bioihbjkbjnl/mcl2 huggingface dataset:
Trauma-focused CBT Versus EMDR in the Treatment of Posttraumatic Stress Disorder
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of trauma-focused cognitive behaviour therapy
      (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of
      trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly
      assigned to TF-CBT or EMDR. Follow-up assessments will be conducted at 3 and 12 months
      post-treatment. In addition to comparing the efficacy of the two protocols, an additional
      focus will lie on identifying predictors for treatment outcome.
    


Intervention name(s): Trauma-focused Cognitive Behavior Therapy; Eye Movement Desensitization and Reprocessing (EMDR)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention comprises 10 sessions of trauma-focused cognitive behavior therapy for PTSD with the components (a) prolonged imaginal exposure, (b) in vivo exposure, and (c) cognitive restructuring.; This intervention comprises 10 sessions of EMDR according to the standard protocol.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of N2O Inhalation and Ketamine in Pediatric PSA
Condition: Moderate Sedation; Laceration
MeSH terms: Lacerations
Study type: Interventional
Phase: Phase 4

Summary: 
      -  Ketamine provides effective and relatively safe sedation analgesia for primary closure
           of lacerated pediatric patients

        -  However, deep sedation and adverse effects suggest the opportunity to develop
           alternative strategies

        -  We compared the efficacy and adverse effects of ketamine to those of N2O gas for
           analgesia and anxiolysis during primary repair of lacerated pediatric patients
    

Detailed description: 
      -  There were 32 children who were randomly assigned

        -  Recovery times were markedly shorter in the N2O group compared with those in the
           ketamine group (median, 0.0 min (interquartile range [IQR], 0.0-4.0 min) vs. median,
           21.5 min (IQR, 12.5-37.5 min), N2O vs. ketamine, respectively, p < 0.05)

        -  Sedation levels were deeper in the ketamine group than in the N2O group, but pain scales
           were comparable between groups

        -  No difference was observed in the satisfaction scores by physicians, parents, or nurses.

        -  N2O inhalation was preferable to injectable ketamine for pediatric patients because it
           is safe, allows for a faster recovery, maintains sufficient sedation time, and does not
           induce unnecessarily deep sedation
    

Intervention name(s): N2O gas vs ketamine
Intervention type(s): Drug
Intervention description(s): Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Duration of Effects of Massage in Healthy Participants
Condition: Healthy; Pressure Pain Threshold; Massage
Study type: Interventional

Summary: 
      Massage is a common rehabilitation treatment for musculoskeletal pain. Prior studies indicate
      massage applied with a deep pressure that induces a moderate amount of pain produces a
      lessening of pain sensitivity compared to light touch, pain free massage. The investigators
      now aim to investigate how long pain sensitivity changes last after 4 minutes of moderately
      painful massage and determine factors that help predict who displays a lessening of pain
      sensitivity.
    


Intervention name(s): Moderately Painful Massage
Intervention type(s): Other
Intervention description(s): Participants will be seated in a chair with his or her shirt on. Participants will receive 60 seconds of manual pressure applied to the myofascial trigger point identified in the participant's upper back. The researcher's thumb or index finger will apply a deep manual pressure such that the participant rates the pain = 50/100 on a 101-point numeric pain rating scale with 0 indicating no pain and 100 indicating the most severe pain imaginable. The participant will be asked to rate his or her pain during the massage so the pressure may be adjusted to maintain the 50/100 related pain. Massage will be applied for 60 seconds, 4 times for a total contact time of 240 seconds. During each 30 second break in which manual pressure is released, Pressure Pain Threshold (PPT) to the foot will be examined. PPT will be assessed 2 times immediately after each of the 4 massage applications.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder
Condition: Bipolar Disorder With Manic or Mixed Episodes
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the potential of MEM 1003 as a safe and effective
      treatment for patients with an acute manic or mixed episode of bipolar disorder.
    

Detailed description: 
      Bipolar affective disorder is one of the most common, severe, and persistent mental
      illnesses. It is characterized by periods of deep, prolonged, and profound depressions that
      alternate with periods of excessively elevated and/or irritable mood (mania). The
      pathophysiology of bipolar disorder is complex, and can include an inheritable component,
      administration of antidepressant medications, behavioral sensitization processes, and
      neuronal calcium dysregulation that leads to apoptosis of critical brain circuitry that
      regulates emotion. Addressing the dysregulation in calcium levels in the central nervous
      system by administering compounds such as MEM 1003 may have the potential for altering the
      cyclical course or progression of bipolar disorder.

      MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central
      nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human
      dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel
      modulators.
    

Intervention name(s): MEM 1003
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bipolar; mania; mixed
Cost-effectiveness of Home Respiratory Polygraphy
Condition: Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objectives:

      The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against
      polysomnography (PSG) using the Epworth scale;

      Secondary Objective:

        1. the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth
           Scale and EuroQol 5D.

        2. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2)
           adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry
           determinations. Design: prospective, randomized, controlled, open, parallel of
           non-inferiority. 440 patients will be randomized to diagnose and follow treatment based
           on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical
           analysis: We will compare the change in the Epworth scale between both arms of treatment
           through analysis of covariance. The premise of non-inferiority is -2 at the lower limit
           of 95% IC. Secondary variables will be analyzed using differences in independent means
           (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness:
           costs generated by one and another method will be evaluated against the effectiveness of
           the primary variable using Bayesian techniques
    

Detailed description: 
      Design: Prospective, randomized, controlled, open, parallel noninferiority. 440 patients will
      be randomized to diagnose and follow treatment based on the PR or PSG generating four groups:
      two treated and two untreated with CPAP. The latter did not undergo self-certification home.
      The monitoring will be 6 months and 4 assessments. Statistical analysis: compare the change
      of the scale Epworth before and after the intervention between both treatment arms using
      analysis of covariance. The premise is non-inferiority of -1.6 at the lower limit of 95%.
      Secondary variables were analyzed by independent means differences (or nonparametric
      equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: the costs generated by the
      two methods will be measured against the effectiveness of the primary endpoint using Bayesian
      techniques
    

Intervention name(s): diagnosis and therapeutic decision; diagnosis and therapeutic decision
Intervention type(s): Procedure; Procedure
Intervention description(s): A conventional polysomnography will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 moths; A home respiratory polygraphy will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep apnea, Portable monitor,autoCPAP
Risk Factors of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin
Condition: Healthy
MeSH terms: Pancreatitis
Study type: Observational

Summary: 
      Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most
      frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been
      proved to be effective in reducing the incidence of PEP. It has been widely used to prevent
      PEP in patients, especially those with potentially high risks of PEP. However, rectal
      indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients
      receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients
      receiving rectal indomethacin remains unclear. The aim of the study was to identify potential
      risk factors in high-risk patients whose received administration of prophylactic rectal
      indomethacin after ERCP.
    


Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent ERCP and received administration of rectal indomethacin.
      
Keywords: post-Endoscopic Retrograde cholangiopancreatography pancreatitis; Risk factors; Indomethacin
Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery
Condition: Ovarian Cysts
MeSH terms: Ovarian Cysts
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg
      may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.
    

Detailed description: 
      In a recent study the investigators found that nebulization of Ropivacaine 30 mg before or
      after gynaecologic laparoscopic surgery significantly reduces postoperative pain and
      postoperative morphine consumption.

      Ropivacaine was effectively administered with non-heating nebulizers (AeronebPro®).

      However, almost all patients still use morphine after surgery.

      The investigators hypothesize that intraperitoneal nebulization of Ropivacaine 150 mg may
      prevent the use of morphine after the laparoscopic ovarian cyst surgery.
    

Intervention name(s): Ropivacaine nebulization; Ropivacaine instillation
Intervention type(s): Drug; Drug
Intervention description(s): Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.; Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.
Other intervention name(s): Ropivacaine; Nebulization; Ropivacaine; Instillation
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ovarian Cysts; Nebulization; Ropivacaine
A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
Condition: Agitation
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M.
      Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to
      be an effective treatment. However, since it is an intramuscular injection, it is more
      complicated and perhaps less acceptable to patients as well as more likely to cause EPS
      (extrapyramidal symptoms). Of late in our emergency room, we started using high dose
      Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising
      results.
    

Detailed description: 
      In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M.
      Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to
      be an effective treatment. However, since it is an intramuscular injection, it is more
      complicated and perhaps less acceptable to patients as well as more likely to cause EPS
      (extrapyramidal symptoms). Of late in our emergency room, we started using high dose
      Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising
      results.

      This study is designed to compare the efficacy and safety of Quetiapine with the routine
      "cocktail for treatment of agitation.

      The primary purpose of this study is to determine the efficacy and safety of Quetiapine by
      using high dose Quetiapine (300 mg) PO to treat agitated patients in the psychiatric
      emergency room.

      The secondary purpose is to test the immediate effect on agitation caused by illicit drug
      abuse or the alcohol abuse.
    

Intervention name(s): Quetiapine; Haloperidol; Lorazepam; Cogentin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD; given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary; given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.; given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.
Other intervention name(s): no other name; no other names; no other name; no other name
Intervention MeSH terms: Lorazepam; Haloperidol; Benztropine; Quetiapine Fumarate; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
Condition: COPD; COPD Exacerbation
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Investigators propose to develop methods to improve early identification of acute
      exacerbations of COPD (AECOPD) among HIV-infected individuals. Investigators hypothesize that
      earlier identification of acute exacerbations through in-home monitoring of respiratory
      symptoms, lung function and medication usage will allow appropriate intervention to reduce
      the morbidity associated with AECOPD. Therefore, the investigators propose using innovative
      mobile health (mHealth) applications to Respond Early to Acute exacerbations of COPD in HIV
      (mREACH). COPD is a co-morbidity of HIV with growing recognition, but remains greatly
      under-recognized among HIV-infected persons. In this application, among HIV-infected
      individuals with spirometry-confirmed COPD, investigators will conduct a pilot randomized
      trial of mHealth monitoring compared to usual care to reduce the symptom and clinical burden
      of AECOPD.
    


Intervention name(s): mHealth Intervention
Intervention type(s): Other
Intervention description(s): See arm description
Other intervention name(s): Home spirometer; Inhaler monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: HIV; mobile health; spirometry
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Behavioral weight loss, the current treatment of choice for moderate obesity, achieves
      impressive short term results, however, weight regain following treatment is a major problem.
      Over 50% of participants in behavioral weight loss programs report difficulty with internal
      antecedents to unhealthy weight control behaviors and this difficulty is associated with
      weight regain following treatment. Current treatment approaches do not adequately address
      these antecedents. The aim of this series of studies is to develop, implement, and evaluate a
      behavioral weight loss program modified to provide participants with skills to deal
      effectively with affective and cognitive difficulties. The study targets men and women with
      BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to
      unhealthy weight control behaviors. The study is an uncontrolled pilot study in 20
      participants to initially assess acceptability and efficacy of the innovative treatment. The
      long-term goal of this research is to improve the weight loss maintenance outcomes of
      behavioral weight loss programs by addressing affective and cognitive antecedents to
      unhealthy weight control behaviors.
    


Intervention name(s): Affective and Cognitive Skills Training
Intervention type(s): Behavioral
Intervention description(s): 24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioral weight loss
Pilot Study of Functional and Morphometric Brain Abnormalities Related to Adolescent Idiopathic Scoliosis (MOR-FO-SIA)
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Adolescent idiopathic scoliosis (AIS) is a complex deformity with different curves. These
      different curves may be distinguished by different physiopathologic mechanisms.

      Without fully convincing model of the emergence and development of AIS, their multifactorial
      nature seems evident. Several pathophysiological theories involving the central nervous
      system have been proposed: the AIS would be associated with disturbances of proprioceptive or
      sensory perception, and/or with integration of this information. This would result in an
      abnormal body image, responsible for sensorimotor asymmetry that may promote or cause the
      deformation.

      The Main aim of this study is to find cortical and subcortical morphometric differences in
      the most common population of AIS (right thoracic AIS) compared to healthy adolescent control
      girls.

      Secondary Objectives are to study the cerebral white matter of the same groups (fractional
      anisotropy in the main white matter tracts), and activation of sensorimotor neural networks
      (fMRI activation and functional brain connectivity).

      Abnormalities of the studied parameters may be used as biomarkers for AIS diagnosis and
      classification.
    


Intervention name(s): MRI
Intervention type(s): Device
Intervention description(s): MRI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: scoliosis; MRI (Magnetic Resonance Imaging)
Use of Allograft Cartilage in Cosmetic and Reconstructive Rhinoplasty
Condition: Rhinoplasty
Study type: Interventional

Summary: 
      This is a single-center, blinded, controlled trial, conducted in healthy adult subjects
      undergoing a reconstructive or cosmetic rhinoplasty involving the use of cartilaginous graft
      (either non-irradiated cartilage sheet allograft compared to autologous harvest and grafting
      of costal cartilage).
    


Intervention name(s): Autologous Costal Cartilage Graft; Costal Cartilage Allograft.
Intervention type(s): Other; Other
Intervention description(s): Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.; Subjects undergoing either reconstructive or cosmetic rhinoplasty will choose which graft will be used in their intervention.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
Condition: Polyp of Ethmoidal Sinus; Surgery
MeSH terms: Nasal Polyps
Study type: Interventional

Summary: 
      The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution
      and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER®
      NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at
      14 days post-surgery.
    

Detailed description: 
      This is a comparative study between two postoperative treatments following ethmoid sinus
      surgery. The purpose of this study is to compare the effect of RESPIMER® NetiFlow® solution
      on nasal tissue repair versus saline solution (0.9% NaCl), the standard treatment.

      The type of surgery selected for this study is total endoscopic ethmoidectomy. This is a
      frequently used standard surgery that requires nasal cleansing for an average of 28 days.
      This process allows the regeneration of the nasal epithelial lining of the wound (areas of
      exposed bone), as well as the healing of swelling and scarring due to the surgery.

      The follow up last 28 days with 4 visits (D7, D14, D21 and D28).

      RESPIMER® NetiFlow® : device of class I, with CE mark, in the indication of sinus
      postoperative care.
    

Intervention name(s): A postoperative care after ethmoid sinus surgery
Intervention type(s): Other
Intervention description(s): A comparison of two products used for nasal cavity cleansing, at the rate of 4 washes/day (240mL per wash), as local postoperative care following endoscopic sinus surgery. This surgery, known as an ethmoidectomy, aims to improve sinus ventilation, treat the chronically infected area, and remove polyps that cause nasal obstruction.
Detailed information concerning the purpose of nasal irrigation, as well as how to use and clean the device, will be given to patients upon inclusion.
The nasal washing procedure will be as follow:
Washing both nostrils using 180mL of solution distributed equally on each side to remove crusting and clotting
Gentle blowing of the nose
Rinsing both nostrils with the remaining 60mL of solution distributed equally on each side (no nose-blowing).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Saline Solution, Isotonic / Administration & dosage; Therapeutic Irrigation / methods; Postoperative Care / methods; Quality of life