bioihbjkbjnl/mcl2 huggingface dataset:
Fitting Children With Contact Lenses
Condition: Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this three-month study is to compare the quality of life and ease of fit among
      children wearing investigational single-vision contact lenses, commercially marketed
      single-vision contact lenses, and commercially marketed multifocal contact lenses.
    


Intervention name(s): Lotrafilcon B contact lens, investigational; Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA); Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL); Contact lens care system (ClearCare)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Investigational silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly; Commercially available silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly.; Commercially available silicone hydrogel, multifocal, contact lens worn on a daily wear basis and replaced monthly.; Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses
Other intervention name(s): AIR OPTIX AQUA; AIR OPTIX AQUA MULTIFOCAL; CLEAR CARE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Myopia; contact lenses; children
Efficacy of Plyometrics to Increase Bone Mass in Men With Osteopenia
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      This study will compare the ability of two types of long term (12 months) weight-bearing
      exercise treatments (1. high-intensity jumping and 2. weight lifting) to increase bone mass
      of the total body, spine and hip in physically active men with osteopenia.
    

Detailed description: 
      The overall goal of this project is to determine the efficacy of chronic (12 months)
      plyometric jump training exercise on bone mineral density (BMD) and markers of bone turnover
      in physically active males cyclists diagnosed with osteopenia below normal bone mineral
      density of the lumbar spine or hip.
    

Intervention name(s): resistance exercise; plyometric exercise
Intervention type(s): Other; Other
Intervention description(s): 12 month training intervention of weight resistance exercise. All participants receive a daily calcium and vitamin D supplement; 12 month training intervention of plyometric exercise. All participants receive a daily calcium and vitamin D supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared
      with continued duloxetine in the treatment of patients with treatment resistant depression
      (TRD).
    


Intervention name(s): Duloxetine; Placebo matching with BMS-820836; BMS-820836; Duloxetine; Placebo matching with Duloxetine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks; Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks; Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks; Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks; Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
Other intervention name(s): Cymbalta; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Essential Amino Acids and High Intensity Interval Training
Condition: Cardiovascular Risk Factor; Obesity
Study type: Interventional

Summary: 
      Purpose: The primary purpose is to determine the combined effects of essential amino acids
      (EAA) supplementation and high intensity interval training (HIIT) on body composition, muscle
      characteristics, and muscle architecture in overweight men and women over the course of eight
      weeks. A secondary purpose is to determine the metabolic effects of EAA supplementation and
      HIIT on whole body protein turnover, metabolic rate, substrate metabolism, and metabolomics.
      A tertiary purpose is to evaluate the modulatory effects of sex on body composition,
      metabolism, metabolic profile, cardiorespiratory fitness, and hunger and satiety in response
      to EAA supplementation and HIIT. Participants: Healthy overweight and obese men and women
      (30-50 years) Procedures (methods): In a block randomized design, 78 healthy, overweight or
      obese men and women will be randomized, to one of four, eight-week intervention groups using
      a 2:2:2:1 group allocation design: 1) essential amino acids (EAA) supplementation (7.2 grams
      EAA daily); 2) HIIT, two days per week of cycle ergometry training; 3) EAA + HIIT; or 4)
      control (CON), receiving no intervention. Measurements of body composition, muscle
      characteristics, resting metabolic rate, substrate metabolism, and cardiorespiratory fitness
      will be measured at baseline, 4-weeks, and 8-weeks. Metabolomics and whole body protein
      turnover will also be measured at baseline and 8-weeks. Subjects will be asked to arrive to
      testing sessions following a 12 hour fast (except for water), consuming no food, caffeine, or
      alcohol. Participants will also be asked to abstain from physical activity for 24 hours prior
      to testing. Subjects will complete one electronic contact (phone/email screening) and up to
      22 in-person sessions (enrollment; 5 testing sessions [2 at base, 1 at 4week, 2 at 8week]; 16
      training sessions [for HIIT and EAA+HIIT]) over the course of 8 weeks.
    


Intervention name(s): High Intensity Interval Training; Essential Amino Acid; High intensity interval training and essential amino acid supplement
Intervention type(s): Other; Dietary Supplement; Other
Intervention description(s): Exercise; Oral ingestion of a powdered dietary supplement; Exercise and dietary supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of Acetylsalicylic Acid on Immunoparalysis Following Human Endotoxemia
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      Rationale:

      The last years, research focus has moved to immunostimulatory agents in order to restore or
      increase the functionality of the immune system during sepsis-induced immunoparalysis.
      Epidemiologic data show that prehospital use of low dose acetylsalicylic acid (ASA) is
      associated with improved outcome of sepsis. Experimental data indicate that ASA exerts
      pro-inflammatory effects during systemic inflammation. However, it remains to be determined
      whether treatment with ASA improves immune function once immunoparalysis has developed and
      whether prehospital use of low dose ASA prevents the development of immunoparalysis. In the
      former case, ASA is a potential immunostimulatory therapy that can treat sepsis-induced
      immunoparalysis. In the latter case, ASA may have a broader indication as an immunomodulating
      agent. Taken together, ASA might be a promising, cheap, well-known, and globally available
      agent to reduce the incidence of secondary infections and improve patient outcome in sepsis.

      Objective:

        -  To determine whether acetylsalicylic acid treatment can reverse endotoxin tolerance,
           which is expressed as a decrease in pro-inflammatory cytokine levels between the first
           and second endotoxin challenge.

        -  To determine whether acetylsalicylic acid prophylaxis can prevent endotoxin tolerance,
           which is expressed as a decrease in pro-inflammatory cytokine levels between the first
           and second endotoxin challenge.

      Study design:

      Double-blind randomized placebo-controlled pilot study in 30 healthy male volunteers during
      repeated experimental endotoxemia. All subjects will receive a 14 day course of study
      medication (low-dose ASA or placebo) and undergo experimental endotoxemia (lipopolysacharide
      (LPS), E.Coli type O113) on day 7 and on day 14. LPS is administrated using an initial bolus
      of 1ng/kg followed by continuous infusion at 1ng/kg/hr during 3 hours.

      Subjects are randomized in three study arms:

        1. Treatment group: 7 days placebo / first endotoxemia / 7 days ASA 80 mg (loading dose on
           first day of 160mg) / second endotoxemia

        2. Prophylaxis group: 7 days ASA 80 mg (loading dose on first day of 160mg) / first
           endotoxemia / 7 days ASA 80 mg / second endotoxemia

        3. Placebo group: 7 days placebo / first endotoxemia / 7 days placebo / second endotoxemia
    


Intervention name(s): Aspirin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Acetylsalicylic acid; ASA
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: human endotoxemia; LPS; acetylsalicylic acid; placebo; endotoxin tolerance
Discordant HER2/Neu Status of Breast Cancer.
Condition: Malignant Neoplasm of Breast.
MeSH terms: Neoplasms; Breast Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine discordant HER2/neu status of primary breast tumor
      and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer
      patients.
    

Detailed description: 
      HER2/neu status of primary breast tumor and axillary lymph nodes were tested by IHC staining.
      In the cases of equivocal result of IHC, FISH test were performed.

      The result of HER2/neu status between primary breast tumor and axillary lymph node were
      analyzed.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breast Cancer Patients Stage I,II and III.
      
Biospecimen description: 
      Paraffin embedded tissue blocks of primary breast tumor and axillary lymph nodes
Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries
Condition: Early Childhood Caries
Study type: Interventional

Summary: 
      Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38%
      SDF solution after sex and twelve months in arresting ECC lesions.

      The Null hypothesis will be that no statistically significant difference will be detected
      between the two groups in the arrest of carious lesions in children with ECC.
    


Intervention name(s): Nanosilver; Silver diamine fluoride
Intervention type(s): Drug; Drug
Intervention description(s): preventive material for arresting caries; preventive material for arresting caries
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Caries arrest, early childhood caries, Nanosilver fluoride
"Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer
Condition: Colonic Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Background. Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in
      colonic laparoscopic resections because of faster recovery and less perioperative
      complications.

      Objective. Aim of this study is to assess safety and feasibility of discharging patients
      operated on by laparoscopic colectomy on Post Operative Day 2 (POD 2), so long as the first
      flatus has passed and in the absence of complication-related symptoms.

      Design & Settings. Non-inferiority, open-label, single center, prospective, randomized study
      comparing "Ultra" to Classic E.R.A.S. with discharge on POD 2 and 4 respectively.

      Patients. 765 patients with resectable non metastatic colonic cancer were analyzed: 384
      patients were assigned to "Ultra" E.R.A.S. and 381 to Classic E.R.A.S.

      Main Outcome Measures. Demographics, clinico-pathological, ASA class and morbi-mortality,
      along with surgical complications, re-operation and readmission rate were recorded and
      compared. Primary end-point was mortality; secondary end-points were morbidity, re-admission
      and re-operation rate.

      Limitations. It is a single center experience; it is not double-blind, with the intrinsic
      risk of intentional or unconscious bias; exclusion criteria because of "non compliance" may
      be considered arbitrary.
    

Detailed description: 
      From January 2008 to September 2015, 765 patients were prospectively randomized for early
      discharge after laparoscopic colectomy according to E.R.A.S. programs: after obtained
      informed consent, 384 patients were randomly assigned to the "Ultra" E.R.A.S. group and 381
      to Classic E.R.A.S. group.
    

Intervention name(s): "Ultra" E.R.A.S.; Classic E.R.A.S.
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colonic cancer; E.R.A.S. programs; Safety
Digital Intervention Postoperative Protocol
Condition: Surgery; Otolaryngologic Disorder; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative recovery after head and neck surgery is complex, and often requires utilization
      of narcotic medications. The aim of this study is to evaluate reduction in pain and use of
      opioid medications through Virtual Reality (VR) and Fitbit wearable activity devices.
    

Detailed description: 
      Enhanced Recovery After Surgery (ERAS) protocols were introduced as a method to optimize
      perioperative patient care. Narcotic medications are frequently utilized in postoperative
      care, but these have risks including sedation or dependence. Non-pharmacologic measures for
      postoperative pain control may help limit the need for opioids in postoperative pain control.

      Early mobilization is also important after surgery, however postoperative mobility is rarely
      monitored and relies on subjective reports.

      The investigators will seek to examine the implementation of an ERAS protocol using VR and
      Fitbit wearable activity devices on postoperative recovery after head and neck surgery. This
      is a prospective, 4-arm, randomized controlled trial.
    

Intervention name(s): Virtual Reality; Fitbit
Intervention type(s): Device; Device
Intervention description(s): Use of any virtual reality experiences available; Use of a Fitbit wearable activity device to track daily step goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Acceptability of Depo-subQ Provera 104 in Uniject vs. Intramuscular Depo-Provera Among HIV+ Women & Providers, Uganda
Condition: Acceptability of Different Contraceptive Injection Types
Study type: Interventional

Summary: 
      The purpose of this study is to assess acceptability and side effects of a low-dose
      injectable contraceptive formulation which is delivered under the skin (subcutaneously), as
      compared with injectable contraception delivered into the muscle (intramuscularly) among
      adult HIV-positive women who attend mobile clinics for HIV care and wish to use injectable
      contraception. The investigators will also assess experiences experiences delivering these
      two types of injections among health care providers working within the HIV care clinics.
    


Intervention name(s): DepoSubQ Provera 104 in Uniject; Intramuscular DMPA
Intervention type(s): Drug; Drug
Intervention description(s): DepoSubQ Provera 104 in Uniject; Intramuscular DMPA
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: injectable contraception; acceptability; intramuscular; subcutaneous
Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial to compare the pharmacokinetic characteristics of
      YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin
      Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2,
      Vd/f, CL/f.
    


Intervention name(s): Lyrica 150Mg Capsule; YNP-1807 330Mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg oral administered (BID); 330 mg oral administered (QD)
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Performance Enhancement and Non-Invasive Brain Stimulation
Condition: Executive Function; Motor Activity; Brain Stimulation
Study type: Interventional

Summary: 
      A promising form of enhancing brain function non-invasively involves stimulating the brain
      using weak magnetic or electric currents. This method is becoming increasingly popular in
      both clinical and commercial circles; a number of portable, at-home devices are available on
      the commercial market for personal use. In this study, the investigators aim to determine
      factors associated with the enhancement of cognitive and motor learning following
      transcranial direct-current stimulation in healthy young adults. Understanding how
      participants respond to brain stimulation is critical to maximizing the effectiveness of
      stimulation and determining its potential as a performance-enhancing aid for mental tasks.
      Future developments of this study may also inform the capacity of brain stimulation to act as
      non-drug alternative to treatment for cognitive decline.
    

Detailed description: 
      This study involves a single session of anodal tDCS, applied over the motor cortex, while
      performing a task of motor dexterity. Pre and post stimulation evaluations will assess any
      effects of the stimulation on motor and cognitive performance.
    

Intervention name(s): Transcranial Direct Current Stimulation; Working Memory Training
Intervention type(s): Device; Behavioral
Intervention description(s): Non-invasive brain stimulation applied to the surface of the scalp; Cognitively challenging game played concurrently with transcranial direct-current stimulation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the effect of repeat oral dose of lapatinib treatment on the pharmacokinetics
      of a single oral and single intravenous dose of midazolam in adult cancer patients. Also to
      assess the safety and tolerability of chronic oral lapatinib therapy in cancer patients.
    


Intervention name(s): Midazolam; Lapatinib
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive midazolam by oral or IV route on Days 1, 3, 9 and 11. Oral midazolam was supplied as 3 mg tablets; IV midazolam was supplied as 1 milligram per milliliter (mg/L) sterile solution.; Subjects will receive 1500 mg lapatinib by oral route once daily from Day 4.
Other intervention name(s): GW572016 oral tablets
Intervention MeSH terms: Lapatinib; Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: midazolam; pharmacokinetics; lapatinib
Effects on Insulin Resistance With Tadalafil in Type 2 Diabetes - a Double-blind, Placebo-controlled Crossover Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim is to continue our program on PDE5 inhibition by evaluating effects on insulin
      resistance, including glucose metabolism and subclinical inflammation, after a 6-week
      administration of tadalafil in T2D patients. The primary objective is to study the effect of
      tadalafil compared with placebo on insulin sensitivity during a euglycemic hyperinsulinemic
      clamp.

      This is a double-blind, placebo-controlled crossover study with one study site. Twenty-five
      T2D patients will be recruited and randomized to per oral intake of tadalafil 20 mg o.d. for
      six weeks and after a wash-out period of eight weeks intake of placebo for another six weeks,
      or vice versa. At the end of each 6 week treatment period a glucose clamp, subcutaneous
      needle biopsies as well as muscle and subcutaneous microdialysis will be performed.
      Endothelial function tests and arginin stimulation of insulin secretion tests will be
      performed after 3 weeks in each treatment arm.
    


Intervention name(s): Tadalafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Per oral intake of placebo for six weeks
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care