bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Controlled Trial of Standard ERP and OC-Go
Condition: Obsessive-Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Phase II of this study will examine the efficacy of the OC-Go application via a randomized
      controlled trial comparing standard exposure and response prevention (ERP) treatment for
      pediatric obsessive compulsive disorder (OCD) to exposure/response prevention (ERP) augmented
      with OC-Go. A cross-over design will be implemented for these 12 sessions of treatment, in
      which participants that were randomized to standard ERP will receive OC-Go augmented ERP for
      the second half of treatment, and vice versa. Efficacy will be investigated in a sample of 32
      children with OCD.
    

Detailed description: 
      This project seeks to refine and assess OC-Go, a HIPAA-compliant web-based clinician portal
      and patient-side mobile application designed to increase patient adherence to evidence-based
      treatment (EBT) for OCD, a common and impairing condition, and provider ability to
      effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments
      to patients on their mobile devices with an optimized user interface that includes patient
      accountability and support features. Accordingly, patients can be guided to do assignments by
      themselves between sessions with increased fidelity over the course of treatment. Once
      therapy assignments are created and shared to a crowd-sourced and curated public library, any
      clinician can assign any task to any patient for homework or in-session use with one touch.
      Use of OC-Go is expected to increase patient engagement, compliance, treatment efficiency,
      dissemination of EBTs, and therapist confidence and expertise.
    

Intervention name(s): Exposure and Response Prevention; OC-Go
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exposure and response prevention is an evidence-based behavioral treatment that primarily focuses on exposures, in which the child faces OCD-related fears in a methodical manner and acquires more adaptive coping strategies.; OC-Go is a HIPAA-compliant web-based clinician portal and patient-side mobile application that allows clinicians to create and push tailored treatment assignments to patients on their mobile devices. Individuals receiving this intervention will receive exposure and response prevention with OC-Go.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will receive 12 weeks of exposure/response/prevention (ERP). Sessions 1 (psychoeducation/hierarchy creation) and 12 (relapse prevention & generalization training) will be identical across both randomization groups.
Treatment sequences for the randomization groups will be as follows:
OC-GO-FIRST - Sessions 2-6: ERP+OC-Go, Sessions 7-11: Standard ERP
STANDARD ERP-FIRST - Sessions 2-6: Standard ERP, Sessions 7-11: ERP+OC-Go
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function
Condition: Renal Impaired; Gilteritinib; Normal Renal Function; Pharmacokinetics of ASP2215
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of
      gilteritinib in male and female participants with severe renal impairment compared to healthy
      male and female participants with normal renal function. This study also evaluated safety and
      tolerability of a single oral dose of gilteritinib in male and female participants with
      severe renal impairment and healthy male and female participants with normal renal function.
      Part 2 of the study (mild and moderate renal impairment) was not conducted based on the final
      pharmacokinetic findings from part 1 (severe renal impairment).
    

Detailed description: 
      This study was comprised of participants with severe renal impairment and normal renal
      function. Participants were residential for a single period of 14 days/13 nights.
      Participants were discharged from the clinical unit on day 14 on the condition that all
      required assessments had been performed and that there were no medical reasons for a longer
      stay in the clinical unit.
    

Intervention name(s): Gilteritinib
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): ASP2215; XOSPATA®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gilteritinib
Effects of Parabolic Flight on Spatial Cognition and Hippocampal Plasticity
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The main objective of this experiment is to assess the impact of parabolic flight on (1)
      spatial memory and orientation, (2) the changes in brain structure and function, and
      particularly the hippocampal formation, and (3) biochemical markers of stress and
      neuroplasticity.

      A preliminary study will be performed with the aims (1) to test during weightlessness
      hardware used to administer visuo-spatial testing and (2) to determine the optimal body
      posture for testing under microgravity conditions (i.e. body posture for which change in
      visuo-spatial testing induced by weightlessness is maximal).

      The main criteria are:

        -  Structural and functional changes of brain evaluated by fMRI;

        -  Cognitive performance, and specifically spatial cognition using a series computer-based
           tasks.

        -  Key neurotrophins determined in venous blood samples The criteria used in the
           preliminary experiment is visuo-spatial performance evaluated with a computer-based test
           assessing spatial cognition.

      The investigators hypothesize that hippocampal structure and function, and particularly the
      dentate gyrus, will be altered after parabolic flight compared to ground based controls.
      Specifically, the 3 tested hypotheses are:

        -  Parabolic flight induces changes in hippocampal structure;

        -  Weightlessness induces changes in cognitive performance, and specifically spatial
           cognition;

        -  There is a correlation between changes in hippocampal structure and changes in
           visuo-spatial memory performance.

        -  There is a correlation between changes in hippocampal structure and changes in key
           neurotrophins.

      The hypothesis tested during the preliminary experiment is that body posture affects the
      changes in spatial cognition performance.
    


Intervention name(s): Assess the impact of parabolic flight
Intervention type(s): Other
Intervention description(s): MRI testing will be performed using a 3T MRI facility in Bordeaux close to Novespace (CHU Pellegrin).
Spatial cognition will be assessed using a battery of in-house virtual paradigms General cognitive performance testing will include a wide range of cognitive functions, and particularly executive control using the Cognition Battery Mental status will be assessed on a tablet computer using a visual analogue scale Vigilant attention will be determined using the 3-min Psychomotor Vigilance Test (PVT) Blood samples (5 mL per collection) will be collected prior to neuroimaging by venepuncture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effectiveness of an 8-week Posterior Shoulder Stretching Program on Varsity-level Overhead Athletes
Condition: Athlete's Shoulder
Study type: Interventional

Summary: 
      To Determine whether an eight-week posterior shoulder stretch was effective in increasing
      dominant arm internal rotation(IR) and horizontal adduction (HAd) range of motion (ROM) in a
      group of overhead athletes identified as having tightness of their posterior shoulder
      structures.
    


Intervention name(s): Sleeper Stretch
Intervention type(s): Other
Intervention description(s): Posterior shoulder stretch technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of LY3031207 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to
      look at safety, how well the study drug is tolerated, and how much of the study drug gets
      into the blood stream and how long it takes the body to get rid of it when given to humans.
      Information about any side effects that may occur will also be collected. Subjects will
      participate in the study for approximately 3 months. This study is for research purposes only
      and is not intended to treat any medical condition.
    


Intervention name(s): LY3031207; Placebo; Celecoxib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Celecoxib; LY3031207
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy
MeSH terms: Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of davunetide for the
      treatment of Progressive Supranuclear Palsy.
    

Detailed description: 
      A Phase 2/3,Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and
      Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy
    

Intervention name(s): Davunetide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Davunetide Nasal Spray 30 mg BID IN 52 weeks; Placebo Nasal Spray BID IN 52 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children
Condition: Healthy
Study type: Interventional

Summary: 
      This is a cross-sectional study investigating the palatability of an oral dispersible tablet
      with no pharmacologically active agent (carrier tablet) in children without underlying acute
      or chronic disease aged 2 to 10 years of age.
    

Detailed description: 
      Oral dispersible tablets (ODTs) are a monolithic solid formulation potentially appropriate
      for a wide range of paediatric age groups. They also have a number of advantages over more
      frequently used formulation types, such as suspensions. Currently few Commercial products are
      available as ODTs for administration to children. Investigators aimed to investigate the
      palatability of an oral dispersible tablet with no pharmacologically active agent (carrier
      tablet) by assessing overall parent-reported, observer-reported and, where appropriate,
      child-reported acceptance of the formulation. In addition, investigators assessed the in situ
      disintegration behaviour of the carrier tablet.
    

Intervention name(s): Oral dispersible tablet
Intervention type(s): Other
Intervention description(s): Administration of a 5 mm calcium carbonate based ODT placed in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years).
Other intervention name(s): Oral dispersible tablet (carrier tablet - no active pharmacological ingredient)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Child
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine
Condition: Hemorrhage; Healthy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this project is to test how ketamine, an analgesics currently employed in the
      pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in
      humans.
    

Detailed description: 
      Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a
      hemorrhagic injury on the battlefield is virtually always associated with pain, it is
      paramount that the selected pain medication does not disrupt appropriate physiological
      mechanisms that are beneficial towards the maintenance of blood pressure and vital organ
      blood flow during that hemorrhagic insult. Current guidelines for the selection of pain
      medications of a hemorrhaging soldier are based upon limited scientific evidence, with the
      vast majority of supporting studies being conducted on anesthetized animals. Thus, the
      interaction between hemorrhagic shock and pain medications commonly employed on the
      battlefield is yet to be determined in the conscious humans.

      With this background, we will test the hypothesis that ketamine will impair the capacity for
      a conscious human to tolerate a hemorrhagic insult.

      The obtained data will provide the necessary scientific evidence in humans to support the
      Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for
      moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data
      will identify the analgesic that least compromises a human's ability to tolerate a
      hemorrhagic insult, ultimately providing critical information to the combat medic on which
      analgesic should be employed for such an injury.
    

Intervention name(s): Ketamine Hydrochloride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): A total of 20 mg of Ketamine Hydrochloride will be administered intravenously; Subjects will receive placebo
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Influenza Vaccine Effectiveness of a Quadrivalent Vaccine in Pregnant Women and Young Infants, 2019-2020
Condition: Influenza in Human
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      Influenza is associated with an increased risk for serious illness, hospitalization and death
      in pregnant women and young infants. The investigators estimated the effectiveness of a
      quadrivalent inactivated influenza vaccine (QIV) in pregnant women and their infants in
      2019-2020 influenza season. Women were activelly followed during the influenza season on a
      weekly basis through telephone call in order to collect data about the onset of fever and/or
      respiratory symptoms by them or their young infants. Polymerase chain reaction testing in
      pharyngeal samples was offered to pregnant women and infants with influenza-like illness
      (ILI). A total of 636 pregnant women and 474 infants were studied. A Bayesian beta-binomial
      model was used.
    

Detailed description: 
      Study period: Influenza 2019-2020 season

      The investigators followed actively the pregnant women and their infants in order to collect
      prospectively data on a weekly basis through phone calls during the entire influenza season.

      Definitions:

        -  ILI was defined as the sudden onset of symptoms and fever, malaise, myalgia or headache,
           and cough, sore throat or shortness of breath.

        -  ARI was defined as the presence of at least one respiratory symptom, regardless of
           fever.

        -  Febrile episode was defined as the presence of fever only.

        -  Fever was defined as a temperature of 38.0 C in at least two measurements within 24h.

        -  The diagnoses of pneumonia and AOM were accepted as reported by the physicians who
           provided care to the women or their infants.

      The 2019-2020 QIV Vaxigrip-Tetra was used to vaccinate pregnant women.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women and their infants
      
Keywords: influenza; quadrivalent influenza vaccine; influenza vaccine effectiveness; pregnancy; pregnant women; infants
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK),
      safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in
      healthy subjects.
    


Intervention name(s): dapagliflozin; dapagliflozin; dapagliflozin; dapagliflozin; dapagliflozin; dapagliflozin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days; Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days; Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days; Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days; Tablets, Oral, 1 mg, once on Day 1 only, 2 days; Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days
Other intervention name(s): BMS-512148; BMS-512148; BMS-512148; BMS-512148; BMS-512148; BMS-512148
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Intranasal Ketamine for Acute Traumatic Pain
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: Ketamine has been well studied for its efficacy as an analgesic agent. However,
      intranasal (IN) administration of ketamine has only recently been studied in the emergency
      setting.

      Objective: To elucidate the efficacy and adverse effects of a sub-dissociative dose of IN
      Ketamine compared to IV and IM morphine.

      Methods: A single-center, randomized, prospective, parallel clinical trial of efficacy and
      safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency
      department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe
      acute traumatic pain (≥80mm on 100mm Visual Analog Scale [VAS]) were randomized to receive
      either 1.0mg/kg IN ketamine, 0.1mg/kg IV MO or 0.15mg/kg IM MO. Pain relief and adverse
      effects were recorded for 1 hour post-administration.

      Primary Outcomes: The primary outcome was efficacy of IN ketamine compared to IV and IM MO,
      measured by "time-to-onset" (defined as a ≥15mm pain decrease on VAS), as well as time to and
      degree of maximal pain reduction.
    


Intervention name(s): Ketamine Hydrochloride; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): Delivered intranasally using an atomizer; Delivered either as an IM injection or a slow IV bolus
Intervention MeSH terms: Ketamine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intranasal Ketamine, Analgesia, Trauma, Morphine, Mass Casualty
Clinical and Echocardiographic Management of Patients With Heart Failure and Diabetes: SCODIAC Follow up Study
Condition: Diabetes; Heart Failure
MeSH terms: Heart Failure; Diabetes Mellitus
Study type: Observational

Summary: 
      The study has been carried out to determine diagnostic and therapeutic pathways in a group of
      HF diabetic patients and to verify whether the use of innovative antidiabetic therapies could
      modify echocardiographic parameters and influence cardiological therapy.
    

Detailed description: 
      406 patients affected with heart failure and Type 2 Diabetes Mellitus, referred to
      Cardiologists and Diabetologists of pertaining healthcare districts in Campania, and followed
      for at least one year between 2018 and 2019, were enrolled in this retrospective study and
      divided in Group A, composed of 136 HF diabetic patients with preserved Ejection Fraction
      (HF-pEF) (>45%) and Group B, formed of 270 HF diabetic patients with reduced EF (HF-rEF)
      (≤45%). All patients had performed periodic clinical evaluations and an echocardiographic
      exam every 12 months. Anthropometric parameters, HF etiology, co-morbidities, complications
      and ongoing therapies were collected.
    

Intervention name(s): Antidiabetic
Intervention type(s): Drug
Intervention description(s): Verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy
Other intervention name(s): SGLT2 inhibitors, gliflozins, echocardiography.
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors; Hypoglycemic Agents
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total of 406 patient with HF and T2DM, referred to ARCA Cardiologists from 17 healthcare
        districts in Campania and to AMD Physicians from 8 Antidiabetic Centers and followed for at
        least one year between 2018 and 2019, were enrolled.
      
Keywords: diabetes; heart failure; ejection fraction
Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses
      of tiotropium bromide compared to placebo in adolescent patients with moderate persistent
      asthma. Efficacy and safety will be assessed by measuring lung function parameters and
      evaluating the effects on asthma exacerbations, on Quality of life, on health care resource
      utilisation an on the number of adverse events.
    


Intervention name(s): tiotropium Respimat low dose; placebo Respimat; tiotropium Respimat high dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IMP; placebo representing comparator; IMP
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week
      administration of oral QAV680 in the treatment of patients with asthma.'
    


Intervention name(s): QAV680; Matching placebo for QAV680; Fluticasone Propionate
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Efficacy; safety; QAV680; pharmacokinetics; corticosteroid; asthma