bioihbjkbjnl/mcl2 huggingface dataset:
Functional Brain Imaging of Pain Phenotype and Genotype
Condition: Pain
Study type: Interventional

Summary: 
      This study has two purposes: first, to locate and identify the "brain activation" (the areas
      of the brain) which respond to pain; and second, to look at how brain activation is
      influenced by a person's genetics (the traits they inherited from their parents). A Magnetic
      Resonance Imaging (MRI) scanner will be used to gather pictures of the brain (similar to an
      x-ray, but based on different scientific principles) that will be used to determine which
      areas are active. The hypothesis is that the variation in brain activity between people can
      be partially explained by genetic differences. This study consists of an two pain tasks
      applied during a one time visit to the MRI suite. There are no followup visits.
    


Intervention name(s): gauze soaked with capsaicin
Intervention type(s): Other
Intervention description(s): This is a basic science study determining the brain activation that results from painful stimulation. All subjects will have the same painful stimulations and brain images collected.
Intervention MeSH terms: Capsaicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pain; Functional Magnetic Resonance Imaging
A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Multiple Ascending Doses of ASP7962 in Healthy Subjects
Condition: Healthy Volunteers; Pharmacokinetics of ASP7962
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability as well as the
      pharmacokinetics of increasing oral multiple doses of ASP7962 in healthy young male and
      female subjects.
    

Detailed description: 
      Subjects will be admitted to the clinical unit and will stay residential for a total of 20
      days/19 nights, to be discharged from the clinical unit on day 19.
    

Intervention name(s): ASP7962; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers; ASP7962; pharmacokinetics
Lab School Day Study for CONCERTA of Older Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate
      HCl), is safe and effective in improving academic performance and behavior in children with
      attention deficit hyperactivity disorder (ADHD), when compared to placebo.
    

Detailed description: 
      The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving
      academic performance and behavior in children with ADHD, when compared to placebo as
      demonstrated using specified study measures. This is a double-blind (neither participant nor
      investigator knows the name of the assigned study drug), randomized (study drug assigned by
      chance), placebo-controlled, crossover study evaluating the academic, behavioral, and
      cognitive effects of CONCERTA (methylphenidate HCl) on older children with ADHD. This means
      that all eligible children will receive treatment with methylphenidate HCl throughout the
      study (the titration and assessment periods) and inactive pill (placebo) on one of the two
      laboratory classroom days. On the other laboratory classroom day they will receive their
      regular dose of methylphenidate HCl. The primary efficacy variable in this study is the
      Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP
      (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and
      comprehension, and memory. Assessments will be completed during each of the laboratory
      assessment days (12.5 hours). Participants will be assessed for adverse events throughout the
      study. Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at
      baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose
      is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a
      maximum of 8 weeks.
    

Intervention name(s): Placebo/ CONCERTA (methylphenidate HCl); CONCERTA (methylphenidate HCl) / Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo once daily on Lab School Day #1 and Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #2; Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #1 and Placebo once daily on Lab School Day #2
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactivity Disorder
A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods
Condition: N/A, as no Specific Medical Condition Will be Treated
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the distribution of IncobotulinumtoxinA (Xeomin) in
      healthy subjects at different volumes, concentrations and doses when administered
      intradermally and subcutaneously using different delivery methods (conventional needle and
      microneedles).
    


Intervention name(s): IncobotulinumtoxinA
Intervention type(s): Drug
Intervention description(s): Intradermal injections using different delivery methods (conventional needle and microneedles)
Other intervention name(s): Xeomin; Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Intra-individual comparison
Masking: None (Open Label)
Primary purpose: Treatment
Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy
Condition: Diarrhea; Radiation Enteritis
MeSH terms: Enteritis; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation
      therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more
      effective than no further therapy for treating gastrointestinal disturbance caused by
      previous radiation therapy.

      PURPOSE: Randomized phase III trial to determine the effectiveness of pentosan polysulfate in
      treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by
      previous radiation therapy to the abdomen and pelvis.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the efficacy of pentosan polysulfate in patients with
      gastrointestinal tract sequelae after radiotherapy to the abdomen and pelvis. II. Determine
      the toxic effects of this drug in these patients. III. Determine the effect of this drug on
      symptoms and quality of life of these patients.

      OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I:
      Patients receive oral pentosan polysulfate three times a day for 2-6 months. Arm II: Patients
      receive oral placebo three times a day for 2-6 months. Both arms: Patients may receive
      retreatment for two months if symptoms return and last for at least 2 weeks. Quality of life
      is assessed before treatment, and at each follow up visit. Patients are followed every 2
      months for 6 months, then every 3 months for 18 months, then annually for 3 years.

      PROJECTED ACCRUAL: A total of 174 patients will be accrued for this study within 3 years.
    

Intervention name(s): pentosan polysulfate sodium; quality-of-life assessment
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Pentosan Sulfuric Polyester
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: radiation enteritis; diarrhea
Virtual Reality and Post-dry Needling Soreness
Condition: Healthy; Epicondylitis of the Elbow
Study type: Interventional

Summary: 
      Application of trigger point dry needling can induce post-dry needling soreness. This is not
      a negative experience, but sometimes some patients want to reduce it as much as possible.
      Different therapeutic strategies targeting to decrease post-dry needling soreness need to be
      investigated. Previous studies have investigated spray and stretch, ischemic compression or
      low-load eccentric exercise as post-needling intervention procedures. There is increasing
      evidence supporting the role of descending pain inhibition mechanisms for paon control. The
      application of virtual reality as a distraction technique could active brain mechanisms
      during dry needling. Therefore, the objective of this study will be to investigate the
      effects of playing virtual reality during the application of dry needling on post-needling
      soreness over trigger points in the extensor carpi radialis brevis muscle. A secondary aim
      will be to determine the prognostic role of baseline scores of pressure pain sensitivity,
      related-disability, anxiety and catastrophizing levels.
    


Intervention name(s): Real Virtual Reality; Placebo Virtual Reality
Intervention type(s): Other; Other
Intervention description(s): Participants will receive a distraction by playing a game of virtual reality with a 3D application; Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: trigger points; virtual reality; Dry needling
Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational
      drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and
      hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either
      placebo, 1 of 3 doses of ertugliflozin [1, 5, or 25 mg], or the approved drug
      hydrochlorothiazide [HCTZ]). The primary hypothesis of the study was that ertugliflozin was
      superior to placebo on the change from baseline in average, 24-hour systolic blood pressure
      (SBP) on Day 28.
    


Intervention name(s): Placebo to Ertuglilflozin 1 or 5 mg; Ertugliflozin 1 mg; Ertugliflozin 5 mg; Ertugliflozin 25 mg; HCTZ 12.5mg; Placebo to HCTZ; Placebo to ertuglilflozin 25 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days; Ertugliflozin tablet 1 mg once daily for 28 days; Ertugliflozin tablet 5 mg once daily for 28 days; Ertugliflozin tablet 25 mg once daily for 28 days; Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days; Placebo to HCTZ 12.5 mg capsule once daily for 28 days; Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Intervention MeSH terms: Ertugliflozin; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 2 diabetes; hypertension; ambulatory blood pressure monitoring
Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction
Condition: Sphincter of Oddi Dysfunction
MeSH terms: Sphincter of Oddi Dysfunction
Study type: Interventional

Summary: 
      The Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction(SOD) study
      (EPISOD) is a randomized sham-controlled study of biliary and pancreatic sphincterotomy as
      treatment for patients with pain after cholecystectomy fitting the criteria for sphincter of
      Oddi dysfunction type III.
    

Detailed description: 
      Clinical Trial Phase: Phase III

      Study Sites Seven clinical centers in US

      Study Period Planned enrollment period - 3 years

      Planned duration of the study - 5 years

      Study Population SOD III Patients

      Primary Study Objective: To ascertain whether subjects with SOD III respond to
      sphincterotomy,

      Secondary Study Objectives

      To evaluate:

        -  the association between the results of Sphincter of Oddi Manometry (SOM)
           (abnormal/normal) and the primary outcome (success/failure);

        -  the success rate (as defined in the primary) of subjects who receive biliary
           sphincterotomy alone versus subjects who receive both biliary and pancreatic
           sphincterotomy in the subgroup of patients with manometrically proven hypertension of
           the pancreatic sphincter;

        -  the effects of pre-specified prognostic factors on the primary outcome;

        -  anxiety and depression scores over time and their relation to study outcomes;

        -  the economic impact of SOD III, and of endoscopic sphincterotomy in patients with SOD
           III; and, to,

        -  conduct a careful follow-up study (EPISOD2) of standard of care treatment (separate
           protocol).

      Study Design The EPISOD Trial is a parallel, randomized, double-blinded, sham-controlled,
      multicenter Phase III clinical trial of endoscopic sphincterotomy as treatment for adults 18
      to 65 years of age diagnosed with SOD III.

      Sample Size A minimum of 214 subjects will be randomized using a 2:1 allocation in favor of
      sphincterotomy and will be followed for 12 months post-randomization.
    

Intervention name(s): ERCP with sphincterotomy; ERCP without sphincterotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): cutting the biliary sphincter muscle (sphincterotomy); ERCP with sphincter manometry, but no sphincterotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sphincter of Oddi Dysfunction; Pancreatitis; Sphincterotomy
Remote Monitoring in Diabetes Disease Management
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary objective of this study is to determine whether remote monitoring in diabetes
      management is more effective at helping patients manage their disease than a standard disease
      management program.
    

Detailed description: 
      To determine whether remote monitoring in diabetes management is more effective at helping
      patients manage their disease.
    

Intervention name(s): DM-Standard; Disease Management Plus
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Device/t+ Medical Diabetes Management System; Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Remote monitoring; Type 1 Diabetes; Type 2 diabetes
Zidovudine Plus Lamivudine in HTLV-I-associated Myelopathy: a Randomised Trial
Condition: HTLV-I-associated Myelopathy
MeSH terms: Paraparesis, Tropical Spastic; Spinal Cord Diseases; Bone Marrow Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To determine whether the use of two antiviral agents in combination will be better than
      placebo in the treatment of an inflammatory sidease of the spinal cord caused by HTLV-I
    

Detailed description: 
      Randomised, double-blind, placebo-controlled two centre study of zidvoudine plus lamivudine
      in HAM/TSP 24 patients randomised 1:1 2-4 week lead-in 6 months randomised phase followed by
      6 months open-label therapy with active drug Primary endpoint: clinical Secondary endpoints:
      virological and immunological
    

Intervention name(s): Zidovudine/lamivudine; Placebos
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lamivudine; Zidovudine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HAM/TSP; HTLV-I-associated myelopathy; zidovudine; lamivudine; antiretroviral therapy
The Effects of Ethanol on Intestinal Permeability and Gut Hormones
Condition: Insulin Resistance; Ethanol; Incretin Effect
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The aime of this study is to envsitigate if ethanol has an incretin effect. This is done by
      administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol.
    


Intervention name(s): Ethanol
Intervention type(s): Other
Intervention description(s): The intervention is two different administrationforms of ethanol, orally and i.v.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Incretin effect; Ethanol
A Pharmacokinetic Study in Healthy Participants to Assess the Pharmacokinetics and Safety of a Supratherapeutic Dose of PCI-32765 (Ibrutinib) Capsule and Solution Formulations Administered With Food
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of
      PCI-32765 (ibrutinib) in healthy adult volunteers.
    

Detailed description: 
      This is an open-label (identity of assigned study drug will be known), 2-period, sequential,
      exploratory study in healthy adult men and women to determine the exposure and safety of a
      supratherapeutic dose of PCI-32765 (ibrutinib) as a capsule or solution formulation
      administered with food. Eight participants (including at least 2 women) will be enrolled and
      receive 2 treatments: PCI-32765 840 mg will be administered as capsule (Treatment A in Period
      1) and solution (Treatment B in Period 2) formulations. All participants will receive both
      treatments with a 7-day washout period between doses. A high-fat breakfast will be provided 2
      hours before dosing. Serial pharmacokinetic (study of what the body does to a drug) samples
      will be collected before dosing and over 72 hours after each dose and safety will be
      monitored throughout the study. The total duration of the study will be approximately 46
      days.
    

Intervention name(s): Treatment A: PCI-32765; Treatment B: PCI-32765
Intervention type(s): Drug; Drug
Intervention description(s): 840 mg capsule formulation administered by mouth on Day 1; 840 mg solution formulation administered by mouth on Day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer; PCI-32765; PCI 45227; JNJ-54179060; Pharmacokinetic
The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      It is well known that postmenopausal women are at risk for osteoporosis. The study hypothesis
      is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with osteomalacia and
      will cause low BMD estimation in DXA scan due to insufficient bone mineralization.

      We assume that among these postmenopausal women, Vitamin D treatment will improve bone
      mineralization and will cause a rapid increase in BMD. According to the results,
      bisphosphonates therapy may be an unnecessary treatment.

      The objective of this study is to evaluate the impact of severe vitamin D deficiency and its
      correction on Bone Mineral Density (BMD) in postmenopausal women.
    


Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Screening in Oculopharyngeal Muscular Dystrophy
Condition: Oculopharyngeal Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Oculopharyngeal
Study type: Observational

Summary: 
      Oculopharyngeal muscular dystrophy (OPMD) is a rare myopathic disease that results in
      progressive degeneration of the oral and pharyngeal muscular, resulting in severe dysphagia
      and dysarthria. OPMD is considered a rare disease; therefore, limited research is available
      on the natural progression of the disease or the utility of biomarkers to identify swallowing
      impairment. The aim of this study is:

        1. To identify accurate, reliable and non-invasive clinical markers of swallowing
           impairment

        2. To determine the discriminate ability of these markers to identify impairments in
           swallow safety and swallowing efficiency.
    

Detailed description: 
      Participants will be recruited from the Neurology clinic at the University of Florida. The
      single evaluation will occur in the PIs research laboratory at the University of Florida,
      Gainesville, Florida.
    

Intervention name(s): Videofluoroscopic swallowing study; Functional Oral Intake Scale; Eating Assessment Tool-10
Intervention type(s): Procedure; Other; Other
Intervention description(s): Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.; The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.; The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
Other intervention name(s): VFSS; modified barium swallow (MBS); FOIS; EAT-10
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The sample population will consist of individuals with a diagnosis of oculopharyngeal
        muscular dystrophy.
      
Keywords: screening; OPMD; dysphagia; dysarthria
A Study of LY3305677 in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety and side effects of
      LY3305677 when it is given as an injection just under the skin to participants with type 2
      diabetes. The study will last about 20 weeks for each participant, not including screening.
    


Intervention name(s): LY3305677; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science