bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of a Crowdsourced Cognitive Reappraisal Intervention
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study evaluates a web-based, crowdsourcing platform to promote cognitive reappraisal.
      Half of participants will be granted access to the crowdsourced reappraisal platform. The
      other half will be provided a web-based expressive writing platform. The investigators
      hypothesize that the crowdsourcing reappraisal platform will be more effective than the
      expressive writing platform in promoting positive psychological outcomes.
    

Detailed description: 
      There are many ways to manage stress and mood, including exercise, diet, and relaxation
      practices. Cognitive-based techniques are also extremely powerful. Simply changing how you
      think about stressful situations can dramatically affect the way you feel. Individuals who
      routinely use strategies like cognitive reappraisal exhibit an enviable affective profile:
      studies suggest these individuals generally have less stress, lower incidence of depression,
      and better social functioning than those who rely on less adaptive emotion regulatory
      techniques. Techniques like cognitive reappraisal are also integral to many evidence-based
      psychotherapeutic traditions, such as cognitive-behavioral therapy and rational-emotive
      therapy.

      Unfortunately, cognitive techniques can be hard to learn. Thinking flexibly about stressful
      thoughts and situations requires creativity and poise, faculties that often elude us when we
      need them the most. In this study, the investigators evaluate a web-based technology that
      uses crowdsourcing and peer-to-peer interactions to help people learn cognitive-based
      techniques and apply them throughout their daily lives.

      The goal of the proposed study is to see whether the investigators' technology is more
      engaging and more effective at reducing depression symptoms than a web-based expressive
      writing platform. While the investigators are most interested in how this intervention
      affects depression symptoms, the investigators will also assess other psychological variables
      and the investigators will open the study to the general population.

      Participation in this study will last three weeks. Participants will be randomly assigned to
      receive either a crowdsourcing reappraisal platform or an expressive writing platform. All
      study procedures (subject recruitment, baseline and follow-up assessments, interventions)
      will be conducted online.
    

Intervention name(s): Crowdsourcing reappraisal intervention; Expressive writing intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3 week access to a web-based crowdsourcing reappraisal platform.; 3 week access to a web-based expressive writing platform.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA)
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS
      396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy
      (SMA). The secondary objective is to examine the safety and tolerability of nusinersen
      administered intrathecally to participants with later-onset SMA.
    

Detailed description: 
      This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc.

      In August 2016, sponsorship of the trial was transferred to Biogen.
    

Intervention name(s): Nusinersen; Sham procedure
Intervention type(s): Drug; Procedure
Intervention description(s): Administered by intrathecal (IT) lumbar puncture (LP) injection; Small needle prick on the lower back at the location where the IT injection is normally made
Other intervention name(s): Sprinraza; ISIS 396443; IONIS-SMN Rx; BIIB058
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy; SMA; SMN; SMNRx; ISIS-SMNRx; ISIS-SMN Rx; ISIS 396443; CHERISH; IONIS-SMNRx; IONIS-SMN Rx
Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial
Condition: Migraine Headaches; Nausea; Restlessness
MeSH terms: Migraine Disorders; Psychomotor Agitation; Emergencies; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Haloperidol is known to be a safe alternative medication to control difficult pain, and has
      been shown effective when compared to placebo for controlling headaches. Investigators
      hypothesized that the combination of haloperidol and diphenhydramine would be a useful
      medication choice for migraine headache patients in the emergency department in comparison to
      a common migraine treatment regimen of metoclopramide and diphenhydramine.
    

Detailed description: 
      Investigators conducted a prospective, double-blind, randomized controlled trial in migraine
      patients who presented to an academic emergency department between June 2013 and November
      2013. Research data was derived from an IRB approved protocol. All subjects met IHS migraine
      criteria and received a one liter bolus of normal saline plus 25 milligrams (mg) of
      diphenhydramine. Subjects were subsequently randomized to receive 10 mg metoclopramide or 5
      mg haloperidol IV. Pain was self-reported at onset and at 20 minute intervals using a 100mm
      visual analog scale (VAS). Adequate pain control was considered to be patient satisfaction
      with symptomatic relief. If adequate pain relief was not obtained after 80 minutes, rescue
      medication was given at the treating physician's discretion. Adverse reactions were recorded
      and electrocardiograms (ECGs) were obtained before and after study medication administration.
      Follow up phone surveys were performed 72 hours after discharge to assess headache
      recurrence, adverse effects, and patient satisfaction.
    

Intervention name(s): Haloperidol; Metoclopramide 10mg; Diphenhydramine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5mg IV; 10mg IV; 25mg IV
Other intervention name(s): Haldol; Reglan; Benadryl
Intervention MeSH terms: Diphenhydramine; Promethazine; Haloperidol; Metoclopramide; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
MELT - MRI Evaluation of Lymphoma Treatment
Condition: Lymphoma, Hodgkin
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Observational

Summary: 
      Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at
      diagnosis and initial treatment response assessment. At each time point (initial staging and
      treatment response assessment) in addition to standard imaging investigations (PET CT, Chest
      CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo an
      extended MRI scan.
    

Detailed description: 
      The trial will be a single centre cohort study in patients newly diagnosed with Hodgkin's
      lymphoma undergoing disease staging at diagnosis and initial treatment response assessment.
      At each time point (initial staging and treatment response assessment) in addition to
      standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis
      and abdominal USS), patients will undergo advanced anatomical and functional MRI sequences.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hodgkin's Lymphoma
Inflammation Regulation in Obese Patients
Condition: Obesity; Insulin Resistance
MeSH terms: Obesity; Insulin Resistance; Inflammation
Study type: Interventional

Summary: 
      Insulin resistance is one of the main mechanisms involved in metabolic diseases. inflammation
      has been implicated in its pathogenesis, due to innate immunity activation by free fatty
      acids, lipopolysaccharides (LPS) and lactate. Free fatty acids, LPS and lactate activate
      innate immunity in squelettal muscle and adipose tissue via Toll-like receptor 2/4, NFkB,
      IRF3 (Interferon Responsive Factor 3) and cytokines secretion (TNFa, IFN g, IL1b, IL6),
      chemokines secretion (MCP1) and leukotrienes (LTB4). Feed back mechanisms involved in TLR
      signaling pathways as RLI (ribonuclease L inhibitor)/ABCE1, have never been studied in
      inflammation due to obesity. RLI inhibits an endoribonuclease, RNase L, which has been
      recently implicated in TLR signaling The purpose of this study is to analyse the role of RLI
      and RNase L in TLR regulation, and its potential implication in the link between obesity,
      inflammation and insulin resistance in adipose tissue and squeletal muscle in humans.
    

Detailed description: 
      The investigators working hypothesis is that RNase L and RLI contribute to chronic
      inflammation regulation and to insulin response through TLR 4 pathway regulation in obesity.
      The investigators main purpose is to compare innate immunity activation pathway between
      insulin sensitive, insulin resistant obese patients and control patients. Insulin sensitive
      and insulin resistant obese patients will be distinguish thanks to the HOMA ir index. The
      investigators second objectives are to evaluate if the degree of inflammation in adipose
      tissue and squeletal muscle is correlated to insulin sensitivity measured by hyperinsulinemic
      euglycemic clamp and to characterise inflammatory pathway and regulation pathway. A special
      focus will be given to the leukotrienes and their potential role in insulin resistance
      pathogenesis. The investigators will have two approaches:- characterisation of subjects with
      normal weight, of obese insulin sensitive and obese insulin resistant through a metabolic
      evaluation, an inflammatory characterisation and a measure of insulin sensitivity at the
      systemic level, in adipose tissue and in squeletal muscle.- an in vitron approach with human
      myoblast and adipocytes culture, extracted from the investigators patients: characterisation
      of inflammation, innate immunity.
    

Intervention name(s): muscle and fat biopsy
Intervention type(s): Other
Intervention description(s): muscle and fat biopsy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: obesity; insulin resistance
Crochet Octopus in The Process of Heel Lance in Neonates
Condition: Procedural Pain
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The main objective of the study was to determine the effect of using crochet octopus in order
      to reduce the acute pain developed during the process of heel lance in neonates.

      The hypothesis of the study was "Crochet octopus is rather effective in reducing the acute
      pain in heel lance process for neonates".
    

Detailed description: 
      The study was conducted as randomized controlled. It included term neonates born between May
      2020 and August 2020 at a training and research hospital. The study was completed with 100
      neonates in total as 50 for experiment and 50 for control groups. During the process of heel
      lance, experiment group neonates were delivered crochet octopus 10 minutes before the process
      and let them touch the octopus 10 minutes more after the process. Control group neonates
      experienced the process without any intervention. As for the data collection, "Newborn
      Identification Form", "Neonatal-Infant Pain Scale (NIPS)" and "Observation Form" were
      utilized. The whole process was video-recorded.
    

Intervention name(s): crochet octopus
Intervention type(s): Device
Intervention description(s): Delivering crochet octopus to the hands of the neonates
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: neonate; pain; heel lance; developmental care
Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the trial is to demonstrate the efficacy of dupilumab administered
      concomitantly with topical corticosteroids (TCS) in participants ≥6 years to <12 years of age
      with severe atopic dermatitis (AD).

      The secondary objective is to assess the safety of dupilumab administered concomitantly with
      TCS in patients ≥6 years to <12 years of age with severe AD.
    


Intervention name(s): Dupilumab; Matching Placebo; Background Treatment: Topical Corticosteroids; Background Treatment: Moisturizers
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Pharmaceutical form: Solution for injection in pre-filled syringe;
Route of administration: Subcutaneous (SC); Pharmaceutical form: Solution for injection;
Route of administration: Subcutaneous (SC); All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.; All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.
Other intervention name(s): DUPIXENT®; REGN668; SAR231893
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eczema
A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The primary objective of this investigation is to test the hypothesis that the Duofix Tibial
      component results in a reduction of immediate postoperative pain compared to the LCS Porocoat
      version.
    

Detailed description: 
      The secondary objectives of this investigation are to evaluate the clinical and patient
      outcomes, biological fixation and survivorship associated with the LCS Duofix and Porocoat
      knee system over 10 years.
    

Intervention name(s): LCS Complete Duofix; LCS Complete Porocoat
Intervention type(s): Device; Device
Intervention description(s): Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces; Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthroplasty, replacement, Knee, LCS Duofix, Porocoat
Intracavernosal Injection of Papaverine/Verapamil Versus Papaverine/Phentolamine in Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Observational [Patient Registry]

Summary: 
      Introduction: Erectile dysfunction is a common condition with a significant effect on quality
      of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes
      the tone of the smooth muscles lining blood vessels, leading to their dilatation.
    

Detailed description: 
      Objective: Evaluating the effect of intracavernosal injection of (Papaverine + Verapamil) and
      comparing it with (Papaverine + Phentolamine) in patients with erectile dysfunction.

      Patients and methods: Each one of the 20 erectile dysfunction patients was subjected to
      intracavernosal injection with (30mg Papaverine + 1mg Phentolamine), where penile duplex &
      clinical evaluation was carried out followed by a wash out interval of 2 weeks after which
      each patient was subjected to the exact previous procedures using (30 mg Papaverine + 5 mg
      Verapamil).

      Keywords: Erectile dysfunction - Intracavernosal injection - Penile duplex - Phentolamine -
      Verapamil.
    

Intervention name(s): Verapamil
Intervention type(s): Drug
Intervention description(s): Local treatment of erectile dysfunction
Other intervention name(s): Calcium Channel Blocker
Intervention MeSH terms: Verapamil; Calcium Channel Blockers
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males complaining of erectile dysfunction
Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of this study is to observe the effect of group Vocal performance
      training and performance experience on patients' reported symptoms and quality of life. The
      effectiveness of PD medications varies significantly in different patients depending on their
      symptoms. By using music-based interventions to improve symptoms that may be inadequately
      treated by medications, the investigators hope to improve quality of life in PD patients.
      "Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in
      Parkinson disease" (PD) is a controlled crossover behavioral intervention study of once
      weekly choral classes for patients with idiopathic PD (progressing toward a group
      performance) and once weekly discussion/support group meetings.
    


Intervention name(s): Group singing; Facilitated Discussion Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks.; Weekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Asthma, Inflammation and G Protein-coupled Receptors (GPCR)
Condition: Asthma; COPD
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The G protein-coupled receptors (GPCRs) are a family of proteins expressed at the cell
      membrane. They are composed of 380 members involved in the important functions of the
      organism and are privileged therapeutic targets.Their expression is highly modulated
      depending on the metabolic state of the cells, in particular in pathological situations.our
      study proposes to determine whether GPCR expression modulation could be used as a biomarker,
      either prognostic or diagnostic, of treatments.To do so , the investigators will determine
      the expression profile of the 380 human GPCRs in human blood cell samples in two chronic
      inflammatory pulmonary diseases : asthma and COPD (chronic obstructive pulmonary disease ) .
      These have opposed inflammatory infiltrates : asthma is associated with eosinophil and Th2
      lymphocyte infiltration whereas COPD shows neutrophils and macrophages within the airways
      with a Th1 lymphocytic population. The GPCR signature (transcriptomic) will be determined on
      total white blood cells as well as on isolated mono- and poly-nuclear populations obtained
      from healthy subjects and patients selected at the asthma or COPD consultation. The
      expression profiling analysis will reveal sub-groups of GPCRs whose expression is modified in
      disease. The specificity of the variation of expression of these biomarker sub-populations
      will be determined, by a study recruiting a hundred patients and controls per disease on this
      restraint number of genes. The outcomes of the project will lead to establish GPCR "identity
      cards" for these chronic inflammatory diseases, which might therefore be used as diagnostic
      or prognostic biomarkers to follow the evolution of a disease or the efficacy of a given
      treatment. In addition, detailed analysis of the identified GPCRs will lead to propose new
      therapeutic targets for inflammatory diseases. This study has therefore the objective of
      validating GPCRs as potential biomarkers for inflammatory diseases.
    

Detailed description: 
      Multicentre non-randomized
    

Intervention name(s): spirometry; blood test
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: GPCR expression; transcriptomic; white blood cells; diagnostic; Control
Evaluate Onset of Action of a Fast Release Aspirin
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety and efficacy (onset, duration of relief and overall efficacy) of a
      single dose of a fast release formulation of aspirin 1000 mg compared to acetaminophen 1000
      mg and placebo for relief of pain following extraction of impacted third molars.
    


Intervention name(s): Acetylsalicyclic acid (Fast release Aspirin, BAY1019036); Acetaminophen (Tylenol extra strength); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of fast release aspirin tablet 1000 mg (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 milliliter [mL]) between 1-4 hours post dental surgery.; Single oral dose of acetaminophen (Tylenol extra strength) caplet 1000 mg (2 x 500 mg) and 2 placebo matching aspirin tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery.; Single oral dose of placebo (2 placebo aspirin tablets and 2 placebo acetaminophen caplets) with a full glass of water (240 mL) between 1-4 hours post dental surgery.
Intervention MeSH terms: Aspirin; Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Drugs, Investigational; Acetylsalicylic Acid; Aspirin; dental pain