bioihbjkbjnl/mcl2 huggingface dataset:
Rod Sensitivity in Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP)
Condition: Retinitis Pigmentosa; AMD
MeSH terms: Macular Degeneration; Retinitis; Retinitis Pigmentosa
Study type: Observational

Summary: 
      A new fundus-guided microperimeter (MP-3S) has been developed by Nidek, Inc. to track the
      fundus of the patient and present stimuli in specific anatomically-defined locations.
      Furthermore, this tracking means that exactly the same locations can be tested on subsequent
      (follow-up) visits. The investigators will use a method called two-color perimetry to map rod
      and cone sensitivity on this device. With this technique, the sensitivity difference
      (blue-red) to chromatic test stimuli can be used to determine whether rods, cones or both
      photoreceptor systems mediate the threshold at a given location in the macula.
    

Detailed description: 
      Despite recent advances in understanding the pathogenesis of retinitis pigmentosa (RP) and
      age-related macular degeneration (AMD), precise characterization of the disease phenotype
      remains elusive. In both diseases, much of the focus has necessarily been on the loss of cone
      function, since visual fields, acuity and contrast sensitivity are typically measured under
      photopic conditions. In RP, we need a greater understanding of patterns of rod loss since
      most disease-causing mutations affect primarily rods. In AMD, recent findings have shown that
      scotopic sensitivity can be much more affected than conventional photopic measurements such
      as visual acuity. For patients, however, it is difficult to maintain stable fixation,
      especially when central vision is compromised. A new fundus-guided microperimeter, the MP-3S,
      has been developed by Nidek, Inc. to circumvent this problem. The investigators will evaluate
      the value of this device for following rod and cone loss in patients with either RP or AMD.
    

Intervention name(s): Rod sensitivity
Intervention type(s): Diagnostic Test
Intervention description(s): diagnostic test for rod loss in central retina
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50 subjects with retinitis pigmentosa 50 patients with AMD 10 normal volunteers ages 18 to
        40 and 10 normal volunteers ages over age 55 years
      
Keywords: microperimetry; rod visual fields
Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Condition: Fluoride Varnish and Oral Health Promotion; Usual Care
Study type: Interventional
Phase: Phase 3

Summary: 
      An intensive intervention of specially trained paraprofessionals, called community oral
      health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish
      and oral health promotion education, compared to usual care, will reduce decayed, missing,
      and filled tooth surface measures at 2 years for children in American Indian Head Start
      Programs.
    

Detailed description: 
      The study design will be a clustered randomized design. Fifty-two head start classes in a
      Southwest American Indian Reservation will be randomized, 26 to the intervention program and
      26 to usual care. The intervention will be comprised of specially trained paraprofessionals,
      called community oral health specialists (COHS), administering fluoride varnish and oral
      health promotion education quarterly for 2 years. Baseline and annual measures of decayed,
      missing, and filled tooth surfaces (dmfs) of the children, and surveys of their caregivers'
      dental knowledge, attitudes, and behaviors will be completed. The study will be a 5-year
      study, with 2 years for intake/accrual, and 3 years of follow-up.
    

Intervention name(s): Fluoride varnish; Oral health education; Dental services delivered by the Indian Health Service.
Intervention type(s): Device; Behavioral; Other
Intervention description(s): Fluoride varnish will be administered by the COHS quarterly for 2 years.; Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
Condition: Inflammatory Bowel Disease (IBD)
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal
      tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent
      epidemiological investigation estimates that nearly 4 million people worldwide are affected
      and approximately 1.4 million of these cases occur in the United States. IBD can lead to
      debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures
      and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic
      corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as
      tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can
      achieve clinical remission and decrease the risk of complications, but also increase the risk
      for opportunistic infections, including influenza.

      Multiple studies have shown lower influenza vaccine responses in patients with IBD compared
      to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF
      inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza
      serum antibody concentration correlates with protection from infection following vaccination.
      Therefore, increasing influenza antibody responses in patients with IBD would appear to be
      critical to improving protection from influenza. A high dose (HD) influenza vaccine
      containing four times more hemagglutinin was licensed based on its ability to induce higher
      antibody concentrations compared to standard dose (SD) in adults 65 years or older.
    


Intervention name(s): Standard dose Influenza vaccine (SDIV); High dose influenza vaccine (HDIV)
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of
      the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency
      ablation (RFA), percutaneous ethanol injection and proton beam radiation (PBR). The goals of
      these treatments are to control tumor growth, to downstage tumor size to meet Milan criteria,
      and to improve survival. Patients who exceed the Milan criteria benefit from tumor
      downstaging as a result of treatment. Patients who meet Milan criteria benefit from tumor
      control to bridge them to liver transplantation. TACE is considered the most common
      locoregional treatment that is used to treat hepatocellular carcinoma (HCC). Proton beam
      radiotherapy has been used in treating HCC in a few centers across the globe. Phase I and II
      trials showed a satisfactory safety and efficacy results. Loma Linda University Medical
      Center is one of these pioneering centers that use proton beam as a treatment for HCC. This
      is the first randomized trial in the medical field that will compare head-to-head the
      efficacy of TACE versus proton beam in treating HCC patients.
    


Intervention name(s): Transarterial Chemoembolization; Proton Beam Radiotherapy
Intervention type(s): Procedure; Radiation
Intervention description(s): Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.; Fifteen consecutive sessions
Other intervention name(s): (TACE)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transarterial chemoembolization; Carcinoma, Hepatocellular; Proton Beam Radiotherapy
TLI & ATG for Non-Myeloablative Allogeneic Transplantation for MDS and MPD
Condition: Myeloproliferative Disorders; Blood Cancer; Myelodysplastic Syndromes
MeSH terms: Preleukemia; Hematologic Neoplasms; Myelodysplastic Syndromes; Myeloproliferative Disorders; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly
      patients with advanced stage MDS and MPD.
    

Detailed description: 
      Total Lymphoid Irradiation and Anti-Thymocyte Globulin as Conditioning for Non-Myeloablative
      Allogeneic Hematopoietic Cell Transplantation for the Treatment of Myelodysplastic Syndromes
      and Myeloproliferative Disorders (except CML). To evaluate the feasibility and safety of
      TLI/ATG conditioning for allogeneic HCT for elderly patients or those with co-morbid
      conditions that preclude myeloablative transplantation for advanced stage MDS and MPD.
    

Intervention name(s): Total Lymphoid Irradiation (TLI); Anti-Thymocyte Globulin as Conditioning (ATG)
Intervention type(s): Procedure; Procedure
Intervention description(s): TLI is administered ten times in 120cGy fractions on day -11 through day -7 and day -4 through day -1; Thymoglobulin will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg. Thymoglobulin doses will be based on the adjusted ideal body weight if the patient is greater than or equal to 15 kg over ideal body weight.
Intervention MeSH terms: Antilymphocyte Serum
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Protective Brace to Prevent Hand and Arm Injuries
Condition: Cumulative Trauma Disorders; Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Cumulative Trauma Disorders
Study type: Interventional

Summary: 
      When people use hand-held power tools, their hands and arms vibrate along with the tool they
      are holding. People who frequently use hand-held power tools may develop injuries related to
      this vibration. This study will evaluate a protective brace designed to prevent
      vibration-related hand and arms injuries.
    

Detailed description: 
      Workers who use hand-held power tools absorb significant vibration energy in their arms and
      hands and may develop musculoskeletal disorders (MSDs) such as carpal tunnel syndrome and
      hand-arm vibration syndrome. Protective braces may be worn to decrease the incidence of
      occupational MSDs. The National Institute for Occupational Safety and Health has identified
      key attributes for protective braces; these attributes include vibration damping, comfort,
      non-interference with worker dexterity, and maintenance of safe hand temperature. Most
      currently available braces do not adequately address these NIOSH requirements. This study
      will evaluate the efficacy of a brace with piezoelectric damping material.

      Participants in the study will be fitted with a brace on each hand. One brace will have
      piezoelectric damping material and the other will be a currently available, off-the-shelf
      commercial brace. Hand-held joysticks and handles mounted to a vibration shaker table will be
      used to simulate power tool use. Participants will undergo a series of tests designed to
      measure hand acceleration and vibration while grasping the study joysticks and handles. The
      tests will take approximately 30 minutes.
    

Intervention name(s): piezoelectric wrist brace
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Repetitive Strain Injuries; Vibration Damping; Protective Brace; Piezoelectric; SmartWear
Effect of a Single Dose of Cranberry Beverage on Inflammation and Oxidative Stress
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of a single dose of cranberry beverage
      in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites,
      and antioxidative and anti-inflammatory activity.
    

Detailed description: 
      Participants will be randomized based on age, sex and BMI, and will consume a low-polyphenol
      diet 2 days prior to the intervention. On the day of the study, baseline blood and urine
      samples will be collected after an overnight fast. Participants will consume the assigned
      beverage within 15 minutes and blood collected at 2, 4, 8, and 24 h (10 mL/blood draw; total
      blood volume per period = 50 mL). Urine will be collected for polyphenol analysis during the
      following periods: 0-3, 3-6, 6-9, 9-12, 12-24 hours. After a one-week washout period,
      participants will receive their second and then the third beverage in a cross-over design;
      blood and urine sampling will be repeated at each of the 3 intervention periods.
    

Intervention name(s): Low Calorie Cranberry Juice Cocktail; Cranberry Extract Beverage; Non-Cranberry Beverage
Intervention type(s): Other; Other; Other
Intervention description(s): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes; Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes; Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Inflammation; Oxidative Stress; Vaccinium macrocarpon
Efficacy Study in Lumbosacral Radiculopathy
Condition: Pain, Neuropathic
MeSH terms: Radiculopathy; Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a double-blind, placebo-controlled, parallel group study. After enrolment
      and initial assessments, subjects will receive 35 days of study medication. During this
      treatment period, they will be randomised to either oral GW856553 7.5mg BID or matching
      placebo in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 128
      evaluable subjects.
    

Detailed description: 
      This is a double-blind, randomised, placebo-controlled, parallel group study. Subjects will
      undertake a screening period which may last up to approximately 3 weeks, followed by a
      baseline period of 1 week, a randomised treatment period of 5 weeks and a follow-up period of
      approximately 2 weeks.

      This is a multi-centre, double-blind, randomised, placebo-controlled study in subjects who
      have at least moderate intensity of neuropathic pain resulting from lumbosacral
      radiculipathy. It will investigate the efficacy, safety and tolerability of GW856553.

      Approximately 142 subjects will be randomised to ensure 128 evaluable subjects. Randomisation
      ratio will be 1:1 for placebo or GW856553 respectively. The dose of GW856553 will be 7.5 mg
      BID.
    

Intervention name(s): Placebo; GS856553
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to match GW856553; GW586553 7.5mg bid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: p38 kinase inhibitor; male and female; patients
CKD-841 Pharmacokinetic/Pharmacodynamic Study
Condition: Postmenopausal Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single dose, parallel design phase I clinical trial to investigate
      the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after
      subcutaneous injection in postmenopausal female.
    

Detailed description: 
      To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj.
      3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.
    

Intervention name(s): LeuplinⓡInj; CKD-841
Intervention type(s): Drug; Drug
Intervention description(s): Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.; Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD-841; Leuplin; Postmenopausal
Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery
Condition: Tranexamic Acid; Trauma; Lower Extremity Fracture
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was done to evaluate the efficacy of Tranexamic Acid (TXA) in reducing blood
      transfusion requirement in patients of lower limb trauma undergoing surgery.
    

Detailed description: 
      This was a single centre, parallel group, prospective randomized control study. 116 patients
      of lower limb trauma presented between April 2017 to August 2018 at Civil Hospital Rajpura.
      16 patients were excluded due to old fracture, percutaneous wire fixation or non-consenting
      patient. The remaining 100 patients were randomized into two groups. 50 patients were given 1
      gram of TXA before surgery and 50 patients were not given TXA. Fall in Hb, requirement of
      blood transfusion, number of days admitted in the hospital after surgery and evidence of deep
      vein thrombosis were monitored.
    

Intervention name(s): Tranexamic acid injection; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): 1 g of TXA in 100 ml of normal saline; 100 ml
Other intervention name(s): Inj Tranexa; NS
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a single centre, parallel group, prospective randomized control study.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Tranexamic acid; Deep Vein Thrombosis; Blood transfusion
Open-label, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects
      designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg
      when injected by means of a prefilled syringe (PFS, reference) or injected by means of a
      injection device (e-Device, test).
    


Intervention name(s): Prefilled syringe (PFS); e-Device
Intervention type(s): Device; Device
Intervention description(s): Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS); Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence; Certolizumab pegol; Human Volunteers
Study Of Right Ventricular Performance In PAH Patients Treated With Rapid Dose Treprostinil (Remodulin)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Observational

Summary: 
      Patients with pulmonary arterial hypertension (PAH) are at much higher risk of death if the
      RV (right ventricle) is weak. The purpose of this study is to get a better understanding of
      the factors that determine RV adaptation and how the RV compensates on therapy. The
      investigator is also interested in how Remodulin (treprostinil) infused over a short period
      (approximately 48-72 hours) affects the patient's quality of life, medical care, and personal
      health behaviors.

      Treprostinil, also known as Remodulin, has been approved by the US Food and Drug
      Administration for use in the treatment of PAH. The investigator has been treating patients
      with Remodulin by rapid infusion (over 48 hours) for over 6 years. The investigator would
      like to establish this practice as safe and effective for the benefit of other centers that
      treat PAH.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Pulmonary Arterial Hypertension
      
Keywords: Pulmonary Arterial Hypertension; Right Ventricular Performance; Treprostinil; Remodulin
Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
      sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine
      once daily both in combination with metformin and glimepiride in Chinese and Japanese
      subjects with type 2 diabetes who have never received insulin before.

      The trial is conducted as a phase 4 trial in China and phase 3 in Japan.
    


Intervention name(s): biphasic insulin aspart 30; metformin; glimepiride; insulin glargine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.; China: Tablets, 500 mg. Min. 1500 mg/day.
Japan: Tablets, 250 mg. Min 500 mg/day.; China: Tablets, 2 mg. Min. 4 mg/day.
Japan: Tablets, 1 mg. Min. 4 mg/day.; Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Aspart; Glimepiride; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment