bioihbjkbjnl/mcl2 huggingface dataset:
Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Magnesium sulphate is given to the patients during the colorectal cancer surgery under the
      hypothesis that it would attenuate the postoperative hypercoagulability. The investigators
      intend to characterize the changes of coagulation in colorectal cancer patients by using the
      point-of-care device after the infusion of magnesium sulphate.
    


Intervention name(s): Magnesium Sulfate; Normal saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the pharmacokinetics (PK) of AMG 510
      administered as 8 x 120-mg tablets and as water dispersion in healthy participants.
    


Intervention name(s): AMG 510
Intervention type(s): Drug
Intervention description(s): Tablets
Intervention MeSH terms: Sotorasib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy participants; AMG 510
A Study to Assess Relative Bioavailability of and Effect of Food on a New Oral Tablet Formulation of GLPG3970
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the relative bioavailability of a GLPG3970 oral tablet formulation
      compared to an oral solution formulation and the effect of food on the bioavailability of a
      single dose of the oral tablet formulation of GLPG3970. It will also evaluate the safety and
      tolerability of a single dose of GLPG3970.
    


Intervention name(s): GLPG3970 oral solution; GLPG3970 tablet
Intervention type(s): Drug; Drug
Intervention description(s): GLPG3970 for oral administration; GLPG3970 for oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reliability and Validity of Urdu Version of the King's Health Questionnaire
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Observational

Summary: 
      This study is aimed to translate King's Health Questionnaire into Urdu language and to test
      its reliability and validity among Pakistani women with urinary incontinence.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Females presenting with Urinary Incontinence
      
Keywords: Urinary Incontinence; King's Health Questionnaire; Reliability; Validity
Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who
      have metastatic malignant melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the efficacy of flavopiridol in patients with previously untreated metastatic
           malignant melanoma.

        -  Assess the toxicity of this treatment in these patients.

        -  Assess the time to progression, early progression rate, and response duration in these
           patients when treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment continues every 21 days
      for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

      Patients are followed at 4 weeks, and then every 3 months until disease progression or death.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18
      months.
    

Intervention name(s): alvocidib
Intervention type(s): Drug
Intervention MeSH terms: Alvocidib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV melanoma
Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)
Condition: MDD; Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients
      with depression coexisting with generalized anxiety disorder.
    

Detailed description: 
      100 patients, recruited from psychiatrist outpatient clinics are planned for enrolment.
      Approximately 50 of these patients will receive vortioxetine as a first treatment for the
      current Major Depressive Episode (MDE) (first treatment patients) and 50 patients will be
      switched to vortioxetine due to inadequate response to the current antidepressant medication
      treatment (switch patients).
    

Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Vortioxetine 10 and 20 mg/day, tablets, orally Patients will receive 10 mg vortioxetine once daily for the first week. At Visit 2, the dose will be increased to 20 mg/day. The dose may subsequently be adjusted to 10 or 20 mg/day at scheduled or unscheduled visits depending on patient's response as per investigator judgment.
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Timing of Tracheostomy in COVID-19 - Impact on Mortality
Condition: Tracheostomy
Study type: Observational

Summary: 
      How timing of tracheostomy in COVID-19 patients changed and its impact on mortality in
      patients with severe COVID-19 ARDS
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with underlying sheer COVID-19 disease and need for endotracheal airway
        management. Who required a tracheostomy due to the prolonged ventilation and ventilatory
        weaning required.
Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD)
Condition: Seasonal Affective Disorder
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Study type: Interventional

Summary: 
      One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal
      Affective Disorder(SAD) or so called winterdepression is a disturbance of circadian rhythms.
      Since the circadian system is especially sensitive for the blue portion of the light
      spectrum, a new light therapy device with more blue light (blue enriched polychromatic light)
      was tested for its efficacy to treat SAD. In chronobiological terms this light is
      hypothesized to be more potent in inducing non-visual effects. In the present study
      fluorescent tubes that emit a high portion of short wavelength light on top of the normal
      wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour
      temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients.,
      The investigators hypothesise that blue- enriched light improve the therapeutic effects of
      light treatment leading to a higher response or the same response in a shorter time schedule
      compared to standard light treatment.
    


Intervention name(s): Original Energy Light,; Original Energy Light prototype; Original Energy Light prototype
Intervention type(s): Device; Device; Device
Intervention description(s): 9000 lux, 30 minutes in the morning; 9000 lux 20 minutes in the morning; 9000 lux 30 minutes in the morning
Other intervention name(s): Philips energy light HF 3308; 2 lamps PLL36W color 5000K; Philips energy light HF 3308; 2 lamps PLL36W color 17000K; Philips energy light HF 3308; 2 lamps PLL36W color 17000K
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seasonal affective disorder; phototherapy; circadian rhythms; blue enriched light; melanopsin; Primary disease: Seasonal Affective Disorder, winter type
Delivery Vehicles for Prenatal Calcium Supplementation
Condition: Pregnancy
Study type: Observational

Summary: 
      The SickKids-led research team is currently developing a prenatal micronutrient powder that
      will contain calcium, iron, and folic acid with different absorption characteristics. Once
      the powder is developed, it can be incorporated into various oral delivery vehicles. The
      overall effectiveness of a micronutrient program is highly dependent on the acceptance and
      regular consumption of supplements (i.e., adherence) by the targeted users. This is a study
      of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the
      innovative prenatal multiple micronutrient supplement: traditional tablets, oral
      disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with
      a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study
      hypothesizes that that the formulation of the delivery vehicle will impact preference,
      acceptability, and palatability.
    


Intervention name(s): Traditional Tablet; Chewable tablets; Unflavoured Powder; Flavoured Powder
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The traditional tablets will be swallowed with liquid. Each tablet will contain 500 mg of calcium (as calcium carbonate), thus participants will be asked to take 3 per day.. Participants will be asked to take the tablets with a liquid of their choosing with a meal. Traditional tablets will function as a control in this study, as they represent what is widely available on the market in Bangladesh.; Chewable tablets are chewed in the absence of additional water. Each chewable tablet will contain 300 mg of calcium (as calcium carbonate), thus participants will be asked to take 5 per day. Participants will be asked to consume the chewable tablets with a meal.; The unflavoured powder with suspension agent will be tasteless and consumed by either adding it to a semi-solid food or drink of one's choosing. Appropriate foods for mixing with the powder will be at the discretion of the participants. This vehicle was selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. A similar product is Sprinkles, a multiple micronutrient powder developed at SickKids by Dr. Zlotkin.; The flavoured powder with suspension agent will be consumed by adding it to clean water with a meal. This vehicle was also selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. Similar products include oral rehydration salts or artificial juice flavour crystals.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who are between 13 and 30 weeks pregnant. Participants will be recruited from
        Shimantik .
      
Keywords: Pregnancy; Calcium; Supplements
Effect of Tooth Cleaning in Smokers and Non Smokers With Gum Disease.
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      This study is intended to measure hepatocyte growth factor levels in smokers and non smokers
      with periodontitis before and after non surgical periodontal therapy.
    

Detailed description: 
      The study was randomised prospective,interventional clinical trial. The sample size for the
      study was 40 individuals aged between 20 to 60 years,equally divided into two groups.

      Group l - smokers with chronic periodontitis (test) group. Group ll - non smokers with
      chronic periodontitis (controls)

      At baseline both the groups were analysed for clinical and biochemical parameters and
      underwent non surgical periodontal therapy( scaling and root planning). All parameters were
      reassesed after 3 months.

      A total of 40 patients( 20 somkers and 20 non smokers) from the outpatient wing of department
      of periodontics, Panineeya mahavidyalaya institute of dental sciences and research centre
      diagnosed with chronic periodontitis and willing to participate in the study.

      Clicical parameters included gingival index and periodontal index. Biochmeical parameters
      included plasma hepatocyte growth factor.
    

Intervention name(s): NSPT; Scaling and root planing
Intervention type(s): Other; Other
Intervention description(s): NSPT was done by ultrasonic scalers after administration of pre procedural mouth rinse in the test group (20 smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to assess the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.; Scaling and root planing was done by ultrasonic scalers after administration of pre procedural mouth rinse in the control group (20 non smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to assess the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy
Condition: Surgical Site Infection; Surgical Wound; Surgical Wound Infection; Surgical Complication; Surgical Wound Dehiscence; Surgical Wound Haemorrhage; Surgical Wound, Healed
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Emergencies; Hemorrhage; Surgical Wound Dehiscence; Wounds and Injuries; Surgical Wound
Study type: Interventional

Summary: 
      The purpose of this study is to find differences in rates of surgical site infections
      following emergency laparotomy with the use of two different incisional negative pressure
      wound therapy (iNPWT)devices.
    

Detailed description: 
      A multi-arm, randomized, single institution trial was conducted. All patients proposed for
      emergency laparotomy for different etiologies where considered eligible. Patients were
      enrolled following signature of informed consent.

      Excluded from this group were patients with recent previous interventions (laparotomy or
      minimally invasive surgery), patients not wishing a iNPWT device or patients with specific
      contraindications to any device.

      Later where excluded from the study patients on laparostomy, Intraoperative diagnosis of
      irreversible disease (Ex: Extensive mesenteric ischemia).

      Following enrollment patients were randomized to 3 groups - control group with standard
      dressings; PICO group with Pico® (Smith & Nephew Inc, Andover, MA) dressing and Prevena group
      using Prevena® (KCI USA, Inc., San Antonio, TX) dressing.

      Following admission the patients were monitored for surgical site occurrences and other
      complications by the investigation team until discharge. Subsequent 2 week post-operative
      evaluation (if patient had been discharged) was carried out in outpatient.

      A final consultation was made 30 days postoperatively.
    

Intervention name(s): Incisional negative pressure wound therapy; Control group - standard wound dressing
Intervention type(s): Device; Other
Intervention description(s): Application of negative pressure wound therapy for prophylaxis of surgical site occurrences; Covering of surgical wound with standard wound dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: iNPWT; Incision negative pressure wound therapy; emergency laparotomy; general surgery; surgical site infection
Efficacy of Dietary Supplementation With Lactobacilllus Reuteri DSM 17938 on Functional Abdominal Pain (FAP) in Children
Condition: Functional Abdominal Pain (FAP) in Children
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency
      and severity in children of 5-16 years old and with diagnosis of FAP.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study. Subjects between of 5-16 years
      of age with FAP as defined in the Rome III criteria and with pain severity of at least 40 mm
      on a 100 mm VAS scale and pain frequency of at least 1 episode per week over the preceding 8
      weeks will be recruited. In accordance to the specific Rome III criteria for inclusion, FAP
      is defined as a variable combination of chronic or recurrent gastrointestinal symptoms not
      explained by structural or biochemical abnormalities.

      A study questionnaire to record pain and other gastrointestinal symptoms will be used.

      One-hundred and six (106) Subjects will be randomized to receive either dietary
      supplementation with L. reuteri DSM 17938 (2 chewable tablets with breakfast), or the same
      number of comparable placebo tablets, for 4 weeks. Supplementation will be stopped after 4
      weeks, and the subjects will be followed up for an additional 4 weeks. The subjects will
      complete a diary to record frequency and intensity of pain, use of medication, deviation from
      the usual diet, physical activities, and absence from school and other activities.
      Gastrointestinal symptoms are assessed by the GSRS (Gastrointestinal Symptom Rating Score).

      Subjects/caregivers will be instructed to maintain the usual diet throughout the study, but
      not to consume other probiotics (foods or supplements) during the entire study period.

      The symptoms diary will be completed daily by the parents and will report information on the
      frequency of pain episodes, location of pain, presence or absence of associated symptoms,
      need to take medication for pain and interference with normal activities. The intensity of
      the symptoms will be assessed by using the Wong-Baker Faces scale.
    

Intervention name(s): L. reuteri DSM 17938 chewable tablets; Placebo chewable tablets
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 chewable tablets with breakfast for 4 weeks; 2 chewable tablets with breakfast for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional abdominal pain; Probiotics; Lactobacilus reuteri
Point-of-Care Follow-Up With Primary Care After Emergency Department Discharge
Condition: Conditions Influencing Health Status
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The purpose of this trial is to determine whether setting up a follow-up appointment for
      patients who received treatment and were discharged from the emergency department increases
      their compliance with the follow-up appointment. We are enrolling patients who need a
      follow-up visit, have health insurance but report do not have a primary care doctor. Patients
      are randomized to one of three treatment groups: (1) assistance setting up a follow-up
      appointment by a research assistant using ZocDoc; (2) ZocDoc information given to the subject
      to set up follow-up appointment by him/herself; or (3) usual discharge instructions by ED
      staff. Subjects are phoned approximately 2 weeks after the ED visit and asked whether they
      completed a follow-up visit, satisfaction with their ED visit, satisfaction with their
      follow-up visit, and additional ED treatment and recovery.
    

Detailed description: 
      This is a randomized controlled trial involving adult emergency department (ED) patients who
      need a follow-up visit as defined by the ED provider (importance of follow-up rated as 5 or
      greater on a 0 to 10 scale). There is software available called ZocDoc that provides a user
      the ability to identify primary care providers who have open appointments and will take the
      person's health insurance (in network and outside of network) and list the doctors based on
      their proximity to the person in need. We are testing whether booking appointments for ED
      patients using ZocDoc vs. giving patients the information to use ZocDoc themselves vs.
      standard discharge instructions given by ED staff (i.e. you should follow-up with a primary
      care doctor) affects compliance with self-reported follow-up visits. We are enrolling
      patients while they are in the ED, completed a short baseline interview and then another
      interview with them over the telephone approximately two weeks after the index ED visit. The
      follow-up interview asks subjects whether they have completed a follow-up visit, satisfaction
      with the ED visit and the primary care visit, any other additional ED treatment and extent of
      recovery from the problem that brought them to the ED the first time.
    

Intervention name(s): ZocDoc Assistance; ZocDoc Information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Research assistant sets up a follow-up appointment for a subject with a primary care doctor using ZocDoc; Providing ZocDoc information to subjects so that they can make a follow-up appointment with a primary care doctor themselves
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Correlation Between Peripheral and Central Venous Blood Partial Pressure of Carbon Dioxide in Critical Ill Patients
Condition: Partial Pressure of Carbon Dioxide
Study type: Observational

Summary: 
      Observational study to analyze correlation between partial pressure of carbon dioxide from
      blood obtained from peripheral and central veins
    


Intervention name(s): Peripheral venous blood sampling
Intervention type(s): Diagnostic Test
Intervention description(s): Blood collected from peripheral venous (extremities) and central venous (central catheter) for blood gas analyses
Other intervention name(s): Central venous blood sampling
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All patients admiited to institutional ICU with central venous catheter in place
      
Keywords: partial pressure of carbon dioxide; carbon dioxide; peripheral venous blood; central venous blood; venous blood gas; blood gas analysis