bioihbjkbjnl/mcl2 huggingface dataset:
Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates
Condition: Neonatal Disease; Neonatal Disorder
MeSH terms: Infant, Newborn, Diseases
Study type: Interventional

Summary: 
      To determine the effects of multisensory stimulation and soft tissue therapy on procedural
      pain and neurodevelopment among neonates admitted to the NICU is the aim of the study. The
      study will be two groups randomized clinical trial of five days intervention program. The
      intervention will be given among two groups. Group A will receive both multisensory
      stimulation and soft tissue therapy, Group B will receive only regular hospital care. The
      PIPP and N-PASS will be used for assessing pain. The INFANIB and Premie-Neuro will be used
      for assessing neuromotor development among neonates. The outcomes will be taken before and
      after the fifth day of the intervention. Multisensory stimulation and soft tissue therapy
      might help in reducing pain and promoting neurodevelopment.
    

Detailed description: 
      This study will utilize two parallel groups, randomised design to analyze the effects of soft
      tissue therapy and multisensory stimulation on pain and neurodevelopment. 104 neonates
      admitted in NICU will be recruited through purposive sampling for the trial. Procedural pain
      will be assessed with PIPP and N-PASS through recorded video. Neurodevelopmental outcomes
      will be assessed with INFANIB Scale and Premie-Neuro. The measurements will be taken after 24
      hours of birth at the baseline and after the fifth day of the intervention. The treatment
      will be given into two groups i.e. Group A (Multisensory stimulation and soft tissue therapy
      group), Group B (routine hospital care). MSS will consist of Auditory Stimulation,
      Tacto-Kinesthetic stimulation, Vestibular stimulation, Visual stimulation, Oral-stimulation,
      and Olfactive stimulation. Soft tissue therapy consisted of stroking, effleurage, skin
      rolling, and kneading techniques, Will be given in 5 Phases-Forehead and face, Back and Neck,
      Chest and abdomen, upper-lower limbs. Total 30 min. of the treatment plan, per day, will be
      given to the neonates, after 30 min. of feed, for up to 5 days of NICU stay.
    

Intervention name(s): Multisensory stimulation with soft tissue therapy; Routine hospital care
Intervention type(s): Other; Other
Intervention description(s): Multisensory stimulation with soft tissue therapy will be given. Multisensory stimulation consists of Auditory, vestibular, tactile, olfactive, oromotor, Visual, and Kinesthetic stimulation. Soft tissue therapy consists of stroking, effleurage, fingertip kneading, tapping, and skin rolling will be given. Total intervention will be given for 30 min. 5 times per week; Routine hospital care will be given to the preterm neonates
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Neonates admitted in the Neonatal intensive care unit will be divided randomly into 2 groups.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neonates; Pain
HCV-796 and Midazolam Drug Interaction Study in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the potential PK interaction of multiple oral doses of HCV-796 and a single oral
      dose of midazolam when coadministered to healthy subjects.
    


Intervention name(s): HCV-796; midazolam
Intervention type(s): Drug; Drug
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Cognitive Training Approaches in Psychotic Disorders
Condition: Psychotic Disorders
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for
      individuals with psychosis, however, there is no gold standard method of cognitive
      remediation available. Cognitive training refers to the training component of CR in which
      people practice computerized exercises that train specific cognitive abilities. There is no
      agreed upon approach within the field as to the type of training that is most effective with
      some studies, training higher level cognitive abilities, some training perceptual abilities,
      and others training general cognitive skills. This study will directly compare two competing
      methods of cognitive training on measures of neurophysiology, neurocognition, functional
      competence, and real-world functional performance.
    


Intervention name(s): Cognitive Remediation - Executive Training; Cognitive Remediation - Perceptual Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability.; Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)
Condition: Chemotherapy-Induced Nausea and Vomiting (CINV)
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of
      participants treated with aprepitant is similar to that of participants treated with
      fosaprepitant at certain timepoints.
    

Detailed description: 
      The third arm of the study (Aprepitant 250 mg) will only be conducted if the real-time
      assessment of the NK1-receptor occupancy data between fosaprepitant 150 mg & aprepitant 165
      mg reveals that the primary hypothesis will not be supported.
    

Intervention name(s): Fosaprepitant 150 mg; Aprepitant 165 mg; Aprepitant 250 mg; Dexamethasone (12-8-16-16 mg); Dexamethasone (12-8-8-16 mg); Ondansetron; MK0999
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): a single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes on Day 1 15 minutes after consumption of a standard light breakfast meal; a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal; a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal; Dexamethasone 12 mg will be administered orally 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg twice daily), and Day 4 (8 mg twice daily) with or without a meal.; Dexamethasone 12 mg will be administered orally 30 minutes after after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg), and Day 4 (8 mg twice daily) with or without a meal.; The intravenous (I.V.) infusion of ondansetron 32 mg will begin 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1 and will be administered as a 15-minute infusion; I.V. infusion of MK0999 containing ~100 MBq (~3 mCi) containing ≤ 5 ug of MK0999)
Other intervention name(s): MK0517; MK0869; MK0869; Dexamethasone; Dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; Fosaprepitant; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NK1-receptor occupancy
Early Discharge in Patients Undergoing Elbow Arthroscopy
Condition: Elbow Arthroscopy Surgery
Study type: Interventional

Summary: 
      Patients undergoing elbow arthroscopy surgery will receive standard anesthesia and analgesia
      (infraclavicular nerve block combined with general anesthesia for surgery; continuous
      infusion via infraclavicular catheter to day 3 post op). Patients in the experimental group
      will be discharged home after one day, with infraclavicular catheter in place; patients in
      the comparator group will stay in hospital for 3 or 4 days, per standard practice. The study
      will compare range of motion as the primary endpoint, in a non-inferiority design, to see if
      early discharge is feasible while providing similar recovery.
    


Intervention name(s): Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op.; Early Discharge; Normal Discharge
Intervention type(s): Procedure; Other; Other
Intervention description(s): Patients undergoing elbow arthroscopy surgery will receive standard anesthesia/analgesia, including infraclavicular nerve block and general anesthesia for surgery followed by infraclavicular catheter infusion of local anesthetic until day 3 after surgery.; Patients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place.; Patients will remain in hospital and be discharged per current discharge criteria, once the infraclavicular catheter has been removed on day 3 post op. Typical discharge occurs on day 3 or 4 post op.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: elbow surgery; infraclavicular nerve block; continuous passive motion; ultrasound guided regional anesthesia; early discharge
Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome
Condition: Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Syndrome
Study type: Interventional

Summary: 
      Venous thromboembolism(VTE) is the third most common cardiovascular complication among
      hospitalized patients, and can even cause death. VTE often occurs in intensive care patients
      and there had been many efforts to prevent such complication. The American College of Chest
      Physicians (ACCP) had published evidence-based clinical practice guideline for VTE
      prophylaxis.

      This study focuses on how VTE prophylaxis is being performed in both medical and surgical
      ICUs in a single University hospital, and sees the differences in such prophylactic patterns.
    


Intervention name(s): dexmedetomidine infusion rate, 0.5 mcg/kg/hr; dexmedetomidine infusion rate, 1.0 mcg/kg/hr
Intervention type(s): Drug; Drug
Intervention description(s): continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr; continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: sleep apnea syndrome, fiberoptic bronchoscopy, IV sedation
Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon
      catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment
      of patients with persistent or longstanding persistent atrial fibrillation.
    

Detailed description: 
      The purpose of this randomized clinical trial is to compare the efficacy and safety of
      pulmonary vein isolation with either the second generation cryoballoon (Arctic Front
      Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter
      (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent
      atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation
      treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by
      a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia
      recurrence at 12 months.Treatment success will be evaluated by using 12-lead
      electrocardiography and 7-day Holter recording.
    

Intervention name(s): Pulmonary vein isolation with cryoballoon catheter.; Pulmonary vein isolation with radiofrequency ablation.
Intervention type(s): Procedure; Procedure
Intervention description(s): Device: Arctic Front Advance™ cardiac cryoablation catheter system.; Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Catheter Ablation
Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will be two parallel group, triple blinded randomized controlled clinical trial
      that based on CONSORT (consolidated standards of reporting trials) guideline .The selected
      participants according to inclusion and exclusion criteria will be randomly allocated in two
      groups using (Research Randomizer Program) .
    

Detailed description: 
      Blinding All participants don't know the type of received restorative material (ACTIVA Kids
      or High -viscosity GI restorative material) and the outcome will be evaluated by a examiner
      other than operator who doesn't know the type of received restorative material also.

      Study setting The study will be performed at pediatric Department and Dental Public Health
      Department of Faculty of Dentistry, Ain Shams University, and at the institute of Graduate
      Studies and Research, Ain Shams University.

      Sample size: 60 participants Recruitment/Setting The all participants of this study have been
      selected after complete clinical examination has been done with full medical and dental
      history , history of medications and history of hospitalization. In patients who receive
      dental treatment as an usual care in clinics of Pediatric Dentistry and Dental Public Health
      Department at faculty of dentistry, Ain-Shams University.

      Informed consent designed to include all data about dental procedures in this study and clear
      more details about time consuming in the procedure and follow up visits, used materials and
      adverse event of this procedure . All participants have the wright to withdraw from this
      study at any time .The consent will be assigned from each patient by the patient's parents or
      guardians after explanation of the study.

      The full mouth rehabilitation will be performed by postgraduate student registered at the
      master Degree at the Pediatric Dentistry and Dental Public Health Department Faculty of
      Dentistry, Ain- Shams University All subjects receive instructions on oral health,
      particularly in relation to oral hygiene and sugar consumption
    

Intervention name(s): Fuji IX EXTRA; ACTIVA KIDS bioactive restorative material
Intervention type(s): Drug; Drug
Intervention description(s): High-viscosity glass ionomer (Fuji IX EXTRA); Modified composite (ACTIVA KIDS)
Other intervention name(s): Extra fast GIC; ACTIVA , Modified composite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bioactive Restorative Material , ART
Effects of Artificial Sweetener on Gastrointestinal (GI) Peptide Secretion
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the influence of artificial sweeteners (aspartame,
      acesulfame K, sucralose) and carbohydrate sugars (glucose, fructose) on the release of
      gastrointestinal satiety hormones in humans.
    

Detailed description: 
      Artificial Sweeteners significantly lower energy density of foods and beverages. They are
      used by diabetics as sugar substitutes as well as by consumers as aids for dietary control.
      Despite numerous studies which show mainly no influence of artificial sweeteners on glucose
      metabolism and food intake, discrepancies consist about the real effects of artificial
      sweeteners. Studies by Blundell and Hill in 1986 have however shown that the consumption of
      artificial sweeteners resulted in an increase of appetite ratings; the efficiency of AS has
      therefore been questioned. With respect to the world wide increase in the prevalence in
      obesity, it seems important to clarify whether artificial sweeteners can help regulate body
      weight or not. This study will explore the effect of artificial sweeteners on the release of
      the gastrointestinal satiety hormones PYY, GLP-1, GIP and ghrelin.
    

Intervention name(s): Artificial sweeteners; Carbohydrate Sugars; Water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): sweetening agent dissolved in tap water, administered via intragastric tube
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: satiety peptides; GLP-1; PYY; ghrelin; appetite profile; Sweetening Agents
Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy
Condition: Gestational Weight Gain; Physical Activity
MeSH terms: Overweight; Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      This study was to construct and develop an application (APP) based on social-cognitive theory
      for overweight and obese women during pregnancy.
    

Detailed description: 
      Our program used and evaluated the mHealth program, which has pregnant women using APP and
      wearable devices to help prevent excessive gestational weight gain, and it continued to
      promote physical activity for overweight and obese pregnant women.
    

Intervention name(s): experimental group
Intervention type(s): Other
Intervention description(s): provide mHealth program, which has pregnant women using wearable device and app
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized control trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: overweight; obese; pregnant women
PH-797804 LPS Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in the
      sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of
      inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for
      patients with Chronic Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): PH-797804; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 MG Single dose; matching placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: COPD; LPS
Child Behavior After Local Anesthetic Injection Using Needless Systems
Condition: Child Behavior
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of needless injection (comfort in ject) on
      child behavior and its effect on adjacent oral mucosa and soft tissue in children during
      local anesthesia injection in comparison to the conventional injection technique
    


Intervention name(s): Local anesthesia injection
Intervention type(s): Procedure
Intervention description(s): Local anesthesia administration
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is:

        -  To compare the effectiveness and safety of weekend atropine augmented with a plano lens
           for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100)
           in children 3 to less than 7 years old.

        -  To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine
           treatment with and without a plano lens.
    

Detailed description: 
      Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for
      the sound eye is an accepted method of enhancing and possibly accelerating the treatment
      effect. Demonstrating additional value of the plano lens in terms of speed of improvement
      will shorten the treatment period, possibly improving child and parental compliance, leading
      to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater
      improvement, then there will be less permanent visual impairment in patients with a history
      of amblyopia. It also is important to determine if the use of a plano lens in conjunction
      with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.

      Little is known about the pharmacologic treatment of severe amblyopia. This study will
      provide important prospectively determined outcome data at little additional expense.

      In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial
      Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend
      atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine
      use (such as using it only on the weekends) has the theoretical potential benefit of the
      sound eye having some time each week during which cycloplegia is only partial. It is possible
      that allowing some loss of the cycloplegic effect over the course of each week may be safer
      for the sound eye.

      The study has been designed as a simple trial that, other than the type of amblyopia therapy
      being determined through the randomization process, approximates standard clinical practice.
      The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once
      each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye
      plus a plano lens for the sound eye.
    

Intervention name(s): Atropine; Plano Lens
Intervention type(s): Drug; Device
Intervention description(s): Atropine 1% once each weekend day; Plano lens for the sound eye
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amblyopia; Atropine; Plano lens