bioihbjkbjnl/mcl2 huggingface dataset:
Gd-EOB-DTPA-enhanced T1 Map for Predicting Postoperative Liver Failure
Condition: Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency
Study type: Observational

Summary: 
      Researchers designed this study to compare the value of the conventional circular
      region-of-interest (ROI) and whole-liver histogram-based analysis on gadoxetic acid disodium
      (Gd-EOB-DTPA)-enhanced T1 map for predicting postoperative liver failure (PHLF). Researchers
      collected and analyzed the data of patients who underwent partial hepatectomy for focal liver
      lesions. Researchers drew circular ROIs on Gd-EOB-DTPA-enhanced T1 maps to get the mean T1
      values. Researchers used a multiparametric analysis software to get histogram parameters.
      Then researchers compared the differences of these parameters between the PHLF group and
      non-PHLF group.
    

Detailed description: 
      The objective of this study is to compare the value of the circular region-of-interest (ROI)
      and whole-liver histogram-based analysis on gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced T1
      map for predicting postoperative liver failure. Forty patients who underwent partial
      hepatectomy for focal liver lesions were retrospectively analyzed. All subjects underwent
      1.5T Gd-EOB-DTPA-enhanced MRI including pre-contrast and hepatobiliary-phase T1 mapping.
      Patients were divided into two groups with (16 patients) and without (24 patients)
      postoperative liver failure according to the criteria established by the International Study
      Group for Liver Surgery (ISGLS). T1 values before enhancement (T1pre) and in the
      hepatobiliary phase (T1HBP) were measured by outlining a circular ROI on the axial T1 maps.
      The reduction rate of T1 relaxation time (rrT1) = (T1 pre - T1HBP) / T1 pre. The whole-liver
      histogram analysis was performed using the prototype MR Multiparametric Analysis software
      (Siemens Healthcare, Erlangen, Germany). Differences of the circular ROI-based mean values
      and the histogram parameters between the two groups were compared. The receiver operating
      characteristic curve (ROC) was plotted. The circular ROI-based mean values and the histogram
      parameters for predicting PHLF was assessed by the area under the curve (AUC).
    

Intervention name(s): T1 mapping on gadoxetic acid-enhanced MRI
Intervention type(s): Diagnostic Test
Intervention description(s): All subjects underwent 1.5T Gd-EOB-DTPA-enhanced MRI including pre-contrast and hepatobiliary-phase T1 mapping.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        the study group comprised 40 patients with an age range of 28 - 83 years (mean age, 58
        years).
      
Keywords: Gd-EOB-DTPA; hepatectomy; liver failure; magnetic resonance imaging
Initiation and Titration of Amaryl
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

        -  To describe the conditions of initiation and titration of Amaryl M, according to
           previous treatment:

        -  initial dose

        -  titration scheme

        -  efficacy after 4 months assessed by HbA1C

        -  tolerability (number and severity of hypoglycaemia)

      Secondary Objective:

        -  Fasting Plasma Glucose

        -  Weight evolution
    


Intervention name(s): GLIMEPIRIDE + METFORMIN
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500
Intervention MeSH terms: Metformin; Glimepiride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
Condition: Diarrhea-predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of YM060 once daily for female patients with
      diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52
      weeks).
    


Intervention name(s): YM060
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Ramosetron
Intervention MeSH terms: Ramosetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: YM060; Ramosetron; long term study; Diarrhea-predominant Irritable Bowel Syndrome; Female
Evaluate the Change in Iron, Vitamin D, and C-Reactive Protein Level (CRP) in a 12 to 24 Week Period
Condition: Anemia; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      The purpose of this study is to observe changes in iron status and vitamin D status during a
      12-24 week supervised training program, specifically males and females between the ages of 30
      and 50 years old.
    

Detailed description: 
      Study subjects will be participants in a triathlon training program through the Avera Sports
      Institute in Sioux Falls, SD. This clinical study will examine changes in iron and vitamin D
      levels. Blood specimens will be collected at baseline and again after 3 and 6 months of
      participating in the training program.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and pre-menopausal women between the ages of 30 and 50 who are participating in the
        Triathlon Training Program through the Avera Sports Institute
      
Biospecimen description: 
      Blood samples will be obtained three times throughout the course of the subject's involvement
      in the study: baseline, 3 months, and 6 months.
    
Keywords: Iron deficiency; Vitamin D deficiency; Anemia; Athletes; Triathletes; Triathlon
The Acute Effects of a Dietary Supplement on Cognitive Performance in Highly Trained Athletes.
Condition: Reaction Time
Study type: Interventional

Summary: 
      This study was designed to determine if a dietary supplement containing extracts of American
      ginseng, bacopa monnieri and coffee fruit can enhance cognitive performance in a population
      of trained athletes.
    

Detailed description: 
      In this study, we hypothesized that consumption of a dietary supplement containing extracts
      of American ginseng, bacopa monnieri and coffee fruit will improve reaction time and
      short-term memory in a population of highly trained athletes.

      In order to test this hypothesis, we will employ a randomized, double blind, placebo
      controlled, parallel arm study design. 40-50 subjects will be recruited and randomized in a
      1:1 ratio to either of two interventions:

      Placebo: consumption of the placebo tablet Treatment: consumption of the supplement
      (treatment) tablet

      On the day of the study, subjects will perform a series of reaction time tasks specific to
      the upper (i.e., arms) and lower (i.e., legs) body. They will also be asked to perform the
      stroop test. At the conclusion of baseline testing, subjects will consume either the placebo
      or treatment tablet. One hour later, the subjects will repeat all reaction time tasks as well
      as the stroop test. Differences in reaction time, as well as the error rate within each
      reaction time or stroop test, will serve as the primary endpoint. The data will then be
      analyzed to determine if there is a difference in the before and after reaction times and
      error rates between subjects on treatment and those consuming the placebo tablets.
    

Intervention name(s): Treatment (CopaPrime+ (USANA Health Sciences); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants received and consumed 2 treatment tablets immediately following baseline testing, and one hour prior to post-treatment testing. Each tablet contained extracts of Bacopa monnieri (150 mg), Coffea arabica (50 mg), and Panax quinquefolius L. (50 mg); Participants received and consumed 2 placebo tablets immediately following baseline testing, and one hour prior to post-treatment testing. Each tablet contained microcrystalline cellulose. The size, shape and appearance of the placebo tablet was identical to the treatment tablet.
Other intervention name(s): CopaPrime+ (USANA Health Sciences)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind placebo controlled randomized clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Whole Body Vibration (WBV) on Spasticity in Poststroke Hemiplegia
Condition: Muscle Spasticity; Physiology
MeSH terms: Muscle Spasticity; Hemiplegia
Study type: Interventional

Summary: 
      The primary purpose of this study is to show whether WBV application has antispastic effect.
      The secondary aim is to demonstrate whether WBV has neuromodulatory activity on increased
      stretch reflex and motor neuron activity, which is the basis of the pathophysiology of
      spasticity.Hypotheses of this study:Whole body vibration in poststroke hemiplegia reduces
      ankle plantar flexion spasticity.

        1. WBV ; reduces plantar flexor spasticity after stroke

        2. WBV decreases poststroke spasticity, by decreasing increased stretch reflex and motor
           neuron activity.
    

Detailed description: 
      Patients with a stroke of at least 1 month before and with a history of ankle plantar flexion
      spasticity will be included in the study. Conventional rehabilitation program will be applied
      to all patients (n=48).The intervention group (n=24) will be applied for 4 weeks, 3days a
      week, a total of 12 sessions with the WBV powerplate pro5 device. In the WBV group, the
      frequency and acceleration of vibration will be 30Hz and 18.0m/s2, respectively. The WBV
      exercise intensity will progressively increase throughout the twelve-session. In the control
      group, the same procedures will be followed. However, unlike the WBV group, a vibration will
      be given whose acceleration is attenuated by 99.5%.The surface Electromyography (EMG) and
      degree of spasticity of soleus muscle will be evaluated at the beginning and end of the all
      sessions. Soleus H-reflex will be recorded with surface EMG.To obtain the H-reflex response,
      the posterior tibial nerve in the popliteal region will be stimulated by using a stimulator
      (FE155 Stimulator HC ADInstrument, Oxford UK) with 1 ms-pulse current. The records will be
      taken with the Ag / AgCl electrodes (Kendall ®Coviden, self-adhesive electrodes) placed on
      skin according to the SENIAM protocol. The degree of spasticity will be measured as a soleus
      muscle tone torque on a fixed angular velocity moving platform.The data will be recorded with
      the PowerLab data acquisition device
    

Intervention name(s): Sham vibrator; Real vibrator
Intervention type(s): Device; Device
Intervention description(s): The Sham control group will have WBV the same time,in the same position with the same frequency but 99.5% weakened amplitude.; The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position
Other intervention name(s): Sham WBV; Real WBV
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Whole Body Vibration (WBV) will be applied to Poststroke Hemiplegia. The patients are divided in two groups; WBV group and shame WBV group.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: muscle; vibration; H reflex; H/M ratio; spasticity
The Effects of Written Emotional Disclosure on Eating Disorder Pathology in a Clinical Eating Disordered Population
Condition: Anorexia Nervosa; Bulimia Nervosa; Eating Disorder
MeSH terms: Anorexia; Bulimia; Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa
Study type: Observational

Summary: 
      A technique that has been found to be effective at relieving the physical and psychological
      symptoms associated with inhibiting emotions and emotional thoughts is written emotional
      disclosure. The goal of this study is to evaluate the effectiveness of written emotional
      disclosure on the remediation of eating disorder behaviour, cognitions, and management of
      emotions.
    

Detailed description: 
      New Partial program participants complete a packet of questionnaires during their initial
      appointment, which will be used as baseline levels of eating disorder symptoms and
      psychological health. Participants will complete the writing as part of their eating disorder
      therapy. The writing will be completed individually. The writing will consist of continuous
      writing for fifteen minutes on three consecutive days. The experimental group will write
      about traumatic or stressful experiences, while the control group will objectively describe
      events. A post-writing packet of questionnaires will be completed one week after completing
      the writing. A follow-up evaluation will occur four-weeks after completion of the
      post-writing packet and will include completing a packet of questionnaires and debriefing.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in the Penn State Hershey Adolescentand Adult Eating Disorders Partial
        Hospitalization Program
      
Keywords: anorexia; bulimia; eating disorder not otherwise specified
Study To Investigate The Potential Drug Drug Interaction (DDI) Between PF-00299804 And Paroxetine In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of a drug drug interaction between Paroxetine and PF-00299804.
    


Intervention name(s): Period 1; Period 2
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a single 45 mg dose of PF-00299804 on Day 1 of Period 1.; Subjects will receive a single 30 mg tablet of paroxetine once daily for 3 days (Days 1 to 3). Then, subjects will be co-administered a 45 mg single dose of PF-00299804 plus a single dose of 30 mg paroxetine on Day 4. Single 30 mg doses of paroxetine will be administered once daily for 6 days (Days 5-10).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: DDI; Healthy Volunteers
taVNS Cold Pressor
Condition: taVNS; Brain Stimulation
Study type: Interventional

Summary: 
      This study explores the use of transcutaneous auricular vagus nerve stimulation (taVNS), a
      new form of neuromodulation which stimulates the ear. 24 healthy subjects without a past
      medical or psychiatric history will be recruited to participate in a phone screen followed by
      1 lab visit. During the lab visit, subjects will participate twice in a validated stress
      induction technique called the cold pressor test, while concurrently receiving either active
      or sham taVNS. The cold pressor test consists of subjects placing their feet in an ice bath
      for a short period of time. Researchers will measure participant's heart rate while they
      receive taVNS (ear stimulation) and participate in the cold pressor test. Assessments of
      mood, anxiety, and stress will be collected at the beginning and end of the visit.
    


Intervention name(s): Active taVNS; Sham taVNS
Intervention type(s): Device; Device
Intervention description(s): Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath).; Electrodes will be attached to the participant's ear with a small sticker or clip, which will deliver mild stimulation. These electrodes will be plugged into the Digitimer DS7a device, which is a device that delivers transcutaneous auricular vagus nerve stimulation or taVNS. Stimulation will be delivered randomly to participant's tragus (the small cartilage knob before the ear canal) for up to 5 minutes while you participate in the stress induction test (by putting both feet into an ice bath). During sham (placebo) stimulation, ear electrodes will be attached to the participant's ear but they will not receive any stimulation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional

Summary: 
      These last years, it has been proven that the solicitation of a muscle using vibration may
      lead to positive effects on the neuromuscular function. Thus, the aim of the current study is
      to assess if the addition of local vibration training sessions on the quadriceps muscle to
      the classic readaptation program (i.e. physiotherapist sessions) may allow a better
      recuperation 2 months after the surgery and the reconstruction of the anterior cruciate
      ligament.

      The aim of the vibration training proposed in the current study is to allow a better
      recuperation 2 months after the anterior cruciate ligament reconstruction when compared with
      conventional physiotherapy alone.
    


Intervention name(s): Vibrasens
Intervention type(s): Device
Intervention description(s): Transcutaneous vibrations are used. This device allows vibrations from 25 to 150 Hz with an amplitude of 1 mm. In our study the frequency used is 50 Hz.
Other intervention name(s): Vibrasens (TECHNO CONCEPT, France).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anterior Cruciate Ligament Reconstruction; Local vibration training; Ligamentoplasty; Anterior cruciate ligament; Corticospinal excitability; Elastography; Knee extensor muscles; Readaptation
Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S
Condition: MERS (Middle East Respiratory Syndrome)
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is a potentially fatal disease
      with a reported lethality of up to 40% that is under tight epidemiologic control by the World
      Health Organization (WHO) and currently without registered prevention or treatment option.

      In this phase I first-in-human clinical trial, healthy volunteers in two different dose
      cohorts will be vaccinated twice with the candidate vaccine MVA-MERS-S. A subgroup will
      additionally receive a late booster vaccination.

      The aim of the study is to assess the safety and tolerability of the candidate vaccine and to
      characterize its immunogenicity.
    

Detailed description: 
      The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the MERS-CoV
      spike glycoprotein (S). A total of 24 participants will receive the following vaccine regime:

      12 participants will receive 10^7 plaque-forming units (PFU) of MVA-MERS-S on days 0 and 28.

      12 participants will receive 10^8 PFU of MVA-MERS-S on days 0 and 28.

      Safety and immunogenicity data will be collected throughout the study, which concludes at day
      180.

      Update March 2019: A subgroup of participants from both dose cohorts will receive a late
      booster immunization of 10^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime
      immunization.
    

Intervention name(s): vaccine candidate MVA-MERS-S
Intervention type(s): Biological
Intervention description(s): vaccination with MVA-MERS-S in two escalating dose regimes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; clinical phase 1; modified vaccinia Ankara vector; MERS-CoV
Brain Oximeter Calibration and Validation Study
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The purpose of the study is to calibrate and to validate the accuracy of the oximeter with an
      estimate of brain oxygen levels assessed by measuring arterial and internal jugular vein
      blood oxygen saturations.
    

Detailed description: 
      The device is a non invasive NIRS monitor. It detects signals from which are derived venous
      and arterial blood brain oxygen levels.

      The device will be used as a adjunct monitor in patients with a brain injury or at risk of a
      brain injury.

      The primary objective of the study is to measure the absolute and relative accuracy of the
      StO2 device by comparing the NIRS-derived brain tissue oxygen saturation with
      blood-referenced CO-oximeter oxygen saturation values. The CO-oximeter oxygen saturation
      values from paired arterial and internal jugular venous blood gas samples are then inserted
      into a weighted-equation to derive the calculated brain tissue oxygen saturation. Accuracy is
      reported over a range of oxygen saturations with study subjects exposed to a controlled
      oxygen desaturation with serial sampling of paired arterial and internal jugular venous blood
      gas samples.
    

Intervention name(s): brain pulse oximeter
Intervention type(s): Device
Intervention description(s): brain oxygen monitoring during hypoxia
Intervention model: Single Group Assignment
Intervention model description: Single group assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: hypoxia
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
Condition: Rheumatoid Arthritis; Polyarticular Juvenile Idiopathic Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Crohn Disease; Ulcerative Colitis; Plaque Psoriasis; Pediatric Plaque Psoriasis; Pediatric Crohns Disease; Hidradenitis Suppurativa; Non-infectious Uveitis
MeSH terms: Spondylitis; Hidradenitis Suppurativa; Arthritis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Arthritis, Juvenile; Crohn Disease; Uveitis; Psoriasis; Hidradenitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK)
      profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe
      (PFS) as single subcutaneous (s.c.) injection of 40 mg.
    


Intervention name(s): 40 mg MSB11022; 40 mg MSB11022
Intervention type(s): Drug; Drug
Intervention description(s): Single dose, as a solution, administered subcutaneously, using an auto-injector.; Single dose, as a solution, administered subcutaneously, using a pre-filled syringe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Biosimilar; Adalimumab; MSB11022