bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is open to adults aged 18 years and older. People without liver problems and
      people who have mild or moderate liver problems can join the study.

      The purpose of this study is to find out how a medicine called BI 1015550 is taken up in the
      blood of people with and without liver problems. Liver problems may change how a medicine is
      taken up in the blood.

      Participants are in the study for about 2 weeks. During this time, they visit the study site
      6 times. On the second visit, participants stay overnight at the study site for 4 nights. At
      the visits, doctors take blood samples to measure the levels of BI 1015550 in participants'
      blood. Then they compare the results between the groups of participants with and without
      liver problems. The doctors also check participants' health and take note of any unwanted
      effects.
    


Intervention name(s): BI 1015550
Intervention type(s): Drug
Intervention description(s): BI 1015550
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The P4 Intervention Study to Improve Adolescent Health
Condition: Adolescent Behavior
Study type: Interventional

Summary: 
      The primary objective is to conduct a pilot study to determine the efficacy of evidence-based
      interventions delivered in primary care clinic settings on parent-teen health communication.
    

Detailed description: 
      Primary care provides a means by which to connect evidence-based interventions with patients;
      however, many interventions have been evaluated using randomized controlled trials (RCTs) in
      non-healthcare settings.

      The primary objective is to conduct a pilot study to determine the effect of evidence-based
      interventions delivered in primary care clinic settings on parent-teen communication about
      alcohol use, sexual health, and safe driving.

      Eligible participants are healthy adolescent patients from the Children's Hospital of
      Philadelphia (CHOP) primary care network with a well-child visit scheduled between the ages
      of 14 to 17 years with one parent willing to participate. Adolescents that hold an
      intermediate driver's license, that are pregnant, or that have pervasive development disorder
      or a developmental delay are excluded from this study.

      Parents will be given written psychoeducational intervention materials on communicating with
      their adolescents about alcohol use, sexual health, or safe driving (e.g.,booklets, tip sheet
      brochures, activity workbooks, web links), receive coaching about using the intervention
      materials, and provider endorsement of the materials during the well-child visit, as well as
      follow-up phone health coaching 2 weeks after the appointment.

      The primary endpoints are evaluating the difference between the intervention and control
      groups on parent-teen communication on the targeted health topics.
    

Intervention name(s): Sexual Health; Alcohol Prevention; Teen Driving
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.; Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.; Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent Health; Sexual Health; Parent-Teen Communication; Teen Driving; Alcohol Prevention
Myofascial Induction Effects on Stabilometry Versus Sham Laser
Condition: Foot Diseases; Myofascial Pain
MeSH terms: Foot Diseases
Study type: Interventional

Summary: 
      The objective is to determine the effectiveness of myofascial induction effects on
      stabilometric variables. Forty healthy subjects will be recruited for a single blind clinical
      trial. All subjects will be randomly distributed into two different groups: control group
      (simulated laser) and experimental group (myofascial induction). Result measurements will be
      performed in the center of the pressure area (stabilometry) using a validated platform. Two
      trials will be recorded for each condition (eyes closed and eyes open)
    


Intervention name(s): Sham Laser; Myofascial Induction
Intervention type(s): Other; Other
Intervention description(s): Sham Laser in plantar fascia; Myofascial Induction in plantar fascia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Intestinal Microbiota Adaptation to Prebiotic Administration
Condition: Healthy
Study type: Interventional

Summary: 
      Non-absorbable, fermentable residues in the diet increase intestinal gas production and
      induce gas-related symptoms, such as flatulence, abdominal bloating and distention; however,
      prebiotics, which are also fermented by colonic bacteria, have been shown to improve this
      type of symptoms. The aim is to demonstrate whether a prebiotic induces adaptive changes in
      metabolic activity of gut microbiota and colonic biomass that explain its beneficial effect
      on gas-related symptoms.

      Single-centre, single arm, open label, proof-of-concept study in healthy subjects. The study
      will consist of a pre-administration phase (2 wk), an administration phase (4 wk) and a
      post-administration phase (2 wk). A soluble prebiotic fiber (resistant dextrin 14 g/d) will
      be administered during the 4 wk administration phase. During 4 days immediately before, at
      the beginning and at the end of the administration phase and at the end of the
      post-administration phase participants will be put on a standard diet and the following
      outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of
      an event marker; b) volume of gas evacuated via a rectal tube during 4 hours after a test
      meal, by means of a barostat; c) microbiota composition by fecal analysis.
    


Intervention name(s): Prebiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Soluble prebiotic fiber (resistant dextrin 14 g/d x 4 weeks)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: intestinal gas; healthy subjects; microbiota; prebiotics
Split Scripts for Pediatric Supracondylar Fracture Repairs
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study is designed to test the hypothesis that increased electronic order-set compliance
      and focused education will decrease the amount of unconsumed opioid entering and remaining in
      the home after pediatric supracondylar fracture repair

      The proposed study will address the hypothesis with the following objectives:

        1. investigators will increase compliance with previously implemented standardized
           precision-based electronic discharge order sets;

        2. investigators will introduce part-fill opioid prescriptions for supracondylar fracture
           repairs;

        3. investigators will increase parental compliance with home administration of simple
           (non-opioid) analgesics;

        4. investigators will decrease opioid amount remaining in the home pre and post 3-week
           follow up.
    

Detailed description: 
      Canada has one of the highest opioid prescribing rates in the world (United Nations, 2018).
      In 2017, Health Quality Ontario published a major report that identified the number of opioid
      prescriptions following surgery were second only to those following dentist office visits. As
      a result, Health Quality Ontario made the reduction of opioid prescribing ('Cut the Count)'
      their number one provincial healthcare priority of 2019.

      To date, investigators have decreased MME amount of opioid entering the home
      post-supracondylar fracture repair at approximately 10 MME per patient and increased the rate
      of return of unused drug by 10 MME per patient. The Hospital for Sick Children alone performs
      some 200 such surgeries per year, representing 4,000 mg of morphine (four grams) that the
      community is no longer exposed to. This is only one surgery type in one hospital; expansion
      of our methodology to other surgeries (currently expanding to dental and cleft palates) and
      other institutions will dramatically decrease unintentional but iatrogenic home exposure of
      children and families to unwarranted and dangerous drugs.

      This latest study aims to address all three steps outlined in the 2020-2021 Health Quality
      Ontario surgical mandate for children discharged from The Hospital for Sick Children after
      supracondylar fracture repair.
    

Intervention name(s): Morphine
Intervention type(s): Drug
Intervention description(s): Children will be provided with morphine for at-home pain management following supracondylar fracture repair
Other intervention name(s): Opioid
Intervention MeSH terms: Morphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso
Condition: Uncomplicated P. Falciparum Malaria in Children
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      Several countries in Africa have changed their first-line treatment for uncomplicated malaria
      to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and
      Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local
      effectiveness of these drugs when they are given to patients in real life conditions, without
      direct observation of the drug administration. Thus, this study aims at investigating the
      effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina
      Faso.
    


Intervention name(s): Artesunate-amodiaquine; Artemether-lumefantrine
Intervention type(s): Drug; Drug
Intervention description(s): Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg); Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg.
Other intervention name(s): ASAQ, Coarsucam; AL, Coartem(R), Riamet(R)
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uncomplicated malaria
Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity
Condition: Vitamin D Deficiency; Obesity; Insulin Resistance
MeSH terms: Insulin Resistance; Vitamin D Deficiency
Study type: Observational

Summary: 
      Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents.
      The investigators hypothesize vitamin D deficiency will be highly prevalent in obese
      adolescents and those who are vitamin D deficient will be more insulin resistant.
    

Detailed description: 
      This is a cross-sectional study of obese female adolescents matched for age, sex and pubertal
      staging. Serum 25-OH vitamin D, intact PTH , lipid profile, serum CRP measurements and oral
      glucose tolerance tests (with glucose and insulin level measurements) will be done to assess
      the prevalence of vitamin D deficiency and to assess the insulin sensitivity- resistance
      indices.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese female adolescents
      
Keywords: Vitamin D deficiency; Obesity; Insulin resistance; Glucose tolerance
Bioavailability Study of Anti Nausea Medication With and Without Food (EUR-1025)
Condition: Nausea
MeSH terms: Nausea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the effect of food on a single dose of Ondansetron when taken with a
      meal on an empty stomach.
    

Detailed description: 
      The objective of this study is to assess the effect of food on the pharmacokinetics of a
      single 24 mg dose of Ondansetron administered as a novel modified-release capsule formulation
      under fed and fasting conditions.
    

Intervention name(s): Ondansetron; Ondansetron
Intervention type(s): Drug; Drug
Intervention description(s): 24 mg one time; 24 mg, on time in the am
Other intervention name(s): EUR-1025; EUR-1025
Intervention MeSH terms: Ondansetron
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether RNS60, in combination with budesonide, is
      safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared
      to a 28-day control period.
    


Intervention name(s): RNS60; Normal Saline; Budesonide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): RNS60, 2ml, nebulized twice daily.; Normal Saline placebo, 2 ml, nebulized twice daily.; Budesonide, in either 0.25 mg or 0.5 mg per 2 ml concentration in liquid suspension, nebulized once per day in combination with RNS60 or NS.
Intervention MeSH terms: Budesonide; RNS60
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Not Invasive Monitoring of Pleural Drainage
Condition: Pleural Effusion
MeSH terms: Pleural Effusion
Study type: Interventional

Summary: 
      This study investigates if data about monitoring the drainage of pleural effusion can be
      collected by non invasive sensors (feasibility).
    

Detailed description: 
      25 patients > 18 years old with pleura effusion will be examined with regard to the
      feasibility of non invasive sensor measurements corresponding to the course of thorax
      impedance and respiration parameters during body fluids loss before and after pleural
      drainage. The measured data will be compared to standard routine reference measurements
      (heart rate, medication, brain natriuretic peptide (BNP), heart minute volume). Additionally
      heart sound analysis via electronic stethoscope will be compared to standard methods.

      Also 25 healthy controls will undergo the same measurements to receive standard values.
    

Intervention name(s): Body Bioimpedance Sensor
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pleural effusion; pleural drainage; thorax impedance; respiration parameters; heart sounds analysis
A Phase Ⅲ Study to Evaluate Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase Ⅲ, randomized, double-blind, placebo-controlled, parallel design, multicenter
      trial to evaluate the efficacy, safety, tolerability, and immunogenicity of subcutaneous
      Tildrakizumab in subjects with moderate to severe chronic plaque psoriasis.

      The trial was divided into two parts: the base study (Week 0- Week 12) and the extension
      study (Week 13- Week 54).
    

Detailed description: 
      Base Study： 220 subjects were randomized in a 1: 1 ratio into the trial, and the treatment
      group received 100 mg subcutaneous Tildrakizumab at Week 0 and Week 4, 100 mg subcutaneous
      placebo at Week 12, while the placebo group received 100 mg subcutaneous placebo at Week 0
      and Week 4, and 100 mg subcutaneous Tildrakizumab at Week 12, and subjects will be evaluated
      for efficacy, safety, tolerability, and immunogenicity as specified in this protocol. At the
      end of the base study, procedures such as data cleaning, locking and unblinding of base study
      data were performed.

      Extension Study： Subjects entered the extension study after completion of the base study and
      will receive 100 mg subcutaneous Tildrakizumab at Week 16, 28, 40, and 52, and will be
      evaluated for efficacy, safety, tolerability, and immunogenicity by the investigator
      according to the regulations of this study.

      At the end of the extension study, all data from the extension study will be entered into the
      database, after the data is reviewed, cleaned, and locked, the entire trial will be analyzed.
    

Intervention name(s): Tildrakizumab 100 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tildrakizumab 100 mg administered SC. Each PFS contains 1 mL of solution, tildrakizumab 100 mg/mL.; Matching placebo to tildrakizumab administered SC
Other intervention name(s): SCH 90022; MK-3222
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Safety and Immunogenicity of a Sublingual Influenza Vaccine NSV0001 in Healthy Male Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of a sublingual
      administration of NSV0001 in healthy male volunteers.
    

Detailed description: 
      NSV0001 is a quadrivalent influenza vaccine with the new adjuvant (ND002) administered by
      sublingual route.

      This study will enroll healthy male adults. Participants will receive two doses of the
      vaccine, 4 weeks apart, and will stay in the investigational site for 2 consecutive days
      after each vaccination.

      Participants will keep a patient diary to record the local and systemic reactions for one
      week after each vaccination. In addition, the safety monitoring will be extended through 6
      months from the last vaccination to detect the potential immune mediated disorders (pIMD).
    

Intervention name(s): NSV0001; Influenza HA vaccine "Biken HA"; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): sublingual; subcutaneous; sublingual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine in subjects with Type 1 Diabetes Mellitus:

        1. Whether glycemic control can be achieved at least as effectively with a) an intensive
           insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH
           insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular
           insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens
           differ only by the route of delivery of the short acting insulin.

        2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if
           any, on measures of pulmonary function.
    


Intervention name(s): Inhaled human insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Animal Assisted Therapy Intervention for Hospitalized Patients in a Tertiary Care Center
Condition: Hospitalized Patients
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the common symptoms leading to an Animal Assisted
      Therapy consult, and to measure its (AAT) influence on the symptoms and feelings of
      hospitalized patients.
    

Detailed description: 
      Animal Assisted Therapy is being provided by the Caring Canines program and is formally
      available to patients by referrals. In this study, we would like to capture why patients are
      being referred and to measure the influence of AAT on the symptoms and feelings of patients.
    

Intervention name(s): Animal Assisted Therapy
Intervention type(s): Behavioral
Intervention description(s): Animal Assisted Therapy is the program where a pet, usually dog will visit and interact with the patients.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion
Condition: Other Surgical Procedures
Study type: Observational

Summary: 
      In laparoscopy, over %50 of the all complications occur during establishment of the
      pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance
      between the abdominal wall and the intrabdominal structures. Elevation of the anterior
      abdominal wall is recommended for the access to peritoneal cavity in literatures however the
      benefit exactly has not proved. This study aimed to determine the distance from anterior
      abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to
      represent this distance -on the average- generate the safe range whether or not and compare
      with this distance and patient's age, BMI and parity.
    

Detailed description: 
      40 patients who undergoing laparoscopic surgery for various indications are enrolled in the
      study. The telescope is inserted at second trocar place and the distances between anterior
      abdominal wall and visceral organs are measured with plastic hysterometry during maximal
      elevation of the abdominal wall.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        the patiens undergoing laparoscopic surgery for various indications
      
Keywords: Laparoscopic access; Abdominal wall lifting; Direct trocar insertion; Safety endoscopy