bioihbjkbjnl/mcl2 huggingface dataset:
A Study of [11C]JNJ-42491293, a Possible PET Ligand for the mGlu2 Receptor, in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate [11C] JNJ-42491293 as a PET ligand in healthy adult
      volunteers.
    

Detailed description: 
      This is an open-label (volunteers will know the identity of assigned treatment) study in
      healthy adult volunteers and will consist of 4 consecutive parts, A, B, C, and D. Advancement
      to parts B, C, and D will occur only if the objectives of the preceding parts are met.
      Healthy adult volunteers will be recruited for each part of the study. This will be the first
      study in which 42491293 will be given to healthy adult volunteers. Part A will investigate
      the measurement of radiation (referred to as radiation dosimetry) of 42491293. Part B will
      measure the regional brain kinetics (activity) and binding properties of 42491293. Part C
      will assess the dose dependent blocking of 42491293 by 40411813 in brain tissues following
      single oral doses of 40411813. Part D will assess the 'duration of occupancy' of the
      metabotropic glutamate receptor-2 (mGluR2) positive allosteric modulator (PAM) site in the
      brain by 40411813 compared to peripheral clearance. In this study, 42491293 will be
      radio-labeled and evaluated as a potential positron emission tomography (PET) ligand for use
      in imaging studies of the brain to detect binding of 40411813, a compound being developed for
      treating patients with psychiatric conditions such as schizophrenia and anxiety disorders. In
      Parts A,B,C, and D, [11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus
      injection. During Part C and D, JNJ-40411813 (up to 500mg) will be administered orally (by
      mouth) 1.5 to 3 hours prior to scheduled PET scans.
    

Intervention name(s): [11C] JNJ-42491293; [11C] JNJ-42491293 + JNJ-40411813; [11C] JNJ-42491293 + JNJ-40411813; [11C] JNJ-42491293
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Part B:[11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection, have a 90 minute PET scan and have arterial and venous blood sampling.; Part C:[11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v.bolus injection. Volunteers will be pre-treated with JNJ-40411813 between 1.5 to 3 hours prior to the second and prior to the third PET scan; Part D:[11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection.
Volunteers will be treated with a single dose of up to 500 mg JNJ-40411813 prior to the second scan and will have a third scan at least 2 hours later to evaluate the rate of clearance of JNJ-40411813 from the brain; Part A: [11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection and have a 120 minute PET scan.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: JNJ-42491293; JNJ-40411813; Metabotropic glutamate subtype 2 receptor (mGlu2R); Positive allosteric modulator (PAM); positron emission tomography (PET)
Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104
Condition: Rheumatoid Arthritis; Complication of Transplant
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study
      evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
    

Detailed description: 
      This study is a first-in-human, phase I, randomized, double-blind, placebo-controlled, single
      center study evaluating single and multiple ascending intravenous doses of FR104 in healthy
      subjects.

      64 healthy male and female subjects are selected according to the inclusion and exclusion
      criteria, i.e., 50 subjects in Part 1 (SAD: 2 cohorts of 22 [Cohort A], 28 [Cohort B],
      respectively) and 14 subjects in Part 2 (MAD). The total duration of the study is 10 months.

      All FR104 doses are administered intravenously by a slow infusion of at least 30 minutes. A
      staggered approach is observed within all dose levels. An interval of at least 14 days (last
      to first administration) is observed between all dose levels. Individual subjects on a same
      day of dosing are dosed at least 60 minutes apart.
    

Intervention name(s): FR104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GMP FR104 is provided to the site in extractable volume vials containing FR104. Appropriate Dilutions in Ringer's lactate solution is made on site.; The placebo injection contains the vehicle. For placebo dosing, vehicle is administered in accordance with the volume of study drug administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: FR104; CD28; immunomodulation; T regulatory cell; Pegylated monovalent anti-CD28 Fab antibody
Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      In recent years, studies have brought knowledge of the difficulties of social cognition in
      Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in
      social cognition mechanisms remain poorly understood. Although recent behavioral studies
      indicated social disturbances in many of these patients, functional studies investigating
      specific theory of mind in MS are lacking. The use of new techniques for morphological and
      functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping
      the achievement and tissue integrity may be related to disorders of social cognition and
      cognitive. The investigators propose to study social cognition in MS patients using
      morphological and functional imaging to determine the mechanisms underlying phenomena such as
      cerebral compensation and its relationship with cognitive impairment.
    


Intervention name(s): Brain MRI - Clinical and cognitive evaluation; MRI
Intervention type(s): Other; Device
Intervention description(s): Neuropsychological evaluation :
Questionnaire for depression and anxiety
Evaluation of executive functions
Evaluation of attention, information processing speed, verbal memory and working memory
Theory of mind evaluation
Clinical Evaluation
MRI Evaluation :
morphological MRI
functional MRI with two tasks of theory of mind : eyes test and test of attribution of intention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: social cognitive; theory of mind; cognitive impairment; functional MRI; brain activation network
Study in Healthy Adults Evaluating PF-07202954
Condition: Non-Alcoholic Fatty Liver Disease; Liver Fibrosis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is planned as a 3 part design with investigator and participant blinded
      (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a
      randomized, open label design, in Part 3 (if conducted).
    


Intervention name(s): PF-07202954 Repeat Dose; PF-07202954 Single Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10, 30, 100, 300, 600, 1200 milligrams (mg); 10, 30, 100, 300, 600, 900, 1200 milligrams (mg); Matching Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Effect of Clarithromycin on LY2216684
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the effect of Clarithromycin on the pharmacokinetics (PK) of
      LY2216684 in healthy participants. Side effects will be documented. There will be 2 study
      periods (5 and 9 days) and follow up will occur at least 7 days after the last dose.
      Screening is required within 45 days prior to the start of the study.
    


Intervention name(s): LY2216684; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Intervention MeSH terms: Clarithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of
      daclatasvir with pegylated interferon alfa-2a and ribavirin.
    


Intervention name(s): Placebo; Daclatasvir; Pegylated interferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, oral, 0 mg, once daily, for 24 weeks; Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks; Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks; Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
Other intervention name(s): BMS-790052; Pegasys®; Copegus®
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
Condition: Hemorrhoid
MeSH terms: Hemorrhoids; Prolapse
Study type: Interventional

Summary: 
      Trial Objectives

      The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid
      and Prolapse Stapling Set:

      overall performance defined by the successful creation of a normal staple line safety as
      measured by the 30 day incidence of adverse events.
    


Intervention name(s): Hemorrhoidopexy
Intervention type(s): Device
Other intervention name(s): Covidien EEA Hemorrhoid and Prolapse Stapling set
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemorrhoids; Hemorrhoid; grade II, III, IV
Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?
Condition: Type 2 Diabetes Mellitus
MeSH terms: Cardiomyopathies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Aging, Premature
Study type: Interventional

Summary: 
      The potential clinical implications of this study are to optimise the selection of a
      population at risk for developing a diabetic cardiomyopathy among diabetic patients in order
      to develop early therapeutic strategies to prevent the left ventricular remodelling.

      Therefore, the originality of this project is to hypothesize that :

        -  Diabetes mellitus is often associated with a premature aging syndrome

        -  Cellular senescence may potentiate the mechanisms that are involved in decreasing
           myocardial contractility in DM and,

        -  DM associated to premature aging may increase the risk of developing a cardiomyopathy
           Thus, the modulation of telomerase activity and the control of telomere length, together
           with the attenuation of the formation of reactive oxygen species, might represent
           important new targets in order to develop therapeutic tools in prevention of diabetic
           cardiomyopathy.
    


Intervention name(s): Cardiac RMI; Analysis telomere; Stress test; echocardiography
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Cardiac RMI; Analysis telomere; Stress test; echocardiography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes mellitus; accelerated aging; cellular senescence; diabetic cardiomyopathy; strain imaging; strain rate imaging,; echocardiography
Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia
Condition: Underdose (Unintentional); Cancer; Tumor
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of
      neutropenia induced by chemotherapy of cancer patients.
    

Detailed description: 
      A dosage climbing for the safety and efficacy studies for the neutropenia induced by
      chemotherapy cancer patients Repeat-dose studies for the safety and efficacy studied for the
      neutropenia.
    

Intervention name(s): rHSA/GCSF
Intervention type(s): Drug
Intervention description(s): for treatment of neutropenia
Other intervention name(s): Long acting rhG-CSF fusion protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neutropenia; chemotherapy; rHSA/GCSF
Standing Computed Tomography (SCT) Imaging of the Knee Joint
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      This study will help us decide the best way to image the knee for diagnostic purposes: Knee
      computed tomography vs knee x-ray. The computed tomography will provide a weight bearing 3D
      view.
    

Detailed description: 
      This will be an ancillary study to the Multicenter Osteoarthritis Study (MOST) second renewal
      #201511711). Using a prototype Curve Beam Standing Computed Tomography (SCT) scanner to get a
      3 dimensional picture of the knee joint, bilaterally. This scanner by Curve Beam 175 Titus
      Ave, Suite 300, Warrington, Pennsylvania 18976, has been approved by the Food and Drug
      Administration (FDA) for ankles and feet. This has been modified to do the scan of the knee
      but is not yet approved by the FDA for the knees. The proposed ancillary study would add the
      key benefit of providing more sensitive and accurate identification of prevalent knee
      osteoarthritis (OA) at baseline and incident knee OA at follow-up than is available with
      plain radiographs. In addition, it would enable biomechanical modeling of the knee joint on a
      larger scale than achieved in any prior study, allowing testing of biomechanical hypotheses
      regarding mechanisms of disease development and progression that have not been possible on
      this scale previously.
    

Intervention name(s): Standing Computed Tomography
Intervention type(s): Diagnostic Test
Intervention description(s): Provides weight bearing 3D view of knees.
Other intervention name(s): SCT
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The existing cohort will be age 62-92 years, average age approximately 71 years, at the
        start of this study. This cohort will consist of participants who already have symptomatic
        knee OA, in many cases advanced disease, or who had risk factors at the start of MOST but
        have not developed symptomatic knee OA. All of the existing cohort who have 1 or 2 "native"
        knees will be approached providing native knees are not considered to be KL grade 4 (bone
        on bone). The new cohort will consist of subjects with knee pain, aching or stiffness at
        baseline and participants without any knee symptoms in the previous 30 days. Both knees
        with KL grades of radiographic OA of 0, 1, or 2 in the tibiofemoral (TF) and patellofemoral
        (PF) compartments.
Evaluation of mediVR-KAGURA Guided Therapy
Condition: Physical Disability; Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The objective is to evaluate mediVR-KAGURA guided therapy for the treatments of physical and
      cognitive dysfunctions regardless of baseline disease in a prospective interventional design.
    

Detailed description: 
      The patients sit on an upright chair, wear a head-mounted display (HMD) and grab two handheld
      controllers in a motion-tracked three-dimensional space called "room scale" of the
      mediVR-KAGURA (mediVR, Inc. Toyonaka City, Osaka, Japan). mediVR-KAGURA can provide users
      with >90 frames per second (fps) graphic operation with an approximately 110° viewing angle
      and accurate three-dimensional tracking technology.

      First, we evaluate conventional and maximum reaching distances at 0°, 45°, and 90° level
      surface for the left hand (0L, 45L, 90L) and at 90°, 135°, and 180° level surface for the
      right hand (90R, 135R, or 180R) for calibration in a sitting position. During rehabilitation,
      patients are instructed to touch a fixed objects or catch a falling objects at the
      pre-specified height and distance levels in each degree. Horizontal distances were classified
      into three categories, namely long, middle, and short which were calculated using the
      following formulas: 0.9 * maximum reaching distance, 0.9 * (conventional + maximum reaching
      distances)/2, and conventional reaching distance respectively. A falling object disappeared
      at a 20 cm height for safety if the patients missed to catch it. The purpose of reaching
      hands was to stimulate and break down body trunk balance, and to train participants to
      balance for stable walking. By thinking about the timing and distance and recognizing the
      next targets repeatedly, cognitive function was simultaneously stimulated for dual-task
      training.

      The 7 parameters of the rehabilitation programs can be set like as follows: (1) distance
      (short, middle or long), (2) direction (0L, 45L, 90L, 90R, 135R, or 180R), (3) height of
      object, (4) size of object (center or outline), (5) size of sensing sphere of the controller,
      (6) falling speed of the square box (from 0 to 300 cm/s), and (7) intervals for each task.
      Participants first underwent practical programs to familiarize themselves with mediVR-KAGURA
      guided rehabilitation, followed by rehabilitation programs. Provision of the rehabilitation
      programs will be personalized.
    

Intervention name(s): mediVR KAGURA
Intervention type(s): Device
Intervention description(s): Approximately 20 min mediVR KAGURA-guided rehabilitation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality; Physical; Cognitive
Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
Condition: Multiple Sclerosis; Neurogenic Bladder; Spinal Cord Diseases
MeSH terms: Multiple Sclerosis; Urinary Bladder, Neurogenic; Spinal Cord Diseases; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder
      symptoms due to spinal cord injury or multiple sclerosis
    

Detailed description: 
      A clinical study to compare the efficacy and safety of solifenacin succinate in patients with
      neurogenic detrusor overactivity. In this randomized, double blind, double dummy study
      solifenacin will be compared to placebo and an active comparator, oxybutynin hydrochloride.
      Patients will be randomized to one of four treatment arms; solifenacin 10mg, solifenacin 5mg,
      placebo or oxybutynin 15mg. Patients will be assessed over a four week treatment period.
    

Intervention name(s): Solifenacin Succinate; Solifenacin Succinate; Oxybutynin Hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral, 10mg; Oral, 5mg; Oral, 15mg; Oral
Other intervention name(s): Vesicare; YM905; Vesicare; YM905
Intervention MeSH terms: Solifenacin Succinate; Oxybutynin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neurogenic bladder; Vesicare
Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      This study will evaluate biomarkers that reflect changes in gut mucosal status during therapy
      with infliximab and determine whether changes in the levels of the selected biomarkers can be
      used to predict endoscopically assessed gut mucosal status changes.
    


Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.
Other intervention name(s): Remicade; SCH 215596; MK-2155
Intervention MeSH terms: Infliximab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 20 participants aged 18 to 60 years with Crohn's Disease will be enrolled
        from gastrointestinal specialist clinics.
      
Biospecimen description: 
      stool, serum, peripheral blood mononuclear cells (PBMC)
    
Keywords: biological markers; endoscopy; gastrointestinal
Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the relative bioavailability of two test tablet
      formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a
      reference.
    

Detailed description: 
      This is a two part study. Part 1 is a single dose, three period, complete crossover study in
      approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in
      approximately 20 subjects.
    

Intervention name(s): ABT-450; ritonavir; ABT-450
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Low dose ABT-450 / ritonavir see Arm Description for more information; ritonavir see Arm Description for more information; High dose ABT-450 / ritonavir See Arm Description for more information
Other intervention name(s): ABT-538, ritonavir, Norvir
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics, Safety