bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with
      ibrutinib and obinuzutumab.

      CC-122 has multiple activities, including immune modulation of several immune cell subsets
      and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety
      profile with some preliminary signs of efficacy with early human experience.
    

Detailed description: 
      The primary objectives of this Phase 1/2 Study are to determine the safety of single agent
      CC-122 and the safety, tolerability, and RP2D of CC-122 when administered in combination with
      ibrutinib and in combination with obinutuzumab to subjects with CLL/SLL. The secondary
      objectives are to evaluate the PK profiles of subjects administered CC-122 in combination
      with ibrutinib and in combination with obinutuzumab, to determine ibrutinib concentrations
      when given alone and in combination with CC-122 and to evaluate the preliminary efficacy of
      CC-122 at selected dose levels/regimens.
    

Intervention name(s): CC-122; Ibrutinib; Obinutuzumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CC-122 will be administered daily starting at Cycle 1 Day 1 in 28-day cycles until disease progression, unacceptable toxicity, or discontinuation for any other reason.; Obinutuzumab will be administered as an intravenous (IV) infusion at a dose of 100 mg on Cycle 1 Day 1 and 900 mg on Cycle 1 Day 2 and 1000 mg on Cycle 1 Days 8 and 15. The dose of obinutuzumab on Days 1 and 2 of Cycle 1 may be adjusted per institutional practice as long as the combined dose equals 1000 mg. Obinutuzumab will be administered at a dose of 1000 mg on Day 1 of Cycles 2 through 6.
Intervention MeSH terms: Obinutuzumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CC-122; Pharmacokinetics; Safety; Ibrutinib; Obinutuzumab; GA101; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption
      immediately after a single dose (immediate effect) and 6 hours following the dose (after
      multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).
    


Intervention name(s): LIK066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LIK066 15 mg, 50 mg and 150 mg
Intervention MeSH terms: Licogliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Using the PHQ-9 and GAD-7 as Feedback Instruments in Brief Psychotherapy
Condition: Depressive Symptoms; Anxiety States, Neurotic
MeSH terms: Anxiety Disorders; Depression
Study type: Interventional

Summary: 
      This study will assess the effects of client feedback, using the Patient Health Questionnaire
      - 9 and Generalized Anxiety Disorder 7-Item Scale, on depression and anxiety in individuals
      undergoing brief psychotherapy. Client feedback allows therapists to monitor treatment
      progress in real time. Identifying an easily accessible treatment intervention, which
      utilizes commonly used scales, that potentially enhances the effect of brief psychotherapy
      and improves treatment outcomes is a valuable endeavor with clear implications for therapy
      practices. It is hypothesized that clients who complete these scales each session will show
      greater symptom improvement than clients who do not complete the scales.
    


Intervention name(s): Continuous Client Feedback; Continuous Self Feedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Clients complete rating scales before each therapy session. The therapist then views these results and discusses treatment progress with the client during the session.; Clients complete rating scales before each therapy session. Progress is not reviewed with the therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study for Mejoral 500 Product
Condition: Pain
Study type: Interventional

Summary: 
      This will be a monocentric, single blinded, randomized, single-dose, two-periods,
      two-sequence, crossover bioequivalence study of two oral formulations in healthy participants
      under fasting conditions.
    


Intervention name(s): Mejoral® 500 Tablets; Tylenol® Caplets
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg tablet of paracetamol; 500 mg tablet of paracetamol
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Immunogenicity and Safety Study of Allantoic Split Inactivated Seasonal Influenza Vaccine (VSI)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a single centre, phase II, double-blind, randomized, comparative trial that
      explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal
      influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18
      to 60 years of age and older than 60 years).
    


Intervention name(s): Allantoic Split Inactivated Seasonal flu Vaccine; VAXIGRIP
Intervention type(s): Biological; Biological
Intervention description(s): Allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/ Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).; Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine. Sanofi Pasteur Serial Number N3E681V
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: phase II; split; vaccine
A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Combination Dry Powder of Fluticasone Propionate and Salmeterol (FSC) 250/50 Microgram (mcg) Twice Daily (BID) in Adults and Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 week
      non inferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg
      capsule-based inhaler and FSC 250/50 mcg multi-dose inhaler each administered BID in adults
      and adolescents with asthma. The primary objective of this study is to demonstrate that FSC
      250/50 mcg administered BID by capsule-based inhaler is non-inferior compared to FSC 250/50
      mcg administered BID by multi-dose inhaler . The study consists of six phases: Pre-screening,
      Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 3 weeks),
      Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the study for
      each subject will be at least 31 weeks.
    


Intervention name(s): FSC; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period; Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multi-Dose Inhaler; safety; Asthma; efficacy; pharmacodynamics; fluticasone propionate/salmeterol (FSC) 250/50 mcg; tolerability; Capsule-Based Inhaler
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      In this first-in-humans dose escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated
      for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs).
      The study is intended to enable future studies of AZD7442's efficacy in preventing and
      treating COVID-19.
    

Detailed description: 
      This is a Phase I, first time in human, randomised, double-blind, placebo-controlled, and
      dose escalation study.

      The study will comprise of:

        1. A Screening Period of up to 27 days (Day -28 through Day -2);

        2. A Treatment Period during which participants will be resident at the Clinical Unit from
           Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1)
           until at least 24 hours after IMP administration, will be discharged on Day 2 after all
           safety evaluations have been completed, and

        3. A Follow up Period lasting 360 days (through to Day 361) after the IMP dose.

      The study will be conducted at a single study centre in United Kingdom.
    

Intervention name(s): AZD7442; Placebo
Intervention type(s): Combination Product; Other
Intervention description(s): Participants randomized to AZD7442 will be administered dose 1, each in Cohort 1a (IM) and Cohort 1b (IV). Participants in Cohort 2 and 3 will receive AZD7442 (IV) doses 2 and 3, respectively. Participants in Cohort 4 will receive AZD7442 (IV) dose 4.; Participants randomised to placebo will receive the same volume of solution as participants on active treatment.
Intervention MeSH terms: Cilgavimab and tixagevimab drug combination
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Coronavirus; Severe acute respiratory syndrome coronavirus 2; Pharmacokinetics; Safety and tolerability
Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective is to compare a fibrinolytic strategy with an interventional strategy
      initiated as early as possible, preferably in the pre-hospital phase, with respect to
      resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In
      Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7
      days after inclusion.
    

Detailed description: 
      Patients in the fibrinolytic group received an intravenous injection of 30 mg enoxaparin
      followed by subcutaneous injections of 1 mg/kg body weight every 12 hours during hospital
      stay.

      Patients in the invasive group were given an intravenous injection of enoxaparin of (0.75
      mg/kg body weight) and abciximab as a intravenous bolus (0.25 mg/kg body weight) followed by
      a 12 hour infusion (10 microg/minute).

      Secondary outcome measures were death, myocardial infarction and stroke alone or as a
      composite at 30 days.

      Data on use of health care resources, loss of production and health-related quality of life
      were collected during one year. Cost-effectiveness was determined by comparing costs and
      quality-adjusted survival.
    

Intervention name(s): reteplase 10+10 U; primary PCI
Intervention type(s): Drug; Procedure
Intervention description(s): comparison to primary PCI; comparison to thrombolysis
Other intervention name(s): Rapilysin; primary percutaneous coronary intervention
Intervention MeSH terms: Reteplase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thrombolysis; primary PCI; abciximab; ST-segment resolution; TIMI flow
Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual
      white light on the colon, will improve the detection of a type of polyp called serrated. The
      polyps are called serrated because of their appearance under the microscope after they have
      been removed. They tend to be located up high in the colon, far away from the rectum. They
      have been definitely shown to be a type of precancerous polyp and it is possible that using
      Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see
      with standard white light.
    

Detailed description: 
      This is a randomized controlled trial comparing the use of Narrow-Band Imaging (illumination
      of the colon in blue light)versus standard white light for the detection of serrated lesions
      in the proximal colon (the colon proximal to the splenic flexure). Recent studies have
      indicated that colonoscopy is more effective in preventing cancer in the left side of the
      colon than the right side of the colon. The reasons for this difference may be partly
      biologic, in that a special group of polyps known as serrated polyps, particularly sessile
      serrated adenomas, are located primarily proximal to the splenic flexure. These lesions share
      molecular features with a group of cancers that occur primarily in the proximal colon. These
      molecular features include CpG island methylator phenotype (CIMP) and microsatellite
      instability. These lesions are endoscopically subtle in that they are often flat, have the
      same color as the surrounding mucosa, and are hard to differentiate from normal mucosa.
      Narrow-Band Imaging has anecdotally been used to highlight the appearance of these lesions.
      This study will test whether Narrow-Band Imaging increases the detection of serrated lesions
      in a randomized controlled trial.
    

Intervention name(s): Inspection with Narrow-Band Imaging(NBI); Standard White Light
Intervention type(s): Procedure; Procedure
Intervention description(s): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.; Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
Other intervention name(s): Colonoscopy; Colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Proximal Colon Cancer; Serrated Colon Lesions; Narrow Band Imaging
Immediate Effects of Eurythmy Therapy on Psychophysiological Parameters
Condition: Eurythmy Therapy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate different effects of Eurythmy Therapy on
      psychological and physiological parameters of circulation and thermoregulation
    


Intervention name(s): Eurythmy Therapy Movement "R"; Eurythmy Therapy Movement "L"; Eurythmy Therapy Movement "B"; Normal movements during walking or standing
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ultrasound Versus Palpation for Epidural Catheterization
Condition: Epidural Anesthesia; Spinal Ultrasound
Study type: Interventional

Summary: 
      The study will assess the benefit of using spinal ultrasound before epidural catheter
      insertion compared to the conventional palpation technique in women undergoing cesarean
      section.
    

Detailed description: 
      The study will compare the ultrasound-assisted and the conventional palpation techniques for
      epidural catheterization as a component of combined spinal-epidural anesthesia for cesarean
      section.

      Participants will be randomly assigned into 2 equal groups. In the ultrasound group:
      Preprocedure lumbar spinal ultrasound will be performed before epidural catheterization. In
      the palpation group: Conventional technique of landmark palpation will be used.
    

Intervention name(s): Double-space combined spinal-epidural anesthesia; Preprocedure spinal ultrasound; Sham ultrasound procedure
Intervention type(s): Procedure; Radiation; Radiation
Intervention description(s): Epidural space identification in Lumbar 2-3 or 3-4 space using loss of resistance to air technique with 18-gauge Tuohy needle, then threading a 20-gauge multi-orifice epidural catheter 4-5 cm into the epidural space. Spinal anesthesia administration in an appropriate lower intervertebral space with intrathecal bupivacaine 12.5 mg and fentanyl 10 mcg through a 27-gauge spinal needle.; Lumbar spinal ultrasound using the 2-5 MHz curved probe, performed in both the longitudinal and transverse planes for identification of the appropriate intervertebral spce, estimation of the depth to the epidural space, and noting the proper angle for subsequent needle insertion. Then skin markings relying on the ultrasound procedure are made identifying 2 intervertebral spaces.; Applying the ultrasound probe on the patient's back while the ultrasound machine is on the freeze position.Then skin markings relying on landmark palpation are made identifying 2 intervertebral spaces.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Understanding Immunity Persistence After Adolescent MenC Vaccination
Condition: Antibody Persistance After Booster Dose of Men C Vaccine
Study type: Observational

Summary: 
      The main purpose of this study is to evaluate the duration of immunity after a booster dose
      of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does
      seroprotection persist beyond teenage years and into the early twenties? This is the age
      group which is most likely to carry the organism and to transmit it to other members of the
      population. If a booster dose of MenC vaccine given to adolescents does produce protective
      levels of antibody which persist into early adulthood, this would strengthen the case for
      such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a
      resurgence of the disease in the future.
    


Intervention name(s): Venepuncture and blood sample collection.
Intervention type(s): Other
Intervention description(s): Venepuncture and blood sample collection.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young adults, approximately 20 - 23 years old.
A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The reason for this study is to see if the study drug LY3209590 is safe and effective in
      participants with type 2 diabetes.
    


Intervention name(s): LY3209590; Insulin Degludec
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity
Condition: Overweight and Obesity
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional

Summary: 
      This human intervention study will test if 12 weeks of supervised HIIT-based intervention
      improves skeletal muscle NOGD capacity in obese subjects.
    

Detailed description: 
      19 overweight-obese (BMI => 27kg/m2), sedentary females and males aged 45-75yr will be
      enrolled in this study.

      Participants will train 3 times/week under supervision during 12 weeks. Before, after and
      during this 12-week training period, there will be multiple metabolic measurements.
    

Intervention name(s): High-intenstiy interval training
Intervention type(s): Behavioral
Intervention description(s): High-intensity interval training is a training of 30 minutes involving 10 bouts of 1 minute high intensity cycling (80-90% of maximum heart rate) interspersed by 2 minutes rest.
Intervention model: Single Group Assignment
Intervention model description: 1 group of participants that performs 12 weeks of HIIT with metabolic measurements before and after this training period
Masking: None (Open Label)
Primary purpose: Prevention
Behavioral Interventions to Target Self-Control
Condition: Tobacco Smoking
Study type: Interventional

Summary: 
      Low self-control has been associated with a number of unhealthy behaviors with low treatment
      success. Alternative non-pharmacological approaches have the potential for enhancing
      self-control. This pilot study will investigate if the practice of yoga and/or health and
      wellness education improve self-control in the context of nicotine addiction, and will set
      the stage for larger clinical trials using behavioral interventions to supplement or replace
      existing treatments and increase the rates of recovery from disorders in which low
      self-control is a susceptibility factor.
    


Intervention name(s): Yoga; Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment