bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to examine whether an antipsychotic combination treatment of olanzapine and
      amisulpride is more effective than olanzapine and amisulpride alone.
    

Detailed description: 
      Polypharmacy in antipsychotic therapy is an important issue when treating patients with
      schizophrenia. It is not well confirmed that a combination of two antipsychotic drugs lead to
      therapeutic benefit in contrast to monotherapy. However there is a highly frequent practice
      of combining atypical non-clozapine treatment that could be due to potential benefits when
      seeking alternatives to a high rate of non-response in acute phase. Therefore there is a need
      for further trials of sufficient power to address efficacy and safety issues of this regimen.
      Combining two selected atypical drugs in a complementary way may minimize side-effects and
      enhance efficacy. In order to specify these advantages it is intend to examine approaches to
      combination treatment: Amisulpride and olanzapine show complementing receptor binding
      profiles and have shown to have efficacy and good tolerability when administered in
      combination in retrospective studies. The object of this trial is to study whether acutely
      ill patients with combination of amisulpride and olanzapine are more frequently in
      symptomatic remission after 8 weeks than those with olanzapine or amisulpride monotherapy.
    

Intervention name(s): Olanzapine; Amisulpride; Olanzapine and Amisulpride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Coated tablet 5-20 mg milligram(s) per day for 16 weeks; 200-800 mg milligram(s)per day for 16 weeks; Zyprexa:
Coated tablet 5-20 mg milligram(s) per day for 16 weeks
Amisulpride:
Coated tablet 200-800 mg milligram(s)per day for 16 weeks
Other intervention name(s): Zyprexa; Amisulprid Hexal; Zyprexa, Amisuprid Hexal
Intervention MeSH terms: Olanzapine; Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; amisulpride; olanzapine; polypharmacy
Simultaneous Measurement of Both Fetal's Lateral Ventricles of the Brain
Condition: Healthy
Study type: Observational

Summary: 
      Study designed to measure simultaneously the width of both lateral ventricles of the fetal
      brain. Thus, will enable to evaluate the normal asymmetry that may exist between the right
      and the left ventricles during the pregnancy.
    

Detailed description: 
      Study will enable to evaluate the normal asymmetry that may exist between the right and the
      left ventricles during the pregnancy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        low risk pregnant women
      
Keywords: ventricles; fetal; brain; asymmetry
The Effect of Remimazolam on Opioid Induced Hyperalgesia
Condition: Hyperalgesia, Mechanical
MeSH terms: Hyperalgesia
Study type: Interventional

Summary: 
      The goal of this prospective, randomized, controlled study is to investigate the effect of
      remimazolam on opioid-induced hyperalgesia (OIH) in patients undergoing single
      port-laparoscopically assisted urologic surgery.

      The main question[s] it aims to answer are:

        -  [The mechanical hyperalgesia threshold]

        -  [Area of hyperalgesia around the surgical incision 24 h after surgery (cm^2)]

      In three groups: Group RHR (Remimazolam- High-dose Remifentanil), Group DHR
      (Desflurane-low-dose Remifentanil) or Group DLR (Control).
    

Detailed description: 
      Ninety-three (n = 31 per group) American Society of Anesthesiologists I-II patients (age
      20-65 years) will be scheduled for single port-laparoscopically assisted urologic surgery.

      Group RHR (Remimazolam-Remifentanil): Administer remimazolam at a dose of 6 mg/kg/h
      initially, followed by 1 mg/kg/h, and remifentanil at 0.3 µg/kg/min.

      Group DHR (Desflurane-Remifentanil): Administer desflurane at 1 minimum alveolar
      concentration (MAC), adjusting the dose by 1 vol% titration to maintain MAP and BIS levels,
      and remifentanil at 0.3 µg/kg/min.

      Group DLR (Control): Administer desflurane at 1 MAC, adjust the dose by 1 vol% titration to
      maintain mean arterial pressure (MAP) and bispectral index (BIS) levels, and remifentanil at
      0.3 µg/kg/min.

      Mechanical hyperalgesia threshold, Time to first postoperative analgesic requirement (min),
      Injected PCA volume containing morphine for 12 h after surgery (ml), Pain intensity: VAS 1 h
      after surgery, VAS 6 h after surgery, VAS 12 h after surgery VAS 24 h after surgery. Area of
      hyperalgesia around the surgical incision 24 h after surgery (cm^2) will be checked.
    

Intervention name(s): Remimazolam; Desflurane; Remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administer remimazolam; administer desflurane; administer remifentanil
Other intervention name(s): Byfavo; desfuralne; Ulitva
Intervention MeSH terms: Remifentanil; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group RHR (Remimazolam- High doses of Remifentanil): Administer remimazolam at a dose of 6 mg/kg/h initially, followed by 1 mg/kg/h, and remifentanil at 0.3 µg/kg/min.
Group DHR (Desflurane-High doses of Remifentanil): Administer desflurane at 1 MAC, adjusting the dose by 1 vol% titration to maintain MAP and BIS levels, and remifentanil at 0.3 µg/kg/min.
Group DLR (Desflurane-Low-dose of Remifentanil): Administer desflurane at 1 MAC, adjust the dose by 1 vol% titration to maintain MAP and BIS levels, and remifentanil at 0.025 µg/kg/min.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: remifentanil; remimazolam; opioid-induced hyperalgesia
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study A
Condition: Obstructive Sleep Apnea; Pathophysiology
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      In obstructive sleep apnea, the upper airway recurrently closes during sleep. The mechanisms
      that lead to airway closure are not completely understood. While the airway of some people
      narrows and airflow decreases during inspiration due to increasing inspiratory effort, others
      maintain constant airflow throughout inspiration. Airway neuromuscular reflexes may protect
      against airway narrowing that occurs due to increasing inspiratory effort. To test this
      hypothesis, the investigators will initially measure airway neuromuscular reflex and
      inspiratory flow and then attenuate neuromuscular reflex through topical pharyngeal
      anesthesia to observe the effects on inspiratory flow.
    

Detailed description: 
      The mechanisms that lead to airway closure are not completely understood. While the airway of
      some people narrows and airflow decreases during inspiration due to increasing inspiratory
      effort, others maintain constant airflow throughout inspiration (negative effort dependence,
      NED). The investigators hypothesize that upper airway neuromuscular reflexes may protect
      against narrowing that occurs due to increasing inspiratory effort. Topical oropharyngeal
      anesthesia has been shown to reduce neuromuscular reflexes. Thus, the investigators also
      hypothesize that patients with stable inspiratory flow will develop NED once the reflexes
      have been impaired with topical anesthetic. The investigators plan to:

        1. measure upper airway muscle EMG to assess how it corresponds to the presence or absence
           of NED. This aim will allow us to test the hypothesis that robust upper airway muscle
           reflexes can protect against NED.

        2. reduce upper airway muscle activity and reflexes by topical oropharyngeal anesthesia.
           This will allow us to test the hypothesis that attenuated upper airway muscle activity
           induced by topical anesthesia can induce NED.
    

Intervention name(s): Pharyngeal topical anesthesia
Intervention type(s): Other
Intervention description(s): Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Obstructive Sleep Apnea; Pathophysiology
Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast
Condition: Renal Cancer; Kidney Cancer
MeSH terms: Kidney Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the blood flow in kidney masses by using ultrasound
      microbubble contrast material, and to see if results from ultrasound contrast studies can
      predict if a kidney mass is benign or malignant. Patterns of blood flow in the kidney mass
      will be examined to see if:

        1. benign kidney masses can be distinguished from kidney cancers and

        2. if slow growing, lower risk cancers have different blood flow compared to clear cell
           cancer which is the most common type of kidney cancer.
    


Intervention name(s): Ultrasound with intravenous microbubble contrast injection
Intervention type(s): Drug
Intervention description(s): Intravenous line will be inserted. After the ultrasound microbubble contrast has been suspended into solution, contrast will be injected intrav via hand bolus with a total activated suspension of 0.2 mL (30 uL octaflouropropane),followed by 10 mL saline flush, with option to rebolus 4 addit time's for tot dose of 150 uL. Post contrast cine images of renal mass will be obtained on commercially available US units primarily using low mechanical index settings & Contrast Pulsed Sequence (CPS®) technique. Images will be acquired at predetermined intervals, for up to 8 min post contrast admin. Manufacturer's guidelines incl immediate post flush image capture, as well as post admin image capture at intervals as 1 min, 2 , 4 & 8 mins. Additional, temporary higher mechanical index imaging of kidney for the purpose of "flash" bubble destruction may be optionally triggered using manufacturer's preset settings & energy w/i FDA guidelines. This will only be performed while imaging the kidney.
Other intervention name(s): Conventional and contrast enhanced US images will be saved to the hard drive; and /or digitally archived, without any unique identifiers, and reviewed at a; later date. Images will be reviewed by three radiologists who are blinded to; the clinical, pathologic, and non ultrasound imaging findings. Grayscale; characteristics, qualitative and quantitative enhancement characteristics will; be recorded.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ultrasound; 07-165
Pivotal Test: WB001
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression
Study type: Interventional

Summary: 
      The purpose of the present randomized controlled study is to investigate if there is a
      difference in postpartum depression symptoms among participants assigned to :

        1. an automated conversational agent based on the most researched and scientifically
           validated psychotherapies, primarily Cognitive Behavioral Therapy (CBT), and accessible
           via an iOS and Android application, or to

        2. a comparison condition without CBT and conversation, though still delivered in an
           interactive smartphone application that is accessible anytime of day.
    


Intervention name(s): WB001; Educational
Intervention type(s): Device; Device
Intervention description(s): The WB001 treatment consists of PPD-specific psychoeducational lessons and CBT-specific skills or tools. The lessons teach PPD-specific information to normalize and contextualize postpartum experiences, as well as provide information on effective mood management and mental health promotion in the context of having recently given birth. Patients complete up to 30 psychoeducational lessons. In addition, patients access and apply core CBT-based tools upon endorsing a negative mood. These tools are core to CBT and are considered transdiagnostic. Examples include thought challenging, behavioral activation, mindfulness, and self-care.; The Comparison Condition provides educational only material about various mental and physical topics, delivered in an interactive smartphone application that is accessible anytime of day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Salivary Antioxidant Capacity Before and After Complete Dental Rehabilitation
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      Salivary samples were obtained from 20 children in their fifth year of life diagnosed S-ECC
      and 20 age and sex matched controls. Complete dental rehabilitation under general anesthesia
      was performed for the 20 children with S-ECC, and follow up salivary samples were obtained
      one week and three months post operatively. The TAC was measured using a commercially
      available Oxygen Radical Absorbance Antioxidant Assay measurement kit (Zen-Bio ORAC™, AMS
      Biotechnology, Abington UK).
    

Detailed description: 
      Background: The association of total salivary antioxidant capacity (TAC) to severe early
      childhood caries (S-ECC) has been studied in the past. It is not clear if TAC is an indicator
      of the inflammatory response to the lesion or a marker of the disease.

      Aim: This study aimed to measure the salivary TAC levels in children with early childhood
      caries before and after dental treatment and compare the results to caries free children.

      Methodology: Salivary samples were obtained from 20 children in their fifth year of life
      diagnosed S-ECC and 20 age and gendersex matched controls. Complete dental rehabilitation
      under general anesthesia was performed for the 20 children with S-ECC, and follow up salivary
      samples were obtained one week and three months post operatively. The TAC was measured using
      a commercially available Oxygen Radical Absorbance Antioxidant Assay measurement kit (Zen-Bio
      ORAC™, AMS Biotechnology, Abington UK).
    

Intervention name(s): Dental rehabilitation under general anesthesia
Intervention type(s): Procedure
Intervention description(s): Dental treatment of all teeth affected by dental caries in a single visit under general anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Children who are on long term medications,

          -  Children with chronic diseases

          -  Children who have had an infection less than three weeks prior to collection of saliva
      
Keywords: Antioxidant Capacity
Sensory Re-learning of the Upper Limb After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The overall aim of this study is to investigate if sensory re-learning in combination with
      task-specific training is more effective than task-specific training alone to improve sensory
      function of the hand, dexterity, the ability to use the hand in daily activities, perceived
      participation and life satisfaction.
    

Detailed description: 
      More than half of stroke survivors suffer from sensory impairments of their affected upper
      limb (UL), which can lead to long term problems to use the UL in daily life, such as personal
      care, household- and leisure activities. Few studies have evaluated if sensory re-learning in
      combination with task-specific training can improve the ability to perform daily hand
      activities and perceived participation. Therefore, there is a need for more studies. This is
      a single-blinded pilot randomized controlled trial with two treatment arms. Thirty persons
      with sensory impairments of the UL after stroke will be recruited and randomized to either
      sensory re-learning in combination with task-specific training or to task-specific training
      only. The training will consist of 2.5 hours of group training per session, 2 times per week
      for 5 weeks. Assessments will be conducted pre- and post-training and at 3 months' after the
      intervention.

      Descriptive statistics (mean (SD) or median (min- max) will be used to characterize the study
      groups. Non-parametric statistics will be used for ordinal data and parametric statistics for
      continues data. To analyze between group differences, the Mann-Whitney test or Independent
      sample t-test will be used and Wilcoxon signed ranks test or paired t-test to analyze within
      group differences. The level of statistical significance will be set at p < 0.05.
    

Intervention name(s): Sensory group; Control group
Intervention type(s): Behavioral; Other
Intervention description(s): The sensory re-learning consists of touch detection practice, i.e., touch discrimination to identify different materials, shapes, textures, weights and temperatures, proprioception and tactile object recognition in combination with task-specific training.; Traditional task-specific training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke, upper limb, sensory training, rehabilitation
Attention Training for Opioid-maintained Cocaine Users
Condition: Addiction; Cocaine; Methadone; Opiates
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the feasibility and preliminary efficacy of
      attention training using a portable electronic device for opioid-dependent cocaine-users
      stabilized on methadone.
    

Detailed description: 
      The investigators propose to test the feasibility and preliminary efficacy of 5-times per
      week daily attentional retraining (AR) delivered via a portable electronic device (PED) in
      comparison with a control condition over the course of a 2-3 week training period.
      Participants in this study will be cocaine and opioid-dependent individuals stabilized on
      methadone. Both cocaine and opioids will be targeted in the AR procedure the investigators
      will test in this study. The retraining or control condition, along with a series of
      assessments, will be delivered on the PED as part of a daily (Monday through Friday)
      appointment at which time participants will also obtain their daily methadone dose.
      Assessments will cover substance use, craving and other issues. In addition to completing the
      retraining or control procedure, participants will also be engaged in standard versions of
      attentional bias tasks (i.e., without retraining) periodically in order to gauge an effect of
      study condition on attentional bias over time. Thus, the investigators will be able to track
      changes in attentional bias over time in a more detailed fashion than has been previously
      possible. Following the 3 week training period, there will be another 3 weeks of treatment in
      which patients will continue to receive methadone and complete limited assessments without
      any AR or control procedures with the PED.
    

Intervention name(s): Attentional retraining; Control condition
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): attentional training; attentional bias retraining
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Opioid-Related Disorders; Cocaine-Related Disorders; Substance-Related Disorders; Mental Disorders; Cocaine; Methadone; Therapeutic Uses
A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate/assess the treatment of moderate to severe
      asthmatics with inhaled corticosteroid.
    


Intervention name(s): inhaled corticosteroid therapy
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: markers, inflammation, optimal, sub-optimal, corticosteroid, bronchial asthma
Imaging the Migraine Brain Pre- and Post-Erenumab
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Researchers are trying to determine if there is a difference between brain images of subjects
      that do respond to treatment with erenumab and subjects who do not respond to treatment with
      erenumab using Magnetic Resonance Imaging (MRI).
    


Intervention name(s): Erenumab
Intervention type(s): Drug
Intervention description(s): Erenumab will be used per label instructions.
Other intervention name(s): Aimovig
Intervention MeSH terms: Erenumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Magnetic Resonance Imaging; Brain Structure; Brain Function