bioihbjkbjnl/mcl2 huggingface dataset:
Individualized Timing of Analgesia and Effectiveness of Labor Analgesia
Condition: Labor Pain; Analgesia, Obstetrical; Early Medical Intervention
MeSH terms: Agnosia; Labor Pain
Study type: Interventional

Summary: 
      Neuraxial analgesia is the gold standard to relieve labor pain. A recent "Practice guidelines
      for obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early
      stage of labor (cervical dilation < 5 cm) or on a individualized basis. The purpose of this
      randomized controlled trial is to investigate whether neuraxial labor analgesia administered
      on an individualized basis can improve analgesia quality and maternal satisfaction.
    

Detailed description: 
      Neuraxial analgesia is the gold standard to relieve labor pain. It also helps to attenuate
      maternal anxiety and improve maternal satisfaction. A recent "Practice guidelines for
      obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early stage
      of labor (cervical dilation < 5 cm) or, for some special patients, be provided on a
      individualized basis. Studies showed that, when compared with late administration, early
      administration of labor analgesia resulted in equivocal findings for spontaneous,
      instrumented, and cesarean delivery. The investigators hypothesize that neuraxial labor
      analgesia provided on an individualized basis will further improve analgesia quality and
      maternal satisfaction. The purpose of this randomized controlled trial is to investigate
      whether neuraxial labor analgesia administered on an individualized basis can improve
      analgesia quality and maternal satisfaction.
    

Intervention name(s): Individualized epidural analgesia; Routine epidural analgesia
Intervention type(s): Drug; Drug
Intervention description(s): Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the numeric rating scale is 5 or higher. Analgesia will be terminated at the end of the third stage of labor.; Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the cervix is dilated to 1 cm or more. Analgesia will be terminated at the end of the third stage of labor.
Other intervention name(s): Individualized analgesia with sufentanil and ropivacaine; Routine analgesia with sufentanil and ropivacaine
Intervention MeSH terms: Sufentanil; Dsuvia; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: severity of labor pain; individualized administration; neuraxial labor analgesia
Smart Digital Denture Conversion (SDDC), a Technique for Full Arch Immediate Loading
Condition: Complete Edentulism
Study type: Interventional

Summary: 
      This study presents a smart digital approach to design and construct a screw retained
      immediately loaded full arch implant supported bridge based on the pre-treatment complete
      denture.
    

Detailed description: 
      After intra oral scanning of the ridge form, implant positions, the denture is used to scan
      the intermaxillary relation and tooth positions and the fixed interim is designed and milled
      from PMMA. This technique is applicable when a single arch is treated or for bimaxillary
      implant rehabilitation cases. In this study 30 patients were grouped into two groups; group I
      in which a converted denture was made conventionally and Group II in which a converted
      denture was made digitally. General satisfaction, chair side working time, and esthetic
      outcome of the prostheses were recorded and quantified with a verbal rating scale following
      insertion of implant-supported prosthesis.
    

Intervention name(s): conventional denture conversion; digital denture conversion
Intervention type(s): Procedure; Procedure
Intervention description(s): conventional workflow usually done to do immediate loading for full arch implant cases; An alternative workflow for construction of the fixed interim requires impressions, model production, and jaw relation records then digitizing all these data then designing and milling the restoration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: immediate loading; denture conversion; full arch implant rehabilitation
Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin
Condition: Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are (a) to determine if drug levels from a single dose of an
      extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given
      every four hours containing lower doses considered safe for over-the-counter use; (b) to
      evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet
      after a single administration; and (c) to assess the safety and tolerability of the
      Codeine/Guaifenesin extended-release and immediate release tablet formulations.
    


Intervention name(s): IR Tablet under Fasted conditions; ER Tablet under Fed Conditions; ER Tablet under Fasted Conditions
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of IR Tablets combination of Codeine Phosphate/Guaifenesin 20mg/400mg every 4 hours for 12 hours total.; Administration of two ER Tablet combination of Codeine Phosphate/Guaifenesin 30mg/600mg; Administration of two Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablets under fasted conditions.
Other intervention name(s): Codeine Phosphate/Guaifenesin 20mg/400mg; Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablet; Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablet
Intervention MeSH terms: Phenylpropanolamine; Codeine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the long-term safety profile of BG00012
      (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term
      efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further
      the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic
      resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301
      (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on
      health economics assessments and the visual function test.
    

Detailed description: 
      The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as
      that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451).
      Subsequent to the initiation of this study, BG00012 was approved in several countries for the
      treatment of MS at a dose of 240 mg BID. For this reason, all participants continuing in this
      study will receive the currently marketed dose of 240 mg BID.
    

Intervention name(s): dimethyl fumarate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BG00012 capsules; Capsules taken to maintain the blind in the 240 mg BID treatment group.
Other intervention name(s): BG00012; Tecfidera; DMF
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: relapsing; multiple sclerosis; remitting; oral
Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is a preventable respiratory characterized by
      airflow obstruction that is not fully reversible. This disease a major cause of mortality
      worldwide. It is projected to rank the third-leading cause of death in 2020.

      The objective of this study is to examine the effects of a physical therapy intervention in
      stable patients with COPD.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) patients have demonstrated important balance
      impairment (1).The deficit in balance control is identified as one of the risk factors of
      fall in subjects with COPD and alters their activities daily life (2,3). Porto and al. (2015)
      reported in a recent review that individuals with COPD have a decline in balance control when
      compared with healthy age matched controls(4).
    

Intervention name(s): ET+RT+ NMES
Intervention type(s): Other
Intervention description(s): Endurance training, resistance training and neuromuscular electrical stimuation were prformed. Intensity was gradually increased.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Differents groups received differents training protocoles during the same duration
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COPD, Exercise training
Effects of Virtual Reality Game on Upper Extremity Function for Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Virtual reality training had already been used in stroke rehabilitation, and previous studies
      supported that it could improve upper extremity ability and increase motivation and pleasure
      than conventional methods. Pablo is a new VR game combined with motion sensor system which
      can detect subject's activities. Unlike commercial camera systems such as Kinect or XBOX, the
      systems require a continuous sightline or enough active range of motion which may increase
      risk of compensatory movement. Few of studies had investigated the rehabilitation effects on
      upper extremity with Pablo for patients with stroke.The purpose of this study is to
      investigate the effects of virtual reality upper extremity training through Pablo system in
      patients with chronic stroke.
    

Detailed description: 
      PURPOSE: The purpose of this study is to investigate the effects of virtual reality upper
      extremity training through Pablo system in patients with chronic stroke.

      METHODS:Patients with mild to moderate motor deficits were recruited and randomly assigned to
      "VR plus standard rehabilitation group"(n=19), and "standard rehabilitation group" (n=19).
      After 12 training sessions (60 minutes a time, 2 times a week), the performance was assessed
      by a blinded assessor. The outcome measures included Fugl-Meyer Assessment-Upper Limb
      section(FMAUE), Box and block test(BBT), Dynanometer, active range of motion of shoulder and
      elbow,and Stroke Impact Scale.Modified Physical Activity Enjoyment Scale and adverse effect
      were recorded after each sessions.Collected data will be analyzed with sample T test by SPSS
      version 20.0, and alpha level was set at 0.05.
    

Intervention name(s): virtual reality game traning; standard treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The controllers were attached to upper extremity to control the game. The game could train the shoulder, elbow, and wrist control.; The program included bilateral hand, grasp/release, and pinch activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Investigation of PJ vs. Sugar on Glucose Levels in Healthy and Prediabetic Subjects
Condition: Diabete Type 2; Pre Diabetes
MeSH terms: Prediabetic State; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Pomegranate fruits and products, including juice, tea, wine and extracts are widely consumed
      and recognized for their health benefits. Pomegranate fruit possesses strong antioxidant,
      anti-inflammatory and antiproliferative properties. The effects of pomegranate on type 2
      diabetic (T2DM) conditions have previously been reported. Although 8 oz. of Pom juice (PJ)
      contains 36.9 g of sugar, 12-week PomJ supplementation did not change plasma advanced
      glycated end-products, fasting glucose and HbA1C, but reduced lipid peroxidation in T2D
      subjects. Additionally, acute PJ consumption has been shown to lower postprandial glycemic
      response of a meal with high glycemic index (GI) and lower fasting blood glucose, and
      long-term PomJ consumption did not worsen diabetic markers. However, a large knowledge gap
      still exists regarding the form of sugars in PJ and the hormonal responses to PJ consumption
      in different physiological conditions. Therefore currently the consumption of PJ is not
      recommended for individuals with T2DM. This clinical study will focus on the short-term
      effects of PJ consumption on different diabetic variables to further evaluate the health
      benefits of PJ for T2DM.
    

Detailed description: 
      This study aims to measure the effects of PJ vs. sugar on glucose and insulin levels in
      apparently healthy normal weight and prediabetic overweight and obese subjects. Participants
      will be asked to consume one serving of PJ, sugar mix and water separated by one week of
      beige diet without PJ consumption (crossover design). The PJ will be provided by
      POMWonderful. Timed blood collections over a three-hour period following the
      juice/sugar/water consumption will be used to measure how PJ vs. sugar mix vs. water affects
      glucose metabolism/insulin sensitivity in human subjects.
    

Intervention name(s): PomJuice; Water; Sugar Water
Intervention type(s): Other; Other; Other
Intervention description(s): Drink 8 oz pomegranate juice; Drink 8 oz water; Drink 8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved in
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pomegranate; antioxidants; prediabetes
Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles
Condition: Peri-oral Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label study to assess safety using Restylane and Perlane in the correction of
      facial wrinkles.
    


Intervention name(s): Restylane and Perlane
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Correction of peri-oral wrinkles
Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites
Condition: Dental Caries Class II
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate
      2-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ
      restorations.

      The null hypothesis tested in this study was that, there would be no difference in the 2-year
      clinical performance of all tested bulk-fill resin composites in Class II restorations.

      Forty patients were enrolled in the study. Each patient received three bulk-fill resin
      composites Class ӀӀ restorations. One dual-cure and two light-cure bulk-fill resin composites
      were used for Class ӀӀ restorations following manufacturer's instructions. A universal
      adhesive was used with all restorations. All restorations were clinically evaluated after 1
      week (baseline), 6 months, 12 months, 18 months and finally after 24 months using the FDI
      World Dental Federation criteria.
    


Intervention name(s): Fill-Up Class ӀӀ restoration; QuiXfil Class ӀӀ restoration; Tetric N-Ceram Bulk Fill Class ӀӀ restoration
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Bulk-fill technique; Bulk-fill technique; Bulk-fill technique
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each patient received three Class ӀӀ restorations with the three tested bulk-fill resin composites.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bulk-fill resin composite; Dual-cure; Light-cure; Class ӀӀ restorations; Clinical performance; Randomized clinical trial
A Study to Assess the Effects of Single Ascending Doses of ASP1707 in Healthy Young Japanese Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to
      assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and
      distributed through the body.
    

Detailed description: 
      The first group receives the lowest dose while the last group receives the highest dose.
      ASP1707 or matching placebo is administered as a single dose under fasted conditions.

      Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic on Day -1
      and remain until Day 5. An end of study visit (ESV) takes place 7-14 days after discharge.

      Escalation to the next higher dose takes place after review of the safety and tolerability
      data from the previous dose.

      Safety assessments are performed throughout the study. Plasma and urine samples are collected
      for pharmacokinetics (PK) analysis. Serum samples are collected for pharmacodynamic (PD)
      analysis.
    

Intervention name(s): ASP1707; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: ASP1707; Japanese subjects; Safety; Pharmacokinetics; Pharmacodynamics
Carotid Artery Stenting With Cilostazol Addition for Restenosis
Condition: In-stent Restenosis After Carotid Artery Stenting
Study type: Interventional

Summary: 
      CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to
      that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting
      (CAS) in patients scheduled to undergo CAS. Study design is Multicenter Prospective
      Ranodomized Controlled Study, rondomized by cilostazol/non-cilostazol group prior to CAS. 900
      patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after
      CAS, evaluated by carotid ultrasound and angiography.
    

Detailed description: 
      Restenosis after carotid artery stenting (CAS) is a critical issue. Cilostazol can reduce
      restenosis after interventions in coronary or femoropopliteal arteries. The investigators
      confirmed and published periprocedural cilostazol administration reduced incidences of
      in-stent restenosis (ISR) or target vessel revascularization (TVR) after CAS,
      retrospectively.

      CAS-CARE study is Multicenter Prospective Ranodomized Controlled Study. Patients, scheduled
      for CAS within 30 days, 50% or more symptomatic carotid stenosis or 80% or more asymptomatic
      carotid stenosis, will enroll and randomize by cilostazol/non-cilostazol group. 900 patients
      will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS,
      evaluated by carotid ultrasound and angiography. And, evaluate cardiovascular events,
      including stroke, myocardial infarction, and hemorrhagic events in periprocedural period and
      followed period. In this study, ISR is diagnosed by ultrasound and DSA/CTA. Equivalence of
      CTA to ultrasound will be studied.
    

Intervention name(s): Cilostazol or Non-Cilostazol
Intervention type(s): Drug
Intervention description(s): Cilostazol group administrate 100-200mg/day per oral, unrestricted use of other antiplatelet agents and concomitant drugs.
Other intervention name(s): Cilostazol (Pretal) group; Non-Cilostazol (Pretal) group
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carotid Artery Disease; Carotid Artery Stenting; In stent restenosis; Cardiovascular event; Intima Media Thickness
Nutrition Status of Adults With PKU Before and During Treatment With Pegvaliase
Condition: Phenylketonurias
MeSH terms: Phenylketonurias
Study type: Observational

Summary: 
      Conduct a prospective, longitudinal study to evaluate nutritional status in adults with
      phenylketonuria (PKU) before and during treatment with pegvaliase (Palynziq™).
    

Detailed description: 
      The investigators will compare intra-subject change in adults with PKU who follow a
      protein-restricted diet (protein intake less than the RDA for protein based on weight (0.8
      g/kg/day) with or without a PKU medical food) within 90 days of starting pegvaliase
      (baseline) and 9 and 15 months later. The investigators will collect laboratory measures of
      nutrition status, anthropometrics, Dual-Energy X-Ray Absorptiometry (DXA) to measure body
      composition and bone mineral density (BMD), and indirect calorimetry to measure resting
      energy expenditure (REE). In addition, three-day food records will be obtained to assess
      protein intake and overall diet quality.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will recruit adults with PKU who are starting therapy with pegvaliase and
        currently following a protein-restricted diet with or without medical food.
Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification
Condition: Heroin Addiction
MeSH terms: Heroin Dependence
Study type: Interventional

Summary: 
      The purpose of this research is to observe the efficacy of comprehensive treatment model to
      improve treatment compliance and relapse prevention.
    

Detailed description: 
      The model include the Chinese traditional medicine JITAI combined with psychological
      intervention and social support for maintenance therapy after acute detoxification of heroin
      addicts.On the basis of the existing community management experience and community of
      professional anti-drug community service，The investigator will adopt the Chinese traditional
      medicine JITAI combined with psychological intervention and social support for maintenance
      therapy after acute detoxification of the community of heroin addicts.The purpose is to
      observe the comprehensive treatment model to improve treatment compliance and relapse
      prevention，then the investigator will form a new model of community humane drug treatment.
    

Intervention name(s): JITAI Combined with psychological intervention; Methadone; Traditional Chinese Medicine JITAI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet，Each tablet weight 0.4g; Oral Solution，1mg/ml; tablet，Each tablet weight 0.4g
Other intervention name(s): JITAI
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: the opioid dependence in rehabilitation phase; community