bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome; Platelet Aggregation, Spontaneous
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to address the anti-thrombotic effects of tocotrienols
      supplementation via modulation of platelet activation, thrombotic markers, inflammatory
      markers and endothelial function.

      It is hypothesized that 2 weeks supplementation of tocotrienols will be able to suppress
      platelet aggregation in subjects with metabolic syndrome.
    

Detailed description: 
      A double-blind, randomized, crossover study comparing the effects of tocotrienols vs. placebo
      will be conducted in subjects with metabolic syndrome. Subjects will be supplemented with
      Tocovid Suprabio 200 mg twice daily (or placebo) for 2 weeks followed by a postprandial
      challenge on Day 14. During the postprandial challenge, venous blood samples will be
      collected during fasting. Subjects are then required to consume a high fat breakfast meal
      containing 50g fat and 100mL milkshake, followed by the assigned capsules. Venous blood
      samples will be drawn at 2, 4 and 6 hours after consumption of capsules. A washout period of
      at least 14 days will be in place before the commencement of the second treatment.
    

Intervention name(s): Tocotrienol-rich fraction 400mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Tocovid Suprabio 200mg is taken twice daily (after breakfast and dinner) for 2 weeks. During postprandial day (Day 14), subjects are requested to consume breakfast meal containing 50g of fat and 100mL of milkshake, follow by capsule consumption; Placebo is taken twice daily (after breakfast and dinner) for 2 weeks. During postprandial day (Day 14), subjects are requested to consume breakfast meal containing 50g of fat and 100mL of milkshake, follow by capsule consumption
Other intervention name(s): TOCOVID SupraBio 200mg; Palm Olein
Intervention MeSH terms: Tocotrienols; Vitamin E; Tocopherols; Tocovid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Tocotrienols; Platelet aggregation; Metabolic syndrome; Platelet activation; Thrombosis
To Evaluate the Effect of Clarithromycin on the Systemic Exposure of Pacritinib in Healthy Subjects
Condition: Drug Interaction Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, single-center, crossover, one-way, drug-interaction study to
      evaluate the effect of 500 mg clarithromycin BID (dosed to steady state) on the PK of a
      single 400-mg dose of pacritinib in healthy male and female subjects.
    

Detailed description: 
      This was a single-center, open-label, one-way crossover, drug-interaction study. On Day 1,
      subjects received a single oral 400-mg dose of pacritinib. On Day 8 through the morning of
      Day 12, following a 7-day washout period, 500-mg oral doses of clarithromycin were
      administered twice daily (BID), 8 to 12 hours apart. It was anticipated that steady-state
      concentrations of clarithromycin would be achieved by Day 12. On Day 12, a single oral 400-mg
      dose of pacritinib was co-administered with the final 500-mg dose of clarithromycin.
    

Intervention name(s): Pacritinib; Clarithromycin; Pacritinib and Clarithromycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single 400-mg dose (four 100-mg capsules) administered in the morning on Days 1 and 12; Twice-daily, 500-mg dose (one 500-mg tablet) administered every 8 to 12 hours on Day 8 through the morning of Day 12; On Day 12, a single oral 400-mg dose of pacritinib was co-administered with the final 500-mg dose of clarithromycin
Other intervention name(s): Pacritinib 100mg; Clarithromycin 500mg; Pacritinib 100mg and Clarithromycin 500mg
Intervention MeSH terms: Clarithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Study type: Observational

Summary: 
      This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern,
      safety and effectiveness in Taiwan real world routine practice. The primary objective of this
      registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The
      secondary objectives include safety profile, objective response rate, and progression-free
      rate in real world routine practice.
    

Detailed description: 
      This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary
      objective is the dose adjustment. Secondary objectives are safety profile, objective response
      rate and progression free survival. Efficacy assessment will be based on investigators'
      judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015
      will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib
      or interferon alpha.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        advanced renal cell carinoma with disease progression on sunitinib or interferon
      
Keywords: advanced renal cell carcinoma, disease progression, sunitinib, interferon alpha
Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
Condition: Diphtheria; Tetanus; Pertussis; Polio; Haemophilus Infection
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives:

        -  To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered
           to children 4 to 6 years of age who have previously received four doses of PENTACEL™
           vaccine.

        -  To present immunogenicity before and after a single dose of DAPTACEL® vaccine
           administered to children 4 to 6 years of age who have previously received four doses of
           PENTACEL™ vaccine.
    

Detailed description: 
      This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine
      administered at 4 to 6 years of age according to the US standard of care. The study
      population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies
      494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization
      between 4 to 6 years of age.
    

Intervention name(s): Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): DAPTACEL®
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: DAPTACEL®; PENTACEL™; Diphtheria; Tetanus; Pertussis; Haemophilus influenzae type b
Incretin-based Therapy in Late Preclinical Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the trial is to study whether daily treatment with liraglutide improves
      endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is
      tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet
      autoantibodies and have dysglycemia.
    


Intervention name(s): Victoza®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.; Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes Type 1; Diabetes, Insulin-Dependent; Liraglutide; Preclinical Type 1 Diabetes; GLP-1 Analogue; Dysglycemia; Prevention
Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Disruption of sleep and alertness is one of the most disabling non-motor symptoms of
      Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not
      well understood, and treatment options remain limited. The proposed research will examine
      markers of the circadian system, sleepiness and sleep quality in PD patients and healthy
      controls. Further, the project will examine effects of bright light exposure on circadin
      function, sleep and alertness in PD.
    


Intervention name(s): Light exposure
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Excessive Daytime Sleepiness; Circadian Rhythms; Light Therapy
Association Between Fatigue and Balance in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      The relationship between fatigue and balance was established. Fatigue was correlated with 8
      parameters of balance scales. Moreover, there was a strong correlation between the level of
      fatigue from one side and depression, quality of life and disease severity from the other
      side.Fatigue seems to be the main problem in patients with MS which may influence other signs
      and symptoms such as balance.
    

Detailed description: 
      Electromagnetic field significantly reduced fatigue level in patients with MS.This effect
      reflected significantly on other symptoms such as balance, depression, disease severity and
      the quality of life in those patients.

      Virtual reality program significantly improving balance and balance perception .Virtual
      reality program also improved quality of life by improving general health, physical function
      and decreasing physical limitation significantly. However, Virtual reality programs did not
      improve fatigue.
    

Intervention name(s): Magnetic field; Virtual reality
Intervention type(s): Device; Device
Intervention description(s): Low pulsed electromagnetic field induced by BEMER machine model type: B.BOX Professional, model NO: 420200, 12-15 Volt, with maximum 300 Watt and average flux density around 35 microtesla- (BEMER Liechtenstein product, USA). Mattress which is flexible, 6 flat coil was used for whole body therapy.; Wii Fit plus machine which required balance board . It is a video game console designed by Nintendo 2009
Other intervention name(s): BEMER; Wii
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: MULTIPLE SCLEROSIS; FATIGUE; BALANCE
CPAP/PSV Preoxygenation in Obese Patients
Condition: Obesity; Anaesthesia
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether continuouse positive airway pressure
      (CPAP), during induction of anaesthesia in morbidly obese patients, result in higher levels
      of oxygen in the blood.
    


Intervention name(s): CPAP 5 cm H2O + PSV 5 cm H2O
Intervention type(s): Procedure
Intervention description(s): Patients in the intervention group received Continuous Positive Airway Pressure (5 cm H2O) and Pressure Supported Ventilation (5 cm H2O)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Obesity; general anaesthesia; preoxygenation; atelectasis
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to determine whether dapagliflozin can improve
      (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal
      impairment.This study will be conducted at approximately 100 centres from countries across
      North America and European regions. It is planned to randomize a total of 302 patients.
    


Intervention name(s): Dapagliflozin 10 mg; Matching Placebo for Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy; Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
Other intervention name(s): Farxiga™
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate whether IMMUNATE S/D is effective and safe in the
      treatment of hemophilia A patients. The study consists of 3 parts: Part 1 is a
      pharmacokinetic comparison of IMMUNATE S/D and its predecessor IMMUNATE. Part 2 is an
      evaluation of efficacy and safety of IMMUNATE S/D. Part 3 is a pharmacokinetic study of
      IMMUNATE S/D.
    


Intervention name(s): Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment)
Intervention type(s): Drug
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Factor VIII Deficiency
Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl.
      dose proportionality, and pharmacodynamics of BI 135585 XX (Part 1), as well as the relative
      bioavailability of two different immediate release tablet formulations versus oral solution
      (Part 2)
    


Intervention name(s): Placebo to BI 135585; BI 135585
Intervention type(s): Drug; Drug
Intervention description(s): Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on on placebo) on Day 1; Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on placebo) on Day 1; Part 2 - oral doses given to 12 subjects on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
Condition: Sepsis; Shock
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Investigators are conducting research about oxygen levels in the body and whether it is
      possible to use a device to measure oxygen in the body's tissues noninvasively, without blood
      draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how
      this device compares to standard measurements using blood from a catheter. This may help
      treat patients who may not be getting enough oxygen to their body.
    

Detailed description: 
      Investigators will enroll patients in the pediatric intensive care unit who have an
      indwelling catheter that allows measurement of central venous oxygen saturation. Measurements
      of central venous oxygen saturation using blood oximetry will be compared with measures of
      tissue oxygenation at the buccal mucosa using a Raman spectroscopy tissue oximeter.
      Investigators will also measure the status of the sublingual microcirculation utilizing
      sidestream dark field microscopy. Basic demographic and clinical variables such as ongoing
      vasoactive infusions, mechanical ventilation, and laboratory data will also be collected.
    

Intervention name(s): Tissue oxygenation monitoring
Intervention type(s): Device
Intervention description(s): The device provides continuous measures with updates based on the previous 10 seconds worth of data. Data is continuously stored.
Other intervention name(s): R-StO2 (Raman Tissue Oxygenation)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: tissue oxygenation; perfusion status
Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus
Condition: Type-2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and
      safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile,
      and adiponectin in subjects with type-2 diabetes mellitus.
    

Detailed description: 
      There will only be one group in this study who will receive study treatment as follows:
      anti-diabetic agents currently used by respective subjects for at least 3 months prior to
      Screening, treatment intensification (lifestyle modification), and DLBS3233 at a dose of 100
      mg once daily for 12 weeks.

      Clinical and laboratory examinations to evaluate the investigational drug's efficacy and
      safety will be performed at baseline and at interval of 6 weeks over the 12-week course of
      therapy.
    

Intervention name(s): DLBS3233
Intervention type(s): Drug
Intervention description(s): Study treatment will be DLBS3233 at a dose of 100 mg once daily (for 12 weeks) in addition to current anti-diabetic treatment used by respective study subjects and treatment intensification (lifestyle modification)
Other intervention name(s): Inlacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type-2 diabetes mellitus; Add-on therapy
Behavioral Economic Approaches to Increase Colorectal Cancer Screening
Condition: Cancer of the Colon
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This is an RCT aimed at testing different population-based approaches to increasing
      colorectal cancer screening through email outreach, including usual email communication,
      active choice, and active choice + financial incentive.
    

Detailed description: 
      This is an RCT aimed at testing different population-based approaches to increasing
      colorectal cancer screening. The investigators will randomize a cohort of employees between
      the ages of 50-64 to 3 arms of email communications: a.) Usual email communication; b.)
      Active choice- usual care + the ability to pre-commit directly through a web form; c.)
      Financial incentive- usual care + active choice + financial incentive for completion.
    

Intervention name(s): Email outreach; Active choice; Financial incentive
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects will receive an email describing the importance of colorectal cancer screening and that s/he has been selected to participate in this VIP concierge service.; S/he will receive the ability to pre-commit and choose from 3 different appointment slots by clicking directly on the email.; The participant will receive the offering of $100 if s/he follows through with screening colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed as a single centre, double blind, placebo controlled, randomized,
      SAD/FE/MAD, safety, tolerance and PK study of BMB-101 in healthy adult subjects. The study
      will be conducted as a 3-part study.
    

Detailed description: 
      This study is designed as a 3-part study:

      Part 1 is designed as single ascending dose (SAD) escalation study investigating 4 dose
      levels. Each cohort will consist of participants to be randomly assigned to receive a blinded
      oral dose of BMB-101 or placebo.

      Part 2 is designed as a randomized, orally administered, single-dose, two-treatment (fed vs
      fasted), two-period, two-sequence crossover to assess the effects of a standard high-fat
      breakfast on PK of BMB-101.

      Part 3 is designed as a multiple ascending dose (MAD) escalation study investigating up to 4
      dose levels. Subjects will be randomized to receive double-blind treatment of BMB-101 or
      matching placebo twice daily for 7 days.
    

Intervention name(s): BMB-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive one of several different oral doses of BMB-101 once or twice daily; Matched Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: SAD, FE, MAD, dose escalating
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to obtain data on the safety and seizure frequency associated with long-term
      oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects
      with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed
      SP0961 (NCT01118949) to continue to receive Lacosamide.
    


Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.
Other intervention name(s): Vimpat®
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Generalized Tonic-Clonic (PGTC) Seizures; Absence Seizures; Myoclonic Seizures; Idiopathic Generalized Epilepsy (IGE)