bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
Condition: Insomnia
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate whether the plasma concentration-time profile and
      pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function
      are similar to those observed in healthy participants; and will evaluate the safety and
      tolerability of suvorexant both in participants with impaired renal function and in healthy
      participants.
    

Detailed description: 
      Study Design:

      This study plans to enroll 16 participants in Part I (8 participants with severe renal
      impairment and a control group of 8 healthy participants) and 32 participants in Part II (8
      participants with moderate renal impairment and a control group of 8 healthy participants;
      and 8 participants with mild renal impairment and a control group of 8 healthy participants).

      Part II will be conducted only if the primary hypothesis is not met in Part I and there is a
      significant difference in the PK of suvorexant between healthy participants and severe renal
      impairment participants.
    

Intervention name(s): Suvorexant
Intervention type(s): Drug
Intervention description(s): single oral dose of 20 mg (administered as 2 x 10 mg tablets) of suvorexant administered with ~240 mL of water after an 8 hour fast
Other intervention name(s): MK-4305
Intervention MeSH terms: Suvorexant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study to bowel cleansing evaluation of mixed two other type bowel
      preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).
    

Detailed description: 
      To evaluate mixed-drug bowel preparation methods for decreasing side effect and increasing
      compliance

      Picolight + Coolprep [Day-Prior] Picolight + Clicolon [Day-Prior] Picolight + Coolprep
      [Split-Dose] Picolight + Clicolon [Split-Dose]
    

Intervention name(s): Picolight + Coolprep; Picolight + Clicolon
Intervention type(s): Drug; Drug
Intervention description(s): Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose]; Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose]
Other intervention name(s): Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate); Coolprep(PEG 3350 + EL, Ascobic acid, Sodium sulfate); Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate); Clicolon(Sodium phosphate)
Intervention MeSH terms: Picosulfate sodium; Sodium sulfate; Magnesium Oxide; Sodium Citrate; Citric Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colonoscopy; Bowel preparation; Picolight; Clicolon; Coolprep
A Phase I Study of an HIV Vaccine in Healthy, HIV Uninfected Adults
Condition: Healthy
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of Modified Vaccinia
      Ankara (MVA) Mosaic vaccine in healthy adult participants.
    

Detailed description: 
      This is a Phase I, placebo-controlled (the use of an inactive substance identical in
      appearance to the active vaccine), double-blind (neither the participant or study personnel
      will know the identity of the treatment administered) study where participants will be
      randomized (treatment type assigned by chance) to receive a Modified Vaccinia Ankara (MVA)
      Mosaic vaccine (at 1x10E8 pfu) or placebo. This design is intended to reduce the likelihood
      of observer and selection bias, provide control for confounding variables, and aid an
      unbiased analysis of the study results. The study will include 4 groups of participants, 2
      groups having previously been vaccinated with Ad26.ENVA.01 (A recombinant adenovirus [rAd]
      vaccine for HIV-1) and 2 groups not previously vaccinated with Ad26.ENVA.01. Participants
      will be randomized in a 4:1 ratio to receive either a MVA Mosaic vaccine or placebo. The
      trial comprises a 4-week screening period, a 12-week vaccination period during which
      participants will be vaccinated at baseline (Day 1) and Week 12 (Day 84), and a 40-week
      follow-up period to the final visit at Week 52.
    

Intervention name(s): MVA Mosaic; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL (1x10E8 pfu) MVA Mosaic (comprised of MVA Mosaic 1 and MVA Mosaic 2 mixed in a 1:1 ratio before administration) will be administered by intramuscular (IM) injection.; 0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Healthy; Human immunodeficiency virus type 1 (HIV-1) infection; Acquired immunodeficiency syndrome (AIDS); recombinant adenovirus (rAd) vector-based vaccines; Vaccination; Ad26.ENVA.01; Recombinant; Modified Vaccinia Ankara (MVA) vector-based vaccines
Perinatal Outcomes and Hematologic Parameters in COVID-19 Pregnancies
Condition: Pregnancy, Infections in; Covid19
MeSH terms: COVID-19; Pregnancy Complications, Infectious
Study type: Observational

Summary: 
      Complete blood count parameters are routinely evaluated cost-effective markers in diagnosis
      and clinical follow-up of infectious diseases.There is increasing number of studies to report
      the course of COVID-19 in pregnancy. The current study aimed to elucidate the changes in
      hematologic parameters in response to SARS-CoV-2 infection and whether there was an increase
      in adverse perinatal outcomes such as increased neonatal intensive care unit admission and
      lower APGAR scores in pregnancies with COVID-19.
    

Detailed description: 
      The objective of this study is to evaluate the relationship between Coronavirus Disease 2019
      (COVID-19) in pregnancy and adverse perinatal outcomes. The secondary aim is to analyze the
      diagnostic value of hematologic parameters in COVID-19 complicated pregnancies.The current
      study is conducted in a high volume tertiary obstetrics center burdened by COVID-19
      pandemics, in Turkey, between March 20 and July 25, 2020. The study included a pregnant women
      cohort who had been regularly followed up and delivered in our clinics. The cohort was
      divided into two groups to reveal the impact of COVID-19 on the complete blood count cell
      indices and unfavorable obstetric and early neonatal outcomes in pregnant women. The
      clinically confirmed diagnosis of COVID-19 cases were included in Study Group (n=39) the
      healthy pregnant women without COVID-19 were included in Control Group (n=69). The study
      achieved a power of 0.89 and 0.98 with a 5% level of significance.
    

Intervention name(s): Clinical assessment
Intervention type(s): Other
Intervention description(s): Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The current study included 39 pregnant women with clinical diagnosis of COVID-19 on the
        obstetric isolation unite and 69 pregnant women without COVID-19.
      
Keywords: COVID-19; Pregnancy; Complete blood count; Perinatal outcome; Monocyte/lymphocyte ratio (MLR)
A Study to Investigate the Potential Interaction Between Telaprevir and Methadone, at Steady-State
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state (constant concentration
      of medication in the blood) telaprevir 750 mg every 8 hours on the steady-state
      pharmacokinetics (how the drug concentrations change over time) of R- and S-methadone.
    

Detailed description: 
      This is a Phase 1, open-label (all people know the identity of the intervention),
      single-sequence study to evaluate the potential interaction of steady-state telaprevir on the
      steady-state pharmacokinetics of methadone. The study consists of 3 phases: the screening
      phase (within 21 days prior to the start of supervised methadone intake on Day -14),
      treatment phase, and follow-up phase. Participants on stable methadone maintenance therapy
      will be enrolled in this study and their methadone doses will not be changed starting at Day
      -14. During the treatment phase, telaprevir will be added for 7 days (from Day 1 to Day 7) to
      participants' current methadone therapy. The methadone dosage will not to be changed from Day
      -14 until Day 7. All the intakes of methadone and telaprevir will be supervised and
      pharmacokinetic parameters will be measured during the study. Safety evaluations for adverse
      events, clinical laboratory tests, alcohol breath test, cardiovascular safety, and other
      evaluations (physical examination, and pharmacodynamic assessments) will be performed
      throughout the study. The total duration of the study for each participant is approximately
      60 days.
    

Intervention name(s): Telaprevir; Methadone
Intervention type(s): Drug; Drug
Intervention description(s): Telaprevir 750 mg will be administered orally, every 8 hours from Day 1 to Day 7, along with methadone, once daily.; Methadone 30 to 130 mg will be administered as a stable oral therapy from Day -14 to Day -1, in combination with telaprevir from Day 1 to Day 7, and then alone as a continued intake dose for an additional 30 to 32 days.
Intervention MeSH terms: Methadone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Pharmacokinetics; Pharmacodynamic; Potential interaction; VX-950-TiDP24-C135; VX-950; Methadone; Telaprevir; Steady-state
A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease.
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      In this Phase I trial the investigators intend to show safety and tolerability of autologous
      MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media. Fresh,
      non cryopreserved, autologous MSCs will delivered intravenously as a single bolus dose in a
      dose escalation phase I study. The investigators intend to test whether the product is
      clinically safe in adults (18-65 years old) with CD and to determine maximal deliverable
      dose. Secondary endpoint will monitor effectiveness using CDAI as an endpoint.
    

Detailed description: 
      EPIC MSC/IBD is made up of autologous marrow-derived mesenchymal stromal cells ex vivo
      expanded numerically for approximately 14 days using pooled human Platelet Lysate (phPL),
      harvested on the day of infusion, washed and suspended at a concentration of 4 million
      cells/ml in Plasmalyte A with 0.5% human serum albumin. This is a phase I dose-escalation,
      open label, non-randomized, non-placebo controlled, single group assignment study to evaluate
      the safety and tolerability of a single intravenous infusion of EPIC MSC2011-001. EPIC EPIC
      MSC/IBD will be infused intravenously and will be administered at one of three dose levels:
      (Tier 1) 2 million cells/kg patient body weight; (Tier 2) 5 million cells/kg, and (Tier 3) 10
      million cells/kg. This Phase I clinical trial will enroll 16-20 subjects with moderate to
      severe Crohn's. The duration of this study for each patient is 12 weeks. The investigators
      anticipate that this study will be completed within 2 years of commencement.

      Primary objective: To describe and compare the safety and tolerability of a single infusion
      of fresh autologous bone marrow derived Mesenchymal stromal cells infused to patients with
      moderate to severe Crohn's disease.

      Secondary objective: Efficacy of autologous bone marrow derived Mesenchymal stromal cells
      infusion to patients with moderate to severe Crohn's disease as assessed through disease
      activity index, and quality of life index.

      Safety variables:Adverse events (AEs),Laboratory parameters (hematology, biochemistry,
      urinalysis), Vital signs.
    

Intervention name(s): autologous mesenchymal stromal cell
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inflammatory bowel disease; Crohn's disease
Evaluation of Continuous Symptom Treatment of ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test the hypothesis that atomoxetine administered orally,
      once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is
      superior to placebo in children with ADHD.
    


Intervention name(s): Atomoxetine Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Morphine Analgesia in Patients With Acute Appendicitis
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate morphine effect on pain reduction and diagnostic
      accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis.
    

Detailed description: 
      Analgesic administration for pain control in patients with acute abdominal pain, regarding
      acute appendicitis, is controversial. Despite the results previous studies indicating the
      safeness of analgesic use in ED for acute abdominal pain, physicians still prefer to postpone
      their use after performing surgical evaluations. Since many patients admitted to ED are
      unlikely to receive prompt surgical consultation, many of them need pain relief to prevent
      unnecessary suffering. On the other hand such pain relief must not interfere with the
      diagnosis and treatment of patients and do not cause any complications. Morphine is a common
      and effective analgesic which, if shown to have no effect on correct diagnosis of acute
      abdomen, can be used for this purpose.

      Thus we evaluated morphine effect on pain reduction and diagnostic accuracy in patients
      admitted to ED with the diagnosis of acute appendicitis.
    

Intervention name(s): Morphine
Intervention type(s): Drug
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Supportive Care
Keywords: MORPHINE; ANALGESIA; ACUTE APPENDICITS
A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 3

Summary: 
      This current Phase 3 study will evaluate the efficacy and safety of administration of
      subcutaneous (sc) IPP-201101 in patients with active SLE.
    


Intervention name(s): IPP-201101; Placebo; Standard of Care
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Lupuzor, regiremod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Complementary Therapies for the Reduction of Side Effects During Chemotherapy for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine wether a complementary therapy consisting of a
      combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation
      concerning nutrition and physical activity can reduce side effects of a chemotherapy in
      breast cancer patients.
    

Detailed description: 
      patients were randomized to receive: (a) individual nutrition consultation with
      recommendations for physical activity before or on the first day of chemotherapy together
      with daily oral medication consisting of selenium (sodium-selenit 100 microg/d), milk thistle
      (silibin 280 mg/d), goldenrod (solidago 1,680g/d) and pineapple enzyme (bromelaine 3.000
      F.I.P. units/d) during the first three cycles till 3-5 weeks later, (b) individual nutrition
      consultation with recommendations for physical activity only and (c) a leaflet "5-a-day" for
      the control group.

      Primary endpoint was the difference of the global health status from the EORTC QLQ-C30 before
      and 3-5 weeks after the third cycle of chemotherapy. Secondary endpoints were the other
      subscales of the EORTC QLQ C3o and BR 23 and anxiety and depression from the HADS-D.
    

Intervention name(s): two complex naturopathic add-on therapies, leaflet 5-a-day
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Chemotherapy; Phytotherapy; Nutritional counseling
Evaluation of Effect and Tolerance of the Association of Baricitinib and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 study is to evaluate the effect and the safety of the combination
      of Baricitinib in combination with phototherapy in adult participants with non-segmental
      progressive vitiligo.
    

Detailed description: 
      Treatment Strategy: Multicentric, parallel double blind randomized phase 2 prospective study
      comparing baricitinib (4mg/day) + narrowband UVB TL01 versus placebo + narrowband UVB TL01
      Follow-up of the study: patients included in this study will start Baricitinib 3 months
      before starting narrowband UVB TL01. Phototherapy will be performed twice a week during 6
      months. Follow-up visit will be done at week 12, 24, 36 and 48.
    

Intervention name(s): Baricitinib Oral Product; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Baricitinib 4 mg/day orally for 36 weeks; Placebo once a day orally for 36 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicenter, randomized, non-comparative, phase II proof-of-concept trial involved patients with progressive vitiligo and uses one of the most common regimens in this phase of study. Assessment of the experimental treatment efficacy will be estimated only on the results obtained in the experimental treatment arm (baricitinib 4 mg/day + narrowband UVB TL01 arm).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vitiligo; phototherapy; baricitinib; randomized
Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB)
Condition: COPD Exacerbation
MeSH terms: Bronchitis; Bronchitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be
      enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be
      compared, ceftidoren 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days.
      Primary objective of the study is to evaluate the effects of the treatment on serum
      inflammatory biomarkers and the secondary objective is to evaluate the clinical and
      microbiological efficacy at the Test Of Cure visit (TOC), DAY 7-10 (end of treatment).

      The study foresees 4 visits: Visit 1 (enrolment, day 1 of treatment); Visit 2 (day 2-4);
      Visit 3 (Test Of Cure-TOC visit, day 7-10 end of treatment), Visit 3 (Late Post Therapy
      assessment, Day 28-30).

      The primary parameter to test the efficacy of the study medications will be the assessment of
      the speed of reduction of inflammatory parameters (CRP, PCT and KL6). Every reduction of 10%
      will be taken into account. The comparison between treatments will be performed at visit 2
      and 3.
    


Intervention name(s): ceftidoren; levofloxacin
Intervention type(s): Drug; Drug
Intervention description(s): ceftidoren 200 mg bid for 5 days; levofloxacin 500 mg once daily for 7 days
Other intervention name(s): Giasion; J01D; levoxacin; J01M
Intervention MeSH terms: Levofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic bronchitis; exacerbations; treatment; ceftidoren; levofloxacin; inflammation
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III, double-blind, placebo-controlled, multicenter study will investigate the
      efficacy and safety of etrolizumab during induction and maintenance of remission compared
      with placebo in the treatment of participants with moderately to severely active ulcerative
      colitis (UC) who have been previously exposed to TNF inhibitors.
    


Intervention name(s): Etrozulimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 105 mg etrolizumab administered by SC injection Q4W.; Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Other intervention name(s): PRO145223; RO5490261; RG7413
Intervention MeSH terms: Etrolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy; Jaundice
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of stem cells for
      cerebral palsy related to neonatal icterus
    

Detailed description: 
      The purpose of this study is to evaluate the safety and effectiveness of autologous bone
      marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus
      at Vinmec International Hospital, Hanoi, Vietnam
    

Intervention name(s): Stem cell transplantation
Intervention type(s): Combination Product
Intervention description(s): Transplantation of Autologous Bone Marrow Mononuclear Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral palsy; Stem cells; Neonatal icterus