bioihbjkbjnl/mcl2 huggingface dataset:
Safety Profile of Applied 100% Manuka Honey in Tympanoplasty
Condition: Chronic Suppurative Otitis Media; Tympanic Membrane; Wound
MeSH terms: Suppuration; Otitis Media, Suppurative; Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Throughout history, honey has been recognized for its healing properties. The use of honey
      for its medicinal properties dates back to 2200 BCE.

      The purpose of this clinical trial is to learn about the otological safety of 100% Medical
      grade Manuka Honey given to tympanoplasty patients

      The main question it aims to answer is: Can 100% Medical Grade Manuka Honey given at the time
      of Tympanoplasty otologically safe?

      Participants in the intervention group will receive a wound dressing of 100% medical grade
      Manuka honey after reconstructive surgery of the tympanic membrane.

      Researchers will compare the intervention group to the control group assess otological
      safety.
    

Detailed description: 
      The aim of the present study is to conduct a randomized clinical trial to evaluate the
      otological safety of 100% medical grade Manuka honey on the tympanic membrane post
      Tympanoplasty compared to the control group. The investigation will involve 64 participants
      with Chronic Suppurative Otitis Media of the mucosal type, who will be randomly put into two
      groups (intervention or control), where the intervention group will receive a dressing of
      100% sterile Manuka honey during surgery. Results of this study will inform practitioners as
      to the otological safety of 100% sterile Manuka honey on the tympanic membrane.
    

Intervention name(s): Manukamed - Manukapli 100% sterile honey wound dressing - Premium medical grade 16+ Leptospermum Scoparium New Zealand honey
Intervention type(s): Drug
Intervention description(s): After surgical reconstruction of the tympanic membrane by grafting, Manukamed - Manukapli 100% Sterile honey wound dressing is applied onto the gelfoam to close the area, followed by an antibiotic tampon.
Other intervention name(s): Manukamed - Manukapli 100% sterile honey wound dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Chronic Suppurative Otitis Media; Manuka Honey; Tympanic Membrane; Otologic Safety
An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain.
      This will then help to make accurate predictions of efficacy and dosing in the future
      development programme.
    


Intervention name(s): AZD2516
Intervention type(s): Drug
Intervention description(s): Fractionated single oral dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Positron Emission Tomography; Phase 1; Healthy volunteers; AZD2516
Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      This pilot-study aims to evaluate the effect size and feasibility of internet-delivered
      cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant
      functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal
      pain and functional dyspepsia according to the Rome III criteria). The main component
      investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli
      and situations. Children will participate along with one of their parents in the treatment.
      The parents will also receive specific modules with information on how to support their child
      in the treatment.
    


Intervention name(s): Internet-delivered CBT
Intervention type(s): Behavioral
Intervention description(s): The treatment is based on an internet-delivered CBT-treatment for adults with IBS and on the adapted version for adolescents with functional gastrointestinal disorders. The protocol has been tested in an open face-to-face CBT study of children aged 8-12 years (n=20) with promising results.
Main component in the treatment is exposure for symptoms. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the child, and to teach the parents how parental behavior can influence symptoms in children as well as how to support exposure. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male
      patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single
      dosing with KAE609
    

Detailed description: 
      There will be a total of approximately 45 patients recruited into this study and six doses of
      KAE609 and will be investigated.The dose groups will run in sequence. Patient will be given a
      single dose of KAE609 and be followed up for 42 days.
    

Intervention name(s): KAE609
Intervention type(s): Drug
Intervention description(s): Patients will receive KAE609 single dose at a different dose level in each cohort.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria, KAE609
Adolescent Substance Abuse: Progressive Treatment
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find out more about how to provide effective further
      treatment for adolescents who have received six weeks of group therapy for substance-use
      problems and continue to use drugs. Treatments used in the study include a group therapy
      (MET/CBT), an individual therapy (CBT), and a family therapy (FFT). The study will look at
      whether abstinence or a very low level of use is a better guide for deciding whether further
      treatment is needed, how well different combinations of treatment work to reduce substance
      use, and whether it is possible to predict in advance which adolescents will respond best to
      which types of treatment. Study investigators expect that a treatment strategy using what is
      learned about these issues in the first half of the project to develop an "adaptive"
      treatment model will work better than a "fixed" treatment to reduce adolescent substance use.
    


Intervention name(s): CBT, Cognitive Behavioral Therapy; FFT, Family Functional Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Eight weekly sessions of individual Cognitive Behavioral Therapy, to develop skills enabling adolescents stop or reduce their drug use.; Eight weekly sessions of Functional Family Therapy designed to strengthen family relationships and build skills to help the adolescent stop or reduce his/her drug use.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adolescent substance abuse
Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring
Condition: Acne Scarring of the Face
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the safety profile and the treatment effect of
      Isolagen TherapyTM and placebo when administered to facial acne scars.
    


Intervention name(s): Autologous Human Fibroblasts (azficel-T); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Collection of 3 mm post auricular skin punch biopsies.
Administration of 3 study treatments administered 14 ± 7 days apart.; Collection of 3 mm post auricular skin punch biopsies.
Administration of 3 study treatments administered 14 ± 7 days apart.
Other intervention name(s): LAVIV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne
Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of the new formulation of
      fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy
      participants.
    

Detailed description: 
      This is a single-center, randomized (study medication assigned to participants by chance),
      open-label (all people know the identity of the intervention), single application and 2-way
      Crossover (the same medications provided to all participants but in different sequence)
      pivotal study to determine the bioequivalence of marketed reference formulation DURAGESIC and
      the test formulation Fentanyl transdermal system (JNJ-35685-AAA-G021). Approximately 56
      healthy participants will participate in this study. Participants will be randomly assigned
      to 1 of 2 treatment sequences. The study will consist of 3 parts: Screening Phase (within 21
      days before the first study drug administration of the first period), an open-label treatment
      Phase consisting of 2 single-application treatment periods (26 days) and End-of-Study (at the
      end of Period 2). The total study duration for each participant will be from 43 days to a
      maximum of 59 days. Participants will receive a single application 100 microgram per hour
      (mcg/h) dose of DURAGESIC fentanyl transdermal system as Treatment A (Reference) and 100
      mcg/h Fentanyl transdermal system (JNJ-35685-AAA-G021) as Treatment B (Test). Bioequivalence
      will be primarily evaluated by pharmacokinetic parameters. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): Fentanyl; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single application of DURAGESIC fentanyl transdermal system 100 µg/h dose in one of the treatment periods.; Participants will receive single application of Fentanyl transdermal system (JNJ-35685-AAA-G021) 100 microgram per hour (µg/h) dose in one of the treatment periods.
Other intervention name(s): DURAGESIC; JNJ-35685-AAA-G021
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Bioequivalence Study; JNJ-35685-AAA-G021; DURAGESIC
FBCx (Alpha-CD) Mechanism of Action Trial
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as
      compared to placebo when consumed with a standardized radiolabeled fatty meal.
    

Detailed description: 
      This clinical investigation will determine the fat losses in stool associated with alpha-CD
      use as compared to placebo when ingested with a standardized liquid breakfast (100 microCi of
      [3H]triolein) and 20 microCi of [14C]tripalmitin). The ingested dose will be 2 g of α-CD at
      each of three meals per day for 2 days.

      Eight subjects will be recruited in a two-way crossover design consisting of two treatment
      periods.

      Treatment 1 requires all subjects to receive α-CD and a meal containing the fatty acid
      radiotracers Treatment 2 requires all subjects to receive placebo and a meal containing the
      fatty acid radiotracers All subjects will be observed for 48 hours as an in-patient, and a
      further 24 hours as an out-patient following the meal containing the radiotracer and will
      then undergo at least a further ≥ 14 day washout period before crossing over to the alternate
      treatment.

      All subjects randomized to the α-CD treatment arm will receive 2 g of α-CD (2 x 1 g tablets),
      at each of three meals per day for 2 days. During the placebo phase, all subjects will
      receive two identical-looking placebo tablets.
    

Intervention name(s): Alpha-cyclodextrin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Alpha-cyclodextrin (α-CD) is a soluble dietary fiber that has a history of use in foods and as a pharmaceutical excipient. Recently the ability of the fiber to bind to dietary fat has led to further investigation of the possible health benefits of dietary supplementation with this fiber.; Identical looking placebo tablet to active (Alpha-cyclodextrin)
Other intervention name(s): Calorease, Nuvexa, Mirafit, FBCx, Alfadex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets
Condition: Hyperuricemia; Gout
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to understand the gastrointestinal transit time and
      disintegration behavior of the formulations in vivo in normal healthy volunteers when
      ALLN-346 formulations are given with light meal or in fasted or other fed states.
    

Detailed description: 
      This study includes two parts. Part One will evaluate two ALLN-346 formulations, a fast
      release and a slower sustained release. Subjects will receive a single tablet of each
      formulation and a capsule of each formulation at separate assessment visits. Subjects will
      attend a maximum of 4 assessment visits. The primary purpose of this part of the study is to
      understand the gastrointestinal transit time and disintegration behaviour of the formulations
      in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal.

      Part Two will involve a second cohort of subjects and will comprise further scintigraphic
      studies on one or both formulation(s) from Part One in fasted and/or fed states. Subjects
      will attend a maximum of 4 assessment visits, the number of treatment arms will be decided
      following completion of Part One.
    

Intervention name(s): Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal; Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state
Intervention type(s): Drug; Drug
Intervention description(s): Dosing or radiolabelled ALLN-346 fast or slow release tablets or capsules. Scintigraphic images will be taken; Selected dosing of Part One treatments in fasted and/or fed states
Other intervention name(s): Engineered urate oxidase radiolabelled; Engineered urate oxidase radiolabelled
Intervention MeSH terms: Rasburicase; Uric Acid
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects in each study Part participate in all treatment arms of that Part.
Masking: None (Open Label)
Primary purpose: Other
Oocyte Activation: Revised or Initial AGT Technique, Which is Better?! A Sibling-oocytes-split Design
Condition: Assisted Reproductive Technology
Study type: Interventional

Summary: 
      This study will be conducted to compare two different Assisted Gamete treatment (AGT) with
      oocyte-sibling-split design control group : AGT- initial protocol for activating oocytes by
      culturing oocytes in calcium ionophore after injection for two rounds of 10 minutes at 37 C,
      30 minutes after injection.

      sample group : AGT-revised protocol oocytes will be injected by sperm previously cultured in
      Ca ionophore and 0.4 pL of calcium ionophore then will be cultured in calcium ionophore after
      injection for 10 minutes
    

Detailed description: 
      investigators performed ICSI then with one of two activation protocols added : AGT-initial or
      AGT-revised For the AGT initial protocol, Oocytes will be injected then will be incubated in
      10 mM calcium ionophore (Sigma-Aldrich) for two rounds of 10 minutes at 37 C, 30 minutes
      after ICSI injection, and then will be rinsed and transferred into culture medium.

      For the AGT-revised protocol, ejaculated spermatozoa will be exposed to calcium ionophore in
      a drop on the ICSI dish before injection. During the ICSI procedure, spermatozoa will be
      aspirated individually from the drop containing calcium ionophore and immobilized in a
      separate polyvinylpyrrolidone drop. Next, approximately 0.4 pL of calcium ionophore will be
      aspirated into the micropipette and will be injected into the oocyte with the spermatozoa.
      Post-ICSI oocytes will be then exposed to 50 mM calcium ionophore for 10 minutes at 37 C, and
      then will be washed and placed in culture medium.
    

Intervention name(s): Assisted gamete activation
Intervention type(s): Procedure
Intervention description(s): compare two different assisted gamete activation protocols to improve ICSI outcome
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: single group of patients will be conducted into sibling-oocyte-split design
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Calcium ionophore; gamete activation; ICSI; male factor
A Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee; Chronic Lower Back Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the analgesic efficacy of ASP7962 relative to
      placebo.

      This study will also evaluate the efficacy of ASP7962 relative to placebo on pain on walking,
      function and stiffness; the time course of efficacy of ASP7962 relative to placebo; the
      improvement in overall patient status of ASP7962 relative to placebo as well as the safety
      and tolerability of ASP7962 relative to placebo.
    


Intervention name(s): ASP7962; Naproxen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants receive ASP7962 100 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).; Participants receive naproxen 500 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).; Participants receive matching placebo orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; ASP7962
A Cognitive Self-Management Intervention for Persons With Multiple Sclerosis: Adapting Web-based Technology
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Development and pilot testing of a cognitive self-management intervention for persons with
      multiple sclerosis (PwMS) emphasizing physical activity (PA) delivered via web-based video
      conference.
    

Detailed description: 
      The primary objective of this study is to develop and pilot test an innovative cognitive
      self-management intervention for PwMS delivered via web-based video conferencing. Data
      derived from interviews will be used to guide the adaptation of Stuifbergen's 8-week Memory,
      Attention, and Problem-Solving Skills in MS (MAPSS-MS) intervention to be delivered via
      web-based video conferencing. The adapted MAPSS-MS intervention will be feasibility tested in
      small groups of PwMS. Outcome variables include: (1) neurocognitive function assessed using
      the NIH Toolbox®, a comprehensive set of psychometrically sound neuro-behavioral measures
      that quickly assesses cognitive functions using an iPad, (2) objective PA and sleep using
      Actigraph™ accelerometers, (3) self-reported sleep, depression, and fatigue using the
      Patient-Reported Outcome Measurement Information System (PROMIS), and (4) MS specific
      self-management using the Multiple Sclerosis Self-Management Scale (MSSM). Community-residing
      PwMS, age 21 to 70, will be recruited from Central Texas to participate in Phase 1 interviews
      (n=5) and Phase 2 pilot testing (n=20) of the adapted version of the 8-week MAPSS-MS
      cognitive self-management intervention emphasizing PA delivered via web-based video
      conferencing. In Phase 2 pilot testing (n=20), an intervention group (n=10) will be compared
      to an "enhanced usual care" control group (n=10).
    

Intervention name(s): Eight weekly 90-minute group educational sessions
Intervention type(s): Behavioral
Intervention description(s): Eight weekly 90-minute group educational sessions, originally developed for the MAPSS-MS intervention, adapted for remote web-based delivery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This pilot feasibility study employs a mixed methods design conducted in a community setting. Phase 1 uses a single-group qualitative design involving a convenience sample of 5 adults with MS; Phase 2 uses a randomized controlled trial (RCT) design conducted with a sample of 20 adults with MS (10 intervention/10 control). Phase 2 data will be collected at baseline (before the intervention) and at 8-weeks (post-intervention). Data includes self-report measures, an objective measure of physical activity, and neurocognitive tests. An "enhanced usual care" control group is selected as most appropriate for this pilot feasibility study of a non-pharmacologic, behavioral intervention.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cognitive function; Physical activity; Self-management
Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the effects of MOA-728 on cardiac repolarization in
      healthy subjects.
    


Intervention name(s): MOA-728
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment