bioihbjkbjnl/mcl2 huggingface dataset:
Probiotics and Gut Health
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the
      major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of
      ~15%, and symptoms of which have a significant negative impact on the sufferer's quality of
      life. One of the hallmarks of chronic constipation is slow progression of contents through
      the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that
      are difficult to expel. Previous studies have shown that probiotics improve colonic transit
      times in constipated patients. In addition, several other studies, employing a range of
      different probiotic strains, have shown a significant increase in defaecation frequency and
      improvement in stool consistency. However, the clinical relevance of these results is
      uncertain, due to small sample sizes and limitations in study methodology. The current study
      is designed to compare changes in gut transit time and gastrointestinal symptoms following 4
      weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled
      manner, in adults with constipation.
    

Detailed description: 
      This is an adaptive, parallel, double-blinded, randomized, placebo-controlled, stratified
      clinical study, comparing three study arms (two quantities of the probiotic active component
      and one placebo)with equal allocation ratio. Recruitment of subjects to the low quantity of
      the probiotic will be after fulfilling certain criteria at interim. After half of the
      subjects in the two study groups of high quantity and placebo have completed the study (40
      subjects), an interim analysis will be performed. Depending on the observed effect size and
      the conditional power, the study may be stopped for futility, continued with the two groups
      or continued with inclusion of the third group of low dose probiotics.
    

Intervention name(s): High quantity probiotic; Low quantity probiotic; placebo
Intervention type(s): Other; Other; Other
Intervention description(s): The intervention type is food product; The intervention type is food product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer
Condition: Non-muscle Invasive Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of
      intravesical cis-urocanic acid in patients with primary or recurrent non-muscle invasive
      bladder cancer.
    

Detailed description: 
      This is a single dose, dose-escalating, Phase I study to evaluate safety, tolerability and
      pharmacokinetics of intravesical cis-urocanic acid (cis-UCA) in patients with primary or
      recurrent non-muscle invasive bladder cancer.

      The primary objectives is to evaluate safety and tolerability of cis-UCA after a single
      intravesical instillation with escalating doses and to determine the maximum tolerated dose
      (MTD) and dose-limiting toxicity (DLT) of cis-UCA after a single intravesical instillation
      with escalating doses.

      The secondary objectives are to evaluate pharmacokinetics of cis-UCA after a single
      intravesical instillation with escalating doses, to obtain preliminary information on
      possible anti-tumor effects of cis-UCA by cystoscopy and histological evaluation after a
      single intravesical instillation with escalating doses, and to evaluate the effects of
      cis-UCA on different surrogate biochemical markers on tumor growth and differentiation after
      a single intravesical instillation with escalating doses.

      The key eligibility criteria are the following: Patients with primary or recurrent non-muscle
      invasive bladder cancer; eligible for intravesical treatment; age 18-80 years; WHO
      performance status 0-2; acceptable liver, renal and hematological function within 30 days
      prior to inclusion.

      At minimum 3 patients and at maximum 24 patients is planned to be included in the study. The
      fixed dose-escalation levels will be used.

      Up to three dose cohorts are planned to be included:

        -  Cohort I: 2% cis-UCA solution (50 ml); min 3, max 12 patients

        -  Cohort II: 4% cis-UCA solution (50 ml); min 0, max 12 patients

        -  Cohort III: 6% cis-UCA solution (50 ml); min 0, max 12 patients
    

Intervention name(s): cis-UCA solution; cis-UCA solution; cis-UCA solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cohort I: 2% cis-UCA solution (50 ml); min 3, max 12 patients; Cohort II: 4% cis-UCA solution (50 ml); min 0, max 12 patients; Cohort III: 6% cis-UCA solution (50 ml); min 0, max 12 patients
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bladder cancer; cis-urocanic acid; primary; recurrent; non-muscle
Psychosocial Outcomes and Transition Readiness in JIA
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Observational

Summary: 
      It is widely acknowledged that the transition from paediatric to adult health services should
      be a multidimensional and multidisciplinary process that addresses the medical, psychosocial,
      and educational needs of adolescents and young adults (AYA). Despite this, there is currently
      a scarcity of research examining the relationships between psychosocial factors (e.g.,
      anxiety, social support) and transition readiness in AYA with juvenile idiopathic arthritis
      (JIA). This study therefore aimed to examine the relationships between psychosocial factors
      and transition readiness in pre-transfer adolescents and post-transfer young adults aged
      10-25 years diagnosed with JIA at a single centre.

      In total, 40 adolescents aged 10-16 years together with a parent/guardian, will take part at
      Sheffield Children's Hospital and 40 young adults aged 16-25 years will take part at
      Sheffield Teaching Hospitals. Participants will be asked to complete a battery of self-report
      questionnaire measuring psychosocial factors (anxiety/depression, social support, family
      functioning, health-related quality of life) and transition readiness (transition knowledge
      and skills, self-efficacy). JIA disease severity was also measured during clinic
      appointments. This study has received full ethical approval, and all participants will give
      their written informed assent or consent before taking part.

      The results from this research will be important in better understanding which psychosocial
      factors affect how ready young people with JIA feel to move from paediatric to adult
      rheumatology services. We hope this research will inform further work to help target
      psychological interventions in this group of patients.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will be patients aged 10-25 years or parents/guardians of patients
        aged 10-16 years who have a diagnosis of juvenile idiopathic arthritis.
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Condition: Nonalcoholic Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12
      weeks of treatment.
    

Detailed description: 
      The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary
      endpoint will be the assessment of the change in the percentage of liver fat mass (assessed
      by MRI-PDFF).
    

Intervention name(s): PXL770; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Brief Intervention in At-Risk First-time Mothers
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Preliminary controlled trial of a brief intervention designed to reduce child maltreatment
      risk among low-income pregnant mothers. Foci will include major risk factors for
      maltreatment, including substance abuse, social isolation, depression, violence exposure, and
      maladaptive child-rearing attitudes/beliefs.
    


Intervention name(s): Brief motivational intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: child abuse, child neglect, substance use, violence exposure, brief intervention
A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures
Condition: Epilepsy, Partial Seizures; Epilepsy, Primary Generalized Tonic-Clonic Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      Study A0081106 is a 12-month open-label study to evaluate the long term safety and
      tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age
      with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with
      primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided
      daily doses for 1 year, in either capsule or liquid oral formulation.
    


Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention description(s): Pregabalin administered as either capsule or liquid oral formulations. Subjects <4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety; partial onset seizures; primary generalized tonic-clonic seizures; pregabalin; pediatric; adult; open-label; long term
Nasal Irritation Study: Individual Factors in Nasal Irritant Sensitivity
Condition: Rhinitis, Allergic, Nonseasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional

Summary: 
      This study seeks to document differences in nasal irritant sensitivity within the population.
      The investigators are interested in knowing whether age, gender, and allergy status (nasal
      allergies) predict nasal irritant sensitivity. This is important in understanding symptom
      reporting patterns in air pollution situations (particularly in so-called "problem
      buildings"), as well as in understanding the reflex mechanism of a response of the nose to
      irritants (e.g., nasal congestion).
    


Intervention name(s): Nasal irritation thresholds and irritant provocation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Keywords: rhinitis; irritation; trigeminal
A Study to Evaluate Safety and Immunogenicity of a COVID-19 Vaccine in People Living With HIV at Risk for SARS-CoV-2 (COVID-19)
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, observer-blinded study evaluating the safety and
      immunogenicity of SARS-CoV-2 with Matrix-M™ Adjuvant in people living with human
      immunodeficiency virus (HIV) (PLWH) and HIV- negative adults, seronegative to SARS-CoV-2 at
      baseline.
    

Detailed description: 
      The investigational product will be a monovalent Serum Institute of India (SII) SARS CoV-2
      vaccine at a dose of 5 µg antigen adjuvanted with 50 µg Matrix-M (referred hereafter as
      NVX-CoV2373).

      Approximately 270 PLWH, 18 to 65 years of age inclusive, will be enrolled into 3 groups and
      stratified at presentation based on the level of control of HIV infection. All PLWH will be
      baseline seronegative (for SARS-CoV-2) and have not received any authorized SARS-CoV-2
      vaccines. PLWH will be randomly assigned 1:1:1 to receive NVX-CoV2373 in either a two dose
      regimen on Days 0 and 21 or Days 0 and 70 or a three-dose regimen on Days 0, 21, and 70.
      Randomization of PLWH will be stratified by level of control of HIV infection to distribute
      well controlled and less well controlled participants approximately evenly among the 3 PLWH
      treatment groups. Approximately 90 HIV negative participants, 18 to 65 years of age
      inclusive, will be randomly assigned 1:1 to receive NVX-CoV2373 in a two dose regimen on Days
      0 and 21 or Days 0 and 70. All HIV negative participants will be baseline seronegative (for
      SARS-CoV-2) and have not received any authorized SARS-CoV-2 vaccines. Placebo (normal saline
      solution) will be administered to participants who receive a two-dose regimen of NVX-CoV2373
      to maintain overall blinding.
    

Intervention name(s): NVX-CoV2373
Intervention type(s): Biological
Intervention description(s): Alternating intramuscular (IM) (deltoid) injections of monovalent prototype vaccine premixed with Matrix-M™ adjuvant (0.5 mL) given either as
2 doses (one on Day 0 and one on Day 21 or Day 70) and an injection of placebo (0.5mL) on Day 21 or Day 70, or 3 doses (Day 0, Day 21, and Day 70).
Other intervention name(s): Monovalent SARS-CoV-2 rS vaccine premixed with Matrix-M adjuvant
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronavirus disease 2019 (COVID-19); HIV
Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to
      < 48 months of age
    


Intervention name(s): Trivalent influenza vaccine (TIVc); Trivalent influenza vaccine-licensed
Intervention type(s): Biological; Biological
Intervention description(s): Licensed influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza; children; safety; tolerability; immunogenicity
Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of
      severe or invasive infections in Ugandan children with sickle cell anemia (SCA).
    

Detailed description: 
      The study will be a randomized, placebo-controlled, double blind clinical trial in which 250
      Ugandan children 1.00-4.99 years of age with SCA will receive zinc (10 mg oral dispersible
      tablet daily) or placebo (identical to zinc in appearance) for 12 months. The primary study
      outcome will be incidence of severe or invasive infections. Secondary outcomes will include
      incidence of all clinical infections, confirmed bacterial infections (by culture or PCR),
      incidence of vaso-occlusive crisis (VOC), change in height-for-age z-score, and incidence of
      zinc-related adverse events.
    

Intervention name(s): Zinc; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 10mg dispersible zinc sulfate tablet; Dispersible tablet with inert ingredients, identical to zinc in appearance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, placebo-controlled, double blind clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Zinc
Impact of Dietary Advice on the Progression of Tooth Wear
Condition: Erosive Tooth Wear
MeSH terms: Tooth Wear; Tooth Attrition
Study type: Interventional

Summary: 
      The aim of this research is to investigate the impact of dietary advice on the progression of
      tooth wear over 6 months using a randomised clinical trial design. Participants with severe
      tooth wear will be recruited. Half of those patients will receive a detailed dietary advice
      and the other half will be receive standard of care dietary advice. Moulds will be made of
      their mouths at the original appointment and 6 months later. These moulds will be scanned and
      superimposed to see if there is any difference in their level of tooth wear
    

Detailed description: 
      A sample size of 60 patients will be recruited separately from an epidemiology study and
      written informed consent will be obtained. Patients presenting with moderate to severe tooth
      wear will be recruited. Those with a Basic Erosive Wear Examination (BEWE) cumulative score
      greater than or equal to 8 but with at least one score of 3 on the occlusal surfaces of the
      lower molars or the incisal edge of the upper central incisor. After randomisation, an
      impression will be taken of the upper and lower teeth using a silicone material. One group
      will receive one-to-one dietary advice (with dietary information sheets) as the intervention
      and the other group will not receive any intervention. The silicone impressions will be
      repeated 6 months later. Impressions will be cast in stone and the occlusal surfaces of the
      upper or lower molars and the buccal surface of the upper central and lateral incisors will
      be scanned to monitor tooth wear progression. The two scans of the involved teeth will be
      superimposed and the level of tooth wear over that time will be calculated.

      The investigators aim to see if giving detailed dietary advice will result in less erosive
      tooth wear.
    

Intervention name(s): Dietary Advice
Intervention type(s): Behavioral
Intervention description(s): Detailed dietary advice and planning, complete with dietary information sheets which were developed with a dietitian and a dental psychologist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
An Efficacy Study of Chlorhexidine Mouthwashes
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare subject gingival health after 6 weeks of twice daily use
      of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.
    


Intervention name(s): Chlorhexidine Digluconate Mouthwash with Alcohol; Chlorhexidine Digluconate Mouthwash without Alcohol
Intervention type(s): Drug; Drug
Intervention description(s): 0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash; 0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this pilot study is to assess the methodology, practical arrangements and
      pulmonary absorption with charcoal blockage for the future bioequivalence studies. In
      addition, PK of budesonide and formoterol after administration from 2 different batches of
      Symbicort TH is compared with each other.
    


Intervention name(s): Budesonide/Formoterol Batch 1; Budesonide/Formoterol Batch 2; Budesonide/Formoterol Batch 1 and charcoal
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single, inhaled dose; Single, inhaled dose; Single, inhaled dose
Other intervention name(s): Symbicort Turbuhaler; Symbicort Turbuhaler; Symbicort Turbuhaler
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer study