bioihbjkbjnl/mcl2 huggingface dataset:
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Condition: Excessive Daytime Sleepiness; Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2b study is designed as multicentre, multinational, randomized, double blind,
      parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in
      subjects with excessive daytime sleepiness with Parkinson's disease.
    

Detailed description: 
      Phase 2b study will be conducted with the aim of investigating the efficacy and safety of
      three fixed doses of Bavisant (0.5, 1 and 3 mg/d) compared to placebo for the treatment of
      excessive daytime sleepiness (EDS) in subjects with Parkinson's disease.
    

Intervention name(s): BEN-2001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bavisant dihydrochloride monohydrate for oral use; Placebo
Other intervention name(s): Bavisant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain
Condition: Pain, Chronic
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      Low back pain is very common problem, variable modalities have been introduced to control
      such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that
      could reduce the herniation disk size and inflammation.
    

Detailed description: 
      Intervertebral disc herniation is the most common problem which induces low back pain LBP.
      The number of patients seek surgical and or alternative therapy increases. The rate of
      re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years
      postoperative.

      Epidural injections with local anesthetics and steroids are one of the most commonly used
      interventions in managing chronic low back pain and lower extremity pain of various causes.
      However, despite their extensive use, debate continues on this medications effectiveness due
      to the lack of well-designed, randomized, controlled studies to determine the effectiveness
      of epidural injections in general, and caudal epidural injections in particular.

      Ozone in mixture with oxygen has been justified in multiple studies have been done, this
      study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation
      over 12 month follow up period .
    

Intervention name(s): ozone oxygen mixture
Intervention type(s): Drug
Intervention description(s): receive 10 ml of ozone oxygen mixture under variable dosing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine efficacy and safety after 12-week administration of ASP7991 in secondary
      hyperparathyroidism patients undergoing hemodialysis
    

Detailed description: 
      This study is a multicenter, double-blind, randomized, Cinacalcet hydrochloride-controlled,
      parallel-group, dose-ascending study. Subjects judged to be eligible will be registered and
      randomized into either ASP7991 group (receiving ASP7991 and cinacalcet-placebo) or Cinacalcet
      group (receiving cinacalcet and ASP7991-placebo), and will receive 12-week (84 days)
      administration of study drug from first dialysis day in a week (treatment period), in a
      double-blind manner. The dose of the study drugs will be increased every 3 weeks in
      dose-ascending manner.

      Follow-up assessment will be performed before starting first dialysis in a week, 1 week (7
      days) after the completion of the treatment period.
    

Intervention name(s): ASP7991; Cinacalcet; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Intervention MeSH terms: Cinacalcet; ASP7991
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mineral bone disease(MBD); Chronic kidney disease(CKD); secondary hyperparathyroidism(SHPT)
ONO-7746 Study in Healthy Adult Subject
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in
      healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and
      pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of
      ONO-7746 when administered with or without a meal.
    


Intervention name(s): ONO-7746; ONO-7746
Intervention type(s): Drug; Drug
Intervention description(s): 1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.; 1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-7746; Healthy adult subjects
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in Healthy Volunteers
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of
      ONO-4474 in healthy volunteers.
    

Detailed description: 
      A Double-blind, Multi-centre, Single Dose, Single and Multiple Ascending Dose, Four-part,
      Randomised, Placebo-controlled Study in Healthy Adult and Elderly Subjects Exploring the
      Safety, Tolerability, Pharmacokinetics of ONO-4474 in Fed and Fasted Conditions, and
      Pharmacology of ONO-4474 in NGF-hyperalgesia.
    

Intervention name(s): ONO-4474 Part A1; Placebo Part A1; ONO-4474 Part A2; Placebo Part A2; ONO-4474 Part B; Placebo Part B; ONO-4474 Part C; Placebo Part C; ONO-4474 Part D; Placebo Part D
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Healthy volunteers; Healthy volunteers; Healthy volunteers; Healthy volunteers; Healthy volunteers; Healthy volunteers; Healthy volunteers; Healthy volunteers; Healthy volunteers; Healthy volunteers
Other intervention name(s): ONO-4474; Placebo; ONO-4474; Placebo; ONO-4474; Placebo; ONO-4474; Placebo; ONO-4474; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dose-Proportionality and Intra-Individual Variability of Intracellular TFV-DP and FTC-TP in Healthy Volunteers
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      Describe the dose-proportionality and intra-individual variability of tenofovir diphosphate
      (TFV-DP) and emtricitabine triphosphate (FTC-TP) at steady-state in healthy human
      participants taking Truvada® (FTC 200mg/TDF 300 mg) under direct observation.
    

Detailed description: 
      This PK study is designed to establish the dose-proportionality of TFV and FTC (serum and
      intracellular forms) with daily to weekly dosing. This information is essential to (1) employ
      drug concentration as an adherence measure in future PrEP studies, and (2) to estimate the
      anticipated concentration of parent and active moieties of TFV and FTC in intermittent PrEP
      regimens associated with full adherence to a prescribed regimen. In addition,
      intra-individual variability will be assessed to improve sample size estimates in future PrEP
      studies that use drug concentration as an adherence measure or where PK-PD correlations are
      planned. The dose-proportionality of intra-cellular phosphates of the two components of the
      study product has not previously been established. Given the complexity of movement of these
      drugs between body compartments (central compartment, vaginal mucosal tissue, vaginal lumen,
      gastrointestinal mucosal tissue, gastrointestinal lumen), into cells within these
      compartments, and intra-cellular phosphorylation, it is possible that non-dose proportional
      kinetics, such as mixed or zero-order saturable processes may be operating.
    

Intervention name(s): Emtricitabine/tenofovir
Intervention type(s): Drug
Intervention description(s): 200mg of emtricitabine 300mg of tenofovir
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Plasticity Using Stimulation and Habit: A Pilot Open-label rTMS Study for MCI
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The goal of this pilot study is to determine whether a high-dose form of non-invasive brain
      stimulation is a promising and safe treatment for Mild Cognitive Impairment (MCI).
      Transcranial magnetic stimulation (TMS) is an FDA approved treatment for depression. In
      studies of TMS for depression and other disorders, individuals have experienced improved
      cognitive function. Thus, the current study is testing whether TMS is safe, feasible and
      effective in improving cognition in individuals with MCI.
    


Intervention name(s): High-dose accelerated rTMS
Intervention type(s): Device
Intervention description(s): A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System will be utilized. All participants will receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within an eight-day span. A single session = 600 pulses at 120% resting motor threshold (rMT), intermittent Theta Burst Stimulation (iTBS) triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 s to left dorsolateral prefrontal cortex. Total pulses = 14,400. To enable adherence and retention, the days do not need to be contiguous. Same day sessions will be separated by 10-15 minutes, but more accounting for participant comfort.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
Condition: Chronic Pain
MeSH terms: Chronic Pain; Alcohol Drinking; Marijuana Use
Study type: Interventional

Summary: 
      Self-medication of pain by consuming alcohol and marijuana is common. However, the research
      regarding pain as a determinant for alcohol and marijuana use has relied on laboratory pain
      induction paradigms with limited clinical relevance. The study will assess demand for alcohol
      and marijuana before and after delayed onset muscle soreness (DOMS) induction in co-users.
      This will provide a clinically relevant, but time-limited, model for the effects of
      musculoskeletal pain on demand.
    


Intervention name(s): Eccentric Biceps Flexion; Concentric Biceps Flexion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Muscle lengthening biceps exercise; Muscle shortening biceps exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS
Condition: AIDS Dementia Complex
MeSH terms: AIDS Dementia Complex; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      This project will investigate the ability of a novel MRI contrast agent to identify and
      quantitate ongoing monocyte/macrophage (M/MΦ)-mediated inflammation in the brains of
      HIV-infected individuals.
    

Detailed description: 
      HIV-associated neurocognitive disorders (HAND) continue to be prevalent despite effective
      combination antiretroviral therapy (cART) and have a significant impact on morbidity and
      quality of life. Monocytes/macrophages (M/MΦ) are believed to play a critical role in the
      pathogenesis of HAND. Neuroimaging HIV research has not focused on assessing M/MΦ-mediated
      inflammation in the brain. Currently, no neuroimaging modality exists that can define the
      extent of active inflammation due to M/MΦ in HAND either as a clinical diagnostic tool or to
      assist in defining objective improvement in clinical trials addressing HAND. Ferumoxytol is
      an ultra-small iron oxide MRI contrast agent avidly taken up by circulating M/MΦ. The
      investigators hypothesize that ferumoxytol-based imaging can identify ongoing inflammation
      due to perivascular M/MΦ which is believed to represent a key pathologic correlate of HAND.
    

Intervention name(s): Ferumoxytol
Intervention type(s): Drug
Intervention description(s): All subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion
Other intervention name(s): Feraheme
Intervention MeSH terms: Ferrosoferric Oxide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: HIV; Dementia; Neuroimaging
Study to Assess the Bioavailability of Ticagrelor OD Tablet vs. IR Tablet
Condition: Bioavailability; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomised, four-period, four-treatment, crossover study in
      healthy male and female of non-childbearing potential subjects, performed at a single study
      centre.

      The objective of the study is to assess the bioavailability of ticagrelor orodispersible (OD)
      tablets when administered with water, without water and suspended in water to be administered
      through nasogastric tubes, compared to ticagrelor immediate-release (IR) tablets
    

Detailed description: 
      Study to evaluate the bioavailability of ticagrelor OD tablets administered with water,
      without water and suspended in water to be administered through nasogastric tubes, compared
      to ticagrelor IR tablets.
    

Intervention name(s): Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water; Ticagrelor OD tablet (90 mg single dose) administered without water; Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube; Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 90 mg single dose; 90 mg single dose; 90 mg single dose; 90 mg single dose
Other intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ticagrelor orodispersible tablet; ticagrelor immediate-release tablet; relative bioavailability; Phase I; healthy subjects
Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects
Condition: Breast Cancer; Tumors; Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of ascending single oral
      doses of bosutinib administered with multiple doses of ketoconazole and to provide the
      pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole
      and with food in healthy adult subjects.
    


Intervention name(s): Bosutinib (SKI-606)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Assessing Consumer's Characterization of the Term Natural in a Food Context
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this project is to gain a better understanding of the underlying consumer
      motivations associated with choosing foods labeled as "natural"; and further, how the use of
      this term impacts the amount of food consumed.
    

Detailed description: 
      This study is a randomized, 1-arm, parallel trial design focused on determining the types of
      food labels people associate with 'natural.' A planned sample size of 100 will be enrolled
      into the study. This study will require one initial screening visit and 1 Study Day. This
      study will take approximately 1 day to 1 week per subject to complete.

      The initial screening visit will provide subject with the informed consent document and
      determine subject eligibility through anthropometric measurements, vital signs, fasting blood
      glucose test (finger prick), and completion of a survey relate to general eating, health, and
      exercise habits.

      If willing and eligible to participate, subjects will be invited to participate in the study
      for 1 Study Day that participants can choose to continue on to after the Screening visit.

      Subject will arrive at the center in a fasted. During the Study Day, each participant will be
      asked to complete a health and mindfulness questionnaire. After completing the questionnaire,
      participants will be confronted with 7 bowls of granola, each with a different food label.
      The participant will be asked to choose the most natural granola to eat with the yogurt.
      After the participant chooses, the participant will then have a selected amount of time to
      consume the food and then after complete a debrief questionnaire regarding their intake
      choice. Subjects will be randomized to receive the food items labelled in different orders.
      The sequences of receiving the food items will be randomly assigned to one of sequences.
    

Intervention name(s): Food Order
Intervention type(s): Behavioral
Intervention description(s): randomly assigned orders of 7 bowls of granola, each with a different food label.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: natural; Food Label Choices
MDD POC Study GSK372475 Subjects Depressive Disease
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the
      treatment of outpatients subjects with major depressive disorder to exhibit decreased
      pleasure, interest and energy.
    


Intervention name(s): GSK372475; Paroxetine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): GSK372475 1.0-1.5 mg/day; Paroxetine 20-30 mg/day; Placebo to Match
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MDD; flexible-dose; Major Depressive Disorder; paroxetine; GSK372475
Study to Evaluate the Efficacy of Bare Performance Nutrition's Peak Sleep Supplementation on Sleep Quality and Duration.
Condition: Sleep
Study type: Interventional

Summary: 
      This is a single-blinded observational randomized-control trial to study the efficacy of a
      dietary supplement and its effect on sleep quality, recovery, and workout performance.
    

Detailed description: 
      This is a single-blinded observational randomized-control trial to study the efficacy of a
      dietary supplement and its effect on sleep quality, recovery, and workout performance.

      It is hypothesized that the dietary supplement "Peak Sleep" will improve sleep quality - as
      defined as deep sleep, REM sleep, and feeling more rested the next day, as well as promoting
      the performance in workouts of trial participants.

      A total of 72 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, and participants will either receive the "Peak Sleep" product
      or receive a placebo - depending on the study group they got randomized in - for eight weeks.
    

Intervention name(s): Bare performance supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): dietary supplement; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-blinded observational randomized-control trial
Masking: Single (Participant)
Primary purpose: Other
Pharmacokinetic Study of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in
      pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded
      formulation. The formal bioequivalence study with adequate power will be conducted by the
      manufacturer. In order to get data independently from the manufacturer and to have this
      information in an earlier phase, this small pilot study is initiated.

      The initial study showed a declined bioavailability of the granules under fasting conditions.
      The study has been extended with an arm determining the pharmacokinetics of the granules
      after food (compared to the oral solution taken with food).
    

Detailed description: 
      Cipla has developed two co-formulated forms of lopinavir/ritonavir for second-line
      antiretroviral therapy for children: Lopimune granules and Lopimune tablets. They contain
      100mg lopinavir and 25mg ritonavir.

      Primary objective of this study:

      To determine the pharmacokinetic profile of lopinavir and ritonavir in two different
      co-formulations (Lopimune granules and Lopimune tablets) after single-dose in HIV-negative,
      healthy adult subjects, and to compare this to the branded product.

      Secondary objective:

      To evaluate the safety of single-dose administration of the two generic co-formulations of
      lopinavir/ritonavir and compare this to the branded product.
    

Intervention name(s): Lopinavir/ritonavir; Lopinavir/ritonavir; Lopinavir/ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lopinavir/ritonavir 200/50mg; 2 tablets; single dose; Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose; Lopinavir/ritonavir 100/25mg; 4 tablets; single dose
Other intervention name(s): Kaletra; Lopimune granules; Lopimune tablets
Intervention MeSH terms: Ritonavir; Lopinavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; pharmacokinetics; HIV infection