bioihbjkbjnl/mcl2 huggingface dataset:
Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children
Condition: Local Anaesthetic; Dental Anxiety
Study type: Interventional

Summary: 
      The study assesses the effect of a new vibration system on pain reduction during the
      injection of local anesthesia. Children undergoing dental treatment are allocated to two
      groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain
      during injection of local anesthetic is assessed using a validated tool in addition to
      assessment of child cooperation during treatment.
    

Detailed description: 
      Eligibility of children for inclusion into the study will be assessed followed by random
      sequence generation and randomization into one of the two study group and allocation
      concealment. Topical anaesthesia will be administered to the two groups followed by
      implementation of the vibration system in the test group. . Behavior and pain will assessed
      at the time of injection.
    

Intervention name(s): Adminstration Technique using Buzzy external distractor; 2% Lidocaine with 1:50,000 epinephrine; Topical Anesthetic
Intervention type(s): Device; Drug; Drug
Intervention description(s): External application of Buzzy distractor during administration of dental anesthetic; Local Dental anesthetic infiltration; 20% Benzocaine gel was applied on the area of infiltration
Intervention MeSH terms: Lidocaine; Epinephrine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Safety and Effects of SLx-4090 After Dosing for 14 Days in Subjects With High Triglycerides
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects
      with high triglycerides.
    

Detailed description: 
      1. Serum triglycerides

        2. Serum lipids and lipoproteins

        3. Safety and tolerability
    

Intervention name(s): SLx-4090; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MEDI9447 Alone and in Combination With MEDI4736 in Adult Participants With Select Advanced Solid Tumors.
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics,
      Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in
      Adult Participants with Select Advanced Solid Tumors
    


Intervention name(s): Oleclumab; Durvalumab
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive IV infusion of oleclumab as stated in arms' description.; Participants will receive IV infusion of durvalumab as stated in arms' description.
Intervention MeSH terms: Durvalumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid Tumors,; MEDI9447,; oleclumab,; MEDI4736,; durvalumab,; CD73,; programmed death ligand-1 (PD-L1),; epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC),; immunotherapy,; pancreatic,; colorectal
Comparison of Two Different Digital Methods in Occlusal Analysis
Condition: Dental Occlusion; Occlusion; Jaw Relationship; Centric Occlusion; Occlusal Analysis
Study type: Observational

Summary: 
      Aim: The aim of this study is to compare the T-Scan digital occlusal analysis system and the
      occlusal analysis mode of the CEREC Omnicam system, which is mainly used for design/
      production, using the data recorded at the centric occlusion position.

      Material-Method: Occlusal recordings were obtained from healthy 20 females and 20 males aged
      18-25 at the centric occlusion position. Records were saved as .jpeg format and transferred
      to Adobe Photoshop CS6 program. Blue, green, and red colors (shown by the same color codes in
      both systems) representing light, intense and tight contacts, respectively, were evaluated in
      terms of the pixel counts. For statistical comparison the differences between the systems
      Independent Sample T-Test and, between the genders, One Sample T- Test were used (α = 0.05).
    


Intervention name(s): Digital Occlusal Recording with T-Scan; Digital Occlusal Recording with Cerec Omnicam
Intervention type(s): Device; Device
Intervention description(s): Occlusal contact recordings of all the teeth were obtained digitally under conditions of maximum bite force and centric occlusion only with the T-Scan (T-Scan III, version 9.1, Tekscan Inc., South Boston, USA).; Occlusal contact recordings of all the teeth were obtained digitally under conditions of maximum bite force and centric occlusion only with the CEREC Omnicam™ (version 4.2, Sirona Dental Systems, New York, USA).
Intervention MeSH terms: Salicylic Acid
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The groups were formed of voluntary participants from undergraduate and postgraduate
        students in the Dentistry Faculty of Gazi University.
      
Keywords: Dental Occlusion; Centric Occlusion; Occlusal Analysis; T-Scan; Cerec Omnicam; Digital Dentistry
LMA Cuff Pressure and LMA-induced Complications
Condition: Sore Throat; Dysphagia; Dysphonia
MeSH terms: Pharyngitis; Dysphonia
Study type: Observational

Summary: 
      The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs and
      allowing them to recoil will put the pressure of the LMA cuff within the safety range. It
      will also determine if remaining within this safety range has an effect on complications
      after surgery..
    


Intervention name(s): Standard inflation of LMA cuff; Pressure check with syringe recoil; Pressure check by pressure transducer
Intervention type(s): Device; Device; Device
Intervention description(s): LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by manual palpation of the cuff per standard practice.; LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by syringe recoil; LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by pressure transducer.
Other intervention name(s): LMA inflation routine clinical practice; LMA cuff pressure by syringe recoil; LMA cuff pressure checked by pressure transducer
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled to undergo a surgical procedure less than 2 hours in duration
      
Keywords: overinflation of LMAs
Düsseldorf Bread Study
Condition: Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The hypothesis is to be tested that eating carbohydrate-reduced bread over three months leads
      to a significant weight difference compared to conventional, carbohydrate-rich bread.
    

Detailed description: 
      Carbohydrate reduction is an important element for weight loss or can also be used to keep
      weight constant. Since the majority of the carbohydrates consumed daily in industrialized
      countries come from bread and rolls, the present study will examine the effect of two
      different types of bread on the weight development of overweight bread consumers. The two
      types of bread differ in their carbohydrate content and the hypothesis is to be tested that
      eating carbohydrate-reduced bread over three months leads to a significant weight difference
      compared to conventional, carbohydrate-rich bread. The comparison of the two types of bread
      is carried out triple blinded. During two visits (before and after the bread consumption
      phase), the health status is determined with physical parameters and laboratory parameters
      from a blood test. The primary endpoint is body weight. Overall, this study will for the
      first time allow extensive statements to be made on the health value of the three-month
      consumption of two different types of bread.
    

Intervention name(s): carbohydrate reduced bread; carbohydrate rich bread
Intervention type(s): Other; Other
Intervention description(s): Consumption of carbohydrate reduced bread for three months.; Consumption of carbohydrate rich bread for three months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3
Condition: Breast Cancer Female
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      An open-label, single center study with 99mTc-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of
      primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where
      the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and
      99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.
    

Detailed description: 
      The primary objectives are:

      Compare SPECT/CT imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 in HER2-positive
      primary tumour of breast cancer patients before system (chemo/targeted) therapy.

      The secondary objectives are:

      To compare the SPECT/CT tumor imaging data with the data concerning HER2 expression obtained
      by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of
      biopsy samples.
    

Intervention name(s): 99mTc-ADAPT6; 99mTc-DARPinG3
Intervention type(s): Drug; Drug
Intervention description(s): One single injection of 99mTc-ADAPT6, followed by gamma camera imaging 2 hours after injection.; One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection.
Other intervention name(s): SPECT; SPECT
Intervention model: Single Group Assignment
Intervention model description: Diagnostic Test: ADAPT6-SPECT and DARPinG3-SPECT Diagnostic SPECT for HER2-positive Breast Cancer primary tumour
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 99mTc-ADAPT6; 99mTc-DARPinG3; Breast Cancer; HER2 expression
Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch)
      compared to placebo in patients with chronic low back pain.
    


Intervention name(s): Bupivacaine TTS (Bupivacaine Patch); Placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): Contains bupivacaine base, in a flexible and rectangular-shaped, transdermal, delivery system. Three patches applied to the lower back every 72 hours for 12 weeks.; Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: chronic low back pain
Myo-inositol in Obese Pregnant Women
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational
Study type: Interventional

Summary: 
      Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of
      living cells and is widespread in many food. It is involved in a number of biological
      processes, including insulin signal transduction, resulting in modulating insulin
      sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two
      hundred and twenty obese pregnant women will be included in the trial and, after an informed
      consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks
      gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at
      24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be
      registered.
    


Intervention name(s): myo-inositol; folic acid 400 mcg
Intervention type(s): Dietary Supplement; Other
Intervention description(s): myo-inositol 2 grams plus folic acid 400 mcg twice a day; 2 pills a day
Intervention MeSH terms: Folic Acid; Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: gestational diabetes; macrosomia; hypertension in pregnancy; HOMA-IR; obesity
Fentanyl Background Infusion for Acute Postoperative Pain
Condition: Analgesia Disorder
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      We investigated the efficacy and the safety of the pharmacokinetic model-based
      patient-controlled analgesia (PCA) regimens of fentanyl for postoperative analgesia after
      total intravenous anesthesia (TIVA).
    

Detailed description: 
      Infusions of fentanyl (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were
      maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr, or at the decremental
      rates of 6.0 ml/hr or 8.0 ml/hr during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during
      3~24 hr, postoperatively.
    

Intervention name(s): FX2-2-2; D6-4-2; D8-4-2
Intervention type(s): Other; Other; Other
Intervention description(s): Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.; Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.; Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
Other intervention name(s): decremental PCA; decremantl PCA 6-4-2; decremental PCA 8-4-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: analgesia; fentanyl; total intravenous anesthesia
Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      As clinical primary endpoints we assessed whether existed differences in:

        1. PSA recurrence rate stratified according to treatment modalities

        2. EGFR and HER2/neu overexpression rate stratified according to treatment modalities

        3. PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.

      As secondary clinical endpoints we assessed whether existed differences in:

        1. prostate cancer-specific mortality according to treatment modalities

        2. prostate cancer-specific mortality stratified according to EGFR and HER2/neu
           overexpression levels.

      For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA
      recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality
      Pre-clinical endpoints As pre-clinical endpoint we assessed whether exist differences in
      efficacy rate of Bicalutamide and Gefitinib treatment in primary tumor cultures stratified
      for high and low EGFR and HER2/Neu expression levels. The evaluation of efficacy rate of
      these treatments was documented by comparing the differences of drugs IC50 values among the
      groups stratified for EGFR and HER2/Neu levels.
    


Intervention name(s): bicalutamide
Intervention type(s): Drug
Intervention MeSH terms: Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection
Condition: Hepatectomy; Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Study hypothesis: N-acetylcysteine (NAC) can reduce ischemia/reperfusion injury in liver
      resection performed under ischemic preconditioning and intermittent portal triad clamping.
    

Detailed description: 
      One of the most important factors in the pathophysiology of liver dysfunction after hepatic
      surgery is the cellular damage derived from the interruption of blood flood with reperfusion
      of the organ. N-acetylcysteine (NAC) has proved beneficial in several conditions involving
      oxidative damage. This study investigates the effects of NAC to reduce ischemia/reperfusion
      injury in liver resection performed under ischemic preconditioning and intermittent portal
      triad clamping.

      Methods: 46 ASA II-III patients scheduled to undergo liver resection where randomised to
      receive NAC (initial dose: 150 mg/Kg; and infusion of 50 mg/kg, from 30 minutes before the
      ischemia up to 60 minutes later to the reperfusion) or placebo in a phase IV clinical trial.
      Blood, hepatic and urinary markers were obtained at basal status and 1, 3 and 24 h post final
      reperfusion.
    

Intervention name(s): Acetylcysteine (NAC); Saline
Intervention type(s): Drug; Drug
Intervention description(s): NAC 150 mg/Kg; and infusion of 50 mg/kg, from 30 minutes before the ischemia up to 60 minutes later to the reperfusion; Na Cl 0.9% infusion
Other intervention name(s): Flumil
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Acetylcysteine
Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to
      stimulate the immune system and stop cancer cells from growing. Fludarabine may help the
      immune system kill more cancer cells.

      PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular
      adoptive immunotherapy in treating patients who have metastatic melanoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+
           antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with
           stage IV melanoma.

        -  Determine the duration of in vivo persistence of these CTL clones in these patients.

      Secondary

        -  Determine the antitumor effect of this regimen in these patients.

      OUTLINE: This is an open-label, nonrandomized study.

      Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood
      mononuclear cells from which autologous antigen-specific CD8+ cytotoxic T-lymphocyte (CTL)
      clones are generated. Patients receive autologous antigen-specific CD8+ CTL clones IV over
      30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable
      toxicity. Patients also receive fludarabine IV once daily on days 14-18.

      Patients are followed for up to 1 year.

      PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 3 years.
    

Intervention name(s): therapeutic autologous lymphocytes; fludarabine phosphate
Intervention type(s): Biological; Drug
Intervention MeSH terms: Fludarabine; Fludarabine phosphate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV melanoma; recurrent melanoma
Cognitive Behavioral Therapy Following Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Myocardial infarction (MI) is one of the leading cause s of health loss globally,
      representing a large proportion of general disability. Anxiety and depression occur in 20-30
      percent of patients following MI and have been identified as risk factors for recurrent
      adverse cardiac event. The purpose of our this study is to develop and evaluate a disease
      specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression,
      increase physical inactivity and quality of life (Q oL) in patients following MI.
    

Detailed description: 
      The study will include 20 patients. The MI-specific CBT lasts for 8 weeks and is delivered
      face-to-face via a secure digital video solution (to minimize cancelled sessions because of
      the COVID-19 pandemic) or at the Karolinska Universitetssjukhuset cardiac research unit, by
      licensed psychologists with expertise in CBT for cardiac disease. During treatment, the
      psychologists will have direct access to a cardiologist assigned to the project and
      treatments are conducted in close interdisciplinary collaboration to ensure patient safety.
    

Intervention name(s): MI-CBT
Intervention type(s): Behavioral
Intervention description(s): Education, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CBT; Cardiac anxiety; Quality of Life; Physical activity
Diet, Exercise and Body Fat in 3-5 Year Olds
Condition: Healthy
Study type: Observational

Summary: 
      To determine how practical and precise different body composition methods are for measuring
      body fat and lean tissue in young children and to determine if certain dietary factors and
      physical activity patterns are related to body fat in children.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We are seeking healthy 3-5 year old children in the greater Little Rock area.
      
Biospecimen description: 
      Urine
    
Keywords: Children; Nutrition; Body Fat; Physical Activity; Diet; Childhood Obesity; Healthy Children