bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and compare the bioavailability of
      fenofibric acid from 2 different dosage strengths of ABT-335.
    


Intervention name(s): ABT-335
Intervention type(s): Drug
Intervention description(s): Once, see arm description for more information
Other intervention name(s): fenofibric acid; Trilipix
Intervention MeSH terms: Fenofibric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability
Comparison Study of Two Chiropractic Treatment Protocols for Knee Pain Due to Patellofemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to compare outcomes of combined chiropractic care in anterior
      knee pain patients with patellofemoral pain syndrome.
    

Detailed description: 
      Exercise is standard of care for PFPS but gives limited pain reduction and functional
      improvement. Previous manipulative therapy for PFPS (with and without exercise) has been
      limited to the patellofemoral joint alone. However, literature suggests additional
      manipulative therapy with exercise and soft-tissue treatment may give a better outcome.
      Further research is needed.

      Therefore, this project is a pilot study to inform a future randomized controlled trial to
      determine if chiropractic adjusting of the full lower extremity (lumbosacral through foot)
      combined with exercise and soft tissue treatment (Protocol and group A) is superior to
      chiropractic adjusting of the knee (alone) combined with exercise and soft tissue treatment
      (Protocol and group B) in the treatment of patellofemoral pain syndrome. We will use the
      Anterior Knee Pain Scale (AKPS) and Visual Analogue Scale (VAS) as valid and reliable primary
      outcome measures, a functional measure (step-ups, step-downs and squats) and a Patient
      Satisfaction Scale (PSS - discharge or refer) as secondary outcome measures. This study will
      help establish the feasibility of conducting quality research at Cleveland Chiropractic
      College Los Angeles.

      In this pilot study there will be two groups of 10 subjects each

        1. Group A will receive CMT to the knee only, exercise and soft tissue treatment (Graston
           Instrument Soft Tissue Mobilization hereafter GISTM)

        2. Group B will receive CMT to the lumbosacral, sacroiliac and (all) lower extremity
           joints, exercise and soft tissue treatment (GISTM).

      Enrolled subjects will receive a total of 6 treatments. The primary endpoint will be a 2
      month follow-up after the 6th treatment.
    

Intervention name(s): chiropractic manipulative therapy; knee exercises; Graston Instrument Soft Tissue Mobilization (GISTM)
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: patellofemoral pain syndrome; chiropractic; knee pain; chiropractic manipulation; Graston Instrument Soft Tissue Mobilization(GISTM)
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to evaluate the effect of GLPG3970 compared to
      placebo on the signs and symptoms of Ulcerative Colitis (UC) in participants with moderately
      to severely active UC.
    


Intervention name(s): GLPG3970; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GLPG3970 powder and solvent for oral solution reconstituted prior to use.; Placebo powder and solvent for oral solution reconstituted prior to use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colitis; Ulcer; Moderately active ulcerative colitis; Chronic inflammatory bowel disease; Inflammatory Bowel Diseases; Digestive System Diseases
Study to Evaluate DNL747 in Subjects With Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of multiple oral doses of DNL747 in subjects with Alzheimer's disease when
      administered for 29 days in a cross-over design
    

Detailed description: 
      This is a Phase 1b randomized, placebo-controlled, double-blind, crossover study to evaluate
      the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL747 in
      subjects with Alzheimer's disease (AD)
    

Intervention name(s): DNL747; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DNL747; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
VR for Pain Management During Adult Burn Dressing Change
Condition: Pain; Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      A randomized controlled trial to evaluate the efficacy of the VR-based Pain Alleviation Tool
      (VR-PAT) in reducing opioid pain medication use during adult burn dressing changes.
    

Detailed description: 
      A pilot three group gender-balanced randomized clinical trial (RCT) among adult burn patients
      (18 years old or above) at OSU Medical Center Inpatient Burn Program. The intervention group
      will receive VR-PAT as a distraction tool during the dressing change procedure (active VR
      group) while the comparison groups will receive either a comparable passive VR distraction
      tool that uses the same hardware and visual/audio features, but requires no active
      interaction (Control Group 1), or no distraction at all (Control Group 2).
    

Intervention name(s): VR-based Pain Alleviation Tool (VR-PAT)
Intervention type(s): Other
Intervention description(s): Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three-group RCT
Masking: None (Open Label)
Primary purpose: Treatment
Prasugrel Versus Placebo in Adult Sickle Cell Disease
Condition: Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to assess the safety of Prasugrel in adult patients with sickle
      cell disease (SCD) by monitoring the rate and severity of hemorrhagic events requiring
      medical intervention compared to placebo for 30 days.
    


Intervention name(s): Prasugrel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally, once daily for 30 days.; Administered orally, once daily for 30 days.
Other intervention name(s): Efient; Effient; LY640315; CS747
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sickle Cell Disease; Sickle Cell Anemia; Adult
Evaluating the Effects of Food Products on Energy and Performance
Condition: Energy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of food products varying in composition,
      on energy in healthy adult subjects.
    


Intervention name(s): Carbohydrate Food Bar; Modified Carbohydrate Food Bar
Intervention type(s): Other; Other
Intervention description(s): Control Food Bar containing carbohydrate; Test Food Bar containing modified carbohydrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Sample Collection in Smoking Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers
      and normal healthy subjects, to compare the biological markers of disease and inflammation.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be selected by advertisements from the general population and primary care.
      
Biospecimen description: 
      serum sputum
Thiamin Deficiency in Obese Thai Children
Condition: Obesity; Child; Thiamine Deficiency
MeSH terms: Thiamine Deficiency; Beriberi
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.
    

Detailed description: 
      This study is a cross-sectional study. The objectives of the study are to determine the
      prevalence of thiamin deficiency in obese Thai children and to assess the associations of
      dietary factors and thiamin deficiency.
    

Intervention name(s): Thiamine 1; Non-thiamine; Thiamine 2
Intervention type(s): Drug; Other; Drug
Intervention description(s): If severe symptoms and signs of thiamine deficiency are present, thiamine is prescribed.
Intervention 1 : severe symptom (heart failure, convulsion, or coma) : 50 mg thiamin administered very slowly intravenously, followed by a daily intramuscular dose of 10 mg for a week, and finally followed by 3-5 mg of thiamine per day orally for at least 6 weeks; no symptoms and signs of thiamine deficiency; If symptoms and signs of thiamine deficiency are present, thiamine is prescribed.
If mild symptom : a daily oral dose of 10 mg thiamin during the first week, followed by 3-5 mg of thiamin per day orally for at least 6 weeks
Intervention MeSH terms: Thiamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: thiamine deficiency; obese children; Thai
A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement
Condition: Penile Enhancement
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate non-inferial study of the after using Volus
      application, compared to the powerfill.
    


Intervention name(s): Volus/Powerfill
Intervention type(s): Device
Intervention description(s): Maximum: 22ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome, High Grade
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A phase I/II study to explore the feasibility and efficacy of autologous CIK cells in
      patients with acute myeloid leukemia (AML)/ high grade myelodysplastic syndrome (MDS)

        1. Group 1: As adjuvant therapy in minimal residual disease state after autologous PBSCT.

        2. Group 2: As an adoptive immunotherapy in untreated disease state when conventional
           therapy with curative intent is not applicable
    

Detailed description: 
      This is a Phase I /II study on the feasibility / efficacy of adoptive immunotherapy with
      autologous CIK cells for the following 2 groups of patients who have AML or high grade MDS :

        1. Group 1 patients in minimal residual disease state post autologous peripheral blood stem
           cell transplant ( PBSCT ), and

        2. Group 2 patients with untreated high grade MDS or AML, who are not fit for standard
           curative intent chemotherapy.

      The CIK cells will be generated by leukapheresis from patients and cultured in GMP
      facilities. Four repeated infusions will be given for a target dose of 1x10e10 T cell per
      infusion.

      Efficacy will be assessed by

        1. Disease free survival compared to historical control in group 1 given CIK cells post
           autologous PBSCT as adjuvant immunotherapy (n=20 over 3 years), and

        2. Effect on the peripheral or marrow leukemia cell load in group 2 patients given CIK
           cells as alternative therapy in place of chemotherapy (n=10).
    

Intervention name(s): Infusion of autologous CIK cells
Intervention type(s): Procedure
Intervention description(s): Autologous CIK cells will be infused at timed intervals after autologous transplant for AML for group 1 patients, and with or without some cytoreduction treatment for group 2 patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute myeloid leukemia; myelodysplastic syndrome; autologous CIK cells; autologous peripheral blood stem cell transplant
HBPL Study of the Impact of the NK1 Antagonist Aprepitant
Condition: Cocaine Dependence; Alcohol Dependence
MeSH terms: Alcoholism; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed research will focus on investigating the determinants and consequences of CAD
      via measurement of physiological, behavioral and subjective effects of physiologic and
      psychologic stress cues in CAD volunteers in the laboratory, and through examination of the
      effects of the effects of Aprepitant, an NK1 antagonist, on the above effects. This study
      will examine the effects of the above stress cues on cocaine and alcohol craving under acute
      Aprepitant dosing, and under placebo conditions. The study is a within-subjects crossover
      design using 24 subjects.
    

Detailed description: 
      Non treatment seeking subjects with DSM IV cocaine and alcohol dependence were included.
      Subjects received double-blind acute dosing of 80 mg of aprepitant (Emend) at session start,
      or matched placebo. During each session subjects were exposed to one of two types of
      stressors, one stressor per session, presented in counterbalanced order across participants.
      The Physiologic stress was the cold-pressor task. Subjects immersed their hand in cold water
      for up to 3 minutes. The psychological stress was the Trier Social Stress Test it was
      completed in 25 minutes: 5 min audio taped instructions, 10 min to mentally prepare for their
      performance tasks, 5 min to complete a public speaking task and 5 min to complete a mental
      arithmetic task. Outcome measures included: Alcohol Craving measured by visual analog scale,
      cocaine craving measured by visual analog scale and The Multiple Choice Procedure. Each
      assessment was done during study screening, and then at multiple times during each study
      session.
    

Intervention name(s): Placebo session 1, Aprepitant session 2; Placebo session 1, Placebo session 2
Intervention type(s): Drug; Drug
Intervention description(s): placebo in session 1, Aprepitant 80 mg in session 2, oral administration.; Placebo, one per session, oral administration
Other intervention name(s): Aprepitant; Placebo
Intervention MeSH terms: Aprepitant; Fosaprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cocaine and alcohol dependence (CAD)
A Study of Mycophenolate Mofetil and Cyclosporin, Without Concomitant Corticosteroids, After a First Renal Transplant
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The trial is planned as a multicentric, randomized, prospective, open study in accordance
      with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with
      chronic renal insufficiency, included in the French national waiting list of the
      Establishment Français des Greffes [French Transplants Institution] and receiving a first
      renal transplant will be included, after signed agreement, in this study. All the patients
      will receive organs taken from brain-dead subjects. The patients will be given
      immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ
      cyclosporin. One group of 100 randomised patients will be given standard corticosteroid
      therapy as well during the first six months following the transplant. This group will be
      compared with a second group of 100 randomised patients who will be given a single dose of
      corticosteroids. The main aim of this study is to evaluate the number of acute rejection
      episodes in patients given a first renal transplant and subjected to an immunosuppressant
      protocol not containing corticosteroids. The hypothesis which is proposed is that, in the
      absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus),
      antilymphocyte serum results in a certain state of "tolerance" in respect of the allograft.
      The second objective concerns the beneficial effect which the absence of corticosteroids may
      have on short- and long-term postoperative morbidity and mortality. One may in fact assume
      that the absence of corticosteroids will result in an extension of the transplant patient's
      life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular
      complications are the most frequent cause of death after a renal transplant.
    


Intervention name(s): Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids.; Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids.
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Cyclosporins; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SHP-141C in Plaque Type Psoriasis
Condition: Plaque Type Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and clinical activity of the
      SHP-141C topical cream formulations in patients with plaque type psoriasis.
    

Detailed description: 
      Psoriasis is a chronic, relapsing immunoinflammatory disorder. Chronic plaque psoriasis is
      the most common (85% - 90%) type. Cutaneous features of individual plaques include circular
      with centrifugal expansion, induration with sharp demarcation from surrounding skin, erythema
      and hyperkeratosis. Psoriasis has a negative impact on physical and mental aspects of life
      that is similar to other major chronic conditions. The modalities of psoriasis treatments can
      be divided into four main categories: topical, phototherapy, systemic drug therapies and
      systemic biological treatments. The currently available treatments for psoriasis result in
      either disease suppression or disease remission.There are many treatment options for the
      management of psoriasis using topical modalities; however all are lacking with respect to
      patient satisfaction and durability of treatment. Most current topical treatments, and many
      treatments in development, are based on modifications of a steroid structure or on Vitamin D.
      Recent research has identified a broad role for histone deacetylase (HDAC) proteins in
      numerous signaling pathways critical to cancer cell survival, such as epigenetic inheritance,
      gene regulation, mitosis,signal transduction and importantly, inflammation. Theoretically
      modulation of HDAC could lead to clinical benefit in inflammatory diseases.
    

Intervention name(s): SHP-141C; Placebo to SHP-141C; Betamethasone Valerate; Calcipotriol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical Cream; Placebo Topical Cream; Topical cream, 0.02%; Topical cream, 0.005%
Other intervention name(s): SHAPE; Placebo to SHAPE; Celestone-M; Daivonex
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis
Psychotherapy of Generalized Anxiety Disorder
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effects of worry exposure with the effects of
      applied relaxation in patients with generalized anxiety disorder.
    

Detailed description: 
      Controlled treatment studies show that there is a lower efficacy of cognitive-behavioral
      treatment of generalized anxiety disorder (GAD) than in other anxiety disorders. The best
      effect sizes are found for applied relaxation (Öst), but there are only three treatment
      studies. Another, yet previously not tested in its pure form, approach is "worry-exposure",
      which aims at confronting the emotionally intensive imaginative contents of worries in GAD.

      Fifty-two randomized patients with GAD as a primary diagnosis will be treated with one of the
      two treatments and will be compared with waiting-list patients. This treatment protocol
      contains 15 sessions (+/-2) and a 6 month and 12 month follow-up.

      The comparisons in this study include: worry exposure versus applied relaxation versus a
      waiting control group.
    

Intervention name(s): Worry exposure; Applied relaxation
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotherapy; Generalized Anxiety Disorder; randomized-controlled trial; worry exposure; applied relaxation