bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects.
Condition: Food-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      to evaluate the comparative bioavailability of valproate from Orfiril long 500 mg prolonged
      release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male
      volunteers under fasting and fed conditions.
    

Detailed description: 
      This was a pivotal, single dose, randomized, open-label, four-period, four-sequence,
      four-treatment, single-centre, four-way crossover design, food effect and comparative
      bioavailability study of Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono
      500 mg prolonged-release tablets in healthy, non-smoking, male subjects under fasting and fed
      conditions. Subjects were randomly assigned to one of the four dosing sequences.
    

Intervention name(s): Sodium valproate; Sodium valproate
Intervention type(s): Drug; Drug
Intervention description(s): fasted; fed
Other intervention name(s): Orfiril long 500 Mg Prolonged Release Oral Tablet; Orfiril long 500 Mg Prolonged Release Oral Tablet
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sunfiber and the Microbiota
Condition: Diet Modification
Study type: Interventional

Summary: 
      The aim of this study is to look at the effect Sunfiber has on the gut microbiota.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled crossover study with a 2 week washout
      period. Healthy volunteers will receive placebo, 4 grams, or 8 grams of Sunfiber in addition
      to their regular diet. Fecal samples will be collected for measurement of bowl function,
      including the gut microbiota.
    

Intervention name(s): Low fiber; Placebo; High fiber
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 3 gram doses; Participants will receive the placebo/dextrose.; Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 6 gram doses
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3 arm crossover, randomized
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to establish the bioequivalence of two
      empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC)
      tablets (Test, T) compared with the same doses of the individual components given in separate
      tablets (Reference, R) when administered together after a high-fat, high-calorie meal.

      The assessment of safety and tolerability will be the secondary objective of this trial.
    


Intervention name(s): Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination); Empagliflozin; Linagliptin; Metformin HCl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single dose; single dose; single dose; single dose
Other intervention name(s): TRIJARDY® XR
Intervention MeSH terms: Metformin; Empagliflozin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency
Condition: Idiopathic Edema
MeSH terms: Edema
Study type: Interventional

Summary: 
      The purpose of this study is to verify the efficacy and safety of the radiofrequency
      stimulation compared to the sham stimulation in reducing lower extremity edema in adult women
      with idiopathic edema.
    

Detailed description: 
      In this study, based on the characteristics of radiofrequency, it was hypothesized that
      radiofrequency could have an effect on the reduction of lower extremity edema and prevention
      of fatigue. The occurrence of edema is interpreted as a problem that blood circulation is not
      smooth due to increased inflow of body fluid, and therefore the degree of edema is also used
      as an indicator of blood circulation.

      Therefore, in this study, based on the principle that radiofrequency promotes phosphorylation
      and blood circulation, the purpose of this study is to investigate whether radiofrequency
      treatment is effective in reducing edema of the lower extremities and changing body heat in
      the lower extremities compared to the gastric stimulation device through exploratory
      research.
    

Intervention name(s): radiofrequency; sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Radiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times; The appearance is the same as the medical device for clinical trials, and when applied, the sound and the amount of light visible from the outside are designed to be the same as the medical device for clinical trials. The external light was the same, and only the high frequency that stimulates the dermis was blocked. The sham device was applied once a day for 30 minutes, a total of 3 times.
Other intervention name(s): high frequency
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg
Condition: Depression; Depressive State; Enuresis
MeSH terms: Enuresis; Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride
      film-coated tablet 10mg & 25mg
    

Detailed description: 
      Randomized, Single dose, 2-way crossover, Open Study to compare the pharmacokinetics profile
      of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline
      Hydrochloride) Tablet 25mg after a single oral administration in healthy male volunteers
    

Intervention name(s): DWETR10; DWETR25
Intervention type(s): Drug; Drug
Intervention description(s): Amitriptyline hydrochloride 10mg(DWETR10) single dose; Amitriptyline hydrochloride 25mg(DWETR25) single dose
Other intervention name(s): Etravil 10mg; Etravil 25mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: depression
The Effects of Memantine and Bupropion on Acute, Reinforcing, and Conditioned Effects of Cigarettes - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      One of nicotine's effects on the body is at the level of the NMDA receptors in the brain.
      Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment
      of nicotine addiction. The purpose of this study is to evaluate the effectiveness of
      memantine using a laboratory model of tobacco addiction. The investigators will compare the
      effects of memantine with bupropion, medication currently used to facilitate smoking
      cessation.
    

Detailed description: 
      Tobacco use is the leading preventable cause of death in the United States. Recent research
      on the effects of nicotine on the brain and behavior presents an opportunity to advance
      medication development. Neurotransmission at NMDA receptors in the brain is associated with
      learning and memory and has been linked to many of nicotine's effects on humans. It is
      possible that altering NMDA neurotransmission may be helpful in treating nicotine addiction.

      The goal of this study is to develop a laboratory model for early-stage testing of new and
      existing compounds for the treatment of tobacco and nicotine addiction. Specifically, the
      study will assess the effect of memantine, a non-competitive NMDA antagonist, versus
      bupropion, a medication currently used to facilitate smoking cessation, on various behavioral
      aspects related to smoking behavior, including reinforcement and cue-reactivity.

      This double-blind, randomized assignment study will consist of three distinct phases
      (placebo, bupropion, and memantine). Each phase will include 10 days of outpatient medication
      maintenance, followed by 3 days of inpatient testing. During the outpatient phase, study
      visits will occur every 2 to 3 days. At these visits, compliance and side effects of
      medication will be monitored, smoking diaries will be collected, and medication will be
      dispensed. During the inpatient period participants will be allowed to smoke only at
      designated times. A variety of assessment will be conducted, including abstinence symptoms,
      acute effects of cigarettes, responses to cigarette cues, and cigarette self-administration.
    

Intervention name(s): Memantine; bupropion; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two capsules of Memantine twice daily for 12 days.
Intervention MeSH terms: Memantine; Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tobacco use
A Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of JNJ-63623872 on the QT/QTc interval at
      supratherapeutic exposure in healthy participants (Panel 2).
    

Detailed description: 
      This is a two-part Phase 1 study consisting of a dose escalation part (Panel 1) and a
      thorough QT (TQT) part (Panel 2). Panel 1 will be a double-blind (neither the researchers nor
      the participants know what treatment the participant is receiving), randomized (study
      medication assigned to participants by chance), placebo-controlled dose escalation study in
      healthy participants to determine the safety, tolerability and pharmacokinetics of
      JNJ-63623872 after administration of single doses of 2400 milligrams (mg) and 3000 mg under
      fasted conditions. The final dose to be used in the Panel 2 will be determined based on the
      results of this dose escalation part. An interim analysis will be conducted on Panel 1 to
      select the dose for Panel 2. Panel 2 will be a double-blind, double-dummy, randomized,
      3-period crossover (the same medications provided to all participants but in different
      sequence), placebo- and positive controlled study to evaluate the effect of JNJ-63623872 on
      the QT/QTc interval in healthy participants. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): JNJ-63623872 2400 milligram (mg); JNJ-63623872 3000 mg; JNJ-63623872; Moxifloxacin; Placebo (Matching with JNJ-63623872 2400 mg); Placebo (Matching with JNJ-63623872 3000 mg); Placebo (Matching with JNJ-63623872 Dose); Placebo (Matching with Moxifloxacin)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-63623872 2400 mg tablet orally once on Day 1 of Panel 1.; Participants will receive JNJ-63623872 3000 mg tablet orally once on Day 1 of Panel 1.; Participants will receive JNJ-63623872 dose selected in Panel 1 tablet orally once on Day 1 of Panel 2.; Participants will receive moxifloxacin 400 mg capsule orally once on Day 1 of Panel 2.; Participants will receive placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1 of Panel 1.; Participants will receive placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1 of Panel 1 and 2.; Participants will receive placebo (matching with JNJ-63623872 dose) tablet orally once on Day 1 of Panel 2.; Participants will receive placebo (matching with Moxifloxacin) tablet orally once on Day 1 of Panel 2.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-63623872; Moxifloxacin
A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
Condition: Safety: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety, tolerability and potential health benefits of the
      dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third
      of subjects will receive the low dose Basis, one third will receive the higher dose Basis and
      one third will receive placebo.
    


Intervention name(s): Basis 250; Basis 500; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Healthy participants; Dietary supplement; Safety; Tolerability; Older Adults; Basis; Nicotinamide riboside; Pterostilbene
Autonomic Correlates of Impulsivity for Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Impulsive Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this pilot feasibility and utility study is to develop and validate a method that
      is reproducible over time for assessing biobehavioral and autonomic markers of impulsivity
      and their utility in assessing treatment outcome in preschool children with ADHD.
    

Detailed description: 
      Assessing biological markers of ADHD among preschoolers has the potential to elucidate
      biology-environment interactions, which may have important implications for treatment, and
      for our understanding of the etiology of ADHD. Although impulsivity is highly heritable,
      long-term changes in biological systems implicated in impulsive behavior can be effected
      through intervention as shown by a 61% increase in electrodermal activity 6-8 years later in
      at-risk preschool children who were randomized to the intervention condition compared with
      controls randomized to no treatment condition. Early intervention may therefore be essential
      if dysregulated trajectories in responding within these systems are to be prevented and/or
      altered.

      Atomoxetine (ATMX) blocks the NE transporter (NET), and increases extracellular levels of NE
      throughout the brain. It is the first nonstimulant drug approved by the FDA for the treatment
      of ADHD. Recent clinical studies have shown that ATMX significantly reduces symptoms of ADHD
      as observed by parents and teachers. ATMX has been shown to improve response inhibition in
      ADHD.

      In the proposed research, pre- and post-treatment bio-behavioral and autonomic markers of
      impulsivity will be assessed in preschool children with ADHD who participate in a double
      blind, randomized, placebo-controlled crossover treatment with a selective NET inhibitor,
      atomoxetine, and placebo.
    

Intervention name(s): atomoxetine (or placebo)
Intervention type(s): Drug
Intervention description(s): Each child will be randomized to receive either ATMX or placebo in the 1st crossover phase followed by the alternative drug condition in the 2nd crossover phase. The study drug (ATMX or placebo) will be administered BID and will be titrated blindly based on clinical response and tolerability. ATMX will be initiated at 0.5 mg/kg/day for 3 days. Based on clinical response, ATMX dose will be titrated to 0.8 mg/kg/day during week 1, 1.4 mg/kg/day during week 2, and a maximum of 1.8 mg/kg/day during week 3, unless serious untoward effects intervene.
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Attention Deficit Hyperactivity Disorder; Atomoxetine; Electrodermal Response; Impulsivity; Preschool Children
Efficacy of Transversalis Fascia Plane Block Versus Wound Infiltration in Varicoselectomy Surgery
Condition: Analgesia; Transversalis Fascia Plane Block; Wound Infiltration; Varicoselectomy
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Before surgery, patients will be divided into 2 groups as transversalis fascia plane block
      will be applied and skin infiltration will be applied. Post-operative analgesic procedures
      will be applied to patients receiving general anesthesia. Postoperative analgesic consumption
      and pain scores of the patients will be evaluated.
    


Intervention name(s): Wound site infiltration; Transversalis fascia plane block
Intervention type(s): Procedure; Procedure
Intervention description(s): Block fluids that were prepared as 20 ml 0.25% bupivacaine before the intervention, will be applied through the upper and lower incision lips on the suprainguinal surgical site.; External, internal oblique, and transversus abdominis muscles will be visualized by the ultrasound device. After transversalis fascia will be seen, transversalis fascia plane block will be performed. As a block fluid 20 ml 0.25% bupivacaine will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Delirium Assessment in the Pediatric Intensive Care Unit
Condition: Delirium
MeSH terms: Delirium
Study type: Observational

Summary: 
      The aim of this study was to show the efficacy of non-pharmacological interventions on
      preventing pediatric delirium in pediatric intensive care unit
    

Detailed description: 
      The aim of this study was to show the efficacy of non-pharmacological interventions on
      preventing pediatric delirium in pediatric intensive care unit. Patients who is followed up
      for at least 48 hours in pediatric intensive care unit will be included in the study. Parents
      of patients will be allowed to stay with the patient as long as the conditions of service is
      appropriate. Parents will provide oral treatments to the patients. Patients will be allowed
      to spend time with their phone, tablet or toy in accordance with their age. Fellow resident
      will screen for pediatric delirium each child using the Cornell Assessment of Pediatric
      Delirium twice a day.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children in PICU
      
Keywords: Delirium; Pediatric intensive care
Study to Evaluate Multiple Doses of ERB-041 in Healthy, Female Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is evaluate the safety, tolerability, and pharmacokinetics of multiple
      doses of ERB-041, an investigational drug, in healthy, female Japanese subjects.
    


Intervention name(s): ERB-041
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: healthy
Outcomes in Rotator Cuff Repair Using Graft Reinforcement
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate patient shoulder functional outcomes following
      rotator cuff repairs reinforced with a surgical mesh.
    

Detailed description: 
      Conexa is a surgical mesh derived from porcine dermis and processed to produce an acellular
      dermal matrix. It is designed to perform as a surgical mesh for use as a soft tissue patch to
      reinforce soft tissue where weaknesses exist and for the surgical repair of damaged or
      ruptured soft tissue membranes. The purpose of this post-market clinical study is to collect
      safety and efficacy data when Conexa is used to repair torn tendons of the rotator cuff.
      Conexa will be used in accordance with its labeling for this clinical study.
    

Intervention name(s): Conexa Reconstructive Tissue Matrix
Intervention type(s): Device
Intervention description(s): Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures
Other intervention name(s): Conexa, Conexa TM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rotator Cuff Tear, Large, Massive, Rotator, Cuff. Tear
Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Evaluating the knowledge and attitudes of healthy participants toward a new diet
      and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal
      cancer screening.

      PURPOSE: This clinical trial is studying the knowledge and attitudes of healthy participants
      toward genetic and environmental risk assessment for colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Part 1

        -  Determine the willingness of healthy participants to enroll in a genetic and
           environmental risk assessment for colorectal cancer.

        -  Determine the impact of decision counseling on knowledge and attitudes about genetic and
           environmental risk assessment (GERA) and colorectal cancer screening in these
           participants.

        -  Determine participants' understanding of GERA.

        -  Determine participants' response to GERA results.

      Part 2

        -  Determine awareness of, and interest in, diet and genetic assessment for colorectal
           cancer among healthy participants at average risk for colorectal cancer who have not
           undergone regular colon cancer screening.

        -  Determine participants' level of knowledge of this assessment.

        -  Determine participants' rate of acceptance into this study.

      OUTLINE: This is a 2-part pilot study.

        -  Part 1: Participants complete a baseline questionnaire on attitudes, beliefs, and
           knowledge about colorectal cancer (CRC), CRC screening, and diet and genetic testing for
           colorectal cancer risk. Two-four weeks later, participants are educated about CRC
           screening options and undergo genetic and environmental risk assessment (GERA) decision
           counseling about the methylene tetrahydrofolate reductase (MTHFR) gene and dietary
           folate intake. Participants who decide to undergo GERA undergo blood testing for MTHFR
           polymorphisms and folate levels. Participants whose blood tests indicate low folate
           levels are further counseled about dietary folate intake.

        -  Part 2: Participants complete a questionnaire on attitudes, beliefs, and knowledge about
           CRC, CRC screening, and diet and genetic testing for colorectal cancer risk.

      Participants in part 1 are followed at 1 week, 1 month, and then at 6 months.

      PROJECTED ACCRUAL: A total of 110 participants (60 for part 1 and 50 for part 2) will be
      accrued for this study.
    

Intervention name(s): counseling intervention; physiologic testing; evaluation of cancer risk factors
Intervention type(s): Other; Other; Procedure
Primary purpose: Screening
Keywords: colon cancer; rectal cancer