bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors
Condition: Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular
      endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent
      inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted
      to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the
      pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-013 at single doses and
      multiple doses .
    

Detailed description: 
      This will be an open-label, phase I study. This study will evaluate the safety and
      pharmacokinetics of HMPL-013 after a single administration followed by a 28-Day continuous
      course of therapy; evaluate the safety and preliminary efficacy in an open-label
      administration of at the MTD. All subjects of this study will be permitted to continue
      therapy with only safety monitoring and bimonthly assessments for progression, if the product
      is well tolerated and the subject has stable disease or better.
    

Intervention name(s): Fruquintinib
Intervention type(s): Drug
Intervention description(s): Fruquintinib is a capsule in the form of 0.25mg , 1mg and 5mg, oral, once a day.
Other intervention name(s): HMPL-013
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
Condition: HIV Infections
MeSH terms: HIV Infections; HIV Seropositivity
Study type: Interventional

Summary: 
      To compare the effect of AS-101 to that of placebo on clinical efficacy and immunologic
      function in HIV positive patients with advanced disease. To compare the effect of AS-101 to
      that of placebo on occurrence of disease progression in HIV positive patients with advanced
      disease as defined by: (1) development of new diagnostically confirmed major opportunistic
      infection(s); or (2) development of AIDS-related dementia. To compare the effect of
      zidovudine (AZT) plus AS-101 versus AZT alone (placebo arm) on clinical efficacy and
      immunologic function in patients who require anti-viral therapy due to disease progression.
      Garlic capsules will be given to all study participants to mask the obvious garlic odor of
      AS-101.
    


Intervention name(s): Zidovudine; AS-101
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine
Masking: Double
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; ammonium trichloro(dioxoethylene-O,O'-)tellurute; Zidovudine
Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status
Condition: Overweight; Obesity; Pregnancy
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Overweight and obesity causes low-grade systemic inflammation, which sharply increases risk
      for iron deficiency. Studies in our laboratory have shown that this is mainly the result of
      reduced dietary iron absorption because of increased hepcidin concentrations. During
      pregnancy, women have a large increase in iron needs because of the expansion of maternal
      blood volume and fetal needs. Iron deficiency anemia in infancy can impair cognitive
      development. Whether maternal adiposity impairs absorption and transfer of iron to the fetus,
      and thereby increases risk of iron deficiency in the mother and the infant is unclear.
    

Detailed description: 
      In obese subjects, hepcidin concentrations are increased and iron absorption is believed to
      be reduced, leading to iron deficiency over time. How all this will influence iron supply of
      the fetus in obese pregnancy has not been well investigated to date. Even if maternal and
      fetal iron uptakes are regulated separately, it is unclear to what extent maternal
      subclinical inflammation might influence this process. A small study by Dao et al. indicated
      that maternal-fetal iron transfer was impaired in obese pregnant women, possibly due to
      hepcidin up-regulation. In this study, both maternal BMI as well as hepcidin were negatively
      correlated with cord blood iron status. Maternal hepcidin and c-reactive protein were
      significantly higher and cord blood iron was significantly lower in the obese compared to the
      normal weight. Hepcidin was shown to have an effect on iron transfer across the placenta in
      the study by Young et al.: the transfer was increased in women with undetectable hepcidin at
      delivery compared to those with higher levels. As of now, clear associations between maternal
      BMI or maternal hepcidin concentration and fetal iron status were not shown.
    

Intervention name(s): Stable iron isotope 57 (57Fe) labeled iron solution; Stable iron isotope 58 (58Fe) labeled iron solution
Intervention type(s): Other; Other
Intervention description(s): test meal labeled with 12 mg 57Fe; test meal labeled with 12 mg 58Fe
Intervention MeSH terms: Iron; Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Iron bioavailability; Hepcidin; Iron absorption
Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer
Condition: Endometrial Cancer; Sentinel Lymph Node
MeSH terms: Endometrial Neoplasms
Study type: Interventional

Summary: 
      The investigators think that trans-cervical endometrial tracer injection will cause more
      paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and
      safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.
    

Detailed description: 
      Endometrial tracer injection will be performed by cervical or transcervical endometrial
      methods. Pelvic and para-aortic sentinel lymph node detection capacity will be assessed in
      this study.
    

Intervention name(s): Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles; Cervical injection of technetium 99 m-labeled human albumin colloid particles
Intervention type(s): Procedure; Procedure
Intervention description(s): Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery. Injection performed with a trans-cervical catheter; Cervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: Endometrial Cancer; Sentinel Lymph Node; Paraaortic nodes involvement
Can MicroRNA's Predict Multicentricity in Breast Cancer?
Condition: Multicentric Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to determine if microRNA's have role in predicting multicentricity
      in breast cancer. If a specific microRNA will be found to be related with multicentricity, it
      will help us to make appropriate decisions on the treatment of patients with multicentric
      breast cancer.
    

Detailed description: 
      In the study that will be held at Bezmialem Vakif University Medical Faculty, General Surgery
      Department, 20 unifocal and 20 multifocal breast cancer patients will be included. Tissues
      will be taken from both tumoral and normal breast tissues and they will be saved in microRNA
      later solution under -80°C. Then, 84 microRNA's will be studied in these tissues to see if
      they express any of these microRNA's.
    

Intervention name(s): miRNA
Intervention type(s): Genetic
Intervention description(s): miRNA's expressed in breast cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: multicentric; breast; cancer
GARDASIL™ Vaccine Impact in Population Study (V501-033)
Condition: Human Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Observational

Summary: 
      This study will assess the impact of GARDASIL™ human papillomavirus (HPV) vaccine in the
      general female population by utilizing nationwide registry databases in the participating
      Nordic countries.
    

Detailed description: 
      Time perspective: The study will be conducted using data collected both
      retrospectively/concurrently from registries and prospectively by questionnaire survey.

      Baseline survey data were collected during a prior study from 2004-2005.

      Safety Monitoring: An expert panel on teratology consisting of one teratologist from each of
      the participating countries will review all available medical records related to any
      congenital anomalies to search for any emerging patterns that may be indicative of an
      association between GARDASIL™ exposure in the mother and the subsequent congenital anomalies
      in the babies.
    

Observational model: Ecologic or Community
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Registry data from the Population, Cervical Cancer Screening, Pathology, Cancer, and Death
        registries; Survey: Questionnaire sent to random sampling of women from the Central
        Population Registry Database; HPV Data: liquid-based cytology and histology samples from
        hospitals in participating countries
      
Biospecimen description: 
      Tissue, cervical cells
    
Keywords: congenital anomaly; pregnancy; GARDASIL®; Nordic; population-based
Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)
Condition: OCD
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT
      treatment for preadolescent children (aged 5 to 12 years old) with OCD.

      Specifically, this study aims to:

        1. Examine outcomes for children who receive the therapist guided, parent-led, CBT
           treatment for preadolescent children with OCD.

        2. Examine parents' experiences and views about the acceptability of the treatment
           approach.
    

Detailed description: 
      This study adapted an existing therapist guided, parent-led CBT intervention for children
      with anxiety difficulties, to ensure suitability for preadolescent children with OCD.

      This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT
      treatment for preadolescent children (aged 5 to 12 years old) with OCD.

      Specifically, this study aims to:

        1. Examine outcomes for children who receive the therapist guided, parent-led, CBT
           treatment for preadolescent children with OCD.

        2. Examine parents' experiences and views about the acceptability of the treatment
           approach.
    

Intervention name(s): Therapist guided, parent-led CBT for preadolescent children with OCD
Intervention type(s): Behavioral
Intervention description(s): This treatment was adapted from an existing evidence based therapist guided parent-led CBT intervention for preadolescent children with anxiety difficulties. It consists of 6 to 8 treatment individual treatment sessions where parents learn CBT techniques to apply at home with their child
Intervention model: Single Group Assignment
Intervention model description: Non concurrent multiple baseline design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD; CBT; parent
Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Atrial Flutter; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety, tolerability and preliminary efficacy of
      vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours
      and less than 6 months duration
    


Intervention name(s): Vernakalant (oral); Placebo comparator
Intervention type(s): Drug; Drug
Other intervention name(s): RSD1235-SR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: AFib; AF
Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia for Post-thoracotomy Pain
Condition: Acute Post-thoracotomy Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative thoracotomy pain is normally managed with an epidural catheter and continuous
      epidural analgesia (CEA). However, for some surgical procedures, patient controlled epidural
      anesthesia (PCEA) is more effective but little research has compared the two methods
      following thoracotomy. The current randomized, prospective clinical investigation did just
      this. Following institutional ethics approval 52 patients scheduled for thoracotomy were
      recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was
      sited preoperatively. Postoperatively all patients were titrated on continuous epidural
      infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) until pain scores were stable at ≤3
      on a numeric rating scale (NRS). Then they were allocated to their preoperatively determined
      randomization (either remained on continuous epidural infusion or they were switched to
      receive 2/3 of the stabilized background dose via continuous epidural infusion with the
      option to self-administer the remaining 1/3rd of the dose via PCEA. Participants remained on
      their allocated analgesic regimens for 48 hours postoperatively. The primary outcome was
      consumption of local anaesthetics/opioids. The secondary outcomes were worst pain and pain
      while coughing (0-10 NRS).
    


Intervention name(s): Patient controlled epidural analgesia; Continuous epidural analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Continuous epidural infusion rates were set to maintain pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in the post anesthesia care unit (PACU) following thoracotomy. Once stabilized patients were switched to Patient controlled epidural analgesia (PCEA) which meant they continued to receive 2/3rds of the dose as continuous background epidural infusions but they had the option to receive the remaining 1/3rd dosage via PCEA.; The continuous epidural analgesia (CEA) infusion rates were titrated to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in post-anesthesia care unit (PACU) (as described for the PCEA group above). Those allocated to the CEA group remained on the same continuous epidural analgesia infusion which maintained the pain scores at ≤ 3.
Other intervention name(s): PCEA; CEA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anesthesia and analgesia; Epidural Anesthesia; administration schedules, drug
The Effects of Different Lipid Emulsions on the Adipokines in Critically Ill Patients With Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      Intravenous lipid emulsions contain a number of biologically active ingredients, but the most
      important are fatty acids. Different fatty acids can affect a number of different
      physiological processes in different ways in critically ill patients. Adipose tissue can play
      an important role in metabolic changes of critical illnesses and in adaptation to stress
      through structural as well as functional changes Although it is known that serum adipokine
      and cytokine response changes in critical sepsis patients, the factors affecting these
      changes and the metabolic consequences of these changes are not well defined. The aim of this
      study was to evaluate the effects of intravenous lipid emulsions on serum adipokine and
      cytokine levels in patients with sepsis. Secondly, this is to determine the adipokine and
      cytokine kinetics in the sepsis process and their relationship with mortality in patients
      with sepsis.
    


Intervention name(s): Olive oil-based intravenous fat emulsions; Soybean-based intravenous fat emulsions
Intervention type(s): Other; Other
Intervention description(s): Parenteral nutrition planned according to the requirements of the patients is given for ten days.; Parenteral nutrition planned according to the requirements of the patients is given for ten days.
Intervention MeSH terms: Soybean oil, phospholipid emulsion; Fat Emulsions, Intravenous
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Critically ill patients with sepsis aged 18-85 years given parenteral nutrition therapy
      
Biospecimen description: 
      Adipokines (adiponectin, rezistin leptin and visfatin) and cytokines (IL-6, IL-10, IL-1β and
      TNF-α) in critically ill with sepsis
    
Keywords: Parenteral Nutrition; Sepsis; Adipokines; Inflammation; Intensive Care
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2027 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and
      pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants.
    


Intervention name(s): E2027; E2027 matched placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive E2027 capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 will be administered orally with 240 milliliter (mL) (8 fluid ounces) of water.; Participants will receive E2027 matched placebo capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 matched placebo will be administered orally with 240 mL (8 fluid ounces) of water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: E2027; Healthy participants; Pharmacokinetics; Pharmacodynamics
Retrolaminar Block for Postoperative Analgesia in Lumbar Herniectomy Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      This retrospective study included 30 patients scheduled for lumbar herniectomy under general
      anesthesia. The patients were randomized to receive either retrolaminar block or intravenous
      analgesia treatment.Numeric Pain Rating Scale (NPRS) was used to measure the pain intensity
      of patients in postoperative period. Postoperative analgesic requirements were recorded to
      asses effectiveness of regional anesthesia.Opiod and NSAİD as rescue medication were recorded
      postoperatively.
    

Detailed description: 
      This retrospective study included 30 patients scheduled for lumbar herniectomy under general
      anesthesia. The patients were randomized to receive either RLB or intravenous analgesia
      treatment. All patients were routinely monitored and their heart rate, blood pressure and
      pulse oxymetry recorded during the anesthesia. Numeric Pain Rating Scale (NPRS) scores
      evaluated at 2, 8, 12, 24 and 48 h after the surgery. Opiod and NSAİD as rescue medication
      were recorded postoperatively
    

Intervention name(s): retrolaminar block
Intervention type(s): Procedure
Intervention description(s): local anesthetic injection on the between the lamina of the vertebra and the paraspinous muscle
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients underwent retrolaminar block
      
Keywords: Retrolaminar block
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to characterize the immunogenicity & safety of a booster dose of
      GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months
      of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's
      Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and
      open-label for the booster phase.
    

Detailed description: 
      The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and
      W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given
      to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In
      addition, this study will provide immunogenicity and safety data on the co-administration of
      Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.

      Depending on the group the subject is assigned to, one or two blood samples will be taken out
      of the subject's arm during the study.

      The protocol posting has been updated following a protocol amendment.
    

Intervention name(s): GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix); GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix); Infanrix®; ActHIB®; Pediarix®
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): One dose in the booster phase as intramuscular injection; Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection; One dose as intramuscular injection; Three doses in the priming phase as intramuscular injection; Three doses in the priming phase as intramuscular injection
Other intervention name(s): Nimenrix; Menhibrix
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Meningococcal disease; Toddlers; Neisseria meningitidis; Meningococcal vaccines; Immunogenicity; Human serum bactericidal assay; Safety; Vaccines, conjugate; Booster vaccination