Kornimate/medical-research-clean huggingface dataset:
prepare (a5361s) ancillary study of reprieve (a5332)

Conditions: HIV-1 Infection

Summary: aging with hiv is associated with earlier development of frailty (weakness) or disability, including loss of physical and muscle strength, and walking speed. few treatments have been shown to prevent or slow these impairments in people with or without hiv. some studies have suggested that the class of drugs called statins (for example, pitavastatin) might be helpful in slowing frailty or disability. this might happen by decreasing fat within the muscle or by decreasing inflammation markers (substances in the blood that determine how the body reacts to infection or irritation) in the blood. other studies have shown that statins increase the risk of muscle aches and pains. this ancillary study was done to determine the impact of the drug pitavastatin on physical and muscle function.

the randomized trial to prevent vascular events in hiv (reprieve (a5332), subsequently referred to as reprieve; nct02344290) was a prospective, randomized, placebo-controlled, multicenter phase iii trial to evaluate pitavastatin as prevention for cardiovascular disease events among people with hiv. prepare (a5361s, subsequently referred to as prepare) was an ancillary study of reprieve to determine the effects of pitavastatin on physical and muscle function. the study enrolled participants: 1. enrolled in both reprieve and its mechanistic substudy (a5333s, subsequently referred to as mechanistic substudy) within 24 of their reprieve enrollment 2. enrolled in reprieve alone concurrently with their reprieve enrollment. the target sample size was 600 participants. the study was conducted at the reprieve u.s. sites participating in the mechanistic substudy, and enrollment from the mechanistic substudy was prioritized to maximize the number of participants with computed tomography (ct) scan data performed as part of the mechanistic substudy. treatment groups (pitavastatin vs placebo) were defined according to randomization in reprieve. participants were enrolled into prepare blinded to their reprieve treatment allocation. no intervention was provided in this ancillary study. originally the study duration was 48 months after participants' reprieve entry. an additional visit was added at month 60 due to missed in-person evaluations during the covid-19 related restrictions in 2020 through early 2021. study visits were scheduled at prepare entry and at months 12, 24, 36, 48 and 60 after reprieve entry. each study visit included evaluation of physical function, frailty and self-reported physical activity and sedentary time. in addition, demographic and clinical data, laboratory specimens and ct scans collected as part of the main study reprieve or its mechanistic substudy were used.

Eligibility criteria:
inclusion criteria: * ambulatory participants enrolled in both reprieve (a5332) and its mechanistic substudy (a5333s) or ambulatory participants who are newly enrolling into reprieve (a5332) at a5333s actg sites. exclusion criteria: * inability to ambulate independently (use of a cane or a walker is permitted) or rise from a chair without assistance.
command early feasibility study: implantable bci to control a digital device for people with paralysis

Conditions: Neurologic Disorder; Paralysis; Paralysis; Stroke; Amyotrophic Lateral Sclerosis; Muscular Dystrophies; Spinal Cord Injuries; Stroke, Lacunar; Stroke Brainstem; Cervical Spinal Cord Injury; Spinal Muscular Atrophy; Tetraplegic; Paralysis; Quadriplegia/Tetraplegia

Summary: the synchron motor neuroprosthesis (mnp) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. the purpose of this research is to evaluate safety and feasibility. the mnp is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. the device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.


Eligibility criteria:
inclusion criteria: 1. severe quadriparesis 2. able to give consent 3. appropriate candidate for neurointerventional procedure 4. able and willing to access all clinical testing and not impeded by geographical location 5. proficient in english 6. have a study partner exclusion criteria: 1. active condition resulting in immunosuppression 2. unsuitable for general anesthesia 3. anaphylactic allergy to contrast media 4. allergy to nickel 5. history of pulmonary embolism 6. history of recent deep vein thrombosis 7. psychiatric or psychological disorder 8. no study partner or caregiver 9. unable to provide evidence of covid vaccination
multicenter clinical study on diagnosis and treatment of skull base trauma

Conditions: Skull Injury Trauma

Summary: the purposes of this study are as follows: 1. to collect the largest epidemiological data of skull base trauma and analyze the related influence factors of mortality and morbidity. 2. to establish a set of standard classification methods of skull base trauma and to establish a standard rating scale for each type of trauma. 3. to select optimized conservative and surgical treatments of skull base trauma and to compare the therapeutic effect between microscope surgery and neuroendoscopic surgery. 4. to clear the epidemiological characteristics of the skull base trauma combined with paroxysmal sympathetic hyperactivity.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of skull base trauma exclusion criteria: * n/a

Keywords: skull base trauma microscope surgery neuroendoscope surgery
effects of almond consumption on the human gastrointestinal microbiota and metabolic health

Conditions: Overweight and Obesity

Summary: the proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health.

this study is a randomized, controlled, investigator-blinded, parallel arm design with two treatment conditions. there will be a phone screening, in person pre-intervention testing, a one-week baseline period devoid of all nuts and seeds followed by a 12-week intervention period, and a post-testing appointment. participants will be randomized to consume almonds or isocaloric snack for 12 weeks. participants will provide stool samples during baseline testing and during the 12th week of the intervention.

Eligibility criteria:
inclusion criteria: * males \& females * 30-60 years of age * bmi 25-34.9 kg/m\^2 * ability to drop off fecal sample within 15 minutes of defecation exclusion criteria: * physician diagnosed metabolic or gastrointestinal diseases * fasting blood glucose \>126 mg/dl * blood pressure \>160/100 mm hg * anemia * elevation in serum transaminases (i.e. \>3 times the upper limit of normal) * evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation * currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or medications known to impact bowel function. * pregnant, breastfeeding or postmenopausal * smoker, tobacco use * allergic to nuts * consume \> 2 alcoholic beverages/day * abuse drugs * have had \> 5% weight change in the past month or \> 10% change in the past year * have taken antibiotics during the previous 2 months * unable to consume the experimental treatments (almonds or pretzels) * bariatric surgery * gallbladder removal * allergic to lidocaine or other topical anesthetics

Keywords: almond gastrointestinal microbiota metabolic health bile acid profiles
effects of low concentration atropine on pupillary size and accommodative amplitude

Conditions: Myopia

Summary: to assess the two-week ocular responses, especially on pupillary size and accommodative amplitude, of nightly application of 0.01% or 0.02% or 0.03% atropine eye drops in children with myopia who were randomized to use of three different low-concentration atropine eye drops

atropine was proven to be effective in controlling myopia progression. however, the most common side effects of the use of atropine eye drop are dilation of pupil and decrease of accommodation. the investigators wish to evaluate the ocular responses of three low concentration atropine eye drops, 0.01% or 0.02% or 0.03%, mainly on the pupillary size and accommodative responses in children aged between 6 to 12 years old over two-week usage.

Eligibility criteria:
inclusion criteria: * able to read and comprehend vietnamese and having parents or legal guardians who give informed consent as demonstrated by signing a record of informed consent. * be between 6 and 12 years old, male or female. * willing to apply eye drops once nightly at bedtime for two weeks and follow the clinical trial visit schedule as directed by the investigator. * willing to answer the questionnaire about subjective measurements * have ocular findings deemed to be normal * no contact lens wearing history * vision correctable to at least 20/25 or better in each eye with spectacles exclusion criteria: * any pre-existing ocular irritation, injury or condition, including infection or disease. * any systemic disease that adversely affects ocular health e.g. diabetes, graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, sjögrens syndrome and systemic lupus erythematosus. conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. * use of or a need for concurrent category s3 and above ocular medication at enrolment and/or during the clinical trial. * use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. nb: systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used. * history of eye surgery * history of use of any myopia control interventions such as orthokeratology, rigid permeable contact lenses eye surgery within 12 weeks immediately prior to enrolment for this trial. * currently treated with other interventions for myopia control * contraindications to atropine such as pulmonary disease, heart conditions and adhd * known allergy or intolerance to ingredients to atropine eye-drops and other derivatives of anti-muscarinic receptor agents. * currently enrolled in another clinical trial.

Keywords: myopia control low concentration atropine eye drops anti-muscarinic receptors pupil size accommodative amplitude
myeloid suppressors in inflammation

Conditions: Asthma

Summary: myeloid-derived suppressor cells (mdsc) have been studied for their ability to suppress t cell responses in vivo and in vitro. as a result, mdsc can regulate cellular responses to chronic inflammatory conditions such as cancer, leading to the induction of tolerance and, ultimately, tumor escape from immune surveillance.


Eligibility criteria:
inclusion 1. ages eligible for study: 18 to 60 years 2. genders eligible for study: male and female 3. signed and dated written informed consent is obtained prior to study blood draw. 4. subjects being actively treated for chronic moderate to severe asthma based on national heart lung and blood institute guidelines (figure 1). subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months. 5. subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician. 6. able to give informed consent. exclusion criteria: 1. use of systemic corticosteroids within the previous two weeks. 2. pregnant and/or lactating females. 3. current tobacco use. 4. severe psychiatric illness. 5. current illicit substance abuse or dependence and/or abuse of alcohol. 6. current use of anti-microbial medications. 7. primary or secondary immunodeficiency. 8. any clinically significant uncontrolled medical condition that would put the patient's safety at risk.

Keywords: asthma
7t mri to evaluate cartilage defects in the knee

Conditions: Cartilage Injury; Knee Injuries; Arthropathy of Knee; Cartilage Damage; Knee Pain Swelling

Summary: the investigators propose to prospectively evaluate the accuracy of a novel 7-tesla (7t) knee mri protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current mri techniques.

the investigators hypothesize that 7t mri will be \~ 80% sensitive for detection of cartilaginous lesions. this will be tested in a prospective multi-reader study of 100 patients who are scheduled to have knee arthroscopy. patients will have two mris of the knee: one standard of care and one experimental 7t mri. subjects will visit at one time point prior to scheduled knee arthroscopy, for a session time of \~1-2 hours for a single 7t mri scan.

Eligibility criteria:
inclusion criteria: * confirmed knee symptomatology * scheduled arthroscopic treatment of knee * adult (equal or greater than 18 years of age) exclusion criteria: * active infections * less than 18 years of age * pregnant

Keywords: 7t magnetic resonance imaging clinical cartilaginous lesion
a study to assess the efficacy and safety of axs-12 (reboxetine) in patients with narcolepsy

Conditions: Narcolepsy; Cataplexy; Excessive Daytime Sleepiness

Summary: this study is a multi-center, double-blind, placebo-controlled, randomized phase 3 trial to assess the safety and efficacy of axs-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (eds).

eligible subjects must have a diagnosis of narcolepsy per the international classification of sleep disorders (icsd-3), and exhibit symptoms of both cataplexy and eds. subjects meeting the entry criteria will be randomized in a 1:1 ratio to receive either axs-12 or placebo for five weeks.

Eligibility criteria:
inclusion criteria: * male or female subjects between 15 and 75 years of age, inclusive * primary diagnosis of narcolepsy with cataplexy * willing and able to comply with the study requirements exclusion criteria: * other clinically significant conditions potentially causing eds * clinically significant psychiatric disorders

Keywords: axs-12 narcolepsy cataplexy excessive daytime sleepiness reboxetine axsome
serological test for the diagnosis of tb

Conditions: Active Tuberculosis

Summary: tb remains a health problem in france with about 5,000 new cases per year. development of new screening tests is a priority for tb. the main objective of the study is to evaluate performances of innovative blood tests to identify active tuberculosis in adults patients living in low-prevalence country. adult patients with possible tb from will be tested for the presence of antibodies directed against m. tuberculosis selected antigens. positive and negative predictive values will be established based on tb culture results.


Eligibility criteria:
inclusion criteria: * signs of possible tuberculosis (tb); testing for tb in routine practice (microbiology) exclusion criteria: * immunosuppression
investigation of ultrasound imaging and spectroscopy for characterizing breast masses

Conditions: Breast Cancer

Summary: our objective in this study is to identify an optimal set of quantitative ultrasound parameters that can be used, non-invasively, to characterize breast masses with high accuracy, as determined histopathologically. breast cancer is the most frequent form of non-epithelial cancer diagnosed in women, with approximately 1.5 million new cases diagnosed annually worldwide. accurate diagnosis and characterization of disease play an important role in therapy planning for breast cancer treatment. currently, the gold standard method of tumour diagnosis is pathological examination of core biopsy specimens. however, the invasive core biopsies can cause post-surgical complications. besides, some lesions require repeat biopsy due to sampling errors during the initial biopsy. also x-ray mammography and ultrasound b-mode images, which are used by radiologists for breast examination, lack reliable information about micro-structural properties of tissues. there is an urgent need of a non-invasive imaging modality that can provide rapid and quantitative information for breast tumour characterization, in real time and at the patient bed. the main goal, as described above, is to select the best quantitative ultrasound parameters that can facilitate breast cancer characterization, non-invasively.

this project is an observational/early validation study in human subjects that will use ultrasound imaging and spectroscopy to characterize suspected breast cancers. patients will be imaged with ultrasound, and the acquired data will be analyzed using quantitative ultrasound techniques, in conjunction with textural analysis on generated parametric images. results of quantitative ultrasound data analysis for these breast lumps will be compared to and correlated with their histopathological characteristics from pathology reports on core biopsy specimens, surgery reports, or radiology reports, available from patient charts. from this data we will potentially estimate the best hybrid ultrasound-based biomarker that can characterize suspected breast cancers, noninvasively.

Eligibility criteria:
inclusion criteria: 1. women or men with suspected breast cancer 2. patients should have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering in the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration 2. receiving any other investigational agents 3. any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Keywords: ultrasound spectroscopy characterization
permeability map to distinguish progression from pseudoprogression in high-grade glioma

Conditions: High Grade Glioma

Summary: the aim of the present study is to assess whether a new method of quantifying therapy-associated hemodynamic alterations based on dce mr imaging may help to distinguish pseudoprogression from true progression in patients with high grade glioma, who received ccrt.

combination temozolomide and radiation significantly prolongs survival compared with radiation alone and has become standard treatment for glioblastoma multiforme (gbm). response assessment in gbm is difficult as a result of the frequent occurrence of early imaging changes indistinguishable from tumor progression, termed pseudoprogression. the majority of patients remain clinically stable. it is often unclear whether current therapy should be maintained or second-line therapy initiated. the incidence of pseudoprogression after concurrent chemoradiation is15%to 30%. a potential mechanism of pseudoprogression is that radiation-induced vascular changes may lead to focal transient increase in gadolinium enhancement. dynamic contrast-enhanced (dce) mr imaging provides a noninvasive means for quantifying tumor vascular properties.

Eligibility criteria:
inclusion criteria: * among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (ccrt) with temozolomide, the patients show the measurable enhancing portion (1 cm in the long diameter according to the rano criteria) in the immediate f/up mri after ccrt. exclusion criteria: * among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (ccrt) with temozolomide, the patients do not show the measurable enhancing portion (1 cm in the long diameter according to the rano criteria) in the immediate f/up mri after ccrt.

Keywords: permeability map high-grade glioma
effect of non-pharmacological therapy on cognitive function of patients with cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: supervised nonpharmacologic therapy improve cognitive function in patients with mild cognitive impairment


Eligibility criteria:
inclusion criteria: * patients 60 years and older with mild cognitive impairment according to petersen criteria * phone number available exclusion criteria: * untreated depression * evidence of a reversible cause of cognitive decline * dementia of any type and stage * severe sensory deficit unresolved * metastatic cancer * hemoglobin level \< 8g/dl * chronic obstructive pulmonary disease gold stage 3 or 4 * congestive heart failure decompensated, unstable angina o functional class iv according to new york heart association * participation in another protocol that prevents its participation in this research * chronic use of benzodiazepines, tricyclic antidepressants * patients whose place of residence can not attend the sessions

Keywords: mild cognitive impairment cognitive training
the alpha-1 foundation's and university of florida's alpha-1 coded testing (act) study

Conditions: Alpha-1 Antitrypsin Deficiency

Summary: the alpha-1 coded testing (act) study was established to study genetic testing and outcomes of individuals at risk for alpha-1 antitrypsin deficiency.

genetic testing for alpha-1 antitrypsin deficiency is sometimes delayed despite established testing indications. all genetic tests have risks and possible benefits. the act study evaluates the population demographics, reasons for testing, and outcomes through a confidential testing program. co-morbidities of alpha-1 antitrypsin deficiency other than lung and liver disease are being investigated. concerns about genetic confidentiality are lessened in this study by a coded testing procedure that returns results through the mail to study participants.

Eligibility criteria:
inclusion criteria: * individuals of any age at risk for alpha-1 antitrypsin deficiency on the basis of symptoms or family genetic risk. exclusion criteria: * any person who has already had genotype and aat level testing completed and has a qualified result.

Keywords: alpha-1 antitrypsin aat genetic testing alpha-1 antitrypsin deficiency aatd
vaccination practices for inflammatory bowel disease patients in china with gastroenterologists

Conditions: Inflammatory Bowel Diseases

Summary: the aim of the current study was to evaluate the knowledge of chinese gastroenterologists on vaccinating patients with ibd under the assistance of chinese crohn's \& colitis foundation. the chinese crohn's \& colitis foundation (cccf) is the first nonprofit,volunteer-driven foundation specifically for patients with ibd in china.it has been joined by ibd specialists at various hospitals in china.

the questionnaire contained questions regarding the respondents'information, including their gender, years in practice, clinical specialty,and source of knowledge on immunization practices. the questionnaire mainly contained three sections: knowledge of vaccinations for hepatitis a virus (hav), hbv, and varicella; current vaccination practices for the ibd group; and reasons for not recommending these vaccinations to patients with ibd. the questionnaire composed of 13 items specifically on the three vaccinations mentioned above for immunosuppressed patients with ibd. all questions were conducted based on recognized guidelines and were reviewed by 18 ibd experts. the questionnaire captured the frequency with which the respondents assessed patients with ibd for anti-hav/hepatitis b surface antigen (hbsag), hepatitis b core antibody, and hepatitis b surface antibody/ anti-hav levels, and acquired infection and immunization histories. whether the respondents recommended these three vaccines to the ibd group before treatment was also elicited.

Eligibility criteria:
inclusion criteria: * gastroenterologists were members of tertiary hospitals exclusion criteria: * pediatricians were excluded, as were retired gastroenterologists and those currently in training

Keywords: inflammatory bowel diseases， vaccination