bioihbjkbjnl/mcl2 huggingface dataset:
Dispersal Pattern for Spine Injections (Gadolinium Contrast)
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      This study will analyze injectate dispersal patterns after standard-of-care cervical epidural
      steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to
      characterize the pattern. Although these procedures are performed with high frequency under
      the assumption that injectate remains localized to injection site, no peer-reviewed studies
      have validated this assumption. Comprehensive characterization of injectate dispersal
      patterns will provide important data regarding safety, as well as diagnostic and therapeutic
      potential of cervical epidural steroid injections.
    

Detailed description: 
      Epidural steroid injections have long had an impact in the treatment of various spine-related
      conditions, particularly radiculopathy. The efficacy of epidural spinal injections has been
      attributed to the anatomic location reached by the injectate. Cervical epidural steroid
      injections are also used as an injury location indicator. This application is based on
      documenting pain relief after injection into a specific location in the cervical spine. Both
      the diagnostic and therapeutic applications for epidurals assume that the injectate remains
      local to the injection site in order to have its effects. However, in a recently completed
      study, the investigators group documented substantial diffusion of injectate after lumbar
      epidurals used computerized tomography (CT) assessments.1 Based on the exposure to ionizing
      radiation associated with CT along with the superior imaging specificity and sensitivity of
      MRI, the investigators are shifting their imaging modality to MRI for future studies. The
      proposed study is designed to evaluate the use of gadolinium and MRI to assess nature and
      amount of diffusion of injectate in the cervical region after standard-of-care epidural
      injections. To the investigators knowledge, this will be the first study to critically assess
      this common procedure in order to evaluate safety and efficacy in a clinical setting.
    

Intervention name(s): Injection with Gadolinium
Intervention type(s): Drug
Intervention description(s): Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system
Other intervention name(s): Gadavist
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cervical Radiculopathy
Energy Intake and Exercise Timing
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The aim of the present study is to compare the effect of an exercise performed 180 or 30
      minutes before lunch on the energy intake of adolescents with obesity.
    

Detailed description: 
      The present study will compare the nutritional response to the realisation of an acute
      exercise 180 or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18
      adolescents with obesity will be asked to randomly complete three experimental sessions: i)
      one control session (rest); ii) one session with an acute exercise realized 180 minutes
      before lunch; iii) one session with the same exercise performed 30 minutes before lunch.
      Their ad libitum energy intake will be assessed during lunch as well as at dinner time.
      Appetite feelings will be assessed at regular intervals and their food reward in response to
      the lunch will also be assessed.
    

Intervention name(s): CON . control condition without exercise / rest condition; EX -30. Condition with an acute exercise set 30 minutes before lunch; EX-180. condition with an acute exercise set 180 minutes before lunch
Intervention type(s): Other; Other; Other
Intervention description(s): Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.; The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.; The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: appetite control; obesity; Adolescents; exercise timing
Vitamin D Supplementation in Childhood Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The goal of this clinical trial is to investigate the therapeutic role of vitamin D
      supplementation in a subset of patients with atopic dermatitis (AD): children with disease
      onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D
      supplementation in patients with either wintertime onset or exacerbation of AD will improve
      Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve
      the Investigator's Global Assessment.
    


Intervention name(s): cholecalciferol (vitamin D); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000 IU once daily x 1 month
Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.; 1000 IU once daily x 1 month
Experimental group will receive Ddrops (Toronto, Canada). Placebo group will receive placebo drops.
Other intervention name(s): Experimental group will receive Ddrops (Toronto, Canada).; Placebo group will receive placebo drops.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D; atopic dermatitis; eczema; winter
Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation
Condition: Rosacea
MeSH terms: Rosacea; Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the effect of topical aminocaproic acid on the
      immune system by assessing the levels of antimicrobial peptides in the skin of patients with
      rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's
      immune system in patients with rosacea by inhibiting activation of antimicrobial peptides.
    


Intervention name(s): Topical aminocaproic acid (ACA) mixed with Vanicream; Vehicle cream
Intervention type(s): Drug; Drug
Intervention description(s): 25% Aminocaproic acid cream twice daily for up to 12 weeks.; Vehicle cream moisturizer twice daily for up to 12 weeks
Intervention MeSH terms: Aminocaproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Rosacea; Dermatology; UCSD; Skin disease
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the efficacy of BIIB033 in participants
      with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.

      Secondary objectives of this study in this study population are to assess the safety,
      tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
    


Intervention name(s): BIIB033; Placebo; Avonex
Intervention type(s): Drug; Other; Drug
Other intervention name(s): anti-LINGO-1 mAb; interferon beta-1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites
Condition: Cirrhosis; Ascites Hepatic
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Study type: Interventional
Phase: Phase 2

Summary: 
      Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients
      with refractory ascites.
    

Detailed description: 
      Terlipressin continuous infusion will be adminstered via an ambulatory pump initially for 7
      days in a clinical pharmacology unit. Serial blood draws for pharmacokinetic analysis will be
      performed to determine steady state concentration of both terlipressin and
      8-lysine-vasopressin during infusion. After establishing safety and tolerance of infusion for
      7 days, patients will be transitioned to an outpatient setting where they will be treated
      with terlipressin continuous infusion for an additional 21 days, monitored daily by home care
      nurses.

      A total of 6 patients will be treated. Monitoring will include successful management of
      ascites, with reduction in paracentesis procedures and decreased ascites fluid volume,
      further supported by improvement in renal function.
    

Intervention name(s): Terlipressin acetate continuous infusion
Intervention type(s): Drug
Intervention description(s): Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
Other intervention name(s): Terlipressin
Intervention MeSH terms: Terlipressin
Intervention model: Single Group Assignment
Intervention model description: Open label prospective study in a cohort of 6 patients
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Terlipressin; Terlipressin acetate
Restylane Silk for Photoaged Thinned Hands
Condition: Photoaged Thinning of the Hands
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands
    


Intervention name(s): Restylane Silk
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this randomized, double-blind, crossover study is to compare two long-acting
      stimulant formulations-once-daily PRC-063 and once-daily lisdexamfetamine (LDX)-through a
      15-hour period on driving performance, as measured with a driving simulator, in adult
      patients with ADHD.
    

Detailed description: 
      Young adult drivers with Attention Deficit Hyperactivity Disorder (ADHD) will be compared on
      a driving simulator after taking PRC-063 or LDX in a repeated-measure, randomized,
      doubleblind, crossover study design. Each subject will be randomized to receive up to a
      21-day course of PRC-063 followed by up to a 21 day course of LDX or vice versa. There will
      be no washout between treatments. On days 1 through 7, subjects will receive the lowest dose
      (45 mg of PRC-063 or 30 mg of LDX) of study medication. On days 8 through 14, subjects will
      receive the middle dose (70 mg of PRC-063 or 50 mg of LDX). On days 15 through 21, subjects
      will receive the highest dose (100 mg of PRC-063 or 70 mg of LDX). During Days 1 through 21,
      if a subject is responding satisfactorily to medication, he or she may remain on that daily
      dose. Driving laboratory testing will be conducted between Day 17 and Day 21. Following the
      laboratory testing, the subject will begin a second titration of the alternate treatment,
      starting on Day 22 through Day 28 at the lowest dose (45 mg of PRC-063 or 30 mg of LDX) of
      study medication, Day 29 through Day 35 on the middle dose (70 mg of PRC-063 or 50 mg of LDX)
      and Day 36 through Day 42 on the highest dose (100 mg of PRC-063 or 70 mg of LDX). During
      Days 22 through 42, if a subject is responding satisfactorily to medication, he or she may
      remain on that daily dose. Following titration with the second treatment, subjects will
      attend a second driving laboratory testing, conducted between Day 38 to Day 42. Subjects will
      subsequently attend a safety and study termination visit.
    

Intervention name(s): PRC-063; lisdexamfetamine dimesylate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral extended-release capsule; Oral capsule; Oral placebo capsule
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
Condition: Posttraumatic Stress Disorder; Sleep Disorders; Nightmares
MeSH terms: Sleep Wake Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of two talk therapies for OEF/OIF
      Veterans at the Michael J. Crescenz and the West Haven VA Medical Centers. Participants will
      randomly receive one of two individual treatments intended to improve the sleep disturbance
      and nightmares of returning Veterans.
    

Detailed description: 
      This is a dismantling study with the objective of determining whether imagery rehearsal is
      essential to the efficacy of imagery rehearsal + CBT-I for improving the sleep and nightmare
      disturbance in Veterans with PTSD and recurrent nightmares.
    

Intervention name(s): CBT for Insomnia plus Imagery Rehearsal; CBT for Insomnia plus psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): patients receive standard CBT for insomnia and psychoeducation combined with techniques of imagery rehearsal aimed at reducing posttraumatic nightmare frequency and distress; patients receive standard CBT for insomnia combined with psychoeducation
Other intervention name(s): Sleep and Nightmare Management
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized controlled trial comparing two forms of psychotherapy.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: posttraumatic stress; nightmares; sleep; psychotherapy; imagery rehearsal; insomnia; behavioral treatment; veterans; Operation Iraqi Freedom; Operation Enduring Freedom
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line
Condition: Esophageal Neoplasms
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      -  To determine the activity and efficacy of the schema specified as dose regimen

        -  To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU
    


Intervention name(s): Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)
Intervention type(s): Drug
Intervention description(s): OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy
Intervention MeSH terms: Fluorouracil; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Corfluvec Vaccine for the Prevention of COVID-19 in Healthy Volunteers
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to investigate the safety and immunogenicity of a two-component
      intranasal vaccine for the prevention of COVID-19 in healthy volunteers 18-60 years old
    

Detailed description: 
      Study include three parts. During the first part the two vaccine components will be
      administered separately to a small number of seronegative participants in low dose and then
      high dose to evaluate each component's safety. During the second part vaccine components
      would be administered one after another with 21 days interval to evaluate safety of the
      complete vaccine regimen (low dose and high dose). During the third part of the study the
      high dose vaccine will be administered to participants to evaluate vaccine immunogenicity.
      The whole study will include 200 participants. Duration of the study for each participant is
      about 6.5 months (no more than 194 days).
    

Intervention name(s): Corfluvec component 1 low dose; Corfluvec component 2 low dose; Corfluvec component 1 high dose; Corfluvec component 2 high dose; Corfluvec low dose; Corfluvec high dose; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Participants will receive single intranasal injection of H3N2 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2; Participants will receive single intranasal injection of H1N1pdm09 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2; Participants will receive single intranasal injection of H3N2 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2; Participants will receive single intranasal injection of H1N1pdm09 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2; Participants will receive two intranasal injections of recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2 tree weeks apart (H3N2 →H1N1pdm09); Participants will receive two intranasal injections of recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2 tree weeks apart (H3N2 →H1N1pdm09); Participants will receive two intranasal injections of placebo three weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: COVID-19; vaccine; influenza vector
Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.
Condition: Injections, Intradermal
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery
      devices can safely and precisely inject liquid into the intradermal layer of the skin in
      three different injection locations
    

Detailed description: 
      This study is a preliminary device safety and performance evaluation in healthy adult
      volunteers (ages 18-55 years).

      Each participant will receive six injections of 0.1 ml of sterile saline solution into the
      skin:

        -  Upper deltoid with the side-load ID adapter

        -  Upper deltoid with the autodisable (AD) ID adapter

        -  Suprascapular (behind the shoulder) with the side-load ID adapter

        -  Suprascapular with the AD ID adapter

        -  Forearm with the side-load ID adapter

        -  Forearm with the AD ID adapter

      Intradermal administration of each injection will be assessed:

        -  The liquid remaining on the surface of the skin will be blotted with absorbent paper and
           the amount of liquid present will be recorded.

        -  The formation of an intradermal wheal will be observed, and the diameter of the wheal
           measured using a ruler or similar measurement tool.

        -  A photo of the injection site will be taken.

      Injections will be assessed for safety by observation of injection sites for any local
      adverse events.
    

Intervention name(s): ID adapter (autodisable); ID adapter (side load)
Intervention type(s): Device; Device
Intervention description(s): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.; Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
Other intervention name(s): Autodisable intradermal adapter; AD ID adapter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intradermal injections; Vaccine delivery devices
Double-blind, Randomized Controlled Study to Assess the Analgesic Effect of 2 g of Magnesium Dipyrone (Metamizol) and Changes in Plasma Beta-endorphin Immunoreactivity Values in Patients Undergoing Elective Inguinal Herniorrhaphy Under Epidural Anesthesia.
Condition: Pain; Beta-endorphin; Dipyrone; Hernia Surgery
MeSH terms: Hernia
Study type: Interventional
Phase: Phase 4

Summary: 
      A double-blind, randomized controlled study is designed to assess the analgesic effect of a
      single intravenous dose of 2 g of magnesium dipyrone (metamizol) and whether the
      administration of the active drug will be associated with changes in plasma beta-endorphin
      immunoreactivity values in patients undergoing elective inguinal herniorrhaphy (Bassini
      operation) under epidural anesthesia. Participants, care givers, and those assessing the
      outcomes will be blinded to group assignment. Participants will be randomized to receive
      dipyrone or a placebo. The active drug or placebo will be administered as an intravenous
      infusion over 10 min. Pain will be evaluated by the patient according to a 100-mm visual
      analogue scale. Assessments will be carried out the day before surgery, immediately after
      operation, at the time of drug administration, and 60 and 180 min after treatment. At the
      same time as pain will be evaluated, blood samples will be drawn for plasma beta-endorphin
      immunoreactivity measurement (immunoradiometric assay).
    


Intervention name(s): Dipyrone administration; Pain assessment; beta-endorphin immunoreactivity; Placebo administration
Intervention type(s): Drug; Behavioral; Biological; Other
Intervention description(s): Dipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.; Pain will be evaluated by the patient according to a 100-mm visual analogue scale (VAS) (from point 0 "no pain" to point 10 "unbearable pain").; Plasma beta-EPIr levels will be measured by an immunoradiometric assay (Allegro Beta-endorphin, Nichols Institute Diagnostics, SAN JUAN DE CAPISTRANO, CA) (normal values 29-40 pg/mL). It will be obtained by venous blood samples (5 mL) at the same time points at pain will be measured.; Placebo in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
Intervention MeSH terms: Dipyrone; Endorphins; beta-Endorphin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care