bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and
      2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored
      polysomnography and in-laboratory polysomnography in pediatric patients.
    

Detailed description: 
      The purpose of the study proposed is twofold. First Investigators will test the feasibility
      of conducting portable sleep monitoring in school aged children using the Clevemed Sleepview
      (www.clevelmed.com), one of the smallest portable sleep monitors commercially available at 57
      grams. Second, Investigators will perform a direct comparison between the results obtained
      with this portable sleep monitor and those obtained from a standard-of-care in-laboratory
      attended sleep study performed at the St. Louis Children's Hospital Pediatric Sleep Center.
      These comparisons will be offered to the participants suspected of having sleep disordered
      breathing who present to the Washington University Pediatric Otolaryngology Department.
      Investigators will obtain the medical history and medications and results of the sleep study
      done at SLCH sleep lab from the medical record for research purposes.
    

Intervention name(s): Portable sleep monitor; In-laboratory Polysomnography
Intervention type(s): Device; Other
Intervention description(s): Type III at home portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis; Polysomnography testing will determine the sleep stages, apnea hypopnea index (AHI), blood saturation oxygen nadir (SPO2 nadir), and average blood oxygen saturation. A McGill Oximetry Score will also be calculated for the in-laboratory PSG.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Childhood OSA
Docetaxel, Doxorubicin, and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill
      more tumor cells.

      PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and
      prednisone together works in treating patients with advanced prostate cancer that has not
      responded to hormone therapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess prostate specific antigen response rate to docetaxel, doxorubicin hydrochloride,
           and prednisone in patients with hormone-refractory advanced prostate cancer.

      Secondary

        -  Assess if treatment with docetaxel, doxorubicin hydrochloride, and prednisone will
           improve health-related quality of life of these patients.

        -  Assess the toxicity of docetaxel, doxorubicin hydrochloride, and prednisone.

        -  Assess response rate in measurable disease.

      OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, doxorubicin hydrochloride IV
      over 15 minutes on days 1 and 8, and oral prednisone once daily on days 1-21. Treatment
      repeats every 21 days for at least 3 courses in the absence of disease progression or
      unacceptable toxicity.

      Quality of life is assessed at baseline, on day 1 of each course, after completion of 3
      courses, and at disease progression.

      After completing study treatment, patients are followed every 6 months for 1 year.

      PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
    

Intervention name(s): docetaxel; doxorubicin hydrochloride; prednisone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Prednisone; Docetaxel; Doxorubicin; Liposomal doxorubicin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent prostate cancer; stage III prostate cancer; stage IV prostate cancer; adenocarcinoma of the prostate
A Safety and Immunogenicity Study of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and
      Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants.
    

Detailed description: 
      This first-in-human study consists of 2 parts: 1) The main study, which is randomized,
      placebo-controlled, observer-blind; 2) A sub-study, which is open-label, uncontrolled,
      non-randomized study evaluating the safety, tolerability, and immunogenicity of MVA-BN-Filo
      and Ad26.ZEBOV administered in different sequences and schedules to healthy adult
      participants. The study consists of a Screening period (up to 28 days in the main study and
      up to 56 days in the sub-study), a vaccination period in which participants will be
      vaccinated at baseline (Day 1) followed by a boost on Day 15, 29 or 57, and a post-boost
      follow-up until all participants have had their 21-day post-boost visit (Day 36, 50 or Day
      78). The total duration of the study will be about 1 year for participants who received
      vaccine and about 3 months for participants who received placebo. Safety will be monitored
      during the study.
    

Intervention name(s): MVA-BN-filo; Ad26. ZEBOV; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): One 0.5 mL intramuscular (IM) injection of 1E8 (50%Tissue Culture Infectious Dose [TCID50]) on Day 1 (Groups 1 and 2), or on Day 29 (Group 3), or on Day 57 (Group 4), or on Day 15 (Group 5).; One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1 (Groups 3, 4 and 5), or on Day 29 (Group 1), or on Day 57 (Group 2).; One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 (Groups 1 and 3), or on Day 1 and 57 (Groups 2 and 4).
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Healthy; Ebola viruses; Ebola Viral Disease (EVD); Filoviruses; monovalent vaccine; Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector; Safety; Immunogenicity
Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables
Condition: Diabete Type 2; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The overall goal is to increase the knowledge that can be used for the development of food
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices
      for people. More specifically the primary purpose of this project is to evaluate effects in
      healthy humans on acute postprandial glucose regulation of plant based lipids. Due to the
      tight connection between cardiometabolic health and cognitive functions, a secondary issue is
      to investigate effects of test foods on cognitive test variables and mood parameters.
    


Intervention name(s): lipids
Intervention type(s): Dietary Supplement
Intervention description(s): Investigations of dose-response effects of 3 different doses of an bioactive plant based lipid consumed at breakfast, after overnight fasting. Total amounts of lipids in each test portion are 15g, and the lower doses are supplemented with a control lipid to sum upp to 15 g total lipids. A control product with15g control lipids and without active lipids is also included. The lipids are supplemented to a white wheat bread, corresponding to 50 g available starch. A White wheat bread portion without lipid supplementation is included as a well studied reference product.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Association Between Dermatoporosis and Fractural Risk
Condition: Dermatoporosis
Study type: Observational

Summary: 
      There is a need for new tools to identify patients who may have osteoporosis before a
      fracture occurs.
    


Intervention name(s): Dual X-ray absorptiometry (DMO) densitometry.
Intervention type(s): Diagnostic Test
Intervention description(s): Simple clinical examination with forearm inspection and palpation;
Radiological examination of BMD;
Calculation of the FRAX® score;
Fact sheet on patients with dermatoporosis, proposal of a topical treatment (cosmetic cream) and completion of the questionnaire specific to dermatoporosis
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Major patients who are to perform dual X-ray absorptiometry (DMO) densitometry.
Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and
      immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.
    


Intervention name(s): PRX002; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to test the safety and tolerability of single ascending
      doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent
      outpatients with major depressive disorder. This study will also characterize the
      pharmacokinetic profile of DVS SR in children and adolescents with major depressive disorder.
    


Intervention name(s): Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Intervention type(s): Drug
Intervention description(s): DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks.
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: MDD; Child; Adolescent; Pharmacokinetic; Outpatient; Pediatrics; Depressive Disorder; Major
NAET Screening for Food Allergy, Sensitivity and Intolerances Using IgE-Specific Antigen Test and NST- NAET®
Condition: Food Sensitivities; Headache; Backache; Indigestion; Eczema, Acne, Hives and Itching of the Skin
MeSH terms: Eczema; Hypersensitivity; Food Hypersensitivity; Headache; Dyspepsia
Study type: Observational

Summary: 
      Food allergy reactions cause various health disorders in sensitive people. These reactions
      may be IgE-mediated,cell-mediated, energy disturbance-mediated, or a combination of the
      three. Certain laboratory diagnostic procedures have been able to identify most IgE-mediated
      or cell-mediated food reactions, but so far there is no test available in traditional
      medicine to test the energy-mediated allergies and sensitivities. NAET® procedures have been
      able to identify food substances triggering to energ disturbances in sensitive people causing
      related health disorders. NAET uses one of the testing procedures called NST (Neuromuscular
      sensitivity testing).The efficacy of NST-NAET to screen food sensitivity will be evaluated in
      comparison with one of the well accepted, established, traditional medicine allergy testing
      known as the IgE-specific antigen test.
    

Detailed description: 
      Forty-two volunteers responded for an advertisement posted on the NAET web site and in the
      community college news bulletin board inviting them to take part in the study. They were
      asked to complete the NAET® Allergy Symptom-Rating (ASR) questionnaire upon arrival at the
      research center. Observing inclusion and exclusion criteria, a total of 32 subjects from both
      sexes with varied health problems were selected out of the forty-two who volunteered for the
      study. All 32 subjects were tested for 21 commonly used food substances via NST. Out of 32
      tested, 26 subjects tested positive for one item each, from the 21 items tested and six
      subjects tested positive for multiple items from the selected food list. The 32 subjects had
      a total of 50 positive NSTs out of 672 (21X32) tests performed. The items that produced
      positive results by NST were further evaluated via laboratory blood serum analysis for
      IgE-specific antigens. According to NST the percentage of observed total food reactions in
      this group of 32 was 7.44%. Soon after the completion of NST the laboratory technicians
      collected blood from 32 subjects for IgE-specific antigen study on 50 positively tested
      items. The IgE-specific antigen tests were found positive on a total of 49 out of 50 tests
      performed.
    

Intervention name(s): NAET Procedures
Intervention type(s): Procedure
Time perspective: Other
Keywords: NST-NAET testing; Food Ssensitivities; Eczema; Acne; Indigestion
Reducing Head Motion With Customized Head Mold in Young Children
Condition: Child Development; Adhd; Neuroimag
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and efficacy of a customized head mold for
      reducing head motion during MRI scanning in young children.
    

Detailed description: 
      Each participant completed a dedicated session for mock scanning before we acquired two sets
      of sMRI and fMRI scans. One scan set was collected using the head mold and the other without,
      and the scans were counterbalanced in order across participants. Using a specialized sMRI
      sequence embedded with vNAVs, we directly measured head motion during sMRI in order to more
      accurately evaluate the head mold's impact on structural metrics. To evaluate the feasibility
      and tolerability of the head mold, we concluded the scanning sessions with a brief interview
      that gauged participants' scanning experience and tolerance of the head mold. We investigated
      whether head molds would reduce head motion compared to standard scanning procedures and
      whether those reductions would result in improved data quality. We also tested the extent to
      which reductions in head motion impacted estimations of cortical volume and functional
      connectivity. Prior to data collection, we evaluated the noise dosage levels of the head mold
      condition, given the limited space available for additional hearing protection devices in the
      head coil while the head mold is on. We also assessed whether the head molds could balance
      head motion between typical and ADHD populations, and whether clinical variables such as ADHD
      diagnosis and trait anxiety, as determined by parent-reported dimensional measures, can
      predict head mold efficacy.
    

Intervention name(s): Caseforge headcase
Intervention type(s): Device
Intervention description(s): We used a custom-fitted styrofoam head mold designed to reduce head motion during MRI scanning.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of multiple oral (PO)
      ascending doses of NRX-1074 in normal healthy volunteers.
    

Detailed description: 
      NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy
      in animal models of affective disorders including major depressive disorder. The purpose of
      this study is to evaluate the safety and tolerability of multiple oral (PO) ascending doses
      of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in
      serum chemistry, hematology, and urinalysis, changes in physical examination findings,
      psychotomimetic findings and subject-reported symptoms.
    

Intervention name(s): Placebo; NRX-1074 375 mg; NRX-1074 500 mg; NRX-1074 750 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral administration of placebo consumption on Day 1; Single oral administration of 375 mg consumption on Day 1; Single oral administration of 500 mg consumption on Day 1; Single oral administration of 750 mg consumption on Day 1
Other intervention name(s): NRX-1074 single oral dose; NRX-1074 single oral dose; NRX-1074 single oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NRX-1074; NMDA Receptor Modulator; Major Depressive Disorder; Glycine Site Modulator
Role of Fat Tissue in Vitamin D Metabolism
Condition: Vitamin D; Adipose Tissue
Study type: Observational

Summary: 
      Vitamin D is a fat soluble vitamin that has important effects on calcium (including
      absorption of calcium from the diet) and bone metabolism. Vitamin D is known to be stored in
      fat tissue, and it is also present in the circulation. The purpose of this study is to
      investigate the relationship between levels of vitamin D in fat tissue and in blood.
    

Detailed description: 
      Although vitamin D is known to be stored in fat tissue, researchers are not sure about the
      role that fat tissue plays in vitamin D metabolism. This study will help develop the
      methodology necessary to further investigate the role of fat tissue in vitamin D metabolism
      and will assess the relationship between levels of vitamin D in fat tissue and in blood. 50
      subjects who are referred for gastric bypass surgery will be enrolled in this study. Subjects
      will complete questionnaires about their medical history, travel history and food intake.
      Prior to or during surgery, subjects will be asked to provide a blood sample for selected
      chemistries related to vitamin D metabolism. During gastric bypass surgery, the surgeon will
      collect small pieces of fat tissue from the fat under the skin and within the abdomen by
      surgical biopsy. These samples will be used to refine the methodology for determining the
      levels of vitamin D in blood and fat tissue and for comparing levels of vitamin D in various
      tissues.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients from Obesity Clinic
      
Keywords: Vitamin D; Adipose tissue; Metabolism
Comparison of Post-pinal Cord Injury (SCI) Locomotor Training Techniques
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background: Body weight supported (BWS) locomotor training improves overground walking
      ability in individuals with motor-incomplete spinal cord injury (SCI). While there are
      various approaches available for locomotor training, there is no consensus regarding which of
      these is optimal. The purpose of this ongoing investigation is to compare outcomes associated
      with these different training approaches.

      Subjects and Methods: Subjects with chronic motor-incomplete SCI have completed training and
      initial and final testing. Subjects were randomly assigned to 1 of 4 different BWS
      assisted-stepping groups, including: 1) treadmill training with manual assistance (TM), 2)
      treadmill training with stimulation (TS), 3) overground training with stimulation (OG), or 4)
      treadmill training with robotic assistance (LR). Prior to and following participation the
      investigators assessed:

        -  Walking-related outcome measures: overground walking speed, training speed, step length
           and step symmetry.

        -  Spinal cord reflex activity

        -  Electromyographic (EMG) associated with walking

      Hypotheses:

      In individuals with incomplete spinal cord injury (SCI):

        1. A 12-week period of body weight supported treadmill training with TS will produce
           improvements in walking function that are significantly greater than those produced by
           training with TM, OG, LR.

        2. TS training will be associated with greater changes to spinal reflex activity than will
           be observed in subjects trained with manual assistance or non-assisted stepping. Changes
           to spinal reflex activation will be such that this activity more closely resembles that
           observed in non-disabled (ND) individuals.

        3. Following participation in this walking regimen, EMG activity observed during walking in
           all groups will be more robust, more consistent and better coordinated than EMG measures
           obtained prior to training.
    


Intervention name(s): Locomotor training
Intervention type(s): Other
Intervention description(s): Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: task-specific training; walking; locomotion; function; body weight support; Individuals with motor-incomplete spinal cord injury