bioihbjkbjnl/mcl2 huggingface dataset:
Bedside Ultrasound to Measure Optic Nerve Sheath Diameter in Pediatric CSF Shunts
Condition: Cerebrospinal Fluid Shunts
Study type: Observational

Summary: 
      Bedside ultrasound in the emergency department is useful for quick assessments of patients.
      One growing use is to measure the optic nerve sheath diameter of patients for whom increased
      pressure in the head is a concern. This study will look at the optic nerve sheath diameters
      of a specific population of pediatric patients with shunts that drain extra fluid from their
      heads.
    

Detailed description: 
      The particular interest of this study is the use of ultrasound to evaluate a child's optic
      nerve sheath diameter (ONSD), or the size of the covering around the nerve behind the eye.
      This covering expands when there is a higher than normal pressure inside the head. The group
      of interest on which this study focuses is the children with cerebrospinal shunts that drain
      extra fluid from their heads to other parts of the body (abdomen, heart, lungs) because the
      brain cannot drain all of the fluid like normal. When these shunts malfunction or fail, this
      can cause a backup of fluid in the brain, and raise the intracranial pressure (ICP) inside
      the skull. Depending on the degree of pressure buildup, this can be a surgical emergency due
      to pressure on the brain. Currently, computed tomography (CT) scans or magnetic resonance
      imaging (MRI) scans are used to diagnose the condition, but a quick screening tool, such as
      use of ultrasound to screen for elevated ICP in the emergency department, would be of great
      benefit to the patients to expedite care. Previous studies have explored the use of bedside
      ultrasound to evaluate the optic nerve sheath diameter in children with shunts. However, to
      date, there have been no reported prospective observational studies that compared before and
      after ultrasound measurements of the ONSD in patients in whom shunt failure is diagnosed and
      treated. Of note, this study is observational and the measurements taken with the ultrasound
      machine will not be used for clinical decision making. The measurements in this study will
      have no clinical impact on patient care. The use of ultrasound to measure the ONSD is an
      already accepted application of ultrasound.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with cerebrospinal fluid shunts who are evaluated in the emergency
        department for any reason, or are admitted to the hospital through the neurosurgery clinic.
      
Keywords: optic nerve sheath diameter; ultrasound; shunt failure
Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.
Condition: Breast Cancer
Study type: Interventional

Summary: 
      Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of
      malignant lesions in breast is required. Sometimes a supplementary MRI is therefore
      recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral
      mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity
      and specificity. Size assessment using contrast-based modalities as CESM has also been shown
      to be significantly more accurate than using mammography. Prospective randomized studies
      using CESM are lacking.

      Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast
      cancer and choice of operation; partial mastectomy or mastectomy.

      A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized
      study.

      Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and
      core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A
      supplementary examination with CESM will be performed. Preoperative extent of the malignant
      lesions are estimated with each modality and is later compared with the extent measured in
      post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT
      or endocrine therapy, breast volume and density is collected, as well as data of diagnosis
      (ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression
      and Ki67 index.

      In this pilot study sensitivity and specificity for each modality is calculated. Multivariate
      analysis will be performed regarding influential factors. Pearson correlation coefficient
      will be calculated for each modality regarding size assessment of the malignant lesions in
      comparison with definitive PAD.
    


Intervention name(s): Contrast Enhanced Spectral Mammography
Intervention type(s): Diagnostic Test
Intervention description(s): Pilot study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Contrast Enhanced Spectral Mammography
Phase I Study of SB-480848(Darapladib) -Repeat Dose Study in Healthy Japanese Male Subjects-
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to provide safety, tolerability, PK and PD data in repeat
      dosing that will allow further studies with darapladib in Japanese patients
    


Intervention name(s): SB-480848 (Darapladib)
Intervention type(s): Drug
Intervention MeSH terms: Darapladib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: darapladib,; SB480848,; Japanese healthy volunteers
L-arginine Effects on Chronic Hypertension in Pregnancy
Condition: Hypertension in Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of oral L-arginine administration on
      pregnant women at second trimester of gestation with chronic hypertension, respect with
      placebo.
    


Intervention name(s): L-arginine; placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral L-arginine 2 g twice a day for 14 weeks; oral placebo 2 g twice a day for 14 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: chronic hypertension in pregnancy
Open Trial of Family-Based Treatment for Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      This trial seeks to investigate the feasibility and effectiveness of delivering a newly
      manualized family-based treatment for adolescents with anorexia nervosa
    

Detailed description: 
      This open trial seeks to investigate the feasibility and effectiveness of delivering a newly
      manualized family-based treatment for adolescents with anorexia nervosa at a site beyond the
      treatment's origin. Adolescents ages 12-17 with anorexia nervosa or subthreshold anorexia
      nervosa were treated with up to one year of this approach.
    

Intervention name(s): Family-Based Treatment
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Anorexia; Eating disorder; Family therapy
STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, double blind, sponsor open, single and multiple ascending dose study to evaluate
      safety, tolerability and pharmacokinetics of PF-07321332 in healthy participants.
    

Detailed description: 
      Combined 5-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3:
      Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5:
      Supra-therapeutic Exposure Part-1,2 and 5 are double blind, sponsor open and Part-3 and 4 are
      open label study.
    

Intervention name(s): PF-07321332 Dose 1; PF-07321332 Dose 2; PF-07321332 Dose 3; PF-07321332 Dose 4; PF-07321332 Dose 5; PF-07321332 Dose 4 or Placebo (Fed)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-07321332 Dose 1 or Placebo; PF-07321332 Dose 2 or Placebo; PF-07321332 Dose 3 or Placebo; PF-07321332 Dose 4 or Placebo; PF-07321332 Dose 5 or Placebo; PF-07321332 Dose 5 or Placebo with high fat meal
Intervention MeSH terms: Nirmatrelvir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Evaluation of the Irinotecan/Bevacizumab Association for Naive Unresectable Glioblastoma
Condition: Naive Unresectable Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment of glioblastoma (GBM) is based on surgery when possible, and chemoradiation with
      temozolomide, which became a standard since the EORTC study (Stupp, 2005). However, the
      prognosis of unresectable GBM remains poor despite chemoradiation with an estimated 10 month
      median survival, in the range of the comparable patients in the RPA class V from the EORTC
      study (Miramanoff, 2006).

      Vredenburgh et al. from the Duke University (Durham, NC) reported at ASCO 2006 (fully
      published in J Clin Oncol, 2007) a 57 % unexpected response rate using a
      bevacizumab/irinotecan schedule in patients with relapsed GBM or grade 3 astrocytomas. This
      unusual high response rate, sometimes with major and sustained responses, was confirmed by a
      cooperative french study of ANOCEF (Guiu et al., 2008). Such a major improvement of treatment
      effectiveness lead ANOCEF, which federates most of the active neuro-oncology teams in France,
      to propose a neo-adjuvant and adjuvant bevacizumab-based chemotherapy framing a standard
      temozolomide-based chemoradiation with the aim to improve the prognosis of unresectable GBM.

      The bevacizumab/temozolomide combination as neo-adjuvant is presently being evaluated by the
      Duke University. We believe that an ambitious comparison of the
      bevacizumab/irinotecan-schedule with the ''standard'' temozolomide-based chemoradiation is a
      fascinating challenge to improve the treatment of this awful disease.

      The ANOCEF proposal '' Evaluation of the irinotecan/bevacizumab association as neo-adjuvant
      and adjuvant treatment of chemoradiation with temozolomide for naive unresectable
      glioblastoma. Phase II randomized study with comparison to chemoradiation with temozolomide''
      has been successfully granted by INCA (Institut National du Fancer, France) through its
      research program ( PHRC : Programme Hospitalier de Recherche Clinique). Implementation of
      this program is now starting .
    


Intervention name(s): Avastin + Campto / radiotherapy + Temodal + Avastin (4 cures); Temodal/radiotherapy
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bevacizumab; Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unresectable glioblastoma
Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3
      doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a
      0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2
      doses of Havrix™ (0-6 months) and Meningitec™ (month 1).
    

Detailed description: 
      The study is open; however, vaccines given to study group at 0-1-6 months and to control
      group will be administered in an observer-blind manner. 3 blood samplings for antibody
      testing: before vaccination and one month after the second and third vaccine doses.
    

Intervention name(s): Meningococcal serogroup B vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylaxis meningococcal serogroup B disease
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are
      either taking no diabetes medication or who are taking metformin only. This study will
      investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will
      measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16
      weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide
      (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up
      visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring
      of any side effects.
    

Detailed description: 
      A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter,
      dose-ranging study to evaluate the efficacy, safety and tolerability of multiple doses and
      multiple treatment regimens of Albiglutide (GSK716155) with Byetta as an open-label active
      reference, in subjects with Type 2 Diabetes Mellitus.
    

Intervention name(s): Albiglutide (GSK716155) or exenatide
Intervention type(s): Drug
Intervention description(s): Albiglutide weekly subcutaneous injection or exenatide twice daily injection
Intervention MeSH terms: Exenatide; rGLP-1 protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GLP-1,; Type 2 Diabetes,; pharmacokinetics,; pharmacodynamics,; GSK716155,; metformin,; exenatide; Type 2 Diabetes Mellitus
Efficacy of MND-2119 in Participants With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to
      EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
    

Detailed description: 
      MND-2119 is a new formulation of Icosapent. This is a phase 3 study to evaluate the efficacy
      and safety of MND-2119 compared to EPADEL CAPSULES 300 in subjects with hypertriglyceridemia.

      The study period is a total of 22 weeks and is comprised of 8 weeks run-in period, 12 weeks
      treatment period and 2 weeks follow-up period.
    

Intervention name(s): Icosapent (MND-2119); Icosapent (EPADEL CAPSULES 300)
Intervention type(s): Drug; Drug
Intervention description(s): Icosapent (MND-2119) capsules.; Icosapent (EPADEL CAPSULES 300) capsules.
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Observational

Summary: 
      Study TRD subjects' resistance to at least 2 different antidepressants, we hypothesize that
      because of their significant depression and treatment resistant status they are most likely
      to exhibit BSMN pathway abnormalities.
    

Detailed description: 
      Potential subjects will be identified during clinical visits. If a patient qualifies to
      participate in the study they will have to stop any antidepressants that they are taking to
      prepare for the use of MAOIs. After a two week washout period, subjects will have an fMRI and
      will be started on a MAOI. They will then be followed up for 8 weeks, which is routine and
      considered standard care.
    

Intervention name(s): Monoamine Oxidase Inhibitor (MAOI)
Intervention type(s): Drug
Intervention description(s): Monoamine Oxidase Inhibitor
Other intervention name(s): Monoamine Oxidase Inhibitor
Intervention MeSH terms: Monoamine Oxidase Inhibitors
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Treatment Resistant Depression and Healthy Controls
      
Keywords: Treatment Resistant Depression
Antiviral Pharmacology and Adherence in Drug Users
Condition: HEPATITIS C; Virus, Human Immunodeficiency
MeSH terms: Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis
Study type: Interventional

Summary: 
      Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users,
      yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent
      and therefore denied potentially life-saving therapy. This assumption can only be confirmed
      or dispelled through prospective pharmacologic and adherence studies in this population. Such
      studies would be greatly enhanced by an objective, quantitative measure of adherence which
      does not currently exist in the HCV field. Through the work proposed in this application,
      sixty HIV/HCV co-infected drug users will be treated with direct acting antiviral agents
      (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no directly observed
      therapy (no-DOT). Patients randomized to no-DOT will have wirelessly observed therapy (WOT)
      which involves use of a portable medication dispenser that sends a signal to a server with
      the date and time when the dispenser is opened. In Aim 1, DAA concentrations will be compared
      in those randomized to DOT vs. no-DOT. DAA pharmacokinetics will also be defined accounting
      for clinical factors like degree of hepatic impairment and use of concomitant recreational
      and antiretroviral drugs. The goal is to quantify adherence in this population and the effect
      of variable adherence on drug concentrations. In Aim 2, DAA concentrations (plasma, cellular,
      hair) will be linked with adherence patterns identified using WOT and DOT. The goal is to
      identify a drug concentration biomarker that predicts adherence in this population. In Aim 3,
      the relationship between DAA adherence (as measured by WOT and DOT and drug concentrations)
      and rate of cure will be established. The goal is to define the degree of adherence needed
      for HCV cure.
    


Intervention name(s): Directly Observed Therapy; Wirelessly Observed Therapy
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): DOT; WOT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV; Hepatitis C; Drug Abuse; Hepatitis C Virus; sofosbuvir; ledipasvir; pharmacology; pharmacokinetics
Immune Status in Solid Organ Transplantation
Condition: Organ Transplants
Study type: Observational

Summary: 
      Immunosuppressive therapy protocols in solid organ transplantation are rudimentary, differ by
      transplant center and no practical strategies are available to guide an individuals' response
      to immune suppression. In this study we will conduct research to assess immunologic status in
      solid organ transplant recipients, predicting immune reconstitution and outcomes after
      transplant to better guide the use of immunosuppressive medications.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tranplant clinic population
Effects of Urocortins on Forearm Arterial Blood Flow in Healthy Volunteers
Condition: Vascular Disease; Heart Disease
MeSH terms: Heart Diseases; Vascular Diseases
Study type: Interventional

Summary: 
      Impairment of the heart's pumping capacity (heart failure) remains a major clinical problem
      with a poor prognosis and the search for novel treatments remains an important area of
      research.

      Urocortins are proteins that appear to increase blood flow and heart pumping activity. There
      has been particular interest in the role of Urocortins 2 & 3 (subtypes of Urocortins) in
      heart failure.

      In this study, we will examine the effects and mechanisms of Urocortins 2 & 3 and the
      Corticotrophin Releasing Hormone Receptor Type 2 (CRH-R2) receptor (through which urocortins
      act) on forearm blood flow and release of natural blood clot dissolving factors in the
      forearm circulation of healthy volunteers.

      In this study, we will look at the role of the lining of the blood vessel (endothelium) in
      response to urocortin types 2 and 3. We hypothesise that urocortins 2 & 3 act via the
      endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen
      activating factor (blood clot dissolving factor). We also hypothesise that urocortins have a
      role in maintaining the normal baseline level of blood flow in forearm arteries. In addition
      to the above, we will also look at the effect of temporarily blocking the effect of
      urocortins, using a specially designed blocker drug (Astressin 2B).

      Utilising the well-established technique of 'forearm venous occlusion plethysmography', we
      will be able to focus on the local effects of urocortins on arterial blood flow in forearm
      vessels, without affecting this system in the body as a whole.
    


Intervention name(s): Astressin 2B
Intervention type(s): Drug
Intervention description(s): After an initial saline washout, increasing doses of Astressin 2B (at 0.032, 0.32, 3.2, 32, 320 and 3200 pmol/min) will be infused, for 10 minutes at each dose,intra arterially using forearm venous occlusion plethysmography. Forearm blood flow will be measured with each incremental dose of Astressin 2B.
Other intervention name(s): Forearm vascular study
Intervention MeSH terms: Astressin
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Astressin 2B; Forearm blood flow; vascular; plethysmography; heart failure