bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D for Chemoprevention
Condition: Gastrointestinal Cancers; Prostate Cancer; Hypertension
MeSH terms: Gastrointestinal Neoplasms; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will help us know the effects of Vitamin D pills in Blacks. The results of this
      study may be the first step in creating ways to prevent the risks of colon and prostate
      cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among
      Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels
      in our bodies.
    

Detailed description: 
      -  Participants will be asked to answer some questions about their diet, exercise and
           health. In addition, participants blood pressure will be taken. These assessments will
           occur at baseline, 3- and 6-month appointments. At baseline only, we will measure skin
           tone with a tool called the Photovolt 577.

        -  A small blood sample will be taken to see how much Vitamin D is the body and will also
           look at levels of other markers of disease such as proteins, hormones, and genes.

        -  Participants will take a vitamin pill every day for three months and be randomly
           assigned to one of four different types of pills.

        -  Participants will be called or visited at least every two weeks. They will be asked
           questions to determine if they have any side effects associated with high levels of
           Vitamin D.

        -  At the beginning of the second and third months, participants will be provided with more
           pills. At the end of the third month, another blood sample will be taken. Three months
           after that, the final blood sample will be taken.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Taken orally every day for three months; Placebo pill taken once daily for 3 month
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; Blacks; cancer; hypertension
A Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation
Condition: Sedation in Intensive Care
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, single-blind, propofol-controlled phase III clinical
      study. In this study, ICU patients undergoing mechanical ventilation are expected to be
      enrolled and will be randomly assigned to the HSK3486 group and the propofol group.
    


Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Loading Dose：0.1 mg/kg, infused with 4 min ± 30 s； Maintenance Dose：Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h. Range of maintenance dose: 0.06-0.8 mg/kg/h; Loading Dose：0.5 mg/kg, infused with 4 min ± 30 s
Maintenance Dose：Maintenance is started at 1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5 mg/kg/h. Range of maintenance dose:
0.3-4 mg/kg/h
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With Food
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of coadministration of a high-fat meal on
      the oral bioavailability of a fixed dose combination of Canagliflozin/extended release
      Metformin (CANA/MET XR) tablet, containing 150 mg CANA and 1,000 mg extended release MET in
      healthy participants.
    

Detailed description: 
      This is a randomized (a sequence of fasted and fed periods accompanying study drug intake
      will be assigned by chance), open-label (physicians and participants know the identity of the
      assigned treatment), single-center, single-dose, 2-period, 2-sequence, crossover study of
      Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of
      150 mg/1,000 mg. Approximately 24 healthy adult participants will be enrolled to ensure that
      at least 20 complete the study.

      After a screening period, participants will be randomly assigned to 1 of the 2 treatment
      sequences (AB or BA) on Day 1 of Period 1. Treatment A means a participant will receive a
      single 150/1,000 mg CANA/MET XR FDC tablet under fasted conditions, and Treatment B means
      that a participant will receive the same drug under fed conditions. Participants will need to
      remain at the study center for 4 days (72 hours postdose) after the drug administration for
      collection of blood samples in each treatment period. There will be a 10- to 14-day washout
      period between Period 1 and Period 2. On Day 4 (72 hours postdose) of Period 2, when
      participants are discharged from the study center, they will be given instructions to return
      for a follow-up visit 7 to 10 days later. For Treatment B (in fed state), participants will
      be provided with a standardized high-fat breakfast. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): CANA/MET XR FDC
Intervention type(s): Drug
Intervention description(s): Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Canagliflozin; Metformin; INVOKANA®; Type 2 diabetes mellitus
A First-time-in-human Study of BGB149
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This clinical trial is a Phase I, first-in-human. The study is designed to evaluate the
      safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of
      BGB149 after single IV doses in healthy male and female subjects. Multiple dose levels will
      be explored.
    


Intervention name(s): BGB149; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single Ascending Dose; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Immune Regulation in Multiple Sclerosis: The Effect of Glatiramer Acetate on MicroRNA Expression in Antigen-Presenting Cells
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in
      many human diseases. The purpose of this pilot study is to determine if microRNA expression
      is changed in untreated and glatiramer acetate-treated patients with multiple sclerosis.
    

Detailed description: 
      MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in
      many human diseases. The purpose of this pilot study is to determine if microRNA expression
      is changed in untreated and glatiramer acetate-treated patients with multiple sclerosis. The
      expression of microRNA will be analysed in cell subsets separated from peripheral blood
      mononuclear cells.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Control human subjects and patients with RRMS will be enrolled in New Brunswick, NJ
      
Biospecimen description: 
      peripheral blood
Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme
Condition: Colorectal Neoplasms; Adenoma Detection Rate
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Interventional

Summary: 
      Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the
      Western world. The decrease in incidence and mortality by CRC in the population undergoing
      screening has been observed. Colonoscopy is the recommended method for detecting tumors in
      early stages, as well as identifying and resecting adenomatous polyps, which are the
      precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence
      and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does
      not prevent right colon lesions in the same way as the left colon lesions, with most of the
      interval cancers located in the right colon. Studies published so far show an increase in the
      adenomas detection rate (ADT) in the right colon in the second visualization of this segment
      and an increase between 2 and 10% if this second examination is performed with the proximal
      retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our
      study is to evaluate the ADT in the right colon by means of a second visualization by
      performing proximal retroflexion or second frontal visualization at random in the CCR
      screening population.
    


Intervention name(s): Proximal retroflexion; Frontal view
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization; The investigator explore twice right colon with frontal viewing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: retroflexion proximal; colorectal cancer screening programme; adenoma detection rate; right colon
An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in
      subjects with advanced Parkinson's disease.
    


Intervention name(s): ABT-SLV187
Intervention type(s): Drug
Intervention description(s): Dose levels will be individually optimized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Efficacy; levodopa-carbidopa intestinal gel; levodopa; carbidopa; Advanced Parkinson's Disease
Study of Single Ascending Doses of PF-07081532 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)
      of single ascending oral doses of PF-07081532 in healthy adult participants.
    


Intervention name(s): PF-07081532; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single ascending doses PF-07081532; Participants will receive placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a double-blinded (investigator- and participant-blinded), sponsor-open, randomized, single-ascending oral dose, 4-period crossover, placebo substitution design in 2 interleaving cohorts of healthy adult participants. An additional cohort, enrolling healthy adult participants in up to 4 crossover periods, may be included to permit assessment of any of the following: repeat of a previously administered dose level; studying additional dose levels as dictated by the evaluated safety, tolerability or PK of earlier dose levels; or any other assessment needed to meet the objectives of this study. A cohort enrolling Japanese participants to receive PF-07081532 or placebo in up to 3 periods, may be included.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: First-in-human study
Transplantation With Ybritumomab Tiuxetan (Zevalin) Plus BEAM Regimen in Patients With Refractory Large B-cell Difusse Lymphom
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin)
      administration in the conditioning treatment of patients with refractory large B-cell diffuse
      lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem
      cells.
    


Intervention name(s): Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan)
Intervention type(s): Drug
Intervention description(s): Day -21: rituximab. 250 mg/m2 iv
Day -14: rituximab. 250 mg/m2 plus Ybritumomab Tiuxetan (Zevalin)(0.4 mCi/kg maximum dose 32 mCi).
Days -6 to -1: BEAM regimen as follows BCNU: 300 mg/m2 over 2 hours, day -6. ARAC: 200 mg/m2/12 hours over 12 hours, days -5 through -2. VP16: 200 mg/m2/day over 2 hours, days -5 through -2. Melphalan: 140 mg/m2/day over 15 minutes, day -1.
Other intervention name(s): Ybritumomab Tiuxetan (Zevalin); Rituximab (Mabthera)
Intervention MeSH terms: Rituximab; Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Z-BEAM; Autologous; Lymphoma; GELTAMO
Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients
Condition: Post Operative Nausea and Vomiting (PONV); Adenotonsillectomy
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      The frequent incidence of postoperative vomiting and severe pain in children undergoing
      adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration.
      Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this group of
      patients, with a reported incidence ranging from 23% to 73%.

      There is growing evidence that the perioperative administration of gabapentinin in adults is
      beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative
      nausea and vomiting, and delirium.

      Only few studies in literature explored the analgesic effects of preoperative gabapentin as
      premedication in pediatric population. However, the antiemetic effect of gabapentin in
      pediatric patients was not systematically investigated before.
    


Intervention name(s): Gabapentin as premedication; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia; Patients will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia.
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Gabapentin; PONV; Adenotonsillectomy; Pediatrics
Propofol Spinal Procedural Sedation for Cesarean Section
Condition: Patient Compliance
Study type: Interventional

Summary: 
      Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians.
      According to evidence, guidelines and quality markers, regional anesthesia is preferred over
      general anesthesia in obstetric surgery. A high level of anxiety is present in obstetric
      patients preoperatively. Patients with high anxiety tend to prefer general anesthesia for
      cesarean section. The anxiety can be reduced variably by non-pharmacologic and pharmacologic
      methods. The evidence supports the benefits of procedural sedation for distressed, anxious
      pregnant women.
    

Detailed description: 
      Propofol provides short onset, rapid predictable action, anxiolysis and amnesia and it is
      more effective than benzodiazepines. Using propofol infusion in low doses during spinal
      injection in CS did not adversely affect the Apgar scores or the neurological and adaptive
      fetal outcomes. The general consensus is that procedural sedation is not a routine for spinal
      interventions, but required for anxious patients. Our hypothesis is that, with the high
      prevalence of maternal anxiety during cesarean section, ensuring painless comfortable spinal
      anesthesia may increase the acceptance rate of regional anesthesia during cesarean section.
    

Intervention name(s): propofol
Intervention type(s): Drug
Intervention description(s): A bolus of 0.7 mg/kg will be given initially, additional incremental doses of 20 mg propofol will be given if the patient complained of pain or moved arms towards the back. Patients will be sitting on the middle of the operating table facing towards the table's foot. The table's foot will be dropped 45 degrees for a comfortable chair position, Monitoring through pulse oximeter (SaO2), non-invasive blood pressure (NIBP) adjusted every 2 minutes automatic measuring and capnography tube in contact with nostrils.
Other intervention name(s): propofol procedural sedation
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of this study is to efficiently evaluate the clinical efficacy and
      safety of different investigational therapeutics among adults who have COVID-19 but are not
      yet sick enough to require hospitalization. The overall hypothesis is that through an
      adaptive trial design, potential effective therapies (single and combination) may be
      identified for this group of patients.

      COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol
      designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding
      (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the
      platform, every investigational product will collect data for both Domain primary endpoints.
      Individual treatments to be evaluated in the platform will be described in separate
      sub-protocols.
    

Detailed description: 
      The platform study allows investigational products with objectives either: evaluating viral
      shedding (Virology Domain); and COVID-19 related Clinical Outcomes (Clinical Domain).

      The primary objective for investigational products within the Viral Domain is:

      A. To evaluate the efficacy of each therapeutic intervention in addition to standard
      supportive care (SSC) compared with SSC in reducing viral shedding of SARS-CoV-2 virus in
      outpatients with COVID-19 disease.

      The primary objective for investigational products within for the Clinical Domain is:

      B. To evaluate the efficacy of each therapeutic intervention in addition to SSC as compared
      to SSC in improving sustained clinical outcomes in outpatients with COVID-19 disease.

      Secondary objectives are:

        1. The objective of the non-assigned domain an investigational product is under.

             1. If under Clinical Domain, reduction in viral shedding.

             2. If under Viral Domain, time to sustained resolution of symptoms.

        2. To evaluate the efficacy of each therapeutic intervention in reducing SARS-CoV-2 related
           hospitalizations, ED visits, or death in outpatients with COVID-19 disease.

        3. To assess the development of antibodies against SARS-CoV-2

        4. To evaluate the safety and tolerability of each therapeutic intervention compared with
           placebo (supportive care).
    

Intervention name(s): Acebilustat; Camostat
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg capsule administered orally once daily; 200 mg (2 x 100 mg tablet) administered orally four times daily (800 mg total daily dose).
Intervention MeSH terms: Camostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Master Protocol; Outpatient
Cybersickness imAgiNg Olfactory Evocation
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to, using fMRI, compare brain activations during olfactory imagery
      induced by different visual supports (words, pictures, colors and colored arrangements) in
      healthy subjects.

      This will allow us to choose the best olfactory imagery facilitator and to assess its effect
      on cybersickness.
    


Intervention name(s): Functional MRI; Virtual Reality: control; Virtual Reality: experimental
Intervention type(s): Device; Other; Other
Intervention description(s): The volunteer will have to imagine the smells evoked by different visual aids. This task will be carried out during 2 acquisition runs of about 10 minutes each. The volunteer should note (on a scale from 1 to 4) the pleasantness of the smell evoked.; The volunteer will be immersed in a virtual maritime environment with nauseating characteristics. In the center of the maritime scene, it will be visible the black outlines of a frame. Every minute, the volunteer will be asked to verbalize the level of his general condition via the Fast Motion Sickness Scale (1 to 20).; The volunteer will be immersed in a virtual maritime environment with nauseating characteristics. The visual support inserted in the center of the virtual scene will be the one defined as being the most facilitator of the olfactory imagination during the fMRI examination. The volunteer will be asked to concentrate on the smell evoked by this support. Every minute, the volunteer will be asked to verbalize the level of his general condition via the Fast Motion Sickness Scale (1 to 20).
Other intervention name(s): fMRI; VR control; VR experimental
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: fMRI