bioihbjkbjnl/mcl2 huggingface dataset:
The Efficiency of Video-Based Exercises in Individuals With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of the study is to compare the video-based balance coordination exercise program and
      the video-based conventional exercise program in patients with subacute stroke.
    

Detailed description: 
      Thanks to telerehabilitation, it will be possible for individuals to learn the exercise
      programs in the most appropriate way and to communicate easily with their physiotherapists
      with video images. In this way, it will be ensured that individuals can perform their
      exercises at the optimum level in non-clinical environments. The aim of the study is to
      compare the conventional home exercise program performed with video-based telerehabilitation
      and the balance coordination program in subacute stroke patients.
    

Intervention name(s): Conventional Exercise Group with Telerehabilitation; Balance Coordination Group with Telerehabilitation
Intervention type(s): Other; Other
Intervention description(s): Exercises such as conventional muscle strengthening and stretching given with telerehabilitation are applied.; Functional muscle strengthening, stretching, balance and coordination exercises given with telerehabilitation are applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Telerehabilitation; Balance; Coordination
Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      The purpose is to assess accuracy of digital retinal image interpretation by technicians and
      direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and
      the presence of diabetic macular edema for the identification of referrals to
      ophthalmologists. The results of both screening methods were compared with comprehensive eye
      examination by ophthalmologists.
    

Detailed description: 
      Diabetic visual disabilities have increasingly become a global concern since a number of
      diabetic patients are expected to surge dramatically in the coming decade. Essential means to
      minimize this problem are detecting vision-threatening diabetic retinopathy early in the
      course of disease and timely interventions by ophthalmologists.

      The American Diabetes Association had issued a guideline for the detection and recommended
      regular comprehensive eye examination as a preferred method. However, it is not likely that
      there will be ophthalmologists enough to comprehensively examine the surging number of
      diabetic patients. Other practical screening methods, such as an interpretation of digital
      retinal images or direct ophthalmoscopy employed by other health care providers, for
      identifying the retinopathy for referral to ophthalmologists, should minimize this problem.
    

Intervention name(s): Digital retina image; direct ophthalmoscopy; comprehensive eye exam
Intervention type(s): Device; Device; Procedure
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Screening
Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to pilot an intervention that was developed to improve uptake
      and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth
      prevention. Non-Hispanic Black (NHB) women are at higher risk for preterm birth compared to
      other racial and ethnic groups. Building on qualitative data from NHB women with input from a
      multidisciplinary stakeholder group, a patient-centered intervention was developed to improve
      uptake and adherence to an IP3 in NHB women.
    

Detailed description: 
      The study team will pilot test the intervention via a pilot randomized controlled trial. 60
      pregnant NHB women will be recruited who have a history of singleton preterm birth and are
      currently pregnant with a singleton gestation. Consenting participants will be randomized to
      the intervention or an active control. The intervention includes: 1) an informational
      narrated powerpoint presentation that reviews the logistical details of the IP3, 2)
      structured encouragement via text messages and 3) employment law education sheet. The
      powerpoints will also be available for review on our you-tube channel for intervention
      patients. The active control arm includes: 1) a narrated powerpoint describing the Duke
      Prematurity Prevention Program and 2) text messages with general pregnancy information (i.e.
      it is safe to take Tylenol in pregnancy). At study intake, we will collect demographic data
      (age, self-described race, pregnancy history, social history, pregnancy-related anxiety
      scale, interpersonal processes of care and maternal social support index.

      The team will collect feedback on the intervention based on an intake questionnaire and an
      exit interview.

      Information will also be collected on adherence to the IP3 based on review of the
      participant's medical record. The primary aim of the study is to evaluation feasibility and
      acceptability. These endpoints will be measured via enrollment and participant feedback
      during the exit interview.
    

Intervention name(s): Intervention Arm Weekly IP3 text messages; Active Control Arm General pregnancy text messages
Intervention type(s): Behavioral; Other
Intervention description(s): Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.; Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention Arm vs. Active Control Arm
Masking: None (Open Label)
Primary purpose: Prevention
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the serum uric acid lowering effects and safety of lesinurad compared
      to placebo in patients who are intolerant or have a contraindication to allopurinol or
      febuxostat.
    

Detailed description: 
      Allopurinol is the standard of care for the treatment of gout. In practice, approximately 20%
      of patients report side effects with allopurinol and 5% discontinue allopurinol due to side
      effects. Allopurinol can cause gastrointestinal intolerance, such as nausea and diarrhea,
      which appears to be dosedependent. Rash develops in about 2% of patients treated with
      allopurinol, and in about 20% of patients treated with allopurinol and ampicillin or
      amoxicillin. Allopurinol hypersensitivity syndrome remains a major concern among physicians.
      Mortality has been estimated to be up to nearly one quarter of AHS cases, with multiorgan
      system disease including hepatocellular changes and renal failure being a serious concern.
      Allopurinol is also relatively contraindicated for use in combination with 6-mercaptopurine
      and azathioprine, for which 1/4 to 1/3 lower doses must be given in order to avoid
      hematologic toxicity. Febuxostat, in clinical trials, has shown a similar AE profile to
      allopurinol. Liver function abnormalities, nausea, arthralgia and rash were the most commonly
      reported AEs. In postmarketing experience, Stevens Johnson Syndrome and hypersensitivity
      rashes have been reported (febuxostat prescribing information). Withdrawals due to AEs were
      similar in frequency to allopurinol as well. Relative contraindications in combination with
      6-mercaptopurine and azathioprine are similar to allopurinol as well. Lesinurad may be an
      important therapeutic option for patients who either cannot tolerate or who have a
      contraindication to the use of allopurinol or febuxostat.
    

Intervention name(s): lesinurad; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 400 mg QD; Tablets, Placebo QD
Intervention MeSH terms: Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gout
A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      A one year double-blind trial to investigate the efficacy and safety of meloxicam oral
      suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral
      suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.
    

Detailed description: 
      Objective: In an international, multicenter, double-blind, randomized clinical trial we
      evaluated the short-term (3 months) and long term (12 months) efficacy and safety of two
      doses of meloxicam oral suspension compared with naproxen in children with oligo and
      polyarticular course juvenile idiopathic arthritis (JIA).

      Methods: Children with active oligo or polyarticular course JIA, requiring therapy with an
      NSAID were eligible for this trial. Patients were randomly allocated to therapy with
      meloxicam oral suspension 0.125 mg/kg body weight in single daily dose, meloxicam 0.25 mg/kg
      body weight in single daily dose, or naproxen 10 mg/kg body weight in two daily doses. The
      trial drugs were administered in a double-blind, double-dummy design for up to 12 months.
      Response rates were determined according to the American College of Rheumatology Pediatric
      30% definition of improvement (ACR Ped 30). Safety parameters were assessed by evaluation of
      the adverse events in the 3 groups.

      Study Hypothesis:

      The null hypothesis of interest is that the magnitude of response with regard to the primary
      endpoint is equivalent between the treatment groups. The alternative is that there is any
      difference (two-sided) between any of the treatment groups.

      Comparison(s):

      Naproxen oral suspension 10 mg/kg body weight.
    

Intervention name(s): meloxicam 0.25 mg/kg; meloxicam 0.125 mg/kg; naproxen 10 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Naproxen; Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine ABA of TAK-831 following a single microdose
      intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi])
      [14C]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period
      1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and
      total radioactivity concentration equivalents in plasma and whole blood following a single
      oral suspension dose of 500 mg (approximately 100 μCi) [14C]TAK-831 in Period 2.
    

Detailed description: 
      The drug being tested in this study is called TAK-831 (also known as luvadaxistat). The study
      will determine ABA in Period 1, and the absorption, metabolism, excretion, and mass balance
      of TAK-831 after single oral administration in Period 2 in healthy adult male participants,
      by collecting plasma, urine, and feces samples for drug concentration analysis, and plasma,
      whole blood, urine, and fecal samples for total radioactivity analysis and metabolic
      profiling.

      The study will enroll approximately 6 participants. The study is designed to consist of 2
      periods: Period 1 (ABA study period) and Period 2 (absorption, distribution, metabolism, and
      elimination [ADME] study period). In Period 1 (ABA study period), all participants will
      receive a single unlabelled oral dose of TAK-831 as tablet and a microdose intravenous
      infusion of 50 μg (approximately 1 μCi) [14C]TAK-831, followed by a washout period of 8 days
      before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a
      single dose of 500 mg (approximately 100 μCi) [14C]TAK-831 as an oral suspension.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 65 days including screening period. Participants
      will be contacted approximately 30 days after the last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): TAK-831 Oral Tablet; [14C]TAK-831 IV Infusion; [14C]TAK-831 Oral Suspension
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-831 tablet.; [14C]TAK-831 IV infusion.; [14C]TAK-831 oral suspension.
Other intervention name(s): Luvadaxistat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Post-Stroke Osteopathy
Condition: Stroke (CVA) or TIA; Fracture; Fall
MeSH terms: Stroke
Study type: Observational

Summary: 
      The sudden biomechanical inactivation, direct neuro-humoral effects and sustained systemic
      stress reaction, which commonly occur after stroke or TIA, all may be of relevance in
      triggering alterations in bone metabolism and remodelling of bone microstructure.

      The objectives of this observational pilot study are to characterize falls and fractures and
      their circumstances (sex and age specific incidence, time course, risk conditions,
      localization) in ischemic stroke patients, study changes in the bone microstructure after
      ischemic stroke supported by high-resolution peripheral quantitative Computer Tomography,
      unravel a molecular mechanisms underlying the increased fracture risk (focus on Wnt-signaling
      and ß-adrenergic projection), establish risk factors to estimate the risk of falls based on
      information from gait analysis as well as construct deep learning algorithms to identify bone
      microstructure parameters for predicting fractures.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        As a sub-study of the STROKE-CARD Registry Study the source population will be all patients
        treated at the Department of Neurology Innsbruck (Austria) for stroke and included in the
        STROKE-CARD Registry Study. The target study population for the Post-Stroke Osteopathy
        Study will be all patients included in the STROKE-CARD Registry Study (clinicaltrials.gov
        ID NCT04582825).
      
Biospecimen description: 
      CTX1 und CTX 2, Osteocalcin, TRAP5b, Bone Alkaline Phosphatase, Sclerostin, Periostin,
      RANKL-OPG-Ratio
    
Keywords: high-resolution peripheral quantitative Computer Tomography; Bone microstructure
High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia
Condition: Anesthesia
Study type: Interventional

Summary: 
      Preoxygenation remains an important determinant of morbidity and mortality in anesthesia
      despite advances in mask ventilation and difficult intubation management.

        1. The usual practice Preoxygenation prior to the injection of the anesthetic agents is the
           administration of pure oxygen to delay the occurrence of hypoxemia during the apnea
           phase and intubation maneuvers. It consists of applying a mask on the patient's face and
           allowing it to ventilate, ensuring a perfect seal of the device. The end of oxygen
           exhalation fraction is a good reflection of the alveolar oxygenation and a value of 95%
           corresponds to a "total" alveolar oxygenation. When this value is reached, the injection
           of the anesthetic agents (hypnotic, morphine and myorelaxant) leads to the loss of
           consciousness and apnea, which forces to continue the manual ventilation to the mask.
           Intubation is performed when the myorelaxation is complete.

        2. Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel
           Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal
           Oxygen.

      The hypothesis of this study is that Humidified High-Flow Nasal Oxygen, should allow
      anesthetic induction without having to impose the patient the establishment of a facial mask
      for several minutes before anesthetic induction and the doctor anesthetist assisted
      ventilation with the mask before intubation.
    


Intervention name(s): Nasal High Flow Oxygen; Facial Mask
Intervention type(s): Device; Device
Intervention description(s): Nasal High Flow Oxygen using Optiflow device of Fisher and Paykel; Preoxygenation with facial mask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anesthesia genral, Oxygen
Phase 1 Safety and Immunogenicity Study in Healthy Adults of VAX125, a Recombinant HA-flagellin Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Is VAX125 safe at doses ranging from 0.1 to 8 ug when delivered i.m. in a single dose regimen
      Is VAX125 able to induce a post-vaccination serum HAI antibody response in healthy adults
      against the influenza A virus H1 HA.
    

Detailed description: 
      Part I: Intramuscular (i.m.) vaccination of a single dose of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3
      µg, 5 µg and 8 µg of STF2.HA1 (SI) (VAX125) to be given on Day 0

      Part II: Intramuscular (i.m.) vaccination of a single dose of placebo or one of two dose
      levels of STF2.HA1 (SI) (VAX125) (optimum dose levels to be determined from the safety and
      immunogenicity data from Part I of this study) to be given on Day 0

      Part I Primary: To assess the safety, reactogenicity, and tolerability of the VAX125 vaccine
      delivered i.m. in a single dose regimen of dose levels of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5
      µg, and 8 µg in healthy adults 18 - 49 years of age, inclusive.

      Secondary: To assess the immunogenicity of the VAX125 vaccine delivered i.m. in a single dose
      regimen at dose levels of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5 µg, and 8 µg, for inducing a
      post-vaccination serum HAI antibody response in healthy adults against the influenza A virus
      H1 HA.

      Part II Primary: To assess the safety, reactogenicity, and tolerability of a single dose of
      the VAX125 vaccine delivered i.m. in one of two dose levels as compared to placebo, (optimum
      dose levels to be determined from the safety and immunogenicity data from Part I of this
      study), in healthy adults 18- 49 years of age, inclusive.

      Secondary: To assess the immunogenicity of a single dose the VAX125 vaccine delivered i.m. in
      one of two dose levels as compared to placebo (optimum dose levels to be determined from the
      safety and immunogenicity data from Part I of this study) for inducing a post-vaccination
      serum HAI antibody response in healthy adults against the influenza A virus H1 HA antigen.
    

Intervention name(s): VAX125
Intervention type(s): Biological
Intervention description(s): Single intramuscular dose
Other intervention name(s): STF2.HA1(SI)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza; recombinant; hemagglutinin; vaccine
Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in Management of Periodontal Intrabony Defects
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in
      comparison with open flap debridement for management of periodontal intrabony defects.
    

Detailed description: 
      Thirty patients suffering from advanced chronic periodontitis were included in this
      randomized controlled clinical trial. Each subject contributed matched two- or three-walled
      intrabony defects. Patients were equally assigned into the experimental group;
      Nano-crystalline hydroxyapatite silica gel or the negative control group;open flap
      debridement. Clinical and radiographic parameters were recorded at baseline and at 3 and 6
      months postoperatively.
    

Intervention name(s): Nano-crystalline hydroxyapatite silica gel; open flap debridement
Intervention type(s): Biological; Procedure
Intervention description(s): it is a type of synthetic bone graft.; a periodontal surgical procedure for the purpose of debridement.
Other intervention name(s): Nanobone; OFD
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the oral intake of the dietary supplement SAMe
      increases blood homocysteine levels in healthy human subjects.
    

Detailed description: 
      S-adenosyl-L-methionine (SAMe or AdoMet) is a commonly used nutritional supplement available
      in the United States since 1999. SAMe is metabolized to homocysteine, a known cardiovascular
      risk factor. No study has determined the effect exogenous SAMe administration has on the
      long-term levels of homocysteine in humans. As a nutritional supplement, SAMe is not
      regulated by the Food and Drug Administration, despite being used to treat clinical diseases
      such as depression and osteoarthritis.
    

Intervention name(s): SAMe; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 800 mg dose daily for 4 weeks.; 2 placebo pills daily for 4 weeks.
Other intervention name(s): AdoMet; S-Adenosyl-L-Methionine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SAMe; AdoMet; Methylation; Homocysteine; Dietary Supplement; S-Adenosyl-L-Methionine