bioihbjkbjnl/mcl2 huggingface dataset:
The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life
Condition: Patient Reported Outcome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the quality of life of patients who underwent FGG
      surgery around the natural tooth and as a second surgery after the implant operation, in
      comparison with general oral health assesment index(GOHAI).
    

Detailed description: 
      Thirty-two participants were included who were referred to the periodontology clinic
      suffering insufficient keratinized gingiva / mucosa deficiency around the implant and / or
      tooth/teeth. GOHAI-total and GOHAI psychological impact, functional limitation, pain and
      discomfort, behavioral impact subcategories were recorded at before and postoperative first
      week and 30th day. Also, satisfaction questionnaires, number of painkillers and visual analog
      scale values were recorded.
    

Intervention name(s): Free Gingival Graft
Intervention type(s): Procedure
Intervention description(s): In the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction. The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth. Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were defined as two study groups: Test Group (TG) consists of patients have free gingival graft around dental implant patients and Control Group (CG) consists of patients have free gingival graft around the teeth.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: quality of life; graft
Proteasis Evaluation in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients.
      Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide
      bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess
      Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be
      included: Healthy smoker subjects, stable COPD patients and COPD patients with acute
      exacerbation. Kallicrein levels in sputum will be compared in these groups.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stable COPD patients were recruited from pulmonary primary care of pulmonary division of
        CHRU of Tours.

        COPD with acute exacerbation were recruited from hospitalisation of pulmonary division of
        CHRU of Tours and intensive care unit of CHRU of Tours.
      
Biospecimen description: 
      Sputum
High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and
      safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for
      6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after
      six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD
      Scale (CAPS) in both active and control groups.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)
Intervention type(s): Device
Intervention description(s): 6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the Right Dorsolateral Prefrontal Cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic.
Other intervention name(s): rTMS machine (MagPro, Medtronic).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fast Food Feeding in Youth
Condition: Obesity
Study type: Interventional

Summary: 
      The primary aim of the proposed pilot study is to assess the effects of fast food meals,
      varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.
    

Detailed description: 
      Using a three-period crossover design, the investigators will evaluate three acute feeding
      conditions.

        -  Under Condition A, the total amount of food in a large fast food meal will be delivered
           on a single tray at Time 0 (start of meal).

        -  Under Condition B, the same fast food meal will be equally divided among 4 separate
           portions, with all portions delivered at Time 0.

        -  Under Condition C, the meal again will be equally divided among 4 separate portions, but
           the portions will be delivered at 15-minute time intervals (Time 0, 15 minutes, 30
           minutes, 45 minutes).
    

Intervention name(s): Condition A (see detailed summary); Condition B (see detailed summary); Condition C (see detailed summary)
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Prevention
Exercise, Brain Imaging, Cognition, and Gait in Parkinsonism
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      There is emerging research detailing the relationship between balance/gait/falls and
      cognition. Imaging studies also suggest a link between structural and functional changes in
      the frontal lobe (a region commonly associated with cognitive function) and mobility. People
      with Parkinson's disease have important changes in cognitive function that may impact
      rehabilitation efficacy. Our underlying hypothesis is that cognitive function and frontal
      lobe connections with the basal ganglia and brainstem posture/locomotor centers are
      responsible for postural deficits in people with Parkinson's disease and play a role in
      rehabilitation efficacy. The purpose of this study is to 1) determine if people with
      Parkinson's disease can improve mobility and/or cognition after partaking in a cognitively
      challenging mobility exercise program and 2) determine if cognition and brain circuitry
      deficits predict responsiveness to exercise rehabilitation.

      Design: This study is a randomized cross-over controlled intervention to take place at a
      University Balance Disorders Laboratory. The study participants will be people with
      Parkinson's disease who meet inclusion criteria for the study. The intervention will be 6
      weeks of group exercise (case) and 6 weeks of group education (control). The exercise is a
      cognitively challenging program based on the Agility Boot Camp for people with PD. The
      education program is a 6-week program to teach people how to better live with a chronic
      disease. The primary outcome measure is the MiniBESTest and the secondary outcomes are
      measures of mobility, cognition and neural imaging.

      Discussion: The results from this study will further our understanding of the relationship
      between cognition and mobility with a focus on brain circuitry as it relates to
      rehabilitation potential.
    


Intervention name(s): Exercise and Education for Parkinson's Disease
Intervention type(s): Behavioral
Intervention description(s): Exercise and Education for Parkinson's Disease for 6 week cross-over intervention.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Freezing of gait; Idiopathic Parkinson's disease; Exercise; parkinsonism
A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV)
      gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The
      anticipated time on study treatment is 3 to 12 months, and the target sample size is 56
      individuals.
    


Intervention name(s): Capecitabine; Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): Capecitabine will be administered orally at 830 mg/m^2 BID (equivalent to a total daily dose of 1660 mg/m^2) as intermittent treatment (given days 1 to 21 q4w).; Gemcitabine will be administered at a dose of 1000 mg/m^2 once weekly via IV infusion as intermittent treatment (repeated 4-week cycles of 3 weeks treatment and 1 week rest).
Other intervention name(s): Xeloda
Intervention MeSH terms: Gemcitabine; Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outpatient Follow-up on Demand in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. Patients were
      randomized electronically with stratification according to biologic and non-biologic
      treatment to the open outpatient clinic programme, or usual care. Patients were evaluated at
      baseline, year 1 and 2, including assessment of disease activity and reporting of outcomes
      measures on a touch screen at the clinic.
    

Detailed description: 
      A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. At baseline,
      patients were randomized electronically with stratification according to biologic and
      non-biologic treatment to the open outpatient clinic programme, or usual care. Patients were
      evaluated at baseline, year 1 and 2, including assessment of disease activity (DAS-28), blood
      tests, bone erosions on plain radiographs of hands and feet, and patient reported outcome
      measures.

      The objective of the study was to compare an outpatient system for Danish RA patients based
      on patient self-controlled outpatient follow up on demand, Open Outpatient Clinic Programme
      with traditional scheduled routine follow-up regarding patient satisfaction and effect on
      traditional disease markers.

      The Danish National Patient Registry (DANBIO) was used to identify eligible patients with RA.
      At pre-planned routine visits with the rheumatologist, identified patients were screened
      according to inclusion and exclusion criteria.

      The intervention group had no scheduled appointments at the outpatient clinic, but they could
      book acute appointments with their contact rheumatologist within 5 days or less whenever they
      deemed it necessary. They also had access to nurse-led consultations without pre-booked
      appointments and to a nurse-led telephone helpline
    

Intervention name(s): Open Outpatient Clinic Programme
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Observation of clinical outcomes in two groups
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Follow-up on demand
Mindfulness-based Intervention in Police Officers - the POLICE Study
Condition: Mindfulness; Police; Quality of Life; Burnout Syndrome
MeSH terms: Burnout, Psychological
Study type: Interventional

Summary: 
      The physical, emotional, economic and social damage of stress in the police corporation
      indicates an urgent call for preventive programs to approach stress reduction, burnout
      symptoms and promotion of quality of life and well-being.

      The aim of the POLICE study is to evaluate the effectiveness of a Mindfulness-based
      intervention (MBI), compare to a waiting list (WL), in promoting quality of life and mental
      health in police officers.
    

Detailed description: 
      Police officers are submitted to a high burden of chronic stress. It is no surprise to find
      that this occupation ranks highest on diseases and accidents rates among all professions.
      These professionals presents a very high incidence of depression, anxiety disorders, alcohol
      dependence and suicidal behavior. In addition to mental health suffering, evidence suggests
      an increase risk of sudden cardiac death, diabetes, obesity and metabolic syndrome.

      Mindfulness-based interventions have been tested and incorporated for several clinical and
      non-clinical conditions for more than three decades, with emphasis on stress reduction,
      promotion of quality of life, chronic pain, anxiety, depression and eating disorders.

      The main hypothesis is that mindfulness training will improve their quality of life and
      reduce burnout symptoms. The investigators expect that individuals allocated in the MBI group
      will report, besides showing a better quality of life, mental health and less burnout, lower
      levels of stress, anxiety and depression symptoms.

      With regard to the working mechanism of the MBI, investigators will examine if the changes in
      mindfulness trait, self-compassion, spirituality, decentering and resilience skills will
      mediate the main hypothesis.

      The study will be conducted in Porto Alegre-RS and São Paulo-SP.
    

Intervention name(s): Mindfulness-based Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids
      reduce atrial fibrillation and other outcomes after cardiac surgery. In this
      placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery
      with or without valve repair will be treated with omega-3 polyunsaturated fatty acids
      perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty
      acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3
      polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery,
      decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids
      decrease intensive care unit and hospital length-of-stay.
    

Detailed description: 
      Atrial fibrillation is the most common complication after bypass surgery. It is a significant
      burden to the healthcare system because it is associated with increased hospital costs and a
      longer hospital length-of-stay. Atrial fibrillation occurring after bypass surgery is
      associated with increased morbidity and mortality. Atrial fibrillation is also associated
      with an increased risk for strokes, use of potentially harmful drugs, and the need for
      pacemaker therapy.

      This study is for patients who are undergoing elective bypass surgery. Patients who meet
      study criteria and who consent to participate in the study will be randomized to treatment
      with omega-3 fatty acids or matching corn oil placebo, prior to surgery. After surgery,
      treatment will continue until the primary endpoint, atrial fibrillation, is reached, or 14
      days, whichever is first.
    

Intervention name(s): Omega Three Polyunsaturated fatty acids
Intervention type(s): Drug
Intervention description(s): 2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days.
Other intervention name(s): Lovaza, Omega three polyunsaturate ethyl esters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: atrial fibrillation; coronary artery disease bypass graft surgery
Administration of Hydrocortisone in Young Healthy Male Volunteers
Condition: Anti-doping Campaign, Detection of Hydrocortisone
Study type: Interventional
Phase: Phase 4

Summary: 
      The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely
      reported in the literature, but to date, no formal testing procedure is available and
      applicable in an anti-doping laboratory to detect hydrocortisone doping abuse , i.e.,
      administration by systemic way.

      The investigators therefore propose to identify biomarkers that clearly distinguish between
      an authorized local administration of hydrocortisone and a prohibited systemic
      administration, by studying the impact of 5-day administration of hydrocortisone per 2
      different routes.
    

Detailed description: 
      Clinical research with two groups of ten volunteers one group with 5 days with local
      administration (cream, applied to healthy skin) one group with 5 days with systemic route of
      administration (per os)
    

Intervention name(s): Hydrocortisone administration
Intervention type(s): Drug
Intervention description(s): Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Monocentric, randomized, open-label study
Distribution of patients in groups according to a ratio (1:1)
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hydrocortisone (cortisol); local administration of cortisol; systemic administration of cortisol; biomarkers
A Study to Evaluate the Safety and Immunogenicity of COVID-19 (AdimrSC-2f) Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the safety and immunogenicity of the preventative vaccine,
      AdimrSC-2f, in healthy volunteers aged from 20 to 60 years old.
    

Detailed description: 
      The objectives of this phase I study are:

        1. to evaluate the safety profile of the AdimrSC-2f vaccine, and

        2. to assess the immunogenicity of the AdimrSC-2f vaccine.
    

Intervention name(s): AdimrSC-2f
Intervention type(s): Biological
Intervention description(s): AdimrSC-2f is a candidate vaccine against COVID-19 developed by Adimmune Corporation (Adimmune). Using the baculovirus-insect cells expression system, the recombinant receptor binding domain (RBD) of SARS-CoV-2 spike (S) protein is amplified and purified. AdimrSC-2f is formulated in the different dosages of Spike (S) protein without/with aluminum content as adjuvant.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Reliability Assessment of Emergency Paramedics' Fatigue Using Automated Pupillometry
Condition: Mental Fatigue; Emergency Paramedics' Fatigue
MeSH terms: Emergencies; Fatigue; Mental Fatigue
Study type: Observational

Summary: 
      Due to the limitations of current approaches to assess emergency paramedics' fatigue, a
      portable, quick, easy, and objective technique is required to be developed. The aim of the
      study was to investigate the reliability of automated pupillometry to assess mental fatigue
      based on a driver simulator.
    


Intervention name(s): pupillometer
Intervention type(s): Diagnostic Test
Intervention description(s): The dynamic changes of PLR were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of PLR with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec. The device provided the examiner with maximum and minimum pupil size (Init and End), constriction percentage (%PLR), latency (LAT), constriction and dilation velocity (CV and DV), and T75.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy postgraduate students from Zhejiang University School of Medicine in China
        voluntarily participated in our study. All participants were asked to follow the below
        requirements before the tests: 1) refrain from alcohol, caffeine and tea within 12 h, 2)
        adequate sleep (almost 6~8 h) the day before, and 3) wash the hair within 24 h. Informed
        written consent and training were provided prior to entering the experiment.
      
Keywords: pupillary light reflex (PLR); automated quantitative pupillometry; Karolinska Sleepiness Scale (KSS); heart rate variability (HRV); electroencephalography (EEG)
A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria
Condition: Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, open-label study to assess the effects of AK002
    

Detailed description: 
      This open-label study is to assess the effects of AK002, given as monthly intravenous
      infusions at up to 3 mg/kg. A total of 47 patients will be enrolled across 2-4 sites. All
      patients enrolled in the study will receive 6 monthly infusions of AK002 and will then be
      followed for another 8 weeks. Some patients will have the option to receive an additional 12
      months of extended dosing.
    

Intervention name(s): AK002
Intervention type(s): Drug
Intervention description(s): AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain Function Predictors And Outcome Of Weight Loss And Weight Loss Maintenance
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      By doing this study, researchers hope to learn whether a person's motivation for food is
      different after he or she loses weight, and if imaging techniques such as fMRI can be used to
      predict whether the person will maintain that weight loss over time.
    


Intervention name(s): Diet Intervention; Assessments and Diet Intake
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: weight loss; diet