bioihbjkbjnl/mcl2 huggingface dataset:
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
Condition: Colorectal Cancer; Adenomas
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the performance of a new prototype colonoscope with a
      standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a
      smaller diameter than the standard colonoscope. The hypothesis to be tested is that the
      prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the
      patient. Both colonoscopes are manufactured by the same company.
    


Intervention name(s): Olympus PCF-Y0014-L; Standard colonoscope
Intervention type(s): Device; Device
Intervention description(s): Screening colonoscopy with a prototype colonoscope; Screening colonoscopy
Other intervention name(s): Olympus PCF-Y0014-L colonoscope; Olympus series 160 colonoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Colonoscopy performance; Pain; Discomfort; Screening; Colorectal cancer; Colorectal cancer screening, diagnostics of adenomas
Treating Acutely Agitated Patients With Asenapine Sublingual Tablets
Condition: Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional
Phase: Phase 4

Summary: 
      Our proposal is to administer asenapine to patients who are clinically agitated and in need
      of immediate intervention. At present there are no controlled studies that we know of that
      explores the use of asenapine for this purpose. Establishing the utility of asenapine for
      this common clinical problem will support its use as an additional treatment option in
      acutely agitated patients.
    

Detailed description: 
      A psychiatrist (blinded) will assess the patient for agitation and their capacity to consent.
      Patients will be informed about the study and asked to complete informed consent prior to
      being included in the study. Patients who decline will not be included. A nurse (blinded)
      will administer either 10mg asenapine or placebo sublingually in a randomized fashion.
      Efficacy in reducing acute agitation will be evaluated using the PANSS-EC. A trained rater
      (blinded) will rate patients at baseline and at 15, 30, 60, 90 and 120 minutes (or endpoint)
      after medication administration. Efficacy in reducing acute agitation will also be evaluated
      using the Clinical Global Impression Scale (CGI). A trained rater (blinded) will rate
      patients at baseline CGI-Severity and CGI-Change at 60 and 120 minutes (or endpoint) after
      medication administration. The need for additional medications, interventions or physical
      restraints will be recorded and constitute the endpoint for that patient. Demographics,
      diagnoses, blood alcohol level, urine toxicology, and urine pregnancy will be collected.
    

Intervention name(s): Asenapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Asenapine Sublingual Tablet 10mg, single-dose; Placebo Sublingual Tablet, single-dose
Other intervention name(s): Saphris; Sugar Pill
Intervention MeSH terms: Asenapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Agitation; schizophrenia; bipolar; psychosis; panss-ec
Nutrition Intervention for Chronic Pain Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The primary objective of the study is to determine the effectiveness of nutrition education
      (individual and group) on the intensity of pain in patients suffering from chronic pain. The
      secondary goal is to determine whether there is a change in the status of the patient's
      nutrition, their quality of life, quality of life, and other indicators of the psychophysical
      condition of the patient.
    

Detailed description: 
      The underlying hypothesis of the study is that patients with chronic pain that go through a
      series of nutrition education (individual and group) specifically tailored to fit their needs
      (based on our preliminary findings), they increase the consumption of foods that have
      antiinflammatory properties, which will result in lower levels of inflammatory cytokines in
      the body (high sensitivity C-reactive protein (hs-CRP ), interleukin (IL) -2, IL-4 and IL-6),
      and consequently reduce the intensity of pain. Also, weight loss in obese patients is
      expected, and it will have an contributing effect of the intervention. Patient's quality of
      life and indicators of their psychophysical condition (eg, depression level) are also
      expected to improve.

      Chronic pain patients who either attend Daily clinic (Control Arm) or the 4-week
      multidisciplinary programme at the Department of Anesthesiology, Resuscitation and Intensive
      Care (Intervention Arm) will be recruited. They will be followed for total of 8 weeks (4 week
      intervention + 4 week follow-up).
    

Intervention name(s): Nutrition Education
Intervention type(s): Other
Intervention description(s): Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.
Other intervention name(s): Chronic Pain Nutrition Education
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain; nutrition education; inflammatory biomarkers
Interaction Study of Clopidogrel 600/150 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

        -  Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 mg/day) on
           Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with
           omeprazole 80 mg/day compared to given alone in healthy male and female subjects

      Secondary Objective:

        -  Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when
           clopidogrel is given either alone or concomitantly with omeprazole
    

Detailed description: 
      The total study duration per subjects is 8 - 9 weeks broken down as follows:

        -  Screening: 2 to 21 days before the first dosing (clopidogrel or omeprazole)

        -  Period clopidogrel/placebo: 7 days including 5 days treatment

        -  Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment

        -  Washout between periods: at least 14 days after last dosing with respect to clopidogrel
           treatment

        -  End of study: 7 to 10 days after the last dosing
    

Intervention name(s): Clopidogrel; Placebo; Omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: matching tablet
Route of administration: oral; Pharmaceutical form: delayed-release capsule
Route of administration: oral
Other intervention name(s): SR25990
Intervention MeSH terms: Omeprazole; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ®
      following administration of a single-dose in healthy volunteers.
    


Intervention name(s): M834; US-Sourced Orencia®; EU-Sourced Orencia®
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Abatacept; Abatacept
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Seasonal Affective Disorder and Visual Impairment
Condition: Seasonal Affective Disorder; Visual Impairment
MeSH terms: Vision Disorders; Vision, Low; Mood Disorders; Seasonal Affective Disorder
Study type: Interventional

Summary: 
      As a subtype of major depressive disorder, seasonal affective disorder (SAD) or winter
      depression causes severe reductions in both quality of life and productivity and results in
      high morbidity and frequent sick leave (1). SAD is a prevalent disorder with rates as high as
      3-5% in central European countries and 8-10% in Scandinavian countries. In our recent
      screening survey among persons with severe visual impairment or blindness (visual acuity <
      6/60), we found a strikingly high prevalence of SAD of 17 % compared to 8% in the fully
      sighted control group. Persons with maintained light perception had a highly increased SAD
      prevalence of 18 % whereas no light perception (NLP) respondents had an SAD prevalence of 13
      %. Light is unquestionably of great importance in the development and treatment of SAD. It is
      suggested that a reduced retinal sensitivity to light leads to sub-threshold light input to
      the brain and consequently to the development of SAD. The novel retinal non-visual
      photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), are
      involved in the regulation of circadian rhythm and mood and their function are in part
      independent of the function of the classical rod and cone photoreceptors which form the basis
      of conscious visual perception. Function of the ipRGCs can be assessed by chromatic
      pupillometry where the sustained pupillary contractions following blue light stimulation
      (PIPR) is the main outcome. In persons with SAD without eye disorder the function of the
      ipRGCs is reduced. We here wish to investigate associations between ipRGC function and SAD
      symptoms, circadian profile and treatment response to light therapy in persons with visual
      impairment.

      Persons with visual impairment (SAD and non-SAD) are assessed for ipRGC function with
      chromatic pupillometry, for seasonal mood variation by interview and questionnaire and for
      diurnal melatonin secretion by saliva analysis summer and winter. In winter SAD participants
      are treated with daily morning bright light for 6 weeks. Reduction in depression scores and
      tolerability is recorded.
    


Intervention name(s): light therapy
Intervention type(s): Device
Intervention description(s): 6 weeks morning treatment with bright light therapy in own home.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study combines two models: a case/control study with observational outcomes where all cases are consequently included in a non-randomized interventional study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pupillometry; light therapy; visual impairment; melatonin; ipRGC
Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Background The purpose of this study was to evaluate the effect of a single-dose intravenous
      dexketoprofen administration for preventive analgesia on postoperative pain and reducing
      swelling in double jaw surgery.

      Material and Methods The authors designed a prospective, randomized, and double-blind cohort
      study. Patients who have Class III malocclusion were randomly divided in two groups. 50 mg
      intravenous dexketoprofen trometamol were administrated 30 minutes before incision in
      treatment group, while intravenous sterile saline was administrated 30 minutes before
      incision in placebo group. The primary predictor variable was treatment group. Primary
      outcomes were pain, swelling and 24-hour opioid intake. Patient- controlled analgesia with
      tramadol was given for management of postoperative pain. Other variables were demographic and
      operation related parameters. Visual analogue scale was used to evaluate postoperative pain.
      3dMD Face System (3dMD, USA) was used to measure postoperative swelling. Data were analysed
      using two independent samples t test and Mann Whitney U test.
    


Intervention name(s): iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey); Steril Salin (control)
Intervention type(s): Drug; Drug
Intervention description(s): The primary predictor variable was preventive analgesia group. Patients were randomly divided in two groups. 50 mg iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey) were administrated 30 minutes before incision in the treatment group (dexketoprofen trometamol n= 15; 30 minutes before incision in the treatment group (dexketoprofen trometamol n= 15) and iv sterile saline were administrated 30 minutes before incision in the placebo group (saline n= 15).
Intervention MeSH terms: Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preventive analgesia; Pain; Swelling; Orthognathic surgery; Dexketoprofen; 3dMD
Comparison of Balance and Fall Risk in Unilateral and Bilateral Total Knee Arthroplasty
Condition: Knee Arthropathy
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Static or dynamic postural control cannot be fully restored in patients with Total Knee
      Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present
      in both extremity after TKA. However, the contralateral knee OA grade, asymmetrical gait
      pattern, and postural sways still remain a risk factor for balance deficits and falls. Based
      on this rationale, the aim of this study is to evaluate the balance and fall risk before and
      after TKA in patients who suffered from bilateral knee osteoarthritis and to clarify the
      balance and fall risk difference between unilateral and bilateral TKA patients.
    

Detailed description: 
      Falls are one of the leading causes of increased morbidity and mortality in the elderly
      population and are substantial contributor to increase healthcare cost burden. Pain, strength
      deficits, knee joint deformities, balance and proprioceptive impairments associated with
      severe knee OA, contribute to an increased risk of falling among elderly, and more than 50%
      of this population experience a fall each year. Static or dynamic postural control cannot be
      fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance
      and postural control may still be present in both extremity after TKA. Increased
      weight-bearing on the operative side after TKA and reduced weight-bearing weight in the
      contralateral osteoarthritic knee can reduce pain and improve balance-related functions.
      However, the contralateral knee OA grade, asymmetrical gait pattern, and postural sways still
      remain a risk factor for balance deficits and falls. Based on this rationale, the aim of this
      study is to evaluate the balance and fall risk before and after TKA in patients who suffered
      from bilateral knee osteoarthritis and to clarify the balance and fall risk difference
      between unilateral and bilateral TKA patients.
    

Intervention name(s): Total knee arthroplasty
Intervention type(s): Procedure
Intervention description(s): Surgical procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fall risk; balance; total knee arthroplasty; function
Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single dose, pharmacokinetic (PK) study conducted at 1 study center in
      the United States (USA). This study will evaluate the absorption, distribution, metabolism,
      and elimination (ADME), mass balance, safety, and tolerability of a single dose of
      intravenously administered 14C-AAI101.
    


Intervention name(s): 1 µCi of 14C-AAI101 + 500 mg AAI101
Intervention type(s): Drug
Intervention description(s): Single dose open label
Other intervention name(s): 14C-AAI101 + 500 mg AAI101 iv infusion
Intervention MeSH terms: Enmetazobactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone
Condition: Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Interventional
Phase: Phase 3

Summary: 
      35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6
      months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter
      more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by
      administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C)
      could make the hepatocytes more resistant and improve survival. The investigators' study's
      primary endpoint was improvement of survival at 6 months. The secondary endpoints were
      survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7
    

Detailed description: 
      AAH patients (Maddrey score > 32 and compatible histological results) should centrally
      randomized into the C-NAC or C groups. Both groups received 4 weeks of prednisolone
      treatment, plus NAC for the combination therapy group (D1: 150, 50 and 100 mg/kg in 250, 500
      and 1000 mL of 5% glucose-saline (G5%) respectively, at t=30 minutes, 4 and 16 hours; D2 to
      D5, 100 mg/kg in 1000 mL of G5%). Group C received 1000 mL of G5%, D1-5
    

Intervention name(s): Corticoids plus N Acetyl Cysteine
Intervention type(s): Drug
Intervention description(s): 40 mg/d prednisolone N Acetyl Cysteine infusion 150mg/kg in 30 minutes then 50 mg/kg in 4 h then 100mg/kg in 16 h and finally 100mg/d2 to d5
Other intervention name(s): AAH-NAC study
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute Alcoholic Hepatitis; Cirrhosis; Alcohol; Alcoholic Liver disease
Mechanisms Defending Fat Mass in Humans After Lipectomy
Condition: Disproportionate Shape; Expanded Fat Pads
Study type: Interventional

Summary: 
      Liposuction surgery is common, yet animal and limited human data suggest that fat returns
      when removed. This study was designed as a 1-year randomized-controlled trial of suction
      lipectomy versus no intervention to determine if adipose tissue is defended, and if so to
      determine the anatomic pattern of redistribution.
    

Detailed description: 
      Specific Aims:

        1. To determine if suction lipectomy fails to modify regional and/or total body fat over
           three years.

        2. To determine if the expression of candidate genes predicts and/or relates to
           subcutaneous adipose tissue growth or depletion in subcutaneous adipose tissue after
           suction lipectomy.

        3. To examine adipose tissue before and after suction lipectomy to uncover novel genes
           where expression predicts and/or relates to subcutaneous adipose tissue growth or
           depletion after subcutaneous suction lipectomy.
    

Intervention name(s): Standard of Care with Liposuction; Standard of Care without Liposuction
Intervention type(s): Procedure; Other
Intervention description(s): Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies, followed by Liposuction surgery.; Standard of Care encompasses body composition measurements, a euglycemic clamp and fat biopsies. Liposuction surgery will not be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fat mass; body composition
Assessment of Colonic Epithelial Integrity With Mucosal Impedance
Condition: Inflammatory Bowel Diseases
MeSH terms: Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      In this study, the investigators propose to use mucosal impedance (MI), a minimally invasive
      technology, to detect mucosal damage (i.e. barrier dysfunction) based on mucosal conductivity
      changes in the colonic epithelium.
    

Detailed description: 
      The intestinal epithelium functions to separate luminal contents from the interstitium.
      Increased intestinal permeability can represent compromise of the epithelium's integrity.
      Prior research has demonstrated that defects in intestinal barrier function are associated
      with inflammatory bowel disease (IBD) and increased intestinal permeability can be important
      in the maintenance of remission in IBD patients. There is currently not a convenient way to
      measure colonic epithelial barrier function in real time which could provide clinically
      relevant information .
    

Intervention name(s): mucosal impedance (MI) testing
Intervention type(s): Diagnostic Test
Intervention description(s): During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be identified by physicians in the endoscopy center at Vanderbilt. Those
        patients undergoing colonoscopy for either the indication of screening colonoscopy or IBD
        surveillance will be asked, on the day of their colonoscopy, whether they want to
        participate in the study.