bioihbjkbjnl/mcl2 huggingface dataset:
Sleep-Disordered Breathing and PAP in Perinatal Depression
Condition: Sleep-disordered Breathing; Major Depressive Disorder
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The goal of this study is to understand the contribution of sleep-disordered breathing (SDB)
      to one of the most common and debilitating adverse pregnancy outcomes, perinatal depression.
      The study is a randomized trial to test the efficacy of positive airway pressure (PAP) on
      sleep and depression symptoms in perinatal women. Participants will be pregnant women with
      depression and sleep-disordered breathing. Participants will be randomly assigned to receive
      either PAP therapy (PAP group) or treatment as usual within obstetrics (TAU group). Mood and
      sleep assessments will be completed at baseline, after 1 week of enrollment, and monthly
      thereafter through 12 weeks postpartum. Cortisol will be measured using saliva collection at
      baseline and again 8 weeks later.
    


Intervention name(s): Positive Airway Pressure (PAP)
Intervention type(s): Device
Intervention description(s): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.
Other intervention name(s): CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of OPC-262 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in
      patients with type 2 diabetes by repeated administration orally for 52 weeks.
    


Intervention name(s): OPC-262
Intervention type(s): Drug
Intervention description(s): OPC-262 5 mg will be orally administered once daily fro 52 weeks.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gene Expression Monitoring of Mononuclear Cells (MNC) Subpopulations and Immunological Status and Metabolome Defining of Healthy Population
Condition: Gene Expression; Metabolomics; Immunological Status
Study type: Observational

Summary: 
      Study on healthy volunteers is focusing on analysis of transcriptome profile fluctuations in
      healthy population in three mononuclear cell types (CD4+ cells, CD56+ cells and CD4+CD25+
      cells)and should provide a reference for comparison with transcriptomic data of any disease
      state.Furthermore, metabolome and immunological status are defined on same samples.
    


Intervention name(s): Blood sampling
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy population
      
Keywords: MNC subpopulations; Gene Expression; Metabolomics; Immunological Status
Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes
Condition: Uterine Myoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The aim of this study protocol will be to compare the technique of intracorporeal
      morcellation using reusable electronic device (standard technique) with a technique of
      removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and
      scalpel blade or with power morcellator used inside the bag itself.
    


Intervention name(s): Extracorporeal morcellation; Intracorporeal morcellation
Intervention type(s): Procedure; Procedure
Intervention description(s): patients treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself; patients treated with standard intracorporeal morcellation, using reusable electronic device
Other intervention name(s): protected morcellation; morcellation in endobag; Power morcellation; Standard intracorporeal morcellation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Myomectomy; Laparoscopic myomectomy; Morcellation; Risk of dissemination; Uterine Sarcoma; Parasitic myoma
Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine that continuous glucose monitoring systems (CGMS)
      with intensive real time feedback about diabetes management from medical staff to the patient
      will affect motivation and/or behavior, in adolescents with poorly controlled type 1
      diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack
      thereof) and patients' sense of self-efficacy will influence their stage of change and
      potentially glucose levels.
    

Detailed description: 
      Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c > = 8 % who are also
      naive to CGMS use will be recruited from the diabetes outpatient population followed at
      Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric
      Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20
      subjects will be assigned to the control group.
    

Intervention name(s): CGMS Device; No Device
Intervention type(s): Device; Other
Other intervention name(s): Continuing Glucose Monitoring Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Type 1 Diabetes; Adolescents; Glucose Monitoring
Proton Pump Inhibitors and Dysbiosis in Cirrhosis
Condition: Cirrhosis; Healthy
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether the use of medications that suppress acid in
      your stomach can change the composition of your bowel bacteria.
    


Intervention name(s): Omeprazole
Intervention type(s): Drug
Intervention description(s): 20mg PO BID for 20 days
Intervention MeSH terms: Omeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: PPI withdrawal (decompensated patients only) and PPI initiation (compensated and decompensated patients)
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children
Condition: Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital
Study type: Interventional
Phase: Phase 3

Summary: 
      Intranasal dexmedetomidine has shown to be an effective sedative when used prior to
      anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in
      previous study and it produced satisfactory sedation in more than 50% of the children at the
      time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg
      with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain
      satisfactory sedation prior to anaesthetic induction when higher dose is used.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sun Protection Factor Assay (341/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987517; SFP Control
Intervention type(s): Drug; Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
(Formulation Code: Z43-094); Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Adherence With Fixed Versus Unfixed Glaucoma Therapy
Condition: Primary Open-angle Glaucoma; Ocular Hypertension; Exfoliation Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Exfoliation Syndrome
Study type: Observational

Summary: 
      A 6-month, parallel, non-interventional trial investigating the level of adherence and the
      impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with
      latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed
      combination therapy once in the evening. All patients participating in this observational
      study will be monitored for their adherence with the use of Medication Event Monitoring
      System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with
      selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This
      study will monitor objectively, for the first time, adherence and intraocular pressure
      control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact of
      dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients who use latanoprost/timolol fixed combination therapy with once-a-day dosing
        in the evening

        All patients already treated with timolol twice daily and latanoprost once in the evening
      
Keywords: Glaucoma; Adherence; Fixed combination therapy
Effects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain
Condition: Chronic Pain; Arthritis Hand; Opioid Use
MeSH terms: Arthritis; Chronic Pain
Study type: Interventional

Summary: 
      The aim of this run-in design, feasibility study is to assess outcomes (including opioid-use,
      pain intensity, emotional function, and general physical function) for an augmented reality
      illusion therapy in participants with chronic hand joint pain due to arthritis.
    

Detailed description: 
      This is a run-in design, feasibility study that uses the enrolled participants as their own
      control. After consenting to join the study, for the first 30 days, participants will be on
      their current Standard of Care (SoC). Then, for the next 30 days, the same group of
      participants will use the Nottingham digital treatment daily. Pre- and Post-SoC and Treatment
      period measures of opioid use and pain, quality of life measures will be administered and
      measured. Additionally, for qualifying participants, Pre- and Post-treatment functional
      Magnetic Resonance Imaging (fMRI) scans will be performed to assess how Nottingham AR therapy
      affects neuroplastic changes in the supraspinal pain network associated with the therapy
      sessions.
    

Intervention name(s): Standard of care; Nottingham AR smartphone app with active intervention
Intervention type(s): Other; Device
Intervention description(s): Standard of care as prescribed by healthcare provider.; AR software treatment delivered by smartphone app and developed by VRx Medical (VRx) using established principles of illusion therapies (e.g. mirror therapy) for pain management.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Augmented Reality; Smartphone application; Digital Therapeutic
Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
Condition: Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study was to assess the long-term safety and tolerability of
      alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl
      glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other
      lipid-modifying therapies (LMTs).
    


Intervention name(s): Alirocumab; Placebo Matched to Alirocumab
Intervention type(s): Drug; Drug
Intervention description(s): Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody; Placebo matched to alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
Other intervention name(s): REGN727; SAR236553; PRALUENT
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Establishing a Normative Database in Pediatric Population of the Head-mounted visuALL Field Analyzer
Condition: Visual Field Defect, Peripheral
Study type: Observational

Summary: 
      The goal of this study is to determine reference values of the VisuALL Field Test in
      pediatric population. Standard Automatic Perimetry (SAP) is the gold standard test for the
      evaluation of different diseases of the visual pathway like glaucoma. Its main goal is to
      measure the differential light sensitivity at several locations in the central field of
      vision. Nevertheless, the accuracy of the current devices is limited by several factors such
      as the inherent inconsistency of the psychophysical test, stressful examinations and
      frequency of testing.

      Several devices have been developed since the advent of the Octopus Perimeter and the
      Humphrey Field Analyzer (HFA) in an effort to improve the early detection of glaucoma.
      Several of these visual field test variants are implemented using laptops, iPads, and virtual
      reality headsets. These modalities bring portability but lack fixation methods, environmental
      control, and hardware standardization. These deficiencies may limit their wide usage.

      The main goal of this study is to develop an initial pediatric reference database of a novel
      visual field test ecosystem that takes advantage of a Head Mounted Device (HMD).
    

Detailed description: 
      This is a cross-sectional observational study. The primary endpoint of the study will be at
      the end of the recruitment phase.

        -  Participants that qualify for the study will be invited to a clinical site of the
           Vanderbilt Eye Institute or equivalent testing space and best corrected visual acuity
           will be checked with standard Snellen Acuity chart.

        -  Once vision is confirmed to meet study requirements, the child will be instructed on how
           to use the headset.

        -  The test will be generated and participant will complete various testing strategies
           including suprathreshold, full threshold and individual point testing and possibly other
           strategies for frequency of seeing curves.

        -  Patient with pathology may be confirmed with formal standard of care visual field
           testing

        -  Short survey will be administered to inquire on ease of device use

        -  Data will be submitted for analysis
    

Intervention name(s): VisuALL Field Analyzer; Humphrey Field Analyzer
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Each participant will conduct a visual field test with the visuaALL headset.; Each participant will conduct a standard of care Humphrey Visual Field.
Other intervention name(s): visual field testing strategy, head mounted device, Olleyes; standard of care visual field test
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Population will be healthy children recruited. All ethnicities will be included and both
        genders.
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating (821/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after
      exercise compared to the full coverage observed prior to exercise
    


Intervention name(s): BAY987517
Intervention type(s): Drug
Intervention description(s): Sunscreen formula Y65-158
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Condition: Hepatitis B; Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This exploratory study is designed to determine the early viral kinetic profile during
      treatment with telbivudine or entecavir at multiple time points over 12 weeks.
    


Intervention name(s): Entecavir; Telbivudine
Intervention type(s): Drug; Drug
Intervention description(s): Entecavir 0.5 mg once daily for 12 weeks.; Telbivudine 600 mg once daily for 12 weeks.
Intervention MeSH terms: Entecavir; Telbivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HBeAg-positive, chronic hepatitis B; telbivudine; entecavir; viral kinetics
Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study design has two components: 1) a cross sectional assessment of brain connectivity
      and response to pain in healthy controls and demographically matched fibromyalgia patients,
      and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to
      either CBT (Cognitive Behavioral Therapy) or a Disease Education condition.

      The investigators will evaluate a group of fibromyalgia patients who will receive CBT
      treatment once a week for 8 weeks, for a total of 8 treatments. Baseline data from these
      patients will be compared to results from pain-free controls and a group of education program
      controls.

      Participants will undergo experimental pain assessments as well as brain neuroimaging.
    

Detailed description: 
      Investigators propose to use fMRI (functional Magnetic Resonance Imaging) to study CNS pain
      processing during the anticipation and experience of acute pain in individuals with FM and
      healthy controls. Investigators will recruit patients who are diagnosed with FM as well as
      healthy controls. After the baseline visit, FM participants will be randomly assigned into
      the CBT or control condition (Education). Overall, FM Participants will attend 8 treatment
      visits, and 6 assessment visits (two at baseline, one at mid-treatment, two at the end of
      treatment, and one at 6 months post-treatment). These assessment visits include a total of 3
      fMRI sessions (at baseline, mid-treatment, and end of treatment). Healthy Controls will
      undergo the same baseline procedures as the FM subjects but will not attend any of the
      treatment or follow up assessment visits. Findings from this research will provide important
      information about catastrophizing's CNS (Central Nervous System) correlates.
    

Intervention name(s): Cognitive Behavioral Therapy; Disease Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.; Providing information about fibromyalgia, including its potential causes and management approaches.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which
      is a drug that lowers blood sugar. The study will look at how the body processes LY900014,
      and the effect of LY900014 on blood sugar levels following a standard meal. For each
      participant, the study will consist of 4 periods and will last approximately 12 weeks from
      screening to final study follow up.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Biological; Biological
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585; Humalog
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on
      the pharmacokinetics of AZD9742.
    


Intervention name(s): AZD9742; Diltiazem; ketoconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL; On Day 7, a single 150 mg IV dose, coadministered after the morning dose of ketoconazole; Orally, daily beginning on Day 4 for 14 consecutive days; 200 mg, orally, every 12 hours starting on Day 4 for 10 consecutive days in which on Day 13 only the morning dose will be administered
Other intervention name(s): Myoderm
Intervention MeSH terms: Ketoconazole; Diltiazem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open label; 2-consecutive-group; 2-period; 1-sequence crossover study