bioihbjkbjnl/mcl2 huggingface dataset:
The Validity and Reliability of the Turkish Version of the CPAQ-8
Condition: Fibromyalgia; Chronic Pain
MeSH terms: Fibromyalgia; Chronic Pain
Study type: Observational [Patient Registry]

Summary: 
      Acceptance of chronic pain is becoming an increasingly important issue in the field of pain
      management. Many researchers argue that patients who accept pain better function better both
      physically and psychologically. In many countries, the Chronic Pain Acceptance Questionnaire
      - 8 (CPAQ-8) has been frequently validated and used to measure the pain acceptance of
      patients with chronic pain.1 However, the CPAQ-8 has not yet been introduced and validated in
      Turkey. In this study, we aimed to translate the English version of CPAQ-8 into Turkish, make
      correct cross-cultural adaptations, and validate the psychometric properties of the Turkish
      version of CPAQ-8 by testing it in Turkish fibromyalgia patients.
    

Detailed description: 
      Chronic pain is an undesirable condition that affects a large part of the society and
      increases the psychological and economic burden of the population it affects. Psychological
      variables are known to be strong in the perception of pain and especially cause patients to
      avoid activity in order to reduce pain. Individuals prefer to avoid painful experiences when
      they are worn out in repetitive attempts to control and prevent pain, which ultimately causes
      pain to become more dominant and destructive, and activities that are valuable to the
      individual are neglected.1 At this point, accepting pain can be seen as the antithesis of
      avoiding painful experiences. Acceptance of pain is a strong predictor of low disability in
      chronic pain.2 The Chronic Pain Acceptance Questionnaire (CPAQ) represents one of the ways in
      which pain acceptance is functionalized and measured in the context of chronic pain. The
      short form of CPAQ, CPAQ-8, was developed and validated recently and shows the same factor
      structure, reliability and validity as the 20-factor version. Given that psychometric testing
      is an incremental process, further evaluation of the questionnaire is desirable, including
      test-retest reliability and replication of results reported by Fish et al.
    

Intervention name(s): Turkish version of the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)
Intervention type(s): Other
Intervention description(s): The aim of this study is to test the validity of the Turkish version of the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8).
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients who applied to our physical medicine and rehabilitation outpatient clinic, agreed
        to participate in the study, were over the age of 18, had at least primary school
        education, were diagnosed with fibromyalgia syndrome according to the 2016 American College
        of Rheumatology (ACR) criteria, and could speak and communicate in Turkish were included in
        the study.
Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The investigators hypothesize that reducing salt in the diet will improve the function of
      blood vessels in middle aged and older adults with moderately elevated systolic blood
      pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and reducing
      the amount of oxidative stress.
    

Detailed description: 
      The improvement in blood vessel function will be determined over a 10 week period. Subjects
      will be randomly assigned to either a 'low salt' condition (placebo pills + 1200 mg dietary
      sodium) or a 'normal salt' condition (2300 mg sodium chloride pills + 1200 mg dietary sodium)
      and monitored for 5 weeks. After the initial set of 5 weeks, the subjects are switched into
      the opposite condition, completing the cross-over study design. During weeks 1-4 and 6-9,
      subjects are monitored weekly with 24 hour urine collections and diet logs. The assessment of
      the primary outcome (blood vessel function) is completed during weeks 5 and 10. BH4 and
      ascorbic acid are also administered during weeks 5 and 10 to measure the effects of sodium
      intake on endogenous BH4 levels and vascular oxidative stress.
    

Intervention name(s): Slow sodium tablets; placebo
Intervention type(s): Drug; Other
Intervention description(s): The normal salt condition is maintained with 2300 mg / day in the form of slowly released salt (NaCl) tablets.; Placebo tablets are administered to maintain the low sodium condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers
Condition: Formulation Bridging; Food Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, two-part, crossover formulation bridging and food effect study to
      assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in
      normal, healthy volunteers.
    

Detailed description: 
      This is a single-dose, two-part crossover formulation bridging (Part A) and tablet food
      effect (Part B) study in normal, healthy volunteers. Part A will be conducted to evaluate the
      pharmacokinetics (PK) and relative bioavailability of 3 formulations of PBI-200; each
      volunteer will serve as their own control. In Part B, PBI-200 tablets will be dosed under
      fasting and fed (low-fat and high-fat meals) conditions to evaluate the effect of food on the
      PK of PBI-200.
    

Intervention name(s): PBI-200 Tablet; PBI-200 Capsule; PBI-200 Suspension
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of PBI-200 tablet; Single dose of PBI-200 capsule; Single dose of PBI-200 suspension
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, open-label, randomized, three-way crossover design
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)
Condition: Elevated Serum Lipoprotein(a)
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of
      Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp[a]).
    


Intervention name(s): Olpasiran
Intervention type(s): Drug
Intervention description(s): Subcutaneous injection
Other intervention name(s): AMG 890
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Elevated serum lipoprotein(a); Olpasiran
Computerised Behavioural Activation for Young People With Depression
Condition: Low Mood; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The primary aim of this non-randomised feasibility study is to 1) examine the acceptability
      of a newly developed computerised Behavioural Activation programme (BALM) in treating young
      people experiencing low mood/depression and 2) assess the feasibility of undertaking a pilot
      Randomised Controlled Trial (RCT) of the intervention.
    

Detailed description: 
      Approximately 20% of adolescents will have had at least one depressive episode by the age of
      18 making depression one of the leading causes of illness and disability in young people.
      Although receiving effective treatment is important, as few as 35% of young people seek help,
      with treatment-related issues (e.g. stigma, negative attitudes about help-seeking,
      accessibility, reluctance to engage one-to-one with a therapist, etc) outlined as reasons for
      this. Computerised therapies, which have increased availability and accessibility, reduced
      stigma and can be delivered in a format attractive to many young people may avoid some of
      these barriers and provide a more effective treatment option for young people.

      Behavioural Activation (BA) - a type of talking therapy focused on increasing liked
      activities has demonstrated effectiveness in treating depression in adults and, owing to
      this, is an evidence-based treatment for depression within NICE (2009) guidelines. Despite
      this, less research has examined its use with young people.

      We have developed BALM (Behavioural Activation for Low Mood), an online BA programme designed
      for use with young people experiencing mild to moderate low mood or depression. The
      development of BALM was based upon the findings of a systematic review and a series of
      qualitative interviews and focus groups with young people and healthcare professionals.

      Eligible young people will be referred to the programme via healthcare professionals working
      in local Child and Adolescent Mental Health Services and mental health practitioners based in
      local secondary schools.

      The findings of this research will allow us to refine the intervention and the research
      methods we employ in preparation for a pilot randomised controlled trial (RCT) of the new
      treatment.
    

Intervention name(s): BALM
Intervention type(s): Device
Intervention description(s): An online Behavioural Activation programme for young people with mild to moderate low mood/depression. The programme comprises 10 treatment sessions lasting 30 to 45 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Young people
Computer- Assisted Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
Condition: Autism; Asperger's Syndrome; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Obsessive-compulsive Disorder
MeSH terms: Anxiety Disorders; Autistic Disorder; Autism Spectrum Disorder; Obsessive-Compulsive Disorder; Phobia, Social; Asperger Syndrome; Anxiety, Separation
Study type: Interventional

Summary: 
      This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT)
      program for children with anxiety and autism spectrum disorders.
    

Detailed description: 
      Many children who have an autism spectrum disorder (ASD) experience substantial anxiety that
      can cause impairment above that of an ASD alone. Few studies have examined effective
      treatment options for anxiety in this population.Preliminary studies have established the
      efficacy of computer-assisted cognitive behavioral therapy in otherwise typically developing
      youth with anxiety. Accordingly, this study seeks to examine the efficacy of computer
      assisted CBT in children with autism and ASD. A randomized-control trial will examine the
      ability of computer-assisted CBT to treat anxiety in comparison to a waitlist condition. This
      study will recruit approximately 40 youth ages 7-12 years. Significant reductions in anxiety
      severity and overall improvement of functioning will establish this treatment's ability to
      treat anxiety. This study aims to evaluate the acute efficacy of CCBT relative to WAITLIST in
      children with ASD and comorbid anxiety disorders;examine the short-term durability of
      treatment gains for youth receiving CCBT; examine whether, relative to WAITLIST, CCBT results
      in improved social; adaptive; and global functioning, as well as reduced child- and
      parent-rated anxiety symptoms; and examine whether, relative to WAITLIST, CCBT is associated
      with greater satisfaction and consumer acceptability.
    

Intervention name(s): Computer assisted cognitive behavioral therapy.
Intervention type(s): Behavioral
Intervention description(s): Those who choose to participate will be required to attend 4 assessments - pre-treatment (week 0), mid-treatment (week 8), post-treatment, and a 4th assessment for a 3 month Follow-up. All children regardless of condition will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
Other intervention name(s): CCAL; CCBT; Camp Cope-A-Lot
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Asperger's Syndrome; Treatment; Cognitive-behavioral therapy; Anxiety; Children; Therapy
Patient Reported Function Following Combined First MTP and First TMT Arthrodesis.
Condition: Hallux Valgus
MeSH terms: Hallux Valgus
Study type: Interventional

Summary: 
      The goal of the study is to gather sufficient patient data to assess real world postoperative
      function after a first metatarsophalangeal (MTP) joint arthrodesis done in conjunction with
      first tarsometatarsal arthrodesis (TMT) (double fusion). Many studies have demonstrated the
      success of a first MTP joint arthrodesis in eliminating pain and reducing the intermetatarsal
      angle. Very little research has been published to assess the outcomes of double arthrodesis.
      Limited research has specifically assessed patients' everyday function and gait following MTP
      arthrodesis and no studies are available to assess real world function following double
      arthrodesis. More data that includes patient reported function during activities of daily
      living is needed to understand the benefits and draw backs of combined first MTP/TMT joint
      arthrodesis used to treat and correct first ray deformity.
    

Detailed description: 
      -  Retrospective clinical data will be collected on a Clinical Data Collection Form from a
           chart abstraction at the research site.

        -  All radiographs will be anonymized and transferred in a secure process to a Central
           Radiologist for the study. The data will be collected in excel spreadsheet or on a
           Radiographic Data Collection Form.

        -  Post-operative function and satisfaction will be collected by study personnel via
           telephone call with the patient

        -  De-identified data will be entered into a database for analysis.
    

Intervention name(s): Lapiplasty
Intervention type(s): Device
Intervention description(s): The Lapiplasty® System instruments and implants will be retrospectively evaluated in patients previously surgically treated with the Lapiplasty® Procedure for Triplane MTP and TMT joint arthrodesis.
Other intervention name(s): Treace Medical Concepts, Inc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bunion
AquaLase Capsule Wash for Pediatric Eyes
Condition: Cataract; Pediatric Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      To determine whether AquaLase capsule wash reduces posterior capsule opacification (PCO) in
      pediatric eyes.
    

Detailed description: 
      Dramatic advances have occurred in the treatment of childhood cataracts in the last 10 years.
      Intraocular lens (IOL) implantation has been universally accepted as the standard of care for
      most children undergoing cataract surgery beyond infancy. Despite advances in cataract
      surgery in children, PCO remained a significant complication following pediatric cataract
      surgery. In addition to being visually disturbing, it also induces amblyopia in children and
      if not treated at the earliest, irreversible visual changes may occur. The younger the child,
      the more acute is the problem: PCO occurs faster and the effect of amblyopia is more
      pronounced.

      To prevent opacification of the visual axis after cataract surgery, primary posterior
      capsulectomy and vitrectomy are routinely needed while managing pediatric cataract. This
      surgical step is not routinely used in adult cataract surgery, where we prefer an intact
      posterior capsule. Researchers are constantly trying to find a way to avoid the need for
      invasive procedures like posterior capsulectomy and vitrectomy for pediatric eyes. Use of
      AquaLase technology has shown some capability in cleaning the capsular bag during cataract
      surgery. Observations of this include anecdotal observation from users. AquaLase for cataract
      removal with the Infiniti Vision System has been used since 2003, is registered, and the FDA
      clearance is 510(k) number K980292. AquaLase uses pulses of warmed balanced salt solution to
      gently emulsify and facilitate aspiration of cataracts. The device under evaluation falls
      under the same FDA clearance. The unique aspect is the application tip which is intended to
      allow more thorough capsular bag cleaning or removal of more residual lens material than is
      currently being achieved. The energy source, controls, and materials are all identical to the
      currently marketed product. The difference is in the geometry of the distal most end of the
      application tip.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children with bilateral cataract undergoing surgery for cataract aspiration and IOL
        implantation. Bilateral cataract in a child aged 6-15 years old.
      
Keywords: pediatric eyes; bilateral cataract; IOL implantation; Aqualase capsule wash; posterior capsule opacification
A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects
Condition: Osteochondrodysplasia
MeSH terms: Osteochondrodysplasias; Mucopolysaccharidosis IV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and
      pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an
      integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study
      design.
    


Intervention name(s): SAR442501; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection; Subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Obesity, PEEP and Postoperative Oxygenation
Condition: Oxygenation
Study type: Interventional

Summary: 
      A study on overweight patients undergoing anesthesia for laparoscopic surgery.

      - evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure
      during awakening on oxygenation in the early postoperative period.
    

Detailed description: 
      Positive end-expiratory pressure (PEEP) is often used during mechanical ventilation to
      preserve end-expiratory lung volume. After emergence and extubation, this volume will
      diminish instantly. Some patients will have difficulties to restore functional residual
      capacity (FRC) during the early phase of recovery. If routine high FIO2 is being delivered
      together with maintained PEEP prior to extubation, several important prerequisites are
      established for the development of postoperative atelectasis. The investigators hypothesize
      that establishing zero positive end-expiratory pressure (ZEEP) immediately prior to emergence
      preoxygenation, will prevent gas with high oxygen concentration from entering dorso-basal
      areas of the lungs, and thereby diminishing postoperative atelectasis formation and improve
      oxygenation.

      This randomized controlled study will study overweight patients undergoing general anesthesia
      for laparoscopic surgery. The patients in the two study groups will receive mechanical
      ventilation with identical settings, comprising low TV, PEEP, and no RM. Randomization will
      occur at the end of surgery, before awakening. The patients will be allocated to zero PEEP
      (ZEEP) or maintained PEEP during emergence preoxygenation and extubation. Importantly, the
      intervention group will have ZEEP established while still having low ETO2 levels, prior to
      any preoxygenation. Arterial blood gases will be collected before, during and after
      anaesthesia. Primary endpoint measure will be change in oxygenation from before awakening to
      after awakening.
    

Intervention name(s): ZEEP during awakening; PEEP during awakening
Intervention type(s): Procedure; Procedure
Intervention description(s): ZEEP will be established 2 min prior to the start of emergence preoxygenation and awakening.; PEEP will be maintained throughout emergence preoxygenation and awakening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Oxygenation; Positive end-expiratory pressure; General anaesthesia; Obesity; Atelectasis; Mechanical ventilation
Occult Obscure Gastrointestinal Bleeding
Condition: Gastrointestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      To test the activity of a polyglucosamine (PG) together with a Standard Management protocol
      (SM) on the occult and obscure gastrointestinal bleeding (OGIB) and the clinical symptoms in
      patients suffering from colonic diverticulitis (CD).
    

Detailed description: 
      The trial was conducted in a single center and subjects were participating to the San
      Valentino Vascular Screening Project (SVVSP). Sixty patients with history of colonic
      diverticulitis (CD) and occult obscure gastrointestinal bleeding (OGIB) were recruited. All
      subjects were following a Standard Management (SM) protocol consisting of diet and lifestyle
      modifications, and were freely choosing to be treated with polyglucosamine (PG) or to follow
      the SM only. Two groups of 30 cases each were formed and followed for 3 months.

      Diet was controlled three times (baseline and during the first and third month), through the
      Food Intake Assessment (FIA) which consisted of the weekly analysis of 25 different servings
      (e,g fruits, vegetables, pulses, first dish, meat, processed meat, cheese). The lifestyle
      modification consisted of physical exercise (9 MET (Metabolic Equivalents) -h/week of brisk
      walking) and oral hygiene.

      The main variable was OGIB, that was measured using Hemoccult Sensa Fecal Occult Blood
      Procedure.

      Ancillary variables where the hs-CRP (high sensitivity C Ractive Protein) and the daily
      gastrointestinal discomfort (GID) measured thorough a visual analogue scale (VAS) from 0 to
      10.

      All variables were taken at baseline, after one and three months with the exception of GID
      that was measured also after one week of treatment.
    

Intervention name(s): PG low molecular weight chitosan
Intervention type(s): Dietary Supplement
Intervention description(s): The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals
Other intervention name(s): Low molecular weight polyglucosamine
Intervention MeSH terms: Chitosan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention