bioihbjkbjnl/mcl2 huggingface dataset:
Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)
Condition: Inherited Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to compare intra-individually the reepithelialization of skin
      lesion(s) in inherited Epidermolysis bullosa (either 1 wound ≥10 cm2 and ≤200 cm2 in size
      divided in 2 equal halves or 2 comparable wounds of ≥5 cm2 each) treated with Oleogel-S10 and
      non-adhesive wound dressing versus non-adhesive wound dressing only.
    

Detailed description: 
      This study was designed as an open-label, prospective, controlled, blindly evaluated,
      monocentric phase II case series documentation in patients with inherited Epidermolysis
      bullosa (EB). The investigator either identified 1 EB wound ≥10 cm2 and ≤200 cm2 in size and
      divided it into 2 halves or selected 2 comparable wounds of ≥5 cm2 each. One (half of the) EB
      wound was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half)
      was covered with a non-adhesive wound dressing only (Mepilex®) as control. Wound dressings
      were changed about every 24 to 48 hours until discharge from hospital or until the end of
      treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'. This was an open-label
      study. The investigator, the participant, and the sponsor knew the identity of the treatment.
      Two independent experts were blind to treatment and assessed efficacy based on chronological
      series of cropped and coded photographs by wound (half) that were taken before start of
      treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28.
    

Intervention name(s): Oleogel-S10; Mepilex® soft silicone faced polyurethane foam dressing
Intervention type(s): Drug; Device
Intervention description(s): 1 cm or 125 µL or 115 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.; Mepilex® soft silicone faced polyurethane foam dressing was changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.
Other intervention name(s): Sericare®; Cutaneous patch
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epidermolysis bullosa; Wound healing; Epithelialization
Therapeutic Neuroscience Education in Individuals With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of Therapeutic Neuroscience Education
      (TNE) in individuals with Fibromyalgia (FM). The study included 25 females with FM, randomly
      separated into two groups as the intervention group (Clinical Pilates Exercises+TNE, n=11)
      and the control group (Clinical Pilates Exercises, n=14).
    


Intervention name(s): Therapeutic Neuroscience Education
Intervention type(s): Behavioral
Intervention description(s): Therapeutic Neuroscience Education (TNE) is an intervention used by physiotherapists, which can be defined as a cognitive behavioral therapy method. By helping patients better understand the biological process that underlies their painful condition, it aims to achieve therapeutic effects such as reducing pain and the fear associated with musculoskeletal injuries and increasing movement and functionality.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glasses for Adolescent Delayed Sleep-Wake Phase Disorder
Condition: Delayed Sleep-Wake Phase Disorder
MeSH terms: Sleep Disorders, Circadian Rhythm
Study type: Interventional

Summary: 
      The purpose of this study is to determine if evening amber glasses combined with stable wake
      times will show an increase in total sleep time (TST) and an advance in sleep onset times
      (shift earlier) compared to the control group.
    

Detailed description: 
      We propose a 3-week field study that examines the efficacy, acceptance, and compliance of
      using evening amber glasses to block evening light combined with a stable wake time in
      adolescents (14-17 years) with DSWPD (International Classification of Sleep Disorders
      [ICSD-3] criteria).3 After 1 week of baseline measurements, subjects will be instructed to
      wear glasses (which allow 14% entry of ambient light exposure) starting 7 h before
      individually calculated midsleep time measured during the preceding week. This corresponds to
      the time when adolescents are most sensitive to phase delaying light according to Co-I
      Crowley's recently published phase response curve (PRC) to light in adolescents (Figure 1).22
      This "amber glasses + stable wake time" group will be compared to a control group: adolescent
      DSWPD patients who will wear clear-lensed glasses (which allow 100% of ambient light to reach
      the eyes, otherwise identical in appearance) in the evening at the same times as the
      alternate group, but without scheduled wake times. Outcome measures will include TST and
      sleep onset time derived from wrist actigraphy, daytime subjective sleepiness, salivary DLMO,
      and assessments of acceptance and compliance.
    

Intervention name(s): Amber Glasses; Clear Lens Glasses
Intervention type(s): Device; Device
Intervention description(s): Half of the participants will be wearing the amber glasses to see if they can help with sleep onset.; Half of the participants will be wearing the clear glasses to see if the glasses help with sleep onset.
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Assessing the Effect of Multiple Doses of Zibotentan on the Pharmacokinetics of Single Doses of Combined Oral Contraceptives in Healthy Female Participants of Non-childbearing Potential.
Condition: Healthy Female Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the Pharmacokinetics (PK) of combined oral ethinyl estradiol (EE) and
      levonorgestrel (LNG) in healthy female participants of non-child-bearing potential, when
      administered alone and in combination with multiple oral doses of zibotentan.
    

Detailed description: 
      This is an open-label, single-sequence study conducted at a single study center.

      The study will comprise of the following:

        -  A Screening Period (Visit 1) of maximum 28 days (Day -28 to Day -2).

        -  Treatment Period 1/Day 1 to Day 5 (in-house stay): Participants will check in at the
           clinical unit on Day -1 and will be resident at the clinical unit until Day 6.

        -  Treatment Period 2/Day 6 to Day 14 (home): Outpatient period.

        -  Treatment Period 3/Day 15 to Day 20 (in-house stay): On the evening of Day 14, the
           participants will check in at the clinical unit and will be resident at the clinical
           unit until Day 20.

        -  A follow-up visit (Day 27) will be conducted 7 days (±2 days) after the last PK sample
           collection (120 hours post-dose [Day 20]).

      Participants will receive two tablets of EE/LNG on days 1 and 15 and 2 capsules of zibotentan
      on days 6-19.
    

Intervention name(s): Zibotentan; EE/LNG
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive two capsules of Zibotentan orally QD from day 6-19.; Participants will receive two tablets of EE and LNG once on Day 1 and Day 15 as a combined oral dose.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ethinyl estradiol; Levonorgestrel; Zibotentan; Chronic Kidney Disease; Non-Child-Bearing Potential; Drug-drug interaction
Safety and Pharmacokinetics Study of Amlodipine 10mg and Candesartan 32mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of
      amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with
      candesartan 32mg in healthy male volunteers.
    


Intervention name(s): candesartan cilexetil 32mg, amlodipine 10mg
Intervention type(s): Drug
Intervention description(s): Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.
Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.
Other intervention name(s): atacand 32mg, norvasc 10mg
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Visual and Optics Impact of Refractive Surgery
Condition: Refractive Disorders
MeSH terms: Refractive Errors
Study type: Observational

Summary: 
      Refractive surgery includes interventions to correct refractive errors, using a medical
      device such as a laser or an implant (intraocular lenses) or surgical instruments. The study
      distinguishes corneal interventions, carried on the surface of the eye, and intraocular
      interventions, performed on the lens or in the anterior or posterior chamber of the eye. The
      number of procedures in refractive surgery is growing significantly. They seem to offer
      satisfactory visual results but a number of issues remains unresolved. In order to get
      emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower
      orders (ie spherical refractive error and astigmatism). This increases high-order aberrations
      (the most common is a bright halo on the edge of the image). The cutting of the flap to the
      surface of the cornea in the case of LASIK increases high-order aberrations, which have the
      effect of reducing post-surgical visual performance (ie visual acuity and contrast
      sensitivity) and can't be corrected by glasses, while the adaptation of contact lenses on a
      post-operative cornea is more complex. It is therefore necessary to limit these post-surgical
      aberrations and to identify their possible sources. Indeed, some authors have provided
      insight into the effects of some high-order aberrations, but the influence of several factors
      characterizing the preoperative eye on refractive surgery are still unknown, such as
      pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or astigmatism.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing refractive surgery
      
Keywords: Refractive Surgery; higher order aberrations
A Study of Intermittent Doses of CERC-301 in MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      There is a significant unmet medical need for rapidly acting treatment of subjects with
      severe major depressive disorder (MDD) who have not adequately responded to antidepressant
      therapy. Alternative therapies require weeks to achieve full efficacy, may have significant
      side effects, and still fail in a high percentage of subjects. Rapid reduction of severe
      depression by pharmacological therapy is important to reduce the need for hospitalization and
      risk of self-harm and mortality. CERC-301, a highly selective, orally bioavailable,
      N-methyl-D-aspartate (NMDA) receptor subunit 2B (NR2B), also referred to as Glutamate NMDA
      receptor subunit epsilon-2 (GluN2B) antagonist, would be a therapeutic breakthrough if it
      provides rapid onset of antidepressant effects and an effect size similar to that seen with
      experimental intravenous NMDA modulators.
    

Detailed description: 
      The study will evaluate the antidepressant effect of one or two administrations of two doses
      of CERC-301 (12 mg and 20 mg) in subjects with MDD who are currently experiencing a severe
      depressive episode despite stable ongoing treatment with a selective serotonin- or
      serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI).
    

Intervention name(s): CERC-301; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CERC-301, a highly selective, orally bioavailable, NMDA receptor subunit 2B (NR2B), also referred to as Glutamate NMDA receptor subunit epsilon-2 (GluN2B) antagonist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Total Occlusion Study in Coronary Arteries - 5
Condition: Chronic Coronary Total Occlusions
Study type: Interventional
Phase: Phase 2

Summary: 
      A prospective, multi-center, double blind, 2 stage, placebo-controlled, phase II study,
      evaluating acute intra-coronary injected collagenase prior to routine standard-of-care
      percutaneous revascularization procedures in subjects with chronic total coronary artery
      occlusions (CTOs).
    


Intervention name(s): collagenase; saline
Intervention type(s): Biological; Drug
Intervention description(s): Local intra-coronary administration of MZ-004 at or into the CTO; Local intra-coronary administration of saline at or into the CTO
Other intervention name(s): MZ-004
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CTO; PCI; Angioplasty
Effects of 5 Weeks Treatment With Dapagliflozin in Type 2 Diabetes Patients on How the Hormone Insulin Acts on Sugar Uptake in Muscles.
Condition: Diabetes Mellitus, Type 2; Skeletal Muscle Insulin Sensitivity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effects of 5 weeks treatment with
      dapagliflozin in type 2 diabetes patients on how the hormone insulin acts on sugar uptake in
      muscles.
    

Detailed description: 
      To investigate if dapagliflozin improves skeletal muscle insulin sensitivity expressed as
      corrected glucose disposal rate (cGDR) in comparison with placebo after 5-week double blind
      treatment. Insulin sensitivity will be determined using a 2-step euglycemic hyperinsulinemic
      clamp (EHC) procedure
    

Intervention name(s): Dapagliflozin
Intervention type(s): Drug
Intervention description(s): The study consist of 5 weeks treatment period 1, 6-8 weeks wash-out period and 5 weeks treatment period 2.
The patient will be administered dapagliflozin 10 mg during Period 1 or Period 2.
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: T2DM, insulin resistance, skeletal muscle, mitochondria, dapagliflozin
Using Immersive Virtual Reality to Treat Pediatric Anxiety
Condition: Specific Phobia; Specific Phobia, Situational; Specific Phobia, Animal; Specific Phobia, Natural Environment; Childhood Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobic Disorders
Study type: Interventional

Summary: 
      Anxiety is a common and impairing problem for children. The principle treatment for pediatric
      anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise
      called exposures. While exposures are effective, some feared situations cannot be confronted
      in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical
      challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to
      rely on imagined exposures, and/or (3) requires families to complete exposures outside of the
      therapy visits. This creates a burden for clinicians and families, and impedes treatment
      success. Immersive virtual reality (VR) presents an innovative solution that allows children
      to face fears without leaving the clinician's office. While VR has been used to distract
      children during painful medical procedures, it has not been well examined as a primary
      treatment for pediatric anxiety. This study proposes to examine the effectiveness and
      acceptability of using immersive VR exposures to treat children and adolescents with specific
      phobias.
    


Intervention name(s): Virtual Reality Exposure Therapy
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exposure Therapy; Virtual Reality
A Study to Evaluate Safety and Tolerability After Single Oral Dosing of AZD1656 in Japanese Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and tolerability of AZD1656 after single
      ascending oral doses in Japanese healthy male subjects
    


Intervention name(s): AZD1656
Intervention type(s): Drug
Intervention description(s): Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Japanese; healthy; volunteers
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate
      rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe
      hemophilia A (factor VIII level < 1%).
    


Intervention name(s): Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM); Recombinant Factor VIII (rAHF)
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of 50 +/- 5 IU/kg bodyweight; Infusion of 50 +/- 5 IU/kg bodyweight
Other intervention name(s): Advate rAHF-PFM; Recombinant Protein-Free Factor VIII (rAHF-PFM); Recombinate rAHF; Antihemophilic Factor (Recombinant)
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Dose Escalation of IBI321 in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human open-label, multicenter, dose-escalation and expansion study is designed
      to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with
      locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does
      not exist, has proven to be ineffective or intolerable.
    


Intervention name(s): IBI321
Intervention type(s): Drug
Intervention description(s): Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate a Nutraceutical Supplement for Treatment of Hair Loss and Thinning in Females
Condition: Hair Loss
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The objective of this study is to assess the safety and effectiveness of a nutraceutical
      supplement for the treatment of hair loss and thinning in females over the course of six
      months of continuous daily use.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, study in adult female subjects with
      mild to moderate hair loss. Following an up to 35-day screening period to determine
      eligibility, subjects will be randomly assigned into one of the following treatment arms:
      Nutrafol® vs. Placebo. Nutrafol® or Placebo will randomly assigned be administered daily to
      the subjects for 6 months starting on Day 2. The subjects will return to the study site at
      Day 90 and Day 180 for assessments. Additionally, the subjects will return to the study site
      approximately 48 hours after Day 0 (Baseline Visit) and D180 in order to assess hair growth
      rate. Nutrafol® or Placebo will be dispensed by the non-blinded study staff with nonlabeled
      containers containing the corresponding tablets. Efficacy ratings will be performed by a
      trained investigator who will not be aware of the subject's treatment randomization in order
      to preserve double-blinding of the study.
    

Intervention name(s): Nutrafol; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Eligible subjects will receive Nutrafol® to take daily for 180 days; Eligible subjects will receive Placebo to take daily for 180 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thinning hair; female pattern hair loss
Medical Polypectomy and Predictors of Response
Condition: Nasal Polyps
MeSH terms: Nasal Polyps
Study type: Interventional
Phase: Phase 4

Summary: 
      This is the first randomized parallel group clinical trial looking at oral prednisolone
      induced medical nasal polypectomy followed by maintenance on topical steroid therapy in
      patients with nasal polyposis. This study also looks at the effect of aspirin sensitivity and
      the factors linking nasal polyps with asthma. We have also taken baseline measurements of a
      variety of blood, surface and biopsy markers to assess for potential to predict steroid
      response. Finally, the still unchartered link between nasal polyps and asthma will be
      explored by measuring Staphylococcal superantigens in serum before and after treatment.
    


Intervention name(s): Prednisolone; Placebo; fluticasone nasal drops; fluticasone nasal spray
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): tablets 25 mg/day; tablets once daily; fluticasone nasal drops 800mcg/d; fluticasone nasal spray 400 mcg/d
Intervention MeSH terms: Fluticasone; Xhance; Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic rhinosinusitis; nasal polyps; oral steroid; intranasal steroid; medical polypectomy