bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after
      single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and
      Formoterol pMDIs, in asthmatic children (5 to 11 years old).
    


Intervention name(s): CHF1535 pMDI + AC Plus; BDP + AC Plus; Formoterol + AC Plus
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Four inhalations for a total dose of BDP/FF 200/24 mcg; Four inhalations for a total dose of BDP 200 mcg; Four inhalations for a total dose of Formoterol 24 mcg
Other intervention name(s): Fixed combination of BDP and FF 50/6 mcg; Beclomethasone Dipropionate 50 mcg with Aerochamber Plus; Formoterol 6 mcg with Aerochamebr Plus
Intervention MeSH terms: Beclomethasone; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; ICS+LABA; Children; Inhalation; pMDI
The Effects of An Addition of Water Enema to PEG for Colon Preparation
Condition: Adenoma, Bile Duct
MeSH terms: Adenoma; Adenoma, Bile Duct
Study type: Interventional

Summary: 
      The purpose of this study is to compare the preparation quality by using Ottawa Bowel
      Preparation Scale between the standard PEG preparation and the addition of water enema in
      participants scheduled for CRC screening
    

Detailed description: 
      Background : Good bowel preparation improves the rate of polyp detection and the time of
      caecal intubation during colorectal cancer (CRC) screening.

      Suboptimal bowel preparation can results in adenoma miss rate up to 42% (95% CI, 35-49) and
      advanced adenoma miss rate up to 27% (95% CI, 17-41) The European Society of Gastrointestinal
      Endoscopy (ESGE) Guideline recommends a split regimen of 4L of polyethylene glycol (PEG)
      solution (or a same-day regimen in the case of afternoon colonoscopy) for a routine bowel
      preparation and the delay between the last dose of bowel preparation and colonoscopy should
      be minimized and no longer than 4 hours.

      The investigators hypothesize that the addition of water enema to the standard PEG bowel
      preparation could provide the better quality of bowel preparation and then result in
      improvement in the rate of adenoma detection among participants scheduled for CRC screening
      with preparation to procedure interval > 8 hr.

      The purpose of this study is to compare the preparation quality using Ottawa Bowel
      Preparation Scale between the standard PEG preparation and the addition of water enema in
      participants scheduled for CRC screening. The secondary aim is to compare the effect of the
      standard PEG bowel preparation and the addition of water enema in terms of adenoma detection
      rate, the completeness of the examination, total and withdrawal time, safety and adverse
      events among those scheduled for CRC screening.
    

Intervention name(s): Water enema
Intervention type(s): Procedure
Intervention description(s): Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study, participants will be randomised 1:1 to water enema group or no water enema group using blocked randomization with random block sizes.
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Bowel preparation; CRC screening
Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy of treatment with oral trofinetide versus placebo in females with
      Rett syndrome
    


Intervention name(s): Trofinetide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Trofinetide solution administered based on the subject's weight at Baseline, twice daily for 12 weeks; Trofinetide placebo solution administered based on the subject's weight at Baseline, twice daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Prosthetic Knee Performance During Sitting and Standing
Condition: Amputation
Study type: Observational

Summary: 
      The Ossur Prosthetic Power Knee claims to assist in helping people with transfemoral
      amputation to walk up stairs and stand up from sitting. We expect to find that this product
      has the ability to help unload the sound knee during these tasks. We plan to collect force
      and motion data while people stand up from a chair. We will compare the data from people
      using several types of prosthetic knees, including the power knee as well as from people who
      are not amputees to see what the force and motion contributions are from the different knees
      evaluated.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons with Transfemoral Amputation
      
Keywords: amputation, transfemoral, lower extremity, prosthetic knee
Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      Lymphatic transport will be examined using Near InfraRed Indocyanine Green fluorescence
      imaging (NIR-ICG) and magnetic resonance lymphography (MRL) of the upper extremities. The
      purpose of the study is to establish if NIR-ICG is a valid clinical outcome for quantifying
      lymphatic vessel drainage.
    

Detailed description: 
      Lymphedema from various etiologies (i.e. infection, cancer, surgery, and rheumatoid
      arthritis) remains a major health concern. Efforts to develop effective treatments for this
      condition have been limited by the absence of quantitative outcome measures for lymphatic
      function. Published articles have supported the fact that human lymphatic contractions can be
      readily visualized after intradermal administration of micrograms of Indocyanine Green using
      laser-induced fluorescence. We recently demonstrated the feasibility of NIR imaging to
      quantify lymphatic drainage in the hands, wrists and forearms of healthy volunteers following
      intradermal web space ICG injection into the hand . To establish this emerging technology as
      a valid clinical outcome measure, however, we must address two major questions that confound
      interpretation of the imaging results: 1) are the ICG filled vessels lymphatic vessels and/or
      small veins?; and 2) does NIR-ICG imaging following web space injection fully capture
      lymphatic flow from the metacarpophalangeal (MCP) joints that are most commonly involved in
      RA? To answer these questions, healthy patients will be recruited to have intradermal and
      intra-articular injections of ICG and gadolinium followed by an imaging sessions (NIR or
      magnetic resonance imaging) to measure lymphatic contraction rates and flow.
    

Intervention name(s): Indocyanine Green; MultiSpectral Imaging System
Intervention type(s): Drug; Device
Intervention description(s): A trained physician will inject 0.1 ml of Indocyanine Green into the web spaces of the hands in both upper extremities. Subjects may have up to five study visits to confirm feasibility, safety, and reproducibility.; Once the Indocyanine Green is injected, the contrast is expected to fluoresce underneath the MultiSpectral Imaging System. Multispectral video and still images will be recorded at the study visits.
Other intervention name(s): ICG; IC-Green; 17478-701-02; MSImager
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Lymphatic Transport; Imaging; Indocyanine Green; Gadolinium; ICG; GAD; NIR-ICG; rhuematoid arthritis; NIR
A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effects of treatment with vildagliptin and metformin as initial
      combination in newly diagnosed patients with type 2 diabetes who have very high levels of
      HbA1c and/or fasting plasma glucose.
    


Intervention name(s): vildagliptin + metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Vildagliptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metformin; vildagliptin; initial combination
Effects of Whey Protein Pre-meals on Post-prandial Glucose
Condition: Prediabetic State
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The aim of this project was to determine if an administration of either 10 g of whey protein
      isolate or 10 g of whey protein microgels 30 or 10 min before a standard meal could reduce
      postprandial glucose response in obese subjects.
    

Detailed description: 
      Monocentric, controlled, randomized, open, complete cross-over study design where
      participants will take 2 test products or water (negative control) at 2 different time
      points.

      The targeted population will be 16 completely healthy males and females at risk for
      pre-diabetes.

      Primary objective: To quantify the effects of whey protein pre-meals administrated at 30 or
      10 min before a meal on post-prandial glucose in the interstitial tissue, as compared to
      water as negative control.

      Secondary objective: To compare glucose response of the different pre-meals (water, whey
      protein isolate, whey protein micelles).
    

Intervention name(s): Whey protein isolate; Whey protein microgel; Water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Oral administration; Oral administration; Oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on
      ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of
      ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.
    

Detailed description: 
      The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of
      ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to
      meet enrollment goals of 108 chronic hepatitis B patients.
    

Intervention name(s): ABI-H0731; Placebo for ABI-H0731; Entecavir; Tenofovir Disoproxil Fumarate; Pegasys
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients; Sugar pill manufactured to mimic the ABI-H0731 tablet; An antiviral medication used in the treatment of hepatitis B virus infection; An antiviral medication used in the treatment of hepatitis B virus infection; Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Other intervention name(s): ETV; TDF; peginterferon alfa-2a
Intervention MeSH terms: Tenofovir; Peginterferon alfa-2a; Entecavir
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Insulin Delivery Using Microneedles in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this study is to determine if microneedles can effectively and painlessly deliver
      insulin to children and young adults with type 1 diabetes.
    


Intervention name(s): Microneedle; Subcutaneous insulin catheter
Intervention type(s): Device; Device
Intervention description(s): Microneedle used to deliver insulin at a depth less than 900 micrometers; Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Other intervention name(s): subcutaneous insulin infusion catheter
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: microneedle continuous subcutaneous insulin infusion
Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Pain
Study type: Interventional

Summary: 
      A randomized single-blind study with the use of three lancing devices equipped with personal
      lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the
      minimum and maximum puncture depth setting.
    


Intervention name(s): Lancing device A; Lancing device B; Lancing device C; 28 G lancet; 30 G lancet; 33 G lancet; Lancing depth setting (1); Lancing depth setting (5)
Intervention type(s): Device; Device; Device; Device; Device; Device; Other; Other
Intervention description(s): Glucoject Dual Plus lancing device; Droplet lancing device; Commercially available lancing device; Droplet 28 G; Droplet personal lancet 30 G; Droplet personal lancet 33 G; The lowest depth setting (1); The highest depth setting (5)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: lancing device; lancet
Effects of Electrical Muscle Stimulation on Waist Circumference in Adults
Condition: Abdominal Obesity
MeSH terms: Obesity, Abdominal
Study type: Interventional

Summary: 
      This randomized, placebo-controlled, double-blind, controlled study was designed to
      investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist
      circumference (WC) reduction in abdominal obese adults.

      60 patients with abdominal obese, man with WC > 90 cm and woman with WC > 80 cm, received EMS
      as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control
      group (CG) 5 times a week for 12 weeks.
    

Detailed description: 
      Background: This randomized, placebo-controlled, double-blind, controlled study was designed
      to investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist
      circumference (WC) reduction in abdominal obese adults.

      Methods: 60 patients with abdominal obese, man with WC > 90 cm and woman with WC > 80 cm,
      received EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS)
      as control group (CG) 5 times a week for 12 weeks.
    

Intervention name(s): Electrical Muscle Stimulation; Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Device; Device
Intervention description(s): Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.; Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine
Condition: Enterovirus Infections; Influenza
MeSH terms: Influenza, Human; Enterovirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects will be recruited and divided into 3 groups:

        1. Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza
           vaccine;

        2. Control Group A (378 subjects): EV71 vaccine only;

        3. Control Group B (378 subjects): influenza vaccine only;

      All blood samples will be collected before and one month after vaccinatioin. The
      immunogenicity and safety of both experimental and control groups will be compared and the
      data be analyzed.
    

Detailed description: 
      To further evaluate the feasibility of simultaneously administration of EV71 vaccine and flu
      vaccine, we design this clinical trial to test its immunogenicity and safety. 1134 subjects
      aged from 6 to 11 months old are divided into one experimental group and two control groups
      (control group A and B).

      378 subjects from the experimental group will be simultaneously administrated with one dose
      of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they
      are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously.
      Blood samples are collected before the first vaccination, and one month following the second
      vaccination.

      378 subjects from the control group A will be only administrated with two doses of EV71
      vaccine (0.5 ml) (1 month apart). Blood samples are collected before the first vaccination,
      and one month following the second vaccination.

      378 subjects from the control group B will be only administrated with two doses of influenza
      vaccine (0.25 ml) (1 month apart). Blood samples are collected before the first vaccination,
      and one month following the second vaccination.

      To evaluate the immunogenicity, we will detect and compare the neutralization antibody
      levels, the seroprotection rates, and antibody geometric mean concentrations. The safety of
      all groups will be monitored as well.
    

Intervention name(s): EV71 vaccine and influenza vaccine; EV71 vaccine; influenza vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): simultaneously administrated with EV71 vaccine and influenza vaccine; administrated with EV71 vaccine only; administrated with influenza vaccine only
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: EV71 vaccine; influenza vaccine; simultaneously administration
Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment Battery
Condition: Healthy
Study type: Observational

Summary: 
      The primary objective of the study is to develop MS patient-matched healthy population norms
      for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of
      the United States (US), France, and Italy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a multinational, multicenter study that will be conducted in healthy adult
        volunteers to establish normative values for the MS-COG. A total of 150 to 200 participants
        in each of the 3 countries will be enrolled. The study sample will include healthy
        participants who are matched in age and level of education to the general MS patient
        population for the respective country and/or region.
Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous
      (IV) infusion as induction treatment in Chinese participants with moderately to severely
      active Crohn's disease (CD) at Week 10.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab. Vedolizumab will be administered
      as an intravenous (IV) infusion in Chinese participants. This study will investigate the
      efficacy and safety of vedolizumab IV as induction and maintenance therapy in participants
      with moderately to severely active Crohn's Disease (CD).

      The study will enroll approximately 300 moderately to severely active Chinese patients with
      CD.

      Induction Phase: participants will be randomized 2:1 to receive:

        -  Vedolizumab IV 300 mg

        -  Placebo IV

      Participants will receive vedolizumab 300 mg or matching placebo, intravenous (IV) infusion
      at Weeks 0, 2, and 6 in the induction phase. At Week 10, participants will be assessed for
      clinical response. Results of Week 10 clinical response will determine the treatment pathway
      in the maintenance phase.

      Maintenance Phase: participants who achieved clinical response at Week 10 will continue to
      receive the same treatment as they received in Induction Phase; every 8 weeks (Q8W) starting
      at Week 14. Participants who received vedolizumab IV or placebo in the Induction Phase and
      did not achieve clinical response at Week 10 will receive vedolizumab every 4 weeks (Q4W)
      starting at Week 14.

      This multi-center trial will be conducted in China. The overall time to participate in this
      study is 60 weeks. Participants will make multiple visits to the clinic, and will be
      contacted by telephone, 6 months after last dose of study drug for a long-term follow-up
      safety survey.
    

Intervention name(s): Vedolizumab IV; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vedolizumab IV infusion; Vedolizumab placebo-matching
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the safety and tolerability of AZD3043
      following administration of single ascending bolus doses (Part A) and single ascending bolus
      doses followed by infusion (Part B).
    


Intervention name(s): AZD3043
Intervention type(s): Drug
Intervention description(s): Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sedation; anaesthesia; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics