bioihbjkbjnl/mcl2 huggingface dataset:
Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion
Condition: General Anesthesia; Breast Disease
MeSH terms: Breast Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the success rate, insertion time and complication
      depending on the use of neuromuscular blocking agent when inserting the laryngeal mask airway
      (LMA).
    


Intervention name(s): use of rocuronium when the LMA is inserted
Intervention type(s): Drug
Intervention description(s): Anesthesia is induced with a propofol and remifentanil in both groups, however rocuronium 0.06 mg/kg is injected only in group R. Insertion of LMA is performed by the standard technique according to the manufacturer's instruction. In group N, rocuronium is administered for the operation.
Other intervention name(s): esmeron
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects
Condition: Japanese Healthy Adult Male Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety, tolerability, and
      pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.
    

Detailed description: 
      This study consists of 8 cohorts, Cohorts 1 to 8. Cohorts 1 to 7 are designed as a
      single-center, single dose, placebo-controlled, randomized, ascending dose, double-blind
      study. Cohort 8 is designed as a single-center, single dose, randomized, open-label,
      two-group, two-period crossover study. Cohort 8 will be initiated after Cohorts 1 to 7 are
      completed.
    

Intervention name(s): E6130; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E6130 matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: E6130; Japanese healthy adult male participants; Phase 1; Pharmacokinetics
Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This single center, randomized, 15-day clinical trial is being conducted to assess the
      changes to the skin microbiome of induced wounds on the back in approximately 35 healthy
      adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin
      physiology assessments will be completed.
    


Intervention name(s): ADHESIVE BANDAGE #1; ADHESIVE BANDAGE #2; ADHESIVE BANDAGE #3; Antibacterial Bandage with 0.8% BZK; Intact and No Bandage; Wounded and No Bandage
Intervention type(s): Device; Device; Device; Device; Other; Other
Intervention description(s): Bandage applied daily to wounded site for 14 days; Bandage applied daily to wounded site for 14 days; Bandage applied daily to wounded site for 14 days; bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days; This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.; This test site will be wounded but will not be treated with a bandage, serving as the positive control site.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microflora; Microbiome; skin physiology; Fitzpatrick Skin Types I-III; Tape-stripped wounds
A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's
      Disease.
    


Intervention name(s): KHK6640; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration; Intravenous administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients
Condition: Bowel Preparation for Colonoscopy
Study type: Interventional

Summary: 
      Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient
      preparation and colonoscopy. The aim of the investigators study is to compare the efficacy
      and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in
      hospitalized patients undergoing colonoscopy.
    

Detailed description: 
      This is a single-center, prospective, endoscopist-blinded study in which hospitalized
      patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one
      gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The
      primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The
      investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa
      scale between arms. Secondary end points are patient compliance and tolerance. N: 120
      hospitalized patients scheduled for diagnostic colonoscopy.
    

Intervention name(s): Split-dose polyethylene glycol; Morning-only polyethylene glycol
Intervention type(s): Other; Other
Intervention description(s): Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy; One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: colonoscopy; bowel preparation; polyethylene glycol
Influence of the Implant Connection on Facial Tissues Maturation
Condition: Bone Loss; Periodontal Bone Loss; Implant Tissue Failure
MeSH terms: Alveolar Bone Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The substitution of a tooth with a fixture often induces undesired morphological changes,
      resulting in a deterioration of the aesthetic appearance. The purpose of this study is to
      compare the soft tissue behavior next to two different implant connections: 5° (group 1) and
      35° hexed (group 2), conical, internal with switching platform design after 12 months of
      functional provisionalization
    


Intervention name(s): implantology
Intervention type(s): Biological
Intervention description(s): placing of implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F)
      following a single microdose intravenous (IV) administration of 50 microgram (μg)
      (approximately 1 microcurie [μCi]) [14C]TAK-935 and a single oral administration of 3×100 mg
      milligram (mg) TAK-935 tablets in Treatment Period 1, and to assess the mass balance,
      characterize the pharmacokinetics (PK) of TAK-935 and metabolite [M-I (N-oxide)] in plasma
      and urine, and total radioactivity concentration equivalents in plasma and whole blood
      following a single oral administration of 300 mg (approximately 100 μCi) [14C]TAK-935 in
      Treatment Period 2.
    

Detailed description: 
      The drug being tested in this study is called TAK-935 (also known as soticlestat/OV935). The
      study determines ABA in Treatment Period 1, and the absorption, metabolism, excretion, and
      mass balance of TAK-935 after single oral administration in Treatment Period 2 in healthy
      adult male participants, by collecting plasma, urine, and feces samples for drug
      concentration analysis, and plasma, whole blood, urine, and fecal samples for total
      radioactivity analysis and metabolic profiling.

      The study will enroll approximately 6 healthy adult male participants. The study is designed
      to consist of 2 periods: Treatment Period 1 (ABA Study Period) and Treatment Period 2
      (Absorption, Distribution, Metabolism, and Elimination [ADME] Study Period). In Treatment
      Period 1, all participants will receive a single unlabelled oral dose of TAK-935 as 3×100 mg
      tablets and a microdose IV infusion of 50 μg (approximately 1 μCi) [14C]TAK-935, followed by
      a Washout Period of 7 days before the dose in Treatment Period 2. In Treatment Period 2, all
      participants will receive a single dose of 300 mg (approximately 100 μCi) [14C]TAK-935 as an
      oral solution.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 65 days including Screening Period. Participants
      will be contacted approximately 30 days after the last dose of study drug for a follow-up
      assessment. This compound was transferred to Takeda and acquired on 29 March 2021. This
      registration is retrospective due to the transfer of ownership.
    

Intervention name(s): TAK-935 Oral Tablet; [14C]TAK-935 IV Infusion; [14C]TAK-935 Oral Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-935 tablet; [14C]TAK-935 IV infusion; [14C]TAK-935 oral solution
Other intervention name(s): OV935; Soticlestat; OV935; OV935
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
The Relationship Between School Readiness and Sensory Processing Disorder in Preterm Preschooler
Condition: Sensory Deficit; Preterm Birth
MeSH terms: Premature Birth
Study type: Observational [Patient Registry]

Summary: 
      The study aims investigate sensory processing disorders and school readiness in pre-school
      preterm children and the relationship between sensory impairment and school readiness
    

Detailed description: 
      A convenience of preterm and term preschoolers recruiting from Gazi University, Faculty of
      Health Science, Department of Physiotherapy and Rehabilitation. Each group contains 30
      children. First, sociodemographic information and histories of children are obtaining. Ages
      and contact information of the parents are recording. Prenatal and natal risk factors of the
      mothers are querying. Gestational ages and height, weight, and head circumferences of babies
      at birth are recording. Number of pregnancies, live births and abortions, type of delivery,
      multiple pregnancies for mothers as well as consanguinity between parents are asking. Marmara
      Primary School Readiness Scale is using to evaluate mental-language development,
      socio-emotional development, physical development, self-care skills,math skills, science
      skills, voice exercises, line exercises and labyrinths. Sensory profile caregiver
      questionnaire screen for the senses (sensory processing), adjustment (modulation), behavioral
      and emotional responses. . All examination wiil be finished in the same day.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Preterm Preschoolers and Term Preschoolers
      
Keywords: Preterm; Sensory processing; School Readiness
A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the allergen-induced late asthmatic response (LAR),
      as measured by maximal percent fall in forced expiratory volume in 1 second, in participants
      with stable mild atopic asthma after treatment with JNJ 40929837 as compared to placebo.
    

Detailed description: 
      This is a multicenter (study conducted at multiple sites), randomized (the study medication
      is assigned by chance), double-blind (neither the physician nor participant will know which
      of the treatments a participant is receiving, but can access the information in case of an
      emergency), and crossover (method used to switch participants from one treatment arm to
      another in a clinical study) study. Approximately 18 participants will participate in the
      study. The study will consist of screening phase (30 days before the administration of study
      drug), treatment phase, and follow-up phase (2 weeks after the end of the last treatment
      period). Participants will be randomly assigned to receive JNJ 40929837, placebo, and
      montelukast. Each participant will receive all the 3 treatments (7 days per treatment) and
      each treatment will be separated by 14 days of wash-out period (no treatment). Safety
      evaluations will include assessments of adverse events, clinical laboratory tests,
      electrocardiogram, vital signs, and physical examination, which will be evaluated throughout
      the study. The maximum study duration for a participant will be approximately 51 days.
    

Intervention name(s): JNJ 40929837; Placebo; Montelukast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): On Day 1: participants will receive 2 tablets of 50 mg JNJ 40929837 in the morning and 1 placebo capsule in the evening; from Days 2 to 6: they will receive 1 tablet of 50 mg JNJ 40929837 in the morning and 1 JNJ 40929837 50 mg tablet + 1 placebo capsule in the evening; and on Day 7: 1 tablet of 50 mg JNJ 40929837 in the morning.; On Day 1: participants will receive 2 placebo tablets in the morning and 1 placebo capsule in the evening; from Days 2 to 6: they will receive 1 placebo tablet in the morning and 1 placebo tablet + 1 placebo capsule in the evening; and on Day 7: 1 placebo tablet in the morning.; On Day 1: participants will receive 2 placebo tablets in the morning and 1 montelukast capsule in the evening; from Days 2 to 6: they will receive 1 placebo tablet in the morning and 1 montelukast capsule + 1 placebo tablet in the evening; and on Day 7: 1 placebo tablet in the morning.
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Mild asthma; Singulair; JNJ 40929837; Montelukast
The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Spatial working memory (ability to remember where objects are in space) is impaired in
      patients with schizophrenia. It is thought that this impairment occurs due to problems with
      the chemical messenger (neurotransmitter), glutamate, and the N-methyl-D-aspartate (NMDA)
      glutamate receptor, particularly in the hippocampal brain region. NMDA receptor activation
      leads to increases in the release of the second messenger Nitric Oxide. Impaired NMDA
      receptor function would therefore be predicted to lead to reductions in Nitric Oxide
      production. Recent work suggests that a drug, sodium nitroprusside, which releases nitric
      oxide, enhances some aspects of cognition in schizophrenia (specifically related to negative
      symptoms). In this study, the investigators will test the hypothesis that sodium
      nitroprusside improves spatial working memory in patients with schizophrenia. 15 patients
      will receive sodium nitroprusside, and 15 will receive a nonactive compound (placebo). Their
      performance on a spatial working memory task will be tested before and after administration
      of sodium nitroprusside or placebo.
    


Intervention name(s): Sodium Nitroprusside infusion; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Nitroprusside
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nitric Oxide; Sodium Nitroprusside; Spatial Working Memory; Psychosis; Schizophrenia
Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
Condition: Hyperphosphatemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the effects of colestilan on the pharmacokinetic profile
      of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours
      after the first daily dose of colestilan administered at doses of 5 g three times daily
      compared to administration of candesartan cilexetil alone, in healthy subjects.
    


Intervention name(s): colestilan; candesartan
Intervention type(s): Drug; Drug
Other intervention name(s): BindRen
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD Stage V; dialysis
The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program
Condition: Unprotected Sex; Contraceptive Usage; Reproductive and Sexual Health Care Utilization
Study type: Interventional

Summary: 
      This study uses a randomized controlled design to evaluate the efficacy of a new mobile app,
      Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based
      mobile health application that can be accessed through mobile smartphones and computers.
      Pulse was designed to increase highly effective birth control use and reproductive and sexual
      health care utilization, and ultimately decrease teen pregnancy. The sample is comprised of
      women with the following characteristics at study enrollment: aged 18-20, not pregnant or
      trying to become pregnant, has daily access to a smartphone, currently living in the United
      States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at
      least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to
      enroll up to 1,300 participants over a one-year enrollment period using social media,
      including Facebook, Instagram, and Twitter.

      Users access Pulse autonomously, on their own terms, and in their own time and place. The app
      consists of 6 sections and includes 3 hours of unique content. It does not require the user
      to follow a specific sequence of content viewed; however, all users will receive a monetary
      incentive after registering with the apps. Youth randomized to the intervention condition are
      given access to Pulse indefinitely and receive daily text messages related to sexual health
      for 6 weeks. Control participants are directed to a free general health/fitness web-based
      mobile application, also called Pulse, and receive text messages related to general health
      for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain
      different content. Participants in both the intervention and comparison groups receive a
      baseline survey and a 6-week follow-up survey. Participants will also receive incentives once
      they complete the baseline and post-intervention survey. Both surveys are conducted online
      via an electronic survey platform. This study is being conducted as a Rigorous Evaluation of
      New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of
      Health and Human Services' Office of Adolescent Health.
    


Intervention name(s): Pulse
Intervention type(s): Behavioral
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group,
      Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to
      evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight
      following administration for 3 months.
    


Intervention name(s): TTP273; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers
Condition: Positron-Emission Tomography; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with
      Multiple Sclerosis compared to healthy volunteers
    


Intervention name(s): F-18 FEDAA1106 (BAY85-8101); F-18 FEDAA1106 (BAY85-8101)
Intervention type(s): Drug; Drug
Intervention description(s): MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET; Healthy controls: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Multiple sclerosis; Diagnostic imaging; Neuroinflammation; PET diagnosis; PET tracer