bioihbjkbjnl/mcl2 huggingface dataset:
Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
Condition: Acute Alcohol Withdrawal
Study type: Interventional

Summary: 
      This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol
      withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive
      dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while
      maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a
      dose-dependent profile of action when it is used for this indication. In addition, this study
      will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and
      potential serum biomarkers of alcohol withdrawal.
    

Detailed description: 
      The objectives of this randomized, double-blind, placebo controlled, dose escalation study
      are a) to determine if adding dexmedetomidine to symptom-triggered, standard therapy of
      severe alcohol withdrawal reduces the dose requirements of conventional sedatives,
      analgesics, and neuroleptics; maintains patient comfort and safety; and prevents and shortens
      tracheal intubation; b) to explore whether dexmedetomidine acts in a dose-dependent manner to
      reduce the dose requirements of conventional sedatives, analgesics, and neuroleptics while
      maintaining patient comfort; and c) determine the association between alcohol withdrawal and
      potential serum biomarkers of alcohol withdrawal and assess whether these are expressed
      differently when dexmedetomidine is used as adjunctive therapy. Dexmedetomidine will be added
      to existing sedative therapies in an effort to decrease the use of these agents while
      maintaining patient comfort. The study will randomize twenty-four patients in a double-blind
      manner to receive placebo or dexmedetomidine at doses of 0.4 or 1.2 µg/kg per hour for a
      maximum duration of five days. All patients will be managed using an existing
      institution-specific, symptom-triggered alcohol withdrawal protocol.
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days; Normal saline for five days.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate SAGE-547 in Participants With Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 2

Summary: 
      Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety,
      tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female
      participants with essential tremor in the upper limb.

      Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and
      effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who
      completed Stage 1 were invited to participate in Stage 2.
    


Intervention name(s): SAGE-547; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Brexanolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cognitive Remediation for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of an innovative, computer driven
      cognitive rehabilitation program for individuals with schizophrenia and related disorders.
    

Detailed description: 
      Schizophrenia is associated with neurocognitive impairment, diminished life satisfaction,
      lack of independence, and poor functioning in social, occupational and other desired and
      expected community roles. The personal, social and economic costs of this illness are
      enormous. Neurocognitive deficits (e.g., slowed thinking, poor attention and memory,
      inadequate problem solving) are now recognized as core features of the illness, and primary
      contributors to functional impairment among patients (Bellack, Gold & Buchanan; 1999; Green,
      1996). While standard antipsychotic medications improve psychotic symptomatology in many
      patients, their impact on neurocognition is modest, at best, and dramatic functional deficits
      remain even after adequate pharmacological treatment (Keefe et al., 1999). Hence, there is
      growing interest in alternative treatment strategies to address cognitive deficits, including
      computer-assisted cognitive remediation.

      The purpose of this project is to assess the efficacy of a computer-assisted cognitive
      remediation program we have developed: Computer Assisted Cognitive Remediation (CACR). Fifty
      individuals with schizophrenia and related disorders will be recruited and randomly assigned
      to one of two conditions: a) 36 sessions of CACR; or b) 36 sessions of a manualized computer
      control condition (RC). The efficacy of CACR will be assessed on behavioral performance in
      three dimensions: (1) on the trained learning exercises, (2) on neuropsychological measures,
      and (3) on role play based assessments of everyday problem solving. We hypothesize that CACR
      will be more effective than the control treatment in each domain.
    

Intervention name(s): Computer Assisted Cognitive Remediation (CACR)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: treatment; cognition; schizophrenia
Effect of Octreotide on Saliva
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of Octreotide on saliva enzymes. The
      study team hypothesizes that Octreotide will decrease the levels of certain proteins,
      specifically the metalloproteinase family.
    

Detailed description: 
      This is a healthy volunteer pilot study. The purpose of this study is to determine the effect
      of a drug, Octreotide, on saliva enzymes in order to see if this drug can help prevent
      pharyngo-cutaneous fistulas (an abnormal tissue connection in the pharynx) in patients
      undergoing laryngectomy.
    

Intervention name(s): Octreotide 1 MG/ML
Intervention type(s): Drug
Intervention description(s): 100 mcg (1 ml) of Octreotide
Intervention MeSH terms: Octreotide
Intervention model: Single Group Assignment
Intervention model description: This is a healthy volunteer pilot study. Subjects will be asked to provide a saliva sample after a 2 hour fast and 5 minutes after rinsing their mouth with tap water. The sample will be collected in an Eppendorf vial. After providing the saliva sample, each subject will be injected subcutaneously with 100 mcg (1 ml) of Octreotide by either a physician or registered nurse. A second sample of saliva will be collected using the same protocol 45-55 minutes after administering the drug.
Masking: None (Open Label)
Primary purpose: Other
Piloting Treatment With Intranasal Oxytocin in Phelan-McDermid Syndrome
Condition: Phelan-McDermid Syndrome
MeSH terms: Chromosome Disorders; Syndrome; Chromosome Deletion
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot study examining the efficacy, safety and tolerability of intranasal oxytocin
      as a novel treatment in Phelan-McDermid syndrome (PMS). This study will utilize a randomized,
      placebo-controlled design for 12 weeks (phase 1), followed by an open-label extension for 12
      weeks (phase 2). The purpose is to evaluate the effect of intranasal oxytocin on impairments
      in attention, social memory, socialization, language, and repetitive behaviors.
    


Intervention name(s): Oxytocin; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal oxytocin; Placebo
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)
Condition: Gastrointestinal Diseases; Laparotomy; Anastomosis, Surgical; Absorbable, Coated Sutures
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal
      surgery as part of a controlled randomized single blinded parallel group trial. The
      applicability and safety of the strand material used in two suture techniques (2-layer suture
      technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the
      operative time consumed for the construction of the 1st anastomosis, the average time of the
      hospital duration for both patient groups, and the frequency of postoperative complications
      after discharge, 1 month and a maximum of 3-4 months. The used suture units are counted and
      the length of sutures determined which will be an indirect measurement of the costs of suture
      material for the two techniques.
    


Intervention name(s): Gastrointestinal Anastomosis
Intervention type(s): Procedure
Intervention description(s): Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques
Other intervention name(s): SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of; pure polyglycolic acid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Gastrointestinal Anastomosis; Multicentre; Randomized controlled single-blind study; synthetic, absorbable, braided and coated suture material; Laparotomy
Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
Condition: Body Dysmorphic Disorder
MeSH terms: Body Dysmorphic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for
      people with body dysmorphic disorder.
    

Detailed description: 
      Body dysmorphic disorder (BDD), a perceived defect in appearance (e.g., a "large" nose or
      facial "scarring"), is a relatively common disorder that causes marked distress and
      impairment in functioning. Recent data suggests that adults with BDD may respond to serotonin
      reuptake inhibitors (SRIs); however, response to SRIs is often only partial. About one third
      of patients do not respond to an SRI. Furthermore, patients may stop taking SRIs because of
      side effects (e.g., sexual side effects). For these reasons, additional monotherapy and SRI
      augmentation strategies are greatly needed.

      Levetiracetam is primarily used as an antiseizure medication and has a wider safety margin
      than other antiepileptics. Preliminary scientific studies may suggest that it may be helpful
      for certain psychiatric symptoms and disorders. In the present study we propose to obtain
      pilot data on 1) levetiracetam monotherapy and 2) levetiracetam augmentation of SRIs in
      patients with BDD.
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: body dysmorphic disorder; levetiracetam
McGRATH vs Macintosh Laryngoscopy Comparison in LMA Insertion
Condition: Intubation Complication; Intubation;Difficult; Anesthesia
Study type: Interventional

Summary: 
      Various techniques have been developed to get a good LMA position, one of them is using a
      laryngoscope. The most popular laryngoscope used for LMA installation is the Macintosh type.
      Technological developments have brought laryngoscopes into the video era, one of which is
      McGRATH's laryngoscope, which from several studies about having an advantage in terms of the
      first attempt, time, complications, and hemodynamic stability of intubation. It needs to be
      proven through research on the comparison of clinical outcomes of LMA installation with
      McGrath laryngoscope and Macintosh laryngoscope.
    


Intervention name(s): McGRATH laryngoscopy; Macintosh laryngoscopy
Intervention type(s): Device; Device
Intervention description(s): Patients who underwent general anesthesia with LMA insertion by using McGRATH video layngoscopy; Patients who underwent general anesthesia with LMA insertion by using classic Macintosh video layngoscopy
Other intervention name(s): Group G; Group I
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: successful intubation; classic LMA; video laryngoscopy; difficulty; cuff pressure leak
Effect of Calcium Chloride on Recovery From Neuromuscular Blockade
Condition: Residual Neuromuscular Blockade
MeSH terms: Delayed Emergence from Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of calcium chloride against residual
      neuromuscular blockade at the end of general anesthesia
    

Detailed description: 
      During general anesthesia, neuromuscular blocking agent is administered to facilitate
      endotracheal intubation and the view of operative field. The neuromuscular blockade should be
      reversed at the end of anesthesia to recover spontaneous breathing of the patient.

      Residual neuromuscular blockade (RNMB) is defined as train of-four ratio < 0.9. RNMB is a
      risk factor for postoperative pulmonary complication and increases postoperative mortality.
      Neostigmine is acetylcholinesterase inhibitor routinely used at the end of anesthesia to
      prevent RNMB. A meta-analysis, however, showed that 40 percent of patients who received
      intermediate-acting neuromuscular blocking agent during anesthesia showed RNMB in PACU.

      Calcium triggers the release of acetylcholine from the motor nerve terminal and enhances
      excitation-contraction coupling in muscle. Increasing calcium concentrations decreased the
      sensitivity to dTc and pancuronium in an animal muscle-nerve model. The effect of calcium
      chloride on residual neuromuscular blockade is not studied yet.

      The purpose of this study is to evaluate the effect of calcium chloride on residual
      neuromuscular blockade at the end of general anesthesia
    

Intervention name(s): Calcium; control
Intervention type(s): Drug; Drug
Intervention description(s): Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg; In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Neuromuscular blockade reversal; TOF ratio; Calcium chloride
Autism Biomarker Consortium for Clinical Trials (ABC-CT): Follow-up Study
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      This is a multicenter longitudinal follow-up study to the main study of an a registered
      already (NCT# ). The Follow-up Study (T4) will assess the Main Study cohort for an additional
      longitudinal time point approximately 2-5 years after the initial study. Children
      participating in the Follow-up Study will be approximately 8-16 years old.

      The aims of the main study is to identify, develop and validate a set of measures that can be
      used as stratification biomarkers and/or sensitive and reliable objective measures of social
      impairment in autism spectrum disorders (ASD) that could serve as markers of long term
      clinical outcome.
    

Detailed description: 
      All participants who were initially eligible for the main study will be eligible and invited
      to return regardless of their participation at T2/T3 or current medication/psychiatric status
      using an intent-to-treat model. The follow-up study will conduct one additional timepoint
      with participants who enrolled in the main study.

      In the Follow-up Study of the Main Study ABC-CT cohort, the investigators will re-administer
      the biomarker and clinical batteries 2-5 years after original study enrollment. This will
      allow the investigators to:

        1. Assess long-term stability of the markers, extending the analyses of reliability and
           consistency from the first phase of the consortium.

        2. Perform a more robust assessment of sensitivity to change, taking advantage of a longer
           developmental window in which participants are expected to exhibit greater clinical
           progression.

        3. Evaluate the longitudinal predictive value of the biomarkers by examining the
           association of their baseline values with later measures of social function.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 children with an autism spectrum disorder between 6-11 years old, and 75 typically
        developing children
      
Biospecimen description: 
      Whole blood.
Trial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）
Condition: Irritable Bowel Syndrome; Traditional Chinese Medicine
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription
      Shugan decoction on irritable bowel syndrome（diarrhea type）.
    


Intervention name(s): Shugan decoction
Intervention type(s): Drug
Intervention description(s): Decoction ,two times a day,one bag of decoction one time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: alternative medicine
Efficacy and Safety of a Purified Standardised Bee Venom Preparation
Condition: Bee Venom Allergy
MeSH terms: Hypersensitivity; Venom Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is performed to assess efficacy and safety of a purified standardised bee venom
      preparation in bee venom allergy
    


Intervention name(s): bee venom
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bee venom allergy; Specific immunotherapy
French Validation Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) Questionnaire
Condition: Acute Low Back Pain; Chronic Low Back Pain
MeSH terms: Musculoskeletal Pain; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Low back pain is a very common disease. Among the persons suffering of acute low back pain,
      about 10% are at risk of developping chronic pain. A screening questionnaire assessing this
      risk has been developed and validated in Swedish and English (Orebro Musculoskeletal Pain
      Screening Questionnaire, Linton, 2003). The aim of our study is to validate a french
      translation of this questionnaire. Patients suffering from acute low back pain will be asked
      to fill in several questionnaires at day 0, and 6 and 12 month later.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males and females 20-55 years old suffering from acute low back pain
      
Keywords: Low back pain
Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children
Condition: Tracheal Intubation in Children
Study type: Interventional

Summary: 
      The purpose of this study is to determine if there is a difference in time for successful
      fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.
    

Detailed description: 
      The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for
      fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be
      performed by residents in training. The primary outcome is of time for successful tracheal
      intubation. The investigators hypothesize that residents will intubate the trachea faster
      when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic
      airway device, fiberoptic grade of laryngeal view, time for device removal after intubation,
      and peri-operative complications will also be assessed.
    

Intervention name(s): i-gel; air-Q
Intervention type(s): Device; Device
Intervention description(s): Patients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.; Patients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Keywords: supraglottic airway; children; fiberoptic guided tracheal intubation; air-Q; i-gel