bioihbjkbjnl/mcl2 huggingface dataset:
Yakima Head Start Fluoride Varnish Study
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to determine whether an annual application of three (3) fluoride
      varnish doses over two weeks is at least as effective in reducing cavities as the current
      semi-annual application.
    

Detailed description: 
      The study population will consist of pre-school aged children who are residents of Yakima
      County, in central Washington State. Children will be recruited from non-migrant Head Start
      programs for ethnic minority farmworker children in the Yakima Valley.

      This study will be a randomized, double blinded trial with one experimental and one standard
      treatment group. Each participant will be randomly assigned to one of two study groups. The
      participant and the personnel conducting the study will not know to which study group the
      participant was assigned.

      This trial has two study groups:

        1. Massive Dose (Experimental):

           Annually for three years, children in the experimental group will receive three .30ml
           applications of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni), followed 6 months
           later by three .30ml applications of placebo varnish in two weeks. There are 18 visits
           over the entire duration of the study. Each participant will receive a dental exam
           annually.

        2. Semiannual Dose (Standard):

      Annually for three years, children in the standard treatment group will receive one .30ml
      application of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni) and two .30ml applications
      of placebo varnish in two weeks. They will receive this regimen again 6 months later. There
      are 18 visits over the entire duration of the study. Each participant will receive a dental
      exam annually.

      Both the experimental and standard treatment children will receive basic restorative dental
      care on decayed surfaces only, as well as toothbrushes for the duration of the study period.
      Parents will fill out questionnaires about behaviors such as diet, hygiene and prior dental
      care. Results will inform future treatment regimens for high-caries-risk populations.
    

Intervention name(s): Fluoride varnish
Intervention type(s): Drug
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Early Childhood Caries
Exercise Training and Cardiovascular Function in Obesity and in Type 2 Diabetes
Condition: Type 2 Diabetes; Obesity
MeSH terms: Obesity; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Obesity and diabetes increase cardiovascular risk by complex and incompletely known
      mechanisms. The aims of this study are :

        1. to compare cardiac and vascular functions at rest and during exercise in 4 groups of
           age-matched men, without cardiovascular diseases but exhibiting increasing
           cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic
           subjects

        2. to test the effects of a 8-weeks long individualized training program on these functions
           in obese subjects and in diabetics patients.
    

Detailed description: 
      Obesity, especially in its truncal distribution, and type 2 diabetes, increase cardiovascular
      risk. Mechanisms underlaying both early preclinical, and clinical cardiovascular
      complications are complex and still incompletely clarified.

      However, relationship between central, i.e. cardiac, and peripheral, i.e. vascular
      dysfunctions remains unclear, as well as their respective role in reduced exercise tolerance
      in these populations.

      Moreover, exercise training can improve both metabolic status and cardiovascular risk, and
      thus, has proven useful in management and prevention of chronic metabolic diseases.
      Nevertheless, respective effects of training on cardiac and vascular functions, and on their
      interaction at rest, but also during exercise, need to be clarified.

      Therefore, the aims of this study are :

        1. to compare cardiac and vascular functions at rest and during a local maximal leg
           exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting
           increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type
           2 diabetic subjects

        2. to test the effects of a 8-weeks long individualized training program on these functions
           in obese subjects and in diabetics patients.
    

Intervention name(s): 8 weeks individualized training program
Intervention type(s): Behavioral
Intervention description(s): no drugs added
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: vascular function; cardiac function; individualized training; ultrasonography; body composition
Effectiveness of Isometric vs. Eccentric Exercise in Chronic Achilles Tendinopathy
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      This is a prospective single blinded randomised controlled trial with a 12-week intervention
      period and a half-year follow-up period. The main purpose is to determine the effects of
      isometric exercise on mechanical, morphological and functional tendon properties versus
      eccentric exercise in chronic Achilles tendinopathy.
    

Detailed description: 
      This research project was funded by means of the "Bundesinstitut für Sportwissenschaft" based
      on a resolution of the German Federal Parliament.
    

Intervention name(s): Isometric exercise; Eccentric exercise
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Achilles tendon; isometric muscle training; competitive sports; strength training; eccentric exercise; isometric exercise; chronic condition; regeneration; tendon; tendon properties; tendinopathy; tendinosis; intervention; training load; high performance sports
Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background: Aloe vera is considered to be the most promising and high-ranking agent as an
      all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to
      evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as
      an adjunct to scaling and root planing in the treatment of chronic periodontitis.
    

Detailed description: 
      Background: Aloe vera is considered to be the most promising and high-ranking agent as an
      all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to
      evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as
      an adjunct to scaling and root planing in the treatment of chronic periodontitis.

      Methods: Twelve subjects diagnosed with chronic generalized periodontitis were selected and
      randomly divided into two groups: Test group which received scaling and root planning (SRP)
      followed by application of aloe vera gel as a local drug delivery agent in the deepest
      periodontal pocket and control group which received SRP alone. Clinical evaluation was
      undertaken using Plaque index (PI), Gingival index (GI), Probing pocket depth (PPD), Relative
      attachment level (RAL) and Gingival marginal level (GML) and microbiologic counts (total
      colony count/ml) were assessed at baseline, 6 weeks and 3 months.
    

Intervention name(s): Aloe Vera
Intervention type(s): Drug
Intervention description(s): Local drug delivery of aloe vera gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512
      compared to placebo in patients with schizophrenia
    

Detailed description: 
      This is a 7-week, Phase II, multi-centre, randomised, double-blind, placebo-controlled,
      parallel group design study in male and female subjects with schizophrenia who are stabilised
      on antipsychotic medication. Subjects will be randomised to receive either GSK239512 or
      placebo for 7 weeks. They will undergo weekly review of safety, tolerability and cognitive
      performance measures.
    

Intervention name(s): GSK239512; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Histamine H3 Antagonist; Placebo to match GSK239512
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: H3 Antagonist; Schizophrenia; double blind; Histamine; randomised; placebo controlled; Cognition
The Establishment of the Integration of Surgery and Postoperative Intensive Recovery of Patients With CSM
Condition: Cervical Myelopathy; Ossification of Posterior Longitudinal Ligament in Cervical Region
MeSH terms: Ossification of Posterior Longitudinal Ligament; Spinal Cord Diseases; Bone Marrow Diseases
Study type: Observational

Summary: 
      This study aims to establish the specialist consensus of the integration of posterior
      approach surgical treatment and postoperative intensive recovery management for CSM or OPLL
      patients, and verify its safety, practicability and reliability.
    

Detailed description: 
      In order to establish the specialist consensus of the integration of posterior approach
      surgical treatment and postoperative intensive recovery management, and verify its safety,
      practicability and reliability, this study enrolled 130 patients with CSM or OPLL undergoing
      C3-7 open-door laminoplasty. Patients are divided in two groups randomly. The study group has
      80 patients, treated with postoperative intensive recovery management, and the control group
      has 50 patients. The data is collected preoperatively, at 3-month follow-up and 1-year
      follow-up.
    

Intervention name(s): Intensive recovery management
Intervention type(s): Procedure
Intervention description(s): Intensive recovery management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty
      
Keywords: Cervical myelopathy; Ossification of posterior longitudinal ligament; Intensive recovery; Quality of life; Surgical outcomes
The Effect of Soy Isoflavone Supplementation on Endothelial Function
Condition: Cardiovascular Disease; Osteoporosis
MeSH terms: Osteoporosis; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized double blind controlled trial was conducted to evaluate the effect of daily
      supplementation with soy isoflavone 100 mg/day for 12 months on 182 postmenopausal women aged
      47 to 60 years at subdistrict South Jakarta Indonesia. The study hypothesis was
      supplementation soy isoflavone 100 mg/day for 6 and 12 months can increase endothelial
      function.
    

Detailed description: 
      The subject were randomized to the intervention group receiving tablets consisting of 100 mg
      soy isoflavone and calcium carbonate 500 mg and the control group receiving 500 mg calcium
      carbonate for 1 year. This study was carried out 13 months(13 x 28 days).

      There were three outcome measure from this study; vascular cell adhesion molecule-(VCAM-1),
      nitric oxide (NO) and malonyldialdehyde (MDA). The outcome measure will be assessed at three
      times; before soy isoflavone supplementation / the beginning of study,post supplementation 6
      months and 12 months. The outcome will be measured change from baseline in the level of
      VCAM-1, NO and MDA.
    

Intervention name(s): soy isoflavone; control group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 100 mg soy isoflavone tablet containing genistein 55%, daidzein 39% and glycitein 6% and calcium carbonate 500 mg in the experimental group for 6 months and 12 months; the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months
Other intervention name(s): kacang kedelai, soya bean; plasebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: endothelial function; postmenopausal; soy isoflavone supplementation; osteoporosis
Avenanthramides and Exercise
Condition: Avenanthramides
Study type: Interventional

Summary: 
      The aim of the proposed study is to examine whether long-term dietary supplementation (8
      weeks) of an oat flour cookie rich in avenanthramides (AVA) could enhance blood antioxidant
      capacity and reduce blood inflammatory markers after a downhill running (DR) protocol among
      human subjects.
    


Intervention name(s): Avenanthramides
Intervention type(s): Other
Intervention description(s): AVAs are a group of diphenolic acids that are found only in oats (Avena sativa).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC administered
      intravenously to subjects with HER2-positive malignant in advanced malignant solid tumors.
    


Intervention name(s): RC48-ADC
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics of CIN-107 in Subjects With Varying Degrees of Renal Function
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, parallel-group study in subjects with varying degrees of renal
      function to assess the safety, tolerability, and Pharmacokinetics of a single 10 mg oral dose
      of CIN-107.
    


Intervention name(s): CIN-107
Intervention type(s): Drug
Intervention description(s): A single 10 mg CIN-107 oral dose (2 X 5 mg tablets).
Other intervention name(s): baxdrostat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety Study to Evaluate Pazopanib Eye Drops in Healthy Volunteers
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to determine the safety and tolerability of pazopanib eye drops. The study will also
      determine how the drug is absorbed and metabolized over time. Repeat doses of eye drops will
      be administered to healthy adult volunteers over a 14-day period with one additional dose
      given on the 15th day of the session. Three groups of subjects may receive either active drug
      or placebo (drops without drug). The first group of subjects will receive a maximum of 1.6mg
      of pazopanib or placebo. The dose of drug to be given to the next two groups will be
      determined based on the results of the first group of subjects. The last group of subjects
      will be of Japanese descent.
    

Detailed description: 
      The purpose of this study is to characterize the ocular safety and tolerability, the systemic
      safety and tolerability, and the pharmacokinetic profile of repeat doses of a higher strength
      ophthalmic formulation of pazopanib, 10 mg/mL. The higher strength formulation provides an
      opportunity to increase the total daily dose of pazopanib administered. In this 3-cohort
      study, healthy adult volunteers will participate in one 14-day repeat-dose session (plus a
      single dose on day 15), randomized to receive either pazopanib eye drops or placebo. Subjects
      in cohort 1 will receive 1 drop four times daily for a calculated total daily dose of 1.6 mg.
      The dosage regimen for two subsequent cohorts will be determined based on the emerging safety
      profile. The Japanese population chosen for the third cohort will provide a safety and
      tolerability profile as well as the pharmacokinetic profile of pazopanib prior to further
      development of this formulation in Japanese patients with AMD.
    

Intervention name(s): pazopanib; pazopanib; pazopanib; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): gw786034; gw786034; gw786034; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pazopanib; Tolerability; Pharmacokinetics; GW786034; Safety
Single Dose Study Of PF-04171327 And Prednisone On Carbohydrate Metabolism
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of a single dose of PF-04171327 or prednisone on
      calculated measures of glucose tolerance and insulin resistance by using a modified oral
      glucose tolerance test
    


Intervention name(s): PF-04171327; PF-04171327; Prednisone; PF-04171327; PF-04171327; Prednisone; Prednisone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT); 25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT); 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT); 3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT); 10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT); 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT); 5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy People; Glucocorticoids; Prednisone
Use of Biopsy Punch for Skin Biopsies for Fibroblasts Culturing
Condition: Fibroblasts
Study type: Observational

Summary: 
      Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial
      growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their
      donor but can be used for experiments where study conditions are much more precisely
      controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima
      Indians for two purposes. Firstly, to look for an in vitro system to measure insulin
      resistance, the underlying abnormality in Pima diabetics. Secondly, to look for biochemical
      markers of diabetes or obesity in Pimas employing two dimensional electrophoresis techniques.
    

Detailed description: 
      Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial
      growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their
      donor but can be used for experiments where study conditions are much more precisely
      controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima
      Indians for two purposes: 1) to look for an in vitro system to measure insulin resistance,
      the underlying abnormality in Pima diabetics; and 2) to look for biochemical markers of
      diabetes or obesity in Pimas employing two-dimensional electrophoresis techniques.
    

Keywords: Skin Biopsy
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to collect large volumes of matched pairs of pre- and
      post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK)
      Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine
      (Bexsero), which serves for the development, qualification, validation, and maintenance of
      immunological assays which supports the preclinical research activities and clinical
      development of GSK Biologicals' vaccines. The safety of the subjects given one of the two
      vaccines (Bexsero or Menveo), as per the recommended dosage and schedule were assessed during
      their participation in the study.
    


Intervention name(s): rMenB+OMV NZ vaccine; Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
Intervention type(s): Biological; Biological
Intervention description(s): Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.; One dose of MenACWY vaccine were administered intramuscularly at Day 1.
Other intervention name(s): Bexsero; Menveo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Immunological assays; Human blood donors; Meningococcal vaccination; Meningococcal disease