bioihbjkbjnl/mcl2 huggingface dataset:
PMC Split Preparation for Colon Cleansing
Condition: Colon Cleansing
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients
      aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated
      to higher efficacy and acceptability in comparison to the standard dose regimen in bowel
      cleansing before colonoscopy
    

Detailed description: 
      Picosulphate/magnesium citrate is a very effective, safe and tolerated low-volume preparation
      for colon cleansing. This study evaluates whether split dosing is associated to a further
      increase in efficacy and acceptability in comparison to the standard dose regimen. This is a
      multicenter, randomized, single-blind study performed in 15 endoscopic services in Italy.

      Adult outpatients undergoing colonoscopy will receive picosulphate/magnesium citrate either
      in the standard dosing (group A, two sachets the day before endoscopy), or in the split
      dosing (group B, the second dose in the morning of colonoscopy). Bowel cleansing will be
      assessed using the Boston Scale (BBPS) and rated as adequate if >2 in each segment. Patient
      acceptance, satisfaction, and related symptoms will be also recorded.
    

Intervention name(s): Sodium picosulphate/magnesium Citrate
Intervention type(s): Drug
Intervention description(s): Comparison of two different dosing regimens of sodium picosulphate/magnesium citrate
Other intervention name(s): Citrafleet
Intervention MeSH terms: Magnesium citrate; Picosulfate sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: preparation, cleansing, colon
Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine
Condition: Norovirus Infections
MeSH terms: Caliciviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the
      safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing
      GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study
      is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels
      of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to
      80 years old)
    

Detailed description: 
      A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the
      safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing
      GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study
      is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels
      of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to
      80 years old).

      Subjects will we randomized in the study utilizing an age and dose escalation schedule. A
      Safety Monitoring Committee will provide oversight of the trial throughout the duration of
      the study.
    

Intervention name(s): VXA-GI.1.NN; Placebo Tablet
Intervention type(s): Biological; Biological
Intervention description(s): GI.1 oral vaccine tablet; Tablets matching in number and appearance to active vaccine tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: norovirus, oral vaccine, elderly
A First in Human Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the safety and tolerability of a single dose of
      JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6
      cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced
      from Salk poliovirus strains (cIPV) as reference.
    


Intervention name(s): sIPV; cIPV
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive single dose (0.5 milliliter [mL]) of sIPV as a suspension for intramuscular injection on Day 1.; Participants will receive single dose (0.5 mL) of cIPV as a suspension for intramuscular injection on Day 1.
Other intervention name(s): JNJ-64152348; IMOVAX POLIO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Slow Versus Rapid Rehydration of Severely Malnourished Children
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The recommendation for correction of dehydration of severely malnourished children with
      diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example,
      in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart
      failure. There is not enough evidence to convince some of the physicians dealing with
      severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid
      rehydration per se is associated with increased incidence of over hydration and heart
      failure. And whether this approach is applicable in the management of severely malnourished
      children with severe cholera, which usually require rapid correction of water and electrolyte
      deficits for prevention of deaths due to hypovolaemic shock and other complications, has not
      been studied carefully. Recently, we have demonstrated that rapid intravenous rehydration
      (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing
      appropriate amount of fluid was found to be safe. We feel that rapid rehydration would help
      in improving the renal function, acidosis and thus improve appetite and reduce ORS failure
      subsequently. Since our study was uncontrolled, so we have planned a randomised controlled
      study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12
      hours) following WHO guideline and 125 patients will be rehydrated with intravenous fluid
      over 6 hours. Children of either gender, age 6 to 60 months, severely malnourished (Wt for
      length <-3 Z score of WHO growth chart or with nutritional oedema) with a history of watery
      of <24 hours with signs severe dehydration attending the ICDDRB Dhaka hospital will be asked
      to participate in this study. After the parents'/Legal guardian's consent, the children will
      be transferred to the study ward and will be treated according to the protocol. All children
      will receive similar treatment except the mode of rehydration, different for the two groups.
      The children will be closely monitored throughout the study period. The primary outcomes
      incidence of over hydration and ORS failure and secondary outcomes improvement of renal
      function and improvement of appetite measured by the food intake will be compared between the
      groups.
    


Intervention name(s): Rapid dehydration; Slow rehydration
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Severe malnutrition; severe dehydration; cholera
Effect of Tofacitinib in Treating ANCA-associated Vasculitis
Condition: ANCA Associated Vasculitis; Drug Use; JAK-STAT Pathway Deregulation
MeSH terms: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the efficacy and safety of tofacitinib 5 mg twice daily
      in AAV patients.
    

Detailed description: 
      Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) represents a group of
      small vessel vasculitides characterized by granulomatous and neutrophilic tissue
      inflammation, often associated with the production of antibodies that target neutrophil
      antigens. The predominantly used treatment for induction of remission in AAV consisted of
      cyclophosphamide (CYC) plus corticosteroids (GCs) which leads to remission in about 90% of
      patients. However, relapses are frequent and remain a challenge. The optimal drug for
      maintenance treatment is not determined. Tofacitinib is a Jak inhibitor which has been proved
      to be effective in multiple inflammatory diseases such as rheumatoid arthritis. Considering
      that T cells and associated cytokine production play an important role in the pathogenesis of
      AAV via activation of the JAK/ STAT pathway, we hypothesized that tofacitinib-mediated
      inhibition of JAK signaling may represent an effective therapy for active AAV. In this
      prospective, open label, single arm study, tofacitinib 5mg twice a day will be added to the
      background treatment of GCs and immunosuppressants in AAV, the safety and efficacy of
      tofacitinib will be assessed.
    

Intervention name(s): Tofacitinib
Intervention type(s): Drug
Intervention description(s): patients enrolled were prescribed tofacitinib 5mg twice a day orally.
Other intervention name(s): Tofacitinib 5mg.bid.po.
Intervention MeSH terms: Tofacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ANCA associated vasculitis; tofacitinib; safety; efficacy
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Condition: Relapsing Multiple Sclerosis (RMS)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96
      weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral
      placebo compared to 14 mg oral teriflunomide/IV placebo.
    


Intervention name(s): Ublituximab; Teriflunomide; Oral Placebo; IV Placebo
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Administered as an IV infusion.; Film coated tablets administered orally.; Administered orally.; Administered as an IV Infusion.
Other intervention name(s): TG-1101
Intervention MeSH terms: Teriflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multi-center, double-blinded, active-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vitamin D Intervention Trial in Healthy Chinese
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the dose-response between the doses of vitamin D3 supplements and raised serum
      levels of 25(OH)D and also the dose of vitamin D3 required to achieve circulating 25(OH)D ≥
      75 nmol/L;
    

Detailed description: 
      Recent epidemiological studies suggested that serum 25-hydroxyvitamin D [25(OH)D]
      concentration ≥75 nmol/L appeared to be optimal for preventing cardiometabolic diseases and
      improving bone health. To achieve this goal, a daily intake of 1000 IU or equivalent amount
      from other sources, is needed, which is twice as much as the RDA recommended by Chinese
      Nutrition Society. Meanwhile,epidemiological evidences show that large proportions of Chinese
      may suffer vitamin D insufficiency or deficiency whereas the current RDA in China might be
      too low to provide adequate vitamin D for people's health.

      In order to fill up this gap, therefore, it is essential to determine the dose-response
      between the doses of vitamin D3 supplements and raised serum levels of 25(OH)D and also the
      dose of vitamin D3 required to achieve circulating 25(OH)D ≥ 75 nmol/L.Ultimately, the
      current study will provide important evidence for establishing optimal vitamin D requirement
      for Chinese people
    

Intervention name(s): Placebo; Vitamin D
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): placebo; 400 IU vitamin D per pill
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vitamin D; deficiency; dose response
Risk Factors for Diabetes After Stem Cell Transplantation
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This study is proposed to investigate the incidence of Post Transplant Diabetes Mellitus
      (PTDM) as well as associated risk factors for the development of PTDM in patients undergoing
      allogenic stem cell transplantation.
    

Detailed description: 
      Allogenic stem cell transplantation from related or unrelated donors has been used
      successfully to cure patients with a variety of hematological malignancies. Graft-versus-host
      disease (GVHD) is an alloreactive immune phenomenon, where the activated donor T cells
      recognizes the recipient as being foreign and effects a cytotoxic response. GVHD occurring in
      the first 100 days after transplantation is termed acute GVHD and is characterized by
      hepatitis, dermatitis, and enteritis.

      High dose corticosteroids remain one of the cornerstone therapies to treat acute GVHD.
      However, an association between corticosteroid therapy and the development of diabetes
      mellitus after solid organ transplantation has become widely recognized. Similarly, post
      transplant diabetes mellitus (PTDM) has been increasingly noted in the allogenic stem cell
      transplant population, however, to date, no systematic study has been completed to identify
      the incidence of PTDM and associated risk factors. We propose to investigate the incidence of
      PTDM as well as associated risk factors for the development of PTDM in patients undergoing
      allogenic stem cell transplantation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients will be enrolled through the Endocrinology, Hematology and Stem Cell
        Transplantation Clinics at Vanderbilt University Medical Center.
      
Keywords: Allogenic Stem Cell Transplantation; Diabetes Mellitus
Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population
Condition: Malignant Neoplasm of Large Intestine
MeSH terms: Colorectal Neoplasms; Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the direct mailing of fecal occult blood testing
      (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to
      improve colorectal cancer screening rates within a low income and racially/ethnically diverse
      population.
    

Detailed description: 
      Patients ages 50 to 80 who are identified through the electronic health record as not being
      up to date on colorectal cancer screening are eligible for the study and will be randomly
      assigned to the intervention or usual care group. Individuals in the intervention group will
      be mailed a letter informing them that they are due for colorectal cancer screening,
      educational material regarding colorectal cancer screening, a fecal occult blood testing
      (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients
      assigned to the intervention versus usual care groups who complete a guideline recommended
      form of colorectal cancer screening within 4 months of the initiation of outreach will be
      compared.
    

Intervention name(s): Care manager outreach
Intervention type(s): Other
Intervention description(s): Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: colorectal cancer screening; fecal occult blood testing (FOBT); vulnerable populations; community health center
A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study.
      The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare
      safety, immunogenicity and pharmacodynamics (PD) between the test product L06006 and the
      reference products US-Prolia and EU-Prolia in healthy male subjects. A total of 300 healthy
      male subjects aged 28 to 65 years (both inclusive) will be randomized 1:1:1 to receive a
      single subcutaneous (s.c.) injection of either LY06006 or US-Prolia or EU-Prolia on Day 1 and
      then be followed for 36 weeks.
    


Intervention name(s): LY06006 (Denosumab Biosimilar); US-Prolia (Denosumab); EU-Prolia
Intervention type(s): Biological; Biological; Biological
Intervention description(s): single dose of 60 mg LY006006 s.c.; single dose of 60 mg US-Prolia s.c.; single dose of 60 mg EU-Prolia s.c.
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multi-center, randomized, double-blind, single-dose, three-arm, parallel-group study designed to demonstrate the PK similarity between LY06006, US-Prolia and EU-Prolia and to evaluate the safety, tolerability, immunogenicity and PD of LY06006 compared with US-Prolia and EU-Prolia.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effects of Energy Drinks
Condition: Energy Drinks
Study type: Interventional

Summary: 
      This study is designed to test the efficacy of energy drinks. This is a double-blinded,
      crossover, randomized clinical trial, measuring the effect of the test drinks compared with
      placebo drink in 200 participants aged 18-70 years.
    

Detailed description: 
      This study is designed to test the efficacy of an energy drink compared to placebo via a
      double-blind, crossover, randomized clinical trial. Energy levels will be assessed before and
      after consumption of the test beverages on 2 days separated by a week in 200 participants
      aged 18-70 years. The study is crossover because the participants will be (randomly)
      receiving one drink on Test Day 1 and the other drink on Test Day 2.

      After signing written informed consent, participants will be fed a light lunch, and their
      pulse, weight and height measured. A baseline battery of computer-based tests to assess
      energy levels will be conducted. These computer-based measures will take ~40 minutes to
      complete and will include: a) a long-term memory test b) a Profile of Mood States (POMS2)
      brief form; c) Rapid Visual Information Processing (RVIP) test, d) The N-Back Task; d)
      Reaction time online test; f) the Flanker Task. Participants will then be asked to fill out a
      baseline survey (30 min), with questions about current health-related behaviors, specifically
      questions about physical activity and diet.

      Upon completing the baseline battery (survey administered at test session 1 only),
      participants will be randomly administered the energy drink or the placebo to consume while
      observed. Subsequently, the battery of computer-based tests to assess energy levels will be
      re-administered 30 minutes, 2.5 hours and 5 hours after consumption of the test drink.

      The study intervention will be double-blinded: participants will be blinded to whether they
      are receiving the active or the placebo drink, and study team members will also not be aware
      of the assignment.

      When the study ends, full compensation will be given if the intervention is fully completed;
      if the intervention is not fully completed, partial compensation will be given.
    

Intervention name(s): Energy drink; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): placebo drink
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effect of Infant Formula Intake on Infant Growth From 0 to 6 Months.
Condition: Child Development
Study type: Interventional

Summary: 
      From birth to 5 months, milk is the essential and unique food of the newborn. The French
      National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at
      least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are
      exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in
      the first few months of life. This decision may be a personal choice or be imposed by
      pathophysiological situations.

      The nutritional requirements of the infant are specific, which implies adequate nutrition.
      Infant formulas and follow-up formulas are therefore complex products, specially developed
      for a group of vulnerable consumers. In fact, the compositional and information requirements
      for infant formula are highly regulated.

      Even clinical studies are not required to market an infant formula, it is important to obtain
      objective date on infant growth. Therefore, this study proposes to evaluate the effect of the
      consumption of an infant formula on the growth of infants from 0 to 6 months in comparison
      with the growth curves of the World Health Organization (WHO).
    


Intervention name(s): Infantil formula
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics,
      and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in
      healthy subjects, and to assess the relative bioavailability of two formulations of
      BMS-986195 with or without food.
    


Intervention name(s): BMS-986195; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified day; Specified dose on specified day
Intervention MeSH terms: Branebrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment