bioihbjkbjnl/mcl2 huggingface dataset:
Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss
Condition: Periodontal Diseases; Dental Plaque
MeSH terms: Periodontal Diseases; Dental Plaque
Study type: Interventional

Summary: 
      The purpose of this study is to compare between plaque control efficacy of interdental
      brushes versus interdental floss , for the prevention of periodontal disease (gingivitis) and
      to determine the most convenient routine interdental plaque control method amongst the two
    


Intervention name(s): Dental floss/Interdental brush
Intervention type(s): Device
Intervention description(s): Initially plaque disclosing tablets were used to disclose plaque and plaque and bleeding scores will be recoded. After mechanical plaque debrided, instructions regarding the allocated interdental device given to the patient along with motivation to continue practicing good oral hygiene. After six weeks patients were recalled for reevaluation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      Between December 2016 and June 2017 a total of 40 eyes from 40 diabetic retinopathy patients
      with diabetic macular edema were recruited at the Ophthalmologic Clinic of University "G.
      d'Annunzio", Chieti-Pescara, Italy.
    


Intervention name(s): Dexamethasone intravitreal implant 0.7 mg; Ranibizumab Injection
Intervention type(s): Drug; Drug
Intervention description(s): Intravitreal Implant of dexamethasone; Injection of ranibizumab
Intervention MeSH terms: Dexamethasone; Ranibizumab
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Patients with no proliferative moderate DR stage (simplified version of the ETDRS
        classification aimed by the American Academy of Ophthalmology Guidelines Committe) and
        cystoid macular edema type without subretinal fluid component were recruited
Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808
      100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.
    


Intervention name(s): YH4808 100 mg; YH4808 100 mg; YH4808 300 mg; YH4808 300 mg; YH4808 300 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days; Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days; Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal); Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal); Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Lymphoblastic Leukemia/Lymphoma
Condition: Lymphoblastic Leukemia; Lymphoblastic Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      T- cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) has an
      increase in proteins in a specific pathway called the mTOR pathway within the cancer cells.
      In cancer cells it can encourage untimely cell growth, cell production, and cell survival.
      Everolimus is an inhibitor of the mTOR pathway and can decrease the growth and survival of
      cancer cells. It also prevents communication within cells and stops proteins from being made
      that may contribute to leukemia. The main purpose of the study is to find the maximum
      tolerated dose of everolimus when used together with standard chemotherapy.
    

Detailed description: 
      T- cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) has an
      increase in proteins in a specific pathway called the mTOR pathway within the cancer cells.
      In cancer cells it can encourage untimely cell growth, cell production, and cell survival.
      Everolimus is an inhibitor of the mTOR pathway and can decrease the growth and survival of
      cancer cells. It also prevents communication within cells and stops proteins from being made
      that may contribute to leukemia.

      Two to six participants will receive the starting dose of everolimus. If the side effects are
      not too severe, the next group of participants will take the study drug at a higher dose
      level. Up to two dose levels of the study drug will be tested. The main purpose of the study
      is to find the maximum tolerated dose of everolimus when used together with standard
      chemotherapy. Everolimus has been found to be safe and effective in adults and children for
      treatment of T- and B-cell leukemias and lymphomas.
    

Intervention name(s): Everolimus; Nelarabine; Cyclophosphamide; Etoposide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Given once daily orally via mouth or NG tube beginning at Dose Level (DL) 1 (4 mg/m2/day). Depending on safety and tolerability, dose levels will be escalated to DL2 (5 mg/m2/day). There is also a dose level de-escalation to DL0 (3 mg/m2/day) if toxicity is noted at DL1. Begins at Day 1 through 28.; 650 mg/m2 IV daily x Day 1-5; 440 mg/m2 IV x Day 1-5; 100 mg/m2 IV x Day 1-5
Intervention MeSH terms: Cyclophosphamide; Etoposide; Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T- cell acute lymphoblastic leukemia; T-ALL; T-cell lymphoblastic lymphoma; T-LLy; Everolimus; Maximum tolerated dose
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of
      single and multiple oral doses of GDC-0853 in healthy Japanese and Caucasian subjects.
    

Detailed description: 
      This study will be a randomized, placebo-controlled, double-blind, single and multiple dose
      study. Approximately 32 healthy subjects will be enrolled in 4 discrete cohorts with 8
      subjects per cohort.
    

Intervention name(s): GDC-0853; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GDC-0853 tablets orally, either a single dose or twice-daily.; GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetic and safety profile of
      alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.
    

Detailed description: 
      Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being
      developed by Takeda Global Research & Development as a treatment for type 2 diabetes
      mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2 important
      incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic
      peptide (GIP). These hormones are responsible for increasing insulin synthesis, regulating
      β-cell proliferation, inhibiting gastric emptying, and inhibiting glucagon secretion.

      To date, alogliptin has not been studied in participants less than 18 years of age. As with
      adults, there is growing evidence of an increase in the prevalence of type 2 diabetes
      mellitus in children and adolescents.

      This study is designed to determine the pharmacokinetic, pharmacodynamic, and safety profiles
      of alogliptin in children and adolescents with type 2 diabetes mellitus. These profiles will
      be compared with those of similarly matched adult participants with type 2 diabetes mellitus.
      Pharmacokinetic, pharmacodynamics, and safety endpoints will be analyzed.
    

Intervention name(s): Alogliptin
Intervention type(s): Drug
Intervention description(s): Alogliptin tablets
Other intervention name(s): SYR-322
Intervention MeSH terms: Alogliptin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Type 2 diabetes mellitus; Non-insulin dependent diabetes mellitus; Drug therapy; Pediatrics
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This single arm study will evaluate the efficacy and safety of MabThera in combination with
      methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one
      or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and
      methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v.
      prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The
      anticipated time on study treatment is 3-12 months, and the target sample size is <100
      individuals.
    


Intervention name(s): rituximab; Methotrexate; Corticosteroid or NSAID; Folate
Intervention type(s): Drug; Drug; Drug; Dietary Supplement
Intervention description(s): 1000 mg i.v. on Days 1 and 15; 10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24; ≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24; ≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24
Other intervention name(s): MabThera; Rituxan
Intervention MeSH terms: Rituximab; Methotrexate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging
      (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer
      based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized
      to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided
      biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI
      evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.
    


Intervention name(s): magnetic resonance imaging, Siemens
Intervention type(s): Device
Intervention description(s): Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: prostate cancer diagnosis; magnetic resonance imaging; prostate biopsy
Ultrasonographic Appearance of the Endometrium After Ulipristalacetate Use and Endometrial Changes
Condition: Uterine Fibroid; Endometrial Cyst
MeSH terms: Leiomyoma
Study type: Interventional

Summary: 
      If endometrial thickening is visualised (>10mm) after the use of ulipristalacetate in case of
      medical treatment for uterine fibroids a saline infusion and sonographic examination will be
      performed to evaluate the endometrium and exclude intra-uterine pathology.
    

Detailed description: 
      When ultrasonographic examination during follow up of a treatment with ulipristalacetate
      shows a thickening of the endometrium of 10mm or more ( thickening described in 10% of
      ulipristalacetate users and is completely benign), a saline infusion can help to exclude
      pathology in the uterine cavity. Saline infusion helps to better delineate the uterine cavity
      and endometrium. If fibroids or polyps are present in the uterine cavity they will clearly be
      seen.

      This study was set up to describe how the endometrial changes after Esmya use appear on
      saline infusion sonography. This study can help to recognize ultrasonographic images in women
      presenting with thickened endometrium after Ulipristalacetate use.
    

Intervention name(s): saline infusion sonography
Intervention type(s): Diagnostic Test
Intervention description(s): Instillation of 10cc of saline infusion in the uterine cavity while performing an ultrasonic evaluation of the uterine cavity and endometrium.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study is designed to test if Baduanjin training can reduce the hyperactive-impulsive
      symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine
      excise. Investigators will also evaluate if the Baduanjin training will positively affect
      Chinese Traditional Medicine (TCM) symptoms compared to controls and if these impacts are
      related to the change of the executive function.
    

Detailed description: 
      ADHD is a common neurodevelopmental disorder characterized by a persistent pattern of
      inattention and/or hyperactivity and impulsivity, resulting in functional impairment in
      multiple settings. The prevalence in China is estimated to be 6.26%. From the point of
      Chinese Traditional Medicine (TCM), ADHD can be divided into 4 categories according to the
      symptom differentiation in TCM.

      Aerobic exercise is known to improve executive function (EF) performance, which is known as
      the core deficit of ADHD, therefore reduce ADHD symptoms. Aerobic exercise with the component
      of self-control and development of character is reported to improve EF.

      Baduanjin is one of the aerobic exercises that has been handed down since the northern song
      dynasty, serving as Chinese physical and breathing exercises. The eight movements of
      Baduanjin are required to be gentle, slow, elastic and appropriate which not only require the
      practitioner to control physical activity but also require a combination of cognitive
      activities. Researchers found that Baduanjin has a positive protective effect on cognitive
      function such as selective attention in patients with mild cognitive impairment adults.

      Therefore, investigators designed the Baduanjin training system. This is a combination of a
      physical and cognitive training program and a video game with a motivation system,
      interesting and engaging for children with ADHD to practice on.
    

Intervention name(s): Baduanjin practice; Regular physical exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Use the Baduanjin training system to practice the whole set of Baduanjin at least once a day and at least 5 days each week for 3 months.; Take physical exercise for at least half an hour every day in addition to regular physical activities at school.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to the Baduanjin intervention or to the regular physical exercise control group.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chinese traditional medicine
Neurolens Headache Study
Condition: Binocular Vision Disorder; Convergence Insufficiency; Headache; Computer Vision Syndrome
MeSH terms: Vision Disorders; Ocular Motility Disorders; Syndrome; Headache
Study type: Interventional

Summary: 
      To understand the benefits of the neurolens Measurement Device and neurolens treatment as it
      pertains to treating symptoms related to Chronic Headaches. It is a Prospective randomized
      double masked two arm performed on a minimum of 200 to a maximum of 300 subjects identified
      as symptomatic (HIT-6 questionnaire score equal to or greater than 56) done across 3-15
      clinical sites. There are two subgroups: a minimum of 100 in each subgroup (subgroup 1:
      pre-presbyopic (18-40 years); subgroup 2: presbyopic subjects (41-60 years).
    

Detailed description: 
      This study is a two-arm crossover study with two subgroups. Subjects will initially be
      assessed for their headache symptoms (Headache Impact Test (HIT-6) questionnaire) and then
      are provided an updated refractive prescription and will wear them for 35 ± 5 days. Symptoms
      will be reassessed after the 35-day control break in. If the subject's symptoms have
      subsided, they will be exited from the study and will keep their lenses. Provided the subject
      has symptoms (HIT questionnaire score ≥ 56) after their 35-day use of their updated
      prescription and they continue to meet the inclusion/exclusion criteria they will proceed to
      the evaluation portion of the protocol. The first arm receiving neurolens first and the
      second arm receiving the control first. The control is a single vision or PAL lens which
      yields the BCDVA and BCNVA of a test subject with no prismatic correction. The neurolens
      prescribed prism will be based on the practitioner's Rx using the subject's best response to
      a prism trial lens and must be within a half prism diopter of the neurolens value output of
      the neurolens Measurement Device and providing the subject's BCDVA and BCNVA. Participants
      will come back after 35 day wear of their first test lens and the symptom questionnaire is
      reassessed. They will be now be crossed over to the second pair of study lenses (i.e.
      subjects in the first arm will not receive control lens and the ones in the second arm will
      not receive neurolens). Participants will come back after 35 day wear of their second test
      lens and the symptom questionnaire is reassessed for the final time.
    

Intervention name(s): Neurolens spectacle lens; Placebo spectacle lens
Intervention type(s): Device; Device
Intervention description(s): spectacle lens; spectacle lens for refractive error correction
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective randomized double masked two arm
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: headache; neurolenses; computer vision syndrome; convergence insufficiency; binocular vision; non-strabismic disorder; Digital vision syndrome
Effects of Functional Kinesio Taping on Subacromial Space in Athletes With Rotator Cuff Tendinopathy
Condition: Sports Physical Therapy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      To determine the effects of functional kinesio taping on subacromial space in athletes with
      rotator cuff tendinopathy.
    

Detailed description: 
      Subacromial impingement is a condition among athletes those involved in overhead sports
      activities such as swimming and volleyball. According to Neer there are two main categories
      of shoulder impingement, these are structural and functional. Structural: caused by reduction
      of the subacromial space (SAS) due to bony growth, calcification or soft tissue inflammation
      whereas functional is caused by or superior migration of the humeral head due to muscular
      weakness imbalance. In some cases subacromial impingement can be result from a combination of
      both structural and functional factors.Maintenance of the SAS during arm elevation is thus
      essential for the prevention of Rotator cuff tendinopathy.

      The aim of this randomized controlled trial (RCT) is to evaluate the long-term effects of
      scapular KT, added to a 6-week rehabilitation program, on the subacromial space at different
      arm positions in athletes with Rotator cuff tendinopathy. To better understand the underlying
      mechanisms of KT, our secondary objective addressed the effects of KT on reliving pain-free
      and full ROM of shoulder joint.
    

Intervention name(s): Kinesio Taping
Intervention type(s): Other
Intervention description(s): Kinesio tape is designed in a specific way that it mimics the human skin nature. It more or less has the same width as the epidermis layer and can be stretched upto 40% of its resting length.Clinically, kinesio tape (KT) is used both alone and with other physiotherapeutic interventions, mainly for the pain control, to reduce inflammation, and to improve functional activity in patients with shoulder pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment