bioihbjkbjnl/mcl2 huggingface dataset:
Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of the study are:

        -  To evaluate the safety and tolerability of three dose levels of MT-1303 in subjects with
           moderate to severe chronic plaque psoriasis.

        -  To evaluate the efficacy of three doses levels of MT-1303 in subjects with moderate to
           severe chronic plaque psoriasis compared to placebo after 16 weeks of treatment on
           Psoriasis Area and Severity Index (PASI).
    


Intervention name(s): MT-1303-Low; MT-1303-Middle; MT-1303-High; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis; Plaque Psoriasis
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Condition: Intraocular Melanoma; Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from DNA may help the body build an effective immune response to
      kill tumor cells. Giving the vaccine in different ways may make a stronger immune response
      and kill more tumor cells.

      PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine
      therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage
      III, or stage IV melanoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the safety and feasibility of particle-mediated epidermal delivery (PMED)
           immunization comprising mouse gp100 plasmid DNA vaccine in patients with stage IIB, IIC,
           III, or IV melanoma.

        -  Compare the immunologic response induced with PMED vs intramuscular jet injection
           methods of vaccination in these patients.

      Secondary

        -  Observe patients with measurable tumor for evidence of any antitumor response generated
           after vaccination.

        -  Assess for disease relapse in patients treated with this vaccine.

      OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive mouse gp100 plasmid DNA vaccine by particle-mediated epidermal
           delivery on days 1, 3, 5, 8, 22, 24, 26, 29, 43, 45, 47, 50, 64, 66, 68, and 71.

        -  Arm II: Patients receive mouse gp100 plasmid DNA vaccine by intramuscular jet injection
           on days 1, 3, 5, 8, 22, 24, 26, 29, 43, 45, 47, 50, 64, 66, 68, and 71.

      After completion of study treatment, patients are followed periodically for 1 year.
    

Intervention name(s): mouse gp100 plasmid DNA vaccine; The Dermal PowderMed® devices; intramuscularly (IM injection)
Intervention type(s): Biological; Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma; ciliary body and choroid melanoma, medium/large size; ciliary body and choroid melanoma, small size; recurrent intraocular melanoma; metastatic intraocular melanoma
Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if treatment with intramuscular hepatitis B virus
      immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe
      for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation.
    


Intervention name(s): intramuscular hepatitis B virus immune globulin
Intervention type(s): Drug
Intervention description(s): Biweekly intramuscular doses of 2000 IU administered during 6 consecutive months
Other intervention name(s): Igantibe
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; HBV; Anti-hepatitis B antibodies; Immunoglobulins; liver transplantation; Protective levels; Recurrence; Intramuscular
The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the intake of kiwi fruits will reduce
      systolic and diastolic blood pressure compared to intake of apples. The investigators
      hypothesize that the increased intake lutein or other components in the kiwi fruit will
      enhance nitric oxide bioavailability and lead to vascular relaxation.
    

Detailed description: 
      An interesting finding in the Oslo Antioxidant Study was that intake of 3 kiwi fruits reduced
      blood pressure in a clinical significant manner compared to controls. The mechanism for the
      blood pressure reducing effect of kiwi or the responsible components are not elucidated.
      However, plasma lutein levels and antioxidant capacity measured by the ferric reducing
      antioxidant power was increased in the kiwi group. Moreover, gene expression was also altered
      by the increased intake of kiwi.
    

Intervention name(s): Kiwi fruits; Apple
Intervention type(s): Other; Other
Intervention description(s): Daily intake of 3 kiwi fruits for 8 weeks; Daily intake of 1 apple (equivalent in energy) for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kiwi fruits; Blood pressure; Endothelial function; Antioxidant capacity
The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA
Condition: Type 1 Diabetes Mellitus; Hypoglycemia Unawareness
MeSH terms: Unconsciousness; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine what the effects are of real-time continuous
      glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus
      and impaired hypoglycemia awareness.
    

Detailed description: 
      The investigators hypothesize that the use of RT-CGM, relative to a control intervention
      using masked CGM, will result in improvement of various measures of glycemia and indicators
      of quality of life, reduce the occurrence of hypoglycemia and hyperglycemia and restore
      hypoglycemia awareness in T1DM patients with IHA. We will test this hypothesis by addressing
      the following research questions:

      What is the effect of 16 weeks of RT-CGM use, versus 16 weeks of CGM use, in patients with
      T1DM and IHA on

        1. (primary objective:) time spent in euglycemia

        2. (secondary objectives:)

             -  (diabetes-specific) markers of QoL, covering diabetes-related emotional distress
                (PAID-5), fear of hypoglycemia (HFS-2), self-efficacy (CIDS), health status (EQ5D)
                and emotional well-being (WHO-5)

             -  other glycemia variables, including HbA1c and time spent in hypo- and -
                hyperglycemia ranges

             -  the incidence and duration of hypoglycemic episodes

             -  changes in hypoglycemia awareness score according to Gold et al.,

        3. (tertiary objectives:)

             -  measures of glucose variability

             -  the autonomic nervous system balance

             -  the duration of wear of the RT-CGM device

             -  patients' therapy adjustments during the interventions

             -  hypoglycemia awareness scores according to Clarke et al.

             -  satisfaction with use of CGM

             -  the number of contact moments not planned according to the study schedule

             -  absence of work of patient (and spouse)

             -  the global estimated costs of use of health care
    

Intervention name(s): Real-time continuous glucose monitor
Intervention type(s): Device
Intervention description(s): Active Comparator: MiniMed Paradigm® Veo™-system Placebo Comparator: iPro™2 Continuous Glucose Monitor (masked)
Other intervention name(s): MiniMed Paradigm® Veo™-system; iPro™2 Continuous Glucose Monitor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes mellitus; Hypoglycemia unawareness; Real-time continuous glucose monitoring; Glucose control
Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens
Condition: Fatigue; Nausea
MeSH terms: Fatigue; Nausea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to establish validated outcome measures for Postoperative
      Fatigue and Postoperative nausea, and to compare clinical impact of postanaesthetic symptoms
      during first week after Propofol or Desflurane based anaesthesia.
    


Intervention name(s): Propofol; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Continuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep.; Continuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep
Other intervention name(s): Suprane
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
The Effect of Chinese Herbal Formula (KSY) on HCV Carrier With Abnormal Liver Function
Condition: Liver Function
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on
      HCV Carrier With Abnormal Liver Function.
    

Detailed description: 
      percentage of change on HCV RNA titer and liver function (GPT).
    

Intervention name(s): KSY
Intervention type(s): Drug
Intervention description(s): Chinese herbal formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: HCV carrier; Chinese herbal medicine; Liver function; HCV RNA titer
Effect of Dried Plum on Bone and Markers of Bone Status in Men
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      The principal objective of this study is to examine whether the addition of 100 g dried plum
      to the diets of men, regardless of their bone status, positively influences their indices of
      bone turnover in comparison with their corresponding baseline values and the control regimen.
    

Detailed description: 
      To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will
      receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will
      receive 500 mg calcium and 400 IU vitamin D daily.

      Evaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and
      serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.
    

Intervention name(s): dried plum; Calcium and vitamin D
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dried plum; Calcium and vitamin D supplement
Intervention MeSH terms: Vitamin D; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assign to one of the arms.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prunes; dried plum; nutrition; bone
Recognition of Abnormal Pediatric Blood Pressures in Primary Care
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study will look at general pediatricians' effectiveness at screening children for
      elevated blood pressure values in the primary care setting. Two new screening tools will be
      introduced and their effectiveness will be measured against current practice by way of
      medical chart review.
    


Intervention name(s): PDA blood pressure screening program and chart reminder
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy
Condition: Tocophobia
Study type: Interventional

Summary: 
      The purpose of this project To study the efficacy of Internet-based guided self-help program
      of Cognitive Behaviour Therapy (ICBT) compared to traditional individual live CBT in a group
      of women with severe fear of childbirth (S-FOC). The treatment groups are compared with a
      control group receiving individual support at their antenatal clinics.
    

Detailed description: 
      In Sweden, every year, about 6000 pregnant women suffer from severe FOC with consequences for
      the women's psychological health before, during and after birth, the way they manage the
      childbirth, and for their postpartum mother-child interaction.

      In this project we want to examine the effect of CBT on SFOC given in two different ways. We
      compare these results with a group receiving support given traditionally on the clinics. But
      also a group without S-FOC. In case there is a significant effect of CBT, that is comparable
      given live as well as ICBT, we should have developed an adequate way of treatment that could
      be implemented in ordinary health care.

      Hypothesis: S-FOC decreases in same extent (30 units on the W-DEQ) in both of the treatment
      groups. The group with S-FOC,that gets treatment as usual is consuming more healthcare than
      the groups receiving therapy.

      One hundred and twenty pregnant women with severe fear of childbirth (S-FOC) according to
      their sum score on the Wijma Expectancy/Experience Questionnaire (W-DEQ vers. A) ≥85, and 40
      women without S-FOC (W-DEQ <85) are recruited at 7 participating clinics in Sweden. In a
      first baseline measuring phase 40 women with S-FOC and 40 women without S-FOC are followed as
      control groups, receiving, if necessary, treatment according to the local routine. In the
      intervention part of the study 80 women with S-FOC are randomized either into ICBT or live
      CBT.

        1. ICBT is as effective as traditional live therapy.

        2. ICBT is as efficient as traditional live therapy

           .

        3. The effect will remain after the childbirth The successful therapy leads to

             -  less fear after childbirth

             -  less traumatic events during delivery

             -  less cesareans or instrumental deliveries

             -  less postpartum depressions

             -  less appointments in urgency during pregnancy

             -  better Mother-child relation at 3 months

             -  better self-estimated quality of life
    

Intervention name(s): Traditional Cognitive behavioural therapy; Internet based Cognitive behavioural therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Therapist supported live therapy; Internetbased CBTwith limited therapist support
Other intervention name(s): Traditional CBT .; Internet CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of oral
      administration of BR9003 compared with BR9003A in healthy adult subjects
    

Detailed description: 
      A total of 24 subjects will be randomized into 6 sequence groups. The Investigational
      Products wil be according to the treatment group (A,B,C) assigned to each sequence group in
      Period 1, Period 2 and Period 3.
    

Intervention name(s): BR9003; BR9003A
Intervention type(s): Drug; Drug
Intervention description(s): Treatment group B:
Once-daily oral administration of one BR9003 2mg tablet in the fasting state.
Treatment group C:
Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it.; Treatment group A:
Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade
Condition: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      We aim to translate these findings into patients with rheumatoid arthritis and other
      conditions treated with anti-TNF (anti-tumor necrosis factor) therapy, such as psoriatic
      arthritis and ankylosing spondylitis. Patients from rheumatology clinics within NHS (National
      Health Service) trusts will be recruited. We will correlate disease activity assessed by
      clinical parameters, ultrasonography, and questionnaires with biomarkers in the blood and
      target tissues, such as synovium and skin.
    

Detailed description: 
      Inflammatory arthritis particularly rheumatoid arthritis (RA), psoriatic arthritis and
      ankylosing spondylitis are potentially disabling conditions which cause joint pain, swelling
      and deformity and treatments are aimed at preventing these complications. Although treatment
      has improved with the advent of anti TNF alpha therapies, up to 30% of patients fail to
      respond to this treatment and in others, treatment is associated with significant side
      effects. The precise mechanisms of this remain unclear. In addition, there are no sensitive
      methods available to monitor or predict disease response to treatment aside from testing
      inflammatory markers in the blood. Understanding the mechanism of action and what governs
      response to anti TNF therapy will allow development of more specific therapies for
      inflammatory arthritis. Work in animal models of rheumatoid arthritis has characterised a
      novel cell type, Th17 cells, important in the inflammatory cascade which are affected in a
      particular way by anti TNF therapies and may underpin their mechanism of action and side
      effects.
    

Intervention name(s): anti-TNF therapy (etanercept or adalimumab)
Intervention type(s): Drug
Intervention description(s): Biological DMARD
Other intervention name(s): Enbrel; Humira
Intervention MeSH terms: Adalimumab; Etanercept
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Rheumatoid arthritis
Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone
Condition: Morbid Obesity; Gallstone
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis; Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      in this study we compare the results of concomitant cholecystectomy with bariatric surgery
      versus delayed cholecystectomy for management of gallstone in obese patients
    

Detailed description: 
      in this study we compare the results of concomitant cholecystectomy with bariatric surgery
      versus delayed cholecystectomy for management of gallstone in obese patients. patients will
      be divided into 2 group: group1, will be operated by the bariatric surgery and
      cholecystectomy in the same session. group 2 will be operated by cholecystectomy at least 6
      months after bariatric surgery or whenever develop complications
    

Intervention name(s): concomitant cholecystectomy
Intervention type(s): Procedure
Intervention description(s): delayed cholecystectomy
Other intervention name(s): delayed cholecystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Accessible and Affordable Moisturizers for Atopic Eczema
Condition: Childhood Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's
      essential drug list (EDL) but are not available to most rural patients. To assess whether
      accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized
      controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two
      separate sub-studies were conducted using a randomized controlled single (assessor) blind
      trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all
      patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG,
      petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and
      IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and antihistamines
      were continued as prescribed.
    


Intervention name(s): Baby oil; petroleum jelly; Glycerine:petroleum jelly 2:1
Intervention type(s): Other; Other; Other
Intervention description(s): patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream; patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser; patients in this arm use glycerine and petroleum jelly mixed at a ratio of 2:1 in place of cetomacrogol as a moisturiser
Other intervention name(s): unscented liquid paraffin
Intervention MeSH terms: Petrolatum; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: atopic eczema; moisturisers; alternatives; affordable
A First Time In Human Study To Assess The Compound GSK615915
Condition: Bronchospasm
MeSH terms: Bronchial Spasm
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's
      future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more
      stable drug suspension, this in turn will produce a consistent dose of drug being delivered
      with each puff.
    


Intervention name(s): GSK615915A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.; Subjects will also receive placebo inhaler.
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: GSK615915 asthma surfactant MDI
Intermittent Hypoxia Intervention in MS Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      This observational cohort study investigates the safety and feasibility of an intermittent
      hypoxia intervention in multiple sclerosis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MS patients with all types of MS
      
Biospecimen description: 
      Blood