bioihbjkbjnl/mcl2 huggingface dataset:
Intraocular Pressure Change Following Intravitreal Injection of Anti-vascular Endothelial Growth Factor Agent
Condition: Intraocular Pressure
Study type: Observational

Summary: 
      The introduction of additional fluid into the vitreous cavity by intravitreal therapy would
      be expected to cause an immediate rise in the intraocular pressure. This transient,
      short-term intraocular pressure elevation (lasting up to 30 minutes) after intravitreal
      anti-vascular endothelial growth factor therapy has been well describe. The investigators aim
      to study the prevalence of the sustained intraocular pressure elevation associated with
      intravitreal injection of anti-vascular endothelial growth factor agents.
    

Detailed description: 
      Intravitreal injections of anti-vascular endothelial growth factor agents are commonly used
      to treat a variety of retinal and choroidal neovascular diseases. The introduction of
      additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause
      an immediate rise in the intraocular pressure.

      Although there is one study showed no significant changes in the intraocular pressure many
      retrospective studies showed the impacts on the intraocular pressure elevation. The
      investigators aim to prospective evaluate the intraocular pressure change in non-glaucomatous
      patients receiving an intravitreal anti-vascular endothelial growth factor therapy.
    

Intervention name(s): Intravitreal injection (bevacizumab or ranibizumab)
Intervention type(s): Drug
Intervention description(s): The intravitreal anti-vascular endothelial growth factor agent of 0.1 ml of bevacizumab (2.5 mg/0.1 ml) or ranibizumab (1 mg/0.1 ml)
Other intervention name(s): anti-vascular endothelial growth factor agent
Intervention MeSH terms: Bevacizumab; Ranibizumab; Endothelial Growth Factors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients scheduled to receive intravitreal injection of anti-vascular endothelial
        growth factor agent (either bevacizumab or ranibizumab) and were recruited.
      
Keywords: intraocular pressure; intravitreal
Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi and PE5i
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      This study will measure the effect of the agent tadalafil on glucose and insulin homeostasis
      in people with metabolic syndrome in the presence and absence of an ACE inhibitor.
    


Intervention name(s): Ramipril; Tadalafil; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ramipril 10 mg per day for three weeks; tadalafil 10 mg every other day for three weeks; placebo matching ramipril; placebo matching tadalafil
Other intervention name(s): Altace; Cialis; matching ramipril; matching tadalfil
Intervention MeSH terms: Ramipril; Tadalafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Prospective Observational Study to Evaluate Long-term Changes in Cartilage Morphology in Subjects Who Previously Received TPX-100 or Placebo in Study TPX-100-1 for Patellar Osteoarthritis Involving Both Knees
Condition: Mild to Moderate Knee OA
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus
      placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.
    

Detailed description: 
      No drug intervention. Study to collect 1 additional MRI of each knee treated in either
      TPX-100-1 or TPX-100-2.
    

Intervention name(s): Previous treated with TPX-100
Intervention type(s): Other
Intervention description(s): No intervention, only observational
Other intervention name(s): AC-100
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Subjects with bi-lateral knee OA that have previous been treated in TPX-100-1 or TPX-100-2
The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The safety/tolerability and pharmacokinetics (PK) of Naftopidil (commercial name: Flivas)
      after oral administration will be investigated in Korean healthy male volunteers. All
      volunteers will be assigned to 2 groups and administered a lower single dose tablet (Period
      1). After one week's wash-over period, the volunteers take higher dosages (Period 2).
    


Intervention name(s): Naftopidil
Intervention type(s): Drug
Intervention description(s): 25mg/ 50 mg/ 75mg dosage tablets
Intervention MeSH terms: Naftopidil
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Safety; tolerability
The Effects of One-Time Pregnenolone, Dehydroepiandrosterone (DHEA), or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers
Condition: Substance Withdrawal Syndrome
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the potential therapeutic value of two neurosteroid treatments (DHEA
      and pregnenolone) in the treatment of tobacco withdrawal symptoms. This will include
      assessing whether these agents relieve craving for cigarettes elicited by exposure to a
      mildly stressful cognitive task. Pregnenolone (400 mg orally), DHEA (400 mg orally) and
      placebo will be administered one at each of the three sessions in a randomized order.
    


Intervention name(s): dehydroepiandrosterone (DHEA); pregnenolone; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): one-time 400mg oral dose of DHEA; one-time 400mg oral dose of pregnenolone; one-time dose oral dose
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cigarette Smokers; DHEA; dehydroepiandrosterone; pregnenolone; Nicotine withdrawal symptoms
Effects of Dietary Fibre on Glucose Metabolism and Satiety
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The experimental model is a semi-acute study where the purpose of the study is to evaluate
      food factors related to colonially derived regulation of glucose metabolism (and related
      parameters) and satiety in healthy subjects.
    


Intervention name(s): Test meal; Reference; Priming; No priming
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The reference or test meal was eaten 3 days prior to measurements of variables.; The reference or test meal was eaten 1 days prior to measurements of variables.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Respiratory Tract Infections; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and
      antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who
      are 35 weeks or greater gestational age and entering their first RSV season.
    

Detailed description: 
      This pivotal Phase 3 study will determine if MEDI8897 will prevent medically attended
      RSV-confirmed lower respiratory tract infections (LRTI) in healthy infants entering their
      first RSV season. The population to be enrolled is healthy late preterm and term infants born
      35 weeks 0 days or greater gestational age (GA) who would not be eligible to receive RSV
      prophylaxis. A total of approximately 3,000 infants will be randomized 2:1 to receive either
      MEDI8897 or placebo. All subjects will be followed for approximately 510 days after dosing.
      Enrollment is planned at approximately 350 sites across the USA, Canada, Europe, Asia, and
      Southern Hemisphere.
    

Intervention name(s): MEDI8897; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anti-RSV monoclonal antibody with an extended half-life; Commercially available 0.9% (w/v) saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory Syncytial Virus; RSV; Late Preterm Infants; Healthy Infants; Lower Respiratory Tract Infection
Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the trial is to investigate the relative bioavailability, influence of
      pantoprazole coadministration and food effect of different oral formulations of BI 113608 in
      healthy male subjects
    


Intervention name(s): BI 113608 PIB; BI 113608; BI 113608; BI 113608; pantoprazole 40 mg STADA; BI 113608
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): powder for oral solution; conventional tablet formulation; conventional tablet formulation; conventional tablet formulation; film-coated tablet; conventional tablet formulation
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study in the Use of Orthotics in Treating Pain in the Front of the Knee
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Musculoskeletal conditions account for the third leading cause of health systems expenditure
      in Australia. Patellofemoral pain syndrome or pain about the knee cap is such a condition
      often treated in primary care. Both the individual and community are affected by this
      condition with an estimated 1 in 4 sufferers having problems and pain up to 20 years after
      first being afflicted. Importantly, it interferes with activities such as walking, jogging,
      gym classes and aerobics, which are often prescribed to prevent serious conditions of the
      heart, diabetes and obesity. Hence, it negatively impacts the health and well being of our
      nation.

      Two popular treatment options that are commonly prescribed for the management of
      patellofemoral pain syndrome are physiotherapy and foot orthotics. To date, there is some
      evidence supporting physiotherapy, especially current best practice methods, such as a
      combined program of therapeutic exercise, manual therapy and kneecap taping. There is a lack
      of evidence for the use of orthotics in treating patellofemoral pain syndrome.

      This project will conduct a randomised clinical trial to evaluate the relative benefits of
      orthotics as the sole treatment of patellofemoral pain syndrome and also when combined with
      physiotherapy. Factors associated with predicting the results of orthotic therapy will be
      studied to see if there are any tests that a health care practitioner can perform to provide
      information early on in a consultation regarding possible treatment outcomes. A cost-benefit
      analysis will also be conducted to calculate the relative economic merits of the treatments.

      A tangible outcome of this project will be the development of clinical guidelines for the
      most effective method of treating patellofemoral pain syndrome in primary health care.
    

Detailed description: 
      Musculoskeletal conditions account for the third leading cause of health systems expenditure
      in Australia. Patellofemoral pain syndrome or pain about the knee cap is such a condition
      often treated in primary care. Both the individual and community are affected by this
      condition with an estimated 1 in 4 sufferers having problems and pain up to 20 years after
      first being afflicted. Importantly, it interferes with activities such as walking, jogging,
      gym classes and aerobics, which are often prescribed to prevent serious conditions of the
      heart, diabetes and obesity. Hence, it negatively impacts the health and well being of our
      nation.
    

Intervention name(s): Foot Orthotics; Physiotherapy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Anterior Knee Pain
ADalimumab in Persistent Early Oligoarthrits Study (ADEOS)
Condition: Oligoarthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate adalimumab, a drug that is currently licensed for
      treatment of patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
      and inflammatory bowel disease (Crohn's disease). It is a protein (human monoclonal antibody)
      that is designed to block the effects of an inflammatory cytokine, tumour necrosis factor
      alpha (TNF alpha) which is a causative factor in joint inflammation. It is given as a
      subcutaneous injection.

      Management of established rheumatoid arthritis has been transformed with the use of
      TNFantagonists, the first in the class of biological agents. The benefits in early RA are
      also continuing to emerge. Oligoarthritis represents a subgroup of early inflammatory
      arthritis that warrants more effective treatment strategy including the potential to modulate
      the disease course and halt further progression. The TNFantagonists offer the potential of
      achieving this, justifying this initial investigation.

      Hence, this study is designed to establish the benefit of adalimumab in preventing
      progression of oligoarthritis. The primary aim of the study is to assess how many patients
      achieve remission i.e. no further evidence of joint inflammation or damage. The investigators
      will do this by including patients who present with inflammation of four or less joints who
      do not fulfil criteria for a definite arthritis condition such as rheumatoid arthritis. The
      investigators will perform clinical, laboratory (blood tests) and imaging assessments at
      regular intervals on these patients to check on safety of the study drug adalimumab and
      evaluate any changes in disease activity that may have resulted from use of adalimumab. All
      patients will receive treatment with a standard therapy (methotrexate) with randomisation of
      half of the patients to receive the active study drug, adalimumab as additional treatment for
      six months.
    


Intervention name(s): Adalimumab; Methotrexate; Placebo; Folic Acid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo to replace adalimumab
Intervention MeSH terms: Folic Acid; Adalimumab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess
      the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the
      reference nicotine gums (2 mg and 4 mg) in healthy smokers.
    


Intervention name(s): Nicotine (2 mg); Nicotine (4 mg)
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg nicotine gum in two formulations; 4 mg nicotine gum in two formulations
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nicotine; nicotine replacement therapy; nicotine gum
The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy
Condition: Multimedia Learning Education; Self-care; Quality of Life; Enterostomy
Study type: Interventional

Summary: 
      This report was an effective evaluation of using multimedia educational program for self-care
      and quality of life in patients with a stoma at postoperative and established a simple
      threshold for enterostomy self-care skills.
    

Detailed description: 
      In a systematic review, evaluated the effectiveness of multimedia education program (MLEP)
      and confirmed that MLEP reduced cost significantly and improved patient participation in
      enterostomy care and self-care ability. However, research was insufficient for whether a
      multimedia education program (MLEP) interventions can improve patient self-care and quality
      of life.
    

Intervention name(s): multimedia education
Intervention type(s): Other
Intervention description(s): The MLEP intervention was based on a literature review of prior research on the content and format of self care related multimedia education programmes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD
Condition: Sickle Cell Disease; Pain
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      Pain is the primary complication of sickle cell disease (SCD), including vaso-occlusive
      crises and more persistent, chronic pain. SCD-related pain is associated with significant
      functional impairment, spanning poor school attendance, decreased quality of life, and stress
      and mood difficulties. Pharmacological approaches are the first-line treatment for
      SCD-related pain, but these can be costly and have unwanted side effects. Given limitations
      from pharmacological approaches and the influence that poor behavioral responses have on
      disease management and health outcomes suggest a critical need for alternative and adjunctive
      treatments. Due to gaps in available behavioral treatments specifically designed for
      addressing common challenges associated with pain management in pediatric SCD, the
      investigators developed a manualized behavioral therapy protocol by tailoring existing
      evidence-based treatments. The overall goal of the intervention is to reduce the impact of
      pain on daily functioning in pediatric SCD. This study will empirically test the feasibility
      and preliminary efficacy of this intervention for youth with SCD. Children and adolescents
      with SCD between the ages of 8 and 17 years old (n=20) will be recruited to complete the
      treatment protocol. Feasibility will be assessed by examining participation and program
      completion rates, as well as feedback from a treatment acceptability questionnaire and
      qualitative interview. Participants will complete baseline assessments, weekly
      questionnaires, and post-treatment assessments (post-intervention assessment, follow-up time
      points: 1-month following the intervention, and 3-months following the intervention).
    


Intervention name(s): The Balance Program
Intervention type(s): Behavioral
Intervention description(s): The Balance Program is a four-week behavioral intervention (each session lasting 60 minutes) developed specifically for the pediatric SCD population based on existing evidence-based treatments to target the unique presentation of pain-related disability in SCD.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

        -  To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in
           hypertensive patients with diabetes and microalbuminuria.

      Secondary objectives:

        -  To determine how well irbesartan 300mg is tolerated versus 150mg

        -  To determine the percentage of patients reaching the blood pressure target of 130/80
           mmHg
    


Intervention name(s): Irbesartan; Irbesartan
Intervention type(s): Drug; Drug
Intervention description(s): Administration throughout the study period; Administration throughout the study period
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of ME1111 in Patients With Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety and efficacy of high and low strength of
      ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.
    


Intervention name(s): ME1111 Solution, Low strength; ME1111 Solution, High strength; Matching Vehicle Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ME1111 Solution, Low strength, applied once daily for 48 weeks; ME1111 Solution, High strength, applied once daily for 48 weeks; Matching Vehicle Solution, applied once daily for 48 weeks
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)
Condition: Adult T-cell Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in
      terms of survival benefit.
    

Detailed description: 
      Nothing to describe.
    

Intervention name(s): VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis; biweekly-CHOP with G-CSF and intrathecal prophylaxis
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ATLL; chemotherapy; phase III study; VCAP-AMP-VECP; biweekly-CHOP
Fiber Fermentation Study
Condition: Intestinal Health
Study type: Interventional

Summary: 
      The aim of the study is to better understand the interplay between the intake of dietary
      fiber and intestinal bacteria, their metabolic activity and the effect on the intestinal
      barrier.

      The effect of two different dietary fiber supplements is tested (arabinoxylan & ß-glucan
      versus inulin & fructooligosaccharides) in a randomized crossover intervention trial
      including healthy volunteers.
    


Intervention name(s): Dietary fiber supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): 16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan)
16g/day: mix of 50% inulin and 50% oligofructose from chicory
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two-armed crossover trial
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Gastroenterology; Gut microbiome; Gut barrier