bioihbjkbjnl/mcl2 huggingface dataset:
Liposomal SN-38 in Treating Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to
      stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing.

      PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients
      with metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the objective response rate following treatment with SN-38 liposome as a
           second-line treatment in patients with metastatic colorectal cancer.

      Secondary

        -  Determine the toxicity profile of this drug in these patients.

        -  Determine the proportion of patients treated with this drug who experience any grade 3
           or greater toxicity.

        -  Determine progression-free survival and overall survival for patients treated with this
           drug.

      OUTLINE: This is a multicenter study.

      Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days
      in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for up to 3 years.
    

Intervention name(s): SN-38 liposome
Intervention type(s): Drug
Intervention description(s): 38 mg/sq m IV infusion over 30 min q 21 days (1 cycle) until progression
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer
A Study to Evaluate the Safety of ASP2408 After Subcutaneous Administration to Healthy Male Subjects
Condition: Healthy; Pharmacokinetics of ASP2408
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of
      single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The
      pharmacodynamics of ASP2408 is also being evaluated.
    

Detailed description: 
      This clinical study will be conducted as a double-blind, placebo-controlled, single ascending
      subcutaneous dose study. As shown in the table below, the study will be conducted using 3
      cohorts, to which a total of 24 subjects will be randomly assigned (18 subjects receiving
      ASP2408 and 6 subjects receiving placebo). Each cohort will consist of 8 subjects, who will
      be randomly assigned to either the ASP2408 group or the placebo group at the ratio of 3 to 1.

      Each subject will need to be hospitalized until Day 8 (start date of study drug
      administration will be regarded as Day 1) and will be observed until Day 90. The investigator
      or subinvestigator will carefully observe each subject for any sign or symptom of adverse
      events.
    

Intervention name(s): ASP2408; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous administration; subcutaneous administration
Intervention MeSH terms: ASP2408
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASP2408
Trial to Assess the Safety and Tolerability of the Liquid Formulation of CAIV-T in Healthy Children.
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T
      against culture confirmed influenza illness in healthy children aged at least 6 months and
      less than 36 months.
    


Intervention name(s): CAIV-T
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Educational/Counseling/Training
Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly
      TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo
      for preventive treatment in Episodic Migraine patients
    


Intervention name(s): TEV-48125; TEV-48125 or placebo; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TEV-48125 will be subcutaneously administered once monthly for 3 months.; TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.; Placebo will be subcutaneously administered once monthly for 3 months.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult
Condition: Developmental Stuttering
MeSH terms: Stuttering
Study type: Interventional

Summary: 
      This study was conducted to determine the effectiveness of digital manipulation of thyroid
      cartilage for the management of stuttering in adult.There were three groups,Group A received
      Digital Manipulation of Thyroid cartilage (DMT),Group B received Fluency shaping
      Therapy(FST),Group C received combination of DMT,FST.
    

Detailed description: 
      The purpose of speech therapy is to stop progression of stuttering while teaching the method
      to client how to cope efficiently his or her stuttering disorder.

      The goal of fluency shaping therapy to eliminate the severity of stuttering by adopting the
      specific pattern of speech production and also reduce negative reaction to stuttering by
      default).

      Digital manipulation of thyroid cartilage decreases tension in vocal fold and reduces
      severity of stuttering and improves production of speech. DMT reduces unnecessary amount of
      tension in vocal tract and participant speaks with relax respiration,phonation, articulation
      and facilitate more fluent.in DMT subject speaks in natural way rather than in specific
      method in every situation.
    

Intervention name(s): Digital Manipulation of Thyroid cartilage; Fluency Shaping Therapy; combination Group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Digital manipulation of thyroid cartilage was applied to the anterior aspect of thyroid cartilage while using the thumb or finger and the patient was asked to speak.
prolongation of vowel is 7 to 8 seconds, voice rest after each set is 10 second.
total repetition is 60.; FST session comprised of speech techniques such as prolongation of sounds, easy onset, continuous phonation, light articulatory contact, in reading and conversation in three speaking situations (speaking with therapist, reading aloud, and free conversation Reading task was for 80 short phrases.; combination group intervention of DMT + FST
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The three group were digital manipulation of thyroid cartilage(DMT) group,fluency shaping therapy (FST) group,combination of DMT,FST. the intervention period for each subject was three month and data was collected on day one and at the end of every 2 weeks. 4th week , 8th week, and 12th week which were aimed to reduce severity of stuttering and improve fluency
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fluency shaping therapy; Digital Manipulation; Stuttering; communication
Study of the Impact of Administering t the Scale of Brazelton on the Mother's Confidence in Her Newborn Born Premature at the Approach of Returning Home
Condition: Infant, Premature
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      In France, the last national perinatal survey show that 6.6% of live births are premature.
      For these infants, transfer in Neonatology sector may result in mother-child separation can
      last several weeks or months. This hospital can complicate the implementation of the
      attachment process that allows parents to recognize their children as their own, to gain
      confidence in their abilities to deal with them and establish a relationship with him.

      A study of mothers of premature shows the interest of the Brazelton scale to help them
      identify the skills their child and adjust their own behavior.
    


Intervention name(s): Brazelton scale
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Mother-child dyads whose infants were born before 36 S.A.
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242
      administered orally to psychiatrically stable subjects with schizophrenia receiving
      antipsychotic and adjunctive medication.
    

Detailed description: 
      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): PF-04958242; PF-04958242; PF-04958242; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-04958242 0.10 mg oral solution Q24 hours for 14 days; PF-04958242 0.20 mg oral solution Q24 hours for 14 days; PF-04958242 oral solution Q24 hours for 14 days (dose to be determined); Placebo oral solution Q24 hours for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-04958242; multiple dose; Safety; schizophrenia
Treosulfan-based Versus Busulfan-based Conditioning in Paediatric Patients With Non-malignant Diseases
Condition: Primary Immunodeficiencies; Inborn Errors of Metabolism; Haemoglobinopathies; Bone Marrow Failure Syndromes
MeSH terms: Bone Marrow Failure Disorders; Pancytopenia; Hemoglobinopathies; Primary Immunodeficiency Diseases; Metabolism, Inborn Errors
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the trial is to describe the safety and efficacy of intravenous (i.v.) Treosulfan
      compared to the conventional (myeloablative) dose of i.v. Busulfan, each administered as part
      of a standardised Fludarabine-containing conditioning regimen and to contribute to a PK model
      which permits - in conjunction with data comparing Treosulfan and Busulfan in adults with
      malignant diseases - to extend the use of Treosulfan in the paediatric population by
      extrapolating efficacy.
    

Detailed description: 
      The prospective clinical phase II protocol MC-FludT.16/NM is to be conducted to verify safety
      and efficacy of Treosulfan-based conditioning compared to Busulfan-based conditioning in
      paediatric patients. Based on the given clinical experience with either Treosulfan-based or
      Busulfan-based conditioning in combination with Fludarabine no increased risk for graft
      failure is expected in paediatric patients. A potential benefit for study patients is
      expected with respect to a probably low non-haematological toxicity of treatment compared to
      myeloablative TBI-based conditioning or high-dose Busulfan-based conditioning in combination
      with Cyclophosphamide.

      However, the allogeneic HSCT procedure itself potentially involves serious risks with regard
      to severe or life-threatening conditions like graft versus host disease (GvHD) and/or
      infectious complications as well as graft failure.

      In summary, the primary goal of this study is to evaluate the Treosulfan-based myeloablative
      conditioning regimen as an alternative in children and to contribute to the current PK model
      for Treosulfan to be able to finally give age (or body surface area [BSA]) dependent dose
      recommendations. The treatment regimens given in the protocol MC-FludT.16/NM are based on
      sufficient clinical safety and efficacy data. Considering the vital indication for allogeneic
      HSCT of the selected patient population, the risk-benefit assessment seems to be in favour of
      the study conduct.

      Moreover, planned interim analyses will ensure the early identification of unexpected risks.
      Therefore, the conduct of the protocol MC-FludT.16/NM is considered reasonably justified.
    

Intervention name(s): Treosulfan; Busilvex
Intervention type(s): Drug; Drug
Intervention MeSH terms: Treosulfan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-malignant diseases, allogeneic stem cell transplantation
Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine
Condition: Bioavailability; Dexmedetomidine
Study type: Interventional
Phase: Phase 3

Summary: 
      Intranasal dexmedetomidine has been studied and used in children for premedication before
      anaesthesia or fro sedation. It can be administered by simple dripping or by Mucosal
      Atomization Device (MAD®).

      Since MAD® delivers intranasal medication in a fine mist, it is possible that absorption and
      bioavailability would be better compares to simple dripping method. To date no
      pharmacokinetic information of intranasal dexmedetomidine delivered by either method is
      available. This investigation is designed to compare the bioavailablity of intranasal
      dexmedetomidine deliver via simple dipping with tuberculine syringe and MAD® in healthy
      adults.
    

Detailed description: 
      This is a three-period crossover double-blinded study. 8 subjects will be recruited and they
      will attend 3 study sessions after informed written and verbal consent. They would have
      dexmedetomidine administered via different rout each time, intravenous, intranasal via
      dripping or intranasal via atomizer. Blood samples are collect to determine bioavailability
      of each mode of drug delivery.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): blood is sampled for quantification of plasma concentration after intravenous, intranasal by atomisation and intranasal by drops.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Near-Infrared Spectroscopy Comparison Study
Condition: Total Aortic Arch Replacement
Study type: Observational

Summary: 
      The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients
      undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System,
      Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to
      determine which modality best correlates with jugular venous oxygen saturation
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Baylor College of Medicine and affiliated Hospitals
      
Keywords: Near Infrared Spectroscopy; Neuromonitoring; Aortic Arch Replacement
Study of Vitamin D for the Prevention of Acute Respiratory Infections in Children
Condition: Acute Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to determine whether weekly oral vitamin D supplementation
      is effective to prevent acute respiratory tract infections in children. The hypothesis of the
      study is that vitamin D supplementation reduces the incidence and severity of acute
      respiratory tract infections in children.
    

Detailed description: 
      Acute respiratory tract infections (ARTIs) are associated with high levels of morbidity and
      socioeconomic impact, particularly affecting young children. Observational studies have shown
      an association between vitamin D (VD) deficiency and higher incidence and severity of
      respiratory infections. Chile has a high prevalence of VD deficiency, particularly in the
      southern regions of the country. The objective of this study is to evaluate the safety and
      efficacy of oral VD supplementation to decrease the incidence of ARTIs in 275 preschool
      children. A randomized, placebo-controlled, double-blind study will be performed in Santiago,
      Coyhaique and Punta Arenas. Children aged 18 to 36 months will be given weekly oral 5600 IU
      of vitamin D3 (VD3), 11200 IU of VD3, or placebo doses during 6 months.
    

Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cholecalciferol administration; Placebo liquid
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Acute respiratory tract infections; vitamin D; cholecalciferol; children; bronchiolitis; pneumonia; prevention
The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery
Condition: Posterior Fossa Tumors
MeSH terms: Infratentorial Neoplasms; Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluate the effects of scalp block versus local infiltration on haemodynamic
      response to head pin replacement and skin incision and postoperative analgesia in posterior
      fossa surgery
    

Detailed description: 
      In this study 15 patients will receive scalp block with bupivacaine, 15 patients will receive
      local infiltration with bupivacaine and 15 patients will receive placebo before surgery. The
      haemodynamic response to head pin replacement and skin incision will be recorded.
      Postoperatively all patients will have a patient controlled analgesia (PCA) device containing
      morphine (1 mg/ml) for analgesia. Visual analogue scale (VAS) for pain evaluation, sedation
      scores, and also postoperative morphine consumption will be evaluated and recorded.
    

Intervention name(s): Bupivacaine; morphine patient controlled analgesia
Intervention type(s): Drug; Drug
Intervention description(s): In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.; End of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours.
Other intervention name(s): Marcaine; MORPHİNE PCA
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: scalp block; local infiltration
A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to understand the blood concetration of PF-06412562 and its metabolite,
      PF-06663872, following a single oral dose of a modified release formulation. The study will
      include two doses of the PF-06412562 modified release formulation to understand the
      proportionality. Effect of food on absorption of PF-06412562 from the modified release
      formulation will also be investigated in this study.
    


Intervention name(s): 3 mg PF-06412562 MR tablets_Fasted; 2 x 15 mg PF-06412562 MR tablets_Fasted; 2 x 15 mg PF-06412562 MR tablets_Fed; 10 mg PF-06412562 IR tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast; Two 15 mg PF-06412562 modified release tablets administered after an overnight fast; Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast; a single immediate release tablet of 10 mg PF-06412562 after an overnight fast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: relative bioavailbility; food effect; pharmacokinetics; ALTERATION OF COGNITIVE FUNCTIONS
A Study of the Absorption, Metabolism, and Excretion of [14C]-Fosgonimeton (ATH-1017)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, nonrandomized, single-dose human, absorption, metabolism, and
      excretion study of [14C]-Fosgonimeton
    

Detailed description: 
      This is a Phase 1, open-label, nonrandomized, single-dose study, designed to evaluate the
      absorption, metabolism, and excretion of [14C]-Fosgonimeton. Healthy male subjects will
      receive a single subcutaneous dose of [14C]-Fosgonimeton.
    

Intervention name(s): [14C]-Fosgonimeton
Intervention type(s): Drug
Intervention description(s): Carbon-14 Radiolabeled Fosgonimeton
Other intervention name(s): [14C]-ATH-1017
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Relative Bioavailability and Food Effect Study of Cobimetinib in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized, 3-way, 6-sequence crossover study in healthy
      participants for determining the relative bioavailability of the tablet formulation to the
      capsule formulation and the effect of food on the relative bioavailability of the tablet
      formulation.
    


Intervention name(s): Cobimetinib
Intervention type(s): Drug
Intervention description(s): Cobimetinib 20 mg will be given orally as tablet formulation in fasted or fed state, or as capsule formulation in fasted state.
Other intervention name(s): GDC-0973; XL518
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science