bioihbjkbjnl/mcl2 huggingface dataset:
Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to test if including personalization in education materials
      about colorectal cancer screening is more effective at helping encourage people to complete
      colorectal cancer screening.
    


Intervention name(s): Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials; Contact Message; Personalized One on One Education; Fecal Immunochemical Test (FIT)
Intervention type(s): Behavioral; Behavioral; Behavioral; Diagnostic Test
Intervention description(s): Educational materials (photonovella +DVD) + Fecal Immunochemical Test (FIT) kit. Offers colorectal cancer screening information using a novella format. Materials describe colorectal cancer and screening tests that are available, and procedures for completing FIT kit.; Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.; Trained study coordinators will meet with participant for a brief 15 minute educational session delivered in clinic that summarizes information from the materials and demonstrates FIT collection.
Email or text reminders with brief messages in clear language will be sent that aim to remind and prompt patients to complete FIT.
For participants that are not responsive to above, trained study staff will address specific FIT specific hinderances by telephone or in clinic.
Participants will receive a one page summary of key points of salience of repeat screening "GET FIT AGAIN". Another FIT kit is provided.; The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Established patients of community health clinics aged 50-75 with average risk of colorectal
        cancer.
      
Keywords: Colorectal Cancer Screening; FIT test; Fecal Immunochemical Test
A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
Condition: Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID)
      administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who
      are treated with metformin and in non-diabetic adults with obesity
    


Intervention name(s): PF-06882961; Placebo
Intervention type(s): Drug; Other
Intervention description(s): PF-68882961 will be provided as tablets twice a day (BID); Placebo comparator will be provided as tablets twice daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Freezing of Gait: Clinical, Cognitive, and Imaging Features
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Freezing of gait (FOG) is among the most disabling motor features of Parkinson disease (PD)
      and is present in other forms of parkinsonism as well. FOG is a brief (usually lasting <30
      seconds) episode of absence or a greatly reduced forward movement of the feet despite
      intention to walk. It typically occurs when patients initiate gait (so-called "start
      hesitation") and when attempting to turn. It is a leading cause of falls and often results in
      a wheelchair-dependent state. FOG greatly interferes with activities of daily living, causes
      social isolation and poor quality of life.

      FOG is one of the least understood features of PD. It possibly may develop independent of the
      other motor features of the disease, and be caused by specific pathological changes in the
      brain. Previous studies on FOG have shown conflicting information and have not lead to clear
      understanding of the pathophysiology. One key reason for this is that there appears to be
      multiple subtypes which have rarely been taken into account.

      The purpose of this study is to show that different types of FOG exist and to see if there is
      a connection to cognitive differences or gait patterns.
    

Detailed description: 
      This study is an observational study to assess FOG via using multiple methods such as:
      clinical features, imaging, cognition and dopamine blood levels. The study consists of four
      parts (plus an optional fifth part) that will be completed over two-three separate days
      within a 30 day span. The four parts will not necessarily be performed in this order. Part
      one will be clinical and written questionnaire assessments of PD and FOG followed by 3D
      motion capture evaluations. Part two are cognitive or neuropsychiatric assessments. Part
      three is a magnetic resonance image (MRI) to examine the brain structure. Part four is
      Positron Emission Tomography (PET) imaging scan that measures norepinephrine transporter
      levels. The optional part 5 is a lumbar puncture that will measure cerebrospinal fluid
      catecholamines and proteomics.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Freezing of gait (FOG) patients with Parkinson disease (PD) will be selected from the Emory
        Movement Disorders Center.
      
Biospecimen description: 
      Plasma
    
Keywords: Freezing of gait
Thora-3DI™ for Evaluation of Severity of Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      To demonstrate differences in tidal breathing patterns measured by SLP(Structured Light
      Plethysmography) between healthy subjects and COPD (chronic obstructive pulmonary disease).
      The correlation between SLP parameters and standard lung function parameters measured by body
      box and spirometry will also be assessed. Trends in SLP breathing patterns between the
      different GOLD (Global Initiative for Chronic Obstructive Lung Disease) stages of COPD, and
      between those and healthy subjects, will be investigated to assess whether SLP can detect
      differences between groups.
    

Detailed description: 
      Structured light plethysmography (SLP) is a novel, non-contact method for assessing quiet
      'tidal' breathing. A number of studies have reported the effects of conditions such as
      chronic obstructive pulmonary disease (COPD) on tidal breathing patterns, and a previous
      study has shown that SLP is able to detect differences in ten tidal breathing patterns
      between healthy subjects and patients with COPD. In this present study, the investigators
      will aim to confirm the previous findings and also to examine the relationship between SLP
      tidal breathing parameters and traditional measurements of lung function measured by
      spirometry and body box plethysmograph. The correlation between SLP parameters with lung
      Function parameters measured by spirometry and body box plethysmography: forced expiratory
      volume in one second (FEV1); Forced vital capacity (FVC), FEV1/FVC (forced expiratory volume
      in one second/forced vital capacity); total lung capacity (TLC) and residual volume (RV).
      Trends in tidal breathing patterns between varying severities of COPD (based on the (Global
      initiative for lung disease (GOLD) grading system.
    

Intervention name(s): Thora-3Di; Body Plethysmography; Spirometry
Intervention type(s): Device; Device; Device
Intervention description(s): Device that uses a grid of structured light to measure chest and abdominal wall movement; A pulmonary function test (PFT) for measuring total lung volume.; A pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume.
Other intervention name(s): Structured Light Plethysmography
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: COPD, Structured Light Plethysmography, COPD severity
A Comparison of Optimal PEEP Determination Guided by EIT and G5 Device in Moderate and Severe ARDS Patients
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional

Summary: 
      To Select the Optimal Positive End-expiratory Pressure in Moderate and Severe Acute
      Respiratory Distress Syndrome Patients by Using:

        1. the novel Non-invasive Electrical Impedance Tomography Guided Method

        2. the Protective ventilation tool G5(MV)
    

Detailed description: 
      1. To titrate PEEP guided by EIT. A global inhomogeneity (GI) index and regional compliance
           based on EIT were developed to quantify the tidal volume distribution within the lung.
           The aim of this study was to test the feasibility of optimizing PEEP with respect to
           ventilation homogeneity using the GI index and regional compliance.

        2. To titrate PEEP with the Protective Ventilation Tool by G5(MV). The new generation of
           ventilator will deliver an optimal PEEP on ARDS patients based on their status
           automatically.
    

Intervention name(s): optimal PEEP guided by EIT; optimal PEEP guided by G5 ventilator
Intervention type(s): Device; Device
Intervention description(s): Patients are randomly assigned to EIT group or G5 group. PEEP selected in EIT group is based on GI index and regional compliance. PEEP decided in G5 group is based on the ventilator.; Patients are randomly assigned to EIT group or G5 group. PEEP selected in EIT group is based on GI index and regional compliance. PEEP decided in G5 group is based on the ventilator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: optimal positive end-expiratory pressure determination; Electrical impedance tomography
CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia
Condition: Psychosis, Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 9 week, multicentre, randomized, double-blind, placebo-controlled trial with two
      parallel groups. There is also an open-label extension phase of 18 weeks. Both medications to
      be used in the study, clozapine and risperidone, are fully approved for the treatment of
      schizophrenia.
    

Detailed description: 
      Subjects may be inpatients or outpatients. All subjects will be treated throughout the study
      with clozapine, at a dose of 400 mg or more, unless limited by side effects. After screening,
      subjects will be augmented with placebo for 7 days. Any subject with a reduction in PANSS
      total score of 20% or greater will be discontinued from the study. Beginning on day 8,
      subjects will be randomized to continued augmentation of clozapine with placebo, or to
      augmentation with risperidone. The initial daily dose of risperidone will be 1.0 mg,
      increased in 1.0 mg increments to a total of 3.0 mg/day over a two week period. Subjects
      unable to tolerate at least one tablet of study medication will be dropped from the study. At
      the end of 8 weeks following randomization, at the choice of the investigator, open-label
      risperidone augmentation can be started.

      The primary outcome measure is the PANSS total score at week 9. Subjects will be classified
      as responders if the improvement in PANSS total score is 20% or greater, and the proportion
      of responders in each group will be determined. Complementary outcome measures will be the
      CGI severity score, CGI improvement score, and SOFAS score. Safety and tolerance will be
      assessed by reports of adverse events and clinically significant changes in vital signs,
      weight, waist circumference, extrapyramidal side effects, metabolic and hematological
      measures.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Psychosis, schizophrenia, schizoaffective, clozapine, risperidone
cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation
Condition: Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic
      liver transplantation. This study compares endoscopic treatment with implantation of multiple
      plastic endoprostheses vs. use of a removable, covered self-expandable metal stent (cSEMS).
    

Detailed description: 
      This is a multi-center randomised trial.
    

Intervention name(s): Non-expandable plastic stent (plastic endoprosthesis); Covered self-expandable metal stent (cSEMS)
Intervention type(s): Device; Device
Intervention description(s): plastic stent (plastic endoprosthesis); Removable, covered self-expandable metal stent (cSEMS)
Other intervention name(s): OptiMed, Boston Scientifiv, MTW; Niti-S biliary stent, fully covered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cSEMS; NEPS; ERCP; biliary stricture; biliary stenosis; liver transplantation
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery
Condition: Lung Cancer; One Lung Ventilation; Gas Exchange; Inverse-ratio Ventilation
Study type: Interventional

Summary: 
      Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation
      (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the
      inspiratory time greater than expiratory time, can be applied for adult respiratory distress
      syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway
      pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV with
      lung protective strategy.
    

Detailed description: 
      Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation
      (OLV) for thoracic surgery. Continuous positive airway pressure or positive end-expiratory
      pressure are usually applied to improve this disorder including hypoxia, but these methods
      are not enough. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time
      greater than expiratory time, can be applied for adult respiratory distress syndrome. The
      effect of IRV is to improve gas-exchange status by increasing mean airway pressure and
      alveolar recruitment. The application of IRV during OLV has not been performed to our
      knowledge, and there is a possibility of IRV to improve oxygenation during OLV. There is a
      possibility of increase of auto-PEEP, or air trapping in subjects with chronic obstructive
      pulmonary disease, but this kind of auto-PEEP can be overcome by external PEEP. Therefore, we
      tried to evaluate the effect of IRV during OLV with lung protective strategy.
    

Intervention name(s): Conventional I:E ratio; I:E = 1:1 ratio
Intervention type(s): Other; Other
Intervention description(s): conventional I:E ratio of 1:2 is applied. Ventilator : Datex-Ohmeda Aestiva/5 ® model; I:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model
Other intervention name(s): I:E ratio of 1:2; Ventilator : Datex-Ohmeda Aestiva/5 ® model; I:E ratio of 1:1; Ventilator : Datex-Ohmeda Aestiva/5 ® model
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: one lung ventilation; gas exchange; inverse-ratio ventilation
Efficacy of Diclofenac Suppository for Pain Control in Ultrasound Guided Biopsy of Prostate
Condition: Carcinoma Prostate
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of
      investigation for prostate cancer in current urology practice. It is considered a minor
      procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the
      redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal
      that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac
      is a local and systemic anti-inflammatory drug and it reduces local mediators involved in
      local pain.The purpose of this study is to find out the role of rectal administration of
      diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post
      procedural pain in prostatic biopsy with adequately calculated sample size and excluding the
      patients with contraindication to procedure or diclofenac administration as these were the
      shortcomings of previous studies.
    


Intervention name(s): Diclofenac suppository plus lidocaine gel; Lidocaine gel only
Intervention type(s): Drug; Drug
Other intervention name(s): Voltral suppository
Intervention MeSH terms: Diclofenac; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioequivalence of Telmisartan/ HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Male Volunteers II
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the bioequivalence of 80 mg telmisartan/12.5 mg hydrochlorothiazide
      (HCTZ) fixed dose combination compared with its monocomponents
    


Intervention name(s): Telmisartan and HCTZ; Telmisartan; HCTZ
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Telmisartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Soleus H-Reflex in Different Sitting Postures
Condition: Compression of Spinal Nerve Root; Spinal Disorder; Low Back Pain
MeSH terms: Spinal Diseases; Low Back Pain
Study type: Observational

Summary: 
      The purpose of this study was to examine the effect of prolonged sitting duration and three
      different sitting postures (erect, slumped, and slouched sitting postures) on spinal nerve
      root function by measuring the soleus (SOL) H-reflex amplitude. In addition, the pressure
      under the ischial tuberosities during the three sitting postures were assessed and correlated
      with the SOL H-reflex amplitude.
    

Detailed description: 
      Participants were assigned to two groups (prolonged sitting group and controls) based on
      their daily sitting duration with 15 participants in each group. The outcome measures were
      recorded during erect, slumped and slouched sitting postures. The differences between the two
      groups and the three sitting postures in the outcome measures were examined for statistical
      significance.
    

Intervention name(s): Sitting posture
Intervention type(s): Other
Intervention description(s): The outcomes were measured while the participants assumed erect, slumped and slouched sitting postures.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults from both genders.
      
Keywords: Lumbosacral spine; Nerve roots; Sitting; H-reflex
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      MRG-110 is intended to promote the growth of new blood vessels by inhibiting a molecule
      called miR-92a. MRG-110 is being studied to determine if it can accelerate healing of wounds
      by improving blood flow into the wound area. The primary objective of this study is to
      investigate the safety and tolerability of MRG-110 when injected into the skin at the site of
      a small skin wound in normal healthy volunteers. Another objective is to study the
      pharmacokinetics of MRG-110 (the movement of a drug into, through and out of the body).
      Participants in the clinical trial will receive either a single dose or multiple doses of
      MRG-110 and/or placebo. Blood samples, urine samples and skin biopsies will be collected to
      measure how MRG-110 is processed by the body, and how the body responds when exposed to
      MRG-110.
    


Intervention name(s): MRG-110; Placebo; MRG-110; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single ascending doses of MRG-110; Single doses of placebo; Multiple ascending doses of MRG-110; Multiple doses of Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers; MicroRNAs; Angiogenesis Inducing Agents
Child Health Improvement Through Computer Automation of Constipation Management in Primary Care
Condition: Constipation; Encopresis
MeSH terms: Constipation; Encopresis
Study type: Interventional

Summary: 
      This project seeks to expand an existing computerized decision support system used in
      pediatric primary care. The expanded system will add a module that helps clinicians recognize
      constipated children and then provides evidence-based reminders for constipation management,
      as well as automates patient educational materials. The current system is deployed across
      multiple sites, and the constipation module will be randomized to deployment in different
      sites. The difference in constipation management and patient outcomes will then be compared
      between sites receiving the intervention and sites not receiving the intervention over a 12
      month period.
    


Intervention name(s): Evidence Based Constipation Reminders
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
Condition: Known Crohn Disease Subjects
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      This study is designed to evaluate the performance of VCE in the assessment of mucosal
      inflammation 6 months after the first VCE procedure
    

Detailed description: 
      This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability
      of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal
      disease activity in CD subjects after 6 months .

      Up to 75 subjects will participate in this study. An interim analysis will be done after
      study completion with 20 subjects. All subjects to be enrolled in this study will be
      pediatric and\or adult subjects with known Crohn's disease
    

Intervention name(s): Capsule endoscopy and Ileocolonoscopy tests
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic