bioihbjkbjnl/mcl2 huggingface dataset:
Developing and Validating Clinical Efficacy for Obesity Digital CBT Model
Condition: Search MeSH
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of the present study is to develop and validate the effects of a new cognitive
      behavioral therapy (CBT) using digital healthcare mobile apps such as Noom Coach and InBody.
    

Detailed description: 
      Seventy female participants whose BMI scores were above 23 and who had no other clinical
      problem except obesity were randomized into an experimental and a control group. Forty-five
      people in the experimental group were connected with the therapist using digital healthcare
      apps, so they got daily feedbacks and assignments for 8 weeks. Twenty-five people in the
      control group also used digital healthcare apps but they were asked to do self-care without
      intervention.
    

Intervention name(s): Cognitive Behavioral Therapy; Self-guided
Intervention type(s): Behavioral; Device
Intervention description(s): Cognitive-behavioral therapy is a psycho-social intervention that is the most widely used evidence-based practice for improving mental health and requires active interactions between the participants and a therapist or coach.; Self-guided refers to any contact between the participants and a therapist or coach.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study is been designed to have pre, post, and follow-up phases.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obesity; Cognitive Behavioral Therapy
Antioxidant Capacity and Vitamin A Profile in Young Adults Who Consume a Snack Bar Made From Tropical Fruits Treated With UV-C
Condition: Nutritional and Metabolic Disease
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The objective of the present study was to evaluate the impact of a snack bar on some health
      indicators associated with diet (plasma antioxidant capacity, lipid profile, vitamin A
      profile (retinol and carotenoids)) and on the nutritional status (impact on energy and
      nutrients consumed) in a group of upper level students.
    

Detailed description: 
      A blind randomized controlled clinical study of healthy adults, which was carried out with
      the approval of the ethics committee of the Centro de Investigación en Alimentación y
      Desarrollo, A.C. (CIAD, A.C.) with registration CE/001/2017. The intervention was carried out
      in a public university in Mexico from January to April 2017. Each subject signed an informed
      consent form. This study lasted 30 days (4 weeks), where each participant consumed daily a
      snack bar irradiated with UV-C. The participants were personally interviewed by the research
      team with a structured selection questionnaire. Thirty subjects who met the inclusion
      criteria were recruited, 15 of them men and 15 women. Through a simple randomization process,
      the participants were assigned in 3 groups of 10 people each with 5 women and 5 men,
      subsequently treatments (without treatment, pineapple snack bar, or mango snack bar) were
      randomly assigned. The outcomes between groups were analyzed with one way ANOVA, with a
      P-value of 0.05 or less when there was statistical significance, using statistical software.
      The participants, and the laboratory technicians were blinded to the treatment assignments
      until the conclusion of the trial.
    

Intervention name(s): No Intervention; Pineapple snack bar; Mango snack bar
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): This gruop did not have an intervention; 30 g daily of pineapple snack bar; 30 g daily of mango snack bar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: antioxidant capacity
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together
      with Best Supportive Care in the treatment of COVID-19.
    


Intervention name(s): Acalabrutinib
Intervention type(s): Drug
Intervention description(s): Acalabrutinib- administered orally
Intervention MeSH terms: Acalabrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study will consist of two arms Arm 1 is acalabrutinib + best supportive care or Arm 2 is best supportive care alone
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 2019 novel coronavirus disease; Acalabrutinib; Btk inhibitor
Sit to Stand Intervention for Allina Health Employees
Condition: Stress; Quality of Life
Study type: Interventional

Summary: 
      A 16 week pilot study for Allina call center employees to look at the psychological outcomes
      and biological markers after an intervention of using a standing work station. There were two
      groups: group 1 received, and was instructed to use, the standing work station for all 16
      weeks, group 2 was a wait-list control group and received, and was instructed to use, the
      standing work station for the second 8 weeks. Psychological outcomes were measured at weeks
      0, 4, 8, 12, and 16. Biological markers were measured at weeks 0, 8, and 16.
    


Intervention name(s): Standing workstation
Intervention type(s): Behavioral
Other intervention name(s): Ergotron Workfit-S
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Standing workstation
Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus
      surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic
      bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen
      tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a
      flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation
      via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the
      Shilly or Rusch DLT. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with
      a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short
      lateral internal diameter of the bronchial lumen and its flexibility may allow for
      advancement to the trachea over the FOB easier than the Shilly tube.

      In the present study, The investigators aimed to test the hypothesis that the silicone DLT
      would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators
      further aimed to compare the intubation time over the FOB between the silicone DLT and PVC
      DLT.
    


Intervention name(s): Fibreoptic intubation with silicone double lumen tube; Fibreoptic intubation with PVC double lumen tube
Intervention type(s): Device; Device
Intervention description(s): Fibreoptic intubation with silicone double lumen tube; Fibreoptic intubation with PVC double lumen tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Fiberoptic intubation; double lumen tube
The Effectiveness of Palatal Brushing on Denture Stomatitis
Condition: Denture Stomatitis
MeSH terms: Stomatitis; Stomatitis, Denture
Study type: Interventional

Summary: 
      Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal
      mucosa. It is the most prevalent oral disease and the main indicator of poor oral health
      among denture wearers, affecting one-third of all complete denture wearers.

      The etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria and
      fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures. However,
      the evidence is ambiguous, inconclusive and recurrence following routine antifungal therapy
      is common.

      The proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing
      in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of
      change in CFU count and clinical inflammation will be carried out at baseline, 3 months and 6
      months.
    


Intervention name(s): Palatal brushing
Intervention type(s): Behavioral
Intervention description(s): Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Denture Stomatitis; Denture Erythematous Stomatitis; Prosthesis Stomatitis; Oral Candidiasis; Palatal inflammation
Cannabis Use and Relapse After One Week of Contingency Management Therapy
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of a seven-day combined contingency
      management (CM) with two sessions of brief Motivation Interviewing (MI) followed by
      standardized individual drug counseling on cannabis use and relapse in the following 90-day
      period in individuals with moderate to severe Cannabis Use Disorder (DSM-5).
    

Detailed description: 
      The primary aim of this study is to examine cannabis use and rates of abstinence and relapse
      in individuals with moderate to severe Cannabis Use Disorder (CUD) after intensive 7-day
      contingency management (CM) procedure to reinforce abstinence from cannabis use. In addition,
      this study will evaluate the effect of CM with two sessions of brief MI on the severity of
      cannabis withdrawal signs during the first 7-days of CM treatment and then during the
      following month.

      The study will also focus on prospectively monitoring the sustenance of abstinence and time
      to lapse and relapse to cannabis use over a 90-day period, using ecological momentary
      assessment (EMA) via a smartphone-based application. An additional aim will be to evaluate
      changes in symptoms of CUD during the period following the 7-day using the diagnostic
      criteria of the DSM-5.
    

Intervention name(s): Contingency Management + Motivational Interviewing
Intervention type(s): Behavioral
Intervention description(s): Seven-day combined CM with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling on cannabis use and relapse.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer
Condition: Advanced Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      This study will collect the data from existing patient medical records at US cancer centers.
      The study will include patients with BRCAwt ovarian cancer who have been prescribed first
      line (1L) olaparib maintenance treatment.
    

Detailed description: 
      This is a United States (US) based multicenter, retrospective, observational cohort study
      with data abstracted from patient medical records.

      In this observational study, it is planned to include approximately 150 US female patients
      with newly diagnosed advanced ovarian cancer (AOC) who were tumor biomarker tested between
      first diagnosis with AOC and first prescription of 1L olaparib maintenance monotherapy as
      tumor breast cancer gene wild type (BRCAwt) with a known homologous recombination deficiency
      (HRD) status.

      This retrospective cohort study will include patients with first olaparib prescription
      between Jan 2017 and Dec 2021. All data collection will be retrospective. Data will be
      collected from the date of first olaparib prescription (index date) with a follow-up period
      of at least 18 months post index date.
    

Intervention name(s): None (Observational Study)
Intervention type(s): Other
Intervention description(s): Not Applicable since observational study
Other intervention name(s): Observational Study
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with newly diagnosed AOC BRCAwt with available HRD status who have been prescribed
        1L olaparib maintenance treatment.
      
Keywords: Real-world evidence; Homologous recombination deficiency; breast cancer gene; breast cancer gene mutated; breast cancer gene wild type
To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To compare the gastroprotective effects of a once-daily dose of PA 325 combination
      tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a
      once-daily dose of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy
      findings in normal healthy volunteers.
    

Detailed description: 
      PA 325 is proposed for the reduction in the risk of aspirin-associated gastrointestinal (GI)
      adverse events in patients requiring daily aspirin. This study is designed as a Proof of
      Concept study to evaluate the gastroprotective effects, pharmacokinetic profile, and safety
      of PA 325 in healthy volunteers.

      To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet
      combining 325 mg pH-sensitive aspirin and 20 mg immediate release omeprazole versus a
      once-daily dose of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy
      findings in normal healthy volunteers.
    

Intervention name(s): aspirin; omeprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroprotective effects; Aspirin
Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin
Condition: Progressive Keratoconus; Thin Corneas
MeSH terms: Keratoconus; Corneal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the corneal pachymetric variations during and after
      corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and
      hypo-osmolar riboflavin solution in thin corneas.
    

Detailed description: 
      To evaluate the corneal pachymetric variations during and after corneal collagen
      cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar
      riboflavin solution in thin corneas.

      Eighteen eyes of 18 patients, 11 men and 7 women, with progressive keratoconus and thinnest
      corneal thickness (TCT) less than 400µm were included in this study.

      After the epithelium removal, iso-osmolar riboflavin was applied to the cornea every 3
      minutes (30 min). Hipo-osmolar riboflavin was then applied every 20 seconds until the TCT
      reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the
      thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar
      riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.
    

Intervention name(s): cross-linking with hypo-osmolar riboflavin
Intervention type(s): Drug
Intervention description(s): Hipo-osmolar riboflavin was applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.
Other intervention name(s): Riboflavin; UVA radiation
Intervention MeSH terms: Riboflavin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: progressive keratoconus; thin corneas; cross-linking; hypo-osmolar riboflavin
Strengthening Exercise and Activities of Daily Living Instructions for Patients With Lumbar Disc Herniation
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      Lumbar disc herniation (LDH) is one of the most common causes of mechanical low back pain
      (LBP) associated with radiating leg pain. Conservative treatment, including exercise,
      analgesic, and physical therapy, is regarded as the first-line treatment of LDH.

      This randomized clinical trial was conducted to evaluate the effectiveness of back and hip
      strengthening exercises combined with activities of daily living instructions (ADLIs) to
      reduce pain intensity in patients with LDH.
    

Detailed description: 
      A total of 70 patients with LDH were randomly allocated to either the intervention group (IG)
      or the control group (CG). Patients in IG received different back and hip strengthening
      exercises five days a week for six weeks. The patients in CG were treated with Naproxen (500
      mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist
      compression for the next three weeks. In addition, the patients in both groups were
      instructed to follow the ADLIs during the intervention and at least 3 months after the
      intervention.

      The straight leg raising (SLR) test and the Visual Analogue Scale (VAS) score were used to
      evaluate the patients' pain intensity. Outcomes were measured at baseline, at three weeks,
      and six weeks of the intervention. Patients were followed up after 3 months of the
      intervention.
    

Intervention name(s): Strengthening exercises; Pharmacological therapy; Hot compression; Activities to daily living instructions
Intervention type(s): Other; Drug; Other; Behavioral
Intervention description(s): Back and hip strengthening exercises. The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects.; Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks; Hot moist compression from week 4 to week 6.; Avoid forward bending.
Avoid heavy weightlifting.
Avoid prolong standing.
Avoid prolong sitting.
Use a plain firm bed.
Lie down in a supine position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Disc herniation; Strengthening exercise; ADL instructions
An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects
      with Rheumatoid Arthritis.
    


Intervention name(s): Adalimumab PFS and Pen
Intervention type(s): Drug
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Measurement of the Eye's Blood Vessels Using the Dynamic Vessel Analyzer (DVA)
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this research study is examine the response of the blood vessels in the eye to
      a light flicker stimulus using the Dynamic Vessel Analyzer (DVA) on two separate days in
      healthy individuals. The DVA uses an instrument which is used during routine eye
      examinations. The hypothesis of the study is that the changes in eye's blood vessel will be
      similar between the two visits; thus establishing reproducibility of the measurements for
      future comparisons to individuals with stroke or heart disease. In addition, this study will
      compare the eye's blood vessel responses to responses of the blood vessels in the arm using
      Doppler ultrasound.
    

Detailed description: 
      Retinal blood vessels have been suggested to be an index of the cerebral and coronary
      microvasculature function. Since the retinal vessels are not under direct sympathetic
      control, this vascular bed is an ideal location to examine local mechanisms of vascular
      regulation(i.e. metabolite/endothelial and myogenic). Based on previously published data on
      animal and human responses, the central purpose for the proposed research is to compare the
      retinal and brachial vasodilatation responses in healthy subjects using the Dynamic Vessel
      Analyzer (DVA). Our rationale for this proposal is to better understand retinal blood flow in
      healthy individuals, gain insight into vascular reactivity in different vascular beds, and
      lastly to establish standards and reproducibility of DVA Measurements.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Subjects
      
Keywords: Vasodilation; Vessel Reactivity; Dynamic Vessel Analyzer; Retina
Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized,
      3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study
      will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with
      ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have
      previously received ticagrelor loading does (LD) and maintenance dose (MD)..
    


Intervention name(s): Prasugrel Loading Dose; Prasugrel Maintenance Dose; Ticagrelor Maintenance Dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 60mg given as six 10mg film coated tablets; 10mg maintenance dose, given as one 10mg film coated tablet; one 90mg film coated tablet
Other intervention name(s): Effient; Effient; Brilinta
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CAD; prasugrel; ticagrelor; antiplatelet; thienopyridine; P2Y12 Inhibitors