bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Tantalus System in Type 2 Diabetic Subjects
Condition: Type 2 Diabetes; Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to
      evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM
      patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and
      glycemic control.
    


Intervention name(s): Implantable pulse generator and electrodes
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      As the licensed pneumococcal vaccine is not always satisfactory in elderly, new
      investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note:
      The study consists of the primary phase (106068): vaccination and follow-up and the extension
      (106072) of the primary phase: 1 year follow-up.

      This protocol posting details the procedures of both the primary & extension phase.
    

Detailed description: 
      No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at
      Month 12 will only be evaluated in the subjects in the Belgian site.

      Upon request, volunteers will receive flu vaccination free of charge. The Protocol Posting
      has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Intervention name(s): 11-valent pneumococcal vaccine GSK513026; Pneumo 23™; Placebo; 10-valent pneumococcal vaccine GSK513026
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Two-dose intramuscular injection. Each group receiving one of the 3 formulations; Single-dose intramuscular injection.; 1 intramuscular injection.; Two-dose intramuscular injection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pneumonia; pneumococcal vaccine; elderly subjects; invasive pneumococcal diseases; Prophylaxis
Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides
Condition: Cow Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Observational

Summary: 
      The main aim of this study is to provide longitudinal growth data in infants with
      moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human
      milk oligosaccharides.
    


Intervention name(s): Food for Specific Medical Purpose
Intervention type(s): Other
Intervention description(s): Infants aged 1 to 8 months with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Full-term infants 1-8 months of age with symptoms suggestive of moderate-to-severe CMPA who
        have failed a trial of extensively hydrolyzed formula (EHF) of at least 2 weeks or who
        require amino acid formula as first line of treatment
      
Biospecimen description: 
      Stool samples
Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent
Condition: ANEURYSM CORONARY ARTERY
MeSH terms: Aneurysm; Coronary Aneurysm
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study in to evaluate efficacy and tolerability of Clopirin and
      clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery
      intervention.
    


Intervention name(s): Clopirin 1; Clopidogrel-Aspirin(co-administration) 1; Clopirin 2; Clopidogrel-Aspirin(co-administration) 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to assess the effect of long-term treatment with
      prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale
      (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment
      responders. The secondary objectives of this study are to compare the change in the PCS of
      the SF-36 between treatment responders and non-responders, to evaluate change from baseline
      in additional quality of life measures among treatment responders as well as changes from
      baseline in treatment responders versus non-responders and to assess the safety and
      tolerability of prolonged-release fampridine 10 mg twice daily.
    

Detailed description: 
      This study has 2 components: a 4-week run-in period during which participants are treated
      with prolonged-release fampridine and undergo subjective and objective assessments of walking
      ability, the results of which are used to determine who responded to study treatment, and an
      observational period, during which treatment responders will continue prolonged-release
      fampridine treatment. The participants who do not meet the criteria to continue study
      treatment will be offered the opportunity to continue study participation but will not
      continue prolonged-release fampridine treatment.
    

Intervention name(s): Fampridine
Intervention type(s): Drug
Intervention description(s): Supplied as a 10 mg twice daily tablet and taken twice daily. Doses must be spaced at least 12 hours apart.
Other intervention name(s): Fampyra; BIIB041; Ampyra; dalfampridine; fampridine prolonged-release tablets
Intervention MeSH terms: 4-Aminopyridine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of Life; Multiple Sclerosis
Cord Blood Transplantation in Severe Aplastic Anemia
Condition: Hereditary Diseases; Acquired Aplastic Anemia; Relapse; Absence of an HLA Identical Donor
MeSH terms: Anemia; Anemia, Aplastic; Genetic Diseases, Inborn; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or
      Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in
      the absence of an HLA identical donor;
    

Detailed description: 
      This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or
      Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in
      the absence of an Human Leucocyte Antigen (HLA) identical donor; 26 patients will be
      recruited, according to a one step Fleming design
    

Intervention name(s): Cord Blood Transplantation
Intervention type(s): Procedure
Intervention description(s): One or 2 cord blood units containing alone or both together more than 4x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients for acquired Severe Aplastic Anemia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: severe aplastic anemia; cord blood transplantation
Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2292767 in Healthy Participants Who Smoke Cigarettes
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first administration of GSK2292767 to humans. The study will evaluate the
      safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat
      inhaled doses of GSK2292767 in healthy smokers. This study is intended to provide sufficient
      confidence in the safety of the molecule and preliminary information on target engagement to
      allow progression to further repeat dose and proof of mechanism studies. This is a two part,
      single site, randomized, double-blind (sponsor open), placebo controlled study. Part A will
      consist of two 3-period interlocking cohorts to evaluate the safety, tolerability and
      pharmacokinetics of ascending single doses of GSK2292767 administered as a dry powder
      inhalation. Part B is planned to follow Part A and progression will be based on an acceptable
      safety, tolerability and pharmacokinetic profiles. Subjects will receive repeat doses of
      GSK2292767 once daily for 14 days during Part B.
    


Intervention name(s): GSK2292767 50 μg; GSK2292767 500 μg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK2292767 50 μg blended with lactose and magnesium stearate per blister as powder for inhalation; GSK2292767 500 μg blended with lactose and magnesium stearate per blister as powder for inhalation; Lactose as powder for inhalation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: repeat dose; GSK2292767; smoke; tolerability; safety; dry powder inhalation; pharmacokinetics; single dose
Is There a Digital Divide in Chronic Kidney Disease (CKD)?
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      This study is looking to improve the safety of patients with chronic kidney disease via
      education provided on a mobile tablet. This study will additionally examine if electronic
      tools, such as mobile tablets, can help.
    

Detailed description: 
      Individuals with CKD are at risk for adverse safety events, yet little is known regarding the
      utility of health information technology (IT) educational tools to reduce these events. The
      results of this project will be invaluable in gaining a better understanding of the
      limitations and potential for use of a patient-centered mHealth patient safety educational
      intervention in high-risk individuals with CKD.

      The study will evaluate the perceived eHealth literacy of patients with CKD and its relation
      to medication errors in the CRIC cohort. The hypothesis is that a novel mHealth-based patient
      safety curriculum designed to address a wide-range of e-literacy will be effective in
      attenuating the identified Digital Divide adversely affecting many CKD patients, and will
      reduce adverse safety events common in this population.

      Study Aims:

        1. Examine the association between surveyed perceived e-literacy and medication errors in
           individuals with CKD

           Hypothesis 1: Medication error rates will be higher among CRIC participants with low
           eHealth literacy.

        2. Assess the acceptance and feasibility of a novel mHealth-based patient safety curriculum
           to improve patient safety risk knowledge among individuals with CKD and determine its
           efficacy in increasing patient safety risk awareness.

      Hypothesis 2a: A low literacy mHealth patient safety curriculum will improve patient safety
      risk awareness among high risk individuals with CKD.

      Hypothesis 2b: Medication error rates will be higher among CRIC participants with low patient
      safety risk awareness.
    

Intervention name(s): mHealth Tool
Intervention type(s): Other
Intervention description(s): The curriculum in the mHealth tool was derived in consultation with patient safety, informatics and adult educational curricula experts, and is comprised of clinical vignettes describing common patient safety themes in CKD and includes a pre- and post-test knowledge assessment. Topics of emphasis included NSAID risk awareness, hypoglycemia awareness, avoidance of volume depletion when ill ("Sick Day Protocol") and avoidance of contrast-induced nephropathy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate
      metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment
      and healthy volunteers.
    


Intervention name(s): WCK 2349
Intervention type(s): Drug
Intervention description(s): levonadifloxacin (active drug) and the sulfate metabolite
Other intervention name(s): levonadifloxacin (active drug)
Intervention MeSH terms: Levonadifloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of JNJ-77474462 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single
      subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation
      concentrations on PK of JNJ-77474462 in healthy participants.
    


Intervention name(s): JNJ-77474462; Anakinra
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).; Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.
Other intervention name(s): Bermekimab
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent
      vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in
      healthy Korean males and females 19 to < 65 years of age.
    

Detailed description: 
      This is a randomized, double-blind, active-controlled, phase I/Ⅱa clinical trial.

      During the Part A phase, all safety data collected from the 12 subjects enrolled in the Part
      A phase will be analyzed to determine the safety and tolerability of the investigational
      product, which should include any solicited and unsolicited adverse drug reactions occurring
      for the first 7 days after vaccination and any adverse events occurring for 28 days after
      vaccination. Antibody titer test will be also performed to evaluate the efficacy
      (immunogenicity) of the investigational product. During the Part B phase, a total of 72
      subjects will be enrolled, and all safety data (including all adverse events) and
      immunogenicity data will be analyzed.
    

Intervention name(s): IL-YANG Flu Vaccine QIV 0.5mL; IL-YANG Flu Vaccine TIV 0.5mL
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long Duration Therapeutic Ultrasound for Tendon Healing
Condition: Tendinopathy; Tendinitis; Tendinosis
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) is intended for use as a
      portable and wearable medical device which, when applied to various areas of the body applies
      Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for
      pain reduction, treatment of muscle spasm and joint contracture, and increasing local
      circulation. This study will look at the use of therapeutic ultrasound to relieve pain and
      enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.
    


Intervention name(s): SAM Ultrasound Diathermy Device
Intervention type(s): Device
Other intervention name(s): sustained acoustic medicine; SAM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sustained acoustic medicine; therapeutic ultrasound; SAM; LITUS
Tele-rehabilitation Through CIMT at Recovering the Function of the Upper Limb and Quality of Life
Condition: Telerehabilitation
Study type: Interventional

Summary: 
      The current pandemic scenario is immensely challenging for healthcare professionals.
      Telerehabilitation,is a promising option that benefited many people, allowing continuity of
      therapeutic processes and promoting the admission of people without prior access to
      rehabilitation programs. This modality has shown comparable results with conventional
      rehabilitation strategies, applied in patients with neurological pathologies. However, the
      modalities applied and the quality of the studies are insufficient to establish their real
      benefits and effectiveness.

      Strategies such as CIMT, have been shown to be effective in improving upper limb function and
      restoring quality of life in stroke survivors. However, there is little evidence on its
      effectiveness when administered under telerehabilitation modality.
    

Detailed description: 
      Objective To determine if movement-induced restriction therapy, delivered through
      telerehabilitation (TeleCIMT), recovers function and improves quality of life in patients
      with brachial sequelae, after a stroke.

      Methodology A prospective, single-group experimental study will be conducted. The sample will
      be of an intentional type, selected according to meeting the inclusion criteria. Each
      participant will be evaluated three times, at the beginning, middle and end of the
      intervention using TeleCIMT. The evaluation scales to be used will be Motor Activity Log-30
      (MAL-30) and Action Research Arm for function and ECVI-38 scale for quality of life. The
      difference between these measurements in each patient (change score) will express the
      progress (or setback) obtained through this modality of intervention via telerehabilitation.
      Specifically, the effects of the TeleCIMT will be examined by one-factor within-subject
      analysis of variance (ANOVA) using time (T1, T2, and T3) as the independent variable and the
      recovery measures as dependent variables. In all analyzes, results with p values less than or
      equal to 0.05 will be considered statistically significant.

      Expected results Through this proposal, the aim is to promote a line of research that allows
      the development of scientific evidence in the area of telerehabilitation in subjects with
      neurological pathologies. This information will benefit numerous professionals, promoting
      timely access to rehabilitation, providing continuity in therapeutic processes and reversing
      levels of disability due to neurological pathologies.
    

Intervention name(s): TeleCIMT
Intervention type(s): Procedure
Intervention description(s): Mode applied remotely, through the principles and components of the CIMT protocol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telerehabilitation; Constraint Induced Movement therapy; Upper limb; Outcomes; Functionality; Quality of life
Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      The study investigates whether the use of eye movement recordings can provide a reliable
      diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in
      Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.
    

Detailed description: 
      Eye movements are recorded for Operations Enduring Freedom or Iraqi Freedom (OIF/OEF)
      veterans with mild traumatic brain injury (mTBI) and compared to the eye movements of those
      without mTBI. By analyzing and characterizing the differences between the two groups, a
      diagnostic measure of mTBI through the use of eye movements can be developed.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult betwenn 18 and 55 years old with and without a diagnosis of MTBI
      
Keywords: Traumatic Brain Injury; Eye movement recording
Clinical Study of Smoke-Break Liquid Cigarettes
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the Smoke-Break nicotine delivery device
      can help smokers quit smoking, while avoiding many of the side effects associated with other
      smoking cessation products.
    

Detailed description: 
      The study has been completed and published. The published study manuscript can be found here:
      http://www.biomedcentral.com/1471-2458/10/155
    

Intervention name(s): Nicotine; Smoke-Break nicotine delivery device
Intervention type(s): Drug; Device
Intervention description(s): Subjects received an amount of "liquid nicotine cigarettes" (containing 1.5mg of nicotine each) based on the amount of nicotine the subjects had been receiving from cigarettes. The number of "liquid nicotine cigarettes" received by each subject was reviewed, and adjusted (if necessary), every two weeks for the duration of the 12-week study.; The Smoke-Break nicotine delivery device is a "liquid nicotine cigarette" designed to mimic the act of smoking. It is an NRT (nicotine replacement therapy) similar in concept to the nicotine patch, gum, and lozenge, except the nicotine is delivered in a way designed to duplicate the cigarette smoking experience. The Smoke-Break nicotine delivery device is non-invasive.
Other intervention name(s): Smoke-Break, liquid cigarette, liquid nicotine cigarette; Smoke-Break, liquid cigarette, liquid nicotine cigarette
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking; smoke cessation; stop smoking; quit smoking; nicotine replacement therapy; Smoke Break; liquid cigarette; liquid nicotine cigarette