bioihbjkbjnl/mcl2 huggingface dataset:
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response
      at the site of Candin intradermal injection in the presence of a targeted immune pathway
      inhibitor.
    


Intervention name(s): Tofacitinib
Intervention type(s): Drug
Intervention description(s): Tofacitinib tablet will be administered orally.
Other intervention name(s): Xeljanz
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers
Condition: Diseases, Metabolic; Insulin Sensitivity
MeSH terms: Insulin Resistance; Metabolic Diseases; Hypersensitivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Many patients in the hospital who are malnourished or not eating received intravenous feeding
      or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk
      of infections and hospital complications. We do not know why TPN increases hospital
      complications, but it may be caused by the high sugar or fat content in TPN solutions. The
      investigators believe that the high sugar and high fat content can limit the ability to fight
      infections and produce stiffness of blood vessels. This study will compare the effect of high
      sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel
      function. The investigators will also compare the effect of different fats (olive oil and
      soybean) in the TPN solution on the risk of infection and blood vessel function on a total of
      12 healthy subjects.
    


Intervention name(s): Intralipid; ClinOleic; Dextrose; Saline (control)
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Infusion of Intralipid (soybean-derived fat); Infusion of ClinOleic (olive oil-based); Infusion of dextrose (sugar) without fat; Infusion of 0.9% normal saline
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Intravenous Feeding; Lipid Emulsions, Intravenous
Treatment Outcomes of a Novel Glaucoma Tube Shunt Implant for Intraocular Pressure Control in Eyes With Refractory Glaucoma
Condition: Glaucoma; Glaucoma, Open-Angle; Surgery; Intraocular Pressure
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Observational

Summary: 
      The aim of this study is to determine the effectiveness of lowering intraocular pressure and
      safety profile of the Paul Glaucoma Implant (Advanced Ophthalmic Innovations, Singapore).
      This is a non-comparative and single-arm observational study and all the participants were
      recruited between 1 Dec 2017 and 1 Dec 2018. Patients between age 21 - 80 years with glaucoma
      and an IOP deemed poorly controlled by the study team despite on maximal tolerated medical
      therapy were included in this study. The participants were recruited from 6 tertiary
      ophthalmology centers including National University Hospital, Singapore, Moorfields Eye
      Hospital, United Kingdom, St Thomas' Hospital, United Kingdom, Chulalongkorn University and
      Hospital, Thailand, International Specialist Eye Centre, Malaysia and Chinese University of
      Hong Kong, Hong Kong. All the eyes were followed-up for a period of 12 months after surgery.
      The examination and investigations included best corrected Snellen visual acuity, slit lamp
      examination, goldman applanation tonometry (GAT), dilated fundus examination and optic nerve
      head imaging. The participants are reviewed before surgery, 1 day, 1 week, 1 month, three
      months, 6 months and 12 months after surgery. All the data were captured in a standardized
      data-collection form for analysis. The primary outcome measure was failure, if was
      prospectively defined as IOP more than 21mmHg or less than a 20% reduction compared to
      pre-operative baseline on 2 consecutive visits after 3 months, IOP less than 6 mmHg on 2
      consecutive visits after 3 months, reoperation for IOP-related indication, loss of light
      perception vision, or removal of the implant for any reason. Intraocular pressure outcomes,
      number of IOP-lowering medications and the rate of surgical complications were secondary
      outcome measures in this study.
    


Intervention name(s): Paul Glaucoma Implant Surgery
Intervention type(s): Device
Intervention description(s): This group of patients had glaucoma surgery with the Paul Glaucoma Implant
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between age 21 - 80 years with glaucoma and an IOP deemed poorly controlled by the
        study team despite on maximal tolerated medical therapy were included in this study
CXCL9, CXCL10, CXCL11, and CXCR3 in Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Observational

Summary: 
      The aim of this study is to investigate the expression of CXCL9, CXCL10, CXCL11, and CXCR3 in
      the tear film and ocular surface of patients with dry eye syndrome.

      Thirty-three patients with dry eye (16 Sjögren's syndrome and 17 non-Sjögren's syndrome
      patients) and 15 control subjects were recruited. The concentrations of CXCL9, CXCL10, and
      CXCL11 in tears were measured using enzyme-linked immunosorbent assay. The correlation
      between chemokine levels and tear film and ocular surface parameters was analyzed. Expression
      of CXCL9, CXCL10, CXCL11, and CXCR3 in the conjunctiva was evaluated using
      immunohistochemistry. Flow cytometry was performed to count CXCR3+ cells and CXCR3+CD4+ cells
      in the conjunctiva.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Biospecimen description: 
      tears, conjunctiva
    
Keywords: Dry eye syndrome; CXCL9 chemokine; CXCL10 chemokine; CXCL11 chemokine; CXCR3 receptor
CP-690,550 and Midazolam Drug-Drug Interaction Study
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is
      designed to assess whether co-administration of CP-690,500 and midazolam will effect the
      metabolism of midazolam in healthy volunteers.
    


Intervention name(s): midazolam; CP-690,550 + midazolam; CP-690,550 + midazolam; midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Period 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID; Period 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone
Intervention MeSH terms: Midazolam; Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug interactions CYP3A4 CYP3A5 midazolam anti-rheumatic agents
A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of Fostamatinib
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different
      Formulations of Fostamatinib.
    

Detailed description: 
      An Open-label, Single-center, Randomized, 4-way Crossover Study to Assess the Bioequivalence
      of R406 in Healthy Volunteers when 100 and 150mg of Fostamatinib are Administered as the 13%
      Drug-loaded Tablet Versus the 38% Drug-loaded Tablet.

      Treatment sequences will be determined using two 2-2 crossover designs in sequence, 1 for
      treatments A and B, and 1 for treatments C and D. The order of the designs containing AB/BA
      and CD/DC within the overall design, as well as the order of treatments within each design,
      will be randomized. This gives a total of 8 possible treatment sequences as follows: ABCD,
      ABDC, BACD, BADC, CDAB, CDBA, DCAB, DCBA.
    

Intervention name(s): MCC-based 13% drug loaded tablets; Mannitol-based 38% drug-loaded tablet; MCC-based 13% drug loaded tablets; Mannitol-based 38% drug-loaded tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50mg tablets, dosed as 2 tablets (100mg total); One 100mg tablet; 3 tablets (150mg total); One 150 mg tablet
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: R406; Fostamatinib; Phase I; Healthy Subjects; Pharmacokinetics; Bioequivalence
Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
Condition: Upper Gastrointestinal Mucosal Damage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by
      assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses
      of aspirin (325 mg) in normal healthy volunteers.
    


Intervention name(s): acetylsalicylic acid
Intervention type(s): Drug
Intervention description(s): 325mg once a day for 7 days
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: To evaluate the acute gastrointestinal safety of PL-2100.
Multiple Doses Study of SHR4640 in Male Subjects With High Serum Uric Acid Level
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-Center, randomized, double-Blind, placebo-controlled, multiple
      ascending-dose Phase I trail.
    


Intervention name(s): SHR4640
Intervention type(s): Drug
Intervention description(s): SHR4640 or placebo once daily for a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Development and Validation of an Internet-based Near and Intermediate-vision Reading Test
Condition: Presbyopia; Refractive Errors; Low Vision; Near Vision; Reading
MeSH terms: Vision, Low; Presbyopia; Refractive Errors
Study type: Observational

Summary: 
      Primary objective of our study is to develop and validate an internet-based digital near and
      intermediate-vision reading test in the greek language.
    

Detailed description: 
      Present study aims to develop and validate a computer-based digital near-vision reading test
      (web Democritus Digital Acuity Reading Test - wDDART) based on the validated digital DDART.

      Specifically, present study aims to develop a new online reading test (wDDART) based on the
      corresponding digital DDART reading test for Windows and to evaluate the level of agreement
      between the two reading tests, as well as test-retest reliability of the online wDDART
      reading test.

      The first part of the study is the development of the online reading test, which will include
      the following new smart features:

        1. Automatic calculation of the reading time of each sentence (each logMAR)

        2. Automatic calculation of the basic reading parameters - RA, MRS, CPS, ACC - immediately
           after the completion of the examination

        3. Adjustment of the font size according to the size of the computer screen used for the
           examination

        4. Real time calculation of the patient-screen distance through a face detection system

      The second part of this study is the clinical validation of the online wDDART reading test.
      In this part, four reading parameters measured with the digital and the online version are
      compared. These parameters are the following:

        1. Reading Acuity (RA)

        2. Maximum Reading Speed (MRS)

        3. Critical Print Size (CPS)

        4. Accessibility Index (ACC) All the comparisons take place in two groups: a) a Normal
           Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the reading
           capacity in a population with a wide range of vision.
    

Intervention name(s): DDART Testing; wDDART Testing
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): One randomly selected eye is included for each study participant. Participants respond to the DDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.; One randomly selected eye is included for each study participant. Participants respond to the wDDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Normal- and low-sighted participants aged 18 to 75 years
      
Keywords: internet-based digital reading test; smart features; face detection; reading acuity; reading speed; critical print size
A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 study designed to test the ability of investigational study drug
      ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to
      further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled
      in this study.
    


Intervention name(s): Placebo; oral; Placebo; oral; ARRY-371797, p38 inhibitor; oral; ARRY-371797, p38 inhibitor; oral; Celecoxib, COX-2 inhibitor; oral; Placebo; oral; ARRY-371797, p38 inhibitor; oral
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): dose 1, dose 2; dose 1; dose 1: multiple dose levels; dose 1: multiple dose levels; dose 2; dose 1; dose 2; dose 2
Intervention MeSH terms: Celecoxib; Cyclooxygenase 2 Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Moksi® 400mg Tablet and Avelox® 400mg Tablet (Moxifloxacin) Under Fasting Condition in Healthy Adult Pakistani Subjects
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Single dose, two way crossover Bioequivalence (BE) study to evaluate the comparative
      bioavailability of moxifloxacin.
    

Detailed description: 
      A single center, single-dose, open-label randomized , 2-way crossover Bioequivalence study in
      healthy Pakistani subjects. Study drugs, Moksi® 400 mg (Moxifloxacin) Tablet manufactured by
      Abbot Laboratories (Pakistan) Limited and Avelox® 400mg (Moxifloxacin) Tablet manufactured by
      Bayer HealthCare Pharmaceuticals Inc were administered in two periods separated by a washout
      period of seven (07) days. After dosing, serial blood samples were collected for a period of
      72.0 hours.
    

Intervention name(s): Moksi® 400mg Tablet; Drug: Avelox® 400Mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.; Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.
Other intervention name(s): Moksi®; Avelox®
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross Over
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Moxifloxacin; Fluoroquinolone; Bioequivalence; Pakistani population
The Effect of a Liraglutide on IVF in Obese PCOS
Condition: Polycystic Ovary Syndrome; Obesity; Infertility, Female
MeSH terms: Polycystic Ovary Syndrome; Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to evaluate the impact of low dose liraglutide in combination with
      metformin compared to metformin alone on IVF pregnancy rate (PR) and cumulatively PR (IVF and
      spontaneous) in infertile obese women with PCOS who had been previously poor responders
      regarding weight reduction with lifestyle modification and resistant to first line
      reproductive treatments.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in
      particular when PCOS is linked to obesity. Obese PCOS has poor IVF outcomes associated with
      impaired oocyte and embryo parameters and morphology. The purpose of this pilot prospective
      study was to investigate the effect of the novel medical therapy (combination of metformin
      and liraglutide (COMBI)) in the specific infertile obese PCOS population. GLP-1 has been
      investigated in regulation of reproductive system in animal models. Current observations
      suggest that it directly regulates kisspeptin and GnRH expression and that ovaries express
      GLP-1 mRNA. In obese PCOS, GLP-1 receptor agonist liraglutide provided positive effects on
      weight reduction and glucose homeostasis
    

Intervention name(s): MET; COMBI
Intervention type(s): Drug; Drug
Intervention description(s): In the MET group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os for 12 weeks. After 1 month IVF was done.; In the COMBI group the initial dose of MET was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg BID. Liraglutide 1.2 mg QD s.c. was added after first two weeks of monotherapy with MET. After 1 month IVF was done.
Other intervention name(s): Glucophage tbl; Victoza 6 mg/ml solution for injection in pre-filled pen
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Obesity; Infertility; IVF
PNF Exercises on Treatment of Temporomandibular Dysfunction
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      Temporomandibular joint dysfunction (TMJD) is an important health problem that occurs
      approximately in 22 to 35 percent of adults, different physiotherapy methods are reported as
      treatment options for management of TMJD. Although that, there is no previous studies about
      the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture. So,
      the purpose of the present double-blind, randomized, controlled trial is to investigate the
      efficacy of PNF exercises in treatment of TMJD in patients with forward head posture.
    


Intervention name(s): proprioceptive neuromuscular facilitation exercises; traditional physical therapy treatment
Intervention type(s): Other; Other
Intervention description(s): PNF exercises will be done for Masseter, Temporalis, Lateral pterygoid and medial pterygoid muscles. Each contraction will be held for 10 seconds, and each stretch (relaxation phase) will be allowed to continue as long as the muscle tension continued to give away.; Ultrasound: Continuous ultrasound at 1MHZ to temporomandibular joint at 1.0-1.25 W/CM2 for 5 min over each affected TMJ and masseter area, with the mouth in a slightly open position.
Forward head posture correction exercises including: chin tuck exercise, Strengthening shoulder retractors, stretching of sternocleidomastoid muscle, and Stretching of pectoralis muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Early Infant Diagnosis Point of Care Pilot
Condition: HIV
Study type: Interventional

Summary: 
      In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months
      of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula,
      Beira and Quelimane. However, test volumes are growing and many parts of the country do not
      have close access to laboratories. Test samples are transported over large distances and this
      can introduce testing delays, especially for patients in rural and remote areas of the
      country. There are now new POC EID technologies becoming available that will enable diagnosis
      of HIV in infants within minutes or a couple of hours on site in the clinic, operated by non
      technical staff and without laboratory infrastructure. This protocol describes a plan to
      conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis (EID) testing
      technologies that are being considered for use in Mozambique, and to pilot those technologies
      in order to provide more effective diagnostics and clinical care to patients. During this
      implementation pilot, sites are randomized to use either conventional or POC EID testing only
      before the inclusion of the patients in the study. No consent will be asked to the parents or
      guardians. A written permission will be asked to the Direção Provincial de Saúde of both
      provinces to implement the POC device as routine in those intervention sites. All the
      information that will be analyzed will be collected from the routine care and it will be
      analyzed as a group.
    


Intervention name(s): Alere q
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: HIV; Diagnostic; children
A Study Investigating the Effect of Floradapt Mature Immune Defense on Nutrient Uptake and Digestive Health in a Healthy Elderly Population
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will be investigating the effect for Floradapt Mature Immune Defense on nutrient
      uptake and digestive health in a healthy elderly population. Approximately 120 healthy older
      adults will be enrolled into the study and will consume either the probiotic or placebo
      supplement for 84 days and complete questionnaires as well as provide blood samples for
      nutrient uptake analysis (for 50 participants), immunological markers, and general markers of
      health. Saliva samples will be provided for analysis of sIgA and cortisol.
    


Intervention name(s): Floradapt Mature Immune Defense + Multivitamin; Placebo + Multivitamin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The product consists of two L. plantarum strains, KABP XXXX and KABP XXXX with a combined strength of >1 x 10^9 CFU. Participants will also consume a multivitamin.; No active ingredients + a multivitamin supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Probiotic; Digestive Health; Healthy; Nutrient analysis; Constipation