bioihbjkbjnl/mcl2 huggingface dataset:
Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Asthma is a chronic disease, which means that it cannot be cured, but the investigators can
      use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and
      irritated which can cause coughing and make the airways tighten. This 'inflammation' is the
      root of the problem in asthma. Doctors have different ways to measure the inflammation in the
      airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by
      the lungs when asthmatic inflammation is present. The investigators have been using NO as a
      test in research labs for many years, but there are still unanswered questions about how it
      changes between morning and night and how quickly medicines work on it. In most asthmatics,
      even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in
      some people this does not seem to happen. The investigators now have portable NO machines
      that are designed for patients to use in the home. The investigators want to follow NO
      readings in patients with high levels to measure how they respond to different doses of
      steroid inhalers. The investigators hope this will help the investigators better understand
      asthma inflammation and treatments.
    


Intervention name(s): Fluticasone Propionate; Fluticasone Propionate
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled Fluticasone Propionate 50mcg bid; Inhaled Fluticasone Propionate 250mcg bid
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia
Condition: Conscious Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the administration of a standard anesthetic drug
      (propofol) using an automatic, expert-based system versus a manually controlled system by the
      anesthesiologist. In addition, the performance of the decision support system will be
      evaluated.
    


Intervention name(s): controlled administration of propofol
Intervention type(s): Drug
Intervention description(s): comparison of propofol sedation
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Surgical Stress and Intracorporeal Anastomosis
Condition: Laparoscopic Right Colectomy
Study type: Interventional

Summary: 
      The short-term advantages of minimally invasive colon resection have been well established in
      several randomized trials. A major factor in the development of morbidity is the surgical
      stress response with subsequent increased demand on the patient's reserves and immune
      competence. Although the advantage in term of stress response of laparoscopic surgery over
      open surgery has been widely reported, little is known about the role of Intracorporeal
      anastomosis.

      In an attempt to evaluate the surgical stress response after totally laparoscopic right
      colectomy a comparative study has been designed.

      Two surgical procedures will be evaluated:

        -  Totally laparoscopic right colectomy with intracorporeal anastomosis (Experimental
           group)

        -  Laparoscopic assisted right colectomy with extracorporeal anastomosis (Control group).
    


Intervention name(s): Laparoscopic right colectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic right colectomy for colorectal cancer with a standard vascular dissection, performing the anastomosis with a side-to-side mechanical anastomosis fashioned intracorporeally versus extra corporeally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Cachexia
MeSH terms: Muscle Weakness; Cachexia
Study type: Interventional
Phase: Phase 2

Summary: 
      Impaired physical function and muscle dysfunction are a major consequence of COPD, which may
      be associated with increased mortality, poor quality of life and increased health care use.
      This is a randomized, placebo-controlled, double-blind, parallel group study to evaluate the
      safety and tolerability of GSK2881078, an SARM over 13 weeks of dosing in older male subjects
      and post-menopausal female subjects with COPD and muscle weakness. This study will also
      assess the effect of GSK2881078 on physical strength and function after 13 weeks of
      treatment. Approximately 100 subjects with COPD and muscle weakness will be randomized into
      two cohorts of 50 male subjects and 50 female subjects. Within each cohort, subjects will be
      randomized to receive GSK2881078 or placebo in a ratio of 1:1. All subjects will participate
      in a standardized home exercise program, which will consist of daily walking, along with
      several resistance or weight-bearing exercises, such as bicep curls, upright rows, step ups
      and a sit-to-stand maneuver. The study will consist of a screening/Baseline period of up to
      30 days, a 13-week treatment period and a post-treatment follow-up period of 6 weeks.
    


Intervention name(s): GSK2881078; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2881078 will be available as capsules for oral administration. GSK2881078 will be administered once daily by the oral route at a dose of 1 mg and 2mg to post-menopausal female subjects and male subjects, respectively.; Subjects will be administered two capsules of GSK2881078 matching placebo once daily by the oral route.
Intervention MeSH terms: GSK2881078
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study treatment will consist of two dosing cohorts: Cohort 1 will comprise of male subjects randomized to receive either placebo or 2 milligrams (mg) of GSK2881078 and Cohort 2 will comprise of post-menopausal female subjects randomized to receive either placebo or 1 mg of GSK2881078.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK2881078; COPD; muscle weakness; post-menopausal; selective androgen receptor modulator
LGG/BB12-pastille Study
Condition: Probiotics
Study type: Interventional
Phase: Phase 1

Summary: 
      We want to study the effect of short-term consumption of probiotics (a mixture of L.
      rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.
    


Intervention name(s): Probiotics in an pastille; Control pastille
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Test group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Treatment for Non-Suicidal Self-Injury in Young Adults
Condition: Non-suicidal Self-injury
MeSH terms: Wounds and Injuries; Self-Injurious Behavior
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate an intervention specifically for non-suicidal
      self-injury (NSSI) in young adults. The goal of this 9-session outpatient intervention is to
      reduce the frequency and severity of NSSI. During Phase I, 12 patients will be treated in an
      open pilot trial. During Phase II, 60 patients will be treated in a randomized controlled
      pilot study in order to determine the feasibility and acceptability of the intervention and
      to investigate change in NSSI frequency and severity over time.
    

Detailed description: 
      Non-suicidal self-injury (NSSI), deliberate harm to the body without suicidal intent, is
      highly prevalent in young adults, with 1 in 10 college students engaging in over 100 episodes
      in their lifetimes. Consequences of NSSI are severe, including physical injury ranging in
      medical severity, distress from shame associated with the behavior, social isolation,
      psychological symptoms, and increased risk and lethality of NSSI over time. Despite the
      prevalence and significant consequences of NSSI, no empirically supported treatments specific
      to NSSI exist. The purpose of this study is to develop, implement, and evaluate an
      intervention specifically for NSSI in young adults, the Treatment for Self-Injurious
      Behaviors (T-SIB). This time-limited intervention will integrate theoretically-based
      strategies whose utility has been identified through empirical research with the goal of
      reducing frequency and severity of NSSI. The research plan consists of 2 phases. During Phase
      1, 12 patients will be treated in an open pilot trial. During Phase 2, 60 patients will be
      treated in a randomized controlled pilot study to determine the feasibility and acceptability
      of T-SIB, investigate change in NSSI frequency and severity between T-SIB and treatment as
      usual (TAU) through a 3-month follow up period, and evaluate the research design of the
      randomized controlled pilot study to inform both the utility and design of a larger
      randomized clinical trial.
    

Intervention name(s): T-SIB; Treatment as usual
Intervention type(s): Behavioral; Other
Intervention description(s): Treatment for self-injurious behaviors; study psychotherapy; Can include other psychotherapy and pharmacotherapy
Other intervention name(s): TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: self-injury; non-suicidal self-injury; deliberate self-harm; self-mutilation
Integrating Patient Reported Outcomes (I-PRO) Study for Multidisciplinary Pain Care
Condition: Chronic Noncancer Pain
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of clinician education, electronic health
      record integrated patient reported outcomes, and electronic health record integrated decision
      support on pain-related care quality, outcomes, and service utilization.
    

Detailed description: 
      The initiative has three components to aid clinicians' care of patients with chronic
      noncancer pain: (1) education, (2) standardized patient reported outcomes data collection,
      and (3) evidence-based brief treatment reminders. Practices will be randomized to either
      receive the three novel components (treatment group) or continue with usual care (control
      group).

      Providers in the treatment group will be asked (a) to complete a series of six online
      education modules in pain care, (b) will be given access to new patient reported outcomes
      questionnaire data collected from patients within the electronic health record, (c) asked to
      review this data and related care recommendations during the patient visit, and (d) asked to
      complete baseline and monthly online surveys related to experiences and satisfaction with
      providing care to patients with chronic noncancer pain.

      Providers in the control group will provide care as usual to patients and will be asked to
      complete baseline and monthly online surveys related to experiences and satisfaction with
      providing care to patients with chronic noncancer pain.

      Primary study outcomes include comparison of treatment and control group provider and patient
      satisfaction surveys. Secondary outcome measures include provider referral rates, patient
      outcomes, patient treatments recommended/ordered, and patient service utilization/costs.
    

Intervention name(s): Providers of Novel Care; Providers of Usual Care
Intervention type(s): Other; Other
Intervention description(s): Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.; Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Noncancer Pain; Musculoskeletal Pain; Neuropathic Pain; Headache Pain
The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries
Condition: PRP; Losartan; Muscle Injury; Sport Injury
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this comparative study is to determine whether or not LOSARTAN with its
      anti-fibrotic action has an added effect when administrated with platelet rich plasma
      injection on skeletal muscle healing and on decreasing the fibrous scar after muscle injuries
      in comparison with the sole administration of platelet rich plasma.
    


Intervention name(s): Autologous platelets rich plasma; Autologous platelets rich plasma + oral LOSARTAN administration
Intervention type(s): Biological; Combination Product
Intervention description(s): 30 ml of venous blood were drawn from the participant by means of venipuncture. The collected blood was mixed with 3 ml anti-coagulant acid citrate dextrose in the centrifugation sterile tube. The blood sample was then centrifuged using the centrifugation machine. 3 ml of PRP from the buffy coat layer were loaded in a 5 ml syringe. After local sterilization and draping of the site of injection and under US guidance the hematoma was aspirated from the injury site and the freshly prepared PRP was injected.; in addition to local PRP injection, 50 mg / day of LOSARTAN (Cozaar® 50 mg film-coated tablets) were administrated to the study group orally every morning from day 5 and till day 30 after injury.
Other intervention name(s): PRP; PRP + LOSARTAN
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cold Water Immersion and Recovery
Condition: Post-exercise Cold Water Immersion
Study type: Interventional

Summary: 
      Cold-water immersion (CWI) is a frequently applied strategy to accelerate post-exercise
      recovery in both recreational as well as professional athletes. However, the effect of
      repeated post-exercise CWI on other recovery strategies remains unclear.
    


Intervention name(s): Water immersion
Intervention type(s): Other
Intervention description(s): Different temperatures of cold water immersion will be assessed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adolescent Survivors of Cancer or Similar Illnesses
Condition: Adolescent Cancer Survivors; Pediatric Cancer Survivors
Study type: Observational

Summary: 
      The purpose of this study is to examine the health behaviors of young adults who have been
      treated for cancer, leukemia, or similar illnesses. We will also ask you some questions about
      your family members' and friends' health behaviors. We plan to use the findings from this
      study to design new programs to help teenage cancer survivors resist doing things that might
      harm their health.
    

Detailed description: 
      This study proposes to explore cancer-risk behaviors and future behavioral intentions among
      adolescent cancer survivors (i.e., 14-19 years old) and compare them to their "healthy" peers
      using population-based normative data. Additionally, it seeks to determine the significant
      theory-driven covariates related to adolescent survivors' health behaviors, which will aid in
      the design of future behavioral interventions.
    

Intervention name(s): Questionnaire or Interview
Intervention type(s): Behavioral
Intervention description(s): Complete a self-report survey once over the telephone or by mail. The questions are about your health beliefs and behaviors, your current health, and your mood. It should not take longer than 45 minutes to complete. About 15 of these people will participate in an additional, short audiotaped interview about sun protection.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Memorial Sloan-Kettering Cancer Center's Department of Pediatrics
      
Keywords: survivors; adolescent; pediatric
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety of Symbicort compared to inhaled
      corticosteroid alone during 6 months in adult and adolescent patients with asthma
    

Detailed description: 
      A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter,
      multinational safety study evaluating the risk of serious asthma-related events during
      treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide)
      and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS
      (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.
    

Intervention name(s): Symbicort pMDI; budesonide pMDI
Intervention type(s): Drug; Drug
Intervention description(s): Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation.; Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Symbicort pMDI; Asthma; safety; budesonide
Brain-heart Interactions in Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X:
Condition: Takotsubo Cardiomyopathy; Cardiac X Syndrome; Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Cardiomyopathies; Microvascular Angina; Takotsubo Cardiomyopathy; Syndrome; Infarction
Study type: Interventional

Summary: 
      The Tako-Tsubo Cardiomyopathy (TTC) and the Cardiac Syndrome X (CSX) are respectively acute
      and chronic heart diseases, which mimic myocardial infarction and stable angina pectoris
      without alterations of large coronary vessels. The causes and the most appropriate and best
      treatment for these diseases have not been yet clarified, but there are indications, that
      mental and psychosocial aspects may also contribute to these two diseases. So far, there is
      no study, which has comprehensively evaluated the interactions between mind and heart in
      these two conditions.

      The purpose of this study is to search for possible differences in mental activity, response
      to stressful events and function of specific areas of the brain deeply involved in relation
      between mind and heart.

      45 subjects will be recruited and divided equally into: patients with CSX, patients with TTC
      (at least 6 months ago) and patients with previous acute myocardial infarction (at least 6
      months ago). All participants will undergo a clinical interview and several questionnaires
      that assess various mental functions, the stress response and the quality of life. In
      addition, in a separate visit the participants will undergo a Magnetic Resonance Imaging
      without contrast medium that helps to assess function of specific areas of the brain.
    


Intervention name(s): Manual for the Assessment and Documentation of Psychopathology (AMDP 8); Million Clinical Multiaxial Inventory 3 (MCMI-III); State-Trait Anxiety Inventory form Y (STAI-Y); SF-36 Health-Related Quality of Life; Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)
Intervention type(s): Other; Other; Other; Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure
Condition: Cirrhosis; Acute Liver Failure; Chronic Liver Failure
MeSH terms: Liver Cirrhosis; Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Liver Failure, Acute; Fibrosis
Study type: Observational

Summary: 
      After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will
      be made. These patients will undergo detail clinical, biochemical and microbiological
      examination at baseline. Clinical examination and Biochemical evaluation will be done daily
      and signs of infection will be noted. Patients will undergo microbiological screening for
      infection every 48 hours. Patients suspected or diagnosed to be suffering from infections
      will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site
      and etiology (bacterial and/or fungal) of infections will be noted in all patients at
      admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care
      Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care
      Unit).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tertiary Care Center.
      
Keywords: Acute on Chronic Liver Failure (ACLF),Cirrhosis,; Institute of Liver & Biliary Sciences (ILBS)