bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes
Condition: Increased Metabolic Requirement; Healthy
Study type: Interventional

Summary: 
      Protein requirements in individuals who participate in endurance-based exercise training have
      been suggested to be greater than the current recommended dietary allowance (RDA).

      The biological value of protein depends on its amino acid composition. Essential amino acids
      are believed to have main role on whole body protein metabolism. However, it remains to be
      determined what role non-essential amino acids (NEAA) may have in regulating protein
      metabolism and contributing to the increased protein requirements after endurance exercise.

      The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid
      requirement in children, normal healthy adult and clinical populations. However, the IAAO
      method has never been utilized for assessing the effect of NEAA on protein requirements after
      endurance exercise.

      The objective of the current study is to investigate the importance of NEAA for
      endurance-trained male subjects.
    


Intervention name(s): BASE egg protein; BCAA-enriched egg protein; small amount of essential amino acids; large amount of essential amino acids
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein; BCAA-enriched egg protein provided as crystalline amino acid.; essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of essential amino acid in BASE egg protein; essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of amino acid in BCAA-enriched egg protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera
Condition: Polycythemia Vera
MeSH terms: Polycythemia Vera; Polycythemia
Study type: Observational

Summary: 
      Jakavi® therapy for polycythemia vera (PV) has so far been studied exclusively in clinical
      trials and at selected clinical trial centres. This observational study is intended to
      document the therapy of PV in daily practice with a broad patient population and a
      geographically representative selection of German centres (both hospitals and practices). The
      prospective mapping of daily practice reality is thus the main goal of this project.
    

Detailed description: 
      To achieve meaningful results in accordance with the study objective and to obtain long-term
      data from daily clinical practice in a real-world setting, the observation period under
      Jakavi® therapy is specified as 36 months.
    

Intervention name(s): Jakavi
Intervention type(s): Other
Intervention description(s): Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.
Other intervention name(s): Ruxolitinib
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult male and female patients with PV for whom Jakavi® therapy is indicated.
      
Keywords: ruxolitinib; polycythemia vera; PV; jakavi
A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single
      oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched
      control subjects with normal hepatic function.
    

Detailed description: 
      This is an open label, parallel-group, single dose, Phase 1 study to evaluate the PK profile,
      safety, and tolerability of a single oral 450 mg dose of vadadustat in subjects with hepatic
      impairment relative to control subjects with normal hepatic function. The study will enroll
      up to 24 subjects in 3 groups of 8 subjects at 2 study sites. Blood samples for vadadustat PK
      and its metabolites will be collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24,
      36, 48, 60, and 72 hours post-dose.
    

Intervention name(s): Vadadustat
Intervention type(s): Drug
Intervention description(s): Oral tablet
Other intervention name(s): AKB-6548
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hepatic impairment; Healthy subjects; Child-pugh; Vadadustat
Pharmacogenomics of Antiplatelet Response - I
Condition: Platelet Aggregation; Platelet Transcriptome; Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial is examining the role of genetic polymorphism on the effect of
      clopidogrel (with or without aspirin) on platelet response in persons at high-risk for
      myocardial infarction or stroke due to family history of early-onset coronary artery disease.
    

Detailed description: 
      The main goal of this study is to explore the impact of the PEAR1 genetic variant
      (rs12041331) on responsiveness to clopidogrel. The investigators will further assess the role
      of other genetic variants in determining the response to single or dual anti-platelet
      therapy. Apparently healthy subjects (N= 2108) from high-risk families are being (a)
      identified from a proband with early-onset CAD and (b) genotyped on the Illumina 1 million
      platform, with imputation to 2.5 million single nucleotide polymorphisms. The investigators
      plan to characterize the variance in platelet aggregation to multiple agonists (ADP,
      collagen, and arachidonic acid) after 1-week therapy with clopidogrel in a high-risk subset
      of GeneSTAR subjects (N=100). The investigators further plan to determine the extent to which
      variants identified in the PEAR1 gene modify platelet responsiveness to inhibition by
      clopidogrel in this high-risk subset. In addition, the investigators aim is to determine the
      extent to which variants in other recently discovered genes, by themselves, and in
      combination with PEAR1, modify platelet responsiveness to clopidogrel alone and with aspirin
      in this high-risk subset. Lastly, the investigators also want to determine what changes in
      platelet mRNA are produced by aspirin alone and by aspirin with clopidogrel.
    

Intervention name(s): Clopidogrel; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Clopidogrel 75 mg daily; Aspirin 81 mg daily
Other intervention name(s): Plavix
Intervention MeSH terms: Aspirin; Clopidogrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Platelet aggregation; Clopidogrel; Platelet transcriptome
Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions
Condition: Subjective Memory Complaints
Study type: Interventional

Summary: 
      The objective of this study is to demonstrate the cognitive enhancement effect and safety of
      Fermented Codonopsis lanceolata, using the cognitive and clinical indicators (e.g. memory,
      attention, and psychomotor speed) and the latest brain imaging methods for healthy adults
      suffering subjective cognitive impairment.
    


Intervention name(s): Fermented Codonopsis lanceolata 525mg; Fermented Codonopsis lanceolata 1050mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Fermented Codonopsis lanceolata 525mg daily for 8 weeks; Fermented Codonopsis lanceolata 1050mg daily for 8 weeks; Placebo daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Pharmacokinetic Interaction of Steady State Tipranavir and Ritonavir or Tipranavir and Ritonavir With Single Dose Didanosine in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to characterise the effects of concurrent tipranavir (TPV) and ritonavir (RTV)
      administration on the single dose pharmacokinetics of didanosine (ddI), to characterise the
      effects of single-dose ddI on the pharmacokinetics of TPV and RTV and to assess the
      short-term safety of this combination
    


Intervention name(s): TPV + RTV (low dose); TPV + RTV (high dose); ddl
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy
      adults aged 18 to 45 years in China.
    


Intervention name(s): Rotarix ™; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Oral, single dose; Oral, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human Rotavirus vaccine
Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety and tolerability of BI 655064 in healthy male volunteers following
      intravenous infusion of escalating single doses and following subcutaneous injection.
      Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and
      determination of the bioavailability of subcutaneous injections of BI 655064.
    


Intervention name(s): Placebo to BI 655064; Placebo to BI 655064; BI 655064; BI 655064
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): intravenous infusion of escalating doses; subcutaneous injection of escalating doses; intravenous infusion of escalating doses; subcutaneous injection of escalating doses
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children
Condition: Tracheal Intubation
Study type: Interventional

Summary: 
      There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In
      general, nasal intubation by any conventional method may be the preferred choice for certain
      procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth
      opening. If nasal intubation is not indicated or preferred, then oral intubation is usually
      performed.

      This study is looking to explore whether or not the nasal route significantly improves the
      ease and time for successful fiberoptic intubation compared to the oral route in children
      less than or equal to 2 years of age. This study will also examine if operator experience
      influence time to tracheal intubation with either route?

      The investigators hypothesize that the nasal route of fiberoptic intubation will be faster
      than the oral route, for both the trainee and the expert, and that there will be minimal
      differences between experts and trainees with nasal fiberoptic intubation.
    

Detailed description: 
      The goal of this prospective randomized study is to compare the effect of nasal fiberoptic
      intubation versus oral fiberoptic intubation in children less than 2 years of age. Other
      factors that will be assesed include operator experience, the ease and time for fiberoptic
      grade of laryngeal view, time for fiberoptic tracheal intubation, and complications.

      This study is looking to explore whether or not the nasal route significantly improves the
      ease and time for successful fiberoptic intubation compared to the oral route in children
      less than or equal to 2 years of age. While also asking, will operator experience influence
      time to tracheal intubation with either route?

      The investigators hypothesize that the nasal route fiberoptic intubation will be faster than
      the oral route, for both the trainee and the expert, and that there will be minimal
      differences between experts and trainees with nasal fiberoptic intubation.
    

Intervention name(s): Fiberoptic Intubation through the nasal route; Fiberoptic intubation through the oral route
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; fiberoptic intubation; oral intubation; nasal intubation; children under the age of 2
A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced
      solid tumors
    

Detailed description: 
      This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and
      dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics,
      immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with
      selected advanced solid tumors.
    

Intervention name(s): MEDI0562
Intervention type(s): Biological
Intervention description(s): Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced solid tumors; immunotherapy; OX40; immuno-oncology
Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin
      fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2
      Diabetes Mellitus (T2DM).
    

Detailed description: 
      The drug being tested in this study is a fixed-dose combination tablet of alogliptin and
      metformin to treat people who have diabetes. This study will look at glycemic control in
      people who take alogliptin and metformin FDC compared with alogliptin or metformin alone. The
      study will enroll approximately 640 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the four treatment groups-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  Alogliptin 12.5 mg twice daily (BID)

        -  Metformin hydrochloride (HCl) 500 mg BID

        -  Alogliptin 12.5 mg and Metformin HCl 500 mg FDC BID

        -  Placebo (dummy inactive pill) - this is a tablet/capsule that looks like the study drug
           but has no active ingredient.

      All participants will be asked to take 2 tablets and 1 capsule twice a day at the same time
      each day throughout the study. All participants will be asked to record any hypoglycemic
      events in a diary. This multi-center trial will be conducted in China, South Korea, Taiwan
      and Malaysia. The overall time to participate in this study is 34 weeks. Participants will
      make 11 visits to the clinic.
    

Intervention name(s): Alogliptin; Metformin HCl; Alogliptin and Metformin Fixed-Dose Combination (FDC); Alogliptin Placebo; Metformin Placebo; Alogliptin and Metformin FDC Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Alogliptin tablets; Metformin HCl capsules; Alogliptin and metformin FDC tablets; Alogliptin placebo-matching tablets; Metformin placebo-matching capsules; Alogliptin and metformin FDC placebo-matching tablets
Other intervention name(s): SYR-322; Nesina; Glucophage; Kazano
Intervention MeSH terms: Metformin; Alogliptin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Effects of Buttermilk on Serum LDL Cholesterol Concentrations
Condition: Hypercholesterolemia; Buttermilk; Dietary Modification; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional

Summary: 
      Rationale and objective:

      Based on the results of a pilot study, the objective of the present study is to evaluate
      whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL
      cholesterol raising effects of eggs.

      Study Design:

      The study has a randomized placebo-controlled factorial 2x2 design. The total study duration
      is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period.
      Subjects will be stratified for age, gender and BMI over the experimental groups.

      Study population:

      One hundred and eight healthy male and female subjects, aged 18-70 years, with slightly
      elevated serum total cholesterol concentrations (5.5-8.0 mmol/l).

      Intervention:

      During the entire study period, volunteers are instructed to consume a diet according to the
      Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates). During
      the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed milk.
      During the 12 weeks experimental period, a first group of subjects will continue drinking the
      skimmed milk (control group), while a second group will consume a low-fat buttermilk, a third
      group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk incorporated into a
      low-fat buttermilk based beverage. The egg-yolk will be enriched in lutein. Whole egg
      consumption (others than provided by us) is not allowed during the entire study.

      Main study parameters/endpoints:

      Measurements will be performed during the run-in period (days 0, 11 and 14) and during the
      experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk
      consumption) will be calculated as the absolute differences between values obtained at the
      end of the experimental (average days 95 and 98) and run-in (average days 11 and 14) periods.
      The primary endpoint is the change in serum LDL cholesterol concentrations. Secondary
      endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and
      hsCRP concentrations.
    


Intervention name(s): Buttermilk without added egg-yolk; Buttermilk with added egg yolk; Skimmed milk with added egg-yolk; Skimmed milk without added egg yolk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Buttermilk without added egg-yolk; Buttermilk with added egg yolk; Skimmed milk with added egg-yolk; Skimmed milk without added egg yolk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Acute Exercise on Pain and Human Movement
Condition: Chronic Musculoskeletal Disease; Chronic Pain, Widespread
MeSH terms: Musculoskeletal Diseases; Chronic Pain
Study type: Interventional

Summary: 
      The aim of this research project is to evaluate the effect of an acute exercise intervention
      on pain intensity and movement control. It also aims to investigate potential differences in
      movement con-trol between patients with chronic musculoskeletal pain compared to healthy
      controls.
    

Detailed description: 
      The aim of this research project is to evaluate the effect of an acute exercise intervention
      on pain intensity and movement control. It also aims to investigate potential differences in
      movement control between patients with chronic musculoskeletal pain compared to healthy
      controls. All tests will be conducted at Dalarna University.

      After the initial baseline tests, participants will be randomised to either acute exercise
      intervention group or to a control group not performing any intervention groups (both
      patients and controls will be randomised to intervention or control). If randomised to the
      control group, participants rests corresponding to the time it takes to perform the
      intervention (30 min), and then preform the post-intervention tests similar as the
      intervention group.
    

Intervention name(s): Acute exercise
Intervention type(s): Other
Intervention description(s): 30 min acute exercise (bicycle at stationary cycle)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised controlled study in patients with chronic pain and healthy controls
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic musculoskeletal pain; Acute exercise; Movement control; Muscle activity
Extension Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, extension study of NS-065/NCNP-01 administered intravenously once
      weekly for an additional 192 weeks to boys with DMD who complete Study NS-065/NCNP-01-201.
    

Detailed description: 
      This is a Phase II, multicenter, open-label, extension study of NS-065/NCNP-01 administered
      intravenously once weekly for an additional 192 weeks to boys with DMD who complete Study
      NS-065/NCNP-01-201. This study will evaluate the safety, tolerability, and clinical efficacy
      of NS-065/NCNP-01 at dose levels of up to 80 mg/kg/week administered by weekly IV infusion
      over an additional treatment period of 192 weeks or until enrollment in a separate long-term
      follow up program of NS-065/NCNP-01, whichever is earlier.

      Patients who complete the Phase II Dose-finding Study NS-065/NCNP-01-201 are eligible to
      enroll.
    

Intervention name(s): NS-065/NCNP-01
Intervention type(s): Drug
Intervention description(s): Received during weekly intravenous infusions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Low Dose cohort of 40 mg/kg and High Dose cohort of 80 mg/kg
Masking: None (Open Label)
Primary purpose: Treatment
HENOX: Enoxaparine in Hemodialysis
Condition: Hemodialysis
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      To assess clinical efficacy of single bolus anticoagulation with Enoxaparin in chronic
      hemodialysis

      Secondary objective:

      To assess safety and tolerability by the number of spontaneously reported adverse events by
      patients
    


Intervention name(s): Enoxaparine
Intervention type(s): Drug
Intervention MeSH terms: Enoxaparin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment