bioihbjkbjnl/mcl2 huggingface dataset:
A Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme
Condition: Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 4

Summary: 
      Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia
      and moderate to severe manic episode.

      Olanzapine is among the many antipsychotic agents associated with weight gain . The mechanism
      for antipsychotic drug-related weight gain is not known, although antagonism of serotonin
      receptors, especially the 5HT2C , and histamine receptors has been hypothesized.

      The purpose of this study is to observe the efficacy of a psychoeducational programme in
      managing the increased weight as a side effect of the olanzapine treatment.

      Interventions to prevent weight gain associated with olanzapine should at least include
      periodic monitoring and recommendations for changes in diet and physical activity.

      This is a phase IV, randomised, parallel study of subjects previously treated with olanzapine
      as antipsychotic monotherapy, which have shown an increase of B.M.I. >7% from the beginning
      of antipsychotic treatment (assessed during the routine visits). For the first 12 weeks of
      the trial approximately 60 outpatients, enrolled in one site during a period of one year,
      will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine + psychoeducational
      programme or olanzapine alone. In the following 12 weeks of the study all patients undergo
      the psychoeducational programme. The efficacy of this programme will be assessed monitoring
      the mean difference from baseline to endpoint in total body weight and BMI.
    


Intervention name(s): olanzapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short-term Effects of Live Music in Preterm Infants
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of pentatonic live music on
      physiological parameters in preterm infants.
    


Intervention name(s): Music
Intervention type(s): Other
Intervention description(s): Pentatonic music
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Preterm infants, music, Neonatal Intensive Care Unit (NICU)
Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy
Condition: Gallbladder Diseases
MeSH terms: Gallbladder Diseases
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effect of lidocaine patch on the
      shoulder pain score after end of surgery.

      The secondary purpose of this study is to investigate the effect of lidocaine patch on the
      total number of analgesic request on ward.
    


Intervention name(s): Lidocaine patch and hypafix; hypafix
Intervention type(s): Drug; Drug
Intervention description(s): Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction; Appliance of hypafix on both shoulder tip after anesthetic induction
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Psychological and Lifestyle Factors on Health Outcomes
Condition: Psychological; Stress; Immune Health; Vaccination; Respiratory Tract Infections; Injury
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      Psychosocial and lifestyle factors in Army recruits likely contribute to increased
      susceptibility to infection and injury during basic Army training. The primary aim of this
      study is to assess the influence of psychosocial and lifestyle factors at the start of basic
      Army training on immune health (e.g. respiratory infection and antibody response to influenza
      vaccination) and injury during training, in an observational design.

      A secondary aim is to establish whether changes in psychosocial and lifestyle factors during
      training impact immune health (e.g. response to hepatitis B vaccination). Using an
      interventional design, participants will be randomly allocated into two experimental groups:
      (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical
      assessment upon entry to basic training and second hepatitis B vaccination 1 month later;
      (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of
      training and second hepatitis B vaccination 1 month later.
    


Intervention name(s): Delayed vaccination
Intervention type(s): Behavioral
Intervention description(s): First and second hepatitis B vaccinations will be delayed by 1 month in the interventional group to establish whether changes in psychosocial and lifestyle factors during training impact immune health.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For aim 1, an observational design will be used to examine the influence of psychosocial and lifestyle factors at the start of basic Army training on immune health (e.g. respiratory infection and antibody response to influenza vaccination) and injury during training.
For aim 2, the recruited cohort will be divided into two groups: (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical assessment upon entry to basic training and second hepatitis B vaccination 1 month later; (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of training and second hepatitis B vaccination 1 month later.
Masking: None (Open Label)
Primary purpose: Basic Science
Daily Vinegar Ingestion and Metabolic Health
Condition: Inflammation; Metabolic Syndrome; Depression
MeSH terms: Metabolic Syndrome; Syndrome; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine if vinegar ingestion promotes beneficial changes to
      metabolic health parameters in healthy, overweight adults.
    

Detailed description: 
      Recent research, in animal and human subjects, suggests that vinegar intake is inversely
      associated with insulin resistance, mood states and depression, inflammation, and other
      disease parameters. The study will be conducted as a randomized controlled trial in
      overweight adults to further examine these relationships and possible mechanisms. Although
      the mechanisms are not known, research suggests that changes in the gut microbiome, a
      response to the ingestion of the postbiotic acetic acid, may factor into the beneficial
      effects of vinegar ingestion. Through analyses of blood, changes in key blood metabolites
      associated with mood states (e.g., gamma-aminobutyric acid) as well as markers of gut health
      (e.g., LPS binding protein) and inflammation (e.g., CRP) will be assessed. Additionally mood
      state will be assessed using validated measures and determine risk for metabolic syndrome, a
      cluster of risk factors associated with many chronic conditions. It is hypothesized that
      vinegar ingestion will promote beneficial changes to these health parameters.
    

Intervention name(s): Liquid vinegar; Vinegar pill
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 tablespoons consumed twice daily with meals; 2 pills consumed upon waking
Intervention MeSH terms: Acetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Participant)
Primary purpose: Other
Keywords: vinegar; acetic acid; LPS
Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers
Condition: Depressive Disorder; Smoking
MeSH terms: Depressive Disorder
Study type: Interventional

Summary: 
      This study will assess whether varenicline (chantix) has antidepressant properties when used
      in addition to other psychiatric medication. It will also assess whether varenicline improves
      the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with
      psychiatric medications.

      Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of
      health, side effects as well as tobacco use for 6-8 weeks.

      Medication will be provided free of charge.
    

Detailed description: 
      Outpatient smokers who are depressed despite current stable psychiatric medication regimens
      will be invited to participate.

      They will receive varenicline dosed according to FDA-approved smoking cessation regime;
      patients will be assessed using QIDS-SR16, snaith-hamilton anhedonia rating scale, SAFTEE and
      clinical global improvement self-report scales and clinician global improvement scales at the
      above time intervals.

      Concurrent medication, psychiatric and non-psychiatric, will be recorded, as will vital signs
      (BP, HR, weight) and tobacco use.
    

Intervention name(s): fixed dose varenicline; varenicline
Intervention type(s): Drug; Drug
Intervention description(s): varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration.; up to 1 mg twice daily
Other intervention name(s): Chantix; Chantix
Intervention MeSH terms: Varenicline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: varenicline; depression; anhedonia; smoking
High Volume Caudal Study
Condition: Male Circumcision
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objective is to evaluate the effect of clonidine on the duration of analgesia
      provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In
      addition, caudal clonidine's effect on length of recovery and post-operative emergence
      agitation will be measured.
    


Intervention name(s): High Volume-Low Concentration without Clonidine; High Volume-Low Concentration with clonidine
Intervention type(s): Drug; Drug
Intervention description(s): The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine) caudal block; The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine).
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, observer blinded study will attempt to determine if there is any benefit to the addition of clonidine to a HVLC caudal block, both in duration of analgesia and occurrence of emergence agitation.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Validation of the Chinese ObsQoR-11
Condition: Cesarean Delivery
Study type: Observational

Summary: 
      Investigation of post-cesarean recovery among Taiwanese pregnant women.
    

Detailed description: 
      Improving postpartum quality of recovery is important particularly for women undergoing
      cesarean delivery. This is because cesarean delivery is associated with significant
      postoperative pain and risks of anesthesia-related adverse effects. To improve the quality of
      recovery after a cesarean delivery, the first step is to find out the most relevant
      perioperative factors.

      In response to this problem, experts including anesthesiologists, obstetricians and midwives
      from University College London Hospital, Royal Free Hospital, London as well as Stanford
      University established a set of 11-item questionaire related to postpartum recovery, namely
      the Obstetric Quality of Recovery-11 score (ObsQoR-11), with a total score of 110. The latest
      systemic review in 2020 also confirmed that this questionnaire is the best option for
      recovery assessment after cesarean delivery. However, for women undergoing cesarean delivery
      in Taiwan, it is still unknown whether this questionnaire is representative or not.
      Therefore, this study aims to include women undergoing elective cesarean delivery from three
      hospitals in Taiwan.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Post-cesarean delivery recovery
      
Keywords: Cesarean delivery,the Obstetric Quality of Recovery-11 score, Chinese
A Study Testing A Radioactive Compound Given Through A Vein With And Without The Non-Radioactive Compound, Given By Mouth, To Characterize Tissue Distribution Using Positron Emission Tomography Scanning
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2
      different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects.
      Positron emission tomography will be used to characterize tissue distribution. The study will
      also characterize how the study drug behaves in the body, its safety, and how the body
      tolerates it.
    


Intervention name(s): [11C]PF-06427878; PF-06427878 10 mg; PF-06427878 600 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single administration via intravenous infusion of 20 ug [11C]PF-06427878 on Day 1 of all 3 Periods; Single oral administration of 10 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration; Single oral administration of 600 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: hyperlipidemia; positron emission tomography
Caffeine and Sodium Citrate Ingestion
Condition: Dietary Supplements; Heart Rate/Drug Effects; Lactic Acid/Metabolism; Physical Education and Training/Methods; Wheelchairs
Study type: Interventional

Summary: 
      A positive ergogenic effect of sodium citrate and caffeine ingestion in a short-term,
      high-intensity exercise task was shown by several studies. These studies were conducted with
      healthy, able-bodied subjects.

      The aim of the study is to investigate whether caffeine or sodium citrate ingestion could
      enhance performance in spinal cord injured wheelchair athletes. It is a double blind, placebo
      controlled and randomized study.
    

Detailed description: 
      The athletes have to complete four 1500m tests on a training roller. Before each treatment
      they get different supplementations. Once they get sodium citrate and a placebo, once
      caffeine and a placebo, once sodium citrate and caffeine and for the fourth treatment they
      get twice a placebo. Two hours after starting with the supplementation they have to complete
      the 1500m as fast as possible. Time to complete 1500m, blood pH, plasma bicarbonate, sodium
      concentration, heart rate, oxygen consumption, blood lactate concentration and rate of
      perceived exertion (RPE) were measured.
    

Intervention name(s): Caffeine; Sodium Citrate; Mannitol; Sodium Chloride
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): gelatine capsule 6mg/kg bodyweight 60min prior test; 0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test; gelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test; sodium chloride diluted in 7dl water 0.045g/kg bodyweight 120-90min prior test
Intervention MeSH terms: Mannitol; Caffeine; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: caffeine; sodium citrate; exercise performance; wheelchair athletes; 1500m
Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
Condition: Hyperglycemia, Diabetes, and Obesity
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise
      in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily
      digested carbohydrate).
    

Detailed description: 
      -  About two-thirds of adults in the United States are overweight or obese which can cause
           adverse health consequences for those individuals. Post-prandial hyperglycemia is one of
           these possible consequences and is associated with a higher risk for Type 2 Diabetes.
           Controlling hyperglycemia is important in the prevention of the onset of diabetes and
           obesity. Resistant starch is a dietary carbohydrate which is not completely digested in
           the gut and produces energy for the body to use. The investigators are interested in
           assessing the effects of resistant starch on postprandial blood glucose and insulin
           concentrations.

        -  Aim: To assess the effects of a resistant starch on post-prandial blood glucose and
           insulin concentrations.

        -  Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial
           rise in blood glucose and insulin concentrations compared to a beverage with
           maltodextrin (an easily digested carbohydrate).
    

Intervention name(s): Resistant Starch; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing resistant starch. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.; Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing maltodextrin. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study of Cephalexin Liquid in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare two different preparations of an antibiotic called
      cephalexin to determine if they are essentially the same. The study has two periods.
      Participants will receive one preparation of cephalexin in each period. At least 7 hours will
      pass between the study periods. The study is expected to last about 2 days for each
      participant, not including screening or follow-up.
    


Intervention name(s): Cephalexin
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): Keflex®; LY066873
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Scoring Method for Describing the Position of a Tracheostomy Tube
Condition: Tracheostomy
Study type: Observational

Summary: 
      Tracheostomies are artificial airway devices inserted into the neck. They can become
      displaced and lead to patient harm. Other than external visual inspection, there is no
      currently described system for describing the position of a tracheostomy tube within the
      airway. The investigators propose to undertake endoscopic inspection of the tracheostomy tube
      with a small fibre-optic camera from above and also through the tube to visualise its
      position within the airway. The investigators will take anonymised paired images and then
      score these using 6 different scoring systems. The investigators will determine which scoring
      system provides the simplest and most reproducible scores between 6 blinded assessors. A
      clinically useful scoring system could be used in future to predict problems with
      tracheostomy positioning.
    

Detailed description: 
      Aims & Outcomes

        1. Develop an appropriate bedside scoring method for describing the position and
           orientation of a tracheostomy tube tip when viewed endoscopically from a standardised
           position

        2. Secondary aims

             -  Correlate the endoscopic views of the tracheostomy tube with the trans-laryngeal
                views.

             -  Is it possible to predict the trans-laryngeal view from the endoscopic view.

             -  Does the position of a tracheostomy tube tip change when the patient is
                repositioned following percutaneous tracheostomy (when viewed endoscopically)

             -  Equipment training: Compare the number of supervised endoscopies required to
                consistently achieve the required standardised view

        3. Primary outcome

           - Determine the scoring system with the best inter-rater agreement as defined by
           weighted kappa and intra-class correlation coefficients.

        4. Secondary outcome

           - Assess correlation between the best scoring system (chosen by above) with the
           translaryngeal view

        5. Tertiary aim - Assessment of training: Determine the number of attempts required to
           obtain adequate standardised views. This will be a manikin based assessment to
           demonstrate competence in performing the endoscopies for the study before any procedures
           are undertaken on patients.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults (>16yrs) who have a tracheostomy performed as part of their intensive care
        management
      
Keywords: Tracheostomy; adverse effects; Critical Care; standards; safety