bioihbjkbjnl/mcl2 huggingface dataset:
ACCESS: AI for pediatriC diabetiC Eye examS Study
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetic Retinopathy; Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to determine if providing in clinic point-of-care autonomous AI
      diabetic retinopathy exams improves screening rates compared to standard of care referral to
      an eye care provider, in a randomized control trial in a racially and ethnically diverse
      cohort of youth.
    

Detailed description: 
      This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes.
      Participants will be randomized to usual care (referral to an eye care provider for a dilated
      eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using
      autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention
      group will receive the diabetic eye exam results immediately from the autonomous AI system,
      and if abnormal will be referred to an eye care provider for a dilated eye exam. Participants
      in the standard of care group will have 6 months to complete the diabetic eye exam.
    

Intervention name(s): Point of Care Autonomous AI diabetic retinopathy exam
Intervention type(s): Diagnostic Test
Intervention description(s): Participants will get a point of care diabetic retinopathy eye exam using autonomous AI. Those that test positive will be referred to Eye Care Provider for dilated eye exam.
Other intervention name(s): IDx-DR
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control Arm - Standard of care referral to an eye care provider + Educational Reinforcement
Intervention Arm - Point of Care Diabetic Retinopathy screening using Autonomous artificial intelligence on a non-mydriatic fundus camera
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Diabetic Retinopathy
Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic
      (the effect of the investigated drug on the body) response of insulin degludec (insulin 454)
      with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.; Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Danhong Injection in the Treatment of Chronic Stable Angina
Condition: Chronic Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of Danhong Injection on the relief of
      angina with the use of the Seattle Angina Questionnaire among patients with stable angina
      patients
    


Intervention name(s): Danhong injection; Standard medical care; Placebo
Intervention type(s): Drug; Other; Drug
Intervention description(s): A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower; Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).; 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Stable Angina; Randomized Controlled Trial; Traditional Chinese Medicine
Unloader One Study on Knee Osteoarthritis Hässleholm Sweden
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of the Unloader one brace on the clinical
      symptoms of patients with knee osteoarthritis (OA) by comparing a functioning brace with a
      dummy.
    

Detailed description: 
      The purpose of this study is to assess the effect of the Unloader one brace on the clinical
      symptoms of patients with knee OA by comparing a functioning brace with a dummy. The dummy
      will be manufactured by Össur and has the same look as the real brace, but lacks the
      fundamental tightening effect of the straps of the real brace (an insert of elastic bands
      assures this), thereby nullifying its unloading capabilities. In a recent trial by Dr.
      Ingvarsson, the brace seemed to lessen the pain from knee OA, but no randomised, controlled
      studies have been conducted. This is mandatory if the effect of the brace and its use as an
      accepted treatment for knee OA is to be advocated for general use.
    

Intervention name(s): Unloader One brace; Placebo brace
Intervention type(s): Device; Device
Intervention description(s): A knee brace used to unload affected compartments in osteoarthritic knees; A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups with same problem of osteoarthritis in knee
Masking: Single (Investigator)
Primary purpose: Treatment
Cardiometabolic Response to a Sodium-bicarbonated Mineral Water
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The effects of consuming a sodium-bicarbonated mineral water rich in bicarbonate, sodium,
      chloride, lithium and silicon are studied in humans. The aim of this assay was to determine
      whether the consumption of this water as part of the usual diet, reduces cardiometabolic risk
      factors in adult men and women.
    


Intervention name(s): Mineral water
Intervention type(s): Dietary Supplement
Intervention description(s): Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Mandibular Overdenture Clinical Trial Comparing Parallel Sided and Tapered Dental Implants
Condition: Dental Implants
Study type: Interventional

Summary: 
      The purpose of the study is to compare two different types of dental implants which will be
      used to support/retain a removable denture in the edentulous mandible. Subjects will have one
      implant placed in the midline of the mandible after which the patient's existing denture will
      be modified to fit the implant. The population of this study consists of healthy edentulous
      individuals 20-75 years of age who have complete dentures in the upper and lower arch.
    

Detailed description: 
      Titanium dental implants have been frequently used in the rehabilitation of edentulous
      patients. Implants may provide adequate denture stability, improve oral function and oral
      health related quality of life. There is evidence that implants supporting fixed and
      removable prostheses have excellent long term success rates. Factors such as implant surface
      characteristics, length, diameter and shape (parallel sided or tapered) may play and
      important role for the outcome of the treatment especially when the immediate loading
      protocol (loading of the implant the same day it is surgically placed) is utilized. There are
      reports indicating that dental implants placed according to the immediate loading protocol
      can be used to support removable prostheses in the mandible. Such protocol would minimize the
      number of surgical procedures and significantly shorten the overall treatment time. Further,
      increased oral health related quality of life has been reported from studies on mandibular
      implant overdentures. Traditionally two implants have been suggested for the support of a
      mandibular overdenture. However, high patient satisfaction rates and appropriate denture
      retention have been reported among patients with a single implant placed in the mid-line. It
      is also important to further evaluate and compare various implant designs to determine
      clinical outcomes. The two dominating types of implant body design on the market are the
      parallel-sided (straight) and the tapered (conical) shaped. Both implants have similar
      threads, and the surgical procedure for placing the implants in the bone tissue is similar,
      but the drills used have a slightly different design and shape. There are today no randomized
      controlled studies evaluating differences in outcomes with respect to the external implant
      design i.e. parallel sided or tapered.
    

Intervention name(s): Nobel Biocare titanium dental implants
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
Condition: Cutaneous Lupus; Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This 76-week, 3-part Phase 1b/2 study is intended to evaluate the pharmacological properties
      (pharmacokinetics and pharmacodynamics), safety, tolerability and preliminary effectiveness
      of TOFA administrated to young adults (18-45 years) with moderately to severely active
      SLE-CL. Subjects will be studied at the Cincinnati Children's Hospital Medical Center (CCHMC)
      and in Cleveland at MetroHealth Medical Center.
    

Detailed description: 
      Cohort 1 (n=10, weight > 40kg and age > 18 years and ≤ 45 years ) will undergo intense
      PK-sampling to determine exposures following TOFA dosed at 5 mg BID. TOFA dose escalation
      will not be considered for inadequate response of SLE-CL.

      Cohort 2 (n=10, weight > 40kg and age > 18 years and ≤ 45 years) will be treated with the
      same dose as Cohort 1. No PK sampling will occur for Cohort 2. Enrollment of Cohort 2 will
      only start once Cohort 1 has completed 8 weeks of TOFA and results of PK analyses from Cohort
      1 are available.

        -  Part A (up to week 8) requires stable background medications;

        -  Part B (up to week 24) allows for tapering of corticosteroids (CS) in the setting of
           significant clinical improvement of SLE-CL as defined by a decrease in Cutaneous Lupus
           Erythematosus Disease Area and Severity Index (CLASI) activity score by >50% from
           baseline , and

        -  Part C (until week 76) permits tapering of other background medications in subjects with
           clinical remission of SLE-CL (CLASI activity score=0). TOFA dosing is kept stable during
           Part C.
    

Intervention name(s): Tofacitinib
Intervention type(s): Drug
Intervention description(s): Tofacitinib 5 mg twice daily
Other intervention name(s): Xeljanz
Intervention MeSH terms: Tofacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
S100B in the Care of Non-traumatic Headaches in the Emergency Department
Condition: Headache
MeSH terms: Emergencies; Headache
Study type: Interventional

Summary: 
      The main objective of this pilot study is to make a first assessment of the discriminating
      ability of a dosage of S100B protein for differential diagnosis between primary headaches and
      secondary headaches.

      For this, the investigators will compare serum S100B protein between two groups of headache
      patients presenting at the emergency department: 1 group of primary headache patients and 1
      group of secondary headache patients.

      If the difference between the two groups proves potentially discriminating, the investigators
      will seek to determine the discriminating ability of the S100B protein by calculating the
      area under the ROC curve.

      The reference diagnostic will be set at one month across the entire clinical picture and
      imaging by an expert committee composed of a neurologist, a radiologist and an emergency
      physician.
    

Detailed description: 
      The secondary objectives of this study are:

      A. To seek an association between S100B protein levels and the onset of pain depending on
      whether it is more or less than 3 hours.

      B. To assess the association between S100B protein levels and mortality at day 28.

      C. To evaluate the association between S100B protein levels and hospital care: average length
      of stay in the emergency department, lumbar puncture, brain imaging, average length of
      hospital stay.

      D. To evaluate the prognostic value of determination of S100B protein on the occurrence of a
      secondary headache at 1 month.
    

Intervention name(s): Plasma S100B levels at inclusion; Magnetic resonance imaging
Intervention type(s): Biological; Device
Intervention description(s): Patients will have blood drawn to measure plasma S100B levels at inclusion.; If not performed under emergency conditions, patients will have an MRI on days 2-4.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions
Condition: Aging
Study type: Interventional

Summary: 
      This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the
      facial temporal regions based on the change in the score of the investigator's Temporal. This
      study will be an open label, single center study.
    

Detailed description: 
      Volume deficit in the temporal area (the side of the forehead) of the face is a common sign
      of aging.

      JUVÉDERM VOLUMA™ XC is a dermal filler, which was FDA-approved in October 2013 for the
      improvement and correction of age-related volume deficit in the mid-face area.

      JUVÉDERM VOLUMA™ XC is a gel implant composed of 20 mg/mL hyaluronic acid (HA) formulation,
      produced by Streptococcus equi bacteria, and 0.3 w/w lidocaine. JUVÉDERM VOLUMA™ XC is a
      clear, sterile, and biodegradable gel indicated for subcutaneous and/or supraperiosteal
      injection.

      JUVÉDERM VOLUMA™ XCwill be injected in the temple area and subjects will be followed for 12
      months.
    

Intervention name(s): JUVÉDERM VOLUMA™ XC
Intervention type(s): Device
Intervention description(s): Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12.
Other intervention name(s): Injectable Dermal Filler
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: voluma temporal, facial, volume loss
Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety,
      tolerability, pharmacokinetic (PK) profile, and immunogenicity of REGN2222 ascending in
      cohorts of healthy adult volunteers.
    


Intervention name(s): REGN2222(SAR438584); placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Long Term Outcome of Hypospadias Repair
Condition: Hypospadias
MeSH terms: Hypospadias
Study type: Observational

Summary: 
      Hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy
      in 250. The opening of the urethra is located on the undersurface of the penis rather than
      the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe
      cases. Although the most commonly practised corrective operation ( TIP procedure) gives
      generally good results, recently published evidence points to a possible long term risk of
      stenosis ( narrowing of the reconstructed urethra). This comparative study will combine
      clinical assessment with non invasive measurements of urinary flow to assess the functional
      outcome of a large series of patients who have undergone hypospadias surgery . The study is
      primarily designed to answer this question : does a modification of the standard operation
      which incorporates a skin graft into the reconstructed urethra lead to improved urinary flow
      and a decreased risk of stenosis? This has not been previously studied . The findings of our
      study could make an important contribution to improvements in the surgical treatment of boys
      born with hypospadias.
    


Intervention name(s): Qualitative
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with hypospadias
Uric Acid and Long-term Outcomes in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Patients in the earlier stages of Chronic kidney disease (CKD) are at risk both for the
      development of end-stage renal disease (ESRD) (define by the requirement for dialysis or
      kidney transplantation) and development of cardiovascular disease (CVD). Although
      controversial, there is literature to suggest that uric acid may play a role in the
      progression of kidney disease and development of cardiovascular disease (CVD). The
      Modification of Diet in Renal Disease (MDRD) Study was a randomized controlled trial in
      patients with CKD, which examined the effects of dietary protein restriction and strict blood
      pressure control on progression of non-diabetic CKD. Extensive data on risk factors for
      progression of kidney disease and development of CVD are available, as is long term follow
      up. 838 of the 840 patients who were randomized have uric acid levels measured at baseline.
      The aims of the present study are to examine the determinants of uric acid in cross sectional
      analysis at baseline, to determine the association between uric acid and development of ESRD,
      and the association of uric acid with all-cause and CVD mortality.

      Level of kidney function will be a major determinant of uric acid levels independent of other
      risk factors.

      Level of uric acid will be associated with development of ESRD independent of level of kidney
      function and other risk factors.

      Uric Acid levels will be associated with both all-cause and CVD mortality independent of
      kidney function and other risk factors.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        838 participants of the randomized arm of the Modification of Diet in Renal Disaese (MDRD)
        Study conducted between 1989-1993
      
Keywords: kidney disease; uric acid; outcomes; cardiovascular; mortality; kidney failure; Uric Acid levels in patients with Chronic Kidney Disease
Innate Neutrophilic Nasal Inflammation in a Pollen Exposure Chamber
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study subjects self recorded nasal and ocular symptoms scores from exposure to
      ragweed pollen in an Allergen Challenge Chamber (ACC). This single site study of seasonal
      allergic rhinitis was designed to enroll up to 35 participants. These participants would be
      age 18-70, male and female, with a mixture of ethnic groups. The study would involve 2
      phases: Screening and Exposure. In the Exposure phase, participants were exposed to pollen
      for up to 180 minutes.
    

Detailed description: 
      This was a study to evaluate self recorded nasal and ocular allergy symptom scores from
      exposure to ragweed pollen in an Allergen Challenge Chamber (ACC). This single site study of
      seasonal allergic rhinitis was designed to enroll up to 35 participants. These participants
      would be age 18-70, male and female, with a mixture of ethnic groups. The study would involve
      2 phases: Screening and Exposure. In the Exposure phase, participants were exposed to pollen
      for up to 180 minutes. For allergic participants, qualification symptom scores at 120 minutes
      of exposure determined if ACC exposure would be continued.
    

Intervention name(s): ragweed pollen
Intervention type(s): Biological
Intervention description(s): three hours ragweed pollen in a allergen exposure chamber
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy non allergic and ragweed allergic subjects were exposed to ragweed pollen in a pollen exposure chamber for 3 hrs and symptom score was recorded
Primary purpose: Health Services Research