bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Study of Relative Bioavailability of PPI-668 Tablet and Capsule Formulations
Condition: Pharmacokinetic Assessments in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the blood levels of PPI-668 resulting from two different formulations
      - the current capsule and a new tablet.
    


Intervention name(s): PPI-668 capsule; PPI-668 tablet
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability
JNJ-41443532 Sex, Race, and Age Pharmacokinetic (PK) Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability pharmacokinetics (how the
      drug is absorbed in the body, how it is distributed within the body and how it is removed
      from the body over time) and pharmacodynamics (the effects of the drug) of JNJ-41443532 in
      healthy male and female Caucasian and male Japanese participants.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), double-blind (neither physician nor
      participant knows the name of the assigned drug), placebo-controlled, parallel group, single
      dose study in male and female Caucasian and male Japanese participants. The purpose of this
      study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)
      study in healthy male and female caucasian and male Japanese participants. For each
      participant, the study will consist of a screening examination (within 28 days of first dose
      on Day 1), a single period of open label treatment (all people involved know the identity of
      the intervention) upon entry in the study and discharge on Day 3), and a final, follow-up
      examination between 7-10 days after discharge from the study. Safety assessments include
      monitoring of adverse events, and evaluation of lab results, cardiac parameters, vital signs,
      and physical exams. Participants receive study medication (JNJ-41443532 or placebo) by mouth
      on Day 1 after an overnight fast of at least 10 hours; planned dose is 250 mg.
    

Intervention name(s): Placebo; JNJ-41443532
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo; 250mg tablet once daily for 1 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Healthy; Japanese; Pharmacokinetics; JNJ-41443532
Pharmacokinetics of Zanamivir After Single and Repeated Dose Infusion Administration in Healthy Chinese Adults
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Zanamivir is a potent and highly selective inhibitor of the influenza virus neuraminidase.
      Intravenous (IV) zanamivir is being developed for treatment of hospitalized patients with
      influenza, especially for those patients who may be in greatest need of parenteral influenza
      antiviral agents. This study is a pharmacokinetic (PK) study to evaluate the
      safety/tolerability and pharmacokinetic profiles of IV zanamivir 300 milligrams (mg) and 600
      mg in Chinese healthy subjects. Subjects will be randomized to receive either 300 mg or 600
      mg IV zanamivir as a single dose followed by repeated dose every 12 hours (h) for 5 days.
      Subjects will be contacted or will return to study center for a follow-up visit, 7 days after
      the last dose or withdrawal from the study. Total number of subjects planned for enrollment
      will be 24 such that approximately 10 subjects complete dosing and critical assessments in
      each dose cohort. The total duration of the study will be approximately 6 weeks from
      screening to follow-up.
    


Intervention name(s): Zanamivir
Intervention type(s): Drug
Intervention description(s): Zanamivir will be supplied as 10 mg/mL sterile clear, colorless, aqueous solution in 20 mL clear glass vials, each containing 200 mg zanamivir. Intravenous solutions will be prepared with normal saline.
Intervention MeSH terms: Zanamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteer; Zanamivir; pharmacokinetics; intravenous
Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo
      controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to
      receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to
      assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia
      patients aged 18-80 years, following the first two nights (immediate effect) and at the end
      of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency
      to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of
      treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The
      secondary endpoints are number of awakenings after sleep onset and the duration of wake after
      sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the study;
      mean of two consecutive nights recordings).
    


Intervention name(s): Neu-P11
Intervention type(s): Drug
Intervention description(s): 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Other intervention name(s): Melatonin agonist
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sleep latency; Sleep maintenance; Sleep fragmentation; Polysomnography
Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to assess the efficacy of peginterferon α-2b, compared to a control arm not
      receiving any maintenance treatment, in adult subjects with multiple myeloma who have
      responded to a prior induction therapy. Peginterferon α-2b will be given once weekly as an
      injection until disease progression or relapse, or for up to a maximum of 5 years (whichever
      occurs first).
    


Intervention name(s): Peginterferon
Intervention type(s): Drug
Intervention description(s): Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intra-operative Injection of Autologous Conditioned Plasma (ACP) Following Partial Meniscectomy
Condition: Meniscectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present double blind controlled study is to evaluate the effects in terms of
      pain control and functional recovery provided by a single intra-operative injection of ACP
      performed at the end of arthroscopic partial meniscectomy.

      Patients included in this trial will be randomized in two treatment groups: the first one
      will receive a single injection of 3-5 cc of ACP (using a dedicated centrifuge) at the end of
      the arthroscopic meniscectomy, whereas the second group will be treated by surgery alone. In
      order to ensure the double blinding of the trial all the patients enrolled will undergo blood
      harvesting before anesthesia, and acp will be produced just for the patients included in ACP
      group.

      All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery by
      the following evaluation tools: IKDC (International Knee Documentation Committee) subjective,
      VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and
      Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and
      at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the
      operated and contralateral knee were documented; also in addition, the trans-patellar
      circumference of both knees was registered to assess the trend of knee swelling over time.

      Drugs assumption during the follow-up period will be recorded for each patient. All eventual
      adverse events occurred during the follow-up period will be registered.
    


Intervention name(s): ACP; Standard Meniscectomy
Intervention type(s): Biological; Other
Intervention description(s): Autologous Conditioned Plasma will be obtained directly in the operatory room from the peripheral venous blood of the patient, and injected intra-articularly at the end of arthroscopic meniscectomy; Patients will receive standard arthroscopic meniscectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autologous Conditioned Plasma; meniscectomy; randomized controlled trial; intra-op injection
The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objective of this study is to determine the effect of a high protein, high fiber
      supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high
      carbohydrate Control product in healthy overweight and obese subjects. The investigators
      hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a
      subsequent meal compared to low protein, low fiber.
    


Intervention name(s): High protein, high fiber dietary supplement; Low protein, low fiber comparator
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: satiety; protein; fiber
Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the drug UE2343, a potential treatment for
      Alzheimer's Disease (AD), is effective by assessing safety, tolerability, pharmacokinetics
      and pharmacodynamics in a Multiple Ascending Dose Study. Protocol amendments to the study
      will examine any food effect and determine if the drug penetrates the Blood-Brain Barrier.
    

Detailed description: 
      Part 1 of this study is a double-blind, randomised, placebo-controlled, multiple ascending
      dose study to assess the safety, tolerability, PK and PD in healthy participants dosed twice
      daily at levels of 10, 20 and 35mg for 10 days.This part of the study will recruit 3 groups
      of 8 participants each.

      Part 2 is a cross-over study to assess the effects of food on the PK of UE2343 in healthy
      participants dosed with two single doses at a level decided from Part 1. This part of the
      study will recruit a total of 12 participants.

      Part 3 seeks to determine the PK of the UE2343 in CSF of healthy participants dosed twice
      daily for 4 days with a dose level determined from Part 1 and 2. This part of the study will
      recruit 4 participants.

      Strategies to ensure adherence to the study include the requirement that participants remain
      at the clinical research facility for the duration of their participation in the study; drug
      accountability checks (i.e. reconciliation of used and unused capsules) by an independent
      clinical research associate; and administration of the capsules to the participant by a
      member of the study site team.
    

Intervention name(s): UE2343; Placebo; Placebo; UE2343; UE2343
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): UE2343
10mg, 20, 35mg
twice daily for 9 days; 10mg, 20, 35mg
twice daily for 9 days; Cross-over study
single dose administered twice (on day 1 and day 8)
study duration 17 days; Cross-over study
UE2343
single dose administered twice (on day 1 and day 8)
study duration 17 days; UE2343
twice daily for 3 days
single dose on day 4
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Xanamem
Safety and Efficacy of U-Shaped Sonic Toothbrush on Plaque and Gingivitis
Condition: Plaque Induced Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The goal of this 30 day, randomized, two group, parallel, examiner-blind clinical study is to
      evaluate the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on
      supragingival dental plaque and gingivitis, compared to an American Dental Association (ADA)
      reference manual soft toothbrush. The extent of gingival abrasion and recession and oral
      safety will be evaluated.
    

Detailed description: 
      This single-center, randomized, controlled, examiner-blind, 30-day parallel designs study
      will consist of Screening and Baseline visits with approximately 80 subjects (age 5-65 years)
      who will read and sign an informed consent form and assent form, be assessed for evidence of
      gingivitis and plaque according to the Modified Gingival Index (MGI) and the Lobene-Soparkar
      Modification of Turesky Modified Quigley-Hein Plaque Index (LSPI) at Baseline, and days 15
      and 30 post-baseline. Oral safety, gingival recession and gingival abrasion will be measured
      at all visits. Subjects will be randomly assigned to one of two groups: twice daily brushing
      with a fluoride toothpaste and 1) two-minute brushing with ADA reference standard manual
      toothbrush, or 2) 30-second brushing with AutoBrush® 360° U-shaped Sonic Toothbrush.
    

Intervention name(s): Power sonic toothbrush; Manual toothbrush
Intervention type(s): Device; Device
Intervention description(s): Subjects will brush twice daily for 30 seconds using a fluoride toothpaste.; Subjects will brush twice daily for 2 minutes using a fluoride toothpaste.
Other intervention name(s): AutoBrush 360 U-Shaped power toothbrush; ADA Reference standard soft manual toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Tissue Oxygen Index and Pulsatility Index in Orthopedic Surgery: a NIRS and TCD Pilot Trial
Condition: Cerebral Microemboli
Study type: Observational

Summary: 
      Cerebral microemboli (ME) are frequently generated during major orthopaedic surgery. The
      primary objective of this study was applying novel transcranial Doppler (TCD) ultrasound
      software algorithm to quantify (ME load/15 minutes) and qualify (particulate vs. gaseous) ME,
      detected as high-intensity transient signals (HITS) in both middle cerebral arteries (MCAs)
      before and after orthopaedic surgery.
    


Intervention name(s): Transcranial Doppler Ultrasound, DWL Doppler BoxX
Intervention type(s): Device
Other intervention name(s): Near Infrared Spectroscopy, Hamamatsu Niro-200Nx
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        orthopedic patients
      
Keywords: orthopedic surgeries; general anesthesia
Non-Nicotine Agents for Smoking Cessation
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine which is the better approach to smoking
      cessation in veterans: bupropion combined with transdermal nicotine or high dose nicotine
      replacement therapy (NRT) using transdermal nicotine combined with nicotine inhaler.
    

Detailed description: 
      This study is a two-arm open-label, randomized controlled trial of bupropion combined with
      transdermal nicotine versus high dose NRT (transdermal nicotine and nicotine inhaler) with
      all subjects receiving a behavioral counseling program for smoking cessation.
    

Intervention name(s): bupropion and transdermal patch; transdermal patch and nicotine inhaler
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking; nicotine; drug therapy; smoking cessation
Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to compare two combinations of drugs, minocycline and creatine
      or celecoxib and creatine, in a phase II trial designed to determine which combination is
      more effective for ALS.
    

Detailed description: 
      Excess free radicals, energy mishandling, excitotoxicity, activation of cell death pathways
      and inflammation likely all contribute to neurodegeneration in ALS. Past trials may have been
      negative in part because they tested single agents, usually influencing only one mechanism of
      cell death. Combinations of agents that affect different and multiple mechanisms of
      neurodegeneration may be necessary to reach meaningful outcomes in trials of ALS.

      This trial has several unique features. First, it compares the neuroprotective potential of
      two combinations of agents that impact multiple mechanisms of cell death. The combinations of
      minocycline/creatine and celecoxib/creatine are the only agents that have had additive
      effects in the mouse model of ALS, reducing neurodegeneration and prolonging survival more
      than individual agents alone. Second, it uses an important new phase II selection trial
      design to determine which combination is superior. Not only does this trial test combination
      therapy, but there is no placebo, so everyone who enrolls in the trial will receive active
      treatment.

      Minocycline, creatine and celecoxib have been tested individually and have been shown to be
      safe in patients with ALS. This will be the first time human trials will be conducted with
      combinations of minocycline/creatine and celecoxib/creatine.

      We will compare combinations of drugs in a phase II trial design to determine which
      combination is superior. If successful, this trial will lead directly to a phase III trial of
      the selected combination. If the design is found useful, this trial will lead to larger phase
      II selection trials assessing greater numbers of agents simultaneously, thereby improving the
      efficiency of drug screening in ALS.
    

Intervention name(s): Celecoxib; Creatine; Minocycline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Celecoxib 400 mg BID with creatine 10 g BID if randomized to the Celecoxib + Creatine study arm.; 10 g BID for either study arm; Minocycline 100 mg BID with creatine 10 g BID if randomized to the Minocycline + Creatine study arm
Intervention MeSH terms: Minocycline; Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; Celecoxib; Creatine; Minocycline; Combination; Selection; ALS; Motor Neuron Disease
Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary Choices
Condition: Eating Habit; Healthy Diet
Study type: Interventional

Summary: 
      This is an open-label observational single-group clinical trial to study the efficacy of a
      commercial superfood blend and its effect on markers of well-being and improvement of
      long-term healthy eating habits.
    

Detailed description: 
      This is an open-label observational single-group clinical trial to study the efficacy of a
      commercial superfood blend and its effect on markers of well-being and improvement of
      long-term healthy eating habits.

      It is hypothesized that the dietary supplement marketed as Your Super Detox Bundle will
      improve subjective wellbeing and health in trial participants. It is further hypothesized
      that the accompanying diet plan will promote beneficial nutritional habits that may persist
      long term outside of the 5-day detox period. Additionally, the included food ingredients are
      reported to improve energy levels and sleep quality, while reducing unfavorable bloating,
      aches, and brain fog.

      A total of 38 participants will be recruited for the trial following the screening. The trial
      will be fully remote, a technology platform will be utilized to screen, enroll and capture
      study data of the participants. Participants will undergo a 5-day detox period involving
      consuming two smoothies daily (for breakfast and dinner) containing variations of the Your
      Super Detox food powders as detailed below. Participants are encouraged to follow the
      provided plant-based nutritional plan for meals and snacks outside of the Your Super smoothie
      meals. Participant adherence to the provided nutritional plan is not mandatory, and lack of
      adherence by some participants will provide further data on the effect of the nutritional
      guidelines on the evaluated outcomes. After the 5-day detox period is completed, participants
      will be followed on for a subsequent 16 days to evaluate the effect of Your Super Detox
      bundle and guidelines to influence prolonged healthy eating habits.
    

Intervention name(s): YOUR SUPER Detox Bundle
Intervention type(s): Dietary Supplement
Intervention description(s): During days 1-5, participants will complete the 5-day Your Super Detox, consuming 2 smoothies daily (breakfast and dinner) containing Your Super Detox superfood powders.
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Primary purpose: Other