bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and the tolerance on 15 days of a
      turmeric extract (Arantal®) on pain related to gonarthrosis.
    


Intervention name(s): Arantal® (highly bioavailable turmeric extract)
Intervention type(s): Dietary Supplement
Intervention description(s): 4 capsules a day, before breakfast
Intervention MeSH terms: Turmeric extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Osteoarthritis; Joint Diseases; Arthritis; Rheumatic Diseases
Rhodiola Crenulata as an Adjunctive Therapy in COPD
Condition: COPD
Study type: Interventional
Phase: Phase 2

Summary: 
      We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with
      moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation
      and anti-oxidation for these patients, and these effects (2) may reflect in the improvement
      of patients' physiological measurements, quality of life and exercise tolerance.
    

Detailed description: 
      This is a single center, randomized, double-blind, placebo controlled clinical trial.

      Eligibility criteria:

        1. moderate-to-severe COPD patients

        2. aged 40-80 years,

        3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,

        4. no acute exacerbation of COPD,

        5. clinically being stable for one month and longer,

        6. not undergoing exercise training program.

      Primary endpoint:

      six-minute walk distance in meters at week 12.
    

Intervention name(s): Rhodiola placebo capsules; Rhodiola Crenulata
Intervention type(s): Drug; Drug
Intervention description(s): Corn starch; Rhodiola Crenulata
Other intervention name(s): Rhodiola
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD, Rhodiola L., clinical trial, biomarkers, spirometry
Frailty in Children With Cardiac Disease
Condition: Pulmonary Hypertension; Heart Failure; Single Ventricle
MeSH terms: Hypertension, Pulmonary; Heart Diseases; Univentricular Heart; Frailty
Study type: Observational

Summary: 
      Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to
      decreased resistance to stressors and is associated with adverse health outcomes. The
      syndrome has been well studied in adults and is quantified by the Fried criteria, which are
      comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and
      diminished physical activity. The concept of frailty is novel in children. A study in young
      adult childhood cancer survivors demonstrated increased incidence of frailty in this
      population along with increased risk of morbidity and mortality. This suggests that frailty
      as a phenotype has relevance outside of the geriatric age group. Pediatric patients with
      single ventricle physiology, heart failure and pulmonary artery hypertension- all represent
      populations with significantly increased risk of mortality, morbidity and decreased quality
      of life. Currently, such patients are monitored outpatient by serial echocardiograms and
      blood work that only gives information about end organ damage. But there is no validated tool
      available to measure global infirmity in such children. Better understanding of the relevance
      and applicability of frailty in pediatrics may allow for identification of the most
      vulnerable pediatric cardiac patients and be of value in optimizing their clinical management
      and improving health outcomes.
    


Intervention name(s): Actigraph to check activity levels at home
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The investigators are studying children with single ventricle physiology, s/p Fontan,
        patients with heart failure and pulmonary hypertension.
An Evaluation of the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective for this study is to monitor the change in patient assessed symptoms of
      constipation in subjects taking the proprietary probiotic blend compared to those taking the
      placebo. The secondary objective for this study is to additionally monitor changes in stool
      consistency, stool frequency, quality of life and microbial composition of feces from
      baseline to Day 29, in all subjects. Safety considerations monitored any changes in blood
      safety parameters as well as incidence of adverse events throughout the entire study for all
      subjects.
    


Intervention name(s): Proprietary Probiotic Blend; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg; The placebo is administered to randomized healthy participants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy
Condition: Hemodynamic Instability; Supratentorial Neoplasms
MeSH terms: Supratentorial Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      There is no clear consensus among neuroanesthesiologists regarding which anesthetic regimen
      is optimal for craniotomy. Propofol and short-acting opioids (such as remifentanil, fentanyl,
      or sufentanil) are commonly used. However, use of opioids is associated with increased risk
      of respiratory depression and postoperative nausea and vomiting. Dexmedetomidine is a highly
      selective α2-adrenoreceptor agonist that has been considered as a useful and safe adjunct to
      anesthesia for various surgical procedures
    

Detailed description: 
      The investigators designed this randomized, double-blind study to evaluate the effectiveness
      of administration of Dexmedetomidine infusion at a dose of 0.5 µg/kg/h without loading dose
      during elective supratentorial craniotomy under GA. The investigators will compare
      intraoperative hemodynamics in both groups, intraoperative analgesic consumption,
      intraoperative blood loss, postoperative sedation scores, intraoperative need for rescue
      hypotensive agents, and finally the satisfaction of surgeons.

      To our knowledge, the present study is the first to evaluate the effect of Dexmedetomidine
      infusion without loading dose in elective supratentorial craniotomy
    

Intervention name(s): Dexmedetomidine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.
Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline Group C: Patients received equal volume and rate of normal saline as Group D.
This dosing regimen was in accordance with existing guidelines [5] [6] [7].; On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.
Group C: Patients received equal volume and rate of normal saline as Group D.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative analgesia; Craniotomy; Dexmedetomidine
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
Condition: Growth Hormone Deficiency; Turner Syndrome; Chronic Renal Failure; Small for Gestational Age
MeSH terms: Kidney Failure, Chronic; Turner Syndrome; Gonadal Dysgenesis
Study type: Observational

Summary: 
      This is an international, multicenter study involving children treated with Saizen®, a growth
      hormone, who will be trained to use easypod, a new electronic injector and will complete a
      questionnaire after 12 week of use.

      Both children naïve to growth hormone and dissatisfied with their current injection device
      will be recruited.
    

Detailed description: 
      An international, multicenter cross-sectional study (Observatoire des pratiques médicales®)
      involving a cohort of children treated with Saizen®, a growth hormone.

      The study does not require any changes to the usual medical management of these patients and
      should not be considered detrimental to their physical or psychological integrity. No
      specific procedures or examinations will be requested, nor does the protocol require any
      particular treatment or follow-up visits.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Overall, 834 children using the electronic auto-injector were recruited. Of these, 824
        children were included in the evaluable population. Of the 824 evaluable children, 601 were
        treatment-naïve and 223 were treatment-experienced.
      
Keywords: Electronic device; Growth hormone treatment
A Study to Assess the Effects of Multiple Doses of Fidaxomicin on a Single Dose of Rosuvastatin in Healthy Male Subjects
Condition: Drug-Drug Interaction (DDI); Intestinal Absorption; Healthy Subjects; Pharmacokinetics of Rosuvastatin; Pharmacokinetics of Fidaxomicin
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effect of multiple doses of fidaxomicin on the single dose
      pharmacokinetics of rosuvastatin in healthy male subjects. Determine the safety and
      tolerability of multiple doses of fidaxomicin in the presence of a single dose of
      rosuvastatin in healthy male subjects. Also determine the pharmacokinetics of multiple doses
      of fidaxomicin and its metabolite OP-1118.
    

Detailed description: 
      Sequence 1:

      Thirteen subjects receive an oral dose of rosuvastatin on Day 1 in Period 1 and on Day 13 in
      Period 2 and twice-daily oral doses of fidaxomicin on Days 8 to 17 in Period 2, according to
      the following treatment schedule:

        -  Period 1: Subjects receive a single oral dose of rosuvastatin on Day 1, followed by a
           5-day pharmacokinetic (PK) sampling period.

        -  Period 2: The same subjects receive fidaxomicin twice daily for 5 days (Days 8 to 12).
           On Day 13, a single oral dose of rosuvastatin and an oral dose of fidaxomicin is
           administered simultaneously in the morning. Twice-daily treatment with fidaxomicin
           continues until the end of Day 17. Subjects are discharged on Day 18 when all
           assessments are performed and if there are no medical reasons to prolong the stay.

      Sequence 2:

      Thirteen subjects receive an oral dose of rosuvastatin on Day 6 in Period 1 and on Day 14 in
      Period 2. Oral doses of fidaxomicin are administered twice daily for 10 days in Period 1,
      according to the following treatment schedule:

        -  Period 1: Subjects receive fidaxomicin twice daily for 5 days (Days 1 to 5). On Day 6, a
           single oral dose of rosuvastatin is administered simultaneously with an oral dose of
           fidaxomicin in the morning. Twice daily treatment with fidaxomicin continues until the
           end of Day 10.

        -  Period 2: Subjects receive a single oral dose of rosuvastatin on Day 14, followed by a
           5-day PK sampling period. Subjects are discharged on Day 19 when all assessments are
           performed and if there are no medical reasons to prolong the stay.

      In both sequences, subjects return to the clinical unit for an End of Study Visit (ESV) 7 to
      14 days after (early) discharge.
    

Intervention name(s): rosuvastatin; fidaxomicin
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Crestor®; Dificlir™; DIFICID®
Intervention MeSH terms: Fidaxomicin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Drug-Drug Interaction; Intestinal Absorption; Fidaxomicin; Rosuvastatin; Multiple Doses; Single Doses
A New Therapeutic Strategy for Urethral Sphincter Insufficiency
Condition: Stress Urinary Incontinence; Urethral Intrinsic Sphincter Deficiency
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      Stress urinary incontinence is a frequent condition that can be caused by urethral sphincter
      insufficiency and results in a dramatic deterioration of the quality of life. We developed a
      new therapeutic strategy for stress urinary incontinence based on the implantation myofibers
      with their satellite cells in the urethra. The aim of this procedure is to generate
      functional tissue acting like a new sphincter in the urethra
    

Detailed description: 
      stress urinary incontinence is a frequent condition that can be caused by urethral sphincter
      insufficiency and results in a dramatic deterioration of the quality of life. We developed a
      new therapeutic strategy for stress urinary incontinence based on the implantation myofibers
      with their satellite cells. The principle of this procedure relies on the activation in vivo
      of the satellite cells present around each myofibers. Satellite cell activation is
      concomitant with myofiber death that occurs after their implantation. Activated satellite
      proliferate and fuse to form myotubes replacing the parental myofibers thus leading to the
      reconstitution of the muscle mass that was initially implanted. Preliminary studies in the
      pig showed the regenerated muscle tissue in the urethra was innervated by urethral nerves and
      developed tonic contractions acting like a new sphincter. This procedure does not include a
      phase of satellite cell amplification ex vivo, as standard methods of satellite cell
      transfer, and rather relies on the natural myogenic capacities of these cells. Thus, the
      procedure of cell transfer into the urethra is considerably simplified and can be performed
      in one step in the operating room.This therapeutic strategy could represent an alternative to
      the artificial urinary sphincter.
    

Intervention name(s): transplantation of the squeletic muscular cells
Intervention type(s): Procedure
Intervention description(s): transplantation of the squeletic muscular cells
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress Urinary Incontinence; striated urethral sphincter insufficiency; myofibers; satellite cells; myotubes; urethral; Muscle fibres
GCF miRNA-223 , -214 Levels in Smokers and Nonsmokers Periodontitis Patients
Condition: Periodontitis, Adult
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Observational

Summary: 
      Objective: Periodontitis is a multifactorial disease that affects a wide range of
      populations. However, its pathogenesis remains unclear. miRNAs are now considered potential
      diagnostic markers for many inflammatory diseases. Thus, the aim of this study was to assess
      the expression of microRNA-223(miRNA-223) and microRNA-214 (miRNA-214) in gingival crevicular
      fluid (GCF) of smoker and nonsmoker with periodontitis.

      Materials and Methods: We conducted a prospective study among 42 participants: 14 healthy
      controls, 14 nonsmoker periodontitis participants, and 14 smoker with periodontitis.
      Eligibility criteria for inclusion were consecutive adults, aged 20-60 years, with stage III
      periodontitis grade B/C and no systemic diseases. All consenting participants had gingival
      crevicular fluid samples collected after diagnosis to assess miRNA-214 and -223 by
      quantitative real-time polymerase chain reaction assay.
    


Intervention name(s): miRNA-223 & -214 detection
Intervention type(s): Diagnostic Test
Intervention description(s): miRNA-223 & -214 detection in GCF samples by PCR kits
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        individuals were recruited from the outpatient clinic of the department of periodontology
      
Biospecimen description: 
      GCF samples
    
Keywords: Periodontitis; microRNA; smoking; GCF; biofluids
Adjuvanting Viral Vectored Malaria Vaccines With Matrix M
Condition: Malaria; Matrix M
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied
      in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated
      viruses which have been modified so that they cannot reproduce in humans. Genetic information
      has been added to make them express proteins of the malaria parasite so that they stimulate
      an immune response against malaria. This trial examines whether a compound called Matrix M™
      can be used in efforts to improve on how well the vaccines work at preventing malaria.

      Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines.
      In this trial, Matrix M™ will be combined with each of the vaccines. The objectives are to
      assess the safety of the vaccines when combined with Matrix M™, and to determine what effect
      Matrix M™ has on the immune responses to the vaccines.

      We will assess the safety of the vaccines (ChAd63 METRAP combined with Matrix M™; and MVA
      METRAP combined with Matrix M™) by administering them to healthy volunteers and monitoring
      them for 6 months in total. Eight volunteers will receive the vaccines with the low dose of
      Matrix M™, eight will receive the vaccines with the standard dose of Matrix M™, and six
      volunteers will receive the vaccines alone as a comparison group. We will also look at what
      effect Matrix M™ has on the immune responses to the vaccines, as measured from blood tests.
      Volunteers will have study visits to the Clinical Centre for Vaccinology and Tropical
      Medicine on the Churchill Hospital site, Oxford, where they will have vaccinations, have
      blood taken to monitor safety and measure immune responses to vaccination, and be monitored
      for symptoms/side effects from vaccination.
    


Intervention name(s): Control Regimen; Low Dose Matrix M Regimen; Standard Dose Matrix M Regimen
Intervention type(s): Biological; Biological; Biological
Intervention description(s): ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56; ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56; ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria vaccine; Matrix M
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy
      treatment of remission, based on composite score of patient-reported symptoms and centrally
      read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
    


Intervention name(s): Ontamalimab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).; Participants will receive 1 mL of sterile aqueous buffered solution.
Other intervention name(s): PF-00547659; SHP647
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative colitis
Effects of Probiotics on Cognition and Health
Condition: Physiological Stress; Cognition - Other
Study type: Interventional

Summary: 
      This research intervention aims to examine the effects of a fermented dairy beverage on
      changes in behavioral and biological measures of cognition and stress among adults.
    

Detailed description: 
      Evidence-based dietary strategies provide behavioral means benefiting physical and cognitive
      function. Pertinent to the proposed work, dietary intake has been recently shown to have the
      potential to directly influence the gut microbiota composition as well as brain function.
      Specifically, the consumption of probiotics or foods containing healthful microbial cultures
      (e.g., fermented milk, yogurts, etc.) are increasingly being recognized as modulators of
      metabolism, cognition, and stress. These foods are readily available in the marketplace,
      however, their implications for physical and cognitive function are not clear. Accordingly,
      the proposed study aims to investigate effects of probiotic beverage consumption on changes
      in behavioral and biological measures of cognition and stress among adults.
    

Intervention name(s): Lactose Free 1% Milk; Probiotic Treatment
Intervention type(s): Other; Other
Intervention description(s): isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.; Probiotic treatment, consumed once daily, over 4-5 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will pass through 2 arms, control and probiotic, in a randomized, counter-balanced order.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science