bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children
Condition: Asthma; Bronchial Hyperresponsiveness
MeSH terms: Bronchial Hyperreactivity
Intervention: Beclomethasone dipropionate HFA; placebo
Intervention description: 100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test; inhalation twice a day for one month, preceded and followed by adenosine challenge test
Intervention MeSH terms: Beclomethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 3 Years
Maximum age: 7 Years
Healthy volunteers: No
Keywords: asthma; preschool children; bronchial hyperresponsiveness; beclometasone dipropionate - HFA; Qvar; Adenosine Challenge test

Summary:

      Respiratory diseases including Asthma are high prevalent among preschool children. Specific
      treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the
      amount of the drug reaching small airways and lungs is bigger how much smaller the particles
      liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately
      emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg,
      that is supposed to reach the small airways at higher concentrations and be more suitable to
      patients who don't cooperate properly to the procedure of inhalation.

      The investigators' group has reported successfully the possibility to perform Pulmonary
      Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported
      relation between asthma control and reduction in airway hyperreactivity. The purpose of this
      study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways
      hyperreactivity in preschool children, as demonstrated by adenosine challenge test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical diagnosis of mild asthma

          -  children aged between 3 - 6 years old

          -  able to perform spirometry and adenosine challenge test

          -  positive challenge test at the time of inclusion

          -  without prophylactic treatment for asthma

          -  signed informed consent to join the research by the parents or legal tutor

        Exclusion Criteria:

          -  other chronic diseases

          -  use of oral steroids in the last two months

          -  emergency room visit in the last two months

          -  pneumonia in the last two months

          -  impossibility to perform lung function tests

          -  disagreement of the parents or legal tutor
Efficacy and Safety of a Hospital Walking Program for Older Adults
Condition: Acute Disease
MeSH terms: Acute Disease
Intervention: Behavioral intervention; Walking Intervention; Friendly visits
Intervention description: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.; Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only; The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Hospitalization; Aged

Summary:

      Low mobility, defined as being limited to bed or chair, is common during acute
      hospitalization. This study will evaluate the impact and safety of a hospital walking program
      for older patients during acute general medical hospitalization. Participants who are 65
      years of age or older, will be randomized to usual care (UC) or to a hospital walking program
      (WP), which includes twice daily walks with assistance, provision of necessary ambulatory
      devices, and a behavioral intervention strategy designed to encourage out of bed activity.
      Throughout hospitalization, the WP and UC veterans will were wireless monitors on the thigh
      and ankle that measure activity. The primary goal will be in increase the length of time
      veterans spend out of bed and to assure this out of bed activity is safe.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater or equal to 65 years;

          2. Admitted to the Birmingham VAMC for a medical condition

        Exclusion Criteria:

          1. Delirious based on positive Confusion Assessment Method (CAM);

          2. Mini-Cognitive Assessment score indicating dementia;

          3. Inability to ambulate 2 weeks prior to admission;

          4. Having a medical diagnosis deemed by the primary physician to be a contraindication to
             ambulation;

          5. patient with an imminently terminal illness; and

          6. Non-English speaking
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; semaglutide; semaglutide; semaglutide; semaglutide; semaglutide; placebo; placebo; placebo; placebo; placebo; liraglutide; liraglutide
Intervention description: 0.1 mg, once weekly, s.c. injection; 0.2 mg, once weekly, s.c. injection; 0.4 mg, once weekly, s.c. injection; 0.8 mg, once weekly, s.c. injection; 0.8 mg with titration, once weekly, s.c. injection; 1.6 mg with titration, once weekly, s.c. injection; 0.1 mg, once weekly, s.c. injection; 0.2 mg, once weekly, s.c. injection; 0.4 mg, once weekly, s.c. injection; 0.8 mg with titration, once weekly, s.c. injection; 1.6 mg, once weekly, s.c. injection; 1.2 mg with titration, once daily, s.c. injection; 1.8 mg with titration, once daily, s.c. injection
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly
      to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or
      liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was
      double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy
      parameter was HbA1c and the treatment duration was 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at
             least three months

          -  Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise
             alone for at least three months

          -  HbA1c: 7.0-10.0 % (both inclusive)

          -  Body weight between 60 kg and 110 kg

        Exclusion Criteria:

          -  Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl
             peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any
             investigational drug, within the last three months

          -  Impaired liver or kidney function

          -  Proliferative retinopathy or maculopathy requiring acute treatment

          -  Clinically significant active cardiovascular disease and uncontrolled
             treated/untreated hypertension

          -  Recurrent major hypoglycaemia or hypoglycaemic unawareness

          -  Present or planned use of any drug which could interfere with the glucose levels (e.g.
             systemic corticosteroids)
Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)
Condition: Non-alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: LYS006; Tropifexor
Intervention description: 5 mg LYS006 capsules orally administered 20 mg b.i.d for 12 weeks; 100 ug LJN452 capsules orally administered 200ug once daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-alcoholic fatty liver disease; NAFLD; Non-alcoholic steatohepatitis; NASH; Platform design; LYS006; LJN452; Tropifexor

Summary:

      This clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and
      efficacy of various single and combination treatments in adult patients with non-alcoholic
      fatty liver disease (NAFLD) who manifest a non-alcoholic steatohepatitis (NASH)-like
      biomarker phenotype.
    

Eligibility criteria:

        Inclusion Criteria:

        Phenotypic diagnosis of NASH based on the presence of all of the following:

          -  ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)

          -  BMI ≥ 27 kg/m2 (race other than Asian) or ≥ 23 kg/m2 (Asian race)

          -  History of type 2 diabetes mellitus with HbA1c ≤ 9%

          -  ELF test score ≥ 8.5 and ≤ 10.5

          -  Liver fat ≥ 8%

          -  Patients must weigh between 40 kg (88 lbs.) and 150 kg (330 lbs.)

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of randomization or within 3
             months, whichever is longer

          -  Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1
             month of randomization

          -  Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7
             days of randomization, whichever is longer

          -  History or presence of other concomitant liver diseases

          -  History or current diagnosis of ECG abnormalities

          -  Patients with contraindications to MRI imaging

          -  Current or history of significant alcohol consumption

          -  Clinical evidence of hepatic decompensation or severe liver impairment

          -  Women of child bearing potential (unless on highly effective methods of contraception)

          -  Presence of liver cirrhosis

          -  Use of OAT3 inhibitors within 5 half-lives or 7 days of randomization, whichever is
             longer
Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
Condition: Masseter Muscle Hypertrophy
MeSH terms: Hypertrophy
Intervention: botulinum toxin Type A; Normal saline
Intervention description: Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.; Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type
      A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).
    

Eligibility criteria:

        Inclusion Criteria:

        -Participants with Masseter Muscle Hypertrophy

        Exclusion Criteria:

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis,
             or any other condition that might interfere with neuromuscular function

          -  Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face

          -  History of dental or surgical procedure for lower facial shaping or masseter muscle
             reduction

          -  History of or current temporomandibular joint disorder (TMJD)
Treatment of Patients With Blepharitis and Facial Rosacea
Condition: Blepharitis; Meibomianitis; Dry Eye
MeSH terms: Blepharitis; Meibomitis; Rosacea
Intervention: COL-101 (doxycycline, USP) capsules; placebo
Intervention description: 40mg, once per day for 84 days; sugar capsule
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of
      patients who have both blepharitis and facial rosacea
    

Eligibility criteria:

        Inclusion Criteria:

          -  blepharitis

          -  facial rosacea

        Exclusion Criteria:

          -  pregnant or nursing women

          -  allergy to tetracyclines

          -  recent eye surgery

          -  past or current use of isotretinoin

          -  patients who are achlorhydric

          -  patients who have had gastric by-pass surgery
Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab
Intervention description: Specified Dose on Specified Days
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the safety of Nivolumab in participants with advanced or metastatic
      non-small cell lung cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non small cell lung cancer (Squamous or non-squamous)

          -  At least one prior anti-cancer therapy that did not work

          -  ECOG Performance Scale 0-1

        Exclusion Criteria:

          -  Cancer that has spread to the brain or leptomeninges unless there is no evidence of
             progression by MRI for 8 weeks after treatment is complete and within 28 days before
             first dose of study drug

          -  Active, known or suspected autoimmune disease or infection

          -  Prior immuno-oncology therapy

          -  Corticosteroids within 2 weeks of study drug administration

        Other protocol defined inclusion/exclusion criteria could apply
Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: AMG 827
Intervention description: 210 mg SC or 140 mg SC
Intervention MeSH terms: Brodalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      This study is an open-label extension of study 20090062 to evaluate extended subcutaneous
      dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was randomized into Study 20090062 and completed the week 16 evaluation.

        Exclusion Criteria:

          -  Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was
             considered possibly related to IP.

          -  Subject experienced an adverse event in Study 20090062 that, in the opinion of the
             investigator, could cause extension of treatment to be detrimental to the subject.
Open-Label Study of Oral Treprostinil in Digital Ulcers
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: treprostinil diethanolamine
Intervention description: sustained release tablet; BID dosing; up to 16 mg BID
Intervention MeSH terms: Treprostinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: systemic sclerosis; scleroderma; digital ulcers; vasculopathy

Summary:

      This open label extension trial will allow ongoing treatment of subjects who participated in
      the randomized controlled trials, and will provide long term information about the safety of
      treprostinil diethanolamine SR in subjects with SSc and digital ulcers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible subjects who completed assessments for the final visit of the previous
             TDE-DU-201 controlled trial and who signed appropriate informed consent were eligible
             to enroll in this extension study.

          -  If a female of childbearing potential, the subject must have agreed to continue
             practicing an acceptable method of birth control (i.e., surgical sterilization,
             approved hormonal contraceptives, barrier methods [such as a condom or diaphragm] used
             with a spermicide, or an intrauterine device).

        Exclusion Criteria:

          -  Have had any change in clinical status that, in the opinion of the Investigator, would
             pose a safety risk for participation in this extension study;

          -  Have been found to be unable to complete study assessments in the previous controlled
             trial;

          -  Have prematurely discontinued study drug during the previous study due to clinical
             worsening or treatment related adverse events.
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
Condition: Overactive Bladder; Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine
Intervention description: 4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8
Intervention MeSH terms: Fesoterodine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Study of fesoterodine in pediatric overactive bladder patients

Summary:

      The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of
      fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive
      bladder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A total body weight >25 kg (55 lbs).

          -  Symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and
             urgency to urinate, with or without urgency incontinence, for at least 6 months prior
             to enrolment, OR

          -  Stable neurological disease and urodynamically confirmed detrusor overactivity, who
             may require intermittent catheterization for management of urinary drainage.

        Exclusion Criteria:

          -  Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is
             longer, before first study dose

          -  Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors

          -  Ongoing use of another drug for treating overactive bladder

          -  Uncontrolled narrow angle glaucoma, urinary or gastric retention
A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Capecitabine; Oxaliplatin
Intervention description: Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m^2 bid orally on Days 1-14, and at a dose of 825mg/m^2 bid on Days 22-35 and 43-56.; Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m^2/d intravenously on Day 1 and 50mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the pathological complete tumor response rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal
             involvement requiring surgery of the primary tumor

          -  Eastern Cooperative Oncology Group performance status 0-2

          -  Adequate values of laboratory parameters

        Exclusion Criteria:

          -  Evidence of distant metastases

          -  Previous Chemotherapy or immunotherapy for colorectal cancer

          -  Previous radiotherapy to the pelvis

          -  Pre-existing condition which would deter radiotherapy

          -  Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ
             cancer of the cervix

          -  Clinically significant cardiac disease or myocardial infarction within the last 12
             months

          -  Lack of physical integrity of the upper gastrointestinal tract or those who have
             malabsorption syndrome

          -  Organ allografts

          -  Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside
             analogues

          -  Dihydropyrimidine dehydrogenase (DPD) deficiency

          -  History of uncontrolled seizures, central nervous system disorders, or psychiatric
             disability judged by the investigator to be clinically significant, precluding
             informed consent or interfering with compliance for oral drug intake