bioihbjkbjnl/mcl2 huggingface dataset:
Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin
Condition: Platelet Dysfunction Due to Aspirin
Study type: Interventional

Summary: 
      Healthy volunteers (n = 28) were recruited from the workplace (14 male, 14 female; age range
      20-50 years). Ethical approval, which included informed consent, was from Cardiff University,
      Schools of Medicine and Dentistry Research Ethics Committee (SMREC16/02). Following a 2-week
      period free from non-steroidal anti-inflammatory drugs (NSAIDs), peripheral blood was
      obtained and platelets isolated. Participants were commenced on aspirin 75 mg once daily for
      seven days and then provided a repeat blood sample. Following a 2-month period, participants
      were invited to repeat samples pre- and post-aspirin, and again a third time 2 months later.
    


Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): 1 week of aspirin supplementation prior to sampling
Intervention MeSH terms: Aspirin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: platelets; phospholipids; aspirin
TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and
      removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral
      tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).
    

Detailed description: 
      The study will consist of 2 parts involving up to 12 healthy male participants. In Part 1, up
      to 6 participants will receive a single 80 mg dose of [14C]-TAK-385 administered as an oral
      solution. In Part 2, up to 6 participants will receive a single oral 80 mg dose of TAK-385
      administered as two 40 mg tablets and an 80 μg intravenous (into a vein) dose of
      [14C]-TAK-385 (containing not more than 37.0kBq [1000 nCi] 14C).

      This single centre study will take place in the United Kingdom.
    

Intervention name(s): [14C]-TAK-385 Oral Solution; TAK-385 Tablets; [14C]-TAK-385 Solution for Intravenous Infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-385 oral radiolabelled solution; TAK-385 tablets 2 X 40 mg; TAK-385 intravenous (IV) radiolabelled solution
Intervention MeSH terms: Pharmaceutical Solutions; Relugolix
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug therapy
Greening the Humanitas Fertility Center: How to Build a More Sustainable Medical Daily Routine
Condition: Sustainability; Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      The goal of this observational study is to redefine an everyday clinical routine at the
      Humanitas Fertility center calculating the effects derived from the reduction of
      inappropriate and avoidable tests, procedures, tools and treatments currently used.

      Anonymized patients data about clinical procedures are used, taken from the internal database
      of the Humanitas fertility center
    


Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All outpatient, surgical and laboratory procedures, considered as daily clinical routine at
        the Humanitas Fertility center, will be taken into account, analysed and defined as
        appropriate or not.
Immunomodulation With Romiplostim in Young Adults With ITP
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to investigate immunomodulatory effects of thrombopoietin-receptor Agonist
      (TPO-RA) in patients with primary ITP, who failed first-line therapy or who became intolerant
      to it. It is hypothesized that the early phase of this autoimmune disease may exhibit a
      stronger immunomodulatory potential in response to a stimulus, such as romiplostim. Such a
      process may subsequently be capable to induce regulatory mechanisms or tolerance.

      Romiplostim (a thrombopoietin-receptor agonist, TPO-RA) will be administered subcutaneously
      once weekly over 22 weeks with a starting dose of 1mcg/kg body weight. The dose will be
      adjusted based on platelet counts as described in the summary of Product Characteristics
      (SmPC).
    


Intervention name(s): romiplostim
Intervention type(s): Drug
Other intervention name(s): Nplate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunomodulation
Missed Opportunities to Pre-exposure Prophylaxis for HIV Infection on Person Newly Diagnosed With HIV
Condition: Virus-HIV
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to
      newly infected with human immunodeficiency virus (HIV) persons. The purposes of this study is
      to understand why despite the fact that pre-exposure prophylaxis exist, these persons have
      been contaminated with HIV.
    

Detailed description: 
      Pre-exposure prophylaxis is a new strategy to prevent the occurrence of new cases of HIV.
      This prophylaxis strategy is based on taking antiretroviral drugs (ARV) before and after
      exposition to a risk of HIV infection which can reduce drastically the contamination with
      HIV. A certain groups of population based on their sexual orientation, for instance man who
      have sex with man (MSM), is among the groups that are highly exposed to this risk. To reduce
      this risk, French national regulatory authority (ANSM), firstly through temporary usage
      recommendation followed by a marketing authorization extension, allowed the prescription of
      these antiretroviral molecules to persons presenting eligibility criteria as defined by
      regulatory authority. Despite these preventive measures, the incidence of HIV such as the MSM
      group still high. The missed opportunity studies has as objectives to try to disentangle real
      obstacles of PrEP use in France and to optimize PrEP criteria if needed.
    

Intervention name(s): self-administrated questionnaire
Intervention type(s): Behavioral
Intervention description(s): Persons who the biological parameters or past screening show that they were recently infected with HIV cf. eligibility criteria, will, after obtaining his consent, answer a series of questions through a self-administrated questionnaire that will take approximately 40 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: VIH; PrEP; risk factors; Prevention; Access to care
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is
      inappropriate (intolerability, contraindication). The second part of the study looks at the
      safety of BI 1356 in this patient population with longer term treatment in comparison to a
      sulfonylurea drug (glimepiride)
    


Intervention name(s): Linagliptin; Linagliptin Placebo; Glimepiride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5mg once daily; 0 mg placebo comparator for part 1 of study (to 18 weeks); 1-4mg for part 2 of study (weeks 19-52)
Intervention MeSH terms: Glimepiride; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Memory Imaging of Normal Aging
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The purpose of this study is to develop imaging techniques that can distinguish functional
      brain changes in people at high risk for dementia years prior to onset of clinical memory
      problems from those with normal changes of aging.
    

Detailed description: 
      The overall goals of this project are to identify consistent patterns of variance in brain
      function in patients at risk for Alzheimer's Disease by using APOE ε4 as a marker for disease
      risk. The activation Blood Oxygen Level Dependency (BOLD) signal will be compared to both
      resting and activation perfusion signals to assess the variability of cerebral blood flow as
      it relates to the BOLD signal. Each participant will be imaged on a 3T MRI scanner while
      performing an associate episodic memory task.

      A total of 90 individuals will be recruited for this study. Participants will be
      non-demented, right handed, adults with or without at least one APOE ε4 allele. Groups will
      be split as follows: A) ages 25-39: non-ε4 (n=15); B) ages 25-39: +ε4 (n=15); C) ages 40-49:
      non-ε4 (n=15); D) ages 40-49: +ε4 (n=15);.E) ages 50-65: non-ε4: F) ages 50-65: +ε4 (n=15).
      These groups will be matched for mean age, mean years of education, gender distribution, as
      well as the presence or absence of a family history of AD in a first degree relative.

      There will be 2 scanning sessions for each participant. Scan session #1 and Scan session #2
      will be acquired within 2 weeks of each other and will take approximately one hour each.
    

Intervention name(s): BOLD and Perfusion brain MRI
Intervention type(s): Procedure
Intervention description(s): Blood oxygenation and perfusion functional MRI performed twice, two weeks apart; each scan lasts 1 hour
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy adults from the community
      
Keywords: Dementia; brain circulation; disease /disorder proneness /risk; neuropathology; neurophysiology; aging; apolipoprotein E; genotype; hemodynamics; memory; temporal lobe /cortex
T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays
Condition: Infection in Solid Organ Transplant Recipients
MeSH terms: Infections
Study type: Observational

Summary: 
      The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T
      cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)]. The T-SPOT
      platform technology can be applied to diagnose and monitor any major disease process driven
      by a T cell response, including a viral disease such as cytomegalovirus (CMV) infection (the
      T-SPOT.CMV assay) or an allograft rejection (the T-SPOT.PRT assay).
    

Detailed description: 
      Approximately 600 subjects who meet inclusion/exclusion criteria will be enrolled in the
      prospective, non-randomized, observational study. Sample size is based on having an adequate
      overall number of subjects to assess the T-SPOT.PRT endpoint (350) and the T-SPOT.CMV
      endpoint (250) in the defined populations. Subjects may be enrolled from pre-transplantation
      to post-transplantation up to completion of antiviral prophylaxis.

      Study duration: 37 months; 25 months to enroll all subjects with 12 months (365 days) of
      patient participation.

      Study population:

      All subjects enrolled in this study will be men or women, aged 18 years or older and
      recipients of a first or subsequent renal transplant.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Active candidate for a kidney transplant. Age equal to or greater than 18 years.

        Male or female.
      
Keywords: CMV
A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study has been designed to investigate the clinical safety and efficacy of
      EDP1815 and to identify an optimal dose in subjects with mild to moderate psoriasis.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort,
      dose-ranging study of participants with mild to moderate plaque psoriasis. This Phase 2 study
      has been designed to investigate the clinical safety and efficacy of EDP1815 and to identify
      an optimal dose in subjects with mild to moderate psoriasis.
    

Intervention name(s): EDP1815; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria; Placebo oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-cohort, dose-ranging study of participants with mild to moderate plaque psoriasis
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PSO; mild psoriasis; moderate psoriasis; plaque psoriasis; psoriasis; EDP1815
Parkinson's KinetiGraph, PKG in Patients With Deep Brain Stimulation and Continuous Levodopa Infusion Therapy
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and
      continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by
      using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device.
      In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing
      it with written patient diaries.
    

Detailed description: 
      In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and
      continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by
      using Parkinson's KinetiGraph™ logger (PKG) device which is a movement and acceleration
      measuring device.

      A measurement is done before and after the implantation of selected therapy. PKG will measure
      automatically in every two minutes the movement of selected limb (usually the more affected
      upper extremity) for six days. At the same time a patient will keep a written diary of
      his/her Parkinsonian symptoms. Diary and collected PKG data will be compared. PKG will also
      remind with vibration the patient of the time drug administration and the patient can confirm
      this with pressing a button on PKG. The collected data will be transmitted to a computer and
      analyzed mathematically to produce a visual graph of daily movements. The aim is to evaluate
      PKG's usability in measuring Parkinsonian symptoms and in evaluation the outcome of DBS and
      levodopa therapy. Main parameters in evaluation are bradykinesia score and dyskinesia score.
    

Intervention name(s): Parkinson's KinetiGraph™ logger
Intervention type(s): Device
Intervention description(s): Logger is recording device which records the movement and acceleration of upper extremity
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population is consisted of patients with advanced Parkinson's disease in HUH
        neurological clinic. The treatment decision of deep brain stimulation and/or continuous
        intraduodenal levodopa therapy is done clinically by the treating physician. The patients
        are enrolled in the study after the clinical decision is made.
Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2
      different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.
    

Detailed description: 
      The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in
      terms of FEV1 maintenance from the age of 10 to 15 before and after 2000.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients affected with Pseudomonas A. living in the N-E area of Italy.
      
Keywords: Cystic Fibrosis; Pseudomonas Aeruginosa
Targeting Right Ventricle in Pulmonary Hypertension Gilead
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is looking to see if giving ranolazine to subjects on stable pulmonary
      hypertension therapies but with right ventricular dysfunction (RVEF <45%) will improve their
      health by improving right ventricular (RV) function.
    


Intervention name(s): Ranolazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks.; Placebo by mouth twice per day for a total of 26 weeks
Other intervention name(s): Ranexa
Intervention MeSH terms: Ranolazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulmonary hypertension; right ventricular function; ranolazine
Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
Condition: Rubella; Varicella; Measles; Mumps
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'
      investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136,
      PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine
      (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.
    


Intervention name(s): PriorixTetra™; Meningitec
Intervention type(s): Biological; Biological
Intervention description(s): One dose administered subcutaneously; One dose administered intramuscularly
Other intervention name(s): MMRV vaccine (GSK208136); MenC vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety; healthy; conjugated; immunogenicity; children; MenC vaccine; MMRV vaccine
Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the effect of cortisol,a stress hormone in the body, on
      memory and attention in people with a history of depression, but who are not in the midst of
      a current depressive episode.

      Cortisol may affect parts of the brain associated with memory and attention directly. It may
      also indirectly affect the brain by controlling how much insulin the body makes. Insulin is
      thought to impact cognition by changing the amount of sugar available in certain parts of the
      brain.

      The investigators are studying this question by giving patients a medication, called
      Mifepristone, which reduces cortisol's effect on the brain. The investigators will compare
      results from several groups of people, including differences between men and women, and
      between those with and without insulin resistance.
    

Detailed description: 
      The specific aims of this study are threefold:

        1. To evaluate the association between glucose utilization and neuropsychological
           performance on tests of verbal memory and attention among patients with a history of
           depression, but who are euthymic, at baseline;

        2. To evaluate changes in neuropsychological test performance among patients with a history
           of depression and who have insulin resistance who are treated with open-label
           mifepristone and,

        3. To explore interactions between changes in patients' glucose tolerance profiles and
           changes in verbal memory and attention. An exploratory aim is to explore the interaction
           of changes in cortisol awakening response and changes in verbal memory and attention
           within subjects with and without IGT, as well as the potential mediating effects of
           gender.
    

Intervention name(s): 28 days treatment with Mifepristone.
Intervention type(s): Drug
Other intervention name(s): Korlym; RU486
Intervention MeSH terms: Mifepristone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognition; prediabetes; mood
Attention Control Training for PTSD in Children
Condition: PTSD
Study type: Interventional

Summary: 
      Participants will complete a pre and post training psychological assessment. Participants
      will be assigned to attention control training or the comparison stimuli computer task in a
      double-blind randomized control trial design. Both computerized dot probe tasks display two
      faces on a computer screen, one above the other, followed by a small right or left arrow
      appearing in the location vacated by one of the faces. Participants are required to respond
      as quickly as they can by pressing the indicated right or left arrow on their computer
      keyboard without compromising accuracy. Participants complete 6 training sessions.
    


Intervention name(s): Attention Control Training; Comparison Task
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Attention control training teaches participants that the emotional salience of cues (i.e., threatening or neutral) is not related to successful completion of the computerized response task, and thus, teaches participants to ignore irrelevant threat-related contingencies (Badura-Brack et al., 2015).; Neutral- neutral stimuli prior to response task
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment