bioihbjkbjnl/mcl2 huggingface dataset:
Needle Procedures Success Rate After Application of Ralydan vs EMLA in Children
Condition: Procedural Pain Relief
MeSH terms: Pain, Procedural
Study type: Interventional
Phase: Phase 3

Summary: 
      Needle-related procedures are among the most common sources of pain and distress for children
      in the health care setting. More than 50% of children reported pain during these procedures.
      The necessity for pain management during these procedures is well established. Topical
      anesthesia has been shown to be effective in managing needle-related pain. Eutectic mixture
      of local anaesthetic (EMLA) cream is the topical anesthetic most used. The application of
      this mixture of lidocaine and prilocaine reduce pain during needle procedures in children. To
      be effective EMLA cream must be applied for at least 60 minutes before needle procedure. This
      is the major limitation for its use in emergency settings.

      Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and
      tetracaine) through the skin. There is evidence of pain relief after 30 minutes from its
      application. Only one randomized controlled trial compared the two topical anaesthetics in
      children during venipuncture and showed that Ralydan patch led to superior analgesia than
      EMLA cream, even if in this study the two anaesthetics were applied only for 35 minutes
      before needle procedure. No differences were found in success rate of the procedure and vein
      visibility. In adult patients, Ralydan and EMLA were equally effective in pain relief after
      60 minutes from application.

      To the best of the investigators' knowledge there is no published study that compared needle
      procedure success rate in children and pain relief effectiveness of lidocaine/tetracaine
      patch and lidocaine/prilocaine cream, at time of their maximum analgesic effect.

      The aim of this study is to compare Ralydan patch and EMLA cream at time of their maximum
      analgesic effect (30 minutes vs 60 minutes), regard to needle procedure success rate at the
      first attempt and pain relief in children.
    


Intervention name(s): Lidocaine/Tetracaine patch; Lidocaine/Prilocaine cream
Intervention type(s): Drug; Drug
Other intervention name(s): Ralydan; EMLA
Intervention MeSH terms: Lidocaine; Tetracaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ralydan; EMLA cream; Procedural pain; Phlebotomy; Child
Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening
Condition: Induced; Birth
Study type: Interventional

Summary: 
      The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical
      ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook
      balloon.
    

Detailed description: 
      Upon presentation for cervical ripening appointment, a sterile vaginal exam will be completed
      to assign Bishop score, as per standard routine. Once the patient has been consented and
      randomized, the participant will have a Cook catheter or Dilapan-S inserted. For the Cook
      catheter, the uterine component of the balloon will be inflated to maximum 60mL, the vaginal
      balloon will not be inflated per standard practice and per the literature that shows slightly
      increased pain and negligible improvement in cervical ripening. The catheter will be taped to
      the inner thigh with gentle traction. For Dilapan-S, 3-5 dilators will be placed.

      After placement, the patient will be discharged home with strict return precautions per the
      outpatient cervical ripening protocol. Patients must return to labor and delivery within 24
      hours of cervical ripening agent placement at their scheduled inpatient induction time.

      Upon return to labor and delivery, if not already expelled, the mechanical ripening device
      will be removed, and an examiner blinded to the cervical ripening method will complete a
      sterile vaginal exam to assign a Bishop score.

      At that point health care providers will manage active labor per usual practice. Labor
      interventions are at the discretion of the healthcare provider. The need for operative
      delivery or cesarean section will be at the discretion of the healthcare provider.
    

Intervention name(s): Dilapan-S; Cook Cervical Ripening Balloon
Intervention type(s): Device; Device
Intervention description(s): Osmotic dilator; Double balloon catheter for cervical ripening
Other intervention name(s): Cook catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Induction of labor; Cervical ripening
Different Endurance Training Protocols in Cardiac Rehabilitation
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      It is the aim of the study to compare the effects of 6 weeks of either high-intensity
      interval training (HIT; carried out at correctly assessed 85-95% of maximal heart rate),
      pyramid, or continuous endurance training, on changes of physical exercise capacity in
      cardiac patients.

      The three exercise arms (isocaloric) are composed as follows:

      Endurance training (n=15): 31min at 65-75% HRmax; HIT (n=15): 4x4min intervals at 85-95%
      HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min;
      Pyramids (n=15): One Pyramid consists of 8 one-minute blocks. Those are grouped starting with
      one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85%
      HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards
      with one block at 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75%
      HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax,
      making it a total of 28min.

      All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70%
      HRpeak.

      Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of
      power output in watt at lactate thresholds at 2 and 4 mmol/l.
    


Intervention name(s): Endurance training with constant work load; Pyramid-Training; High-intensity interval training
Intervention type(s): Other; Other; Other
Intervention description(s): Endurance training with constant work load(n=15): 31min at 65-75% HRmax; Pyramid-Training (n=15): One Pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block at 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.; HIT (n=15): 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Masticatory Performance and Patient Satisfaction for Conventional and 3D Printed Implant Overdentures
Condition: Patient Satisfaction
Study type: Interventional

Summary: 
      The aim of this crossover clinical study was the evaluation and comparison of masticatory
      performance and patient satisfaction for patients rehabilitated with conventional heat cured
      acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.

      it was concluded that 3D printed implant overdenture showed promising results regarding
      chewing efficiency and patient satisfaction compared to conventionally fabricated implant
      overdenture.
    

Detailed description: 
      The aim of this crossover clinical study was the evaluation and comparison of masticatory
      performance and patient satisfaction for patients rehabilitated with conventional heat cured
      acrylic resin and 3D printed mandibular implant overdentures retained with bar attachment.

      Materials and Methods: Twelve completely edentulous healthy participants received new
      conventional dentures. Four interforaminal implants were inserted in the mandible. After
      osseointegration, bar was constructed with trapezoidal configuration. Each patient received
      randomly the following overdentures using a crossover design: conventional heat cured acrylic
      resin overdenture, 3d printed overdenture ( developed by scanning of mandibular conventional
      overdenture). Masticatory performance was evaluated with the two-colour mixing ability test
      after 5, 10, 20, 30, and 50 masticatory cycles. Patient satisfaction was also measured using
      McGill Denture Satisfaction Questionnaire. Evaluation was done after 3 months of using each
      overdenture.

      Conclusion: Within this clinical study limitations, 3D printed implant overdenture showed
      promising results regarding chewing efficiency and patient satisfaction compared to
      conventionally fabricated implant overdenture.
    

Intervention name(s): Dental implant placement; Bar attachment
Intervention type(s): Device; Device
Intervention description(s): Procedure/ surgery: Surgical placement of dental implants, four interforaminal dental implants were placed; Device: attachment, implants were connected to each others by 3 implant assembly in a trapezoidal design implants were loaded after 3 months of osseo-integration Control Group: patients received coventionally constructed heat cured overdenture Study Group: patients received 3d printed overdenture
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each patient received two prostheses; conventional and 3D-printed implant overdentures. The succession of complete denture insertion was randomized to diminish the effect of the order of complete denture use on the results. First, each denture was used for three months, followed by two weeks of rest; then, the other denture type was delivered to the patient and used for another three months.
Masking: Single (Investigator)
Primary purpose: Treatment
A Study of LY3084077 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of the study drug
      known as LY3084077 in healthy participants. The study will also investigate how much of the
      study drug gets into the blood stream and how long it takes the body to get rid of it.
      Information about any side effects that may occur will also be collected. The study is
      expected to last approximately 8 weeks for each participant.
    


Intervention name(s): Placebo; LY3084077
Intervention type(s): Drug; Drug
Intervention description(s): Given as a SC injection.; Given as a SC injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures
Condition: Femoral Fracture; Cognition Disorders; Cortisol; Hypersecretion
MeSH terms: Fractures, Bone; Femoral Fractures; Cognition Disorders
Study type: Interventional

Summary: 
      Spinal anesthesia blocks acute pain in older patients with femur fracture. Delirium is a
      common complication seen after femur fracture, affecting approximately 10-16% of patients. It
      is associated with increased mortality at 1st year, delayed rehabilitation efforts, prolonged
      length of hospital stay, poorer functional outcomes, and increased risk of nursing home
      placement.

      Intrathecal dexamethasone administration improves quality of anesthesia in patients with
      femur fracture compared to conventional spinal anesthesia.
    

Detailed description: 
      The aim of this research was to establish the influence of intrathecal dexamethasone
      administration in spinal anaesthesia with levobupivacaine on postoperative pain and changes
      of consciousness, values of cortisol levels and quality of treatment for patients with
      femoral fractures compared to spinal anaesthesia with only local anaesthetic.

      The study was planned as a prospective, observational, randomised clinical trial. A total of
      60 patients ASA2 and ASA3 status, scheduled for surgical procedures were sorted into two
      groups and underwent surgery in spinal anesthesia with levobupivacaine with or without
      dexamethsone.
    

Intervention name(s): 8 mg of dexamethasone; 12,5 mg of 0,5 % of levobupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.; Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.
Other intervention name(s): Dexamethasone KRKA, Chirocaine Abbott; Chirocaine Abbott
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Levobupivacaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: spinal anesthesia; femoral fracture; dexamethasone
Heritability of Opioid Effects: A Twin Study
Condition: Pain
Study type: Interventional

Summary: 
      Proposed twin study will test to what degree inter-individual differences in pain sensitivity
      and amount of pain relief in response to opioid therapy are inherited or alternatively, are
      due to environmental factors. This knowledge is important to guide future studies trying to
      explain such inter-individual differences. For example, finding that differences are largely
      due to environmental factors would discourage genomic studies and emphasize epidemiological
      studies.
    

Detailed description: 
      The principal hypothesis to be evaluated is that the degree of analgesia provided by opioids
      in humans displays substantial familial aggregation, and is, in fact, heritable. These
      studies will use a classical twin paradigm to determine the role of genetics and the
      environment in influencing analgesia and a range of other opioid effects.

      Specific Aims: (1) Determine the degree to which opioid analgesic responses show familial
      aggregation and make preliminary estimates of heritability using both a heat and cold pressor
      pain model, and (2) determine the degree to which non-analgesic opioid responses show
      familial aggregation and make preliminary estimates of heritability. Side effects such as
      sedation, nausea, respiratory depression, and pruritus, as well as the positive affective
      response, a measure of abuse potential, will be monitored. Monozygotic (MZ) and dizygotic
      (DZ) twin pairs (125 total pairs) will be tested under controlled pain laboratory conditions
      for their responses to opioid infusion using the complementary pain models while monitoring
      side effects and additional psychometric indices of mood, sleep, and abuse potential. The
      selected models provide unique mechanistic information because they involve different
      peripheral and/or central pain pathways. DNA samples will be collected for zygosity testing
      and banked for future studies.
    

Intervention name(s): Alfentanil; Saline placebo infusion
Intervention type(s): Drug; Other
Intervention description(s): Target controlled intravenous infusion of alfentanil at a plasma concentration of 100ng/ml; Intravenous infusion of normal saline
Other intervention name(s): Alfenta
Intervention MeSH terms: Alfentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents
Condition: Anxiety Disorder; Depressive Disorder; Emotional Disorder
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This study represents the first research program to assess the efficacy of transdiagnostic
      cognitive behavior therapy (T-CBT) delivered via internet for anxiety and depression in
      adolescents. The primary aim of the study was to implement the program AMTE (Aprende a
      Manejar tus Emociones [Learn to Manage Your Emotions]), an internet delivered T-CBT protocol
      designed to target both anxiety and depression symptoms and disorders (major depression
      disorder, dysthymic disorder, panic disorder, agoraphobia, generalized anxiety disorder, and
      social anxiety disorder) in adolescents, and to establish its preliminary efficacy on anxiety
      and depressive symptomatology. A secondary objective is to demonstrate its potential effect
      regarding: (a) transdiagnostic measures associated with etiology of emotional disorders
      including negative affect, anxiety sensitivity, and emotional avoidance, and (b) positive
      factors including satisfaction with life and positive affect. It is expected that the T-CBT
      condition will be more effective than the waitlist (WL) control group on the primary (anxiety
      and depression) and secondary (transdiagnostic and positive factors) outcome measures.
    


Intervention name(s): The AMTE protocol
Intervention type(s): Behavioral
Intervention description(s): The AMTE program is an adaptation of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018) to be applied as an internet-based protocol. Like the UP-A, the program AMTE implements a set of core principles to address common factors underling youth anxiety and depressive symptoms. It includes the following 10 modules: (1) Understanding emotional problems and disorders, (2) Getting to know your emotions and behaviors, (3) Enjoy your positive activities, (4) Mindful emotion awareness, (5) Being flexible in your thinking, (6) Confronting physical sensations, (7) Situational emotion exposure, (8) How to regulate the emotional avoidance, (9) Respiratory relaxation training, and (10) Relapse prevention.
Other intervention name(s): "Aprende a Manejar tus Emociones" (AMTE) Protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Transdiagnostic-CBT, anxiety, Depression, Internet-Delivered
Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study should estimate the dose proportionality of BAY94-8862 IR tablets.
    


Intervention name(s): BAY94-8862 (1.25mg); BAY94-8862 (2.5mg); BAY94-8862 (5mg); BAY94-8862 (7.5mg); BAY94-8862 (10mg)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cardiac disorders
Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia
Condition: Hypothermia; Anesthesia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      Previous research has shown beneficial effects of prewarming on preventing inadvertent
      perioperative hypothermia (IPH). Warming the surface of the body before the induction of
      anesthesia can reduce the temperature difference between the core and periphery, thereby
      reducing the degree of core-to-peripheral thermal redistribution. It has been proved that
      initiation of warming before surgery can be more useful for preventing IPH than warming only
      during surgery. Nevertheless, there are not many researches on effects of short period (<30
      min) prewarming, especially in gynecologic laparoscopic surgery. Accordingly, the
      investigators designed this study to test if IPH can be effectively prevented when 10 minutes
      of prewarming is added to intraoperative active warming in patients undergoing gynecologic
      laparoscopic surgery.
    


Intervention name(s): Prewarming
Intervention type(s): Device
Intervention description(s): In the operating theater, participants allocated in Prewarming group received 10 min-prewarming, which is cutaneous warming before induction of anesthesia. For prewarming, forced air warming system (WarmTouch WT 6000 Warming Unit, Medtronic, Minneapolis, MN, USA) was used and the warming temperature of the device was set to 45°C.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Perioperative hypothermia; Core body temperature; Prewarming; Gynecologic laparoscopic surgery