bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Voglibose Compared With Acarbose in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to evaluate the efficacy of voglibose versus acarbose
      combined with metformin in participants with type 2 diabetes mellitus (T2DM) by evaluating
      levels of glycosylated hemoglobin.
    

Detailed description: 
      The drug being tested in this study is called voglibose. Voglibose is being tested to treat
      type 2 diabetes in people who have diabetes that is inadequately controlled on metformin
      alone. This study will look at glycemic control in people who take voglibose.

      The study will enroll 494 patients. All participants will be enrolled in a 2-week screening
      phase and a metformin run-in phase. Eligible participants will be randomly assigned (by
      chance, like flipping a coin) to one of the two treatment groups:

        -  Metformin and Voglibose 0.2 mg

        -  Metformin and Acarbose 50 mg

      All participants will be asked to take their current dose of metformin tablets and either
      voglibose or acarbose tablets three times a day throughout the study.

      This multi-center trial will be conducted in China. The overall time to participate in this
      study is up to 20 weeks and participants will make 8 visits to the clinic.
    

Intervention name(s): Metformin; Voglibose; Acarbose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Metformin tablets; Voglibose tablets; Acarbose tablets
Other intervention name(s): Glucophage; Basen; Glucobay, Precose, Prandase
Intervention MeSH terms: Metformin; Acarbose; Voglibose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Parkinson's disease is a major neurodegenerative disorder in which there is a progressive
      loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of
      dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a
      precursor of DA that crosses the blood brain barrier, and also to the use of selective
      inhibitors of MAO B, the major DA metabolising enzyme in man.

      This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi
      national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.)
      versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects
      with early idiopathic Parkinson's Disease.

      The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score
      from baseline to endpoint, was chosen based on regulatory guidance and prior use in other
      trials in similar populations.
    


Intervention name(s): Safinamide (as add-on therapy); Safinamide (as add-on therapy); Safinamide (as add-on therapy)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative; Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist; Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
Other intervention name(s): Apokyn; Parlodel; Mirapex; Requip; Cabergoline (not approved in US); Lisuride (not approved in US); Pergolide (withdrawn from US Market March 2007); Apokyn; Parlodel; Mirapex; Requip; Cabergoline (not approved in US); Lisuride (not approved in US); Pergolide (withdrawn from US Market March 2007); Apokyn; Parlodel; Mirapex; Requip; Cabergoline (not approved in US); Lisuride (not approved in US); Pergolide (withdrawn from US Market March 2007)
Intervention MeSH terms: Cabergoline; Pramipexole; Ropinirole; Bromocriptine; Lisuride; Apomorphine; Pergolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The goal of postoperative pain management is the provision of comfort, early mobilization and
      improved respiratory function without causing inadequate sedation and respiratory compromise,
      which can be achieved through using regional anethesia.

      This study aimed to assess the analgesic effect of adding dexamethasone or magnesium sulphate
      with bupivacaine in ultrasound-guided QLB to prolong its duration in patients undergoing open
      abdominal surgeries in the early postoperative period regarding pain relief After approval of
      the ethical committees in Ain Shams University Hospitals, patients undergoing open abdominal
      surgeries were included in the study, and were divided into three groups (n=22; each); group
      M, D and group C. In Group A, patients (n=22) received 20 ml bupivacaine 0.25% plus 5 ml of
      10% MgSO. In group B, patients (n=22) received 20 ml bupivacaine 0.25% plus 8 mg
      dexamethasone (2 ml) plus 3 ml 0.9% NaCl. In group C (control), patients (n=22) received 20
      ml bupivacaine plus 5 ml 0.9% NaCl.
    


Intervention name(s): Bupivacaine- Magnesium; Bupivacaine dexamethasone; Bupivacaine saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.; Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS.; Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Is a Front-of-package Label Contaning Information on Both Nutrient Profile and Ultra-processing Well Understood?
Condition: Objective Understanding of Nutritional Label
Study type: Interventional

Summary: 
      A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic
      mention when the product is ultra-processed, has been proposed. The investigators aim to
      study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the
      impact of this modified version on the objective understanding of foods' nutritional quality,
      and on the identification of UPFs as primary outcomes. They also aim to study as secondary
      outcomes the impact of this label on purchasing intentions and the product perceived as the
      healthiest.
    

Detailed description: 
      Two arms will be enrolled. The control arm will not have access to any FOP Label (the current
      situation in Europe), and the experimental arm will have access to Nutri-Score 2.0.
      Participants of both arms wil be asked to rank food products of 3 categories (breakfast
      cereals, cookies, ready-to-eat meals) according to their nutrient profile, and to identify
      ultra-processed foods.
    

Intervention name(s): Front-of-pack label NutriScore 2.0
Intervention type(s): Other
Intervention description(s): Participants in the experimental arm can see, in case the product is ultra-processed, a black banner surrounding the Nutri-Score, with the word "ultra-transformé", meaning ultra-processed, and no black banner otherwise. Participants in the control arm had no label at all. The intervention (the Nutri-Score 2.0) was added on the packaging on the products included in the 3 sets of images that participants recieved via the questionnaire.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Process Versus Outcomes Incentives for Lipid Management
Condition: Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and
      cost-effectiveness of improving cholesterol levels among participants who are at high risk of
      CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial
      incentives. Participants will use electronic pill bottles that continuously monitor statin
      adherence. The primary outcome will be change in LDL cholesterol over 12 months.
    


Intervention name(s): Process Incentive; Outcome Incentive
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Daily sweepstake conditional on daily medication adherence; Incentives conditional on LDL cholesterol reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In a 4-arm, randomized controlled trial, we propose to evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence.
Masking: None (Open Label)
Primary purpose: Prevention
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for FFR Measurement
Condition: Coronary Artery Disease; Coronary Disease; Myocardial Ischemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
Study type: Observational

Summary: 
      TruePhysioTM Sensor-equipped Ultrathin Pressure Microcatheter (referred to as TruePhysioTM
      Microcatheter below) is a novel device for evaluating the functional significance of coronary
      stenosis. This study will compare the differences, if any, between the coronary fractional
      flow reserve (FFR) measured by the TruePhysioTM Microcatheter and the Pressure Wire.
    

Detailed description: 
      Many studies have reported that FFR-guided coronary revascularization leads to improved
      long-term clinical outcomes and reduced costs compared with angiography-guided coronary
      revascularization alone. Current guidelines emphasize the measurement of FFR as the standard
      of reference when determining the functional significance of coronary artery stenosis in
      stable patients when evidence of ischemia is not available (class IA indication). But FFR is
      still underutilized in clinical practice. One of the reasons may be the difficulty in
      manipulating the Pressure Wire.

      TruePhysioTM Microcatheter is a novel device for evaluating the functional significance of
      coronary stenosis, which may simplify FFR measurements by allowing the use of standard
      guidewires best suited to negotiating the patients' anatomy. This study is a prospective,
      open label, multi-center study with the purpose of comparing the differences, if any, between
      FFR measured by the TruePhysioTM Microcatheter and Pressure Wire. The secondary purpose is to
      analyze the correlation between FFR measured by the TruePhysioTM Microcatheter and Pressure
      Wire. A total of 239 patients will be recruited at 4 centers in China.
    

Intervention name(s): TruePhysioTM Microcatheter; Pressure Wire
Intervention type(s): Device; Device
Intervention description(s): Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).; Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).
Other intervention name(s): FFR Microcatheter; PressureWire
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with coronary artery disease for whom FFR measurement is thought to be clinically
        indicated.
Project MiCRIM- Sleep and Stress Intervention
Condition: Sleep; Stress
Study type: Interventional

Summary: 
      The purpose of Project MiCRIM is to test the feasibility and effectiveness of an online
      4-week mindfulness-based intervention that incorporates informational elements about sleep,
      mindfulness, thoughts, emotions, and acceptance using a control sample of Criminology and
      Criminal Justice majors as a proxy for Corrections officers.
    

Detailed description: 
      The study will use a waitlist-control design to examine the effectiveness of a brief (4-week)
      online mindfulness-based intervention aimed at reducing stress and improving sleep quality. A
      proxy, convenience sample of 50 criminology majors will be recruited and randomized into the
      active intervention or waitlist condition. The intervention requires participants to complete
      one mindfulness education module every week for 4 weeks, and to practice a 15-minute formal
      guided mindfulness meditation at least five times per week across the 4 weeks. Participants
      will also be taught evidence-based sleep improvement techniques, will be provided education
      for when to use the techniques, and will be encouraged to implement the techniques to improve
      sleep. Validated self-report measures of stress, anxiety, mood, and sleep quality will be
      assessed pre- and post-intervention. Adherence to the mindfulness practice will be monitored
      online and self-report assessments of sleep technique implementation will be collected. Sleep
      patterns will be assessed using a Philips Respironics Spectrum 2 Actiwatch, which is a
      wrist-worn device that measures movement and light exposure and estimates sleep-wake
      patterns. Lastly, multiple saliva samples pre- and post-intervention will be collected and
      analyzed by ELISA with a multiplex cytokine assay. Cortisol, α-amylase, and the four analytes
      with known deleterious roles in cellular and behavioral stress responsiveness will be
      measured simultaneously: interleukin-1beta, interleukin-6, interleukin-8, and Tumour Necrosis
      Factor-alpha will be examined pre- and post-intervention.
    

Intervention name(s): Mindfulness-based intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will complete one mindfulness education module every week for 4 weeks, and to practice a 15-minute formal guided mindfulness meditation at least five times per week across the 4 weeks. Participants will also be taught evidence-based sleep improvement techniques, will be provided education for when to use the techniques, and will be encouraged to implement the techniques to improve sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention and control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness; sleep; stress
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment
Condition: Myocardial Infarction [C14.907.585.500]
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to measure the effect of low- and high-dose lipid-lowering
      treatment with rosuvastatin on the coronary physiology parameters.
    


Intervention name(s): Low-dose Rosuvastatin; High-dose Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 5mg/day for one year; Rosuvastatin 40mg/day for one year
Other intervention name(s): Crestor; Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Index of microcirculatory resistance; Fractional Flow Reserve
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Extended-release Bupropion Hydrochloride Tablets in Chinese Healthy Volunteers
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      Bupropion is used in psychological disorder mainly in major depressive disorder (MDD). In
      China, buproprion Immediate Release (IR) and Sustained Release (SR) tablet have been in
      market for the treatment of MDD. Bupropion Hydrochloride (HCl) Extended Release (XL) tablets
      formulation is proposed for marketing approval in China for same indication. Therefore, a
      pharmacokinetic study is planned to be conducted in Chinese subjects. It is an open label,
      single-centre and single cycle study to evaluate the pharmacokinetics, safety and
      tolerability of 150 milligram (mg) and 300 mg following single and repeated daily doses.
      Approximately 16 males and females Chinese healthy subjects will be enrolled into the study
      to get 12 completed subjects.
    


Intervention name(s): Bupropion HCl XL tablet 150mg; Bupropion HCl XL tablet 300mg
Intervention type(s): Drug; Drug
Intervention description(s): The 150 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed.; The 300 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed.
Intervention MeSH terms: Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depressive disorder; Extended release Bupropion
Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty
Condition: Adductor Canal Block; Levobupivacaine; Dexmedetomidine
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Total knee arthroplasty surgery is associated with severe postoperative pain and adequate
      pain management is necessary for early postoperative mobilization and rehabilitation.
      Although good postoperative pain control may be achieved by continuous epidural anesthesia or
      femoral nerve block, both methods have adverse effects such as muscle weakness, which may
      delay postoperative mobilization.
    

Detailed description: 
      The adductor canal block (ACB) is a relatively new block providing analgesia for knee
      surgery, which not only blocks the largest sensory branch of the femoral nerve but also
      results in less reduction of quadriceps muscle strength, compared with the femoral nerve
      block (FNB) in adult patients.

      Randomized controlled trials have revealed that ACB provides at least equal analgesia as FNB,
      preserves quadriceps muscle strength better than FNB, and thus allowing for functional
      recovery within the first 24-hour post-TKA. However, one important limitation of single-shot
      peripheral nerve block is the short duration of analgesia. Because the average duration of
      severe pain after TKA takes 2-3 days, a continuous ACB via catheter would seem to be a good
      choice. Unfortunately, perineural catheters may be technically difficult to insert, are prone
      to premature dislodgement, and may increase infection risk. There also were some case reports
      of local anesthetic-induced myotoxicity after continuous ACB.
    

Intervention name(s): Dexmedetomidine Hydrochloride; Levobupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine; 20 mL of 0.25% levobupivacaine plus 1 mL normal saline
Intervention MeSH terms: Dexmedetomidine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dexmedetomidine; levobupivacaine; Adductor Canal Block
A Comparison of Sustained and Extended Release Bupropion Following Bariatric Surgery
Condition: Roux en Y Gastric Bypass
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to evaluate how the body absorbs and processes the sustained
      release (SR) and extended release (XL) medication bupropion (Wellbutrin®). Subject who are
      1-3 years post gastric bypass surgery will be invited to participate. Non-surgical controls
      will also be enrolled based on a matching criteria to post gastric bypass subjects.
      Participants will be asked to complete two 12-hour study days approximately 11 days apart.
    


Intervention name(s): Bupropion SR and XL
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness
Condition: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will compare the airway responses to two bronchoconstricting agents, mannitol and
      methacholine.
    


Intervention name(s): Methacholine (Provocholine); Mannitol (Aridol); Methacholine (Provocholine)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL; single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).; two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL every 20 seconds a deep inhalation is performed
Intervention MeSH terms: Mannitol; Methacholine Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic