bioihbjkbjnl/mcl2 huggingface dataset:
RESTART C0168Z05 Rheumatoid Arthritis Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Infliximab
Intervention description: 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Intervention MeSH terms: Infliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis; remicade; infliximab; Centocor; etanercept; enbrel; adalimumab; humira; restart; swollen joints; tender joints.

Summary:

      The purpose of this study is to assess the effectiveness of treatment in patients with active
      rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment
      with etanercept or adalimumab in addition to methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have rheumatoid arthritis

          -  Patients must have greater than or equal to 6 tender joints and greater than or equal
             to 6 swollen joints

          -  Patients must have inadequate disease response to etanercept or adalimumab

          -  Patients must have received etanercept or adalimumab in combination with methotrexate
             for a minimum of at least 3 months prior to the screening visit. The last dose of
             etanercept must have been given at least 1 week but not more than 2 weeks prior to
             first infliximab infusion. The last dose of adalimumab must have been administered at
             least 2 weeks but not more than 4 weeks prior to first infliximab infusion.

        Exclusion Criteria:

          -  Patients who have a history of latent or active TB

          -  Have inflammatory disease other than rheumatoid arthritis

          -  Have had a chronic or recurrent infectious disease.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Ribavirin; peginterferon alfa-2a [Pegasys]
Intervention description: 1000/1200mg po bid for 36 or 60 weeks; 180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in
      patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with
      PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the
      target sample size is >100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients at least 18 years of age

          -  CHC infection, genotype 1

          -  unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks
             of treatment

          -  use of 2 forms of contraception during the study in both men and women

        Exclusion Criteria:

          -  women who are pregnant or breast-feeding

          -  medical condition associated with chronic liver disease (eg, hemochromatosis,
             autoimmune hepatitis, alcoholic liver disease, toxin exposures)

          -  patients with decompensated cirrhosis

          -  patients receiving any systemic antiviral therapy or investigational drug, other than
             PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug
Bisphosphonate Therapy for Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta; Osteoporosis; Paget Disease of Bone
MeSH terms: Osteoporosis; Osteogenesis Imperfecta; Bone Diseases; Osteitis Deformans
Intervention: Alendronate; Pamidronate
Intervention MeSH terms: Alendronate; Pamidronate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Osteogenesis Imperfecta; Fractures; Pediatric; Osteoporosis; Juvenile Pagets

Summary:

      The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for
      Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine,
      are characterizing the changes effected by oral bisphosphonate therapy and comparing them to
      a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in
      children with other disorders that result in low bone mass and fractures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of OI, as defined by genetic analysis revealing a defect of type I collagen,
             OR by bone mineral density (BMD) <2.5 standard deviations (SD) for age plus two of the
             following:

               -  Family history of OI

               -  Frequent fractures

               -  Blue sclerae

               -  Multiple wormian bones on skull x-ray

               -  Hearing disturbance

               -  Dentinogenesis imperfecta

          -  Age between 3 and 21 years at the start of the study period.

          -  Children must be able to swallow whole tablets

          -  Parents of children must be able to understand protocol and give informed consent.

        Exclusion Criteria:

          -  Therapy with bisphosphonates during the past 12 months.

          -  Other "non-traditional" therapy for OI in the last 6 months, such as growth hormone or
             anabolic steroids.

          -  Other chronic diseases besides OI that interfere with bone morphology or
             gastrointestinal absorption
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Trifarotene cream; Doxycycline hyclate; Trifarotene Vehicle; Doxycycline Placebo
Intervention description: Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.; Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.; Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.; Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.
Intervention MeSH terms: Doxycycline; Trifarotene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 202.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789)
      50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and
      effective for the treatment of severe AV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4
             (Severe)

          -  Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to
             120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2
             nodules (less than [<]1 centimeter [cm] in diameter) on the face, excluding the nose

          -  Agrees to provide written informed consent

          -  Participant is a female of non-childbearing potential (premenarchal or postmenopausal
             [absence of menstrual bleeding for 1 year prior to Screening, without any other
             medical reason], hysterectomy or bilateral oophorectomy)

        Exclusion Criteria:

          -  Participant with any acne cyst on the face

          -  Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne
             (chloracne, drug-induced acne, etc.)

          -  Participants with facial dermal conditions (example [e.g.] tattoo, skin abrasion,
             eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments
             in the opinion of the investigator

          -  Participants who is at risk in terms of precautions, warnings, and contraindications
             for trifarotene or doxycycline hyclate

          -  Currently receiving any prescription testosterone therapy (e.g., testosterone
             cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or
             on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone
             [DHEA], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate,
             testosterone propionate, testosterone phenylpropionate) or testosterone supplements
             (e.g., Tribulus).
The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)
Condition: Exercise-induced Bronchoconstriction (EIB)
Intervention: Comparator: montelukast sodium; Comparator: Comparator: placebo (unspecified)
Intervention description: Patients 4-5 years: 4 mg Montelukast chewable tablet daily
Patients 6-14 years: 5 mg chewable tablet daily; Patients 4-5 years: 4 mg Pbo chewable tablet daily
Patients 6-14 years: 5 mg Pbo chewable tablet daily
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 364.0
Sex: All
Minimum age: 4 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      This study will see if there is a change in breathing after exercising when the child
      receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer
      before exercising and measured again several times after exercising.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The child is 4 years to 14 years of age

          -  The child is a non smoker

          -  The child has exercise-induced bronchoconstriction (EIB)

        Exclusion Criteria:

          -  The child has active or chronic breathing disease, other than asthma

          -  The child has required insertion of a breathing tube for asthma

          -  The child had major surgery within the last 4 weeks

          -  The child is currently in the hospital

          -  The child has or had an upper respiratory tract infection within the last 2 weeks

          -  The child has been hospitalized or visited the emergency room or had a change in their
             medication for asthma within the last 4 weeks

          -  The child has been in a research study in the last 4 weeks

          -  The child has stomach, brain, heart, kidney or liver disease

          -  The child drinks more that 4 caffeinated drinks a day
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
Condition: Infertility
MeSH terms: Infertility
Intervention: GnRH agonist trigger; hCG trigger
Intervention MeSH terms: Triptorelin Pamoate; Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 35 Years
Maximum age: 44 Years
Healthy volunteers: No

Summary:

      Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely,
      human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the
      natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural
      cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To
      induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing
      hormone (GnRH) agonist can be given.

      The purpose of this study is to find out which approach may work better in IVF patients who
      experienced 4 IVF failures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  IVF patients with at least 4 consecutive failures.

          -  On trigger day, no more than 10 follicles of 12 mm and up

        Exclusion Criteria:

          -  History of moderate or severe OHSS.
AZISAST Study: AZIthromycin in Severe ASThma Study
Condition: Asthma
MeSH terms: Asthma
Intervention: Azithromycin 250 mg; Placebo
Intervention description: Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks; Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Inadequately controlled severe asthma

Summary:

      The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of
      azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain
      inadequately controlled despite GINA (2006) step 4 or 5 therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. patients who have given written informed consent

          2. males or females of any race

          3. 18-75 years of age

          4. with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history
             consistent with GINA step 4 or 5 clinical features

          5. receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening

          6. patients who have suffered multiple (i.e. at least two) independent documented severe
             asthma exacerbations within the previous 12 months

          7. patients must be never-smokers or ex-smokers with a smoking history of ≤ 10
             pack-years.

        Exclusion Criteria:

          1. females who are pregnant or who are breastfeeding

          2. patients with severe bronchiectasis

          3. patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)

          4. patients with significant underlying medical conditions (e.g. infection, hematological
             disease, malignancy, neurologic, renal, hepatic, coronary heart disease or other
             cardiovascular disease, endocrinologic or gastrointestinal disease) within the
             previous 3 months

          5. who are unable to perform spirometry or complete a patient diary or complete
             questionnaires

          6. patients with known hypersensitivity to azithromycin or other macrolide antibiotics

          7. patients who's heart rate corrected QT interval is prolonged

          8. patients who have - in the judgement of the investigator - a clinically relevant
             laboratory abnormality

          9. patients currently treated with macrolide antibiotics or recent macrolide treatment
             (in the past twelve weeks)

         10. anti-IgE treatment
Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Dyslipidemia Associated With Type II Diabetes Mellitus; Percutaneous Coronary Intervention
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
Intervention: Evolocumab; Placebo
Intervention description: Patients will receive evolocumab 420 mg administered subcutaneously; Patients will receive placebo administered subcutaneously
Intervention MeSH terms: Evolocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: All
Healthy volunteers: No

Summary:

      Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The
      study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and
      Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible
      patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2)
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes Mellitus

          -  Dyslipidemia

          -  Undergoing elective PCI

        Exclusion Criteria:

          -  Patients with recent Acute Coronary Syndrome (≤1 month)

          -  Patients on dual antiplatelet treatment (DAPT) with ticagrelor or prasugrel

          -  Patients undergoing urgent/emergent PCI for stent thrombosis

          -  Severe acute or chronic medical or psychiatric condition

          -  Pregnancy

          -  Participation in another experimental clinical trial, without formal approval

          -  Unwillingness or inability to comply with the requirements of this protocol
Stress During Deep Sedation With Propofol With and Without Alfentanil
Condition: Sedation
Intervention: propofol; alfentanil
Intervention description: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation; alfentanil 10 ug/kg immediately prior to propofol dose
Intervention MeSH terms: Alfentanil; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: propofol; alfentanil; procedural sedation; stress biomarkers; Deep procedural sedation in the ED

Summary:

      This is a randomized clinical trial of deep procedural sedation with propofol with and
      without supplemental alfentanil. Patients will be assessed for total and fractionated serum
      catecholamines before and after the procedure in addition to usual procedural sedation
      outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental
      opioid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who will require deep procedural sedation with propofol in the ED

        Exclusion Criteria:

          -  age <18

          -  intoxication

          -  unable to provide informed consent

          -  allergy to propofol or alfentanil

          -  pregnant

          -  ASA physical status score > 2
Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-Up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins
Condition: Healthy Skin
Intervention: adapalen 0.1%; Cetaphil®
Intervention description: Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks.
Visits will be conducted weekly for a maximum of 5 visits.; Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks.
Visits will be conducted weekly for a maximum of 5 visits.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral
      (split-face) comparison.

      The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in
      reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female subjects of Chinese origins

          -  aged 21 years or older

          -  with healthy skin;

        Exclusion Criteria:

          -  skin pigmentation which interferes with the reading of skin reactions

          -  with sunburn, eczema, atopic dermatitis, perioral dermatitis, or rosacea on the area
             to be treated

          -  with a washout period for the following topical treatment(s) Corticosteroids, oher
             anti-inflammatory drugs, retinoids

          -  with a washout period for the following systemic treatment(s): Medications that may
             increase photosensitivity, corticosteroids, anti-inflammatories, retinoids
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
Condition: Head Injury
MeSH terms: Brain Injuries; Craniocerebral Trauma; Wounds and Injuries
Intervention: -7 cm H2O ITPR; -12cm H2O ITPR
Intervention description: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations.; Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 1.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: traumatic brain injury; TBI; ITPR; intrathoracic pressure regulator; hepatic encephalopathy; pseudotumorcerebri; obstructive hydrocephalus; intracranial hemorrhage

Summary:

      The purpose of this study is to demonstrate proof of clinical concept that application of the
      Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion
      Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head
      injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥15 years of age

          -  intubated and mechanically ventilated on a volume controlled mode

          -  head injury or other intracranial pathology with ICP of ≥15 mmHg

          -  arterial line in place

          -  SpO2 ≥95%

          -  MAP >60

          -  in ICU or about to undergo neurosurgery with planned placement of an ICP monitor

          -  inclusion presents no significant delays to planned emergent neurosurgery

          -  prior written informed consent

        Exclusion Criteria:

          -  cardiac or pulmonary injury impacting intrathoracic pressure

          -  confirmed pneumothorax or hemothorax

          -  PaO2/FiO2 <300

          -  serious neck injury resulting in neck swelling with jugular venous compression

          -  evidence of ongoing uncontrolled bleeding

          -  respiratory disease such as COPD, interstitial lung disease, or other parenchymal or
             pulmonary vascular disease

          -  congestive heart failure