bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate factor levels of the pro coagulant factors II, VII,
      IX, X, and the anticoagulant factors protein C and S in healthy volunteers during the intake
      of elevated levels of vitamin K in order to investigate whether there is any evidence that
      high dose vitamin K intake increases plasma coagulation factor activity.
    

Detailed description: 
      1. Recruit 8 male healthy individuals with no prior history of arterial or venous
           thrombosis (2 each from each of the following age ranges: 20-34, 35-49, 50-64, >65).

        2. Visit 1: Measure baseline activity levels of Factor II, Factor VII, Factor IX, Factor X,
           and levels of D-Dimer, TAT complexes, protein C and S activities. Also measure thrombin
           generation potential. Collaboration with a research laboratory will be sought to also
           determine factor VIIa levels.

        3. Visit 2: Measure activity of Factor II, Factor VII, Factor IX, Factor X, levels of
           D-Dimer, TAT complexes, protein C and S activities and thrombin generation potential at
           the end of the 2 week period.

        4. Have each individual consume 20 mg of Vitamin K2 orally per day for two weeks.

        5. Visit 3: Measure Factor II, Factor VII, Factor IX, Factor X, D-Dimer, TAT complexes,
           protein C and S activities and thrombin generation potential at the end of the 2 week
           period.

        6. Total length of study is 4 weeks.

        7. Analyze the data sets for changes in levels / activities due to Vitamin K
           supplementation.
    

Intervention name(s): Vitamin K, 20mg
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will take 20mg vitamin K by mouth in capsule form everyday for 14 continuous days.
Other intervention name(s): Carlson Vitamin K2 Menatetrenone, in 5mg capsules
Intervention MeSH terms: Vitamins; Vitamin K; Vitamin K 2; Menatetrenone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vitamin K; Thrombosis
Lofexidine Pharmacokinetics in the Presence of Paroxetine in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics, safety and tolerability of
      lofexidine HCl in the presence of paroxetine in healthy adults.
    

Detailed description: 
      This is a Phase 1, open-label, single-sequence study to determine the pharmacokinetics,
      safety and tolerability of lofexidine HCl in the presence of paroxetine in healthy adults.
      Lofexidine HCl is an alpha-2 adrenergic agonist under development for the treatment of acute
      withdrawal from short-acting opioids. Paroxetine HCl is an orally administered psychotropic
      drug indicated in the treatment of major depressive, obsessive compulsive, panic, social
      anxiety, and generalized anxiety disorders. Paroxetine is a strong CYP2D6 inhibitor.
    

Intervention name(s): Lofexidine; Paroxetine
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will receive two single doses of lofexidine HCl; one 0.4 mg dose taken alone on Day 1 and one 0.4 mg dose taken with 40 mg once daily paroxetine HCl at steady-state on Day 13.; All subjects will receive daily single doses of paroxetine HCl; one 20 mg dose taken Days 4-6, one 40 mg dose taken Days 7-19, one 20 mg dose taken Day 20, one 10 mg dose taken Days 21-22.
Intervention MeSH terms: Lofexidine; Paroxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Lofexidine; Paroxetine; Volunteer
Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with
      metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2
      diabetic patients with inadequate glycemic control despite treatment with alogliptin 25 mg in
      addition to diet and exercise therapy.
    

Detailed description: 
      The drugs being tested in this study are called alogliptin and metformin hydrochloride.
      Alogliptin in combination with metformin hydrochloride was being tested to treat people who
      have Type 2 diabetes mellitus (T2DM) with inadequate glycemic control despite treatment with
      alogliptin in addition to diet and exercise. This study looked at the efficacy and safety of
      alogliptin 25 mg once daily (QD) + metformin hydrochloride 500 mg QD compared to alogliptin
      25 mg QD + metformin hydrochloride 250 mg twice daily (BID) and alogliptin 25 mg QD
      administered alone.

      The study enrolled 374 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the three treatment groups-which remained undisclosed to the
      patient and study doctor during the study (unless there was an urgent medical need):

        -  Alogliptin 25 mg QD + metformin hydrochloride 500 mg QD

        -  Alogliptin 25 mg QD + metformin hydrochloride 250 mg BID

        -  Alogliptin 25 mg QD

      This multi-center trial was conducted in Japan. The overall time to participate in this study
      was 36 weeks (12-week screening period and 24-week treatment period). Participants made
      multiple visits to the clinic including a final visit 24 weeks after the start of study
      medication.
    

Intervention name(s): Alogliptin; Metformin hydrochloride; Metformin hydrochloride Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin tablets; Metformin hydrochloride tablets; Metformin hydrochloride placebo-matching tablets
Other intervention name(s): SYR-322; Nesina®; Glycoran®
Intervention MeSH terms: Metformin; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine: Electronic Cigarette and Cigarette
Condition: Nicotine Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are 1) to determine the pharmacokinetics of nicotine after
      multiple dose administration by electronic cigarette and 2) to compare the acute effects of
      multiple dose of nicotine administrated by electronic cigarette compared with those obteined
      by cigarette.
    

Detailed description: 
      Electronic cigarettes (e-cigarettes) are battery-operated devices that deliver nicotine via
      inhaled vapour or "vaping". At present, e-cigarettes are becoming increasingly popular among
      smokers worldwide. However, knowledge about e-cigarette nicotine pharmacology remains
      limited.

      The aims of this study are 1) to determine the pharmacokinetics of nicotine after multiple
      dose administration by electronic cigarette and 2) to compare the acute effects of multiple
      dose of nicotine administrated by electronic cigarette compared with those obteined by
      cigarette.
    

Intervention name(s): Nicotine; Nicotine
Intervention type(s): Drug; Drug
Intervention description(s): Multiple dose nicotine; Multiple dose nicotine
Other intervention name(s): Nhoss®; Marlboro®
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Nicotine; Electronic cigarette; Cigarette
Effect of Crossed Legged Position on Ultrasound Measured Posterior Longitudinal Ligament Length in Parturients.
Condition: Pregnancy
Study type: Observational

Summary: 
      To investigate if sitting in flexed cross legged position for neuraxial techniques in term
      pregnant patients widens the size of the ultrasound acoustic window as measured by the
      visualized posterior longitudinal ligament length, during lumbar spine ultrasonography using
      longitudinal paramedian view, in comparison to the standard sitting flexed position.
    

Detailed description: 
      This is a prospective observational study involving a total of 30 healthy term gestation
      pregnant patients with singleton fetuses.Patients will be randomly allocated to sit crossed
      leg or in standard position first. Using ultrasonography, the acoustic window for lumbar
      spinal anesthesia at L3-4 will be evaluated in both traditional sitting and crossed leg
      positions. Ultrasonography will be performed sequentially to measure the best visualized
      length of posterior longitudinal ligament,ligamentum flavum and interlaminar distance in the
      paramedian view.The scanned image will be saved to be remeasured by a third observer.
      Patients will be asked to score their comfort level while sitting in both positions.
    

Intervention name(s): Ultrasonography
Intervention type(s): Device
Intervention description(s): Length of Posterior Longitudianl Ligament, Ligamentum Flavum and Interlaminar distance visible in paramedian longitudinal view during lumbar spine ultrasonography in cross legged position will be compared to standard sitting position.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant patients at term in the Labour and Delivery Suite, as well as those booked for
        elective cesarean sections who meet the inclusion criteria.
      
Keywords: Maternal Analgesia; Ultrasonography Lumbar Spine
Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Condition: Parenteral Nutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison
      to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral
      nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and
      coagulation variables, vital signs and adverse events. Further objectives to evaluate are the
      influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative
      properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red
      blood cells and serum.
    


Intervention name(s): SMOF lipid and Intralipid
Intervention type(s): Drug
Intervention description(s): 1-2 g, 5-7 days, 28 days
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Pharmacokinetics of Ulimorelin in Subjects With Hepatic Impairment and Healthy Subjects
Condition: Digestive System Disorders
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a
      single intravenous (IV) dose in order to identify potential patients at risks in terms of
      severity of hepatic dysfunction and to determine whether their dosage should be adjusted.
    


Intervention name(s): Ulimorelin
Intervention type(s): Drug
Intervention description(s): Single dose of 480 micrograms/kg administered as a 30 minute intravenous infusion
Other intervention name(s): TZP101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulimorelin; Hepatic Impairment
Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to characterize tumour uptake of somatostatin analog
      68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators
      hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor
      which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor
      uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status
      of the tumor specimen.
    


Intervention name(s): [68Ga]DOTATOC
Intervention type(s): Drug
Intervention description(s): 120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery.
Intervention MeSH terms: Edotreotide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glioma; 68Ga-DOTATOC; PET/CT; Somatostatin receptor
PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease
Condition: Chronic Kidney Disease; Diabetes
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to ask whether treating non-diabetic chronic kidney disease
      (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and
      13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The
      investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher
      adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to
      11g/dL.
    

Detailed description: 
      Anemia is common among patients with chronic kidney disease (CKD) and is associated with an
      increased risk of cardiovascular and renal events. Although erythropoiesis stimulating agent
      (ESA) has been used to correct anemia, use of ESA (hemoglobin level at approximately 13 g/dL)
      did not reduce cardiovascular or renal events in diabetic CKD patients. Subgroup analysis of
      a recent randomized study suggested that use of darbepoetin alfa targeting Hb between 11 and
      13 g/dL may preserve renal function better than targeting Hb between 9 and 11g/dL in
      non-diabetic CKD patients.
    

Intervention name(s): Darbepoetin alfa
Intervention type(s): Drug
Intervention description(s): Darbepoetin alfa is used for targeting Hb level of 11-13g/dL in high Hb group, and 9-11g/dL in low Hb group.
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal anemia; erythropoiesis stimulating agent; hemoglobin; non-diabetes; CKD; Chronic Kidney Disease patients without diabetes
Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students
Condition: Papilloma Viral Infection
MeSH terms: Virus Diseases; Papillomavirus Infections; Papilloma
Study type: Interventional
Phase: Phase 4

Summary: 
      Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island,
      CCU is the third leading cause of cancer in women (standardized incidence rate on the world
      population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate
      standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France
      where it was 1.7 / 100,000 in 2018.

      CCU results from infection with the human papillomavirus (HPV), which is the most common
      sexually transmitted viral infection.

      CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV)
      which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on
      incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted
      sexually, it is important to vaccinate before the start of sex.

      In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by
      Public Health France at 8.1% among girls aged 16 years in 2018, while the already low
      national average was established 23.7%.

      Thus, in view of the epidemiological situation in Reunion island (high incidence and
      mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to
      study the impact of a health promotion program sex and prevention of sexually transmitted
      infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV
      vaccination among young students in middle school.
    


Intervention name(s): Gardasil 9, 9-Valent Intramuscular Suspension
Intervention type(s): Drug
Intervention description(s): access to HPV vaccination near the college in a health bus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study is a randomized controlled trial that tests the effectiveness of a novel
      intervention called the Push-Pull-Hold program on improving self-care in patients with heart
      failure. This intervention was developed based on our previous quantitative and qualitative
      findings and existing psychological concepts. Results would inform current understanding of
      the intention-behavior link in self-care and inform future policy and intervention
      development to improve patient and caregiver outcomes.
    


Intervention name(s): Push-Pull-Hold Program
Intervention type(s): Behavioral
Intervention description(s): Developed based on concepts of motivational interviewing, temporal framing, empowerment. It is tailored to Singaporean patients and includes contextual self-care information and tips.
Other intervention name(s): PPHP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: heart failure; self-care; behavio*; intervention; randomized controlled trial
Pharmacological Modulation of Hippocampal Activity in Psychosis 2
Condition: Schizophrenia; Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether administration of levetiracetam (LEV), a
      commonly used anti-epileptic that alters neurotransmitter release, can reduce hippocampal
      hyperactivity in people with psychotic disorders. Specifically, the investigators will
      utilize two functional magnetic resonance imaging (MRI) techniques: 1)
      blood-oxygen-level-dependent (BOLD) contrast will assess activity with a visual scene
      processing task that engages the anterior hippocampus and 2) arterial spin labeling (ASL)
      will assess baseline activity. Previous studies in people with psychotic disorders have shown
      that the hippocampus is hyperactive and more activity correlates with worsening of clinical
      symptoms. Therefore, the aim of this study is to use an intervention to further understand
      the underlying mechanisms of the hippocampus in psychosis.
    


Intervention name(s): Levetiracetam (LEV) 500 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The levetiracetam pill will look just like the placebo pill.; The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2-way crossover, double-blind, randomized controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Interval Training Study in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional

Summary: 
      Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced
      physical function. Patients have a higher risk of cardiovascular disease and a higher body
      mass index.

      A pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation
      after 12 weeks of high-intensity interval training.

      The primary aim of this study is to determine whether high-intensity interval training
      affects the disease activity in psoriatic arthritis. This intervention is believed to result
      in benefits in terms of inflammation, body composition and risk factors for cardiovascular
      disease.
    


Intervention name(s): interval training
Intervention type(s): Behavioral
Intervention description(s): 4x4 high intensity interval training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise Therapy
The Brain Symphony For Post-Stroke Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Music listening intervention has made great strides in improving the condition of stroke
      survivors. Thus, this research explores the effects of music listening intervention on
      post-stroke survivors during rehabilitation by using P. Ramlee songs.
    

Detailed description: 
      Objective: Music listening intervention has made great strides in improving the condition of
      stroke survivors. Thus, this research explores the effects of music listening intervention on
      post-stroke survivors during rehabilitation by using P. Ramlee songs.

      Materials & Methods: In the first phase, surveys were conducted to determine the selection of
      songs to be used in the second phase. The second phase is applying music listening
      intervention on a small sample of 20 subjects, aged 55 years old and above. The participants
      were categorized into two groups: stroke survivors and healthy individuals and randomized
      into control group (without music) and experimental group (with music). The second phase
      consists of three stages. Stage one is to pre-screen and select potential subjects before the
      experiment. The second stage aims to determine the effect of P. Ramlee music on stroke
      survivors during their rehabilitation through augmenting their brain neuroplasticity with
      measurement of the MEP using TMS. The final stage compares the effects of MEP between lesion
      and non-lesion areas.
    

Intervention name(s): With Music; Without Music
Intervention type(s): Other; Other
Intervention description(s): each subject was placed in a TMS laboratory with music for 20 minutes; each subject was placed in a TMS laboratory without music for 20 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were categorized into two groups: stroke survivors and healthy individuals and randomized into control group (without music) and experimental group (with music).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Music Listening; Stroke; Rehabilitation; Transcranial Magnetic Stimulation (TMS); Neuroplasticity; P. Ramlee Music