bioihbjkbjnl/mcl2 huggingface dataset:
Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery
Condition: Postoperative Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect and safety of prucalopride on recovery of
      gastrointestinal function in patient undergoing major gastrointestinal surgery. The
      investigators hypothesize that patients who take prucalopride after major gastrointestinal
      surgery will have shorter duration of postoperative ileus.
    

Detailed description: 
      Postoperative ileus (POI), an interruption of bowel motility function, virtually occurs in
      all patients undergoing major gastrointestinal(GI) surgery. This functional impairment
      persists for a variable duration, usually resolving within 1 day in the small intestine, 1 to
      3 days in the stomach and 3 to 5 days in the colon. Therefore, time of return of colonic
      function is the the major determinant of duration of POI. Attempts to reduce the duration of
      POI have prompted the implementation of fast track surgery including early removal of the
      nasogastric tube, early feeding, alvimopan, gum chewing, and prompt ambulation. However, it
      is still reported to be more than 4-5 days in most of the randomized trial. Therefore,
      methods specifically aiming at promoting postoperative colon motility may further enhance the
      GI function recovery, and prucalopride may be one of the options.

      Prucalopride, a substituted benzamide with selective 5-HT4 agonist activity, has been shown
      previously to significant improve colon motility and transit, but it only has mild effect on
      gastric or small bowel transit. The drug is well tolerated with no significant adverse
      effects. Recently, prucalopride has been approved in Europe and America for the symptomatic
      treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
      However, its usage in the postoperative period has not been tested. This study will test the
      ability and safety of prucalopride given 24hrs after GI surgery to hasten the recovery of GI
      function.
    

Intervention name(s): Prucalopride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Prucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment; Vitamin, 50mg, tablet.
Other intervention name(s): Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Prucalopride; Gastrointestinal Diseases; Postoperative ileus; Randomised trial
A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to see if the use of the InPen® for teens and young adults up to
      age 21 years with type 1 diabetes helps to decrease burden and improve glycemic control.
    

Detailed description: 
      Investigators will perform a randomized, cross-over prospective interventional study. Half of
      the participants will be randomized to the InPen® and the other half will continue with their
      conventional insulin injection protocol. After 90 days, participants will switch to the
      second arm. Randomization will occur via block randomization. Teaching to use the InPen® will
      be done by Sarah Jackson, DO with supervision by Ana Creo, MD, which can be done by a
      telemedicine visit if it does not align with clinic visit. You will be followed for three
      months with hemoglobin A1c at the beginning and the end of the study. Data from the
      (Continuous Glucose Monitor (CGM) and InPen® will be analyzed including time in glucose goal
      range (70-180 mg/dL), glucose standard deviation, percentage of time that is spent high
      (>180-250 mg/dL), very high(> 250 mg/dL), low(54-70 mg/dL) and very low(<54 mg/dL), along
      with total daily insulin dose. Data on missed insulin doses will be assessed via data from
      the InPen®. You will be randomized to traditional injections we will ask them to record
      missed insulin doses weekly. You should still adjust insulin doses at home, like they do at
      baseline. If insulin adjustments are made while in one arm of the study they should still
      continue that dosing when they cross over. Investigators will also assess quality of life and
      fatigue related to technology with surveys prior to start of the study and at the end.
      Specifically, investigators will assess diabetes distress, transition readiness, and parental
      experience of childhood illness scales. Investigators will also utilize the insulin delivery
      satisfaction survey to assess how you view your current regimen and then how you view the
      effects of the InPen in managing your type 1 diabetes.
    

Intervention name(s): InPen®
Intervention type(s): Device
Intervention description(s): A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Adolescents; Young Adults; Continuous Glucose monitoring (CGM)
Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at different tablets with a new study medicine called semaglutide. It is to
      treat diabetes. The aim of the study is to find out how much study medicine from 4 different
      tablets is taken up in the body. Participants will either get semaglutide in the tablet
      currently being studied in large studies, or 1 of the 3 new tablets that also contains
      'semaglutide' - which treatment participants get is decided by chance. The tablet version of
      study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as
      injections for the treatment of diabetes in some countries. Participants will get 1 tablet
      per day for 10 days. The tablets should be taken in the morning by mouth together with half a
      glass of water. After dosing participants have to wait 30 minutes before participants may eat
      or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the
      study doctor. Some of the visits are overnight stays. Participants will have blood tests at
      every visit.
    


Intervention name(s): Semaglutide 3 mg; Semaglutide 7 mg; Semaglutide B 3 mg; Semaglutide B 7 mg; Semaglutide C 3 mg; Semaglutide C 7 mg; Semaglutide D 3 mg; Semaglutide D 7 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.; Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.; Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.; Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.; Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.; Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.; Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.; Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation
Condition: Bronchiectasis Adult
MeSH terms: Bronchiectasis
Study type: Observational

Summary: 
      No study have evaluated the efficacy and safety of airway clearance therapy (ACT) and
      bronchoalveolar lavage (BAL) under bronchoscope for bronchiectasis.

      This study aimed to evaluate the clinical efficacy and safety of tran-bronchoscopy airway
      clearance and bronchoalveolar lavage in the treatment of moderate to severe bronchiectasis
      with acute exacerbation:A randomized, prospective cohort study.
    

Detailed description: 
      The aim of this study was to evaluate the efficacy and safety of ACT combined with BAL for
      bronchiectasis patients with acute exacerbation through the whole study process, which will
      provide a high quality of evidence-based strategies for the treatment, revision and
      optimization of international and domestic clinical guidelines for bronchiectasis. All the
      participants will be required to check the various efficacy and safety indicators.
    

Intervention name(s): Version BF-1T26 electronic bronchoscope
Intervention type(s): Device
Intervention description(s): Interventions involving the therapy of airway clearance and bronchoalveolar lavage by Version BF-1T26 electronic bronchoscope
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with bronchiectasis being suffering an acute exacerbation of this disease.
Media Project and Health Study - Spanish Version
Condition: Depression, Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      We seek to test the efficacy of the Spanish version of the "Catalina" web-app intervention
      compared to an attention control web-app in reducing symptoms of depression and/or anxiety
      and motivate women to take action to get help.
    


Intervention name(s): Catalina Story-Based Web-App; Attention Control Web-App
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Latinas in the experimental group will view a story-based web-app featuring a character named "Catalina" and psycho-therapeutic modules to motivate them to take action and get help for their symptoms of depression and/or anxiety.; Latinas in the attention control group will view non-story based media that is informational.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Determination of the Best Positive End-expiratory Pressure (PEEP)
Condition: Positive Expiratory Pressure; Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Determination of the best positive end-expiratory pressure (PEEP) based on oxygenation or
      driving pressure in patients with acute respiratory distress syndrome (ARDS) after
      cardiothoracic surgery

      The use of a positive end-expiratory pressure in acute respiratory distress syndrome is
      obvious in ARDS management. On the one hand it serves to fight against the reduction of
      functional residual capacity (FRC) and enable the limitation of hypoxia; and on the other
      hand it allows the limitation of "opening/closing" lesions in pulmonary alveoli which lead to
      increase "bio trauma".

      However elevated PEEP has harmful effect such as hemodynamic effect on the right ventricle
      and distension on healthy part of the lung.Other adverse effects are: decreasing cardiac
      output, increased risk of barotrauma, and the interference with assessment of hemodynamic
      pressures.

      Ideally the adjustment of PEEP level must be done by taking into account each patient
      characteristic. PEEP titration based on blood gas analysis is one of the most used techniques
      by physicians.

      Current guidelines for lung-protective ventilation in patients with acute respiratory
      distress syndrome (ARDS) suggest the use of low tidal volumes (Vt), set according to ideal
      body weight (IBW) of the patient, and higher levels of positive end-expiratory pressure
      (PEEP) to limit ventilator-induced lung injury (VILI). However, recent studies have shown
      that ARDS patients who are ventilated according to these guidelines may still be exposed to
      forces that can induce or aggravate lung injury.

      Driving pressure (DP) is the difference between the airway pressure at the end of inspiration
      (plateau pressure, Ppl) and PEEP.

      Driving pressure may be a valuable tool to set PEEP. Independent of the strategy used to
      titrate PEEP, changes in PEEP levels should consider the impact on driving pressure, besides
      other variables such as gas exchange and hemodynamics. A decrease in driving pressure after
      increasing PEEP will necessarily reflect recruitment and a decrease in cyclic strain. On the
      contrary, an increase in driving pressure will suggest a non-recruitable lung, in which
      overdistension prevails over recruitment.

      The main purposes of this study are to assess the optimal PEEP based on the best driving
      pressure or the best oxygenation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient admitted to adult intensive care with ARDS following cardiothoracic surgery.
Modified Constraint Induced Movement Therapy in Children With Obstetric Brachial Plexus Injury
Condition: Obstetric; Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The aim of this study was to increase and improve the use of affected extremity in obstetric
      brachial plexus palsy children while restricting the use of less affected arm and the purpose
      was to improve the function, Range of motion and disability in affected arm of children with
      brachial plexus injury.
    


Intervention name(s): Conventional physical therapy treatment; Constraint induced movement therapy
Intervention type(s): Other; Other
Intervention description(s): The control group (group A) will receive the exercise program which focused on improving the arm function as well as shoulder abduction and external rotation for 10 week.
stretching Aeroplan positioning; The study group (group B) who will receive Modified constraint induced movement therapy for 3 hrs. a day 12 hrs. a week in addition to the same exercise program given to the control group for 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: birth injuries therapy; arm function; constraint induced movement therapy; brachial plexus neuropathies
Sleep Quality and Amyloid-Beta Kinetics
Condition: Amyloid-beta
MeSH terms: Amyloidosis
Study type: Interventional

Summary: 
      The purpose of this study is to change the concentration of amyloid-beta in human
      cerebrospinal fluid (CSF) by modification of sleep efficiency.
    

Detailed description: 
      The purpose of the study is to investigate whether or not increasing sleep efficiency will
      change the concentration of amyloid-beta in cerebrospinal fluid (CSF).
    

Intervention name(s): Suvorexant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.; Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.
Other intervention name(s): Belsomra; sugar pill
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
A Study of LY3045697 After Multiple Oral Dosing in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of LY3045697 after
      multiple doses and to determine how long LY3045697 remains in the body. Each participant is
      expected to complete 3 dosing periods. At least 7 days will pass between dosing periods.
    


Intervention name(s): LY3045697; Placebo; Spironolactone; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered as oral solution; Administered as oral solution; Administered as capsule; Administered as capsule
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
PHASE IIA: Trial of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)(OND003IND)
Condition: Methamphetamine Dependence; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to determine the outcome of a drug combination treatment on
      detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users. The
      combination regimen consists of oral administration of a generic immediate-release
      methylphenidate (MPh-IR) formulation (e.g., Ritalin®) and a novel delayed, pulsatile-release
      formulation of the antiemetic ondansetron (Ond-PR002). Various psychological assessment tools
      and functional magnetic resonance imaging (fMRI) will be used to assess the treatment
      outcome. In addition to the treatment outcome measures, we will determine whether the 14-day,
      once-a-day treatment leads to significant changes in the pharmacokinetic/pharmacodynamic
      (PK/PD), safety and tolerability parameters of MPh-IR and/or Ond-PR002 formulations and
      drug-drug interactions between the two drugs.
    


Intervention name(s): OND-PR002 and MPh-IR; Placebo: Two dextrose capsules for Ond-PR002 and MPh-IR
Intervention type(s): Drug; Other
Intervention description(s): Drug: OND-PR002
Single daily oral doses of 8 mg Ond-PR002
Drug: MPh-IR
Single daily oral doses of 20 mg MPh-IR; Single daily oral doses
Other intervention name(s): Ondanasetron; Zofran®; Methylphenidate; Ritalin®; Placebo
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Social Media on the Development of Anorexia Nervosa
Condition: The Focus of Study Were the Medical Students Whose Eating Behaviors Were Studied
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      The study involves the recruitment of medical students from all government medical colleges
      of Karachi,Pakistan. The sample size was 214. The study is a cross sectional study that
      requires the participants to fill out an online questionnaire after giving an informed
      consent online.
    

Detailed description: 
      The study involves the recruitment of medical students from all government medical colleges
      of Karachi, Pakistan. The sample size was 214. The study is a cross sectional study that
      requires the participants to fill out an online questionnaire after giving an informed
      consent online.The questionnaire contained 15 items related to their social media use and its
      impact on their body image and eating behaviours.
    

Intervention name(s): survey based information
Intervention type(s): Other
Intervention description(s): Only survey based information collected
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Medical students of Karachi
Comparison of 25mg Versus 5 mg Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a randomised, parallel-group, multicenter phase III study for maintenance
      therapy with lenalidomide in patients with multiple myeloma who were treated with high-dose
      therapy and autologous stem cell transplantation as first line therapy.
    

Detailed description: 
      High-dose therapy will be performed as first line treatment. After high-dose therapy and
      autologous stem cell transplantation the patients will be included and randomised. Three
      month after high-dose therapy all patients will receive consolidation therapy with 6 cycles
      of lenalidomide 25 mg daily for 21 days every 28 days. Afterwards patients will receive
      maintenance therapy according to their assigned treatment arm. Randomisation will be
      performed in a 1:1 ratio to continuous maintenance therapy with either 25mg or 5mg
      lenalidomide daily for 21 days every 28 days.Randomisation will be stratified by ISS-stage
      (1+2 vs 3, age (younger than 66 years versus 66 years or older), response after high-dose
      therapy (CR+vgPR vs PR vs MR/SD. Patients will be treated until disease progression.
    

Intervention name(s): Lenalidomide; Lenalidomide
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive maintenance therapy according to their assigned treatment arm: 25 mg daily for 21 days every 28 days. During the treatment period patients will be seen every 4 weeks until disease progression is documented. All patients who have to discontinue the study drug will be followed until disease progression.; Patients will receive maintenance therapy according to their assigned treatment arm:5 mg daily for 21 days every 28 days. During the treatment period patients will be seen every 4 weeks until disease progression is documented. All patients who have to discontinue the study drug will be followed until disease progression
Other intervention name(s): Revlimid; Revlimid
Intervention MeSH terms: Lenalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Multiple Myeloma; maintenance therapy; lenalidomide