bioihbjkbjnl/mcl2 huggingface dataset:
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Condition: Nasal Polyps; Chronic Rhinosinusitis
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall purpose of this study is to evaluate the safety, efficacy, and durability of
      response of omalizumab in an open-label setting in adult participants with chronic
      rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase
      III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for
      enrollment in the study at, or within 28 days after, the Week 24 visit of Studies
      GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants
      will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment
      observation phase of the study. Baseline in this OLE study is defined as the last
      pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline
      of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24
      inclusive will come from Studies GA39688/GA39855.
    


Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.; Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety of GH001 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate the safety of GH001 (containing
      5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in
      healthy volunteers.

      The study will evaluate single, ascending doses of GH001 in Part A and an individualized
      dosing regimen of GH001 in Part B.
    


Intervention name(s): 5 Methoxy N,N Dimethyltryptamine
Intervention type(s): Drug
Intervention description(s): GH001 administered via inhalation
Other intervention name(s): GH001; 5-MeO-DMT
Intervention MeSH terms: N,N-Dimethyltryptamine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A: Dose ranging in four dose groups Part B: One group with individualized dosing
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers; 5-MeO-DMT; 5-methoxy-dimethyltryptamine
Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this dual phase cross-sectional, controlled and prospective, open label,
      exploratory study is to determine the general characteristics of visuospatial exploration and
      its neural substrate in subjects with Parkinson's Disease (PD) and to explore the impact of
      professional art therapy intervention in a cohort of subjects with Parkinson's Disease on
      visuospatial exploration, visuomotor integration, neuropsychological and emotional sphere,
      quality of daily living and motor symptoms.
    


Intervention name(s): PAT sessions
Intervention type(s): Behavioral
Intervention description(s): PD subjects will be tested twice, that is, within four weeks before (Baseline) and after the completion of 9 PAT projects (Follow up).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Art Therapy
Role of Interleukin-1 in the Regulation of Muscle Derived Interleukin-6 During Exercise
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      Aim: Evaluate the regulation of muscle derived Interleukin-6 (IL-6)during exercise and in
      particular whether it is regulated by the Interleukin-1 (IL-1) system.

      Rationale: It has been shown that IL-1 antagonism improves glycemia and insulin secretion in
      patients with type 2 Diabetes. However, IL-1 antagonism also decreases IL-6 levels. The
      effect if IL-6 on the glucose metabolism has been unclear in the past and subject to intense
      debate, with recent evidence indicating a beneficial role in regulating glucose metabolism.
      However little is known about regulation of muscle-induced IL-6 produced during exercise. It
      is therefore our aim to investigate whether exercise induced increases in IL-6 are dependent
      on the IL-1 system. If IL-1 antagonism does decrease IL-6 and along with it, the beneficial
      potential of IL-6, this may require additional medication like IL-6 substitution or
      dipeptidyl peptidase-IV (DPP-IV)antagonists.

      In addition, the investigators will assess the effect of IL-1 antagonism on insulin and
      Glucagon like peptide-1 (GLP-1) secretion as well as muscle soreness,fatigue and vascular
      function in response to an acute exercise bout.
    

Detailed description: 
      This is a randomized placebo-controlled, double blind, cross-over, proof-of-concept study.

      The study will consist of one screening visit followed by 3 study visits. During the first
      two study visits, the subjects (20 apparently healthy, lean men) will perform a submaximal
      exercise bout on a treadmill for 60 minutes. Subjects will be randomly assigned into two
      groups consisting each of 10 subjects receiving study medication in a double-blinded, crossed
      over manner.
    

Intervention name(s): IL-1Ra; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg, s.c, once only; 100mg, s.c., once only
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: IL-1; IL-6; Inflammation
The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497
Condition: Respiratory Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of CKD-497
    


Intervention name(s): CKD-497 200mg; CKD-497 300mg; CKD-497 placebo; Comparator; Comparator placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): CKD-497 200mg; CKD-497 300mg; Placebo of CKD-497; Comparator; Comparator placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute upper respiratory infection; Acute bronchitis
Influence of Ambient Temperature on Resting Energy Expenditure of Healthy Adults
Condition: Resting Energy Expenditure
Study type: Interventional

Summary: 
      The aim of this study is to investigate the influence of four different ambient temperatures
      (18, 22, 28, 38°C) on the resting energy expenditure of healthy adults by respiratory gas
      analysis. It is assumed that the resting energy expenditure is higher at 18°C and 38°C than
      at the temperatures in between.
    

Detailed description: 
      In a crossover-design, 32 healthy men and women participate in four interventions. Each
      intervention includes a measurement of the resting energy expenditure by respiratory gas
      analysis at a different ambient temperature (18,22, 28 and 38°C). During this time body core-
      and surface temperature are assessed, as well as body composition via bioelectrical impedance
      analysis. For each participant the four individual study days take place in a randomized
      order on consecutive weekdays within a week.
    

Intervention name(s): Respiratory analysis at cold temperature; Respiratory analysis at room temperature; Respiratory analysis at thermoneutral temperature; Respiratory analysis at hot temperature
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Respiratory analysis at an ambient temperature of 18°C; Respiratory analysis at an ambient temperature of 22°C; Respiratory analysis at an ambient temperature of 28°C; Respiratory analysis at an ambient temperature of 38°C
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Resting energy expenditure; Resting metabolic rate; Ambient temperature; Environmental temperature
Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving
Condition: Cannabis
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking
      Cannabis use disordered participants. Participants will then undergo either active, or sham
      rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.
    

Detailed description: 
      Our primary aims are to determine the effect of a single session of 10 Hz L DLPFC rTMS on
      cannabis cue induced craving (Aim1), and behavioral tasks of impulsive decision making
      (Aim2), in non-treatment seeking individuals with Cannabis Use Disorder. The aims of the
      study will be accomplished by performing a double-blind, sham-controlled crossover trial.
      Non-Treatment seeking individuals with CUD will be recruited through media advertisements, as
      well as via a pre-established database of non-treatment seeking individuals who have
      participated in previous Cannabis trials and agreed to be re-contacted. Interested
      individuals will undergo a brief phone screen to determine if they meet general
      inclusion/exclusion criteria, and if so will be invited to meet with study personnel in order
      to sign informed consent, and undergo a screening visit. There will then be two experimental
      visits separated by at least one week. During each of these visits participants will undergo
      either a real, or sham rTMS treatment, as well as a cannabis cue Paradigm. Data on craving as
      well as on impulsive decision making will be collected before and after each treatment.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS); Sham Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): rTMS will be delivered at 110% rMT to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.; rTMS will be delivered via an electronic sham coil that mimics real rTMS in appearance, sound, and feeling. Pulses will be delivered to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cannabis; rTMS; Craving; Decision making
Effect of Pulsed Magnetic Field Versus Low Level Laser Therapy on Functional Performance in Children With Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      the purpose of this study is to compare between the effect of pulsed magnetic field versus
      low level laser therapy on functional performance in children with juvenile idiopathic
      arthritis
    

Detailed description: 
      This study directed to investigate effect of pulsed magnetic field versus low level laser
      therapy on functional performance in children with juvenile idiopathic arthritis children
      with juvenile idiopathic arthritis suffer from some problems such as pain, swelling and
      limited motion in knee joints here in this study i used these devices to help in solving
      these problems pain was measured by visual analogue scale swelling was measured by tape
      measurement and Range of motion was measured by digital geniometre
    

Intervention name(s): pulsed magnetic field; Low level laser
Intervention type(s): Device; Device
Intervention description(s): Children in this group received pulsed magnetic therapy in addition to traditional exercise program; Children in this group received low level laser therapy in addition to traditional exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: assignment
Masking: Single (Participant)
Primary purpose: Treatment
Artificial Intelligence for Detecting Retinal Diseases
Condition: Artificial Intelligence; Retinal Diseases
MeSH terms: Retinal Diseases
Study type: Observational

Summary: 
      The objective of this study is to apply an artificial intelligence algorithm to diagnose
      multi retinal diseases from fundus photography. The effectiveness and accuracy of this
      algorithm was evaluated by sensitivity, specificity, positive predictive value, negative
      predictive value, and area under curve.
    

Detailed description: 
      The objective of this study is to apply an artificial intelligence algorithm to diagnose
      referral diabetes retinopathy, referral age-related macular degeneration, referral possible
      glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal
      membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal
      lesions from fundus photography. The effectiveness and accuracy of this algorithm was
      evaluated by sensitivity, specificity, positive predictive value, negative predictive value,
      area under curve, and F1 score.
    

Intervention name(s): Retinal diseases diagnosed by artificial intelligence algorithm
Intervention type(s): Diagnostic Test
Intervention description(s): An artificial intelligence algorithm was applied to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is derived from an anonymous database that contains health examination
        results of the general population.
A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the PK similarity of epoetin administered as Hospira MDV versus
      Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects
      enrolled at a single center.
    


Intervention name(s): Epoetin Hospira SDV; Epoetin Hospira MDV
Intervention type(s): Drug; Drug
Intervention description(s): Epoetin Hospira Single Dose Vial; Epoetin Hospira Multi-Dose Vial
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Epoetin Hospira; Pharmacokinetics
Interactive Motor Imagery in Virtual Reality
Condition: Spinal Cord Injury; Stroke
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This project will build and test the first rehabilitation system employing virtual reality
      (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and
      motor dysfunction in participants with an incomplete spinal cord injury or another
      neurological disorder, eg. stroke: iCTuS-L (Interactive Computer-based Therapy System for
      legs). Patients using the system will control virtual representations of their legs to engage
      in entertaining gaming interactions.
    


Intervention name(s): iCTuS-L
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Test the Effect of 2 Different Doses of Topical GW870086X on Atopic Dermatitis Also Including a Postive Control and a Placebo
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of
      GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. Subjects
      will be assigned to take 3 out of the 4 possible treatments for 21 ±2 days: GW870086X 0.2%
      cream, GW870086X 2% cream, FP 0.05% cream (as a positive control) and placebo cream. All
      subjects will be randomised to receive placebo cream. Three index lesions located on the arms
      and/or legs (one on each) will be identified per subject and each treatment will be applied
      to the same lesion.
    

Detailed description: 
      This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of
      GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. The
      primary objective of this study is to assess 3 lesions using the Three Item Severity (TIS)
      score. The secondary objectives are to assess safety and tolerability of GW870086X, assess
      individual lesions using the Investigators Global Assessment (IGA) and to assess the
      pharmacokinetics of 21 days dosing of GW870086X administered as a cream. Twenty-five (25)
      subjects with atopic dermatitis will be randomised to receive placebo and 2 of the following
      treatments: GW870086X 0.2%, GW870086X 2%, FP 0.05% and placebo. All subjects will receive
      placebo. Subjects will apply all 3 treatments once daily during the 21 day treatment period.
      Three index lesions located on the arms and/or legs (one on each) will be identified per
      subject and each treatment will be applied to the same lesion throughout the 21±2 day
      treatment period. Each index lesion should represent the most common lesions for each patient
      i.e. not the most or least severe lesions.
    

Intervention name(s): GW870086 2.0%; GW870086 0.2%; FP 0.05%; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): White to slightly colored opaque cream; White to slightly colored opaque cream; White cream; White to slightly colored opaque cream
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; GW870086X; TIS; IGA
Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of
      co-administration of Clomipramine HCl 15mg and Sildenafil citrate 100mg compared to the
      effects after single oral administration in Korean healthy male volunteers.
    

Detailed description: 
      Clomipramine is a dibenzazepine-derivative tricyclic antidepressant (TCA) and is a potent
      inhibitor of serotonin and norepinephrine reuptake. Clomipramine may be used in a variety of
      indications. Condencia Tab contains low dose of 15mg of clomipramine HCl as an active
      ingredient, which is newly approved to market for the treatment of premature ejaculation.

      This study is a prospective, randomised, open-labeled, 6-sequence, 3-period, 3-treatment,
      crossover, and single-center clinical trial. A total of 30 healthy male volunteers will be
      enrolled and randomised into one among 6 groups (5 subjects per a group). The safety and
      PK/PD characteristics of co-administration of Clomipramine HCl and Sildenafil citrate will be
      investigated closely compared to the effects after single dose administrations.
    

Intervention name(s): Treatment 1; Treatment 2; Treatment 3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): An oral single dose administration; An oral single dose administration; Co-administration of oral single doses
Other intervention name(s): Clomipramine HCl 15mg (Condencia Tab); Sildenafil citrate 100mg (Viagra Tab); Clomipramine HCl 15mg (Condencia Tab); Sildenafil citrate 100mg (Viagra Tab)
Intervention MeSH terms: Sildenafil Citrate; Clomipramine; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clomipramine; Premature ejaculation
To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers
Condition: Psychosis
MeSH terms: Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioequivalency of generic Haloperidol tablets versus Haldol in
      normal volunteers.
    


Intervention name(s): Haloperidol 10 mg Tablets (Cord Laboratories); Haldol 10 mg Tablets (McNeil Pharmaceuticals)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Typical Antipsychotic