bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating Color Perception Under LED Red/Green and Green Dominant Light
Condition: Color Blindness, Acquired
MeSH terms: Blindness; Color Vision Defects
Study type: Observational

Summary: 
      The investigators are testing a Light-emitting Diode (LED) flashlight from First-Light™ USA
      called the Tomahawk MC Tactical Light to determine the range of colors people are able to see
      with these flashlights at night. The flashlight has been designed to reduce visibility of the
      user and uses a combination of green and red LED lamps to achieve this. In this study
      investigators wish to determine how well a subject can differentiate colors at night in a
      quantifiable manner. Investigators will use the Farnsworth Munsell 100 hue test which
      requires the user to put shades of red, green, blue and yellow into progressive color order
      which is scored according to the manufactures specifications.
    


Intervention name(s): White LED Flashlight; Red/Green Green Dominant LED Flashlight
Intervention type(s): Device; Device
Intervention description(s): white light setting; Green LED light dominant setting
Other intervention name(s): Tomahawk serial number TMC12420; Tomahawk serial number TMC12420, green dominant setting
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal color vision status
Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
Condition: Atopic Dermatitis; Plaque Psoriasis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to provide data on efficacy, safety, tolerability and PK of
      PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild
      to moderate plaque psoriasis.
    


Intervention name(s): PF-07038124 ointment; Vehicle ointment
Intervention type(s): Drug; Drug
Intervention description(s): PF-07038124 ointment at 0.01% with QD dosing for 6 weeks; Vehicle ointment with QD dosing for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atopic dermatitis, plaque psoriasis
Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial
Condition: Gestational Age; Birth Weight; Anaemia; Gestational Diabetes Mellitus; Type of Delivery
MeSH terms: Diabetes, Gestational; Birth Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators investigated the effects of a supervised maternal exercise training program
      (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health
      outcomes in a group of previously sedentary healthy women. A matched control group was
      assessed over the same time period. Given the fact that most studies in the field have used
      aerobic exercises, here the investigators largely focused on very light resistance, toning
      exercises.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Women in the intervention group were enrolled in three sessions/week of individually supervised, resistance exercise training performed over the second and third trimester of pregnancy (in total 26 weeks, ~80 training sessions). Heart rate (HR) was carefully and individually controlled (≤80% of age-predicted maximum HR value, 220-age) through a heart rate monitor during the training sessions. In brief, each session consisted of 35-40 minutes of exercise divided in a light intensity (≤60% maximal heart rate) warm-up period (~8 minutes), followed by toning and very light resistance exercises (~20 minutes) and a light intensity cool-down (~8 minutes) period. Resistance exercises were performed with barbells (≤3kg per exercise) or low-to-medium resistance bands (Therabands).
Allocation: Randomized
Primary purpose: Prevention
Investıgatıon of The Effıciency of Pulsed Electromagnetıc Field Therapy and Stretching Exercises
Condition: Muscle Injury; Pulsed Electromagnetic Therapy; Muscle Stretching Exercise
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      In this study, a total of 69 Wistar Albino rats were used, five of which were in the
      preliminary study. The preliminary study was planned to determine the ideal PEMF treatment
      time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF,
      INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the
      effects of the treatments. At the end of the experiment, genetic, histopathological, and
      immunohistochemical evaluations were made in the muscle tissue.
    

Detailed description: 
      Purpose: The aim of this study was to evaluate the efficacy of stretching exercise and the
      pulsed electromagnetic field (PEMF) method in the treatment of muscle injury (INJ).

      Methods: In this study, a total of 69 Wistar Albino rats were used, five of which were in the
      preliminary study. The preliminary study was planned to determine the ideal PEMF treatment
      time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF,
      INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the
      effects of the treatments. At the end of the experiment, genetic, histopathological, and
      immunohistochemical evaluations were made in the muscle tissue.
    

Intervention name(s): Exercise; Pulsed Electromagnetic Field Therapy
Intervention type(s): Other; Device
Intervention description(s): 5 day/week, two week, one session stretching exercises consisting of ten repetitions of one minute; 5 day/week, two week,two sessions consisting of 180 minutes
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Muscle Injury; TGF-Beta 1; Fibrosis
Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes
Condition: Nicotine Vaping; Nicotine; Vaping
Study type: Interventional

Summary: 
      This is a single-center, randomized, controlled, open-label, cross-over study with healthy
      adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two
      e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible
      cigarettes.

      In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral
      assessments), will be evaluated to provide further insights on product evaluation, craving,
      liking, puffing topography. The study will be conducted with three periods and six sequences
      in a cross-over design.

      This study is exploratory and there is no pre-specified hypothesis to be tested.
    

Detailed description: 
      The purpose of the study is to evaluate the nicotine pharmacokinetics (PK) profiles of two
      e-liquid variants used with the P4M3 Gen 2.0 e-cigarette versus cigarettes following a six
      minutes ad libitum use period. In addition, pharmacodynamic effects (PD), including
      subjective effects and related behavioral assessments, as well as human puffing topography
      (HPT) will be evaluated, to provide further insights on P4M3 Gen 2.0 product acceptance and
      product use. Safety will be assessed throughout the study.

      The aim is to evaluate if P4M3 Gen 2.0 can provide an acceptable alternative to smoking
      cigarettes in terms of both, nicotine delivery and sensorial satisfaction for current adult
      smokers who would otherwise continue smoking cigarettes.
    

Intervention name(s): CA35; CM35; Cig
Intervention type(s): Other; Other; Other
Intervention description(s): Nicotine concentration: 3.5 % e-liquid flavor: Tobacco; Nicotine concentration: 3.5 % e-liquid flavor: Menthol; Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Other intervention name(s): P4M3 variant CA35; P4M3 variant CM35
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Nicotine; Pharmacokinetics; Smoking; Cigarette; E-Cigarette
Improving Brain Function After Breast Cancer Study
Condition: Breast Cancer Survivors
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study will explore the feasibility and potential effects of a simple, home-based daily
      meditation intervention on breast cancer survivors' cognitive and psychological functioning
      as well as inflammatory regulation.
    

Detailed description: 
      This study will compare two home based 8-week interventions (Kirtan Kriya meditation vs.

      relaxing instrumental music listening) in 40 breast cancer survivors ages 21-75 who completed
      chemotherapy 3 months to 5 years prior.
    

Intervention name(s): Kirtan Kriya meditation; Music listening program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The program incorporates song with visualization and mudras, and is a multi-faceted, multisensory exercise that appears to engage several areas of the brain implicated in cognitive decline, yet is simple to learn and practice. The meditation includes a repeated Kirtan or song, a mudra or physical/motor component, and a visualization component. The meditation sound file will contain a user friendly introduction to the Kirtan Kriya meditation technique along with detailed instructions and meditation tracks. Three tracks will contain 12 minute guided meditations with the same female voice, and 2 with nature sounds, 2 without any additional sounds. Another 2 tracks will provide only the timing cues (1 with nature sounds, 1 without) so that the participant can conduct the meditation session without guidance if they chose.; The participants will receive audio files and an instruction sheet to facilitate their practice.
The audio tracks are 12 minutes in length and contain relaxing instrumental music from Mozart, Bach, Beethoven, Debussy, and Pachebel. Participants are instructed to sit comfortably with their eyes closed and listen to a track of their choice for 12 min daily, for 8 weeks and to record each session on their practice log.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Etanercept (Enbrel®) in Psoriasis - Pediatrics
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with
      Psoriasis.
    

Detailed description: 
      On enrollment, participants underwent randomization in a 1:1 ratio to receive placebo or
      etanercept during the initial double-blind period. Participants could enter an escape group
      and receive open-label etanercept until week 12 if, at or after week 4, their Psoriasis Area
      and Severity Index (PASI) score either increased by more than 50% over baseline and by a
      minimum of 4 points at one visit or increased by more than 25% and by a minimum of 4 points
      at each of two consecutive visits.

      During the open-label treatment period, all patients (including those who entered the escape
      group) received open-label etanercept. Participants who did not achieve PASI 50 at week 24 or
      PASI 75 at week 36 could discontinue the study or add topical standard-of-care therapy
      (low-to-moderate-potency topical corticosteroids) and continue to receive open-label
      etanercept until week 48.

      At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were randomly assigned
      to placebo or etanercept for 12 weeks in the withdrawal period. Participants in whom PASI 75
      was lost resumed open-label etanercept through week 48 in the re-treatment period.
    

Intervention name(s): Etanercept; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week; Placebo matching to etanercept administered by subcutaneous injection once a week
Other intervention name(s): Enbrel®
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric Psoriasis
Effects of LMWH in Healthy Subjects Treated With TB-402 and Effects of TB-402 in Healthy Subjects Treated With Warfarin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Administration of LMWH in healthy male subjects treated with TB-402 and administration of
      TB-402 in healthy male subjects treated with warfarin
    


Intervention name(s): LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects
Intervention type(s): Drug
Intervention description(s): Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Interaction with LMWH or warfarin
Post-conditioning to Reduce Infarct Size
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      When angioplasty (PTCA) and stenting of the blood vessels of the heart is the treatment for a
      Heart Attack, there is damage to the heart muscle that is caused by the sudden opening of the
      blood vessels. This is called "reperfusion injury". The cell death is due to inflammation and
      the generation of free radicals.

      The primary objective of this study is to determine if post-conditioning(four brief (30
      second) PTCA balloon inflations) reduces damage to the heart muscle. This will be measured by
      heart enzyme tests-CK measurements- and by cardiac MRI.
    


Intervention name(s): Post-conditioning
Intervention type(s): Procedure
Intervention description(s): The post-conditioning protocol consists of performing 4, 30-second PTCA balloon occlusions followed by 30 seconds of reperfusion for a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery and flow is restored. Following this protocol the vessel will be stented as part of usual practice for treatment of acute MI.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Reperfusion injury; Post-Conditioning; Infarct size
Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.
Condition: HIV Infections; Cognition Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the chemical efficacy and safety of intranasally administered peptide T on
      neurocognitive function in HIV seropositive individuals.

      Previous studies have shown that treatment with peptide T can result in cognitive improvement
      in HIV-infected patients.

      Patients are randomized to receive either peptide T or placebo for the first 6 months. All
      patients then receive open-label peptide T for approximately 6 additional months.
      Neuropsychologic tests are used to determine drug effects.
    


Intervention name(s): Peptide T; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex
Study to Evaluate the Effect of GSK1265744 on Cardiac Conduction
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to comply with the Food and Drug Administration (FDA)
      recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization
      effects through electrocardiographic evaluation. Therefore, this study will evaluate the
      effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead
      continuous digital data in healthy adults. This study will evaluate the effect of three doses
      of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to
      placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity
      of the study in detecting QTc change. This study consists of three treatment periods (each
      separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last
      dosing. The total duration of study including follow-up visit will be approximately 62 days.
      Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical
      assessments.
    


Intervention name(s): GSK1265744; GSK1265744 matching placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): White to slightly colored film coated tablet with unit dose strength of 30 mg and dose level of 150mg (5 tablets of 3 mg) administered orally every 12hours for 3 doses.; GSK1265744 matching placebo tablets administered orally every 12hours for 3 doses (5 tablets per dose).; Dull red, oblong, convex film coated tablets with unit dose strength of 400 mg administered orally as a single dose.
Intervention MeSH terms: Moxifloxacin; Cabotegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK1265744; HIV; placebo; cardiac repolarization; 12-lead ECG; moxifloxacin; QTc
Effectiveness and Safety of Inhaling Hypertonic Saline in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of inhaled hypertonic saline has been extensively documented in asthma,
      bronchiectasis, cystic fibrosis and COPD as method of bronchial challenge and sputum
      induction, but studies that evaluated others endpoints are required. The objective of this
      study was to analyse the effects of inhaling hypertonic saline compared with placebo with
      respect to functional exercise capacity, dyspnoea and quality of life. In a double-blind
      randomised parallel placebo-controlled trial, conducted at the Clínicas Integradas of the
      Evangelical Faculty of Paraná,sixty-eight patients (age 67 ± 6.5 years; FEV1 38.9 ± 16.2
      predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34), combined
      with a program of exercise, three times a week, for 8-weeks.
    

Detailed description: 
      Background: The use of inhaled hypertonic saline has been extensively documented in asthma,
      bronchiectasis, cystic fibrosis and COPD as method of bronchial challenge and sputum
      induction, but studies that evaluated others endpoints are required. Objective: To analyse
      the effects of inhaling hypertonic saline compared with placebo with respect to functional
      exercise capacity, dyspnoea and quality of life. Design and Setting: This was a double-blind
      randomised parallel placebo-controlled trial, conducted at the Clínicas Integradas of the
      Evangelical Faculty of Paraná. Methods: sixty-eight patients (age 67 ± 6.5 years; FEV1 38.9 ±
      16.2 predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34),
      combined with a program of exercise, three times a week, for 8-weeks. Results: After the
      8-weeks the treatment period, both groups showed significant changes in functional exercise
      capacity (p<0,001), dyspnoea (p<0,001) and quality of life. When compared both groups, there
      was a significant improvement in placebo group in functional exercise capacity (p<0,001).
      Conclusion: the present study concluded that inhaling HS reduces the functional capacity,
      compared to placebo and being associated with the appearance of coughs and bronchial spasms.
    

Intervention name(s): hypertonic saline
Intervention type(s): Other
Intervention description(s): inhaled hypertonic saline (at a dose of 5 ml of a 3% solution) three times a week, combined with a program of physical exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Hypertonic saline; Quality of life; Dyspnoea.
PharmacofMRI of Anxiolytic Medications (Pregabalin)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy
      controls to examine the acute effects of certain anxiolytic medications on brain function. In
      this case, the medication pregabalin will be used. The investigators hypothesize that
      pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala
      and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.
    

Detailed description: 
      Increased amygdala and insula activity have been implicated in neurobiological models of
      anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to
      decrease activation in these areas during the processing of emotional stimuli. This study
      aims to replicate those results but by using a different medication, pregabalin. An eventual
      aim of this study, in combination with future studies, is to evaluate the utility of fMRI as
      a tool to identify anxiolytic function in both established and novel compounds that may be
      used to treat anxiety.
    

Intervention name(s): Pregabalin 50mg; Pregabalin 200 MG; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan; One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan; One dose of matched oral placebo to be administered one hour prior to fMRI scan
Other intervention name(s): Lyrica; Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: anxiety; functional magnetic resonance imaging; fMRI; pregabalin; Lyrica
Cardiac Rehabilitation After Pacemaker Implantation
Condition: Bradycardia; Pacemaker
MeSH terms: Bradycardia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators assessed whether short-term cardiac rehabilitation following pacemaker
      implantation was enough to improve both physical function and quality of life.
    

Detailed description: 
      Exercise-based cardiac rehabilitation (CR) improves clinical outcomes in patients with
      cardiovascular diseases. However, few data exist regarding the role of early short-term CR in
      patients undergoing pacemaker (PM) implantation. The investigators assessed whether
      short-term CR following PM implantation was enough to improve both physical function and
      quality of life (QOL).
    

Intervention name(s): cardiac rehabilitation
Intervention type(s): Behavioral
Intervention description(s): cardiac rehabilitation after pacemaker implantation
Other intervention name(s): exercise-based cardiac rehabilitation: step-box, lower extremity recumbent ergometer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment