bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of an oral testosterone
      undecanoate formulation for use as testosterone-replacement therapy in men with low
      testosterone.
    


Intervention name(s): Oral testosterone undecanoate, LPCN 1021; Topical testosterone gel 1.62 %
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Testosterone; Male hypogonadism; Low testosterone; LPCN 1021; Androgel; Testim; Testopel; Fortesta; Axiron.; Hypogonadism; Eunuchism; Gonadal Disorders; Endocrine System Diseases; Testosterone enanthate; Testosterone undecanoate; Testosterone 17 beta-cypionate; Methyltestosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anabolic Agents
Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with
      methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis
      (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of
      radiographically confirmed joint damage progression over a one-year period as a primary
      endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be
      discontinued, and the subjects will be monitored for one more year (the follow-up period) to
      investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory
      purposes.
    

Detailed description: 
      This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on
      12/04/2012.
    

Intervention name(s): Placebo; CZP; methotrexate (MTX)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous (SC); SC; oral
Other intervention name(s): CDP870; certolizumab pegol; Cimzia®
Intervention MeSH terms: Certolizumab Pegol; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cimzia; Early RA; Certolizumab Pegol
Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling wIth COVID-19
Condition: Covid19; Burn Out; Post Traumatic Stress Disorder
MeSH terms: COVID-19; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this work is to monitor the level of stress and overload of a group of
      front-line health workers (physicians, nurses and physiotherapists) who will participate in
      the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its
      Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in
      reducing stress for those who wish to use it.
    

Detailed description: 
      The Bonsai study is a two-arm, parallel-group, individually randomized (1:1 allocation
      ratio), controlled with general measures (supporting motivational videos, fitness videos),
      participant and investigator unblinded, evaluator by phone will be blinded, single-site
      superiority trial of oral CBD 300 mg daily for 28 days to prevent burnout and distress in
      health care workers dealing with SARS-CoV-2 exposure. At 28 days, there is an open-label
      extension wherein all participants are offered a 28 days course of CBD 300mg daily. The
      objective of this work is to monitor the level of stress and overload of a group of
      front-line health workers (physicians, nurses and physiotherapists) who will participate in
      the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its
      Emergency Unit (HCRP), for four weeks, and evaluate the CBD's effectiveness in reducing
      stress for those who wish to use it.

      This research intends to :

        1. Assess the level of stress and emotional overload of front-line health workers
           (physicians, nurses and physiotherapists) during their performance in the pandemic
           caused by COVID-19.

        2. Assess whether the daily use of CBD 300 mg, for four weeks, reduces the level of stress,
           during the period of performance of professionals in the care of patients with COVID-19.

        3. Assess whether the daily use of CBD 300 mg, for four weeks, will modify inflammatory
           parameters, such as cytokines, measured from the serum of professionals in the care of
           patients with COVID-19.

        4. Assess whether the daily use of CBD 300 mg, for four weeks, prevents depression, burnout
           and Acute Stress Disorder and PTSD.

        5. Assess the possible adverse effects of using CBD
    

Intervention name(s): Cannabidiol
Intervention type(s): Drug
Intervention description(s): Cannabidiol 300 mg daily for 4 weeks
Other intervention name(s): general clinical supportive measures
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
Condition: Pneumococcal Vaccines
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the immune responses of the infants who have been given 13vPnC in the
      mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in
      the single-dose syringe formulation.

      It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all
      infants who are vaccinated.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.; Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevenar 13; 13vPnC; Healthy Subjects
A Phase I SAD and MAD Clinical Trial of CNM-Au8 in Healthy Male and Female Volunteers
Condition: Healthy Volunteers - Male and Female
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, First-Time-In-Humans, randomized, placebo-controlled, double-blind,
      escalating single- and multiple-dose study to evaluate the safety, tolerability, and
      pharmacokinetics of CNM-Au8 in healthy male and female volunteers. There will be 2 phases to
      this study: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase.
      The SAD Phase will be conducted first followed by the MAD phase of the study.
    

Detailed description: 
      SAD Phase:

      A total of 8 subjects will be randomly assigned in a 3:1 ratio to receive a single dose of
      either CNM-Au8 (n=6) or placebo (n=2) at an initial dose level of 15 mg CNM-Au8. Additional
      cohorts of 8 subjects will be enrolled to investigate escalating single doses of CNM-Au8 at
      30, 60, and 90 mg. Cohorts will be balanced by sex with no more than 2/3rd of subjects being
      of one sex.

      MAD Phase:

      A total of 12 subjects will be randomly assigned in a 3:1 ratio to receive a multiple dose of
      either CNM-Au8 (n=9) or placebo (n=3) once daily for 21 days at an initial dose level of 15
      mg CNM-Au8. Additional cohorts of 12 subjects will be enrolled to investigate escalating
      multiple doses of CNM-Au8 at 30, 60, and 90 mg CNM Au8 administered once daily for 21 days.
      Cohorts will be balanced by sex with no more than 2/3rd of subjects being of one sex.
    

Intervention name(s): CNM-Au8; Placebo
Intervention type(s): Other; Other
Intervention description(s): Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class; Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
Other intervention name(s): Nanoparticles, clean surface nanocrystals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Benefits of Group Psychotherapy Programs in the Treatment of Obesity
Condition: Obesity; Psychotherapy; Psychotherapy, Group
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity has reached pandemic proportions in recent years, affecting not only the physical
      health, but also the mental health, of obese people. According to Spain's National Health
      Survey 2011-12, the prevalence of obesity in the adult population of Spain was 17%, having
      increased by 2.5% since 2006. Therefore, a constant and worrying increase in the prevalence
      of obesity is being observed, which is having a great impact, both individually, in terms of
      health and quality of life, and socially, inter alia, by raising health expenditure due to
      increased morbidity.

      In this context, the desirability of a comprehensive approach that includes psychological
      intervention in attending obese patients (Rev Cochrane, 2006), has been given greater
      prominence. Paying attention to the emotional and psychopathological aspects related to
      obesity has proven to be an action that could have positive impact on obesity intervention
      models.

      The aim of this project is to measure, through a clinical trial, the efficacy of a
      psychotherapy group program for obesity patients who are attended by the consulting
      endocrinologist at the Infanta Leonor Hospital (Madrid). The impact of body mass index,
      psychological wellbeing, psychopathology and quality of life of two experimental study groups
      will be compared, one a control group of patients that follows the standard treatment, the
      other an experimental group that follows not only the standard treatment, but also the
      psychotherapy group intervention program.
    


Intervention name(s): Psychotherapy group
Intervention type(s): Other
Intervention description(s): Added to standard treatment patients will participate in a standardized group of psychological intervention. 21 sessions with 10 to 12 members closed-ended groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; Psychotherapy; Psychotherapy Group
Introduction of the Surgical Safety Checklist
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      In January of 2007, the World Health Organization's (WHO) World Alliance for Patient Safety
      initiated a project called "Safe Surgery Saves Lives" to identify minimum standards of
      surgical care that can be universally applied across countries and settings. Through a two
      year process involving international input from surgeons, anesthesiologists, nurses,
      infectious disease specialists, epidemiologists and others, the WHO created a surgical safety
      checklist that encompasses a simple set of surgical safety standards that can be used in any
      surgical setting. Each safety step on the checklist is simple, widely applicable, and
      measurable. The Surgical Safety Checklist was piloted in 8 hospitals around the world and
      results demonstrated a significant decrease in death rate and postoperative complications.

      This study proposes to introduce an adaptation of the Surgical Safety Checklist for an
      ambulatory care surgical program and to assess the efficacy of its adaptation and
      implementation on staff safety attitudes and patient outcomes. Specific ambulatory-based
      items will be included in the checklist and patient outcomes will be assessed using the
      Institute for Health Improvement's Perioperative Surgical Outcomes Tool which will also be
      adapted for use for the ambulatory setting as well as routine follow up phone calls with
      patients on the 1st postoperative day.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ambulatory surgical patients
      
Keywords: Patient Safety; Team work; Communication; Ambulatory surgical patients
GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study
Condition: Cervicobrachial Neuralgia; Cervical Discopathy
MeSH terms: Neuralgia; Brachial Plexus Neuritis
Study type: Observational

Summary: 
      This is a prospective clinical study to assess the performance of the prosthesis according to
      a composite success criterion. The clinical and functional results and the patient's quality
      of life up to 24 months of follow-up will also be recorded.

      Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.
    

Detailed description: 
      Anterior cervical arthrodesis has been widely used to treat the degenerative cervical spine.
      Although the results of ACDF are generally in the good to excellent range, interbody fusion
      of the cervical spine after cervical discectomy, aside from causing restriction of neck
      movements, also accelerates degeneration of adjacent disc levels because of the increased
      stress from fusion. Long-term radiographic follow-up of patients with anterior cervical
      fusion has demonstrated degenerative changes in the non-fused segments of the spine including
      disc space narrowing and osteophyte formation.

      To conclude, fusion provokes a functional overload of the discs bordering the fusion that is
      directly correlated to the number of fused levels. Radiographic observations show a greater
      mechanical stress on the discs, especially in the arthrodeses involving more than one level.

      Artificial discs were designed to replace the entire intervertebral disc and to preserve the
      physiological motion of the operated level. Several prostheses with different concepts were
      commercialized. Published clinical studies reported a preserved motion and improved clinical
      results (Neck Disability Index, Pain Visual Analogic Scale, Quality of Life).

      The cervical disc prosthesis GRANVIA®-C was designed to replace the intervertebral discs of
      the cervical spine, to restore the disc height and to restore segmental motion.

      A prospective clinical study has been set up to evaluate the performance of the prosthesis

      Granvia-c is a device NOT FDA-approved and NOT under investigation in the USA.
    

Intervention name(s): Cervical arthroplasty surgery with Granvia-C
Intervention type(s): Device
Intervention description(s): Discectomy and Cervical arthroplasty according to standard practice of the surgeon
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with Cervicobrachial neuralgia due to symptomatic cervical discopathy
      
Keywords: Cervicobrachial; neuralgia; symptomatic cervical discopathy
The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for
      the interventional treatment of new and non-stented restenotic lesions in the superficial
      femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients.
    


Intervention name(s): IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Intervention type(s): Device
Intervention description(s): IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter originally developed, approved and commercialized by Invatec Technology Center GmbH is the investigational medical device used in the study. Medtronic Inc. acquired Invatec on April 21, 2010. Medtronic
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atherosclerosis; Superficial Femoral Artery; Proximal Popliteal Artery
An Active Approach to Treat Amblyopia: Perceptual Learning and Video Games
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of
      vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This
      study uses psychophysical measures to study neural plasticity in both adults and children
      with amblyopia.
    

Detailed description: 
      Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of
      vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. Our
      previous findings (see CITATIONS) show that the adult amblyopic brain is still plastic and
      malleable, suggesting that active approach is potential useful in treating amblyopia. The
      goal of this project is to assess the limits and mechanisms of neural plasticity in both
      normal and amblyopic spatial vision. This study uses psychophysical measures to study neural
      plasticity in both adults and children with amblyopia. Research participants will be asked to
      practice a visual discrimination task (perceptual learning) or to play video games with the
      amblyopic eye for a period of time. A range of visual functions will be monitored during the
      course of treatment.
    

Intervention name(s): Perceptual learning; Video Games; Occlusion therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Research participants will be asked to practice a visual discrimination task (e.g. position acuity, contrast sensitivity, stereoacuity etc) in our laboratory for a period of time (2 hrs/day, 5 days/week).; Research participants will be asked to play "off-the-shelf" video games in our laboratory for a period of time (2 hrs/day, 5 days/week).; Research participants will be required to cover the good eye during the day in order to push the brain to use the amblyopic eye (2 hrs/day, 5 days/week for 2-4 weeks).
Other intervention name(s): vision therapy; vision training; vision therapy; vision training; vision training,; vision therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amblyopia treatment; neural plasticity; perceptual learning; vision therapy; spatial vision; video games; occlusion therapy
A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus
      (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the
      immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.
    

Detailed description: 
      This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In
      Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0,
      1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If
      no serious adverse events are observed within 1 week after the first injection in these first
      15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive
      HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5
      volunteers receive the placebo.
    

Intervention name(s): HIV p24/MF59 Vaccine
Intervention type(s): Biological
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: Reference Values; Placebos; AIDS Vaccines; HIV Core Protein p24; HIV Seronegativity; MF59 oil emulsion
Safety, Reactogenicity and Immunogenicity of an H5N1 VLP
Condition: Pandemic Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the
      safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or
      placebo in healthy adults 18 to 40 years of age.
    


Intervention name(s): H5N1 VLP Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Two doses - Day 0 & Day 28; Two doses - Day 0 & Day 28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Subcutaneous Lecanemab in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the absolute bioavailability and
      pharmacokinetic (PK) profile of a single dose of lecanemab when administered subcutaneously
      (SC) in healthy participants.
    


Intervention name(s): Lecanemab; Lecanemab
Intervention type(s): Drug; Drug
Intervention description(s): Lecanemab IV infusion.; Lecanemab SC injection.
Other intervention name(s): BAN2401; BAN2401
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Lecanemab; Bioavailability; Subcutaneous