bioihbjkbjnl/mcl2 huggingface dataset:
Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      To show an improvement in HbA1c control after 4 months of treatment with insulin glargine +
      Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD)

      Secondary objective:

      Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to
      target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life
      with basal+ OAD regimen.
    


Intervention name(s): Insulin Glargine
Intervention type(s): Drug
Intervention description(s): Once daily and up-titrate accordingly
Intervention MeSH terms: Insulin Glargine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic Response to 3-day Fast Versus Carbohydrate-free Diet in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The investigators hypothesis is that a carbohydrate-free diet, ingested for 3 days, results
      in a change in blood glucose that is similar to the change observed after 3 days of fasting.
    

Detailed description: 
      In addition to plasma glucose concentrations, other hormones and metabolites known to be
      affected by fasting will be measured. These include insulin and glucagon, which are hormones
      that have an important role in regulating fuel use in the body.
    

Intervention name(s): 3 day fast; 3 day CHO-free diet
Intervention type(s): Other; Other
Intervention description(s): Subjects will fast for 72 hours; Subjects will receive a carbohydrate-free diet for 72 hours
Other intervention name(s): 3-Day Fast; Carbohydrate-free diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Diabetes
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza
      vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
    


Intervention name(s): GSK Biologicals' quadrivalent influenza vaccine; GSK Biologicals' trivalent influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Single intramuscular dose on Day 0.; Single intramuscular dose on Day 0.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Primary study; immunogenicity; safety
The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery
Condition: Pregnancy; Cesarean Section
Study type: Interventional

Summary: 
      The purpose of the study is to determine if listening to your choice of music with a portable
      mp3 player before and after a cesarean section for delivery of a baby will decrease the
      patient's anxiety level.
    

Detailed description: 
      Music has been suggested and evaluated as a therapeutic intervention to reduce preoperative
      anxiety for surgical patients. Music intervention in the immediate preoperative period may be
      effective in lowering anxiety levels during Cesarean delivery. If this investigation shows
      that music intervention before and after Cesarean delivery reduces anxiety levels, this
      intervention can be integrated into future operative care for women having scheduled or
      emergency Cesarean deliveries. Music therapy could be expanded to included patients
      undergoing other surgical procedures under regional anesthesia. The effect of reducing
      anxiety levels could aid in lactation initiation and improve infant bonding in new mothers,
      but it could also shorten postoperative recovery time for all surgical patients.
    

Intervention name(s): Music group; Non music group
Intervention type(s): Other; Other
Intervention description(s): The patients randomized to the music group of the study will listen to music 30 minutes in the holding room prior to their c/s. They will then listen to music after their c/s for 30 minutes. They will complete the STAI before and after their c/s.; Patients randomized to the non music group will complete the STAI before and after their c/s, but not listen to music.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Pregnancy; Cesarean Section
Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part I
Condition: Depression, Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      This pilot study is a precursor to a subsequent clinical trial that will test the impact of a
      set of automated motivational messages on patient engagement with a digital mental health
      intervention. The pilot study aims to systematically employ patient feedback to develop the
      automated motivational messages that will be used in the subsequent clinical trial.
    

Detailed description: 
      This is an in situ user-centered design pilot study to generate feedback on the automated
      motivational messaging the investigators are developing. Participants will download a digital
      mental health intervention (IntelliCare) to use for three weeks. During this three-week
      period, participants will receive automated motivational messages on a randomized schedule.
      That is, each day they will be randomized to either receive an automated motivational message
      (60% likelihood) or not receive an automated motivational message (40% likelihood). On days
      when a participant receives a message, the participant will be prompted to complete a brief
      survey on their reaction to the message received. At the end of three weeks, participants
      will be asked to complete a qualitative interview to provide further feedback on messages
      under development.

      The primary outcome in this study is participant ratings from the brief surveys provided
      after automated motivational message delivery. We will also, however, look at participant
      feedback on messages under development in the qualitative interview as well as whether
      receiving a message makes users more likely to engage with the DMHI (IntelliCare) during the
      three hours following message delivery.
    

Intervention name(s): IntelliCare with automated motivational messaging
Intervention type(s): Behavioral
Intervention description(s): Digital mental health intervention with automated motivational messaging
Intervention model: Single Group Assignment
Intervention model description: Single group, micro-randomized pilot trial design
Masking: None (Open Label)
Primary purpose: Other
Keywords: mHealth; Engagement; Depression; Anxiety
Individual Differences in Diabetes Risk: Role of Sleep Disturbances
Condition: Sleep; Diabetes
MeSH terms: Dyssomnias; Parasomnias; Diabetes Mellitus
Study type: Interventional

Summary: 
      The hypothesis for this study is that some individuals may be at much higher risk to develop
      type 2 diabetes and that the individual diabetes risk will be predicted by the individual
      level of slow wave sleep activity (SWA).
    


Intervention name(s): normal sleep times; bedtime restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8.5 h bedtimes; 4.5 h restricted bedtimes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sleep; Diabetes Risk
Secondhand Smoking in Asthmatic Children
Condition: Asthma in Children; Wheezing
MeSH terms: Asthma; Respiratory Sounds
Study type: Observational

Summary: 
      This study will investigate the interaction between GSTP1 / TNFa polymorphisms and passive
      smoking in children with asthma/wheezing. Contemporary second hand-smoke exposure will be
      confirmed by laboratory testing.
    


Intervention name(s): Lung function; White blood cell DNA extraction; Urinary testing
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Spirometry test; GSTP1 and TNFa polymorphisms with PCR; Urinary nicotine and cotinine detection
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects attending the Pediatric Outpatient Clinic
      
Biospecimen description: 
      Whole blood
    
Keywords: Asthma; Wheezing; GSTP1; TNFa; Secondhand smoking; Passive smoking; Intrauterine smoking
Validation of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population
Condition: Cerebral Palsy; Drooling
MeSH terms: Sialorrhea; Cerebral Palsy
Study type: Observational

Summary: 
      The aim of this study is to present the French translation of the Drooling Impact Scale
      (DIS-F) and to explore its validity, reliability and responsiveness to change in a group of
      children with Cerebral Palsy (CP)
    

Detailed description: 
      Drooling in children with CP is likely underestimated and under treated. It is an
      over-handicap for these children, because it causes many complications and may lead to a
      decline in self-esteem and to social isolation, altering the quality of life for patients and
      families. The therapeutic arsenal for the management of drooling includes rehabilitation
      techniques, oral drug treatments, local treatments or surgical treatments whose effectiveness
      is variable. In order to evaluate the efficacy of these therapies, standardized and valid
      assessment tools must be used. The Drooling Impact Scale (DIS) developed by Dr. Sue Reid's
      team in Melbourne in 2008, shows good validity and sensitivity to change, especially after
      botulinum toxin injection. It is commonly used in English-speaking studies, but no validation
      in French is available yet.

      The aim of this study is to present the French translation of the Drooling Impact Scale
      (DIS-F) and to explore its validity, reliability and responsiveness to change in a group of
      children with CP.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fifty-five children were included, 33 in the stable group and 22 in the intervention group.
Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain
Condition: Pulpitis - Irreversible
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg
      diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic
      irreversible pulpitis.
    

Detailed description: 
      Patients with moderate-to-severe preoperative pain are selected. Patients receive either a
      single-dose of 50 mg diclofenac potassium (group A) or a placebo tablet as a control (group
      B). All patients receive the assigned premedication one hour before single-visit root canal
      treatment. Postoperative endodontic pain is measured at the following time points: 6 ,
      12,24,48 h after treatment. The incidence of analgesic intake is also recorded.
    

Intervention name(s): Diclofenac Potassium 50mg Tab.; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.; A placebo will be taken one hour before initiation of endodontic treatment.
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomly divided into 2 groups:
Experimental group:
50 mg Diclofenac Potassium to be administered one hour before treatment.
Control group:
Placebo to be administered one hour before treatment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pulpitis, irreversible Pulpitis,; Diclofenac Potassium; Premedication, Preoperative Analgesic; Postoperative pain
A Two-year Study of Telbivudine in HBeAg Negative Hepatitis
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an
      individualized telbivudine treatment roadmap strategy designed to achieve optimal viral
      suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes
      adding ADV treatment at different time points according to individual patient response. China
      CHB Guidelines (China Medical Association 2010) make impress on and confirm LDT ROADMAP
      strategy particularly, which may be a large potential to expand the naïve patients. We are
      lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total CHB patients. In
      GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA <7log showed a good 2 year
      efficacy, but we still look forward to more efficient treatment and lower resistance rate.
      This study complies with the principle of individualized therapy recommended and ethical
      principles. It is expected that this study design with individualized treatment approach may
      improve efficacy and lower the resistance rates. In addition, it will provide important
      information on how to bring greater benefits to patients with CHB.
    

Detailed description: 
      This study is an open-label, multicenter, PCR response adaptive clinical study design, with
      intensification of treatment (addition of adefovir to telbivudine treatment) depending on HBV
      DNA level at week 24. All patients commence with Telbivudine 600mg daily. At week 24 they
      will be divided into 2 Groups according to virological response. Patients with PCR detectable
      HBV DNA will add on ADV(Group I). Patients with PCR undetectable HBV DNA(Group II)will
      continue telbivudine monotherapy. ADV will not be added on unless viral breakthrough occurs.
    

Intervention name(s): Telbivudine, Adefovir dipivoxil
Intervention type(s): Drug
Intervention description(s): All patients will take Telbivudine 600 mg PO daily from baseline. Some patients will take Adefovir dipivoxil 10 mg PO daily if they meet the criteria of adding Adefovir dipivoxil.
Other intervention name(s): Sebivo, LDT
Intervention MeSH terms: Adefovir; Adefovir dipivoxil; Telbivudine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HBV DNA; LdT; ADV; HBeAg negative hepatitis; CHB
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the potential impact of elagolix on disordered pituitary and ovarian
      hormones in women with polycystic ovary syndrome (PCOS).
    

Detailed description: 
      This is a phase 2, multicenter, double-blind (sponsor-unblinded), randomized,
      placebo-controlled study to assess the safety and efficacy of elagolix in women with PCOS.
      PCOS is one of the most common hormonal disorders in women of reproductive age, yet few
      treatment options are available. This study will help determine if elagolix can impact
      disordered hormonal dynamics in women with PCOS and at what dosage.
    

Intervention name(s): Elagolix; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule administered orally; Capsule administered orally
Other intervention name(s): Orilissa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Hormone; Elagolix
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
Condition: Postherpetic Neuralgia; Pain
MeSH terms: Neuralgia; Neuralgia, Postherpetic; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of
      V116517 versus placebo.
    


Intervention name(s): V116517 50-mg tablets; V116517 30-mg tablets; Pregabalin capsules; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Taken orally twice daily; Taken orally twice daily; 1-2 capsules taken orally twice daily; Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Neuralgia, Postherpetic
Probiotic Sport Study
Condition: Oxidative Stress; Inflammation; Endotoxemia
MeSH terms: Endotoxemia; Inflammation
Study type: Interventional

Summary: 
      We investigate the impact of a probiotic-based dietary supplement on oxidative stress and
      endotoxemia before and after strenuous exercise.

      Hypotheses (H1):

        -  Supplementation has an influence on oxidative stress parameters before and post exercise

        -  Supplementation has an influence on parameters of endotoxemia and inflammation before
           and post exercise

        -  Strenuous exercise has an influence on parameters of oxidative stress, inflammation and
           endotoxemia
    


Intervention name(s): probiotic-based dietary supplement; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day; 24 trained men receive a placebo for 16 weeks with same dosage compared to active group
Other intervention name(s): active group; passive group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oxidative stress; inflammation; endotoxemia; strenuous exercise
Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery
Condition: Intensive Care Unit; Cardiac Surgery
MeSH terms: Cough
Study type: Observational

Summary: 
      Weaning from mechanical ventilation represents 50% of the time spent under mechanical
      ventilation (1). The risk factors identified in the failure to wean from mechanical
      ventilation are:

        -  left heart dysfunction with LVEF < 30%.

        -  an ineffective cough

        -  presence of resuscitation neuromyopathy

        -  mechanical ventilation time >7 days

        -  presence of a delirium

        -  age >65 years old

        -  abundant bronchial secretion

        -  presence of underlying lung pathology An ineffective cough is found in 40% of patients
           requiring reintubation. However, cough assessment is most often approximate, based on a
           subjective assessment of cough strength by asking the patient to cough spontaneously on
           his or her tube).

      The objective evaluation of cough is based on the measurement of the peak expiratory flow
      rate at cough, commonly referred to as peak expiratory flow rate at cough (PEFD), the patient
      is asked to take a deep breath and then cough as hard as possible.

      Subjective cough assessment does not predict the occurrence of ventilatory withdrawal
      failure. Conversely, all studies that objectively assessed the strength of cough before
      extubation by measuring the PEFD found a significant association with the outcome of
      extubation: a low PEFD increases the risk of extubation failure by a factor of 5 to 9.

      The investigators hypothesize that the increase in parietal abdominal muscle contraction
      obtained by using a non-invasive ultrasound method indicates an effective cough. Conversely,
      an ineffective cough can be detected by this simple ultrasound criterion, which can be
      performed at the patient's bedside and extrapolated to all intensive care units equipped with
      an ultrasound scanner. This evaluation will be carried out before extubation: during the
      spontaneous ventilation test on a tube in a half-seated position (>45°) and within 24 hours
      after extubation.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient admitted to intensive care, intubated after cardiac surgery by sternotomy.
      
Keywords: cough evaluation; intensive care unit; utrasound evaluation
Safety, Pharmacokinetic and -Dynamic Study of PR-15, an Inhibitor of Platelet Adhesion
Condition: Thrombosis; Acute Coronary Syndrome; Myocardial Infarction; Stroke
MeSH terms: Myocardial Infarction; Thrombosis; Acute Coronary Syndrome; Infarction; Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time,
      evaluation of antibody titer and safety laboratory tests

      Secondary objectives:

      To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending
      single intravenous doses of PR-15 in healthy volunteers
    

Detailed description: 
      Primary objective:

      To evaluate safety and tolerability by using adverse events (AEs), vital signs including
      blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), bleeding
      time, evaluation of antibody titer and safety laboratory tests (biochemistry, hematology,
      coagulation, urinalysis)

      Secondary objectives:

      To evaluate the pharmacokinetics and pharmacodynamics (collagen-induced platelet
      aggregation)of six ascending single intravenous doses of PR-15 in healthy, male volunteers
    

Intervention name(s): revacept (PR-15)
Intervention type(s): Drug
Intervention description(s): single intravenous administration of revacept (PR-15), an inhibitor of platelet adhesion, in various strengths (10, 20, 40, 80, 160 mg) in healthy male volunteers.
Other intervention name(s): GPVI-Fc dimer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: platelet adhesion and aggregation; acute coronary syndrome; myocardial infarction; stroke; inhibition of platelet adhesion to plaques; collagen-induced platelet aggregation
Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      This study of adalimumab (Humira) will be conducted to clarify the following with regard to
      the treatment of ankylosing spondylitis with this drug:

        -  Unknown adverse drug reactions (especially important adverse drug reactions)

        -  Incidence and conditions of occurrence of adverse reactions in the clinical setting

        -  Factors that may affect the safety and effectiveness of Humira
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who receive Humira for the treatment of ankylosing spondylitis
      
Keywords: Ankylosing Spondylitis