bioihbjkbjnl/mcl2 huggingface dataset:
Testing Native Language Neural Commitment at the Subcortical Level
Condition: Language Development
Study type: Observational

Summary: 
      This mentored student research project is funded by the Graduate Research Partnership Program
      with a projected timeline for data collection in the summer of 2015. Previous research has
      shown that language experience alters the way the human brain processes speech information.
      This phenomenon takes place very early in life and is referred to as Native Language Neural
      Commitment. For instance, as the Japanese language does not have the l-r speech sound
      contrast, Japanese infants start to show difficulty in hearing differences between the
      English l and r sounds at 12 months of age but not when they were at 6 months old. Learning
      the l-r distinction later in life proves to be very difficult for the Japanese school
      students and adults. Brain imaging studies have further revealed specific brain regions that
      are changed by language learning. But the evidence in support of the Native Language Neural
      Commitment theory is based on cortical-level measures. The proposed study extends the
      measurement to the subcortical level at the brainstem. The target language that the
      investigators are interested in studying is Mandarin Chinese, which is known for its use of
      lexical tones to express different words. For instance, the Chinese syllable "ma" means
      "mother" when it is spoken with a flat tone, and it means "hemp" when spoken with a rising
      tone. English, by contrast, does not employ lexical tones, and it is considered a non-tonal
      language. Does the Chinese learning experience fundamental change the way that pitch
      information is coded in the human brain? Does it happen at both cortical and subcortical
      levels? Previous research has shown evidence for a positive answer to both questions. But the
      direct evidence for brain-behavior correlations at the subcortical level is still missing.

      The proposed cross-language study will test Chinese-speaking and English-speaking adults to
      investigate Native Language Neural Commitment at the subcortical level. The investigators are
      interested in differences in the two subject populations by examining the relationship
      between brainstem pitch tracking and behavioral pitch perception in linguistic and
      nonlinguistic stimuli.

      The results of the proposed project will contribute to the understanding the role of the
      subcortical brainstem in Native Language Neural Commitment, which have significant
      implications for the development of auditory/speech training programs and assessment tools
      utilizing the brainstem frequency following measure to monitor progress in second language
      learning and test clinical populations.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Normal healthy adult population.
      
Keywords: Brainstem; Encoding; Pitch
A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 2

Summary: 
      Recurrent herpes labialis are usually a minor malady of limited duration, although they are
      often painful and are uniformly discomforting for patients. Oral antivirals represent an
      advance in the treatment of recurrent herpes labialis, but the clinical implications are
      modest. Randomized, controlled clinical trials have shown that oral antivirals decrease the
      duration of lesion episodes and pain by approximately one day. In recurrent HSV infections
      including herpes labialis, many instances of viral re-activation occur without symptoms, and
      can only be identified by detection of virus on the lips of infected individuals. In these
      cases, the virus is cleared from the local site without the development of a classical
      ulcerative herpes lesion. In the other cases, the triggered specific immune response rapidly
      stops viral replication in the skin and also causes the development of the herpes lesion
      prodrome and a considerable part of the symptoms associated with a classical ulcerative
      herpes lesion. One could therefore predict that treatment with an antiviral drug alone would
      help the immune system in shortening the virus replication, but may not substantially reduce
      the disfiguring symptoms caused by the immune reaction. In dermatology, the principle of
      using an anti-inflammatory drug improve clinical outcomes by reducing inflammation-related
      symptoms associated with the infection has been well established. We have found that a
      topical formulation of VDO is useful for alleviating pain and inflammation associated with
      infection caused by herpes virus.
    

Detailed description: 
      In the treatment of oral herpes labialis, it is desirable to have local absorption of the
      drug to provide pain relief directly at the lesion sites while minimizing overall exposure.

      The present study is designed to elucidate the effects of VDO ( on recurrent herpes simplex
      labialis.
    

Intervention name(s): VDO gel; placebo
Intervention type(s): Drug; Drug
Intervention description(s): VDO gel; matching placebo gel
Other intervention name(s): RMN3001; RMN3001 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: herpes labialis; cold sore
Stopping Cavities Study: Diammine Silver Fluoride
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to test whether the use of diammine silver fluoride (also
      called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.
    

Detailed description: 
      Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free
      water. Subjects are 200 preschool children in good general health with untreated tooth decay.
      Intervention is topical application of the study drug to the open cavity. Primary outcome is
      caries activity at 14-21 days.
    

Intervention name(s): 38% diammine silver fluoride; Water
Intervention type(s): Drug; Other
Intervention description(s): treatment of cavity with study agent; Fluoride free, distilled water
Other intervention name(s): silver fluoride; silver diamine fluoride
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: silver diamine fluoride; diammine silver fluoride; children
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken
      without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was
      evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)
    


Intervention name(s): WE941 OD tablets; Brotizolam
Intervention type(s): Drug; Drug
Other intervention name(s): Lendormin®
Intervention MeSH terms: Brotizolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sport Cord Test Following ACL Reconstruction
Condition: Injury of Anterior Cruciate Ligament
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      The primary purpose of this study is to determine the interrater reliability and validity of
      the Sportcord Test as a measure of physical performance following anterior cruciate ligament
      (ACL) reconstruction. A secondary purpose is to systematically track subjective and objective
      outcomes on patients following ACL reconstruction to help identify differences between those
      who have subsequent knee problems and those who do not. The study hypotheses are the
      following:

      1) The Sportcord Test will provide a valid and reliable measure of functional performance
      following ACL reconstruction. 2) Patients who have subsequent knee problems in the 12 month
      study period will exhibit different scores on clinical special tests compared to those who do
      not.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving physical therapy/rehabilitation for an ACL surgery and are returning to
        participation in sports.
      
Keywords: Physical Therapy; Return to sport
A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and preliminary performance of the ROX
      Anastomotic Coupler System (ACS), with standard of care (as defined per GOLD) in patients
      with Chronic Obstructive Pulmonary Disease (COPD) as compared to standard of care alone.
    

Detailed description: 
      Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease that leads to irreversible
      changes in the lung structure, but also to systemic changes in the body that can influence
      the severity of the disease. The irreversible changes to the lungs can be seen in limitations
      to the pulmonary function. The purpose of this clinical investigation is to evaluate the
      performance and efficacy of the ROX percutaneous Anastomotic Coupler System.
    

Intervention name(s): ROX Anastomotic Coupler System (ACS)
Intervention type(s): Device
Intervention description(s): The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung Disease; Chronic Airflow Obstruction; Chronic Bronchitis; Pulmonary Emphysema; Walk
Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission
Condition: HIV Infections; AIDS; Sexually Transmitted Diseases; HIV Seroconversion
MeSH terms: Sexually Transmitted Diseases; HIV Seropositivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study are to determine whether Carraguard® Gel can prevent the
      transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe
      for vaginal use.
    

Detailed description: 
      This study is designed to show if Carraguard® can protect women against HIV if it is used
      before sex, and is safe for long-term use.
    

Intervention name(s): Carraguard (PC-515)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Microbicide; HIV; AIDS; STIs; STDs; Efficacy; HSV; Women; South Africa; seroconversion; condom; safe-sex; vaginal intercourse; prevention; HIV Seronegativity
Effect Of Probiotic Lactobacillus Paracasei Lp-33 For The Management Of Rhinitis In People Sensitized To Allergens
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to show an improvement of quality of life on the 5th week of product
      consumption (probiotic Lactobacillus paracasei LP-33)(as assessed by RQLQ global score) in
      subjects with persistent allergic rhinitis currently treated with Loratadine or oral
      anti-histaminic treatment.
    

Detailed description: 
      Oral H1-antihistamines are first treatment recommended for allergic rhinitis (Bousquet et al,
      2008) however they do not completely alleviate symptoms. This new study will therefore assess
      the effect of Lactobacillus paracasei LP-33 in the management of nasal and ocular symptoms,
      in addition to H1-antihistamines treatment. The main objective is to evaluate the effect of
      Lactobacillus paracasei LP-33 on quality of life. Additionally allergic rhinitis symptoms
      (nasal and eye symptoms) and immunological parameters will be evaluated, before and during
      the supplementation. Lactobacillus paracasei LP-33 is targeting the general population and
      improving quality of life of people sensitized to allergens. The study will be conducted in
      Europe on adult subjects with persistent allergic rhinitis.
    

Intervention name(s): Placebo; Lactobacillus paracasei LP-33
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Description:
- capsule size 3
Composition of the product:
45 mg of microcristalline cellulose,
132 mg of maltodextrin,
3 mg of magnesium stearate.
Composition of the capsule:
46 mg of hypromellose,
1 mg of titanium dioxide.
Packaging:
Products are packaged in aluminium tubes of 30 capsules.
Storage:
The product should be stored in a fridge. Direction for use: subject should consume 1 capsule daily together with a meal, with a glass of water.
The study products will be consumed daily for 7 weeks.; Description:
minimum 2.0x109 CFU of Lactobacillus paracasei LP-33
capsule size 3 1 capsule daily together with a meal, with a glass of water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Allergic rhinitis-Probiotic Lactobacillus paracasei LP-33-
Effect of Upper Limb Ergometer on the AIP in Post Menopausal Obese Women.
Condition: Post Menopausal Obese Women
Study type: Interventional

Summary: 
      Participants had randomly divided into two equal groups. Group (A) which is the control group
      receive normal routine medication. Group (B) will receive normal routine medication with the
      treatment program of moderate intensity upper limb ergometer for 15 minute with frequency
      three times per week for four weeks.
    

Detailed description: 
      Control group (A):

        1. Each participant will sign a consent form after receiving a detailed explanation about
           the procedure.

        2. A blood sample will been taken by a nurse in a heparinized tube and delivered to lab
           within six hours.

        3. BMI will been measured body weight(Kg) and height (m2)

           a. BMI= body weight (Kg)/ height (m2).

        4. Waist circumference will be measured.

        5. After one month blood analysis evaluation will be done to record the response to the
           routine medication.

      Training Procedure for group (B):

        1. Each participant will sign a consent form after receiving a detailed explanation about
           the procedure.

        2. A blood sample will been taken by a nurse in a heparinized tube and delivered to lab
           within six hours.

        3. BMI will been measured body weight(Kg) and height (m2)

           a. BMI= body weight (Kg)/ height (m2).

        4. Waist circumference will be measured.

        5. The maximum heart rate will be determined from Tanaka formula (208- 0.7 *age of the
           participant)

             -  Then the exercise load will be determined according heart rate reserve of the
                participants ( maximum heart rate - resting heart rate).

        6. Start with sitting resting without any effort for 5 min then Start at a low speed and
           intensity for 5 minutes to warm up the body.

        7. Increase the speed and intensity for 10-30 seconds before dropping it back for 2-5
           minutes and Repeat according to the intensity.

        8. Finally, a five minutes of cooling down with no resistance had performed.

        9. After one month blood analysis evaluation will be done to record the response to the
           routine medication.
    

Intervention name(s): Electronic Upper limb( body) ergometer
Intervention type(s): Device
Intervention description(s): Electronic pedal for the upper limb using for training the upper body. Intensity, speed and resistance can be adjusted.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants had randomly divided into two equal groups. Group (A) which is the control group receive normal routine medication. Group (B) will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks.
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Tucatinib on Cardiac Repolarization in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is looking at how the study drug, tucatinib, affects the heart. Tucatinib is being
      studied as a possible treatment for breast cancer. This study will recruit healthy
      volunteers. There are 3 parts in the study. Each volunteer will be in all 3 parts. One part
      will be to take the study drug, the second part will be to take a placebo (pill with no
      medicine), and the third part will be to take moxifloxacin. The volunteers will only know
      what part of the study they are in when they take moxifloxacin. For the study drug and
      placebo parts, volunteers will take 2 pills by mouth for 5 days. For the moxifloxacin part,
      volunteers will take 1 pill by mouth for 1 day.
    

Detailed description: 
      This study will evaluate the effects of a steady state therapeutic dose of tucatinib on QTcF
      (QT interval corrected for heart rate using Fridericia's method) in healthy individuals. In
      this design, study treatment will be dosed in 3 sequential treatment periods:

      Treatment A: Oral doses of 300mg tucatinib for 5 days

      Treatment B: Oral doses of matching placebo for tucatinib for 5 days

      Treatment C: A single oral dose of 400 mg of moxifloxacin

      Patients will be randomized based on 2-Williams-square design to 1 of 6 treatment sequences
      to maintain the study blind for tucatinib and placebo.
    

Intervention name(s): tucatinib; placebo; moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300mg oral dose; Matching placebo for tucatinib; 400mg single oral dose
Intervention MeSH terms: Moxifloxacin; Tucatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects
Condition: Coagulation Disorder
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A single centre, double-blind, randomized, parallel group, placebo-controlled study in
      healthy subjects conducted in two parts:

      Part 1: Single ascending doses in healthy subjects aged 18 to 49 years to assess safety,
      pharmacokinetics (PK) and pharmacodynamic (PD) effects of VMX-C001.

      Part 2: Healthy subjects aged 50 to 79 years to assess safety, PK and PD effects of VMX-C001
      in the presence of DOACs.
    


Intervention name(s): VMX-C001; Placebo; Apixaban; Rivaroxaban; Edoxaban
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): VMX-C001 is human factor X engineered to be insensitive to factor Xa DOACs; VMX-C001 matched placebo; FXa Inhibitor; FXa Inhibitor; FXa Inhibitor
Intervention MeSH terms: Rivaroxaban; Apixaban; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo controlled, single ascending dose.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Direct oral anticoagulant (DOAC); Human coagulation factor X
Understanding and Treating Heart Failure With Preserved Ejection Fraction: Novel Mechanisms, Diagnostics and Potential Therapeutics
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The objectives of this study are: 1) to design new diagnostic criteria used to accurately
      define heart failure with preserved ejection fraction (HFpEF); 2) to better define the risk
      factors associated with HFpEF; 3) to elucidate the clinical, cellular and molecular
      mechanisms involved with the development and progression of HFpEF; 4) to design and test new
      therapeutic strategies for patients with HFpEF.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents of Alberta, Canada with heart failure or at risk for developing heart failure
Bioequivalence Study of Crushed Elbasvir/Grazoprevir Compared to the Whole Tablet
Condition: Hepatitis C; Deglutition Disorders
MeSH terms: Hepatitis C; Deglutition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Elbasvir/grazoprevir (Zepatier®) is a once-daily tablet for the treatment of chronic
      hepatitis C virus (HCV) GT1a, 1b or 4 infection containing the NS5A inhibitor elbasvir (ELB)
      50 mg and the NS3/4A protease inhibitor grazoprevir (GZR) 100 mg.

      For patients with swallowing difficulties, administration of whole tablets can be
      problematic. In addition, HCV patients that are hospitalized (at intensive care units) due to
      severe illness (co-infections/ liver failure) might not be able to swallow medication.
      Therefore it is useful to know whether it is possible to administer ELB/GZR through a
      different route, like a feeding tube.

      In daily practice, information about the safety and efficacy of crushed tablets is lacking
      which might result in noncompliance, interruption or discontinuation of expensive HCV
      therapy. However, it is not recommended to interrupt treatment because there is no evidence
      about the efficacy of the therapy after discontinuation (and restarting).

      Currently, patients and healthcare professionals are crushing tablets without information
      about efficacy and safety. Depending on the biopharmaceutical characteristics of a drug
      formulation, crushing tablets can lead to altered pharmacokinetics of drugs.

      It is important to know whether pharmacokinetic parameters are influenced by crushing of
      tablets; both a decrease and an increase in exposure may occur. A decrease of the plasma
      concentrations of ELB and/or GZR potentially reduces the therapeutic effect of the drugs.
      Higher doses or switching to other HCV-drugs might be needed. In contrast, in case a higher
      Cmax and/or AUC occurs there might be an increased risk of toxicity.

      As a result, crushing the drug is a contra-indication based on the available data. Therefore
      this study will be conducted to investigate whether a crushed ELB/GZR tablet is bioequivalent
      to ELB/GZR as a whole tablet.
    


Intervention name(s): Zepatier whole tablet; Zepatier crushed tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose ELB/GZR as a whole tablet in a fasted state.; Single-dose crushed ELB/GZR in a fasted state.
Intervention MeSH terms: Elbasvir-grazoprevir drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, 2-period, randomised, cross-over, single-centre, phase I, single-dose trial in 14 healthy adult subjects.
Intrasubject comparison of PK parameters after different administrations of Zepatier
Masking: None (Open Label)
Primary purpose: Treatment