bioihbjkbjnl/mcl2 huggingface dataset:
A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate dose-response of Rapid Acting Intramuscular Olanzapine in Agitated Patients
      with Schizophrenia
    


Intervention name(s): olanzapine-RAIM; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers
Condition: Respiratory Disorders
MeSH terms: Influenza, Human; Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8
      different formulations of investigational NTHI vaccine in current and former smokers, 50-70
      years of age.
    

Detailed description: 
      This Protocol Posting has been updated following Protocol Amendment 1, dated 10 October 2012,
      leading to a change in an inclusion criterion.
    

Intervention name(s): NTHI vaccine GSK2838500A (formulation 1); NTHI vaccine GSK2838501A (formulation 2); NTHI vaccine GSK2838502A (formulation 3); NTHI vaccine GSK2838503A (formulation 4); NTHI vaccine GSK2838504A (formulation 5); NTHI vaccine GSK2838505A (formulation 6); NTHI vaccine GSK2838508A (formulation 7); NTHI vaccine GSK2838509A (formulation 8); Placebo comparator
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Drug
Intervention description(s): Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.; Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: non-typeable Haemophilus influenzae; immunogenicity; reactogenicity; safety
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain
      in subjects experiencing pain due to Multiple Sclerosis.
    

Detailed description: 
      The purpose of this study is to determine the safety and efficacy of Cesamet™ in the
      symptomatic treatment of pain due to Multiple Sclerosis.

      This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™
      treatment for control of pain due MS. The study has two phases: a Pretreatment Phase and a
      Treatment Phase.
    

Intervention name(s): Cesamet™ (nabilone)
Intervention type(s): Drug
Intervention MeSH terms: Nabilone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Thorough QT Study of Intravenous Amisulpride
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomised, single-dose, crossover, placebo-controlled study to see if intravenous
      amisulpride has any effect on the heart rhythm, in particular the QT interval, in healthy
      adult volunteers.
    

Detailed description: 
      Phase 1, randomised, single-dose, period-balanced, crossover, placebo- controlled study to
      assess the effects of iv doses of amisulpride on the QT interval, corrected for heart rate by
      Fridericia's formula (QTcF), in healthy male and female subjects of Caucasian and Japanese
      ethnicity aged 20-45 years.
    

Intervention name(s): APD421 5 mg; APD421 40 mg; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Therapeutic dose of amisulpride; Supra-therapeutic dose of amisulpride; Positive control for assay sensitivity; Placebo comparator to establish baseline for calculating change in QTcF
Other intervention name(s): Amisulpride 5mg; Amisulpride 40mg
Intervention MeSH terms: Moxifloxacin; Amisulpride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: TQT; amisulpride; volunteer; ECG
A Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual
      tablet in healthy adult subjects.
    


Intervention name(s): Y-2 Sublingual Tablet; Y-2 Sublingual Tablet; Y-2 Sublingual Tablet; Y-2 Sublingual Tablet; Y-2 Sublingual Tablet; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive one Y-2 sublingual tablet sublingually once daily for Day1 and Day 19 and twice daily for Day 6 to Day 18.; Subjects will receive two Y-2 sublingual tablets sublingually once daily for Day1 and Day 19 and twice daily for Day 6 to Day 18.; Subjects will receive Y-2 sublingual tablet with 3 different conditions once daily for Day1 Day 6 and Day 11. Day 1 with condition A, Day 6 with condition B and Day 11 with condition C.; Subjects will receive Y-2 sublingual tablet with 3 different conditions once daily for Day1 Day 6 and Day 11. Day 1 with condition B, Day 6 with condition C and Day 11 with condition A.; Subjects will receive Y-2 sublingual tablet with 3 different conditions once daily for Day1 Day 6 and Day 11. Day 1 with condition C, Day 6 with condition A and Day 11 with condition B.; Placebo, sublingually, single and multiple ascending dosing in group 1 and 2 subjects.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
European Drug Utilization Study
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose of this retrospective observational study is to evaluate the characteristics of
      patients receiving Seroquel XR as treatment for their Major Depressive Disorder. The study
      will also investigate how the medication is used for these patients and if there are any
      differences in drug utilisation between the included countries. The study is observing
      patients initiating Seroquel XR during a 9 month period corresponding to 3 to 12 months
      following the launch of the product in each country for the MDD indication. A drug
      utilisation questionnaire will be used to collect study data from patients' medical records.
    

Detailed description: 
      A Multinational, Multicenter, Retrospective, Observational Drug Utilisation Study of Seroquel
      Extended Release (XR) Prescribed by Psychiatrists as Treatment for Major Depressive Disorder
      (MDD) in Selected Countries in the European Union (EU)
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        500-2000 patients that are broadly representative of the overall Major Depressive Disorder
        population in Europe. Patients are distributed at medical healthcare centres, private
        practice, as well as university and community hospitals in five European countries.
      
Keywords: Seroquel XR; Quetiapine XR; Drug utilization; Major depressive disorder (MDD)
The Effect of Dual Tasking on Physical and Cognitive Functions in Patients With Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The ability of performing multi-tasking procedures is impaired in patients with Parkinson's
      disease. In this study, our goal was to detect the effects of dual-task training with
      treadmill training on walking and balance and to compare its effects on quality of life,
      cognitive functions and risk of fall, to treadmill training alone.
    


Intervention name(s): Dual task; Treadmill Training; Standard exercise programme
Intervention type(s): Other; Other; Other
Intervention description(s): The patients in the dual task group received cognitive tasks during treadmill training sessions.; Standard treadmill training; Standard exercise programme for Parkinson Disease
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this prospective, randomized, controlled, double-blinded study the patients were randomized to three groups as; dual-task group, single-task group and control group. All of the patients were scheduled on standard exercise programme. The patients in dual-task group received treadmill training with cognitive tasks and the patients in single-task group received treadmill training alone in addition to standard exercise programme. The training was scheduled as 30 minute sessions under supervision of a specialist, three times in a week for four weeks.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dual task, treadmill, cognitive rehabilitation
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
Condition: Primary Biliary Cirrhosis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Interventional
Phase: Phase 2

Summary: 
      An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to
      evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis
      (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)
    

Detailed description: 
      Primary:

      To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 8 weeks of
      treatment

      Secondary:

      To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 12 and 26 weeks of
      treatment

      To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 52 weeks of
      treatment

      To evaluate the pharmacokinetics (PK) of MBX-8025

      Exploratory:

      To evaluate the effect of MBX-8025 on bile acids, additional markers of inflammation and
      renal function

      MBX-8025 doses of 1 mg and 15 mg may be evaluated if dose adjustment occurs
    

Intervention name(s): MBX-8025 2 mg Capsule; MBX-8025 5 mg Capsule; MBX-8025 10 mg Capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Initial 8-week treatment:
• MBX-8025 2 mg
Extension:
The 2 mg group will be started after safety and efficacy review of the 5 mg and the 10 mg groups has been completed.
Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons.; Initial 8-week treatment:
• MBX-8025 5 mg
Extension:
Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons.; Initial 8-week treatment:
• MBX-8025 10 mg
Extension:
Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons.
Other intervention name(s): MBX-8025; seladelpar; MBX-8025; seladelpar; MBX-8025; seladelpar
Intervention MeSH terms: Seladelpar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PBC; Primary Biliary Cholangitis (PBC)
Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall objective of this study is to assess the efficacy and safety of treatment with
      PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation
      powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to
      very severe COPD.
    


Intervention name(s): GFF MDI; GP MDI; FF MDI; Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®); Placebo MDI
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID); GP MDI administered as two puffs BID; FF MDI administered as two puffs BID; Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI); Inhaled placebo administered as two puffs BID
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of metformin component of the
      canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet
      compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and
      fasted participants.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), open-label
      (identity of study drug will be known to volunteer and study staff), single-center,
      single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study
      group to another in a clinical trial, like the flip of a coin) study in healthy adult
      participants. The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22
      to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3
      days each [Day -1 to Day 2], each separated by a washout period of 7 days) and Follow-up
      Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4). All
      the eligible participants will be randomly assigned to 1 of 4 treatment sequences and will
      receive 2 treatments under fasting and 2 treatments under fed conditions. Blood samples will
      be collected for evaluation of pharmacokinetics (how the drug is absorbed in the body,
      distributed within the body, and how it is removed from the body over time) at pre-dose and
      post-dose of study treatment. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]; Canagliflozin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed or fasted condition in each treatment period as per treatment sequence.; Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablet) under fed or fasted condition in each treatment period as per treatment sequence.; Participants will receive metformin 500 mg tablet orally under fed or fasted condition in each treatment period as per treatment sequence.
Other intervention name(s): CANA/MET IR FDC; CANA; MET
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Metformin; Canagliflozin; Healthy
Does Incorporation of EPA and DHA in Lipoproteins Differ According to Apolipoprotein E Genotype?
Condition: Healthy
Study type: Interventional

Summary: 
      Genetics and nutrition both clearly affect the risk of Alzheimer's disease (AD) in the
      elderly. Apolipoprotein E (APOE4) is the most important known genetic risk for AD and is
      prevalent in 20-25% of Canadians, but at present, knowing an individual's ApoE genotype does
      not help the diagnosis, treatment or prevention of AD. Furthermore, fish intake containing
      docosahexaenoic acid (DHA, 22:6 omega-3) and eicosapentaenoic acid (EPA, 20:5 omega-3) may be
      incorporated as a prevention strategy for lowering the risk of AD. However, fish intake seems
      not to protect APOE4 carriers from developing AD. One explanation as to why APOE4 carriers
      may not benefit from fish intake is potentially linked with imbalances in omega-3 fatty acid
      metabolism. The investigators recently reported that after 3g/d of EPA+DHA for 6 weeks,
      increases in the two fatty acids was less for carriers resulting in a significant
      gene-by-diet interaction. ApoE is a component of lipoproteins and ApoE genotypes modulate the
      fasting lipoprotein response to fish-oil supplementation. Therefore, the investigators
      hypothesis is that APOE4 genotype is associated with imbalances in lipoprotein concentrations
      which has the consequence to be associated with imbalances in EPA and DHA transport. The
      investigators will recruit and test 100 healthy young adults since at older ages carriers of
      ApoE4 usually take medication altering their lipoprotein profile. They will receive an EPA +
      DHA supplement for one month. This period was chosen because the 3 class of lipoproteins
      (VLDL, LDL and HDL) have different concentrations in TG, phospholipids and cholesteryl esters
      and to fully investigate lipoprotein fatty acid changes, one month of supplementation is
      needed to change EPA and DHA in all lipid classes. The investigators will monitor the
      distribution of EPA and DHA in the lipoproteins over a one month supplementation with fish
      oil and the investigators will separate the investigators groups by APOE4 carriers and
      non-carriers.
    


Intervention name(s): omega-3 fatty acids
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will take 700 mg/d of EPA and 500 mg/d of DHA as ethyl esters for one month (Ocean Nutrition, Dartmouth, NS) which is about 10 times the current estimated intake of young adults (21). This corresponds to one capsule with breakfast and one capsule with diner.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Health young participants
Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
Condition: Tattoo
Study type: Interventional

Summary: 
      Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.
    

Detailed description: 
      A non-significant risk, single center, prospective device trial to evaluate the number of
      passes of Q-Switch laser treatment that can be completed with a Q-Switch Laser alone compared
      to use of the Soliton Planar Acoustic Wave Device System (AWD) System as an accessory to
      Q-switched laser in tattoo reduction treatment.
    

Intervention name(s): planar acoustic wave device
Intervention type(s): Device
Intervention description(s): accessory to laser treatment
Other intervention name(s): AWD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tattoo; laser
New Technologies in the Rehabilitation of Chronic Stroke
Condition: Stroke; Hemiplegia
MeSH terms: Stroke; Hemiplegia
Study type: Interventional

Summary: 
      The objective of the current study is to develop and investigate training concepts involving
      rehabilitation technology, which aim at exploiting the potential for regaining the ability to
      perform skilled movements by maximizing training intensity and keeping the motivation of
      patients high.

      The evaluation focuses on feasibility and cost-benefit analyses
    

Detailed description: 
      This feasibility project aims to establish an efficient setting for intensive rehabilitation
      with new technology in four trailblazer clinics. This will enable them to provide intensive
      therapy to the patients in accordance with the study protocol. If this setting is integrated
      into the clinical routine, the investigators will be able to collect data to get some first
      insight into economic and functional data required to calculate changes in socioeconomic
      costs
    

Intervention name(s): Rehabilitation technology
Intervention type(s): Other
Intervention description(s): Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
The training can take place in an outpatient or inpatient setting.
Training will be organized in individual one-to-one or group session
Other intervention name(s): Lokomat; Erigo; Andago; Armeo (Boom, Senseo, Spring, Power); Valedo motion; Amadeo; Myro; NuStep; Bi-Manu Trainer; EksoGT; The Float; MOTOmed; Allegro
Intervention MeSH terms: Frovatriptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research