bioihbjkbjnl/mcl2 huggingface dataset:
Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that
      rNAPc2 (AB201), a novel, potent and highly selective tissue factor inhibitor with
      anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to
      recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer
      levels.
    

Detailed description: 
      Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that
      rNAPc2, a novel, potent and highly selective tissue factor inhibitor with anticoagulant,
      anti-inflammatory and potential antiviral properties, shortens time to recovery compared to
      heparin in hospitalized patients with COVID-19 and elevated D-dimer levels. Study
      participants and Clinical Endpoint Committee (CEC) members assessing the clinical endpoints
      will be blinded to treatment assignment. The protocol comprises sequential Phase 2b and Phase
      3 studies. Analysis of Phase 2b data could lead to study discontinuation, adjustment of
      eligibility criteria or sample size, and will inform the rNAPc2 dose level to be studied in
      Phase 3.
    

Intervention name(s): rNAPc2; Heparin
Intervention type(s): Drug; Drug
Intervention description(s): two dose levels of rNAPc2; standard of care heparin per institution (therapeutic or prophylactic regimen)
Other intervention name(s): AB201; Recombinant Nematode Anticoagulant Protein c2
Intervention MeSH terms: Heparin; Protein C; Anticoagulants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: investigational product compared to active comparator
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: D-dimer; Thromboprophylaxis; Anti-coagulant; Thrombotic Events; Coagulation; Inflammation; Heparin
Tissue Biomarker for Pegvisomant Action
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional

Summary: 
      Acromegaly is a disease of the pituitary gland that involves overproduction of growth
      hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout
      the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I
      levels in the blood. However, no studies have evaluated the effects of blocking GH receptors
      in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and
      IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with
      pegvisomant.
    


Intervention name(s): Pegvisomant
Intervention type(s): Drug
Intervention description(s): Pegvisomant used as indicated
Other intervention name(s): Somavert
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly
Using Conversation Maps to Reinforce Self-Care
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      Many people with type 2 diabetes are not able to keep their blood glucose in good control.
      Improving blood glucose control and maintaining that improvement is important for diabetes
      patients because doing so delays the onset and progression of severe complications of
      diabetes. Although educational programs may be helpful, their effect is not always
      long-lasting. This project is studying whether the Conversation Maps program (an interactive
      diabetes education program) reinforces diabetes education and information and thus helps type
      2 diabetes patients take better care of their diabetes and blood glucose levels. Half of the
      patients will attend the Conversation Maps program and half of the patients will attend an
      educational program about blood pressure and cholesterol. Also, all patients will come in for
      4 or 5 appointments to complete surveys and other tests and have their blood drawn. The group
      of patients who attend the Conversation Maps program will be compared to the group of
      patients who attend the blood pressure and cholesterol program to see if the educational
      programs helped diabetes patients to improve their diabetes control and quality of life and
      to maintain that improvement over time.
    


Intervention name(s): Conversation Maps Diabetes Education; Heart Healthy Living Diabetes Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Conversation Maps program is a set of innovative, interactive diabetes education tools developed by the Healthy Interactions, Inc (Healthy I) and endorsed by the American Diabetes Association. It consists of four conversation maps covering: 1) Diabetes Overview, 2) Diabetes and Healthy Eating, 3) Blood Glucose and Monitoring, and 4) The Natural Course of Diabetes (a fifth map covering gestational diabetes will not be used in this study), and a program manual to help educators successfully implement the program.; The Joslin Clinic offers a series of two 120-minute classes specifically for people with diabetes that address dyslipidemia and blood pressure problems. A registered nurse and/or a registered dietitian teach the classes, which have a formal written curriculum, including PowerPoint slides.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes; Education
Anesthesia and Motor Evoked Potential (MEP) Recruitment
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Test the hypothesis to recruit larger motor responses to transcranial stimulation.
    

Detailed description: 
      The study is designed to test the hypothesis that it is possible to recruit larger motor
      responses to transcranial stimulation by increasing the number of stimulating pulses under
      both baseline conditions and conditions of increased anesthetic suppression of the motor
      responses.
    

Intervention name(s): Desflurane
Intervention type(s): Drug
Other intervention name(s): Suprane
Intervention MeSH terms: Desflurane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intra; operative; neurophysiologic; monitoring; transcranial; motor; evoked; potential; anesthesia; pulses
A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4
      study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a
      lower severity of flu-like symptoms (FLS) as compared to the evening administration, in
      subjects with relapsing multiple sclerosis (RMS).
    


Intervention name(s): Rebif®; Rebif®
Intervention type(s): Drug; Drug
Intervention description(s): Rebif® will be administered at a dose of 44 microgram (mcg) subcutaneously three times a week in the morning using RebiSmart® self-injector device for 12 weeks.; Rebif® will be administered at a dose of 44 mcg subcutaneously three times a week in the evening using RebiSmart® self-injector device for 12 weeks.
Intervention MeSH terms: Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis, Relapsing-Remitting; Interferon beta 1a; Rebif®
Prognostic Study of Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease Based on Metabolomics, and Lipidomics
Condition: Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      To investigate whether there were differences in metabolomics and lipidomics in patients with
      coronary artery disease who had major adverse cardiovascular events during follow-up compared
      with those who did not.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        major adverse cardiovascular events ( cardiac death, myocardial infarction, heart failure,
        stroke ) in patients with coronary artery disease
Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness and safety of ABP 501 against
      adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an
      inadequate response to methotrexate (MTX).
    


Intervention name(s): ABP 501; Adalimumab
Intervention type(s): Biological; Biological
Intervention description(s): Solution for subcutaneous injection in pre-filled syringe; Solution for subcutaneous injection in pre-filled syringe
Other intervention name(s): AMJEVITA™; Adalimumab-atto; HUMIRA®
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis; Rheumatoid
Concurrent Training and Nutritional Management in Cancer
Condition: Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      A case control study with before-after design. A concurrent training and a nutritional
      management intervention was offered by a patient with head and neck cancer, in order to
      compare outcomes related to strength and endurance performance and to body composition
    

Detailed description: 
      Cancer causes important public health problems around the world and it is one of the most
      frequent cause of death overall. Among non-pharmacological treatment, physical exercise has
      shown improvements in different types of cancer and patients, but it is important to define
      the optimal dose. Our aim is to determine the effects of a concurrent training program and a
      nutritional management developed during radiotherapy treatment on physical performance and
      body composition. A patient with an oral cavity cancer will develop three sessions per week
      of concurrent training: resistance training included 9 standard exercises involving major
      muscle groups (4x8-12 RM), and cardiovascular training included a High-Intensity Interval
      Training (HIIT). Nutritional management will include a diet controlling macronutrients
      (~4g/kg/day for carbohidrates, ~2g/kg/day for proteins, and ~1g/kg/day for fats), along with
      some nutritional supplements such as beta-hydroxybeta-methylbutyrate (HMB), arginine,
      glutamine, omega-3 fish oil concentrate, and BCAA's during training sessions. Intervention
      took place during radiotherapy period (7 weeks). We expect that body composition will remain
      invariable, and 1RM will increased. VO2max is expected to be almost the same, but intensity
      tolerated at maximum VO2max could be higher. If our results confirm that, we could conclude
      that a combination between resistance exercise and HIIT along with a nutritional management
      developed during radiotherapy could be effective to prevent muscle mass loss and muscle
      function decrease in a young patient with oral cavity cancer.
    

Intervention name(s): Physical exercise; Nutritional management
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): Physical exercise controlled program supervised by an accredited exercise specialist; Nutritional management controlled by a PhD clinical and sport nutrition specialist
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Case study
Masking: None (Open Label)
Primary purpose: Prevention
Patient's Management Receiving Eplerenone Therapy
Condition: Left Ventricular Dysfunction Post Myocardial Infarction
MeSH terms: Myocardial Infarction; Ventricular Dysfunction; Ventricular Dysfunction, Left; Infarction
Study type: Observational

Summary: 
      On a population of patients followed by an office-based cardiologist and treated with
      eplerenone, the objectives of the survey are:

        -  To describe the characteristics of the population treated.

        -  To describe the methods of use of eplerenone (posology, duration of treatment, medicinal
           combinations).

        -  To describe the follow-up methods of the treatment.

        -  To describe the possible interruptions of the treatment
    

Detailed description: 
      A sample size in the region of N = 400 patients will allow this accuracy of estimation, as
      for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a
      confidence interval of maximum width. In view of the type of survey and the need for 12
      months of monitoring in the context of standard practice, it may be anticipated that the
      drop-off rate will be about 20%. A sample size of N = 500 patients was therefore chosen.
    

Intervention name(s): Prospective Observational
Intervention type(s): Other
Intervention description(s): this is an observational study non interventional
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The following patients may be selected to participate in the survey:

          -  Those undergoing treatment with eplerenone in accordance with the MA or not, with a
             known start date.

          -  Those likely to be followed by the same physician for a minimal period of twelve
             months.
      
Keywords: patients with MI- on top of treatment add Eplerenone - assess LVEF and BP
The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
Condition: Mental Fatigue; Healthy
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      To assess the changes in brain activation and cerebral blood flow due to mental fatigue in a
      placebo-controlled study. More specifically we want to assess whether brain activation
      [measured with Blood Oxygen Level Dependent (BOLD) functional resonance imaging (fMRI)] is
      decreased during a Flanker task in a mentally fatigued state and whether this coincides with
      a decline in cognitive performance. In addition we also want to evaluate whether cerebral
      blood flow [measured with arterial spin labeled (ASL) fMRI] in a resting state is reduced
      when mentally fatigued.
    


Intervention name(s): Mental fatigue; Control
Intervention type(s): Other; Other
Intervention description(s): A modified Stroop task of 90 min, partitioned in 8 blocks of 252 stimuli, will be used as mentally fatiguing task. The Stroop task requires inhibition and sustained attention on controlled processes.; In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of
      CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)
    

Detailed description: 
      This will be a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study
      to evaluate the safety, tolerability, PKs, and efficacy of CS0159 in the treatment of
      patients with NASH over 12 weeks.
    

Intervention name(s): CS0159 (Linafexor)
Intervention type(s): Drug
Intervention description(s): Oral QD
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) Versus the CoronaVac Vaccine
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a randomized, double-blinded, and active-controlled phase III clinical trial of
      the SARS-CoV-2 inactivated vaccine. The purpose of this study is to evaluate the efficacy,
      safety, and immunogenicity of the experimental vaccine in healthy adults aged 18~55 years.
    

Detailed description: 
      This study is a randomized, double-blinded, multi-center, active-controlled phase III
      clinical trial in adults aged 18~55 years. The purpose of this study is to evaluate the
      efficacy, safety, and immunogenicity of the experimental SARS-CoV-2 inactivated vaccine. A
      total of 40.800 subjects will be enrolled. The participant will be assigned to receive two
      doses of experimental vaccine or CoronaVac on the schedule of days 0, 28.
    

Intervention name(s): TURCOVAC; CoronaVac
Intervention type(s): Biological; Biological
Intervention description(s): Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,28; Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) vaccine at the schedule of day 0, 28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: COVID-19, SARS-CoV-2 Vaccine
A Multi-Center Phase I Study of Intravenous Deforolimus (AP23573, MK-8669) Administered QDX5 Every Other Week in Pediatric Patients With Advanced Solid Tumors (8669-028)(COMPLETED)
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Ridaforolimus (Deforolimus, AP23573, MK-8669) is an mTor inhibitor shown to have promising
      activity in adults with a variety of solid malignancies, particularly the sarcomas. To date,
      no studies to evaluate appropriate dosing or to obtain pharmacokinetic data in pediatric
      patients have been conducted. Sarcomas are the second most common solid malignancies in
      children and young adults, and for those patients with recurrent or refractory disease, new
      therapies are needed. This initial evaluation of ridaforolimus will help define appropriate
      dosing and toxicity evaluations, as well as establish the first pharmacokinetic and biologic
      correlative data in pediatric patients treated with ridaforolimus.
    


Intervention name(s): ridaforolimus
Intervention type(s): Drug
Intervention description(s): Ridaforolimus is given as an IV infusion over 30 minutes on days 1-5 and 15-19 of each 28 day cycle. For children less than 10 kg body weight, dosing will be adjusted.
Other intervention name(s): AP23573, deforolimus, MK-8669
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Solid Tumor; CNS Tumor; Lymphoma
DatScan With Prototype Collimator
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      A collimator is an accessory to a SPECT/CT scanner. It can be compared to a camera lens or
      filter that enhances or improves photos. The prototype collimators are able to magnify target
      organs about four times compared to the current collimators. In this study we are validating
      a new collimator design, which will allow for quantitative measurement of dopamine receptors
      within the brain, not previously performed using a single photon gamma camera.
    

Detailed description: 
      Previously PET/CT has been used for this measurement but the L-DOPA is not FDA approved and
      thus of limited availability. DatScan (I123 ioflupane) is an FDA approved and clinically
      indicated biomarker, which has a high binding affinity for presynaptic dopamine transporters
      (DAT) in the brains of mammals, in particular the striatal region of the brain. A feature of
      Parkinson's disease is a marked reduction in dopaminergic neurons in the striatal region. By
      introducing an agent that binds to the dopamine transporters a quantitative measure and
      spatial distribution of the transporters can be obtained. The use of SPECT/CT (with the new
      validated collimators) and the FDA approved DATScan biomarker would allow for readily
      available diagnosis of Parkinson's disease
    

Intervention name(s): Prototype UHRSZ (UltraHigh Resolution Smart Zoom) Collimator
Intervention type(s): Device
Intervention description(s): In DATScan SPECT scans, the UHRSZ collimator will be exchanged for the standard collimator following completion of the clinically ordered scan. A scanning sequence will be repeated with the prototype collimator in place. Images from the two scanning sequences will be compared.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to Nuclear Medicine for a clinically indicated DatScan for the diagnosis
        of Parkinson's disease
Feasibility Study of the NEW NORMA-SENSE
Condition: Vaginal Infection
MeSH terms: Infections
Study type: Observational

Summary: 
      -  In-vitro study

        -  Collect data regarding the color appearance on the new developed indicator strips (NEW
           NORMA-SENSE), in contact with vaginal secretion with elevated pH

        -  Measure the buffering capacity of vaginal secretion from non-symptomatic and symptomatic
           subjects

        -  Detect these indicator strips' performance, in contact with urine
    

Detailed description: 
      This in-vitro study was designed to collect data regarding the color appearance on the new
      developed indicator strips (NEW NORMA-SENSE) when coming in contact, in-vitro, with vaginal
      secretion with elevated pH, and to measure the buffering capacity of vaginal secretion from
      non-symptomatic subjects and symptomatic subjects, and to detect these indicator strips'
      performance when come in contact with urine.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Women, age between 18 years and 45 years with or without symptoms of vaginal infection.
      
Biospecimen description: 
      Vaginal secretions.
    
Keywords: vaginal infection; color appearance; new developed indicator strips (NEW NORMA-SENSE); in-vitro; vaginal secretion; elevated pH
Treatment of Male Pattern Baldness With Botulinum Toxin
Condition: Male Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This proof of concept study seeks to demonstrate that Botulinum toxin injections are a safe
      and effective method for treating this form of hair loss.
    


Intervention name(s): Botulinum Toxin - A injections
Intervention type(s): Drug
Intervention MeSH terms: Botulinum Toxins
Primary purpose: Screening
Keywords: male pattern baldness; androgenetic alopecia; hair loss