bioihbjkbjnl/mcl2 huggingface dataset:
Lingzhi for Cancer Children
Condition: Pediatric Cancers
Study type: Interventional
Phase: Phase 3

Summary: 
      Ganoderma lucidum (Lingzhi) is a Traditional Chinese Medicine which is widely used as a means
      to 'strengthen immunity' among patients with cancers. However, there is no published
      randomized controlled clinical trial on its efficacy and safety despite the many in vitro
      studies on its anti-viral, anti-oxidative, anti-tumour, radioprotective, hepato-protective
      and immunomodulatory effects. This study was a randomized, double-blind, placebo-controlled,
      parallel clinical trial that investigated the benefits and safety of Ganoderma lucidum
      (Lingzhi) in treating children with cancers. Patients were randomized to receive identical
      capsules of either Lingzhi or placebo for six months. The primary outcome was the general
      Paediatric Quality of Life score. Secondary outcomes included immune functions,
      infection-related morbidities, complete blood counts and serum biochemistry, and overall and
      event-free survival.
    

Detailed description: 
      Alternative and complementary medicine are widely used in treating children with cancers. A
      population-based survey in British Columbia revealed that they were used by 42% of the
      respondents. Among Chinese in Hong Kong, Traditional Chinese Medicine (TCM) is also widely
      practiced. Some 60% of the population had consulted TCM practitioners at one time or another.
      TCM use could be dated back to more than five thousand years ago, and written records were
      available for over two thousand years. TCM is considered to be an integral part of the
      Chinese culture. In our experience, TCM is believed to be commonly used to 'strengthen
      immunity and promote health' among local children with cancers, despite the lack of
      well-designed study to prove its usefulness. Ganoderma lucidum (Ling Zhi) is a mushroom
      long-used in China for a broad range of disorders. Its use is common in the general
      population and among both adults and children with a wide range of malignancies. However,
      there is no randomized controlled trial to support its clinical efficacy and safety.
      Therefore, we conducted this clinical trial of Ganoderma lucidum (Ling Zhi) among Hong Kong
      children with cancers.
    

Intervention name(s): LingZhi capsule
Intervention type(s): Drug
Intervention description(s): LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group
Other intervention name(s): Ganoderma lucidum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized controlled trial; Lingzhi; Immune functions; Quality of life; Survival
Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and
      transporters in vivo. It consists of the administration of probe substances metabolised by a
      specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the
      determination of a metabolic ratio or the evaluation of the plasmatic or urinary
      concentrations of the probe substances. The administration of a cocktail containing several
      probe substances allows the simultaneous evaluation of the activity of several cytochromes
      and P-gp in a single test.

      When a cocktail approach is used it is important to make sure that no drug-drug interactions
      occur between the probes within the cocktail. The validation of the lack of interactions,
      which is the aim of the study, consists of demonstrating that there is no difference in the
      pharmacokinetic parameters and/or metabolic ratios when a probe is administered alone or as
      part of the cocktail. The Geneva cocktail consists of caffeine, bupropion, flurbiprofen,
      omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of
      CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.

      Probe and metabolite concentrations will be measured in capillary blood using a dried blood
      spot (DBS) analysis. To further facilitate sampling, a new simple device will be used to
      ensure the precision of capillary blood collection.
    


Intervention name(s): Caffeine, omeprazole, flurbiprofen, dextromethorphan, midazolam; Bupropion; Fexofenadine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fexofenadine; Flurbiprofen; Midazolam; Dextromethorphan; Caffeine; Bupropion; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acidosis
Study type: Interventional

Summary: 
      This study evaluates the effect of oral sodium bicarbonate treatment on the intrarenal
      renin-angiotensin-system in adult patients with a metabolic acidosis and chronic kidney
      disease. This treatment is compared to sodium chloride treatment, which serves as control for
      increased sodium-intake and no treatment, which serves as time-control.
    

Detailed description: 
      In chronic kidney disease (CKD), as glomerular filtration rate decreases, excretion of
      hydrogen ions fails, leading to progressive metabolic acidosis (arterial pH < 7.35 and a
      serum bicarbonate concentration < 22 meq/L). Metabolic acidosis enhances further progression
      of CKD. It is known that the intrarenal renin-angiotensin system (RAS) is stimulated during
      metabolic acidosis, but it's specific role in the renal response on changes in the acid-base
      balance is unknown. Correction of metabolic acidosis by administration of bicarbonate is a
      common intervention in patients with metabolic acidosis due to chronic kidney disease. It is
      proven to slow down progression of CKD. There is no knowledge on the effect this therapy has
      on the intrarenal RAS. Since acidosis does not change serum renin levels, and bicarbonate
      therapy has no effect on blood pressure, it seems to have no effect on the systemic RAS. The
      investigators hypothesize that bicarbonate therapy diminishes intrarenal RAS activity without
      affecting the systemic RAS.
    

Intervention name(s): Sodium bicarbonate; Sodium chloride
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolic Syndrome and Male Infertility
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male; Metabolic Syndrome
Study type: Observational

Summary: 
      Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who
      conduct their sperm test through their diagnosis of infertility
    

Detailed description: 
      Assessment of sperm parameters and metabolic syndrome relations in men attending a
      Reproductive Biomedicine centre for an infertility of their couple.

      Secondary objectives are to study relationship between sperm parameters and:

        -  adiposity and insulin resistance

        -  inflammation

        -  oxydative stress in blood and semen

        -  hormonal status Innovative parameters will also be assessed to determine the quality of
           semen (length of fingers, wrist circumference and epigenetics studies)
    

Intervention name(s): Blood sample, sperm sample and clinical examens
Intervention type(s): Other
Intervention description(s): Blood sample, sperm sample and clinical examens will be done at the day of the inclusion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Man consulting for primary or secondary infertility, with or without earlier notion of
        paternity
      
Biospecimen description: 
      Blood and sperm samples will be collected from all patients BLOOD :Whole blood was collected
      on dry, heparin or EDTA tubes. After several soft turnings, tubes were centrifuged at 1900g
      for 10min.Then plasma, serum, buffy coat or red blood cells were taken in microtubes and
      frozen at -80°C.

      SPERM: After liquefaction, total sperm was centrifuged at 600g for 10min. Seminal plasma was
      collected directly on microtubes and stored at -80°C. After trypsinisation, spermatozoa were
      fixed in Carnoy solution and stored at -20°C.

      DNA was separated from buffy coat using DNA extract kit
    
Keywords: Metabolic syndrome; Epigenetic; Male infertility; Sperm parameters; Biomarkers
Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole
Condition: Bowel Diseases, Inflammatory
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen
      plus omeprazole
    


Intervention name(s): Celecoxib; Placebo; Ibuprofen plus Omeprazole
Intervention type(s): Drug; Other; Drug
Intervention description(s): 200 mg oral capsule twice daily for 2 weeks; Matched placebo for 2 weeks; ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks
Intervention MeSH terms: Ibuprofen; Celecoxib; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bowel Disease
Working Toward Wellness
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Working toward Wellness is a telephone care management and outreach monitoring program
      designed to help Medicaid recipients who are experiencing major depression to enter and
      remain in evidence-based treatment. To study the effects of Working toward Wellness,
      individuals receiving Medicaid in Rhode Island who are eligible for mental health services
      through United Behavioral Health were screened by telephone for depression. Those who were
      found to have major depression and who agreed to be in the study were randomly assigned.
      Program participants received intensive monitoring from Master's level clinicians called care
      managers to facilitate and support clinical treatment. The control group received usual care
      that included only referrals to mental health treatment providers. The study hypothesis is
      that telephonic care management would increase visits to mental health professionals and use
      of appropriate medication, which in turn would reduce depression severity and lead to greater
      employment and productivity at work.
    


Intervention name(s): Telephonic care management
Intervention type(s): Behavioral
Intervention description(s): Individuals received intensive outreach from care managers, first to help them to enter treatment and then, if treatment began, to remain in it for an appropriate time. Treatment is based on the American Psychiatric Association's Evidence-Based Practice Guidelines for Major Depression, which includes psychotherapy and antidepressant medications. Outreach and care management took place by telephone.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telephonic care management
Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System
Condition: Facial and Neck Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      This prospective, multi-center, single treatment clinical trial evaluates the clinical
      outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and
      neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner
      below the surface of the skin.
    

Detailed description: 
      The primary objective of this clinical trial is to demonstrate the effectiveness of the
      Ulthera® System to obtain improvement in overall lifting and tightening of skin.
    

Intervention name(s): Ulthera® System treatment
Intervention type(s): Device
Intervention description(s): Single treatment of focused ultrasound energy delivered below the surface of the skin.
Other intervention name(s): Ultherapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Chitosan Chewing Gum Study in Dialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      The purpose of the pilot study is to determine the impact of short-term administration of
      chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate
      levels.
    

Detailed description: 
      The impact of using salivary phosphate binders in ESRD patients is not fully known. The
      purpose of the pilot study is to determine the impact of short-term administration of
      chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate
      levels.
    

Intervention name(s): Chitosan
Intervention type(s): Dietary Supplement
Intervention description(s): The product chitosan is contained in a chewing gum formulation
Intervention MeSH terms: Chitosan
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatient hemodialysis facility
      
Keywords: serum phosphate; chitosan; kidney disease; salivary phosphate
Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
Condition: Tetanus; Diphtheria; Pertussis; Whooping Cough
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to describe immunogenicity of a single booster dose of Adacel
      vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.

      Primary objective:

        -  To describe seroprotection rates against tetanus and diphtheria in subjects randomized
           to receive either Adacel or Boostrix vaccine.

      Observational objectives:

        -  To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean
           antibody concentrations (GMCs) in subjects randomized to receive either Adacel or
           Boostrix vaccine.

        -  To describe booster response rates against tetanus, diphtheria, and pertussis in
           subjects randomized to receive either Adacel or Boostrix vaccine.

        -  To describe the rates of adverse events (AEs) immediately post-vaccination, and the
           rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with
           Adacel or Boostrix vaccine from Visit 1 through Visit 2.
    

Detailed description: 
      Participants will be randomized in a 1:1 ratio to receive either Adacel or Boostrix vaccine.

      Subjects will be monitored for immediate reactions for 15 minutes post-vaccination.
      Unsolicited adverse events and serious adverse events will be collected from Visit 1 through
      Visit 2.
    

Intervention name(s): Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Adacel®; BOOSTRIX®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adacel® vaccine; Tetanus; Diphtheria; whooping cough; Pertussis; BOOSTRIX® vaccine
Teachers and Parents as Partners During Middle School RCT
Condition: Behavior Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      There are two aims of this study (a) to examine the effect of Teachers and Parents as
      Partners on student, parent, and teacher outcomes in middle school and (b) identify barriers
      and facilitators to implementing Teachers and Parents as Partners in middle school for
      students with behavior concerns.
    

Detailed description: 
      In the business-as-usual control condition, participants will have access to any services
      that a school would routinely provide (e.g., develop and implement a behavior support plan)
      as well as services families can access in the community (e.g., mental health support).

      Teachers and Parents as Partners will occur in a series of stages comprised of approximately
      four structured meetings over approximately 8 weeks. A Teachers and Parents as Partners
      consultant will meet together with a student's parent(s), teachers, other school personnel
      (as appropriate), and the student (as appropriate). The Teachers and Parents as Partners team
      will collaboratively address behavior problem solving objectives. Specific TAPP objectives
      include: identifying strengths and specific behaviors of concern, specifying alternative
      prosocial behaviors, creating measurable behavior goals, co-constructing behavior
      intervention/support plans to address the target concerns, creating sustainable conditions to
      support plan implementation at home and school, and evaluating the plan to assess progress
      toward goals.
    

Intervention name(s): Teachers and Parents as Partners
Intervention type(s): Behavioral
Intervention description(s): Family-school partnership intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention condition and business-as-usual control condition
Masking: None (Open Label)
Primary purpose: Treatment
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients
Condition: Influenza; Multiple Myeloma; Waldenstrom's Macroglobulinemia; Plasma Cell Disorders; MGUS
MeSH terms: Influenza, Human; Multiple Myeloma; Waldenstrom Macroglobulinemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster
      to all patients with monoclonal gammopathies (irrespective of age) will lead to
      seroconversion rates exceeding 50% and more importantly, will reduce influenza-related
      morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the
      end of the flu season
    

Detailed description: 
      Influenza is a major cause of morbidity in the US. Patients with monoclonal gammopathies are
      known to have increased risk of developing influenza. Furthermore, several of the medications
      (such as proteasome inhibitors), commonly used to treat these tumors, are known to further
      increase the risk of these tumors. Seasonal influenza vaccination has been shown to reduce
      influenza related morbidity and is approved for routine prophylaxis in US. In 2009, Fluzone®
      high- dose vaccine was FDA approved in 2009 for adults aged 65 and older based on the data
      regarding higher rates of seroprotection (defined as hemagglutination antibody inhibition
      (HAI) titer of 40 or higher).

      In this study, the investigators will administer Fluzone® High-Dose vaccine with a planned
      booster to patients with monoclonal gammopathies irrespective of age versus a standard of
      care control group. Primary endpoint is composite of documented influenza infection rate and
      disease progression (as defined by International Myeloma Working Group criteria) at the end
      of the flu season. Based on the background data, the investigators expect a higher rate of
      success in the experimental arm. As such, the investigators power for success rates of 90%
      and 70% in the experimental and control arms, respectively.

      The investigators will also analyze several secondary endpoints including rates of influenza
      related morbidity, the analysis of humoral and cellular immune response to these vaccines and
      the rate of disease control (defined as lack of disease progression by standard international
      myeloma working group criteria).
    

Intervention name(s): Fluzone High Dose Vaccine; Standard of care/Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: influenza; multiple myeloma; Waldenstrom's macroglobulinemia
Evaluation of an Apple Juice Drink With POs-Ca
Condition: Food Preferences
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The null hypothesis tested was that there are no differences in the taste palatability of the
      apple juices before and after adding POs-Ca.
    


Intervention name(s): apple juice; apple juice with 0.5% POs-Ca; apple juice with 1% POs-Ca; apple juice with 1.5% POs-Ca; apple juice with 2% POs-Ca
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): unaltered(0% POs-Ca) commercially available apple juice; Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 0.5% by weight to a commercially available apple juice; Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 1% by weight to a commercially available apple juice; Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 1.5% by weight to a commercially available apple juice; Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 2% by weight to a commercially available apple juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: POs-Ca; calcium additives; drink
Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Condition: Appendicitis Acute
MeSH terms: Appendicitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      surgical site infiltration using ketamine versus Bupivacaine for analgesia in post-operative
      Appendectomy operation by Ketamine versus Bupivacaine
    


Intervention name(s): Ketamine Versus Bupivacaine
Intervention type(s): Drug
Intervention description(s): Drugs Ketamine versus Bupivacaine
Intervention MeSH terms: Ketamine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of firsocostat
      in adults with nonalcoholic steatohepatitis (NASH).
    


Intervention name(s): Firsocostat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules orally once daily.; Placebo matched to firsocostat orally once daily.
Other intervention name(s): GS-0976
Intervention MeSH terms: Firsocostat
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment