bioihbjkbjnl/mcl2 huggingface dataset:
Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy and safety of vedolizumab
      intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab
      IV dosing regimen over a 30 week treatment period in participants with moderately to severely
      active ulcerative colitis (UC) and high vedolizumab clearance, based on a Week 5 predefined
      serum vedolizumab concentration threshold less than (<) 50 microgram per milliliter
      (microg/mL) and who are Week 6 non-responders based on partial Mayo score.
    

Detailed description: 
      The drug being tested in this study is called Vedolizumab. Vedolizumab will be administered
      as an IV infusion. It is being tested in this study with new doses. This study will
      investigate the efficacy and safety of dose optimization of vedolizumab IV, compared with
      standard dosing of vedolizumab IV, over a 30-week treatment period.

      The study will enroll approximately 250 moderately to severely active subjects with UC in
      order to randomize approximately 100 non-responder subjects with high vedolizumab drug
      clearance. Subjects will receive induction therapy of vedolizumab IV 300 mg on Day 1 and Week
      2 (Lead-in Period). At Week 5, serum vedolizumab concentration will be measured. At Week 6,
      subjects will be assessed for clinical response based on partial Mayo score.

      Results of both Week 5 vedolizumab concentration and Week 6 clinical response will determine
      the treatment pathway. Those who are non-responders based on partial Mayo score at Week 6 and
      who are assessed as having high vedolizumab clearance, based on a predefined Week 5 serum
      vedolizumab concentration threshold (<50 microg/mL) will be randomly assigned (by chance,
      like flipping a coin) to one of the two treatment groups:

        -  Vedolizumab IV Standard Treatment

        -  Vedolizumab IV Dose Optimized

      All randomized subjects will receive vedolizumab IV either 300 mg or 600 mg every 4 or 8
      weeks.

      This multi-center trial will be conducted in United States of America and Canada. The overall
      time to participate in this study is 56 weeks. Subjects will make multiple visits to the
      clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long
      term follow-up safety survey.
    

Intervention name(s): Vedolizumab IV
Intervention type(s): Drug
Intervention description(s): Vedolizumab intravenous infusion.
Other intervention name(s): Entyvio; MLN0002
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
Evaluate the Drug-drugs Interaction Between Lobeglitazone 0.5mg and Empagliflozin 25mg
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-398
    

Detailed description: 
      A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic
      profiles and safety of CKD-398 in healthy volunteers under fasting conditions
    

Intervention name(s): CKD-398; CKD-501, D745
Intervention type(s): Drug; Drug
Intervention description(s): Test Drug; Reference Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Repeated Treatments of QLT091001 in Subjects With Leber Congenital Amaurosis or Retinitis Pigmentosa (Extension of Study RET IRD 01)
Condition: LCA (Leber Congenital Amaurosis); RP (Retinitis Pigmentosa)
MeSH terms: Blindness; Retinitis; Retinitis Pigmentosa; Leber Congenital Amaurosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

        -  To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once
           daily for 7 days in subjects treated previously with a single 7-day course of QLT091001
           in Study RET IRD 01

        -  To evaluate whether up to 3 additional courses of oral QLT091001 administered once daily
           for 7 days can maintain or improve visual function.
    


Intervention name(s): QLT091001
Intervention type(s): Drug
Intervention description(s): oral QLT091001 administered once daily for 7 days
Intervention MeSH terms: Retinol acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Diastasis m. Rectus Abdominis in Postpartum Women
Condition: Diastasis of m. Rectus Abdominis
Study type: Observational

Summary: 
      This study will evaluate the prevalence of diastasis m. rectus abdominis after delivery.

      Relationship of Diastasis Recti Abdominis with urine leakage, pelvic floor muscle function
      and morphometry in postpartum women.
    

Detailed description: 
      Evaluation of the width of the linea alba within the evaluation of diastasis of the rectus
      abdominis by 2D USG relation to pelvic floor muscle function (strength and endurance of
      pelvic floor muscles) and pelvic floor muscle morphometry by 3D/4D USG .
    

Intervention name(s): 2D usg and 3D/4D usg
Intervention type(s): Diagnostic Test
Intervention description(s): IRD distance measured by a linear probe 2D usg. Pelvic floor muscle morphometry measured by 3D/4D usg
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women from six weeks to up to 6 months after birth, age over 18 years old.
The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a
      single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and
      pharmacodynamic(PD) measurements are done for the next 24 hours.

      It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is
      seen in Pk or PK of tramadol
    


Intervention name(s): escitalopram and tramadol; placebo; placebo and tramadol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg escitalopram for 3 days 20 mg escitalopram for 6 days 150 mg tramadol as a single dose on day 9; placebo identical for 10 mg/ 20 mg escitalopram and 150 mg tramadol; 9 days of placebo equivalent to 10 / 20 mg escitalopram, one single dose of 150 mg tramadol on day 9
Other intervention name(s): Lexapro; Ultram; placebo; Ultram
Intervention MeSH terms: Tramadol; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy subjects
Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001
Condition: Copd
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of
      CHF6001 and CHF5259, in comparison with the single components, administered in healthy
      subjects via a multi-dose reservoir NEXThaler® DPI.
    

Detailed description: 
      This is randomised open label, 3-way cross-over study. Each 14-day treatment period is
      separated from the following one by a 21-day wash-out period. Subjects will reside at the
      clinic facilities during the 14 days treatment period.
    

Intervention name(s): CHF5259 and CHF6001; CHF5259 + placebo; CHF6001 + placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): b.i.d. for 14 days; b.i.d. for 14 days; b.i.d. for 14 days; b.i.d. for 14 days
Other intervention name(s): Test Treatment; Reference Treatment 1; Reference Treatment 2; Matching number of inhalations
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nutrition Education in Cardiac Rehabilitation
Condition: Cardiometabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Coronary heart disease is one of the United Kingdom's biggest killers. In the UK alone
      175,000 myocardial infarctions are recorded annually. To lower the financial burden on the
      National Health Service, cardiac rehabilitation facilitates a systematic and
      multidisciplinary approach to secondary prevention aimed to improve functional capacity and
      health-related quality of life, lower rehospitalisation rates and reduce all-cause and
      cardiovascular mortality with exercise training being the cornerstones. The effectiveness of

      Cardiac rehabilitation programmes in delivering effective secondary prevention has long been
      established. Improvements are recorded in cardiovascular endurance, muscular strength and
      endurance, balance, co-ordination, and quality of life. However, many patients see little or
      no change in body mass and body mass index, an independent risk factor for coronary heart
      disease. Interestingly, the inclusion of nutrition education is rarely reported within
      specific Cardiac rehabilitation settings, therefore evidence of best practice remains elusive
      and warrants further investigation.

      The aim of this trial is to compare:

        -  Usual care - Where patients access to two exercise classes per week and all facilities
           normally available as part of their cardiac rehabilitation programme. Patients in this
           group will undergo this approach for 12-weeks.

        -  Usual care + Biggest loser - In addition to Usual care, patients in this group took part
           in the 'Biggest loser' program in which the patients attended weekly sessions outside of
           their usual exercise class times. Each session follows a specific theme based on British
           Heart Foundation healthy eating guidelines. Participants will undergo this approach for
           6-weeks and then switch to usual care for 6-weeks.

        -  Usual care + New Education programme. In addition to Usual care, the same weekly topics
           as the biggest loser are covered yet with bespoke information regarding portion sizes
           and recipes provided each week and patients given a challenge each week in relation to
           the topic being covered e.g. include more vegetables. Participants will undergo this
           approach for 6-weeks and then switch to usual care for 6-weeks.

      Patients will be tested at baseline, 6-weeks and 12-weeks.
    


Intervention name(s): Nutrition knowledge
Intervention type(s): Behavioral
Intervention description(s): Nutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser'
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improvement of Insulin Resistance With Traditional Chinese Treatment in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of Traditional Chinese Treatment(TCT)
      on insulin sensitivity and other related factors in type 2 diabetes by using an double-blind,
      randomized, parallel control and prospective study This traditional compound Chinese herb
      preparation is referred to this study, with three kinds of plants: 50 mg of Coptis Chinensis,
      30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica, all of which are selected
      by The Chinese Academy of Medical Sciences among those traditionally considered effective and
      safe in the treatment of diabetes.

      Patients enrolled were randomized into TCT group and placebo group administrated with TCT and
      placebo respectively. Glucose disposal rate (GDR), fasting plasma glucose (FPG), postprandial
      plasma glucose (PPG), HbA1C and other metabolic components were assessed at baseline and end
      point
    


Intervention name(s): Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg of Coptis Chinensis, 30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Traditional Chinese Treatment
A Study to Evaluate the Pharmacokinetics and Absolute Bioavailability of GSK962040 Given as an Oral Dose Simultaneously With an Intravenous Microtracer Dose of [14C]-GSK962040 in Healthy Volunteers
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the absolute oral bioavailability and intravenous
      pharmacokinetics of GSK962040. The oral dose of 50 mg has been selected because it was well
      tolerated following single oral administration and it is considered to be within therapeutic
      dose range. The need to characterize the intravenous disposition of GSK962040 is in
      anticipation of drug use in special populations such as critically.
    

Detailed description: 
      GSK962040 is a selective non-peptide motilin receptor agonist which is being developed for
      the treatment of conditions associated with slow rates of gastric emptying. The purpose of
      this study is to determine the absolute bioavailability and the metabolic profile of
      GSK962040. Subjects will be administered a single oral dose of 50 mg followed by a single
      intravenous dose of 10 mL containing 100 microgram (not more than 270 nCi, 10 kBq) 14C
      GSK962040, administered by infusion over 15 minutes, beginning at 90 min after administration
      of the oral dose (approximate Cmax). The oral dose of 50 mg was well tolerated following
      single oral administration and is predicted to be a therapeutic dose. There is need to
      characterize GSK962040 disposition in anticipation of drug use in special populations such as
      critically ill patients. The intravenous (infused) microdose (100 microgram) is 500-fold
      lower than the oral dose, therefore exposure to GSK962040 originating from the infused
      microdose is considered negligible.
    

Intervention name(s): A; B
Intervention type(s): Drug; Drug
Intervention description(s): GSK962040 (50 mg, SD, oral); 14C GSK962040 (100 μg, SD, iv)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Entero-test; Phase I; GSK962040; i.v. microtracer; radioactivity; pharmacokinetics; healthy volunteer
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI
      655075 following intravenous administration of single rising doses of BI 655075 when
      administered alone and after administration of dabigatran.
    


Intervention name(s): Placebo to dose; Idarucizumab; Placebo to Idarucizumab; dabigatran; Idarucizumab
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): placebo; short infusion; Placebo to Idarucizumab; 2 capsules dabigatran; short infusion
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
Condition: Chronic Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after
      administration of a single 5 mg oral dose of preladenant in participants with hepatic
      impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with
      participants with mild hepatic impairment. Part 2 compares healthy volunteers with
      participants with moderate hepatic impairment. Healthy volunteers in each part of this study
      are to be matched with participants with hepatic impairment by race, age, gender, and body
      mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI,
      the area under the concentration-time curve from time 0 extrapolated to time of the last
      quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched
      healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within
      the interval [0.50, 2.00].
    


Intervention name(s): Preladenant
Intervention type(s): Drug
Intervention description(s): After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.
Other intervention name(s): SCH 420814; MK-3814; Adenosine 2a Antagonist
Intervention MeSH terms: Adenosine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson disease
Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and
      200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with
      partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant
      antiepileptic drugs.
    


Intervention name(s): Placebo; Brivaracetam; Brivaracetam; Antiepileptic drugs with market authorization available per country
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period; Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period; Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period.
Intervention MeSH terms: Brivaracetam; Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures; Adjunctive treatment
Internal Jugular Vein Cross Sectional Area
Condition: Central Venous Pressure
Study type: Observational

Summary: 
      The Trendelenburg position is used to distend the central veins, improving both success and
      safety of vascular cannulation. The purpose of this study is to measure the cross-sectional
      area of the internal jugular vein (IJV) in three different positions, using surface
      ultrasound.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to Intensive care unit.
      
Keywords: CVP; US; Trendelenburg position; Ultrasound; Head Down Tilt
Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those
      patients who complete participation in the main segment of the study (double blind) together
      with other clinically stable not previously enrolled (de novo patients) may opt to
      participate in this extension segment, where they will receive active Risperidone ISM® (75 mg
      or 100 mg)under open-label conditions every four weeks for approximately 12 months.
    

Detailed description: 
      Patients who have completed planned participation in the double-blind segment of the study
      PRISMA-3 (NCT03160521) through to the end of the treatment period, may be eligible to enter
      into this optional long-term extension segment of the study. During this extension,
      open-label Risperidone ISM® (i.e., either 75 or 100 mg) will be administered to all
      participating patients once every 4 weeks for approximately 12 months. Patients who enter
      into the extension segment of the study will begin participation in the extension segment
      immediately upon completion of the end-of-treatment visit assessments and procedures.

      In addition to patients continuing from the double-blind segment of the study PRISMA-3
      (rollover patients), clinically stable patients not previously enrolled in the study (de novo
      patients) may be eligible to enter the long-term extension segment of the study. These
      patients will be evaluated for eligibility at a screening visit and, if eligible, will be
      allocated to receive either 75 or 100 mg Risperidone ISM every 4 weeks for approximately 12
      months.

      Approximately 100 de novo patients are planned to be enrolled in the extension segment of the
      study, in addition to rollover patients.
    

Intervention name(s): Risperidone ISM 75 mg; Risperidone ISM 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle.; Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment