bioihbjkbjnl/mcl2 huggingface dataset:
Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy
Condition: Chemotherapy Induced Anemia; Cancer
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and
      pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in
      anemic cancer participants receiving chemotherapy.
    

Detailed description: 
      This was a Phase 2, open-label, multi-center, sequential dose finding study with up to 6
      treatment cohorts receiving chemotherapy with 15 participants per cohort. The primary
      objective of this study was to determine the dose of peginesatide administered every 3 weeks
      (Q3W) by subcutaneous injection associated with a hemoglobin increase of ≥ 1 g/dL in ≥ 50% of
      anemic cancer participants receiving chemotherapy at 9 weeks following the first dose.
    

Intervention name(s): peginesatide
Intervention type(s): Drug
Other intervention name(s): Omontys; Hematide; AF37702 Injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anemia; cancer; chemotherapy; chemotherapy induced anemia; CIA; hemoglobin; Hb; Hgb; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; Hematide; Omontys; peginesatide; red blood cell; red blood cell production
PDL1 in Ovarian High Grade Serous Carcinoma
Condition: Ovarian Cancer
MeSH terms: Cystadenocarcinoma, Serous
Study type: Observational

Summary: 
      the main purpose is to study the prognostic effect of PDL1 in ovarian cancer especially HGSC.
      Therefore, in the present study the investigators analyzed the expression of PDL1in HGSC by
      immunohistochemistry, and results were correlated to prognosis.
    

Detailed description: 
      this cross-sectional study on 54 specimens of primary ovarian high grade serous carcinoma
      cases who attended to Oncology Centre, Mansoura University, Mansoura, Egypt in the period
      from 2012 till 2019. The cases were chosen randomly. All clinicopathological data including
      tumor stage (T), L.N metastases (N), metastasis (M), (FIGO) staging system, ascites,
      recurrence, residual tumor, CEA level, CA125 level, and peritoneal deposits analyzed. The
      investigator followed the clinical outcomes in the form of disease free survival (DFS) and
      overall survival (OS). The mean duration of follow up will be 43.4 months. The OS were
      calculated from the time of diagnosis to death. DFS is the time from the end of therapy to
      first recurrence or metastases. the specimens were stained with PDL1 marker in pathology
      department Port Said university.

      Statistical analysis: Data was analyzed using SPSS software V.16. Continuous data was
      presented in the form of mean (SD) or Median (min-max) according to the results of
      Shapiro-Wilk testing for the assumptions of normal distributions of data. Categorical data
      will be presented in the form of frequencies and percentages. Statistical significance will
      be tested by Welch's t-test, or Mann-Whitney U for continuous data (with respect to presence
      or absence of normal distribution of data). Also, chi square test or Fisher's Exact Test will
      be performed for categorical data (with respect to the minimal expected values in the
      contingencies tables). Correlations of different tumour markers will be calculated using
      Spearman's rho Coefficient. Kaplan-Meier test was used to test for overall survival and
      disease free survival of patients with respect to tumour expression of PDL1. Comparisons will
      be done using Log Rank (Mantel-Cox). Significance level is set at 0.05.
    

Intervention name(s): immunohistochemical staining
Intervention type(s): Diagnostic Test
Intervention description(s): immunohistochemical staining of programmed death-ligand 1 (PDL1) marker
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        all patients diagnosed with primary serous ovarian cancer and subjected to staging
        laparotomy
A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, randomized, 2-way crossover study will assess the absolute bioavailability
      and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to
      one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B)
      RO6811135, with a washout period of at least 7 days between dosing.
    


Intervention name(s): RO6811135; RO6811135
Intervention type(s): Drug; Drug
Intervention description(s): Single subcutaneous dose; Single intravenous dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Mechanism of IL-10 Pathway-mediated Regulatory B Cell Dysfunction in Osteoarthritis
Condition: Osteoarthritis; Knee Arthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Our previous work has shown that Treg function is impaired in OA patients, but the cause of
      Treg deficiency has not been investigated. Since Breg has been shown to promote Treg
      differentiation and tissue repair, it is highly likely that the absence of the
      immunomodulatory effect of Breg in OA patients leads to impaired Treg differentiation. Based
      on the above data, we hypothesized that Breg plays a protective role in the course of OA by
      regulating T cell composition and promoting Treg differentiation through the secretion of
      anti-inflammatory factor IL-10
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with knee osteoarthritis come to our hospital
Prasugrel Re-load Strategies
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      A higher degree of platelet inhibition remains the goal of peri-interventional and long-term
      anti-thrombotic therapy in patients with coronary artery disease. In clinical practice,
      patients undergoing percutaneous coronary intervention with stent implantation who are
      already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior
      observations showing that higher inhibition of platelet aggregation may be achieved by giving
      a loading dose of clopidogrel in patients with coronary artery disease while on chronic
      clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet
      aggregation can be achieved by adding a prasugrel loading dose in patients on chronic
      prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel
      re-load strategy in patients on already on chronic prasugrel therapy will be useful.
    


Intervention name(s): Prasugrel
Intervention type(s): Drug
Intervention description(s): Prasugrel 10mg, 30mg, or 60mg
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: coronary artery disease; percutaneous coronary revascularization; prasugrel therapy
Clinical Outcomes After AcrySof® ReStor IOL Surgery in Faculty Practice at UTSW Medical Center at Dallas: A Retrospective Review
Condition: Outcomes Following Restor IOL Lens Implant
Study type: Observational

Summary: 
      To evaluate the clinical outcomes of AcrySof® ReSTOR® IOL for the Faculty Practice at UTSW
      Medical Center at Dallas
    

Detailed description: 
      The AcrySof® ReSTOR® intraocular lens (IOL) is the latest advance in vision surgery. This IOL
      has been uniquely designed to improve vision throughout the entire visual spectrum, up close,
      far away and everything in-between. Thus, giving cataract patients their best chance ever to
      function free of glasses.

      The pre-operative and post-operative data from ReSTOR® IOL implant cataract surgeries will be
      analyzed to determine whether the desired outcome was achieved, i.e. excellent vision with no
      correction. Variables to be studied include patient age, gender, number of ReSTOR® IOL
      implants, ocular comorbidities, preoperative and postoperative corrected and uncorrected
      visual acuities, keratometry readings, and corneal topography readings. A patient survey will
      also be sent to patients having undergone the surgery to measure their level of satisfaction.

      Project Goals: The ultimate outcome of this project is to learn more insight on the
      following:

        1. Visual acuity with and without correction of distance and near at 3-6 months

        2. Percent of patients requiring keratorefractive surgery

        3. Ocular comorbidity subgroup analysis

        4. Monocular implantation subanalysis (prior to LASIK)

        5. Comparison of post-op spherical equivalent to target refraction

        6. Posterior capsule opacity that may be treated with laser procedure known as a YAG laser
           capsulotomy?

        7. Subjective patient satisfaction

        8. Validated questionnaire assessing visual function and quality of life
    

Intervention name(s): Restor IOL
Intervention type(s): Device
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients of any race and sex between the ages of 18-90 years of age who have undergone
        ReSTOR® IOL cataract surgery will be recruited in this retrospective project.
      
Keywords: Higher Order Abberations
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic
      (the exposure of the trial drug in the body) properties of FIAsp (faster-acting insulin
      aspart) in children, adolescents and adults with type 1 diabetes.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): A single dose will be administered subcutaneously (s.c. under the skin); A single dose will be administered subcutaneously (s.c. under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)
Condition: Vaccines, Combined; Hexavalent Vaccine
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objectives of this study are to evaluate the safety, tolerability, and
      immunogenicity of a booster dose of Vaxelis™ (V419) given at ~11 to 13 months of age in
      healthy participants who were previously vaccinated with a 2-dose primary infant series of
      either Vaxelis™ or Hexyon™.
    


Intervention name(s): Vaxelis™
Intervention type(s): Biological
Intervention description(s): Vaxelis™ 0.5 mL sterile suspension in prefilled syringe for intramuscular administration.
Other intervention name(s): V419
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to investigate the duration of P-glycoprotein inhibition after
      oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK
      tablet.
    


Intervention name(s): HM30181AK 1mg; HM30181AK 5mg; HM30181AK 15mg; HM30181AK 60mg; Loperamide 2mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): HM30181AK 1mg tablet; HM30181AK 5mg tablet; HM30181AK 15mg tablet; HM30181AK 60mg tablet; Loperamide 2mg capsule
Intervention MeSH terms: Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pgp inhibitor; P-glycoprotein inhibitor
Nutrition Intervention to Measure Metabolic Response in Children
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The long-term objective of this study is to determine if habitual consumption of high-quality
      protein at breakfast will lead to improved energy metabolism and decreased daily energy
      intake in normal weight and overweight children. The investigators hypothesize that
      increasing protein intake at breakfast will improve energy metabolism and reduce energy
      intake throughout the day in overweight/obese school-aged children. The significance of the
      study is that improving nutrient intake at breakfast can potentially lead to a future
      reduction in childhood obesity rates.
    


Intervention name(s): Control Breakfast Beverage; Omega-3 Breakfast Beverage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.; Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Evaluate The Effects of RO5545965 in Participants With Negative Symptoms of Schizophrenia Treated With Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, three period crossover
      study to evaluate the effects of RO5545965 on the functioning of key brain circuitry involved
      in negative symptoms using functional magnetic resonance imaging (fMRI) and reward-based
      learning in stable participants with mild to moderate negative symptoms of schizophrenia
      treated with antipsychotics. Participants will be randomized to one of six different
      sequences during which each participant will receive three 3-week treatment courses with
      RO5545965 5 milligrams (mg), RO5545965 15 mg and placebo. Each treatment period will be
      separated by a washout period of 14 days. Total duration of study will be approximately 17
      weeks.
    


Intervention name(s): Placebo; RO5545965
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive placebo matched to RO5545965 capsules orally daily in any of the three intervention period.; Participants will receive RO5545965 5 mg capsules or RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily in any of the three intervention period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients Undergoing Colonoscopy
Condition: Health Behavior
Study type: Interventional

Summary: 
      Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines
      recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the
      high-volume PEG still results in lower compliance to the regime and increased cost.

      Some high risk factors for inadequate BP have been identified, including old age,
      constipation, diabetes, the use of narcotics and prior history of inadequate BP. For
      average-risk patients without the high risk factors, the procedure of BP could be easier. In
      the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk
      patients achieved adequate BP. Here investigators hypothesized that compared with the
      standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while
      may be accompanied with better tolerability.
    


Intervention name(s): Single dose of 2L PEG; Split dose of 4L PEG
Intervention type(s): Drug; Drug
Intervention description(s): Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.; All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PEG; Bowel preparation; Colonoscopy
Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
Condition: Chronic Myelomonocytic Leukemia
MeSH terms: Leukemia; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to assess the activity of decitabine in the treatment of CMML.
    


Intervention name(s): Decitabine
Intervention type(s): Drug
Intervention description(s): Decitabine will be administered at a dose of 20 mg/m2 infused over a 1 hour period once daily for 5 consecutive days. The totale amount per course is 100 mg/m2. Cycles will be administered every 4 weeks (1 cycle of 28 days).It is recommented that patients be treated for a minimum of 4 cycles.
Intervention MeSH terms: Decitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Decitabine
Activating and Identifying Neural Responses to Social Rejection: a Combined tDCS and fMRI Study
Condition: Healthy
Study type: Interventional

Summary: 
      This research study identifies neural pathways regulating negative moods during rejection by
      combining transcranial direct current stimulation (tDCS) and fMRI in a sample of healthy
      controls.
    

Detailed description: 
      Aim 1: To test the behavioral effects of tDCS during social rejection. The first step will be
      to obtain behavioral effects of transcranial direct current stimulation (tDCS) during social
      rejection without functional magnetic resonance imaging (fMRI). Whereas previous studies used
      "Cyberball" (a computerized ball-tossing game that simulates social exclusion), we will use
      the Social Feedback Task. This task was created by Dr. Hsu to be more ethologically-relevant,
      has been shown to sustain negative moods during rejection and activates the right ventral
      lateral prefrontal cortex (rVLPFC) (preliminary fMRI data from 50 healthy controls in Dr.
      Hsu's previous study). Anodal tDCS will be applied over the right or left VLPFC to measure
      changes in mood during rejection and neutral conditions. Depending on results, alternate
      regions in separate subjects may also be stimulated: dorsolateral prefrontal cortex, insula,
      anterior cingulate cortex, pre-supplementary, and supplementary motor area [all regions may
      be right or left hemisphere]. All of these regions have been shown to be involved in emotion
      regulation. Questionnaires will be given before, during, and after the task to assess
      cognitive and emotional states.

      Aim 2: To identify neural pathways regulating negative moods during social rejection, using
      tDCS for activation and fMRI for assessment. Using a cross-over, sham-controlled design
      similar to previous tDCS+fMRI studies, we will measure the effects of anodal tDCS over the
      right or left VLPFC on neural activity and negative mood during rejection and neutral
      conditions. Alternate regions in separate subjects may also be stimulated including the
      dorsolateral prefrontal cortex, insula, anterior cingulate cortex, pre-supplementary, and
      supplementary motor area [all regions may be right or left hemisphere]. All of these regions
      have been shown to be involved in emotion regulation.
    

Intervention name(s): tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): tDCS; Sham tDCS
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: within-subjects crossover design
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: tDCS rejection affect mood fMRI
AM-101 in the Treatment of Acute Tinnitus 2
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to test the safety and effectiveness of the study drug,
      AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an
      injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with
      tinnitus can take part in the study, if their tinnitus started within the last 3 months.
    

Detailed description: 
      This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of
      repeated intratymanic AM-101 injections in the treatment of acute peripheral tinnitus (up to
      3 months from onset).
    

Intervention name(s): AM-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AM-101 gel for intratympanic injection; Placebo gel for intratympanic injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment