bioihbjkbjnl/mcl2 huggingface dataset:
Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy
Condition: Nerve Block
Study type: Interventional

Summary: 
      Moderate to severe postoperative pain often influence patients quality of recovery after
      hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after
      hepatectomy in many medical center, but the analgesic effect can be limited and undesirable
      side effects may bring about negative effects on patients recovery. Regional block has been
      proved to improve patients postoperative recovery in many kinds of surgeries.

      The investigators therefore designed a prospective, randomized, subject and assessor blinded,
      parallel-group, placebo controlled study to test the hypothesis that continuous right
      thoracic paravertebral block increase patients quality of recovery score on the 7th
      postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia
      (PCA) with morphine.
    


Intervention name(s): Continuous Paravertebral block with ropivacaine; Continuous Paravertebral Block with Saline; Patient-controlled analgesia with morphine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine 0.5%ropivacaine with 1:200,000 adrenaline, 25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of ropivacaine 0.2% ropivacaine, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg; Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
Device: PAJUNK Contiplex S Catheter Drug: single dose saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose; Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Concurrent Training and Metabolic Profile, Lung Function, Quality of Life and Stress
Condition: Sedentary Lifestyle; Metabolic Disorders; Concurrent Exercise; Lung Function Decreased; Stress; Quality of Life; Office Worker
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      Physical inactivity and sedentary time are highly prevalent worldwide and are associated with
      many adverse health outcomes. Workers adults spend two-thirds of their workday sitting, so
      they are particularly at risk. Exercise is considered a preventive and treatment tool for
      diseases, however, the effects of Concurrent Training (that is, aerobic plus resistance
      training) are not well established in healthy adults.

      This research project aims to analyze the effects of a concurrent training program on
      metabolic profile, lung function, stress and quality of life, as well as body composition and
      physical fitness in sedentary adults.

      This is a single-blinded two-arm RCT with parallel groups. After completion of baseline
      assessments, eligible participants will be randomized in a 1:1 ratio to participate in
      concurrent training group or control group. Repeat assessments will be taken immediately post
      8 weeks and post 16 weeks of intervention.
    


Intervention name(s): Concurrent training program
Intervention type(s): Behavioral
Intervention description(s): The experimental group will perform 16-weeks of exercise. The exercise sessions will occur three times/week.
The participants should conduct their daily activities as usual outside of the study and maintain the same diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blinded two-arm RCT with parallel-groups (1:1 allocation ratio).
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad
      pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.
    

Detailed description: 
      This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single
      administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety,
      tolerability, PK and PD of HM12470 will be compared with that of commercially available
      insulin.
    

Intervention name(s): HM12470; Active comparator
Intervention type(s): Biological; Biological
Intervention description(s): Single dose subcutaneous administration ranging from a very low dose to high dose; Single dose subcutaneous administration of active comparator
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of Patients With Post-ischemic Left Ventricular Dysfunction
Condition: Left Ventricular Diastolic Dysfunction
MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Observational

Summary: 
      This is an observational, prospective, multicenter study (12 hospitals belonging to the
      Italian Cardiology Network) in patients with STEMI ST elevation myocardial infarction (STEMI)
      treated successfully with primary percutaneous coronary intervention (PCI), that will be
      followed for 12 month after the acute event, in order to ascertain the predictive value of
      myocardial viability measured with cardiac magnetic resonance (1.5 T; based on the transmural
      distribution of late enhancement in the infarcted segments) for the identification of left
      ventricular (LV) remodelling (REM) 6 months after STEMI.
    

Detailed description: 
      The present study is divided into 3 appointments following the standard inpatient stay for
      the index event (STEMI).

      T0: Inpatient stay for index STEMI. Assessment of eligibility for participation in the study:

        -  STEMI diagnosis

        -  Primary PCI

        -  Confirmation at second-day transthoracic echocardiogram and pre-discharge echocardiogram
           of left ventricular dysfunction

        -  Biomarker assay

      Visit 1 (V1): between 30 and 40 days post-STEMI. Clinical evaluation and performance of
      cardiac MRI with paramagnetic contrast agent (gadolinium) for measurement of infarct
      territory size and myocardial viability.

      Visit 2 (V2): 6 months after STEMI. Clinical evaluation and second cardiac MRI, without
      contrast medium, for measurement of left ventricular volumes and consequently for measurement
      of the presence of adverse left ventricular remodeling.

      Visit 3 (V3): 12 months after STEMI. Clinical re-evaluation with collection of data regarding
      events of interest for secondary endpoint. Performance of transthoracic echocardiogram.

      The examinations and follow-up visits included in this study are part of clinical practice
      for treatment and risk assessment in patients who suffered STEMI with the exception of
      cardiac MRI without contrast medium at 6 months.

      Cardiac magnetic resonance (CMR) data (1 month and 6 months) will be centrally analyzed post
      hoc at the MRI center.
    

Intervention name(s): Cardiac magnetic resonance
Intervention type(s): Diagnostic Test
Intervention description(s): Evaluate the predictive value of myocardial viability measured with cardiac magnetic resonance for the identification of LV REM 6 months after STEMI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients with acute ST-segment elevation myocardial infarction (STEMI) treated
        with effective primary angioplasty (PCI)
Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors
Condition: Vascular Disease; Coronary Artery Disease Risk Factors Multiple
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, intravenous, single-dose escalation study to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of PZ-128 (pepducin inhibitor of PAR1) in
      subjects with vascular disease or who have 2 or more coronary artery disease (CAD) risk
      factors.
    


Intervention name(s): PZ-128
Intervention type(s): Drug
Intervention description(s): Sequential single-dose escalation; 1 to 2 hour continuous intravenous infusion
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cardiovascular Diseases; Vascular Diseases; Coronary Artery Disease; Coronary Disease; Arteriosclerosis; Platelet Aggregation Inhibitors
Evaluation of Co-Administration of Betahistine as Adjunctive to Olanzapine in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to evaluate the safety and pharmacokinetics of extended release and standard
      formulations of betahistine when administered as monotherapy and as compared to their safety
      and pharmacokinetics when co-administered with olanzapine and to determine potential dose
      limiting toxicities and/or drug-drug interactions affecting the pharmacokinetics or safety of
      either medication, with particular emphasis on somnolence and weight gain secondary to
      olanzapine treatment
    


Intervention name(s): Betahistine standard formulation; Betahistine Extended Release formulation; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): betahistine 24 mg tablets; betahistine 32 mg tablets; matching placebo
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: betahistine olanzapine weight sleepiness; olanzapine induced weight gain and sleepiness
Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
Condition: Overuse Injury
MeSH terms: Wounds and Injuries; Cumulative Trauma Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to look at the effect of strength training in preventing overuse
      injuries in female runners
    

Detailed description: 
      This randomized clinical trial will compare the effects of 9-months of strength training to a
      control group on: (1) injury rates in female runners during the 9 month intervention period,
      and for 9 months after completing the intervention, and (2) on the potential mechanisms of
      injury including strength, joint and tissue loading, and psychosocial factors.
    

Intervention name(s): Strength Training Exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Magnetic Spiderman for Preparation of Liver Donation
Condition: Liver Transplant; Complications; Surgical Injury
MeSH terms: Intraoperative Complications
Study type: Interventional

Summary: 
      Due to many vascular branches on the supra-hepatic vena cava (SHVC) and infra-hepatic vena
      cava (IHVC), in the whole procedures of preparation of liver donation, preparation of hepatic
      vena cava (HVC) is the most key and troublesome step. Magnetic Spiderman (MS) is a novel
      surgical instrument, designed and created to solve the vital problems of preparation of liver
      donation's HVC. Therefore, the aim of this study is to evaluate the feasibility and security
      of MS when using it prepare the liver donation's HVC.
    

Detailed description: 
      From January 1 2020 to June 30 2020, after inclusion and exclusion, donors' livers will be
      divided to MS group and manual (MA) group. In MS group, MS grips the SHVC and IHVC,
      respectively. MS's magnets are adsorbed on the wall of the basin and MS can pull the HVC
      accordingly. By changing the position of MS on the wall of the basin, the attending can
      expose the surgical field that make the operation convenient. In MA group, assistants use
      vessel forceps to pull the HVC according to the attending's requirements. In both groups,
      right adrenal vein, phrenic veins and other branches of the HVC are isolated and ligated,
      then SHVC and IHVC where MS's clamps gripped are cut off. After preparation, the SHVC and
      IHVC remain at least 1.5 cm. Excess diaphragms are removed. Outcomes of two groups are
      compared.
    

Intervention name(s): MS
Intervention type(s): Device
Intervention description(s): Magnetic Spiderman (MS) is a novel surgical instrumentIt. It consists of a circular neodymium iron boron magnet packed in a stainless-steel case with a spring and a jagged clamp, which gives it a spider-like appearance.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Bioavailability of a Single 12 mg Dose of Perampanel for Three Intravenous Infusion Durations Relative to a Single 12 mg Perampanel Oral Tablet in Healthy Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate the bioavailability of a single 12 milligram (mg)
      dose of perampanel intravenous infusions of different durations relative to a single 12 mg
      dose of perampanel oral tablet in healthy participants.
    


Intervention name(s): Perampanel; Perampanel
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion; Oral tablet
Other intervention name(s): E2007; E2007
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Perampanel
Effect of the Anti-oxidant N-acetylcysteine on Beta-cell Function in Type 2 Diabetes
Condition: Type 2 Diabetes; Oxidative Stress
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Insulin is secreted by cells in the pancreas called beta-cells. Beta-cell dysfunction is a
      critical feature of type 2 diabetes (T2DM). High glucose levels can exacerbate beta-cell
      dysfunction with oxidative stress proposed as a major mediator of this "glucotoxic" effect.
      High glucose levels have also been shown to contribute to vascular dysfunction and
      inflammation and these adverse responses decreased with the use of antioxidants. The
      hypothesis is that antioxidants improve beta-cell function in individuals with elevated
      glucose levels by decreasing oxidative stress. In this study the investigators will
      specifically test whether the antioxidant N-acetylcysteine (NAC) can improve beta-cell
      function in individuals with type 2 diabetes by decreasing oxidative stress.

      This study will be a dose finding study to determine the tolerability of 600 mg versus 1200
      mg twice a day of NAC and the effects on beta-cell function, glucose tolerance and oxidative
      stress markers in persons with type 2 diabetes.
    

Detailed description: 
      Beta-cell dysfunction is a critical feature of type 2 diabetes (T2DM). High glucose levels
      can exacerbate beta-cell dysfunction with oxidative stress proposed as a major mediator of
      this "glucotoxic" effect. High glucose levels have also been shown to contribute to vascular
      dysfunction and inflammation and these adverse responses decreased with the use of
      antioxidants. The hypothesis is that antioxidants improve beta-cell function in individuals
      with elevated glucose levels by decreasing oxidative stress. In this study the investigators
      will specifically test whether the antioxidant N-acetylcysteine (NAC) can improve beta-cell
      function in individuals with type 2 diabetes by decreasing oxidative stress.

      This initial study will be a dose finding study to determine the tolerability of 600 mg
      versus 1200 mg twice a day of NAC and the effects of NAC treatment on beta-cell function,
      glucose tolerance and oxidative stress markers in persons with type 2 diabetes. Study
      procedures will include a fasting urine sample and performance of a 2 hour 75 gram oral
      glucose tolerance test at baseline, after 2 weeks on 600 mg twice daily NAC and again after 2
      more weeks on 1200 mg NAC twice a day.
    

Intervention name(s): N-acetylcysteine
Intervention type(s): Drug
Intervention description(s): 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks.
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin secretion; beta-cell function; oxidative stress; type 2 diabetes
Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-02)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia
      patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital
      therapeutics.
    

Detailed description: 
      This was a randomized, double-blinded, sham-controlled trial. Overall, 68 subjects were
      randomized into the following groups:

        -  WELT-IP group: WELT-IP (insomnia digital therapeutics) use

        -  Control group: sham app use Subjects in both groups continued to receive their
           clinician-directed standard-of-care treatment for insomnia, if applicable, including
           pharmacotherapy. After screening of sleep diary, subjects were randomized and in WELT-IP
           group used WELT-IP and subjects in control group used a sham for a period of 6 weeks.
    

Intervention name(s): WELT-IP; Sham
Intervention type(s): Device; Device
Intervention description(s): WELT-IP (an investigational digital therapeutic) is an CBT-I based intervention designed to treat insomnia, conducted in 6 sessions. It is a comprehensive program delivering sleep restriction, stimulation control, muscle relaxation, cognitive treatment, and sleep hygiene education. Main features are sleep diary, sleep reports, daily lessons of CBT-I, muscle relaxation techniques, and cognitive intervention through chatbot.; Sham was downloaded to the subject's phone and was subject was instructed to complete sleep diary and sleep educational contents as needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blinded design, with three points of measurement. The subjects will receive either the WELT-IP app or sham app.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: digital therapeutics
Relative Bioavailability For Palbociclib Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the relative bioavailability of palbociclib hard gelatin capsule
      formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule
      formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib hard
      gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single 125 mg
      oral doses under fed conditions in healthy volunteers.
    


Intervention name(s): Palbociclib Formulation Reference; Palbociclib Formulation Test; Palbociclib Formulation Test
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 1, which is representative of the intended commercial hard gelatin capsule.; 125 mg single dose of palbociclib formulation with 41 micrometer API particle size and dissolution level 1; 125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 2
Intervention MeSH terms: Palbociclib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteer; bioavailability; palbociclib; formulation
The Effect of American Ginseng Root and Its Components on Glycemia in Healthy Individuals
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effect of polysaccharides from American ginseng root on postprandial
      glycemia in healthy individuals.
    

Detailed description: 
      Glycemia-lowering effects of American ginseng root have been repeatedly observed in healthy
      individuals and in type 2 diabetes. It is unclear which components trigger these effects.
      Pre-clinical evidence suggests that, aside from ginseng saponins, ginseng polysaccharides may
      reduce glycemia. This assumption has not been investigated so far in humans.

      We therefore undertook a double-blind randomized controlled clinical trial to determine the
      effect of American ginseng root polysaccharides, at escalating doses, on postprandial
      glycemia, in comparison to the American ginseng root and control in healthy individuals. We
      hypothesized that polysaccharides will reduce glycemia comparably to a dose of ginseng root
      that contains polysaccharides at an equivalent amount to the average polysaccharide dose. We
      therefore tested polysaccharide doses equivalent to 9, 12 and 15 g of rot, 12 go of ginseng
      root and a wheat bran control. Each subject received each treatment in random sequence, after
      a 12-hour overnight fast and 40 minutes prior to a 25-g oral glucose tolerance test.
      Capillary blood samples were collected at baseline, prior to glucose ingestion and at 15, 30,
      45, 60, 90, 120 minutes after the start of glucose intake. Capillary blood glucose was
      measured.
    

Intervention name(s): American ginseng root / polysaccharides
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ginseng; polysaccharides; postprandial glycemia; area under the glucose curve; peak incremental glucose