bioihbjkbjnl/mcl2 huggingface dataset:
Real World Perspectives on Advancements in Hearing Aid Technology
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      This study will compare different microphone technologies in a noisy environment when the
      dominant speaker is at the front, back, left, or right side of the listener.
    

Detailed description: 
      Understanding speech in a noisy environment can be difficult for people with hearing loss
      even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e.,
      directional micro-phones, noise reduction, noise cancelers) to try to improve the
      signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening
      situations.

      This study is evaluating different microphone technologies to determine listening effort when
      speech is to the back or side of the listener in noisy environment.
    

Intervention name(s): Phonak Audeo previous generation hearing aids; Phonak Audeo Lumity hearing aids
Intervention type(s): Device; Device
Intervention description(s): Receiver-in-canal (RIC) hearing aids with universal earpieces; Receiver-in-canal (RIC) hearing aids with universal earpieces
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Impact of Vitamin D on 25-hydroxyvitamin D Levels and Physical Function
Condition: Vitamin D Deficiency; Sarcopenia
MeSH terms: Sarcopenia; Vitamin D Deficiency
Study type: Interventional

Summary: 
      This one-year study will test the hypothesis that supplementation with vitamin D will improve
      lower extremity muscle performance in older men and women with vitamin D insufficiency.
    

Detailed description: 
      Vitamin D may have favorable effects on muscle but evidence is mixed. It appears that
      subjects with low starting levels of 25-hydroxyvitamin D (25OHD) who receive adequate doses
      of vitamin D are the most likely to benefit. Vitamin D supplements are being widely
      recommended, however the amount of vitamin D needed to achieve the desired level of
      25-hydroxyvitamin D in the circulation varies widely among individuals. In this randomized,
      placebo-controlled trial, we will determine whether treating older adults with low starting
      25OHD levels for one year with up to 1600 IU per day of vitamin D3 will improve muscle
      performance (e.g., lower extremity muscle power) and reduce muscle wasting (defined as
      reducing nitrogen excretion). Subjects in the vitamin D group will initially take 800 IU of
      vitamin D3 daily. If they have not achieved the desired level of 70 nmol/L after 4 mo, their
      dose will be doubled to 1600 IU per day for the remainder of the one-year study. The maximal
      dose of vitamin D3 to be taken in this study,1600 IU per day, is lower than the current safe
      upper limit of 4,000 IU per day set by the Institute of Medicine. Up to 100 healthy men and
      women, age 60 years and older will participate in this study. This investigation should
      increase our understanding of the impact of supplemental vitamin D on muscle performance.
    

Intervention name(s): vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Dose for intervention arm is 800 IU/day for first 4 months. At 4 months, if vitamin D level <70 nmol/L, a second 800 IU capsule will be added to regimen (total of 1600 IU/d) for remainder of study.; Those in the placebo group will receive 1 capsule for first 4 months. At 4 month visit, one capsule will be added to regimen to be taken throughout the remainder of the study.
Other intervention name(s): cholecalciferol; microcystalline cellulose
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: vitamin D; muscle performance; falls
Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the
      assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.
    

Detailed description: 
      Single-centre, open-label, randomised, two-way crossover study in healthy young male and
      female volunteers. The study was to consist of 2 treatment periods separated by a washout
      period of 14 days or more. In one period, subjects were to receive a single-dose of 25 mg BIA
      9-1067 with a single-dose of racemic 25 mg warfarin. In the other period, a 25 mg warfarin
      single-dose was to be administered alone.
    

Intervention name(s): BIA 9-1067; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): BIA 9-1067 25 mg; Warfarin 25 mg
Other intervention name(s): OPC, Opicapone; Varfine®
Intervention MeSH terms: Opicapone; Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease (PD); BIA 9-1067; Opicapone
Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+
      T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are
      needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic
      approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization
      of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2
      beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by
      autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in
      humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1
      Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and
      autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or
      humoral markers of the disease (such as serum miRNA).
    


Intervention name(s): Blood samplings
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Family-based Outcome Results
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Many obesity related risk factors are strikingly apparent in minority populations.
      Mexican-American children have the highest rates of overweight. The goals of this study are
      to: 1) test the acceptability of a 14-week family-based intervention with 3-5 year old
      children and their parents; 2) Estimate the effectiveness of a 14-week family-based
      intervention designed to show smaller changes, on average, in BMI appropriate for growth; 3)
      estimate the effectiveness of a 14-week family-based intervention designed to produce changes
      in television viewing, physical activity, fat, fiber, and fruit and vegetable intake in 3-5
      year old Latino children and their parents at post-intervention and Year 1 follow-up.
    


Intervention name(s): behavioral intervention; Obesity prevention intervention trial
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Families were randomized to a 14-week family based obesity prevention intervention or a 14-week general health intervention; Families were randomized to a 14-week obesity prevention intervention or a 14-week general health intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: childhood obesity; minorities; diet; physical activity; parents
A Study of SHR-1316 and Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of SHR-1316 in combination
      with Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients
    


Intervention name(s): 1.Experimental: A (Part 1): Fluzoparib and SHR -1316; 2.Experimental: B (Part 1): Fluzoparib and SHR -1316; 3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).; 2．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).; 3．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
Intervention MeSH terms: Fluzoparib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chronic Sleep Restriction and Driving
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Young subjects and patients with nocturnal respiratory disorders are frequently involved in
      sleep-related accidents. This study assess the impact of chronic sleep restriction (4 hr of
      sleep during 5 days) or total sleep deprivation in young or mature healthy subjects or
      snorers on simulated driving, objective and subjective sleepiness and objective and
      subjective cognitive performances. The effects of recovery night on these parameters are also
      assessed.
    

Detailed description: 
      Principal objective :

      To determine whether chronic sleep restriction affects more snorers driving performances than
      healthy subjects' driving performances.

      To determine whether chronic sleep restriction affects more young people driving performances
      than mature subjects' driving performances.

      Secondary objective :

      To determine whether chronic sleep restriction affects more snorers reaction time performance
      and sleepiness than non snorers subjects'.

      To determine whether chronic sleep restriction affects more young people reaction time
      performance and sleepiness than mature subjects'.

      To determine how age and snoring intensity affects the degradation of performance over the 5
      days of sleep deprivation.

      To determine age-related changes in the time course of sleepiness during 5 days of chronic
      sleep restriction.

      To compare the impact of total sleep or chronic sleep restriction on driving performances
      according to the age and snoring intensity.

      To determine recovery facilities to chronic sleep restriction according to the age and
      snoring intensity.

      Study plan :

      G2: Group of subjects:

        -  patients

        -  controls

      B1: Baseline normal night:

      One night of normal sleep

      A2: Acute sleep deprivation:

      Night 1: night of total sleep deprivation Night 2: night of sleep recovery

      C6: Chronic sleep deprivation:

      Night 1 to 5: nights of sleep restriction Night 6: night of sleep recovery

      Experimental plan : S20 <G2> *B1 * A2 *C6
    

Intervention name(s): Chronic sleep restriction and driving simulator
Intervention type(s): Other
Intervention description(s): One night of normal sleep
Driving simulator
Night 1: night of total sleep deprivation
Night 2: night of sleep recovery
Night 1 to 5: nights of sleep restriction
Driving simulator after night 1 to 5
Night 6: night of sleep recovery
Driving simulator
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Age, Snoring, Driving simulator, Sleep deprivation, chronic sleep restriction, objective and subjective sleepiness
Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an
      absence of signs and symptoms of the disease. However, the optimal way of reaching this goal
      is not known.

      Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a
      number of advantages over other advanced imaging techniques such as magnetic resonance
      imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a
      short period of time. However, the additional benefit of using this modality in terms of
      patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US
      leads to better care for RA patients.

      This study will assess if the use of a treatment strategy incorporating information from
      ultrasonography assessment will allow for better outcomes of patients with RA, than a
      strategy based on clinical and laboratory assessments alone.
    


Intervention name(s): Ultrasonography
Intervention type(s): Device
Intervention description(s): Standardized ultrasonographic assessment of 32 joints, assessed for both grey scale synovitis and power doppler signal, at each visit. Dose escalations based on DAS response in combination with change in US score. All joints with US Power Doppler signal are targets for intra articular injections.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; ultrasonography; remission; imaging remission; tight control; treat to target
Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
Condition: Diabetic Retinopathy; Macula Edema
MeSH terms: Macular Edema; Diabetic Retinopathy; Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment
      for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need
      of repeated injections, which carries both economic and compliance problems to the
      patients.there is a growing evidence that recognises the effectiveness of the use of
      micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a
      subthreshold laser that is above the threshold of biochemical effect but below the threshold
      of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is
      available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The
      current study was conducted in order to compare the efficacy of both MPL techniques in the
      treatment of center involving DME.
    

Detailed description: 
      This was a prospective randomized comparative study that included 30 eyes of 15 patients with
      bilateral DME. The patients were recruited from the Retina Clinic at Kasr Al Ainy Hospital,
      Cairo University. The study's protocol was reviewed and approved by board of the
      ophthalmology department, Cairo University, and was in concordance with the tents of
      Declaration of Helsinki. Eligible patients were informed about the study's objectives,
      methodology, risks and benefits. A written informed consent was obtained from every patient
      included in this study.Preliminary examination was in the form of slit-lamp examination,
      fundus examination, intra ocular pressure measurement, and best corrected visual acuity
      (BCVA) measurement. A spectral domain optical coherence tomogram (OCT) scan was performed to
      all patients before treatment to measure the central retinal thickness (CRT). The eyes were
      randomized into two groups; one eye (right eye) of each patient was treated with 577-nm
      yellow MPL and the other eye (left eye) of the same patient with Infrared 810-nm diode MPL.
      Changes in the BCVA and CRT were measured after treatment at 1 and 3 months of follow up.
    

Intervention name(s): Yellow micro-pulse laser; Diode micro-pulse laser
Intervention type(s): Device; Device
Intervention description(s): applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea; applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: micro-pulse laser; trans-foveal
Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
Condition: Pulmonary TB
MeSH terms: Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, double-blind, randomized clinical trial to evaluate the safety,
      tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the
      two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM
      injections in healthy adult subjects (aged 18 - 55).
    

Detailed description: 
      Subjects will receive a total of two doses administered IM on Days 0 and 56. Subjects will be
      monitored for approximately 421 days (one year following the last study injection), including
      safety laboratory analyses done just prior to and 7 days following each study injection.
      Tears and nasal swabs will be obtained for exploratory antibody analysis at Days 0, 70, and
      224. Blood samples will be obtained for immunological assays (secondary and exploratory) at
      Days 0, 7, 14, 56, 63, 70, 84, and 224).
    

Intervention name(s): ID93 + GLA-SE
Intervention type(s): Biological
Intervention description(s): The single-vial lyophilized vaccine will be reconstituted with WFI. For the two-vial presentation, the lyophilized ID93 will be reconstituted with WFI and mixed with liquid GLA-SE.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine, recombinant, adjuvant, GLA-SE, ID93
A Study of Tirzepatide 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: 
      This is a study for participants with type 2 diabetes mellitus. The main purpose of this
      study is to learn more about how tirzepatide, semaglutide and placebo affect the body's
      ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks,
      including a 28-week treatment period.
    


Intervention name(s): Tirzepatide; Semaglutide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Yoga for Stress and Mental Health
Condition: Physiological Stress; Psychological Distress; Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study looks at an 8-week hatha yoga intervention for women reporting high levels of
      stress, a risk factor for various forms of psychopathology.
    

Detailed description: 
      Yoga practice appears to reduce stress and associated emotions. Specifically, yoga has been
      associated with significant decreases in depression, anxiety, and perceived stress. These
      findings underscore the promise of yoga practice for improving mental health in women prone
      to stress.

      This study aims to examine the feasibility, acceptability, and efficacy of an eight-week
      Hatha Yoga intervention for improving stress and mental health. To this end, the
      investigators will recruit 40 women high in stress to receive an 8-week hatha yoga
      intervention consisting of two weekly 90-minute sessions. At baseline and at
      post-intervention, participants will undergo several cognitive, emotional, and behavioral
      assessments, followed by a relaxation time. Primary feasibility outcomes will be the time
      required to recruit 40 participants, the number of screen failures, participant retention and
      participant adherence to the study protocol. Acceptability will be evaluated with
      questionnaires and an interview during the final visit. Primary efficacy outcomes will be
      group differences in pre- to post-intervention change in perceived stress and various mental
      health parameters.
    

Intervention name(s): Hatha Yoga
Intervention type(s): Behavioral
Intervention description(s): The yoga intervention will last eight weeks and include two 90-minute sessions each week. Each yoga session will consist of the same series of 26 Hatha yoga postures, two breathing exercise, and two savasanas (i.e., a resting/relaxation posture), in a room heated to 104 degrees Fahrenheit, which aids in safe muscle stretching. Each participant will be given a yoga studio scan card valid for two months, and, like all yoga studio members, they will be required to scan their card prior to their yoga class.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133)
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy, tolerability, and effect on the quality of life of
      infliximab in adults with moderate-to-severe psoriasis who are resistant to etanercept after
      12 weeks of treatment or have failed 24 weeks of treatment with etanercept. Infliximab will
      be administered as an intravenous infusion of 5 mg/kg at Baseline (Week 0), Visit 3 (Week 2),
      Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
    


Intervention name(s): Infliximab
Intervention type(s): Biological
Intervention description(s): Infliximab 5 mg/kg IV infusion.
Other intervention name(s): Remicade, SCH 215596
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in ART-Naive & First Switch Patients
Condition: Drug-induced Hypotension
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Hypotension does not occur with Maraviroc at a dose of 600 mg/day
    

Detailed description: 
      A qualitative description of orthostatic hypotension in patients receiving once daily
      Maraviroc at 600 mg with Epzicom measured by a validated questionnaire
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HIV impacted individual on therapy with once daily Maraviroc
Study to Investigate ADME of 14C Labeled SLV334 After an i.v. Infusion
Condition: Pharmacology, Clinical
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the absorption, distribution, metabolism and excretion after
      giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be
      determined.
    


Intervention name(s): SLV 334
Intervention type(s): Radiation
Intervention description(s): 2000 mg via i.v. solution
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 14C labeled ADME (Aborption Distribution Metabolism and Elimination) study; Phase I