bioihbjkbjnl/mcl2 huggingface dataset:
Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II open-label, single-arm, multicenter, international study to evaluate the
      clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed
      to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into
      2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy
      [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative
      radiation therapy [40 to < 54 Gy or hypofractionated BED])
    

Detailed description: 
      This is a Phase II open-label, single-arm, multicenter, international study to evaluate the
      clinical activity of durvalumab in patients with Stage III unresectable NSCLC who have an
      Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and who were treated with radiotherapy
      but are ineligible for chemotherapy. Patients will be enrolled into 2 cohorts according to
      the dose of radiotherapy received prior to study entry (Cohort A: Standard Radiotherapy [60
      Gy ± 10% or hypofractionated BED]; Cohort B: Palliative Radiotherapy [40 to < 54 Gy or
      hypofractionated BED]). Patients must not have progressed following radiation therapy, and
      radiation therapy must be completed within 6 weeks (42 days) prior to first study drug
      administration. The last dose of radiation therapy is defined as the day of the last
      radiation treatment session. All patients will receive 1500 mg durvalumab via IV infusion
      every 4 weeks (q4w) for up to a maximum of 12 months (up to 13 doses/cycles)
    

Intervention name(s): Durvalumab
Intervention type(s): Drug
Intervention description(s): All patients will receive 1500 mg durvalumab via IV infusion q4w for up to a maximum of 12 months.
Other intervention name(s): MEDI4736
Intervention MeSH terms: Durvalumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiation therapy; Phase II; Palliative Radiotherapy
Using Self-evaluation to Increase Visit Intervals in Juvenile Idiopathic Arthritis
Condition: JIA; Self-Evaluation
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      In the THUIS study, JIA patients in clinical remission will skip one 3-monthly hospital
      control visit and instead monitor their disease activity at home. Outcomes at 6 months will
      be compared to those from a historical cohort.
    

Detailed description: 
      Background:

      Children with juvenile idiopathic arthritis (JIA) commonly visit their pediatric
      rheumatologist every 3 months. This costs time and money for the patient, their parents or
      guardian, the hospital and other stakeholders. Therefore, the THUIS study aims to demonstrate
      that JIA patients in clinical remission can safely increase their visit interval by
      home-monitoring disease activity using the EuroQol five-dimensional youth questionnaire with
      five levels (EQ-5D-Y-5L) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR).

      Methods:

      JIA patients in remission from the Wilhelmina Children's Hospital in Utrecht, the
      Netherlands, will skip one 3-monthly control visit and instead complete an online EQ-5D-Y-5L
      and JAMAR questionnaire at home. The home-monitoring results will be evaluated by a research
      nurse in consultation with the treating pediatric rheumatologist in order to determine if the
      patient can safely remain at home or has to be planned in for a short-term control visit at
      the hospital. Primary and secondary outcomes after 6 months will be compared with a
      historical cohort of matched JIA patients in order to prove non-inferiority.
    

Intervention name(s): Home-monitoring
Intervention type(s): Procedure
Intervention description(s): Questionnaires for home-monitoring will be send to the participants 11 weeks after the baseline visit via e-mail using Castor EDC and can be completed using a computer, tablet or smartphone. Home-monitoring can be done together with a parent or guardian, if needed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Juvenile idiopathic arthritis; Remote monitoring; E-health; Patient-reported outcomes; Disease activity; Healthcare costs; Non-inferiority trial
Assessment of Device for Treatment of Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      The study will evaluate the effect of Reviview™, a dichoptic video display device for
      administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.

      The effect of the treatment will be measured by the change from baseline in Visual acuity and
      in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.
    


Intervention name(s): Daily watching videos using Reviview™, a dichoptic video display device, for 60 min
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amblyopia
A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Inadequate Glycaemic Control
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg
      co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or
      dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin
      monotherapy.
    


Intervention name(s): Dapagliflozin; Placebo for Dapagliflozin; Saxagliptin; Placebo for Saxagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5mg, orally, Green, plain, diamond-shaped, film-coated tablet; Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet; 5mg, orally, Plain, yellow, biconvex, round, film-coated tablet; Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet
Other intervention name(s): Forxiga; Onglyza™
Intervention MeSH terms: Dapagliflozin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 2,; saxagliptin,; dapagliflozin,; metformin
Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression
Condition: Endodontically Treated Teeth
MeSH terms: Tooth, Nonvital
Study type: Interventional

Summary: 
      This clinical trial will be conducted to evaluate the amount of Il-8 expression before and
      after the application of intracanal irradiation with diode laser 980 nm versus placebo in
      failed endodontic cases with periapical lesions.
    

Detailed description: 
      -  Thorough medical and dental history for the eligible patients

        -  Thorough intraoral and extraoral diagnosis

        -  Local anesthesia

        -  Isolation and removal of any previous filling or restoration

        -  Removal of old gutta percha and establish patency to the full working length.

        -  1st sample: will be collected using 3 sterile paper points

        -  Chemo-mechanical preparation.

        -  2nd sample collection

           • Laser group: The canals will be irradiated with a high-power diode laser, with
           wavelength of 980 nm, maximum output of 3 watts and coupled with a fiber optic tip of
           200 µm diameter.

           • Mock laser application (Placebo group): The fiberoptic tip will be inserted inside the
           root canal, mimicking the laser irradiation, but not activated.

        -  3rd sample collection

        -  A piece of dry cotton will be placed in the access cavity, and then will be sealed with
           glass ionomer filling material

        -  2nd visit: 1 week later, 4th sample collection then Obturation

        -  Number of visits & follow up period: Two visits
    

Intervention name(s): Intracanal Diode laser irradiation; Placebo
Intervention type(s): Device; Other
Intervention description(s): After endodontic retreatment, root canals will be irradiated with a 980 nm diode laser coupled with optical fibre 200 μm (Litemedics, Italy) with setting 1.2-watt power, in pulsed mode. The irradiation protocol will be of 5-sec irradiation followed by a 10-sec pause, which constituted one lasing cycle. The lasing cycle will be performed four times for each tooth. The tip will be positioned 1 mm short of the apex. Followed by activation during which it will be slowly dragged at a speed of approximately 2 mm/ sec in a way that the root canals will be irradiated from the apical to the coronal portion, in a helicoidal movement touching the canal walls.; After endodontic retreatment, mock laser application (Placebo group) will be applied:
The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diode laser; Endodontic retreatment; IL-8 expression
Study of 1.25 mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients.
Condition: Hyperparathyroidism; Hypercalcemia
MeSH terms: Hypercalcemia; Hyperparathyroidism
Study type: Interventional
Phase: Phase 2

Summary: 
      A prospective, randomized, controlled multicenter trial to evaluate 1.25 mmol/L
      (physiological) vs. 1.5 mmol/L calcium dialysate on serum markers of mineral metabolism,
      secondary hyperparathyroidism and cardiovascular calcification in prevalent haemodialysis
      patients. And the long term safety of the 1.25 mmol/L calcium dialysate was also considered.

      There are two phases of study for each subject. Phase 1 (screening phase). During this phase,
      each potential subject will be evaluated to determine if he/she is eligible for the study.

      Phase 2 (intervention phase). Each subject will be randomly allocated to physiological
      calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD group), and normal calcium
      dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The follow-up duration was 36
      months.
    

Detailed description: 
      All patients recruited from these centers who met the inclusion criteria were randomly
      allocated to physiological calcium dialysate (1.25 mmol/L calcium dialysate) group (PCD
      group), and normal calcium dialysate (1.5 mmol/L calcium dialysate) group (NCD group). The
      follow-up duration was 36 months.

      Calcium carbonate was mainly used as the phosphate binder. Active vitamin D metabolite,
      calcitriol (Rocaltrol, Hoffmann La Roche, and Basel, Switzerland) was given as to control the
      secondary hyperparathyroidism. The doses of these agents were adjusted according to the serum
      calcium level, serum phosphate level, calcium-phosphorus product and serum iPTH level, which
      were recommended by the K/DOQI Guidelines 6.3b and 8B. Aluminum hydroxide might be introduced
      as a phosphate binder for no more than 4 weeks in addition to calcium carbonate and dietary
      restriction when serum phosphate level could not get a good control (serum P level≥1.78
      mmol/L, lasting above 4 weeks). A non- calcium-containing phosphate binder could be
      administered for 1~2 weeks in patients with hypercalcaemia during the observation. At the
      time of the study, non-calcium, non-aluminum based phosphate binders as well as calcium
      acetate were not available in our country.
    

Intervention name(s): physiological (1.25 mmol/L ) calcium dialysate
Intervention type(s): Drug
Intervention description(s): Using the physiological calcium dialysate (1.25 mmol/L calcium dialysate)for Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
Intervention MeSH terms: Dialysis Solutions; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dialysate calcium; Mineral metabolism; Parathyroid hormone; Calcification; Cardiovascular disease; Haemodialysis
Pharmacokinetic Study of Vivitrol in Healthy Participants
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-center, single arm, open-label study, to establish the
      pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug
      Administration (FDA) approved medication.
    

Detailed description: 
      This is a Phase I, single-center, single arm, open-label study, to establish the PK
      parameters of Vivitrol 380 mg IM injection (IP), a US FDA approved medication. Participants
      will be healthy volunteers with no significant medical or mental health disorders, who have
      completed participation in clinical trial GM0017 (i.e. have received the OLANI treatment and
      have subsequently provided two consecutive plasma levels of naltrexone (NTX) <0.1ng/mL).

      This study will examine the PK profile of Vivitrol IM 380 mg over 6 doses for a treatment
      period of 196 days. Intense sampling will occur after the 1st and 6th dose of Vivitrol.
      Participants will be without a DSM 5 - Substance Related Disorders classification.
      Participants will be required to undergo a Naloxone Challenge Test (NCT) to confirm opiate
      naivety before administration of the IP. No randomization will occur.
    

Intervention name(s): Naltrexone 380 MG
Intervention type(s): Drug
Intervention description(s): Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
Other intervention name(s): Vivitrol
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: naltrexone; opioids; Opioid Use Disorder
Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation
Condition: Agitation, Emergence
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare the efficacy of mother's recorded voice versus
      dexmedetomidine injection on postoperative agitation in children undergoing elective surgery.
    

Detailed description: 
      A written informed consent will be taken from the patients' legal guardians.Patients will be
      assigned randomly to three groups (30 subjects each) to be anesthetized and either randomly
      assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes
      before induction of anesthesia till induction of anesthesia is ended) and (during emergence
      from anesthesia till complete recovery) (Group M) or will be given a single bolus of
      dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of
      anesthesia) and (at the end of surgery) (Group D) or given the same volume of saline IV at 2
      times (in the holding area 3 minutes before induction of anesthesia) and (at the end of
      surgery) (Group C).To keep blinding, group M will be injected IV with the same volume of
      saline at the same 2 times as in groups D & C while in groups D & C, headphones will be
      putted as in group M at the same 2 times with no recorded voice.
    

Intervention name(s): the mother's recorded voice; Dexmedetomidine; saline 0.9% placebo
Intervention type(s): Behavioral; Drug; Other
Intervention description(s): Children will be assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery).; Children will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery).; Children will be given the same volume of saline at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery).
Other intervention name(s): Precedex; Normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)
Condition: Complicated Intra-abdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the efficacy of ceftolozane/tazobactam (MK-7625A) plus
      metronidazole versus meropenem in adults diagnosed with complicated intra-abdominal infection
      (cIAI). The primary hypothesis is ceftolozane/tazobactam plus metronidazole is non-inferior
      to meropenem, as measured by the clinical response rate at the Test-of Cure (TOC) visit in
      the Clinically Evaluable (CE) population.
    


Intervention name(s): Ceftolozane/Tazobactam; Metronidazole; Meropenem; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ceftolozane 1000 mg / tazobactam 500 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive ceftolozane 500 mg / tazobactam 250 mg.; Metronidazole 500 mg by IV infusion every 8 hours for 4 to 14 days.; Meropenem 1000 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive IV infusion every 12 hours.; Saline by IV infusion every 8 hours for 4 to 14 days.
Other intervention name(s): MK-7625A
Intervention MeSH terms: Metronidazole; Meropenem; Tazobactam; Ceftolozane; Ceftolozane, tazobactam drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ventilator Associated Tracheobronchitis in the First 14 Days in ICU
Condition: Airway Colonization; Tracheobronchitis and Pneumonia Associated With Ventilator
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      To investigate the clinical course and risk factors for VAT and the impact of VAT on
      Intensive Care Unit (ICU) morbidity and mortality.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ICU patients ventilated > 48hours
      
Biospecimen description: 
      blood, sputum
    
Keywords: airway colonization; tracheobronchitis; pneumonia
A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, two-part in healthy adult males. There will be up to 12
      subjects with 6 subjects in each part of the study. Subjects from Part A are eligible to
      participate in Part B.

      For Part A, each of the 6 subjects will complete two periods of the study with washout period
      of 7 days between. Each subject during participation in the study will receive a dose of PXS
      5382A orally in a fed state and a fasted state.

      For Part B, repeated oral BID administration of PXS-5382A will be performed in the Fed state
      and dose will be dependent on analysis of Part A.

      In both part A and B PK, PD and safety assessments will be collected.
    


Intervention name(s): PXS-5382A
Intervention type(s): Drug
Intervention description(s): Orally once daily or twice daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to
      evaluate efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in patients with
      ankylosing spondylitis.

      BCD-055 is biosimilar of infliximab (JSC "BIOCAD", Russia)
    


Intervention name(s): BCD-055; Remicade®
Intervention type(s): Biological; Biological
Other intervention name(s): infliximab; infliximab
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI
      therapies in forthcoming randomized controlled multi-centre clinical trials following
      international standards and guidelines
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospital