bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Two Toothpastes on Bacteria in Saliva
Condition: Oral Health
Study type: Interventional

Summary: 
      This study investigated the ability of two zinc-containing toothpaste formulations (Zinc A
      and Zinc B) to reduce the level of bacteria in saliva in the two-hour period after their use,
      compared to the effect of rinsing with water alone.
    

Detailed description: 
      This was a single centre, three treatment, randomized, blinded, cross-over study which
      involved rinsing with slurries of two sodium fluoride-silica dentifrices containing zinc
      chloride and sodium citrate, and with water alone. The study consisted of four Visits: Visit
      1 (Screening), Visit 2 (Treatment 1), Visit 3 (Treatment 2), Visit 4 (Treatment 3). There was
      a minimum two days wash out period before the first treatment visit and between treatment
      visits to avoid any treatment carry-over effect. During that time participants brushed as
      normal (twice-daily) at home with a washout toothpaste and a toothbrush which was provided at
      screening. Participants were required not to brush their teeth on the morning of the
      treatment visits and not to eat or drink for 2 hours prior to the treatment visits.
    

Intervention name(s): Zinc-A toothpaste; Zinc-B toothpaste; Mineral water
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants received 6.0 grams (g) [± 0.3g] of the Zinc-A toothpaste in the form of slurry, one day per treatment (with at least 2 [generally 7] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.; Participants received 6.0 grams (g) [± 0.3g] of the Zinc-B toothpaste in the form of slurry, one day per treatment (with at least 2 [generally 7] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.; Participants received 6.0g (±0.3g) of mineral water (by weighing out), one day per treatment (with at least 2 [generally 7] days between treatments). Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.
Intervention MeSH terms: Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease
Condition: Heart Failure; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination
      with dapagliflozin compared with dapagliflozin alone and to assess the dose-response
      relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on
      urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with
      heart failure (HF) with left ventricular ejection fraction (LVEF [below 60%]) and chronic
      kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between ≥ 20 and ≤ 60
      mL/min/1.73 m^2, with at least 20% of participants with eGFR ≥ 20 to <30 mL/min/1.73^2 and a
      maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m^2]).
    

Detailed description: 
      After screening, eligible participants will undergo a run-in period where all participants
      receive dapagliflozin for up to 7 weeks depending on pre-study use of SGLT2i or not. At the
      end of the run-in period, eligible participants will be randomly assigned with a 1:1:1:1
      ratio to receive once daily administration of one of the following 4 study treatments group
      for 12 weeks. To ensure blinding, the study treatment will be administered in the form of 3
      oral capsules of AZD9977 or placebo and 1 oral tablet or dapagliflozin.

        1. AZD9977 Dose A + dapagliflozin 10 mg

        2. AZD9977 Dose B + dapagliflozin 10 mg

        3. AZD9977 Dose C + dapagliflozin 10 mg

        4. Dapagliflozin 10 mg

      Participants will be randomized to one of the above treatment group, according to type 2
      diabetes mellitus [T2DM (yes/no)] and eGFR (≥ 20 to <30 mL/min/1.73^2; or ≥ 30 to < 45
      mL/min/1.73^2; or ≥45 mL/min/1.73^2).

      The total duration of participation will be approximately 22 to 24weeks.
    

Intervention name(s): AZD9977; Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive AZD9977 as per the arms they are randomized.; Participants will receive dapagliflozin as per the arms they are randomized.
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants who meet the eligibility criteria will be randomized to one of the following treatment group:
AZD9977 Dose A + dapagliflozin 10 mg
AZD9977 Dose B + dapagliflozin 10 mg
AZD9977 Dose C + dapagliflozin 10 mg
Dapagliflozin 10 mg
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Type 2 diabetes mellitus; Diabetic kidney disease; Chronic kidney disease; Mineralocorticoid receptor modulator; Sodium-glucose co-transporter-2 inhibitor; AZD9977; Dapagliflozin; Urinary albumin creatinine ratio
Just Kwit: Mobile Intervention for Tobacco Cessation
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The intervention will be use of a smartphone app to support tobacco cessation. The app's main
      features include sending motivational messages, displaying money saved, and allowing the user
      to log cravings.
    

Detailed description: 
      The investigators will recruit hospitalized young adult smokers aged 18-30 interested in
      cessation over a six-month period. Patients will all receive a UPMC Tobacco Treatment Service
      counseling session focused on motivational interviewing prior to participation in the study.
      Upon consent, participants will then be randomized 1:1 to either standard patient-initiated
      follow-up or use of the Kwit app. Participants will be stratified by sex because males and
      females are known to have highly variable responses to existing tobacco control
      interventions. Investigators will systematically assess feasibility using established
      Likert-type items factors such as interaction, features, engagement, trust, and impact.

      If a participant consents to the study, they will be given a brief survey to collect general
      information related to their smoking behavior. After 30 days, a follow-up survey will be
      conducted to assess their current smoking behavior. Participants randomized to the
      experimental arm will be asked additional questions about their use of the smartphone app.
    

Intervention name(s): Kwit smartphone app
Intervention type(s): Other
Intervention description(s): Kwit smarphone app
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic Cougher
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy
      as an anti-tussive agent in cough patients.
    


Intervention name(s): AG1321001(drug)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cough; Chronic bronchitis; PNDs; Post Nasal Drip syndrome; GERD; gastroesophageal reflux disease; bronchiectasis
Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction
Condition: Malocclusion, Class I/II
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Corticotomy and micro-osteoperforation (MOP) have been proven to accelerate tooth movement
      and shorten orthodontic treatment time, compared to conventional treatment. MOP is less
      invasive; however, it is unclear whether it is as effective as a corticotomy. The purpose of
      this study was to compare the maxillary canine retraction achieved by these techniques.
    

Detailed description: 
      Thirteen patients (5 females, 8 males; mean age, 18.07±6.74 years) with healthy permanent
      dentition requiring the extraction of maxillary first premolars were included in a
      split-mouth randomized clinical trial. Subjects with previous orthodontic or endodontic
      treatment of canines were excluded. At least 3 months post-extraction, MOPs, and
      corticotomies were performed distal to the canines. Mini-screws with closed-coil springs
      (150g) were used for canine retraction. Dental casts were attained at baseline (T0) and 3
      months post-intervention (T1). Calibrated examiners measured the distances from the canine to
      the second premolar on both sides. A Signed-rank sum test was used to compare canine
      retraction achieved in 3 months (T0-T1) in two sides
    

Intervention name(s): Micro-Osteoperforations; Corticotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): MOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA).
Six perforations were made along 2 parallel vertical lines (each line with 3 holes spaced ~2mm apart) distal to the canine and perpendicular to the buccal cortical bone.
The mini-screws were placed. A NiTi closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g); A full-thickness labial mucoperiosteal flap was reflected. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed. The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex, until bone marrow was exposed.
Cortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites.
The mini-screws were placed. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014"SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g)
Other intervention name(s): MOP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a split-mouth randomized clinical trial.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Corticotomy; MOP; Tooth movement
Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the rate and extent of absorption of
      mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus
      Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single oral
      dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or 1 x
      400 mg delayed-release capsule under fasting conditions.
    

Detailed description: 
      Safety population The safety population is defined as all subjects who received at least one
      dose of the study medication.

      Pharmacokinetic Population The pharmacokinetic population will include all subjects
      completing at least 2 periods and for whom the pharmacokinetic profile can be adequately
      characterised.

      Any subject with pre-dose concentrations for mesalamine will be excluded from the
      pharmacokinetic population for this analyte if the pre-dose concentration is greater than 5%
      of the Cmax value of that period for this subject.

      Data from subjects who experienced emesis during the sampling interval and who were not
      withdrawn as per criterion established under section 9.10 may be evaluated after completion
      of the pharmacokinetic analysis. Any subject who experienced emesis within 2 times median
      Tmax of the current study (based on the Reference product) will be excluded from the
      statistical analysis. Data (concentrations and pharmacokinetic parameters) from subjects
      excluded due to a pre dose concentration greater than 5% of their Cmax or from subjects
      withdrawn due to adverse events or vomiting episodes will be presented but excluded from
      descriptive statistics.
    

Intervention name(s): IBD98-M:; IBD98-M without HA; Delzicol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single adiministration; single adiministration; single adiministration
Other intervention name(s): Mesalamine-Sodium Hyaluronic 400 mg-57.5 mg; IBD98-M without HA: Mesalamine 400 mg; Mesalamine 400 mg
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Long-Term Follow-Up Gene Therapy Study for Leber Congenital Amaurosis OPTIRPE65 (Retinal Dystrophy Associated With Defects in RPE65)
Condition: Leber Congenital Amaurosis (LCA); Eye Diseases; Eye Diseases, Hereditary; Retinal Diseases
MeSH terms: Blindness; Eye Diseases; Retinal Diseases; Retinal Dystrophies; Leber Congenital Amaurosis; Eye Diseases, Hereditary; Genetic Diseases, Inborn
Study type: Observational

Summary: 
      This study is a longer-term follow-up study for patients who have been administered
      AAV2/5-OPTIRPE65 in the Phase I/II, open label, non-randomised, two-centre, dose escalation
      trial in adults and children with retinal dystrophy associated with defects in RPE65.
    

Detailed description: 
      The follow up study is designed to collect data on longer-term safety and efficacy of
      AAV2/5-OPTIRPE65 administration in the OPTIRPE65 trial.
    

Intervention name(s): AAV OPTIRPE65
Intervention type(s): Biological
Intervention description(s): comparison of different doses of AAV RPE65
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population are those with Leber Congenital Amaurosis (LCA) with gene mutation
        RPE65 who have participated in the OPTIRPE65 trial.
The Injury and Its Consequences in the Sports Lower Limb Amputee
Condition: Leg Lower Amputation; Traumatic Amputation
MeSH terms: Amputation, Traumatic
Study type: Observational

Summary: 
      This study was motivated by the lack of data in the literature on the injury of the major
      lower limb amputee playing sports and its socio-professional impact.

      It aims to study sports-related injuries in lower limb amputees. Its objective is to
      determine the prevalence, but also to describe the injuries (type, location, duration, type
      of management) and their repercussions in terms of after-effects, and repercussions on
      sports, professional and personal practice. It also aims to begin a correlation between
      injury and sports load, type of sport (discipline, practice modality), technical aids used
    


Intervention name(s): completion of a questionnaire on the practice of sports and possible injuries
Intervention type(s): Other
Intervention description(s): completion of a questionnaire on the practice of sports and possible injuries
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Lower limb amputee or agenic lower limb with regular physical activity (at least 1x/week)
      
Keywords: sport; lower limb amputation
Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation
Condition: Shoulder Dislocation
MeSH terms: Joint Dislocations; Shoulder Dislocation
Study type: Interventional

Summary: 
      The purpose of this study is to compare non-operative treatment versus operative treatment in
      patients who suffer a complete, acute acromioclavicular (AC) joint dislocation. This study
      will show if one method is superior to the other and will also show advantages and
      disadvantages associated with each treatment method.
    

Detailed description: 
      All patients presenting to the hospital with a Type III, IV or V acute acromioclavicular (AC)
      joint dislocation and meeting the eligibility criteria will be approached and asked to enter
      this prospective, randomized clinical trial. After obtaining consent, the subject will be
      managed in accordance with one of the two randomized treatment strategies. The first
      treatment strategy will involve conservative (nonoperative) management of the AC joint
      dislocation. The second treatment strategy will involve operative fixation (i.e. ORIF) of the
      dislocation with a hook plate and screws.

      The subjects in both treatment groups will receive post-operative care according to the same
      standards and protocol. The surgeon and research staff will be responsible for study
      follow-up (clinical and radiological assessment) of the patient on admission (baseline), on
      discharge from the hospital and at post-operative intervals of six weeks, three months, six
      months, one year and two years. Primary and secondary outcomes will be monitored at these
      post-operative intervals.
    

Intervention name(s): Open Reduction Internal Fixation of AC joint dislocation; Non operative treatment of AC joint dislocation (sling)
Intervention type(s): Procedure; Other
Intervention description(s): Definitive surgical treatment (i.e., ORIF) will be performed within 28 days of the injury. In all cases the procedure will be performed by an orthopedic staff surgeon with the assistance of a fellow/resident(s). The operating surgeon will determine the positioning of the patient for surgery. ORIF of the AC joint dislocation will be carried out as follows:
Anatomic reduction of the AC joint
Definitive fixation with a hook plate and screws; Standard protocol for conservative treatment will consist of the implementation of a sling, for shoulder support and patient comfort, for four weeks followed by physiotherapy. Pendulum exercises may be implemented at any time as dictated by the attending surgeon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromioclavicular Joint; Shoulder dislocation; AC dislocation
A Study With Darapladib to Collect Tolerability Information
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects will receive their first dose of darapladib in the clinical research unit (CRU), and
      the remaining 9 days of dosing will occur at home. Subjects will record any adverse events
      throughout the dosing period in a paper diary. Subjects will return to the CRU 10-14 days
      after the last dose of darapladib for a follow-up visit. The total study duration for each
      subject including the screening, treatment and follow-up periods will be approximately 4
      weeks.
    


Intervention name(s): SB-480848 (darapladib)
Intervention type(s): Drug
Intervention description(s): 160 mg darapladib
Intervention MeSH terms: Darapladib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SB-480848; darapladib; tolerability
BioFeedBack Breathing Training Influence Cardiac Autonomic Nervous System in Children With Cerebral-Palsy.
Condition: Cerebral Palsy; Autonomic Nerveus System
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The effect of breathing biofeedback training to influence the function of the cardiac
      autonomic nervous system at rest and in activity in children with cerebral palsy.

      Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most
      common injury that causes physical handicapped in childhood. There are a few researches that
      investigated the autonomic function in cerebral palsy children. Those researches found
      hyperactivity of the sympathetic autonomic system, including high resting heart rate compare
      to their typically developed pears. The recommended treatment for cerebral palsy is activity,
      muscle strengthening and mobility. The impairment in the autonomic system influences the
      everyday function and has correlation with secondary morbidity.

      As far as we know there are no researches who investigated the following issues.

      In this study we would like to:

        1. Describe the autonomic cardiac function, Breathing function, motor function and the
           correlation between them in children with cerebral palsy.

        2. Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic
           breathing.

        3. Test the influence of breathing training on Heart rate variability parameters at rest,
           in aerobic test right after the breathing training program and one month after, in
           children with cerebral palsy
    

Detailed description: 
      Participants:

      60 children with cerebral palsy age 6-11 who can walk and understand simple instructions.

      Main outcome measures:

      Heart rate variability using Polar watch and transmitter RS810CX.

      Secondary outcome measures:

        1. Lung functioning using Sensormedics Vmax 29 spirometry:Forced Vital Capacity, Forced
           Expiratory Volume in one,Tidal Volume.

        2. Biofeedback

        3. Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and
           transmitter.

        4. Gross Motor Function Classification System

        5. Gross Motor Function Measure

        6. Functional Mobility Scale

        7. Children Assessment of Participation and Enjoyment

        8. Autonomic function questionnaire
    

Intervention name(s): Biofeedback training
Intervention type(s): Other
Intervention description(s): usual treatment +12 biofeedback training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; autonomic nerveus system; heart rate variability