evaluate potential beneficial effects of ttfd® ex plus (prince pharmaceutical co., ltd., yunlin county, taiwan) on fatigue and ergogenic functions following physiological challenge. the test used a double-blind crossover design and supplementation for 28 days. 32 male and female 20-30 year-old subjects were divided into two groups in a balanced order according to each individual's initial maximal oxygen uptake and were assigned to receive a placebo with equal gender (non ttfd® ex plus with same color/day, n=16, 8 male and 8 female) or ttfd® ex plus (600mg/tablet/day, n=16, 8 male and 8 female) every morning. after the intervention, there were 28 days of wash-out, during which time the subjects did not receive further interventions.


Eligibility criteria:
inclusion criteria: * \>20 years old * \>health exclusion criteria: * no smoking * drinking habits * no nutritional supplements or medications * no food allergies * normal liver and kidney function * no diabetes and other chronic diseases
optimizing detection and prediction of changes in cognitive function in multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the researchers will use technology-assisted ambulatory assessment techniques to examine cognitive dysfunction in people with multiple sclerosis (ms). the researchers will determine if ambulatory assessments are sensitive to subtle declines in cognitive functioning. they will also explore the impact of modifiable factors, such as sleep, physical activity, mood, and somatic symptoms on cognitive function. these efforts will uncover behavioral and medical intervention methods. finally, they will explore whether variability in cognitive functioning predicts short- and long-term changes in other patient-centered functional domains, social participation and physical functioning.


Eligibility criteria:
inclusion criteria: 1. are able to fluently converse and read in english. 2. multiple sclerosis (ms) diagnosis (confirmed from neurologist, all relapsing and progressive subtypes included) 3. ambulate either independently or with the use of a cane or walker (or similar device) for at least 50% of the time at baseline exclusion criteria: 1. ms relapse within the past 30 days (may become eligible after 30 days; criteria used at t1, t2, and t3). 2. inability to use study data collection tools (i.e., actigraph wrist-worn activity watch, smart phone app).

Keywords: cognitive dysfunction
inflammation in children with attention-deficit/hyperactivity disorder

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: the aim of this study is to investigate the inflammatory response in children with this disorder.

attention deficit-hyperactivity disorder (adhd) is a prevalent childhood neuropsychiatric disorder, characterized by age-inappropriate and impairing levels of inattention, hyperactivity and impulsiveness. approximately 5-10% of school-age children are affected by adhd, and in many cases, symptoms persist into adolescence and adulthood. cytokines are key mediators of immune function and can be either pro-inflammatory or anti-inflammatory. recently few studies have suggested involvement of cytokine pathways in subjects with adhd. polymorphism of il-1 receptors antagonists' alleles have been suggested in families and subjects suffering from adhd. moreover, a new variant of inflammatory bowel disease, another immunological based disease, was recently suggested in children with adhd and other developmental disorders. there are no other published reports on cytokine production in children who suffer from adhd.

Eligibility criteria:
inclusion criteria: 1. a defined condition of adhd according to tova test (tova score \> (-1.8), connor's questionnaire (connor's score \> 15 points) and achenbach's questionnaire; 2. a consent form signed by parents or legal guardianships; exclusion criteria: 1. a history of any other neurological or major psychiatric disorder or other significant medical problems; 2. no current medications;

Keywords: adhd cytokines cr-p
istat comparison study, irb3785

Conditions: Pleural Effusions

Summary: pleural fluid glucose levels measured with bed-side point of care methods such as finger stick glucometers and i-stat device correlate with the traditional in-lab testing methods.

this is a prospective study which will identify patients in vamc with a diagnosis of pleural effusion and undergoing diagnostic thoracentesis.the investigators plan to analyze the two bedside point-of-care fluid glucose testing methods (i- stat device and finger stick glucometer) to measure pleural fluid glucose levels. the results obtained from these two methods will be compared to the traditionally in lab measured pleural fluid glucose levels.

Eligibility criteria:
inclusion criteria: * any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis. exclusion criteria: * inability to provide informed consent by the patient or the surrogate to enroll for the planned study.

Keywords: pleural glucose glucometer i-stat
a relative bioavailability study of 75mg indomethacin extended-release capsules

Conditions: Inflammation

Summary: the purpose of this study is to demonstrate the bioequivalence of indomethacin er capsules.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening exclusion criteria: * positive test results for hiv or hepatitis b or c * no allergies to indomethacin or related drugs

Keywords: anti-inflammatory