bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to support long-term dentinal hypersensitivity (DH) relief
      claims of 0.454 percent (%) stannous fluoride (SnF2) containing toothpastes in China.
    

Detailed description: 
      This study will be a single centre, randomised, controlled, examiner-blind, 3 treatment arm,
      parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the
      2 selected 'test teeth'), with a treatment period of 8 weeks, to investigate the clinical
      efficacy of a SnF2 dentifrice in the reduction of DH in a Chinese population. The SnF2 test
      dentifrice will be compared to commercialised negative and positive control dentifrices.
      Participants will be instructed to brush teeth with their assigned dentifrice according to
      the product use instructions provided. DH assessments will be conducted at Baseline, 4 and 8
      weeks. Participants will also be requested to complete a short-form version of the Dentine
      Hypersensitivity Experience Questionnaire (DHEQ-15) at the Baseline and Week 8 Visits.
    

Intervention name(s): Sensodyne Sensitivity & Gum; Crest Cavity Protection Fresh Lime; Sensodyne Repair and Protect
Intervention type(s): Other; Other; Other
Intervention description(s): Sensodyne Sensitivity & Gum toothpaste containing 0.454% SnF2.; Crest Cavity Protection Fresh Lime is containing 1150 parts per million fluoride as Sodium fluoride.; Sensodyne Repair and Protect dentifrice containing 5.0% weight/weight calcium sodium phosphosilicate.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
Condition: Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation,Psychomotor
MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to
      evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation
      symptoms in subjects with agitation associated with Alzheimer's disease.
    

Detailed description: 
      Enrolled patients will first enter a 9-week, open-label stabilization period, during which
      they will be treated with AXS-05 and monitored for a treatment response. Patients who
      experience a treatment response during the stabilization period will then be randomized into
      the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to
      switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.
    

Intervention name(s): AXS-05; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AXS-05 tablets, taken twice daily; Placebo tablets, taken twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: AD agitation; AXS-05; NMDA receptor antagonist; dextromethorphan; bupropion; Axsome; ACCORD
Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects
Condition: Renal Impairment; Renal Disease; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in
      adult participants with renal impairment and healthy adults.
    

Detailed description: 
      This study is being conducted to assess the pharmacokinetics of the major Nitazoxanide active
      metabolite as well as the safety and tolerability in renal impaired (mild, moderate and
      severe) and healthy matched control adults following repeated oral dose administration of NTZ
      500 mg twice a day for 7 days.
    

Intervention name(s): Nitazoxanide
Intervention type(s): Drug
Intervention description(s): 500 mg Twice Daily for 7 days
Other intervention name(s): NTZ
Intervention MeSH terms: Nitazoxanide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Healthy Volunteer; Renal Disease; Kidney Disease; Renal Impairment; Antiparasitic; Antiprotozoal
Effect of Cocoa Flavanols on Vascular Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular
      events in patients with coronary artery disease (CAD). CAD patients also show impaired
      function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate
      in adult blood and contribute to endothelial repair. Clinical studies suggest that
      endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa.
      Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an
      additive, positive effect in patients who are already receiving the maximal recommended
      therapies for risk factor modification. Therefore, the researchers propose to perform an
      investigator-initiated, randomized controlled cross-over study administering flavanol-rich
      cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement
      of endothelial function as measured by flow-mediated dilation (FMD) will be the primary
      endpoint of this study. The researchers propose to also measure determinants of FMD such as
      microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the
      number and function of EPCs in the blood. Importantly, detailed food questionnaires and
      plasma flavanols/metabolites will help to further support a causal link between
      flavanol-intake and improved vascular function.
    


Intervention name(s): Cocoa Flavanols; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Cocoa Flavanols (BD for 21 - 28 days); Placebo (BD 21 - 28 Days)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: CAD Patients on Optimal Treatment
Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Fats and oils are made up of >90% triacylglycerol fat molecules which consist of a glycerol
      backbone to which 3 esterified fatty acids are attached. The positions of fatty acid
      attachment are referred to by stereospecific numbers, sn -1, -2 and -3. There is existing
      evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with
      predominantly palmitic acid (16:0) or stearic acid (18:0) in the sn-1 and sn-3 positions of
      fat molecules do not raise serum cholesterol levels. These observations have come to be known
      as or explained by the "sn-2 hypothesis". New evidence have also emerged to show that
      saturated fatty acids (16:0, 18:0) in the sn-1 and -3 positions reduces fat deposition in a
      rat model. In this proposed study, the effects on the outcome measures investigated of three
      test fats [namely palm olein IV64 (POP), virgin olive oil (OOO) and cocoa butter (POS)], with
      oleic acid primarily at the sn-2 position but differing amounts of palmitic, stearic and
      oleic acids at the sn-1/sn-3 positions of the triglyceride molecule, are investigated
    

Detailed description: 
      To investigate the effects of different dietary fats with primarily oleic acid in the sn-2
      position on the cardiovascular risk profile in healthy Malaysian volunteers
    

Intervention name(s): Diet: Palm olein IV64; Diet: Cocoa butter; Diet: Virgin olive oil
Intervention type(s): Other; Other; Other
Intervention description(s): Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat Palm Olein IV64 which was incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily.; Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat cocoa butter which was incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily.; Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat virgin olive oil which incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Healthy subjects
A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®.

      Secondary Objective:

      To assess the safety and tolerability of SAR341402.
    

Detailed description: 
      The total study duration for a screened subject will be about 3 - 8 weeks (excluding
      screening of 2 to 28 days), treatment period of 2 days for each 3 periods (1 overnight stay),
      a washout period of 5-18 days (preferentially 7 days between consecutive dosing), and an
      end-of-study visit of 1 day between Days 5 and 14 after the last administration of the
      investigational product.
    

Intervention name(s): SAR341402; Insulin Aspart; Insulin Aspart
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous
Other intervention name(s): NovoRapid®; NovoLog®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sorafenib Plus S-1 in Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        1. To define the recommended dose for phase II study of S-1 combined with sorafenib

        2. To evaluate the dose-limiting toxicities of the combination therapy

      Secondary Objectives:

        1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination
           therapy

        2. To investigate the impact of genetic polymorphisms of metabolic genes on the PK of
           sorafenib and S-1, respectively, as well as on the toxicity profile of the combination.

        3. To determine the changes of biomarkers between pre- and post-treatments.
    


Intervention name(s): Sorafenib; S-1
Intervention type(s): Drug; Drug
Intervention description(s): Name: Sorafenib
Dosage form: 200 mg / Tablet
Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1; Name:S-1
Dosage form: 20 mg or 25 mg / Capsule
Dosing schedule: 20-40 mg/m2 bid,po, 14 days on & 7 days off
Other intervention name(s): Nexavar; TS-1
Intervention MeSH terms: Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sorafenib; S1; Advanced Solid Tumors; RD; MTD; DLT; PK; PG; Biomarker
Investigation of the Metabolism and Pharmacokinetics of [14C]BI 1744 CL and [14C]BI 1744 CL Administered as an Oral Solution in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To determine the basic pharmacokinetics of BI 1744 BS, its metabolite BI 1744 BS -
      glucuronide and [14C]-radioactivity including excretion mass balance, excretion pathways and
      metabolism following intravenous and oral administration of [14C]BI 1744 CL

      Secondary objective:

      To determine safety and tolerability following intravenous and oral administration of [14C]BI
      1744 CL in healthy male subjects
    


Intervention name(s): BI 1744 CL i.v.; BI 1744 CL oral
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olodaterol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Survey of Health Preferences in Cancer Patients (QALY-Cancer)
Condition: Breast Cancer; Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      This study will evaluate health utilities in patients with breast or colorectal cancer.
    

Detailed description: 
      The cost-utility analysis (CUA) is an increasingly used method to help health decision-maker.
      The CUA uses the Quality Adjusted Life Years (QALY) that combines the length of life with the
      health related quality of life (HRQoL) into a single score.

      In Quebec, no QALY calculation tool has been adapted to its linguistic and socio-cultural
      context, neither for its general population nor for a particular subpopulation, like patients
      with cancer.

      The objectives will be to analyze the extent of the divergence in terms of health states
      utilities between the general population and patients with breast or colorectal cancer; to
      develop a QALY preference weights dataset for patients with cancer; to perform "mapping" with
      different health-related quality of life questionnaires by correlating SF6Dv2 with EQ-5D-5L,
      EORTC QLQ-C30 and FACT- G. The data will be collected with a self-administered online survey.
      Patients outcomes will be measured at the beginning of the chemotherapy treatment cycle and
      about 8 days after the start of chemotherapy. Health utilities will be measured with a hybrid
      method using the time-trade-off (TTO) and the discrete experimental choice (DCE) method using
      SF6Dv2 questionnaire for health states.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The target population consists of the Quebec population aged 18 and over who have breast
        cancer or colorectal cancer.
      
Keywords: QALY; Cost-utility analysis; Time-trade-off method; Discrete choice experiment method
The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The primary aim of the study was to determine the effectiveness of a form of supported
      employment, Individual Placement and Support (IPS) compared to existing good quality
      rehabilitation and vocational services for people with psychotic illnesses in terms of 'open'
      employment outcomes (in the competitive labour market), and to examine its relative
      effectiveness in the context of different European welfare systems and labour markets. The
      primary hypothesis was that IPS patients would be more likely to obtain open employment than
      control service patients. Secondary hypotheses were that they would be in open employment for
      longer than the control patients, and that they would not spend more time in hospital.
    

Detailed description: 
      An RCT was conducted in six European centres: London (UK), Ulm-Guenzburg (Germany), Rimini
      (Italy), Zurich (Switzerland), Groningen (the Netherlands) and Sofia (Bulgaria). Patients
      were included if they had a diagnosis of SMI (psychotic illness including bipolar disorder),
      were aged 18 to retirement age, had been ill and had major role dysfunction for at least two
      years, were living in the community at baseline, had not been in competitive employment in
      the preceding year and expressed the desire to enter competitive employment. They were
      randomly allocated to receive either IPS or the 'Vocational Service' (control service). Given
      the need to consider the impact of gender and work history on vocational outcomes (20),
      service allocation was stratified by centre, gender and work history (more or less than a
      month's competitive employment in the five years prior to baseline). Randomisation was
      conducted centrally using MINIM Version 1.5. A researcher at each centre recruited the
      patients, submitted them to the statistician for randomisation and received the allocation by
      email. The allocation sequence was concealed until the services had been assigned, but it was
      not possible for patients, professionals or researchers to be blind to service allocation
      thereafter.
    

Intervention name(s): Individual placement and support (vocational rehabilitation)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vocational rehabilitation; psychosis; cross country comparison
Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of
      E3710 following oral administration to Healthy Male Japanese Subjects
    

Detailed description: 
      This study will be conducted in healthy, male, Japanese subjects using an open-label,
      randomized, crossover design with comparison under multiple oral doses of E3710. Rabeprazole
      or Esomeprazole will be used in this study as marketed comparators. In each arm,
      pharmacodynamics will be measured in regard to intragastric pH. The measurements will be
      recorded using a pH probe with esophageal measurement capability for 24 hours post-dose.
      Pharmacokinetics measurements will also be conducted in all dosing stages for collecting
      serial blood samples.
    

Intervention name(s): E3710; E3710
Intervention type(s): Drug; Drug
Intervention description(s): Arm A:
E3710 40 mg→RPZ 10 mg→E3710 20 mg
RPZ 10 mg→E3710 20 mg→E3710 40 mg
E3710 20 mg→E3710 40 mg→RPZ 10 mg
Crossover study of E3710 40 mg, E3710 20 mg, and PRZ 10 mg, once daily, for 5 days, oral administration.; Arm B:
E3710 40 mg→E3710 80 mg→EPZ 40 mg
E3710 80 mg→EPZ 40 mg →E3710 40 mg
EPZ 40 mg→E3710 40 mg→E3710 80 mg
Crossover study of E3710 40 mg, E3710 80 mg, and EPZ 40 mg, once daily, for 5 days, oral administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proton Pump Inhibitors; Gastroesophageal Reflux Disease; pharmacokinetics; pharmacodynamics
Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-labeled (laboratory blinded), randomized, two period, single-center,
      crossover, comparative study, where each participant will be randomly assigned to the
      reference (Toradiur®, 10 mg) or the test (Torasemide, 10 mg) formulation in each period of
      study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both
      formulations are bioequivalent
    


Intervention name(s): Torasemide tablet 10 mg; Toradiur® tablet 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): Torasemide is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 10 mg of torasemide.; Toradiur® is manufactured by MEDA Manufacturing Cologne, Germany. Each tablet contains 10 mg of torasemide.
Other intervention name(s): The test product; The reference product
Intervention MeSH terms: Torsemide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Torasemide; Bioequivalence; Toradiur®
Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion
Condition: Catheter Obstruction; Vascular Access Devices
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicentre, open-label, randomised, phase III study designed to evaluate the
      efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD
    


Intervention name(s): Actilyse; Saline solution; Actilyse; Actilyse
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.; Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II; Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O.; Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.
Intervention MeSH terms: Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment