bioihbjkbjnl/mcl2 huggingface dataset:
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
Condition: Excessive Daytime Sleepiness; Obstructive Sleep Apnea; Impaired Cognitive Function
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of study JZP110-405 is to determine whether solriamfetol is effective at
      improving cognitive function in participants with excessive daytime sleepiness (EDS)
      associated with obstructive sleep apnea (OSA) plus impaired cognitive function.
    


Intervention name(s): Solriamfetol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solriamfetol 75 mg/d Solriamfetol 150 mg/d; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Axsome; SHARP; Solriamfetol; EDS; OSA; Cognition; Cognitive Function; DSST
A Study to Evaluate the Pharmacokinetics and Safety of ASP015K in Healthy Chinese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of ASP015K after
      single-dose and multiple-dose administration in healthy Chinese participants.
    


Intervention name(s): peficitinib
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): ASP015K
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: peficitinib; ASP015K; pharmacokinetics
Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers
Condition: Chronic Hepatitis b
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional

Summary: 
      A single-center, open-Label, randomized, single-dose, two-period, two-sequence, crossover
      study to assess the bioequivalence of test formulation entecavir tablets 1.0 mg with
      reference formulation entecavir tablets (Baraclude®) 1.0 mg in healthy adult subjects under
      fasting conditions.
    

Detailed description: 
      This is a single-center, open-label, randomized, single-dose, two-period, two-sequence,
      crossover study to assess the bioequivalence of test formulation Entecavir Tablets 1.0 mg
      with reference formulation Entecavir Tablets (Baraclude®) 1.0 mg in healthy adult subjects
      under fasting conditions. Each subject will be randomized to one of two treatment sequences
      (TR, RT) according to a randomization schedule prepared prior to the start of the study.
      There will be a 21-day washout between each single dose administration. Subjects in each
      group will be dosed on the same day for Day 1 of Period 1, and all subjects in each group
      will be crossed over to the alternate formulation and will be dosed on the same day for Day
      22 of Period 2.
    

Intervention name(s): Baraclude® tablets,1.0 mg; Entecavir tablets,1.0 mg
Intervention type(s): Drug; Drug
Intervention description(s): oral,once,under fasting condition; oral,once,under fasting condition
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Single-Center, Open-Label, Randomized, Single-Dose, Two-Period, Two-Sequence, Crossover Study
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Trial Comparing Carbonated Drink With Water as a Solvent for Colonoscopy Solution
Condition: Colonoscopy
Study type: Interventional

Summary: 
      This prospective randomized trial will be conducted in all patients undergoing elective
      colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite
      by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on
      inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml
      solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight
      aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and
      before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy.
      Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects,
      and willingness to repeat the preparation.
    

Detailed description: 
      This prospective randomized trial will be conducted in all patients undergoing elective
      colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite
      by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on
      inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml
      solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight
      aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and
      before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy.
      Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects,
      and willingness to repeat the preparation.

      90ml of sodium phosphate will be added to 800ml of solvent and taken in divided doses one day
      prior to procedure. Whole solution will be finished 3 -4 hours before colonoscopy. The
      instructions about how to take the solution will be clearly explained at the time of booking.
      Complete Blood Count and hepatitis B and C screening as routine shall be done. All procedure
      will be carried out under monitored sedation by trained colorectal surgeon from the faculty
    

Intervention name(s): Sodium phosphate; Water; Zero calorie carbonated drink
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 90ml of sodium phosphate will be added to 800ml of solvent( water or zero calorie carbonated drink) and taken in divided doses one day prior to procedure. Whole solution will be finished 3 -4 hours before colonoscopy.; 800 ml of water will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy; 800 ml of zero calorie diet cola will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy
Other intervention name(s): Colonoscopy solution; Diet cola
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of this clinical study is to investigate the extent to which ear acupuncture has an
      effect on insomnia in women with breast cancer. It will be investigated whether changes in
      sleep quality, fatigue, quality of life, stress, and psychological well-being can be
      achieved. In addition, a proinflammatory cytokine will be meassured.
    


Intervention name(s): Ear acupuncture; Psychoeducation
Intervention type(s): Procedure; Behavioral
Intervention description(s): Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.; Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Initiation and Maintenance Disorders; Acupuncture, Ear; Cytokines; Breast Neoplasm
A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes
Condition: Pre-Symptomatic Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of golimumab in
      children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus
      (T1D).
    


Intervention name(s): Golimumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area.; Matching placebo to golimumab.
Other intervention name(s): SIMPONI
Intervention MeSH terms: Golimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL)
Condition: Diffuse Large B-cell Lymphoma (DLBCL)
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Observational

Summary: 
      A retrospective, non-interventional cohort study was used to address the study objectives.
      This study aimed to provide a better understanding of real-world healthcare resource
      utilization (HRU) and healthcare reimbursement costs associated with CAR-T therapy among
      patients with r/r Diffuse Large B-cell Lymphoma (DLBCL).
    

Detailed description: 
      A retrospective, non-interventional cohort study was used to address the study objectives.
      This study aimed to provide a better understanding of real-world HRU and healthcare
      reimbursement costs associated with CAR-T therapy among patients with r/r DLBCL.

      Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy or allo-HSCT
      between January 1, 2017 to September 31, 2019 were identified from the Centers for Medicare &
      Medicaid Services (CMS) 100% Medicare Database. The CAR-T cohort was further classified into
      CAR-T IP and CAR-T OP cohorts based on the infusion setting.

      The index date was defined as the date of CAR-T therapy administration or allo-HSCT. Baseline
      period was defined as three months prior to the index date. Study period was defined from the
      index date to the end of health plan coverage based on insurance enrollment file or death,
      whichever occurred earlier.

      Two sets of comparisons on HRU and healthcare reimbursement costs were conducted, one between
      IP vs. OP infusion of CAR-T, and the other between patients who received CAR-T therapy vs.
      allo-HSCT.
    

Intervention name(s): CAR-T; Allo-HSCT cohort
Intervention type(s): Other; Other
Intervention description(s): infusion of CAR-T therapy among patients with r/r DLBCL; Patients received allogeneic hematopoietic stem cell transplant
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with DLBCL who received CAR-T therapy or allo-HSCT procedure between January
        1, 2017 to September 31, 2019
      
Keywords: CAR-T,; DLBCL,; Inpatient,; Outpatient
Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is
      to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.
    

Detailed description: 
      Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate
      acute pain for up to 4 days.
    

Intervention name(s): Zipsor®
Intervention type(s): Drug
Intervention description(s): Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treament. Drug taken by mouth.
Other intervention name(s): Diclofenac
Intervention MeSH terms: Diclofenac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; NSAID; moderate pain; mild pain; acute pain; mild acute pain; moderate acute pain; mild or moderate acute pain
The PK/PD Study of SHR2285 Tablets in Healthy Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of
      cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant
      therapies is bleeding. The primary objective of this study is to assess the safety and
      tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide
      information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.
    


Intervention name(s): SHR2285; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending dose oral adminstration; Ascending dose oral adminstration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of Fiber on Glycemic Index
Condition: Healthy
Study type: Interventional

Summary: 
      Primary objective is to investigate the effect of polydextrose on postprandial glucose
      concentrations in healthy adults when added to a food product.

      Secondary objective is to assess gastrointestinal tolerance and acute bowel changes.
    

Detailed description: 
      This study is a randomized, 4-arm, single-blinded, controlled, cross-over trial design
      focused on determining the health benefits associated with Polydextrose intake.

      A planned sample size of 40 will be enrolled into the study. This study will require one
      initial screening visit and 4 weekly study visits. This study will take approximately 4 weeks
      per subject to complete.

      The initial screening visit will provide subject with the informed consent document and
      determine subject eligibility through anthropometric measurements, vital signs, fasting blood
      glucose test (finger prick), and completion of a survey relate to general eating, health, and
      exercise habits.

      If willing and eligible to participate, subjects will be invited to participate in the study
      for 4 study days. Subjects will be instructed to maintain their usual diet pattern and
      physical activity throughout study duration. A dinner meal will be provided the day before
      the study visit to control the second meal effect from the food and beverage intake of the
      night before the study visit.

      Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and
      rested. Each study visit will require blood draws throughout the visit. After evaluation of
      subject's health status (via anthropometric, vital sign and blood glucose measurements and
      in-person interview), a Licensed health Care Professional will place a catheter in subject's
      arm for the purpose of multiple blood sample collections and take the initial blood draw in
      the fasting state. Subjects will be randomized to receive a placebo or treatment beverage
      based on randomized treatment sequences for 4 study visits. The sequences of receiving the
      beverage treatments at each visit will be randomly assigned to one of sequences.

      Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5,
      1, 2, 3 hour (h) for assessment of change in plasma glucose and insulin concentrations.
    

Intervention name(s): 8 g Polydextrose; 12 g Polydextrose; 16 g Polydextrose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 8g of Polydextrose; 12 g of Polydextrose; 16 g of Polydextrose; 0 g of Polydextrose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Fiber; Polydextrose; Glycemic Index
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
Condition: Cancer
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative
      3-arms of 140 patients (i.e. 420 total patients).

      Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months
    


Intervention name(s): warfarine - low molecular heparin
Intervention type(s): Drug
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vascular Access for Hemodialysis and Inflammation
Condition: Vascular Access for Hemodialysis and Inflammation
MeSH terms: Inflammation
Study type: Observational

Summary: 
      The aim of the present study was to investigate patients free of active infection and/or
      thrombosis to assess if the type of vascular access (AVF, AVG, TCC), could influence:

        1. the levels of serological markers of inflammation (CRP, IL-6, TNF-a);

        2. the degree of expression on monocyte surface of inflammation and immune response
           modulating molecules: CD14, CD32 and CD44.

        3. the amount of monocytic cells expressing a senescent phenotype (CD14 and CD32).
    

Detailed description: 
      Patients with AVF assumed ticlopidine 250 mg/die, patients with TCC and AVG assumed warfarin
      to maintain target INR between 1.8 and 2.5.

      Six wash out consecutive sessions were carried out before starting the study with Fresenius
      FX8 Helyxone® , for patients who underwent HD, or with FX 80 Helyxone®, for patients who
      underwent hemodiafiltration (HDF). After the wash out period, fresh whole blood and serum
      samples were drawn on starting dialysis, during the midweek HD session for 4 consecutive
      weeks. For each patient the mean value of the 4 blood samples was considered. All patients
      continued HD or HDF with FX8 or FX 80 Helyxone® during the whole study period.In order to
      estimate the normal ranges of the parameters that we evaluated, 60 anonymous healthy
      volunteers were also submitted to the same assays.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The three groups of patients were homogeneous for: a) demographic characteristics; b)
        dialysis adequacy; c) vascular access blood flow; d) white cell count.
      
Keywords: AVF; AVG; TCC; inflammation; monocite senescence
GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of multiple increasing
      oral doses of GLPG0259 compared to placebo.

      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing
      oral doses, and potential drug-drug interaction with single dose methotrexate will be
      assessed.
    


Intervention name(s): placebo; GLPG0259; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral solution, daily for 14 days; oral solution; 7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14
Other intervention name(s): Ledertrexate®
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Pharmacokinetics
A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the uptake of oxytocin following intravaginal administration of
      Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after
      vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70
      years old with vaginal atrophy will be included and will self-administer Vagitocin
      intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a
      single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels
      after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at
      timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours,
      relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic
      variables will be calculated. The % of oxytocin which was absorbed following vaginal
      administration (bioavailability)will also be calculated.
    


Intervention name(s): Vagitocin
Intervention type(s): Drug
Other intervention name(s): Oxytocin gel 400 International Units
Intervention MeSH terms: Oxytocin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib
Condition: Qt Interval, Variation in
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of
      celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive
      control, and crossover study. Volunteers will be mainly checked up through ECG to find out
      changes of QT/QTc interval during the study.
    


Intervention name(s): Celecoxib; Moxifloxacin; Water
Intervention type(s): Drug; Drug; Other
Intervention description(s): Celecoxib 400mg capsule; Moxifloxacin 400mg tablet; Pure water 150ml
Other intervention name(s): Celebrex; Avelox
Intervention MeSH terms: Moxifloxacin; Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and
      genitals in men and women. Several types of HPV infection are transmitted by sexual activity
      and, in women, can infect the cervix (part of the uterus or womb). This infection often goes
      away by itself, but if it does not go away (this is called persistent infection), it can lead
      in women over a long period of time to cancer of the cervix. If a woman is not infected by
      HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the
      consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing
      processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in
      young adolescents and women of 10-25 years of age at study start. Approximately 750 study
      subjects will receive different lots of the HPV vaccine administered intramuscularly
      according to a 0-1-6 month schedule.
    


Intervention name(s): HPV-16/18 L1/AS04
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention