bioihbjkbjnl/mcl2 huggingface dataset:
A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Naturalistic Setting
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in
      patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout
      period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of
      3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.
    

Detailed description: 
      To address the unmet need for early morning ADHD symptom control, Ironshore has developed a
      novel drug delivery system that incorporates the active ingredient methylphenidate HCl in a
      delayed/extended release formulation. This formulation provides a controlled, approximately
      8-hour delay in initial drug release, followed by a subsequent controlled rate of drug
      release throughout the day. The goal of this system is to enable nighttime dosing of
      methylphenidate to provide control of ADHD symptoms at the beginning of the next morning
      (immediately upon awakening) and throughout the remainder of the day.

      At Visit 2, Baseline Visit), subjects were randomized to receive either HLD200 or placebo and
      instructed to begin dosing at 40 mg each evening (8:00 pm ±30 minutes) for 1 week, with
      scheduled titration, as medically indicated and tolerated, over the subsequent 2 weeks to 60
      mg (Visit 3) and 80 mg (Visit 4) and/or a dose not to exceed 3.7 mg/kg (based on the
      subject's most recently assessed weight). Following dose escalation above 40 mg (i.e., after
      Visit 3), subjects were permitted to reduce the dose by 1 step (i.e., from 60 to 40 mg or
      from 80 to 60 mg), if necessary, for safety or tolerability. Subjects who were unable to
      tolerate a dose of at least 40 mg during the final (third) week of treatment, from Visit 4 to
      5, were discontinued. Subjects were also permitted to adjust the timing of the evening dosing
      at Visits 3 and 4 in increments of 30 to 60 minutes/week to achieve optimal morning control
      of observed ADHD symptoms; however, the dose was not to be taken any later than 9:30 pm or
      any earlier than 6:30 pm, regardless of the ±30-minute dosing window.
    

Intervention name(s): HLD200 methylphenidate hydrochloride (MPH) Capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HLD200 Doses: 40, 60 or 80 mg
Other intervention name(s): methylphenidate
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products
Condition: Smoking; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label,
      crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of
      abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological
      measures during and following ad libitum use of the study investigational products (IPs) by
      generally healthy subjects.
    

Detailed description: 
      Cigarette smokers and smokers who also use smokeless tobacco (SST) [e.g., snus, moist snuff]
      will be recruited into the study.

      Starting on Day -1, eligible subjects will be confined at the clinical site for 6 days.
      Subjects will be randomized to evaluate one IP in each of five separate Test Sessions, such
      that each subject will evaluate five IPs: one of two forms of the nicotine lozenge in three
      different regimens, a commercially-available nicotine replacement therapy (NRT) nicotine
      lozenge, and the subjects' usual brand (UB) cigarettes.

      Each Test Session will last for approximately 6 hours during and following IP use and will
      include collection of subjective measures, PK assessments and physiological measures.

      On Day -1, subjects will be instructed on how to use both the specific lozenge IP in their
      assigned study arm and the NRT lozenge and will have one trial use of both IP.
    

Intervention name(s): Product A; Product B; Product C; Product D; Product E; Product F; Product G; Product H
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Usual brand (UB) filtered, combustible cigarette; Nicorette® Mint 4 mg nicotine lozenge; CSD1903-11, a hard nicotine lozenge, 2 mg nicotine; CSD1903-11, a hard nicotine lozenge, 4 mg nicotine; CSD1903-11, a hard nicotine lozenge, 8 mg nicotine; CSD1903-12, a soft nicotine lozenge, 2 mg nicotine; CSD1903-12, a soft nicotine lozenge, 4 mg nicotine; CSD1903-12, a soft nicotine lozenge, 8 mg nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Controlled MAP in the Brain Injury Patient (COMAT Study)
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The goal of this randomized controlled trial will be to show that the use of a novel
      automated system to guide vasopressor administration in brain injury patients will results in
      more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of
      the target MAP) compared to patients managed without any automated system (manually
      management)
    

Detailed description: 
      In brain injury patients, the maintenance of MAP within a very narrow range is desired to
      avoid complications related to hypoperfusion (undertreatment) or hypertension (over
      treatment). However, the MAP needed to reach can vary over time based on intracranial
      pressure. Additionally, it is well know that the nurses in the Intensive care unit managed
      multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust drugs
      infusions. Using a novel automated system can overcome this issue and may lead to more time
      in MAP target (+/- 5mmHg) than the traditional management.

      After initial rescuscitation of the patients, patients in both groups will have the same
      baseline maintenance fluid administration of 1-2 ml/kg/h of crystalloid solution and
      additionnal fluid boluses administered following the EV1000 monitoring device. The only
      difference will be the management of vasopressor titration (manual by nurses vs automated via
      a closed-loop system)
    

Intervention name(s): EV1000 and closed-loop system; Control group
Intervention type(s): Device; Device
Intervention description(s): This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system; This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: manual versus automated management of MAP
Masking: Single (Participant)
Primary purpose: Treatment
Study of TNFR:Fc (Enbrel) in the Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study is a phase II clinical trial of TNFR:Fc therapy in a segmental allergen
      bronchoprovocation model of atopic asthma. The goal of this study is to assess whether
      inhibition of tumor necrosis factor (TNF) bioactivity can attenuate airway inflammation in
      mild-to-moderate allergic asthmatics. This protocol will utilize a randomized, double-blind,
      placebo-controlled trial design. TNF bioactivity will be inhibited via systemic
      administration (e.g., subcutaneous injection) of a dimeric fusion protein consisting of the
      extracellular ligand binding domain of the 75-kilodalton TNF receptor linked to the Fc
      portion of human IgG1 (TNFR:Fc, Immunex). The data generated by this study will address the
      utility of anti-TNF therapy for patients with asthma.
    

Detailed description: 
      The proposed study is a phase II clinical trial of TNFR:Fc therapy in a segmental allergen
      bronchoprovocation model of atopic asthma. The goal of this study is to assess whether
      inhibition of tumor necrosis factor (TNF) bioactivity can attenuate airway inflammation in
      mild-to-moderate allergic asthmatics. This protocol will utilize a randomized, double-blind,
      placebo-controlled trial design. TNF bioactivity will be inhibited via systemic
      administration (e.g., subcutaneous injection) of a dimeric fusion protein consisting of the
      extracellular ligand- binding domain of the 75-kilodalton TNF receptor linked to the Fc
      portion of human IgG1 (TNFR:Fc, Immunex). The data generated by this study will address the
      utility of anti-TNF therapy for patients with asthma.
    

Intervention name(s): TNFR:Fc
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bronchoprovocation; Airway Inflammation; Tumor Necrosis Factor; Bronchoalveolar Lavage; Pulmonary Function Test; Asthma
Environmental Game After Appendicitis Surgery
Condition: Healthy
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      This study was conducted to determine the effect of environmental play and mobilization on
      fear and pain levels of children aged 6-12 years who had acute appendicitis surgery.
    

Detailed description: 
      It was conducted with children aged 6-12 years in the postoperative period in a randomized
      controlled manner. Children in the intervention (n:50) group were mobilized by playing
      environmental games.The children in the control group (n:50) underwent routine mobilization
      of the clinic.

      The data were collected with the "Child Follow-up Form", which was created to evaluate the
      child's demographic characteristics, physiological parameters, pain and fear.
    

Intervention name(s): game
Intervention type(s): Device
Intervention description(s): The game is played with a maximum of four people. Beginning points are marked with blue, red, yellow and green colors, the game progress direction is The starting color for the player is determined with the help of arrows. Dice with the biggest number The child who throws starts the game first from the starting point that belongs to him. Play ground Each child who completes a circuit around him reads from his second point. it tries to go inwards (to the world square) in the direction it points. Equivalent to card check box The next child draws one of the face down cards. the instruction written on the back of the card.
implements. Then he puts the card on the back of the other cards. Cards are reward (go forward), penalty (backward) git) cards. Coming second to the same frame during the game The child first starts the game from the starting point of the child in the square. First The child who manages to enter the world square wins the game.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pain; Fear; Pediatric surgery; Game; Appendicitis
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the single-dose pharmacokinetic (PK) and
      bioequivalence of Darunavir (DRV) in the presence of Cobicistat (COBI) when administered as a
      DRV/COBI fixed dose combination (FDC) tablet dispersed in water compared to the
      co-administration of the separate available formulations (DRV suspension and COBI tablet)
      under fed conditions in healthy participants.
    


Intervention name(s): DRV/COBI FDC; COBI; DRV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral dose of DRV/COBI FDC tablet dispersed in water as per assigned treatment sequence.; Participants will receive a single oral dose of COBI tablet as per assigned treatment sequence.; Participants will receive single oral dose of DRV suspension as per the assigned treatment sequence.
Other intervention name(s): TMC114/JNJ-48763364; JNJ-48763364; TMC114
Intervention MeSH terms: Darunavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
Condition: Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232
      at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen
      1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain
      relief effectiveness up to 6 hours after administration of the study drug.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo- and active-controlled, parallel
      group study to evaluate the efficacy, safety and pharmacokinetic profile of JNJ-10450232,
      administered as a single dose in capsules (250 or 1000 mg), over a 24 hour period after molar
      extractions. Subjects will stay at the research center for ~24 hours after administration of
      study drug. Healthy male subjects, ages 18 to 45 years inclusive, will be screened by medical
      history, vital signs, an electrocardiogram (ECG), and clinical laboratory tests. Eligible
      subjects will return to the clinic on the day of surgery and complete baseline vital signs
      and clinical laboratory tests. They will undergo dental extraction of a minimum of three
      third-molars and, if qualified, will be randomly assigned to one of four study treatments for
      pain.
    

Intervention name(s): JNJ-10450232 / Not yet marketed; JNJ-10450232 / Not yet marketed; JNJ-10450232 / Not yet marketed; acetaminophen / Tylenol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.; Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.; Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.; Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental pain; post-surgical dental pain
Adding Vertical Correction to Scapular Recognition on Patients With Frozen Shoulder
Condition: Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      OBJECTIVE: To study the effect of adding a continual vertical downward correction to dynamic
      scapular recognition exercise on scapular dyskinesis and shoulder pain and disability in
      patients with frozen shoulder.

      Design: A double-blinded randomized controlled study Setting: Out-patient clinic Subjects:
      Sixty-seven subjects with unilateral frozen shoulder Interventions: Participants were
      distributed into two groups. The intervention group performed the dynamic scapular
      recognition exercise and continual vertical downward correction using rigid taping with
      50%-75% tension. The control group performed a similar dynamic scapular recognition exercise
      using a wireless biofeedback system and placebo taping. A scapular dyskinesis test with
      caliper was utilized to measure scapular dyskinesis, a digital inclinometer was utilized to
      evaluate the scapular upward rotation and shoulder ROMs, and the Shoulder Pain and Disability
      Index (SPADI) was utilized to evaluate the shoulder pain and disability.
    


Intervention name(s): Dynamic Scapular Recognition exercise
Intervention type(s): Other
Intervention description(s): The intervention group received continual vertical downward correction using a standardized rigid tape. A hypoallergenic tape (Hypafix; BSN Medical GmbH, Hamburg, Germany) was used with 50% to 75% tension. Two rigid tapes were applied; the first one is placed from just superior to the midpoint of the superior border of the scapula to the level of T12 and the second tapes were placed from just superior to the superior angle of the scapula to the level of T12. The level of T12 was used as the end of both taps to increase the lever arm of the applied force and to decrease the incidence of peeling off of the tape. No tape was applied from the lateral angle of the scapula because it might impair the upward rotation of the scapula. Both taps were performed after each session and removed immediately before the next session
Other intervention name(s): Rigid Taping
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded Randomized Controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia
Condition: Cytopaenia
MeSH terms: Anemia; Anemia, Aplastic
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a non-randomized, open-label, phase II study to assess the efficacy and safety of
      eltrombopag in Japanese moderate or more severe aplastic anemia (AA) subjects with a platelet
      count <30,000/microliter who were refractory to anti-thymocyte globulin (ATG)-based
      immunosuppressive therapy (IST), who have relapsed after ATG-based IST, or who are ineligible
      for ATG-based IST.

      Eltrombopag was expected to improve trilineage blood cells and decrease transfusion frequency
      based on the result from the previous study in patients with severe AA. This study used the
      hematologic response rate, defined as the proportion of subjects showing improvement in at
      least one of the three blood cell lineages or a decrease in blood transfusion volume, as the
      primary endpoint.

      A total of 36 subjects were screened and 21 were enrolled in the study. Treatment with
      eltrombopag started at 25 milligram (mg)/day and increased by 25 mg/day every 2 weeks
      according to the platelet count up to 100 mg/day. Response assessment was performed at 3
      months after starting the study treatment (Week 13). Subjects in whom the treatment was
      assessed as effective continued with the study treatment. Subjects in whom the treatment was
      assessed as effective (when meeting any of the response criteria) at 6 months after starting
      the study treatment (Week 26) might enter the extension phase and continue the treatment with
      eltrombopag. The primary endpoint was the hematologic response rate at Week26.
    


Intervention name(s): Eltrombopag 12.5 mg; Eltrombopag 25 mg
Intervention type(s): Drug; Drug
Intervention description(s): White, round, film-coated tablets containing 12.5 mg of eltrombopag free acid (SB-497115-GR, eltrombopag) in each tablet; White, round, film-coated tablets containing 25 mg of eltrombopag free acid (SB-497115-GR, eltrombopag) in each tablet
Other intervention name(s): Revolade; Revolade
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eltrombopag; Aplastic Anemia (AA); Thrombocytopenia; Thrombopoietin; Bone Marrow; Bone Marrow Biopsy; Hematopoietic Stem Cells; Mature Blood Cells; Pancytopenia; Leukopenia; Platelets
The CLOCK Study - A Human Dietary Intervention Study on Peripheral Circadian Clocks and Energy Metabolism
Condition: Metabolic Response to Dietary Modification
Study type: Interventional

Summary: 
      This human dietary intervention study with a cross-over design aims to investigate the effect
      of two different diurnal patterns of meal composition on peripheral circadian clocks and
      energy metabolism in healthy men.
    

Detailed description: 
      In this cross-over study, healthy male participants are randomly allocated to one of two
      study groups: In study group (A) participants consume isocaloric carbohydrate-rich meals (65%
      Carbohydrates; 20% Fat; 15% Protein) in the morning and fat-rich meals (35% Carbohydrate; 50%
      Fat; 15% Protein) in the evening for four weeks. After a washout-phase participants consume
      isocaloric fat-rich meals in the morning and carbohydrate-rich meals in the evening for
      another four weeks. Study group (B) receives the same interventions in the reversed order.
    

Intervention name(s): Carbohydrate-rich (HC); Fat-rich (HF)
Intervention type(s): Other; Other
Intervention description(s): 65% Carbohydrate; 20% Fat; 15% Protein; 35% Carbohydrate; 50% Fat; 15% Protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science