bioihbjkbjnl/mcl2 huggingface dataset:
Wedged Orthoses and Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The five-year goal of this project is to investigate the effect of in-shoe wedged orthoses on
      lower extremity function in patients with knee osteoarthritis. In general, our aims address
      the long-term effects of orthoses. The investigators hypothesize that subjects who use the
      lateral wedged in shoe orthosis will result in altered gait mechanics that reflect a
      reduction in the frontal plane knee joint moment compared to subjects who use a neutral in
      shoe orthosis.
    

Detailed description: 
      Introduction: In shoe wedged orthoses have been shown to be an effective conservative
      approach in reducing pain in patients with osteoarthritis (OA). The mechanism responsible for
      this pain reduction is not well-understood. It is not known whether placing a medial or
      lateral wedge in the shoe results in alterations in lower extremity alignment, knee joint
      moments or some combination of the two. The longterm effects of this intervention on OA
      patients' functional status as well the progression of their OA has not been studied.
      Therefore, the purpose of this study is to examine the effect of in-shoe wedged orthoses in
      patients with knee OA on the frontal plane knee joint moment. Methods: 38 patients between
      the ages of 40-70 yrs with knee OA (grades I-IV) will be recruited from within the medical
      community. Subjects with a diagnosis of unilateral knee OA of greater than 3 months duration,
      as defined by the American College of Rheumatology Guidelines, will be included. 19 subjects
      will be assigned to a treatment group and 19 subjects will be assigned to a control group.
      The treatment group will receive custom molded orthotics with a lateral wedge. Both the
      treatment and control groups will be tested initially and then again 1 year later. The
      dependent variable is peak knee adduction moment. Statistics: A two-way ANOVA will be used to
      test the hypothesis. This design will include 2 levels of group (control and treatment) and
      two levels of trial (pretest and 1 yr posttest). Significance will be determined at a level
      of p<.05.
    

Intervention name(s): wedged inshoe orthosis; neutral inshoe orthosis
Intervention type(s): Device; Device
Intervention description(s): Treatment subjects were prescribed an inshoe wedged orthosis; Control subjects were prescribed a neutral inshoe orthosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: knee osteoarthritis; orthosis; wedge; gait
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)
Condition: Pruritus; Notalgia Paresthetica
MeSH terms: Pruritus; Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the
      efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with
      notalgia paresthetica and moderate to severe pruritus.
    

Detailed description: 
      The study will consist of a 37-day Screening period, a 7-day Run-In period, a 8-week
      Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow
      Up visit approximately 14 days after the last dose of study drug.

      All subjects will sign an informed consent form (ICF) and undergo screening for study
      eligibility.

      Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a
      dose of 2.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.

      Subjects who complete the Placebo-Controlled Treatment period of the study will transition
      into the Active Extension period upon completion of the Week 8 visit assessments. All
      subjects in the Active Extension will receive difelikefalin (CR845).
    

Intervention name(s): difelikefalin 2.0 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral difelikefalin 2.0 mg administered twice daily; Oral Placebo administered twice daily
Other intervention name(s): CR845
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Notalgia Paresthetica; Pruritus; CR845; Chronic Itch; difelikefalin; Itch; Itching; Generalized pruritus; NP; Neuropathic itch
Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The overarching goal of this project is to evaluate the feasibility of implementing
      dialectical behavior therapy DBT for adolescents with bipolar disorder in an outpatient
      mental health clinic. In collaboration with the University of Pittsburgh, this study will
      measure study therapists' knowledge of the DBT model, adherence to the treatment model, and
      satisfaction with the treatment model.
    

Detailed description: 
      This study proposes to implement dialectical behavior therapy (DBT) for adolescents with
      bipolar disorder (BD) in an outpatient mental health clinic serving youth with bipolar
      spectrum disorders. In collaboration with the University of Pittsburgh, this study will
      systemically operationalize, implement, and examine the specific training, supervision, and
      programmatic systems needed to successfully implement and sustain the intervention in an
      adherent manner to achieve positive patient outcomes. This study therefore presents a unique
      opportunity to enhance understanding of the necessary procedures for implementing the
      treatment in the community, while allowing us to examine effectiveness of the intervention at
      the community level.

      Aim 1: To examine the short- and longer-term feasibility and acceptability of a training
      program in DBT for adolescents with BD through clinician satisfaction ratings.

      Aim 2: To examine the short- and longer-term effects of the training on practitioner
      knowledge and performance, and patient outcomes.
    

Intervention name(s): Dialectical behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): DBT will be conducted over 1 year, and divided into two modalities: skills training, conducted in 60 minute biweekly family meetings and individual therapy conducted in 60 minute biweekly sessions. Family skills training proceeds as follows: psychoeducation about DBT and bipolar disorder, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the adolescent in applying skills in their daily lives. We adopt the standard DBT hierarchy of treatment targets, whereby the individual therapist selects behaviors to focus on based on the following priorities: 1) decreasing life-threatening behaviors, 2) decreasing therapy-interfering behaviors, 3) decreasing quality-of-life interfering behaviors, and 4) increasing behavioral skills. Therapists will be available to participants and their participating family members by cell phone for in-vivo skills coaching between sessions.
Other intervention name(s): DBT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dialectical behavior therapy
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency
Condition: Diabetes Mellitus, Type 2
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial is designed to provide additional information on the safety and
      tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in
      patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular
      filtration rate (GFR) < 30 mL/min) for a period of 24 weeks.
    


Intervention name(s): vildagliptin; Sitagliptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes, vildagliptin
Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
    


Intervention name(s): Clonazepam
Intervention type(s): Drug
Intervention description(s): 1 Dose
Intervention MeSH terms: Clonazepam
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CBT With Disulfiram and Contingency Management
Condition: Cocaine Abuse
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of four treatments for chronic cocaine use and may help study participants to
      control their drug use. All participants will receive weekly individual cognitive behavioral
      therapy (CBT).
    

Detailed description: 
      This study will compare four types of treatment involving skills training and incentives for
      attending sessions or taking study medication. Disulfiram is a widely prescribed deterrent to
      alcohol use. In addition to weekly cognitive behavioral therapy (CBT), participants will be
      assigned to one of the following treatments:

        1. placebo

        2. disulfiram

        3. placebo plus incentives for cocaine abstinence and medication compliance (prize CM)

        4. disulfiram plus incentives for cocaine abstinence and medication compliance
    

Intervention name(s): disulfiram; Placebo; Placebo plus Contingency Management; Disulfiram plus Contingency Management
Intervention type(s): Drug; Drug; Behavioral; Drug
Intervention description(s): 250mg per day of Disulfiram plus CBT; Placebo plus CBT; Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT; 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
Other intervention name(s): antabuse; antabus; antabuse; antabus
Intervention MeSH terms: Disulfiram
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: disulfiram; cognitive behavioral therapy; contingency management; drug abuse therapy; educational/resource design/development
A Phase I Open-Label Study of the Effects of Tacrolimus and Cyclosporine on CP-690,555 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A new immunosuppressive drug, based on the inhibition of important enzymes in the immune
      system, called JAK, is being developed by Pfizer to prevent transplant rejection. Since many
      treatments for transplant rejection may be administered together, this research study will
      analyze the effects of common transplant rejection therapies, Tacrolimus and Cyclosporine, on
      the JAK inhibitor, CP-690,550.
    


Intervention name(s): CP- 690,550 and Tacrolimus; CP- 690,550 and Cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg, single dose of CP-690,550 on Day 1 5 mg, every 12 hours of Tacrolimus on Days 1-8 10 mg, single dose of CP-690,550 on Day 8; 10 mg, single dose of CP-690,550 on Day 1 200 mg, every 12 hours of Cyclosporine on Days 1-6 10 mg, single dose of CP-690,550 on Day 6
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins; Tofacitinib
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunosuppression, JAK3 inhibitor, calcineurin inhibitors, tacrolimus, cyclosporine, pharmacokinetics, safety, tolerability
EUS GUIDED Transduodenal Biopsy Using the 19G Flex
Condition: Abdominal Neoplasms
MeSH terms: Abdominal Neoplasms
Study type: Interventional

Summary: 
      This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in
      nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the
      acquisition of samples for histologic analysis. Patients with lesions that can be approached
      only from the duodenum will be prospectively enrolled.
    

Detailed description: 
      A 19 gauge needle in nitinol (Flex needle) has been recently become available for EUS guided
      procedure.

      The use of nitinol should guarantee a better needle flexibility with a theoretical advantage
      on the use of this needle for lesions that need to be sampled through the duodenum. Moreover,
      samples for histologic examination seems to be easy to interpret than cytologic ones allowing
      evaluate of the overall architecture of the tissue, better performance of immunohistochemical
      staining, and may be of additional value to perform tissue profiling that in the future will
      be very important to guide individualized therapies

      The existing data on the performance of the Flex needle for EUS-guided transduodenal biopsy
      are coming form a single study performed in one single center. Thus, the reproducibility of
      these results is unknown and multicenter prospective studies are warranted to answer this
      important question.
    

Intervention name(s): Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)
Intervention type(s): Device
Intervention description(s): EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: EUS-guided biopsy, EUS-FNB
Electronic Intervention to Chronic Opioid Therapy
Condition: Chronic Opioid Therapy
Study type: Interventional

Summary: 
      This pilot study will attempt to apply an electronic chart intervention to improve safety for
      patients on chronic opioid medications.
    


Intervention name(s): opioid prescribing
Intervention type(s): Other
Intervention description(s): Individualized taper and safety recommendations will be communicated to prescribers via an electronic medical record encrypted message.
Intervention MeSH terms: Analgesics, Opioid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets
Condition: Diabetes Mellitus, Non-Insulin-Dependent; Hyperglycemia
MeSH terms: Hyperglycemia; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The objective of this study is to determine the bioequivalence of Glipizide GITS (Glucotrol
      XL) 2.5 mg tablets manufactured at the Brooklyn, New York facility versus tablets
      manufactured at the facility in Barceloneta, Puerto Rico.
    


Intervention name(s): Glipizide GITS
Intervention type(s): Drug
Intervention MeSH terms: Glipizide
Time perspective: Prospective
UCP Glaucoma Treatment for Primary Glaucoma in China
Condition: Glaucoma Treatment Using Focused Ultrasound
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      To collect safety and efficacy data on Ultrasound Cycle Plasty treatment (UCP) in primary
      glaucoma asian patients.
    


Intervention name(s): Ultrasound Cyclo Plasty (UCP)
Intervention type(s): Device
Intervention description(s): Cyclocoagulation using High Intensity Focused Ultrasound
Other intervention name(s): UCP by EyeOP1 device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glaucoma, ciliary body, ultrasound
MicroRNAs as Biomarkers in Patients With Chagas Disease
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Observational

Summary: 
      The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the Chagas
      Disease prognosis. This analysis will be done through the correlation between the plasmatic
      levels of this molecule with functional and laboratory tests.
    

Detailed description: 
      The patients included in the study must at first sign the written consent. They shall be
      accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael -
      Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests,
      including:

        -  Collection of Blood samples for biochemical analysis;

        -  Electrocardiogram;

        -  Holter Electrocardiogram;

        -  Echocardiogram;

        -  Treadmill Test;

        -  X-Ray Imaging;

        -  Magnetic Resonance Imaging;

        -  Evaluation of the quality of life through the application of questionnaires (SF 36 and
           the Minnesota Living With Heart Failure Questionnaire).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Tertiary Hospital
      
Biospecimen description: 
      Plasma, Serum, Whole Blood
    
Keywords: MicroRNAs; Chagas disease; Biomarkers
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively
      and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2
      years, and substantial weight loss, oral and i.v. midazolam are administered once more and
      blood samples are taken again.
    


Intervention name(s): Midazolam
Intervention type(s): Drug
Intervention MeSH terms: Midazolam
Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects
Condition: Pharmacokinetics of ASKP1240; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and
      pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in
      healthy subjects.
    


Intervention name(s): ASP1240; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): infusion; infusion
Other intervention name(s): Sodium Chloride solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Healthy Volunteers; B cell CD40 receptor occupancy; anti-CD40 monoclonal antibody
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1
      dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced
      elevations in serum triglycerides. The study has a 2-part design with sequential conduct of
      Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The
      overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned
      to be identical, however, data from Part 1 will be used to determine whether to conduct Part
      2.
    


Intervention name(s): PF-06865571; PF-05221304; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet
Other intervention name(s): DGAT2i; ACCi
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose-ranging of combination doses
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Fiber Tolerability in Children
Condition: Signs and Symptoms, Digestive
MeSH terms: Signs and Symptoms, Digestive
Study type: Interventional

Summary: 
      Assessment of the digestive tolerability of the PROMITOR® .
    

Detailed description: 
      The trial will be multicenter, double-blind, placebo-controlled, randomized with a 4-arm
      parallel-design. The subjects wil be randomized to one of the four arms, i.e. four doses of
      investigational product balanced in maltodextrin, given at the doses of 6, 9 or 12 g
      (corresponding to 4, 6, or 8 g of fibers) twice a day with the meals of the morning and of
      the evening versus control (maltodextrin, no fibers) over one week of intake.

      The total sample size is 40 healthy children from 8 to 12 years old, male and female.
    

Intervention name(s): Placebo (including Maltodextrin); PROMITOR® (including Maltodextrin); PROMITOR® (including Maltodextrin); PROMITOR® (including Maltodextrin)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Investigational product dose 1; Investigational product dose 2; Investigational product dose 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Fiber tolerability; Children