bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of a Candidate ZIKV Vaccine (ZIKA001)
Condition: Zika
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a FIH, open-label, dose escalation, phase I clinical trial to assess the safety and
      immunogenicity of the candidate ChAdOx1 Zika vaccine in healthy volunteers administered
      intramuscularly.
    

Detailed description: 
      Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and
      Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and a total of 24 volunteers
      will be enrolled. Groups 1-3 will receive ChAdOx1 Zika alone. Staggered enrolment will apply
      for the first three volunteers within each group.
    

Intervention name(s): ChAdOx1 Zika
Intervention type(s): Biological
Intervention description(s): Single dose of ChAdOx1 Zika at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaccine
Safety and Immunogenicity of Malaria Vaccines AdCh63 AMA1, MVA AMA1 and AMA1-C1/Alhydrogel®+/- CPG 7909
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to compare the safety and immunogenicity of AdCh63 AMA1 and MVA AMA1vaccine
      candidates administered alone and with adjuvants in various schedules. These vaccines consist
      of inactivated viruses which have been modified, so they cannot reproduce in humans, and also
      to include genetic material for malaria protein AMA1 which is expressed by the malaria
      parasite during blood stage infection. The vaccines are designed to stimulate an immune
      response to this malaria protein and thus provide protection against malaria infection.
      Adjuvants are a crucial component of modern vaccine regimens, increasing the immunogenicity
      and potency of protein vaccines. In this study we will assess whether virus vectored vaccines
      combined with protein in adjuvant AMA1-C1/Alhydrogel® and CPG 7909 adjuvant (emulsion
      containing TLR agonist) can induce stronger and more durable immune response.
    


Intervention name(s): AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909; AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909; AdCh63 AMA1 + AMA1-C1/Alhydrogel®; AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909; AdCh63 AMA1 + MVA AMA1
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 5x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 56, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections; 5x10^10 vp AdCh63 AMA1 Day 0,AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 56. IM injections; 5x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel® (80ug, 800ug respectively) Day 56. IM injections; 5x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections; 5x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 112. IM injections
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immune response
Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury
Condition: Inhalation Injury
MeSH terms: Respiratory Aspiration; Wounds and Injuries
Study type: Interventional

Summary: 
      this study designed to examine the effect of Acu-TENS applied bilaterally on Ding Chuan
      acupoint to boost pulmonary functions, improve diaphragmatic excursion and decrease dyspnea
      in patients with inhalation injuries.
    


Intervention name(s): acupoint TENS
Intervention type(s): Device
Intervention description(s): TENS was applied bilaterally on acupoint Ex-B1, 4Hz frequency, and 200 μs pulse width and intensity was set at the best highest tolerable intensity by the patient sensitivity without a sensation of discomfort for 45 minutes, three times/week for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Assessment of Alcon's Ocular Image Quantification System
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate ocular responses with different allergen
      provocation methods.
    

Detailed description: 
      Subjects demonstrating a successful allergen response to a common allergen received the first
      study treatment and used as instructed for 5 days, after which they entered the Environmental
      Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After
      waiting at least 7 days, subjects received the second study treatment and used as instructed
      for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed
      with an escalating concentration of the allergen. Subjects dosed with study treatment
      approximately 15 minutes prior to each allergen provocation test.
    

Intervention name(s): Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol); Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
Intervention type(s): Drug; Other
Intervention description(s): One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.; One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Other intervention name(s): Patanol®; Tears Naturale II
Intervention MeSH terms: Olopatadine Hydrochloride; Dextrans; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Allergic conjunctivitis
Effect of Nutrition Supplementation Combined With Resistance Exercise in Elderly With Sarcopenia.
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The purpose of this study was determine whether milk or soy milk supplements combined with
      resistance exercise improved sarcopenia in the elderly. This study was randomized controlled
      trail that recruited elderly people ≧65 years old with sarcopenia in the nursing home of
      Taipei Veterans General Hospital Su-Ao and Yuanshan Branch from June 2017 to December, 2017.
      The participants were divided into three groups, such as control, milk supplement and soy
      milk supplement. The milk and soy milk groups provided 200 mL milk or soy milk two times per
      day. Moreover, all participants joined the resistance exercise training program, three times
      per week (30 min/time). After 12 weeks, the anthropometry, sarcopenia index, blood
      biochemical index, nutrition status index, inflammation index, insulin resistance index, and
      dietary intake were measured.
    

Detailed description: 
      The anthropometry data included body weight and body fat. The sarcopenia index included
      appendicular skeletal muscle mass index, calf circumferences, hand grip and gait speed.
      Moreover, blood biochemical index (liver function as ALT, kidney function as creatinine),
      nutrition status index (prealbumin, 25-hydroxyvitamin D) were also analyzed. The blood hsCRP
      level was as inflammation index and insulin resistance index included fasting blood sugar,
      insulin, HbA1c and HOMA-IR. The daily dietary intake were also recorded.
    

Intervention name(s): milk supplement; soy milk supplement; resistance exercise
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Intervention description(s): Intervention groups provided 200 mL long life milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time); Intervention groups provided 200 mL long life soy milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time); The participants joined the resistance exercise training program, three times per week (30 min/time)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were divided into three groups, such as control, milk supplement and soy milk supplement. The milk and soy milk groups provided 200 mL milk or soy milk two times per day. Moreover, all participants joined the resistance exercise training program, three times per week (30min/time).
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: sarcopenia; milk; soy milk; resistance exercise
PK/PD Pediatric ADHD Classroom Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the association between blood drug levels and the
      corresponding scores of commonly used behavioral instruments based upon data collected
      following administration of three different methylphenidate hydrochloride extended-release
      drug products in children with ADHD.
    

Detailed description: 
      This is a randomized, double-blind, 4-treatment and 4-period crossover study conducted in a
      school laboratory environment to evaluate the hour-by-hour behavioral instrument scores and
      hour-by-hour PK of 3 different extended-release MPH formulations as well as placebo in
      children with ADHD. The complete study consists of three periods: Screening, Dose Titration
      and Double-Blind Crossover in a Laboratory Classroom.

      The double-blind phase will consist of four periods (or four weeks): each week will consist
      of blinded administration with one of the three active methylphenidate hydrochloride
      treatments or placebo from Sunday through Saturday. On the last day of each period
      (Saturday), study participants will be evaluated in a laboratory classroom setting. On
      Saturdays, the blinded doses of each study drug will be administered at the school site by
      study staff on the morning of the test laboratory classroom day. On the other days, the
      medication will be taken in the morning at home.
    

Intervention name(s): Methylphenidate HCl ER tablets 1; Placebo; Methylphenidate HCl ER tablets 2; Methylphenidate HCl ER for suspension
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; ADHD
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
Condition: Renal Transplanted Recipients
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation
      versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure
      cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium
      (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will
      be compared to a third control group, who will receive treatment consisting of cyclosporine
      micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.
    


Intervention name(s): Everolimus (RAD001); Cyclosporine (Calcineurin Inhibitor (CNI)); Methylprednisone/prednisone; Mycophenolate sodium (MPA)
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Certican®; Neoral®; myfortic®
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Prednisone; Everolimus; Cyclosporins; Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplantation; everolimus; Immunosuppressants
Association Between Laser Interferometric Measurement of Fundus Pulsation and Pneumotonometric Measurement of Pulsatile Ocular Blood Flow in Patients With Age-related Macular Degeneration
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      Several methods have been proposed for the measurement of pulsatile ocular blood flow (POBF).
      The pneumatic tonometer, which is commercially available, assesses POBF by measurement of
      intraocular pressure (IOP) changes during the cardiac cycle. The investigators have recently
      developed a method for the measurement of ocular fundus pulsation, which is based on laser
      interferometry. In contrast to the Langham system the method is non-contractile and yields a
      high topographic resolution. Moreover, the pneumatic tonometer assesses the ocular pressure
      pulse, whereas ocular fundus pulsation is a point measure of the ocular volume pulse. These
      two parameters are related by the ocular rigidity, which refers to the mechanical properties
      of the eye coats.

      Age-related macular degeneration (AMD) is the most common cause of blindness in the
      industrialized nations. The mechanisms behind this severe eye disease are, however, still
      obscure. It has been hypothesized that alterations in choroidal blood flow and ocular
      rigidity may contribute to the development and progression of AMD. However, there is
      currently little data to confirm this hypothesis. The present study is an attempt to
      investigate choroidal blood flow and ocular rigidity by employing laser interferometric
      measurement of fundus pulsation and pneumotonometric measurement of fundus pulsation.
    


Intervention name(s): blood flow measurement
Intervention type(s): Procedure
Intervention description(s): Fundus pulsation amplitude measurement Pulsatile ocular blood flow measurement
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AMD; rigidity; pulsatile ocular blood flow; Physiology of the eye
Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single site, double-blind, randomized, placebo-controlled, crossover study to
      assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy,
      opioid-experienced, non-treatment-seeking subjects.
    


Intervention name(s): RDC-0313 + Buprenorphine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 and 4 mg (1 dose for each) + 8 mg; 0 mg
Intervention MeSH terms: Buprenorphine; ALKS-33
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients
Condition: Immunosuppression
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a study to compare less intense immunosuppression with a more traditional approach.
      The hypothesis was that less immunosuppression will provide similar protection against
      rejection than typical 2-3 drug therapy.
    

Detailed description: 
      This was a prospective, randomized, controlled (open-label) trial of 2 different strategies
      of immunosuppression in de novo post-heart transplant patients. The hypothesis was that
      immunosuppression with tacrolimus and mycophenolate mofetil, coupled with rapid steroid
      weaning would provide similar anti-rejection efficacy as tacrolimus with only a 2 week course
      of mycophenolate mofetil but including the same rapid steroid wean.

      The primary endpoint was the mean International Society for Heart and Lung Transplantation
      (ISHLT) biopsy score over the first 6 months post-transplant. Secondary endpoints included
      the incidence of adverse events over the first year post-transplant, as well as all-cause
      mortality, 12 month ISHLT biopsy score (mean), along with the incidence of proven
      cytomegalovirus disease. In addition, the incidence of allograft vasculopathy as assessed by
      angiography or intravascular ultrasound was compared between groups.
    

Intervention name(s): Tacrolimus; combination therapy
Intervention type(s): Drug; Drug
Intervention description(s): tacrolimus; MMF
Other intervention name(s): Prograf; mycophenolate mofetil / CellCept
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunosuppression; steroid withdrawal; rejection; coronary disease; cytomegalovirus infection
A Dangerous Triad in Ageing and in Chronic Obstructive Pulmonary Disease (COPD) - Reduced Muscle Mass, Impaired Muscle Function and Malnutrition
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Malnutrition
Study type: Observational

Summary: 
      The investigators have taken part in the development of simple muscle function tests and
      studied physical training and energy turnover in patients with chronic obstructive pulmonary
      disease, COPD. The investigators have found that muscle wasting in COPD is related to poor
      prognosis and that physical training might lead to improved, less energy-demanding muscle
      function. Elderly subjects also suffer from muscle wasting that leads to frailty, poor
      autonomy and, secondarily, fractures. In the planned study the investigators will validate
      simple muscle function tests (hand grip strength, heel rise test, voluntary quadriceps muscle
      strength, 30 m walking test and balance tests) in both groups by relating them to an
      involuntary, magnet stimulated, test of quadriceps force, HRQL, tests of body composition
      (impedance, DXA) and recordings of physical activity. The relation between food intake,
      systemic inflammation, muscle mass and function will be analysed.

      The study has been ethically approved and started in COPD patients and will be expanded to a
      representative sample of elderly.

      Simple, evaluated muscle function tests applied in primary care may be used for early
      detection of muscle dysfunction in COPD patients and elderly so that early intervention
      against impaired muscle function can be started. Analyses of food intake and of inflammatory
      markers might identify factors of special importance for muscle dysfunction, which eventually
      might lead to improved dietary therapy and pharmacological interventions.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatients (COPD) and older adults living in Gothenburg
fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients
Condition: D020521
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study evaluates cognitive-motor interference in stroke patients who is responsible an
      alteration of spatio-temporal gait parameters. It's proved in the literature but the
      underlying pathophysiological mechanisms remain poorly understood. fNIRS is a functional
      imaging technique that evaluates this interference under optimal conditions. The purpose of
      this study is to evaluate the hemodynamic activity of the CPF in walking post-stroke patients
      under different DT conditions.
    

Detailed description: 
      Walking is a motor task that involves cognitive functions. The parameters of walking and
      brain activity are modified in situations requiring significant attentional and cognitive
      demand. fNIRS is an interesting functional neuroimaging technique for studying cortical
      activity when performing a Dual Task (DT). To our knowledge, no studies have examined
      cerebral oxygenation levels in post-stroke patients based on different cognitive loads during
      walking. Understanding cognitive contributions in a dual-task walking situation is necessary
      to providing targeted interventions and preventing falls.

      Patients included in the study will be evaluated in single cognitive task, with two levels of
      difficulty, single walking motor task, and dual task with two levels of cognitive difficulty.
      The fNIRS will record the hemodynamic activity of the prefrontal cortex for the cognitive
      slope and the GAITRite will record the walking parameters.
    

Intervention name(s): Walking and Record Cortical Activity
Intervention type(s): Diagnostic Test
Intervention description(s): The cortical activity of each patient is recorded by NIRS under the following conditions:
Simple task : The patient walks on an electronic walking track (GAITRite system) over 10 meters. The data collected are the spatio-temporal parameters of walking.
Cognitive task alone : two conditions of the n-back test (1-back and 2-back) to study neural activities related to working memory. The duration of realization will be 30 seconds by condition and we retain the number of errors realized.
Double Task : Achievement of the motor task (10-meter walk) is performed at the same time as a "weak" cognitive task (1-back) and a "high" cognitive task (2-back). The spatio-temporal parameters and the number of errors are collected by the observer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stroke, dual-task, gait parameters, fNIRS
Seri Surgical Scaffold Support of the Lower Pole of the Breast
Condition: Recurrent Ptosis of the Breast
MeSH terms: Prolapse
Study type: Interventional

Summary: 
      Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help
      shape and hold the breast up on the chest preventing re-stretching and bottoming out of the
      breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be
      measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D
      Imaging system reporting the amount of breast tissue above and below the nipple level.
    

Detailed description: 
      Patients having augmentation mastopexy or breast reduction will be informed about Seri
      Scaffold and allowed to have Seri support included in their surgery or not. If the choose the
      scaffold will be placed under the skin in the lower pole of the breast as an internal hammock
      to help take weight off of the breast and potentially help prevent future stretch of the
      lower pole.
    

Intervention name(s): Seri Surgical Scaffold
Intervention type(s): Device
Intervention description(s): An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
Other intervention name(s): Seri; Seri Scaffold
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Recurrent; Ptosis; Reduction; Mammoplasty; Mastopexy