bioihbjkbjnl/mcl2 huggingface dataset:
Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325
Condition: Anxiety
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is carried out in order to determine the relationship between the dose of AZD7325
      and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to
      the GABAA receptors.
    


Intervention name(s): AZD7325; Radioligand (11C) flumazenil
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of oral solution or capsule. 3 times per subject.; Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325)
Intervention MeSH terms: Flumazenil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Anxiety; GABA receptors; Positron Emission Tomography; PET; phase I
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      relative to placebo in adolescent outpatients (12-17) with major depressive disorder.
    


Intervention name(s): Placebo; Vilazodone; Vilazodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose matched placebo tablets, once per day, oral administration.; Vilazodone tablets, 15 mg per day, oral administration; Vilazodone tablets, 30 mg once per day, oral administration
Other intervention name(s): Viibryd; Viibryd
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Uterus Transplantation From Live Donor
Condition: Primary Uterine Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Uterus transplantation, as a possible future treatment for uterine factor infertility, has
      been developed in animal species during the last decade.

      The study protocol includes transplantation of the uterus from a live donor (mother,
      relative, friend) into women with absolute uterine factor infertility (lack of uterus from
      birth or due to life saving hysterectomy).The recipient will be treated by standard
      immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted
      when at least 12 months have passed from transplantation. Approval for a case series
      including up to 10 patients has been acquired.
    

Detailed description: 
      The study is ongoing, with inclusion of 9 patients.
    

Intervention name(s): uterine transplantation
Intervention type(s): Procedure
Intervention description(s): Transplantation of the uterus from live donor and IVF treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uterus; transplantation; infertility
Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India
Condition: Visceral Leishmaniasis; Post-kala-azar Dermal Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe
      and whether it can or cannot produce a protective response against visceral leishmaniasis
      when injected to healthy subjects.
    

Detailed description: 
      The purpose of this study is to determine the safety, tolerability, and immunogenicity of an
      investigational vaccine being developed for immunotherapy of visceral leishmaniasis (VL) and
      post kala-azar dermal leishmaniasis (PKDL). The vaccine, identified as Leish-111f + MPL-SE,
      consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f) together with
      adjuvant MPL-SE.

      The primary objective is to evaluate the safety and tolerability of the Leish-111f + MPL-SE
      vaccine given as three subcutaneous injections every 28 days at each of three dose levels of
      the Leish-111f protein (5 μg, 10 μg, or 20 μg) together with MPL-SE adjuvant (25 μg) in
      healthy adults.

      The secondary objective is to assess the immunogenicity of the vaccine by evaluating T-cell
      and antibody response to the Leish-111f protein of the vaccine.
    

Intervention name(s): Leish-111f + MPL-SE Adjuvant
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: visceral leishmaniasis; vaccine
SynapDx Autism Gene Expression Analysis Study
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      This study will prospectively enroll approximately 660 children, at least 18 months and less
      than 5 years of age, who have been referred to a pediatric developmental evaluation centers.
      Enrolled children will have blood drawn for RNA gene expression analysis and undergo a
      clinical evaluation to determine the presence or absence of a diagnosis of ASD.

      The sequential co-primary objectives of this study are:

        -  To develop an algorithm to classify blood RNA gene expression patterns to maximize
           agreement between the classification and a clinical assessment of presence or absence of
           Autism Spectrum Disorders (ASD).

        -  To prospectively assess the clinical sensitivity and specificity of the blood RNA gene
           expression classification algorithm (the SDX-002 test) in children referred to a
           developmental evaluation clinic for a possible developmental disorder.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children 18 months to < 5 years referred to a developmental evaluation centers for
        evaluation of a possible developmental disorder.
      
Biospecimen description: 
      DNA, RNA
    
Keywords: autism; autism spectrum disorders; RNA; gene expression; developmental delay
Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T Cell Lymphoma Patients
Condition: Effect of Drugs
MeSH terms: Lymphoma, T-Cell; Lymphoma, Extranodal NK-T-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is phase II study. Efficacy and safety evaluation of IBI308 in patients with
      relapsed/refractory extranodal NK/T cell lymphoma, nasal type: a multicenter, single arm.
    

Detailed description: 
      Extranodal NK/T cell lymphoma, nasal type(ENKTL) accounts for about 6% of all lymphomas in
      china. Epstein Barr virus (EBV) infection is found in all cases of ENKTL and maybe plays an
      important pathogenetic role.

      Conventional anthrocycline-based regimens are not preferred to be used in ENKTL because of
      high p-glycoprotein expression. ORR of L-asparaginase based regimens is about 80% and no
      salvage regimens are recommended in ENKTL so far after failure of L-asparaginase based
      regimen.

      Recently, a phase II clinical trial result demonstrated high ORR of anti-PD-1 antibody
      treatment in ENKTL.IBI308, a humanized monoclonal antibody (mAb) directly against PD-1, is
      investigated in this phase II Chinese ENKTL clinical trial.

      Additionally the correlation between PD-L1 expression and the response to IBI308 treatment in
      Chinese ENKTL subjects will also be assessed.
    

Intervention name(s): Sintilimab
Intervention type(s): Drug
Intervention description(s): Sintilimab (IBI308) 200mg IV Q3W
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors
Condition: Non Small Cell Lung Cancer Squamous (NSCLC-Sq); Head and Neck Squamous Cell Carcinoma (HNSCC); Small Cell Lung Cancer (SCLC); Pancreatic Ductal Adenocarcinoma (PDAC); Colorectal Cancer (CRC); Metastatic Castration-resistant Prostate Cancer (mCRPC)
MeSH terms: Lung Neoplasms; Prostatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Adenocarcinoma; Small Cell Lung Carcinoma; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety and tolerability, describe the dose-limiting toxicities, assess the
      preliminary antitumor activity, determine the maximum tolerated dose (MTD) or the highest
      protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and
      a recommended dose for further evaluation of MEDI7247 in patients with selected advanced or
      metastatic solid tumor malignancies that have received at least 1 prior line of treatment.
    


Intervention name(s): MEDI7247
Intervention type(s): Drug
Intervention description(s): Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medi7247; non small cell lung cancer; head and neck cancer; small cell lung cancer; colorectal cancer; prostate cancer; pancreatic adenocarcinoma
Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to investigate the development of partial pressure of carbon dioxide
      during the 6-min walking test and during night in Chronic Obstructive Pulmonary Disease
      (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide, oxygen
      saturation and the heart rate are registered by a device called "Sentec" during the mentioned
      periods. In addition a measurement of activity is realised by an activity monitor
      ("Sensewear").
    


Intervention name(s): 6-minute walking test
Intervention type(s): Procedure
Intervention description(s): submaximum exercise test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COPD; carbon dioxide; 6-minute walking test
Effects of Cyclosporine A on Pancreatic Insulin Secretion
Condition: Chronic Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Our primary aim is to investigate if cyclosporine A reduces insulin secretion.
    

Detailed description: 
      Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or
      more. In order to get cyclosporine A naïve patients we will perform this investigation in
      dialysis patients on the waiting list for a renal transplantation. In addition we will
      investigate if also the peripheral insulin sensitivity and endothelia function is affected by
      cyclosporine A treatment in these patients. Since these patients will be treated with
      cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of
      investigation and repeat this investigation at the time of the first week following
      transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in
      predefining the dose to be used at the time of transplantation.
    

Intervention name(s): cyclosporine A
Intervention type(s): Drug
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glucose intolerance; insulin; microvascular function; genotyping; CYP3A5; pharmacokinetics; renal transplantation
Drip-infusion of Remifentanil for RIH
Condition: Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Observational

Summary: 
      The development of remifentanil-induced hyperalgesia (RIH) is an unpleasant experience for
      surgical patients. An alternative management, gradual withdrawal of remifentanil was
      effective in prevention of RIH. The investigators designed a simple modality to assess if
      under withdrawal of remifentanil and further drip-infusion of remifentanil immediately after
      extubation affected postoperative pain score, the requirement of rescue analgesics, and
      adverse effects.
    

Detailed description: 
      In clinical practice, the gradual withdrawal of remifentanil during surgery is unsatisfied.
      Thus, the investigators conducted a simple modality in a single center retrospective cohort
      study to assess how under baseline gradual withdrawal of remifentanil and further drip
      infusion of remifentanil immediately after extubation affected postoperative pain score and
      use of analgesics.
    

Intervention name(s): remifentanil
Intervention type(s): Drug
Intervention description(s): postoperative drip-infusion of remifentanil
Other intervention name(s): drip-infusion
Intervention MeSH terms: Remifentanil
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients receiving surgery with age between 20-80 years
      
Keywords: Remifentanil; Hyperalgesia; Drip-infusion
Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting
Condition: Postoperative Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or
      adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of
      super-hydration with 0.9% saline in children undergoing specifically elective
      otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended
      period of fasting that interrupts the perfusion in gut. Based on this knowledge, we
      hypothesized that administration of supplemental fluid would reduce the incidence of
      postoperative vomiting.
    

Detailed description: 
      At the initiation of the study, 160 patients we enrolled consecutively . Six of the patients
      were excluded according to the inclusion/exclusion criteria. Remaining one hundred fifty four
      were American Society of Anesthesia (ASA) I-II classified children , aged 2-15 yr, undergoing
      elective tonsillectomy, with or without adenoidectomy, under general anesthesia . Induction
      and maintenance of anesthesia were standardized with fentanyl, lidocaine, rocuronium and
      sevoflurane in nitrous oxide (N(2)O). Subjects were assigned to two groups administered with
      saline solution (%0.9 saline) at different rates; either 10 ml/kg/h or 20ml/kg/h delivery
      arms.
    

Intervention name(s): Group 1; Group 2
Intervention type(s): Other; Other
Intervention description(s): Intravenous access was established and 10 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation.; Intravenous access was established and 20 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027
      on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and
      computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly
      intravenous (IV) infusions of BMS-241027
    


Intervention name(s): BMS-241027; BMS-241027; BMS-241027; Placebo matching BMS-241027
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks; Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks; Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks; Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis
Condition: Chronic Plaque-type Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo and positive controlled, single and multiple dose study
      to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in
      chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this
      trial.
    


Intervention name(s): CJM112; Secukinumab; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Monoclonal antibody; Monoclonal antibody; Liquid for subcutaneous injection without active drug.
Other intervention name(s): AIN475
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis, chronic plaque-type psoriasis, IL17, monoclonal antibody
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral
      doses of PF-04878691.
    


Intervention name(s): PF-04878691 3mg; PF-04878691 6mg; PF-04878691 9mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral solution, 3mg, twice weekly, 2 weeks; Oral solution, 6mg, twice weekly, 2 weeks; Oral solution, 9mg, twice weekly, 2 weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HCV; Toll-like receptor 7; Multiple oral dose escalation study of PF-04878691
Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to
      quantify liver stiffness in children and young adults with chronic liver disease. ARFI
      results will be compared to the current clinical standard of Magnetic Resonance Elastography
      (MRE) and to liver biopsy when available.
    

Detailed description: 
      ARFI US is a novel technique, recently FDA approved for use in children and adults, which
      provides an alternative method for quantifying liver stiffness. ARFI US has been shown in a
      small pilot investigation in Europe in children to be reliable and rapid in estimating
      moderate to severe liver stiffness using histology as a reference gold standard. ARFI
      measures the speed of a shear wave in the examined tissue, expressed in m/s. This shear wave
      velocity can be mathematically converted into a liver stiffness value, which can then be used
      to estimate degree of liver fibrosis. The technique is non-invasive, uses no ionizing
      radiation, and is fast (several minutes to complete). It is possible that ARFI US will be
      more accurate than MRE in quantifying liver stiffness. In addition, ARFI US will ultimately
      be a less expensive clinical test, shorter in duration, and will not require
      sedation/anesthesia in younger children as MRE requires.
    

Intervention name(s): Acoustic Radiation Force Imaging
Intervention type(s): Device
Intervention description(s): ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness.
Other intervention name(s): ARFI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, 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 arsenic trioxide works in treating patients
      with metastatic liver cancer that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of arsenic trioxide in patients with unresectable metastatic
           hepatocellular carcinoma.

        -  Determine the safety and tolerability of this drug in these patients.

      OUTLINE: Patients receive a loading dose of arsenic trioxide IV over 1-2 hours once daily on
      days 1-5* in week 1 and then twice weekly in weeks 2-8. Courses repeat every 8 weeks in the
      absence of disease progression or unacceptable toxicity.

      NOTE: *The 5-day loading dose is only administered during course 1.

      After completion of study treatment, patients are followed at 30 days and then periodically
      for up to 2 years.

      PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
    

Intervention name(s): arsenic trioxide
Intervention type(s): Drug
Intervention MeSH terms: Arsenic Trioxide
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; advanced adult primary liver cancer; recurrent adult primary liver cancer
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions
Condition: Herpes
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets
      under fed conditions.
    


Intervention name(s): famciclovir
Intervention type(s): Drug
Intervention description(s): 500 mg tablet
Other intervention name(s): Famvir
Intervention MeSH terms: Famciclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment of herpes