bioihbjkbjnl/mcl2 huggingface dataset:
The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare insulin lispro low mixture [LM] and insulin glargine both in
      combination with the patient's oral diabetes medicines, for their ability to control blood
      sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with
      regard to the length of time that the overall blood sugar can be controlled.

      This study will also determine whether the safety of insulin lispro LM and any side effects
      that might be associated with it are different from those observed with insulin glargine,
      both in combination with the patient's oral diabetes medications.

      The addendum study (Intensification Addendum) will compare how different insulin treatments
      work to control blood sugar in patients whose diabetes could not be controlled by either
      insulin lispro LM or insulin glargine.
    


Intervention name(s): Insulin glargine; Lispro Low Mix; Lispro Mid Mix; Lispro
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous injection daily; Subcutaneous injection twice daily.; Lispro Mid Mix subcutaneous injection 3 times daily.; Lispro subcutaneous injection 3 times daily.
Other intervention name(s): Lantus; Humalog Mix 75/25; Humalog Mix 50/50; Humalog
Intervention MeSH terms: Insulin Glargine; Insulin Lispro; Insulin, Isophane; Biphasic Insulins; Isophane insulin, insulin lispro drug combination 50:50
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; type 2
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, open-label, multi-centre, Phase II study in patients with newly
      diagnosed glioblastoma.

      62 patients with newly diagnosed glioblastoma are enrolled in the study in a 1:2 allocation
      (standard of care (SOC): ALECSAT as an adjunct therapy to SOC).

      Patients recruited into this study will receive either:

        -  ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma
           (first line therapy: Stupp regimen, followed by second line therapy at the
           Investigator's discretion) or

        -  Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp
           regimen, followed by second line therapy at the Investigator's discretion).
    


Intervention name(s): ALECSAT; Radiotherapy; Temozolomide
Intervention type(s): Biological; Radiation; Drug
Intervention description(s): 3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months; Radiotherapy 5 days/week for 6 weeks; Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks
Intervention MeSH terms: Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma, GBM, immunotherapy, autologous lymphoid effector cells specific against tumour cells, ALECSAT, Stupp regimen, TMZ, radiotherapy
Effectiveness of Online Therapy to Prevent Burnout
Condition: Burnout; Risk Reduction; Cognitive Change
MeSH terms: Burnout, Psychological
Study type: Interventional

Summary: 
      This study aims to address the reliability and validity of the Empowerment for Participation
      (EFP) batch of assessments to measure Burnout risk in relation to the efficacy of online
      interventions to provide proactive rehabilitation using Cognitive Behavioral Therapy (CBT)
      and floating to achieve improved mental health and wellbeing.
    

Detailed description: 
      An Empirical design using raw EFP psychometric data to measure the effectiveness of online
      therapy to reduce the risk for Burnout between a control group and an online therapy group.
      The aim is to test whether or not there is a statistically significant difference in the
      effectiveness on online therapy to reduce the Risk for Burnout compared to that of a Control
      Group. Fifty participants were randomly selected. The rehabilitation and control Group
      consisted of twenty-five normally distributed employees (N25) each. The rehabilitation group
      received therapy, and the control had not yet received any form of therapy. SPSS was used to
      analyze the data collected, a Repeated Measure ANOVA, an ANCOVA, a Discriminant analysis, and
      a Construct Validity analysis were used to test for Reliability and Validity.

      The group was randomly selected from a list of employees within the My-E-Health ecosystem.
      The group (N50) normally distributed group met all assumptions and consisted of a Control
      Group (N25) and a Therapy Group (N25). The post assessment value was used as the dependent
      variable.

      The Burnout measure (30 questions) is obtained from the Empowerment for Participation (EFP)
      batch of assessments (110 questions). All assessments and CBT were done digitally online and
      floating was done at a designated location. The full EFP assessment is integrated into a
      digital ecosystem designed for this purpose and therapy. The online digital system is an
      integrity-based platform offering both the employee and caregiver a secure and encrypted
      ecosystem or secure data tunnel or channel between the therapists and patients.
    

Intervention name(s): EFP Psychometric assessment to determine level of afflication
Intervention type(s): Diagnostic Test
Intervention description(s): Patients were asked to complete a psychometric assessment in relation to their psychological wellbeing. Results were presented to the patient and validdated by the patient.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: An empirical and parallel design using raw EFP psychometric data to measure the effectiveness of online therapy to reduce the risk for Burnout between a control group and an online therapy group.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Mental Health; Cognitive Behavioral Therapy; Interactive Online Therapy; TeleHealth
Laser Therapy on Orthodontic Tooth Movement
Condition: Laser Therapy; Orthodontic Tooth Movement; Bone Remodeling
Study type: Interventional

Summary: 
      The aims of this study will be to evaluate if a Lower Level Laser Therapy (LLLT): (1)
      enhances the levels of important pro-inflammatory chemokines involved in the bone remodeling
      process; (2) increases the rate of orthodontic tooth movement (OTM) on human subjects.
    


Intervention name(s): Low-level Laser Therapy; Orthodontic force
Intervention type(s): Device; Procedure
Intervention description(s): Low-level laser therapy is applied on premolars that will be extracted for treatment plan reasons; Mechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low-Level Light Therapy; Tooth Movement; Bone Remodeling
Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of
      certain fats in their blood. The blood vessels and heart of most of these individuals do not
      work normally and people with T2DM also have an impaired ability to perform exercise. The
      purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily
      decrease the level of fat in the bloodstream of people with T2DM and observe the
      physiological changes to blood vessel function and exercise capacity and insulin sensitivity.
      This will help the investigators to understand ways of improving blood vessel function and
      the ability to exercise effectively in people who are overweight or have T2DM.
    


Intervention name(s): Acipimox; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.; Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
Other intervention name(s): Olbetam
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; exercise; cardiovascular; heart; insulin sensitivity
Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This single and repeat increasing dose study will collect information on safety, tolerability
      and drug levels in the body of the CCI15106 inhalation powder. The study will also look at
      the level of CCI15106 that will be released into the air and may be found in the blood of the
      people standing around the person inhaling it (bystanders). This is a two-part study in which
      Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part
      2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and
      approximately 22 subjects with COPD will be randomized in this study for dosing. The total
      study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C
      Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.
    


Intervention name(s): CCI15106; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.; One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study, subjects will be randomized to receive either study drug or placebo in a parallel manner.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bystander; inhalation powder; monodose device; COPD; pharmacokinetics; safety; Healthy; CCI15106; tolerability
Safety and Tolerability of Lu AG06474 in Healthy Young Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and
      what the body does to Lu AG06474 after swallowing single doses of the drug.
    

Detailed description: 
      Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
    

Intervention name(s): Lu AG06474; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): solution, orally (Parts A and B); solution, orally (Part A only)
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Identify Clinical Conditions That Increase Circulating DNA Levels
Condition: Pregnancy; Pulmonary Embolism; Myocardial Infarction; Autoimmune Disease
MeSH terms: Pulmonary Embolism; Myocardial Infarction; Embolism; Autoimmune Diseases; Infarction
Study type: Observational

Summary: 
      The investigators are developing a test that is expected to measure the amount of radiation a
      patient has been exposed to after a nuclear bomb. The investigator will do this by measuring
      the DNA in the patients blood from cells killed by the radiation.

      Many diseases and medical conditions can put DNA in the blood. The investigator needs to know
      how much DNA in order to better interpret our radiation detection test. Therefore, the
      investigator is collecting blood from several patients with different diseases or medical
      conditions and also healthy volunteers to measure their DNA content.

      Patients that will be included in this study are pregnant women, patients who have suffered a
      pulmonary embolism within the past 48 hours, patients who have suffered from myocardial
      infarction in the past 48 hours, patients with autoimmune diseases and health patients.
    

Detailed description: 
      The investigator will collect 8 mL (one and one half teaspoons) of blood one time only. The
      investigator may also collect the patient's past medical history, test results and disease
      treatment.
    

Intervention name(s): One time blood draw to look at patient's DNA
Intervention type(s): Other
Intervention description(s): One time blood draw to look at patient's DNA
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Seeking healthy volunteers, pregnant women, patients who recently suffered a heart attach
        or pulmonary embolism, and patiebts with autoimmune disease. Patients who are health
        individuals will also be asked to participate.
      
Biospecimen description: 
      4-5 ml of blood will be processed and the plasma will be divided into 150 μl aliquots
    
Keywords: Pregnancy; pulmonary embolism; myocardial infarction; autoimmune disease; healthy controls
Acitretin and Etanercept in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether acitretin plus etanercept is more effective than etanercept alone in
      clearing psoriasis plaques in adults.
    

Detailed description: 
      This study will include patients with moderate to severe psoriasis who have been taking
      etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They
      will be given acitretin 25 mg/day. The combined treatment will occur over 6 months. Subjects'
      progress will be assessed monthly, based on the improvement of their PASI and PGA scores.
    

Intervention name(s): acitretin
Intervention type(s): Drug
Intervention description(s): Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.
Other intervention name(s): Soriatane
Intervention MeSH terms: Acitretin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psoriasis; etanercept; acitretin
Implementation of Internet-based Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It
      is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Results
      from a pilot study shows that outpatients of Children and Youth Psychiatry can improve their
      sleep and depressive symptoms by receiving internet-based cognitive behavioral therapy for
      insomnia (iCBT). This study is designed to evaluate implementation of the treatment in
      routine care.The study will evaluate aspects of the implementation process such as
      organizational attitudes towards iCBT before implementation, level of knowledge about the
      condition and intervention among health-care providers before and after the implementation,
      and clinical outcomes in routine care.
    


Intervention name(s): Internet-based Cognitive Behaviour Therapy (iCBT)
Intervention type(s): Behavioral
Intervention description(s): Guided self-help for 7 weeks. Contact with therapist 2 times per week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Short and Long Term Prognosis of Patients Admitted to the ED With Acute Heart Failure
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Study type: Observational [Patient Registry]

Summary: 
      Heart failure (HF) is the leading cause of hospitalization ,rehospitalization and mortality
      for adults over 65 years of age.

      This study aimed to assess mortality, and hospitalization rates at 30 days and one year after
      dicharge of patients with heart failure (HF) with reduced ejection fraction (HFrEF) compared
      to HF with preserved ejection fraction (HFpEF).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study included all patients ,with either reduced ejection fraction (HFrEF) defined as
        LVEF <45% or preserved ejection fraction (HFpEF) defined as LVEF ≥45% ,admitted to the ED
        of Monastir between 2009-2020 with a principal discharge diagnosis code for HF. The
        diagnosis of HF categories should rely on the recent transthoracic echocardiographic
        findings and clinical judgement according to the guidelines.Collected data include clinical
        features biological markers (BNP or NTpro BNP) and echocardiography findings. The diagnosis
        of HF categories should rely on the recent transthoracic echocardiographic findings and
        clinical judgement according to the guidelines. A follow-up period of at least 1 year was
        required to notice all cause mortality and preferably HF-specific rehospitalization .
      
Keywords: acute heart failure prognosis
Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine
      (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and
      immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the
      secondary endpoint.
    


Intervention name(s): UB-311; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Intramuscular injection; Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Predicting Favorable Outcomes in Hospitalized Covid-19 Patients
Condition: COVID; Corona Virus Infection; Adverse Event
MeSH terms: Coronavirus Infections
Study type: Observational

Summary: 
      Testing use of predictive analytics to predict which COVID-19+ patients are at low risk for
      an adverse event (ICU transfer, intubation, mortality, hospice discharge, re-presentation to
      the ED, oxygen requirements exceeding nasal cannula at 6L/Min) in the next 96 hours
    

Detailed description: 
      To assess if display of low risk of adverse event in EPIC can safely reduce length of stay
      and plan for discharge.
    

Intervention name(s): EPIC risk score display
Intervention type(s): Other
Intervention description(s): Display of risk score/ colored flag in Epic patient list column
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult hospitalized COVID19+ patients predicted to have no adverse event at 96 events with a
        threshold at 90% PPV, with at least one low risk during their admission who are discharged
        alive and have not been in the ICU
Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens
      with a refractive implant. Two colors of implants are available: white implants, filtering
      out ultraviolet and yellow implants, filtering and more blue light. No clinical data are
      available to assert the superiority of an implant according to its color and the choice is
      made according to the preference of the surgeon and / or "markets".

      It is established in humans that blue light has an important role on the secretion of
      melanopsin, a key mediator of the circadian cycle. This "clock" regulates most neuroendocrine
      functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The question of the
      impact of these neuro endocrine functions of the installation of a blue light filter into the
      eyes of patients operated thus arises.
    


Intervention name(s): white implant; yellow implant
Intervention type(s): Other; Other
Intervention description(s): st intervention (in the month following the inclusion): Randomization of the color of the implant
nd operation (1 to 3 months after the first surgery): Installation of a same color as the first implant operated eye; st intervention (in the month following the inclusion): Randomization of the color of the implant
nd operation (1 to 3 months after the first surgery): Installation of a same color as the first implant operated eye
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cataract
Therapeutic Massage for Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the relative effectiveness of three relaxation
      treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in
      reducing anxiety in persons with Generalized Anxiety Disorder.
    

Detailed description: 
      Anxiety and stress are costly problems that afflict millions of American adults. Together,
      they are among the most common reasons for which adults use complementary and alternative
      medical (CAM) therapies as well as more conventional relaxation therapies. Although massage
      is one of the most popular CAM treatments for anxiety, its effectiveness for this problem has
      never been rigorously evaluated. This study is designed to evaluate the effectiveness of
      massage as a treatment for a diagnosed anxiety disorder. Massage will be compared with two
      other relaxing treatments: thermotherapy and time in a relaxing environment, which reflect
      the types of activities that persons with anxiety might try to relieve their symptoms.
    

Intervention name(s): massage; thermotherapy; relaxing environment
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): therapeutic massage; heat therapy; time in a relaxing environment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: massage therapy; relaxation treatments