bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating Treatment Resistant Dermatitis TaroIIR
Condition: Atopic Dermatitis; Psoriasis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Intervention: Phone calls; Desoximetasone 0.25% spray
Intervention description: Phone calls twice daily; Desoximetasone 0.25% spray applied twice daily
Intervention MeSH terms: Desoximetasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a
      significant amount of patients in most dermatological practices. Topical corticosteroid
      agents are often prescribed for treatment of both these conditions, especially when they are
      localized rather than wide spread. The development of resistance to treatment is termed
      tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary
      cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to
      determine, under conditions designed to assure good adherence, whether topical 0.25%
      desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory
      skin disease defined by failure of previous topical steroid treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Male or female ≥18 years of age at baseline visit.

        Documentation of plaque-type psoriasis or atopic dermatitis diagnosis as evidenced by one
        or more clinical features

        Written informed consent (and assent when applicable) obtained from subject or subject's
        legal representative and ability for subject to comply with the requirements of the study

        Exclusion Criteria:

        Pregnant, breastfeeding, or unwilling to practice birth control during participation in the
        study.

        Presence of a condition or abnormality that in the opinion of the Investigator would
        compromise the safety of the patient or the quality of the data.

        No access to a phone throughout the day

        Subject is diagnosed with a disease that is known to effect adherence and would otherwise
        bias our results (Such as Alzheimer's or dementia)

        Patient had a history of allergy or sensitivity to corticosteroids or history of any drug
        hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise
        the safety of the patient or the results of the study.
QVA Mechanistic Efficacy Study (Receptor Effects, Etc)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Placebo
Intervention description: QVA149 110/50 μg o.d. capsules for inhalation, supplied in blisters via the Concept 1 inhalation device, a single dose dry powder inhaler.; Matching placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Smokers; Ex-smokers

Summary:

      The purpose of this study was to assess global ventilated lung volume in moderate to severe
      COPD patients using MRI lung imaging after treatment with QVA149 compared to placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Males and females with COPD aged 40 years and above, weighing ≥45 kg and ≤100 kg, who were
        smokers and ex-smokers who had a smoking history of at least 10 pack years, and diagnosed
        with moderate to severe COPD according to GOLD 2015 criteria were included in the study.
        Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC < 0.70 and by
        a post-bronchodilator FEV1 ≥ 30 % and <80 % were included in the study. Post-bronchodilator
        refers to 1 hr (+/- 5 minutes) after sequential inhalation of 84 µg ipratropium bromide (or
        equivalent dose) and 400 µg salbutamol/360 µg albuterol (or equivalent dose).

        Key Exclusion Criteria:

        Patients with conditions which could compromise patient safety and compliance (as judged by
        the investigator), as well as conditions that required oxygen therapy for chronic
        hypoxemia, ≥25% emphysematous changes on a scan within 6 months to screening, those with
        lower respiratory infections within 6 weeks of screening, and patients with concomitant
        pulmonary disease were excluded from the study. Patients with asthma were also excluded
        from the study.

        Pregnant or nursing (lactating) women, patients with poorly controlled Type I or Type II
        diabetes, patients with poor renal function, and those who were unable to use a dry powder
        inhaler or perform spirometry, and had contraindications to MRI were also excluded.
Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
Condition: Staphylococcal Infection; Abscess; Staphylococcal Skin Infection; Folliculitis
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Infections; Staphylococcal Skin Infections; Folliculitis
Intervention: clindamycin; cephalexin
Intervention description: clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days; cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cephalexin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 200.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: clinical trial; randomized; blinded; controlled

Summary:

      The purpose of this study is to help define the role of antibiotics in the treatment of
      pediatric skin infections caused by community-associated methicillin-resistant Staphylococcus
      aureus (CA-MRSA). The investigators hypothesize that treatment with cephalexin, a
      penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not
      result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is
      most often susceptible.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between the ages of 6 months and 18 years of age (inclusive)

          -  Suspected purulent staphylococcal skin or soft tissue infection

          -  No hospitalization within the previous 14 days

          -  Must have reliable means of follow-up contact (e.g. working phone)

          -  Outpatient management in the judgement of treating physician

        Exclusion Criteria:

          -  Hospitalization on initial visit

          -  Voluntary withdrawal by the treating physician in order to dictate the antibiotic
             being used

          -  Patients with a history of hypersensitivity to or intolerance of cephalexin (or other
             beta lactams) or clindamycin.

          -  Patients with altered immunity (inherited or acquired)

          -  Patients with skin infections related to surgical wounds or hardware.

          -  Patients currently on antibiotic therapy
Methadone and Hydromorphone For Spinal Surgery
Condition: Hydromorphone Use; Acute Postoperative Pain; Patient Satisfaction; Chronic Persistent Surgical Pain
MeSH terms: Pain, Postoperative
Intervention: Methadone; Hydromorphone
Intervention description: Methadone 0.2 mg/kg administered at induction of anesthesia; Hydromorphone 2 mg administered at the conclusion of anesthesia
Intervention MeSH terms: Methadone; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: methadone; hydromorphone; acute postoperative pain; chronic persistent surgical pain

Summary:

      Patients undergoing major spinal surgery continue to experience moderate-to-severe pain
      during the first 2-3 days following the operative procedure. Pain complicates the recovery
      process, despite the routine practice of using potent opioid analgesics. The primary reason
      that pain is poorly controlled in patients undergoing major surgery is that most
      commonly-used opioids only produce analgesia for 2-4 hours. The intermittent use of these
      drugs results in periods of time when a patient will experience discomfort (at which time a
      nurse administers more drug or the button on a patient-controlled analgesic (PCA) system is
      pressed to deliver more medication). The use of a long-acting opioid may be advantageous in
      the perioperative setting. Methadone is an opioid that has a median duration of analgesia of
      24-36 hours. Therefore, a single dose administered in the operating room may reduce the need
      for pain medication and improve pain control for the first few postoperative days. The aim of
      this randomized clinical trial is to examine the effect of methadone (compared to
      hydromorphone) on postoperative pain management in patients undergoing major spine surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients presenting for elective posterior lumbar or thoracic spinal fusion
             surgery will be eligible for enrollment.

        Exclusion Criteria:

          1. Preoperative renal failure (defined as a serum creatinine > 2.0 mg/dL.)

          2. American Society of Anesthesiologists Physical Status IV or V

          3. Pulmonary disease necessitating home oxygen therapy

          4. Allergy to methadone or hydromorphone

          5. Preoperative recent history of opioid or alcohol abuse

          6. Inability to use a PCA device or speak the English language
Extension Study of the Efficacy and Safety of Deferasirox Treatment in Beta-thalassemia Patients With Transfusional Hemosiderosis (Study Amended to 2-year Duration)
Condition: Beta-thalassemia Major; Hemosiderosis; Iron Overload; Rare Anemia
MeSH terms: Thalassemia; beta-Thalassemia; Hemochromatosis; Iron Overload; Hemosiderosis
Intervention: Deferasirox
Intervention description: Deferasirox was administered orally once daily. Deferasirox was available as 125 mg, 250 mg, and 500 mg tablets.
Intervention MeSH terms: Deferasirox
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 233.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Transfusional hemosiderosis; Beta-thalassemia major; Deferasirox; iron overload; rare anemia; iron overload due to transfusion

Summary:

      To allow patients treated with deferasirox in the core study to continue iron chelation
      therapy for 2 years or until the drug became locally commercially available. To evaluate the
      long-term safety and efficacy of deferasirox by measuring treatment success, change in liver
      iron content (LIC) and change in serum ferritin levels. Safety was mainly assessed by
      incidence of adverse events (AEs)and clinically significant lab parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients completing the planned 12-month core study (NCT00171171)

          -  Female patients who have reached menarche and who are sexually active must use an
             effective method of contraception, or must have undergone clinically documented total
             hysterectomy and/or ovariectomy, or tubal ligation

          -  Written informed consent obtained from the patient and/or legal guardian on the
             patient's behalf in accordance with the national legislation

        Exclusion Criteria:

          -  Pregnant or breast feeding patients.

          -  Patients being considered by the investigator potentially unreliable and/or not
             cooperative with regard to the core study protocol, or the planned extension protocol
Long-term Varenicline Treatment for Smoking Cessation
Condition: Smoking
Intervention: varenicline; varenicline; Individual smoking cessation counseling
Intervention description: Extension of 1 mg twice daily treatment to 52 weeks; Double-blind switch to placebo after 12 weeks of open-label therapy; Brief (<10 minutes) smoking cessation counseling delivered at clinic visits
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking; relapse; withdrawal

Summary:

      This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy
      in conjunction with individual counseling for smoking cessation. Adult volunteers in
      generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of
      open-label varenicline therapy. At 12 weeks after their target quit date, they will be
      assigned in a random, double-blind manner to either 40 additional weeks of varenicline or
      placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for
      the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks
      post-treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  daily smoker

          -  5+ cigarettes per day for at least one year

          -  expired carbon monoxide level of 5+ ppm

        Exclusion Criteria:

          -  current use of smoking cessation pharmacotherapies

          -  current or history of psychotic disorder

          -  current major depressive disorder

          -  history of suicidal ideation in the previous 3 months

          -  unstable medical condition

          -  pregnant, nursing, or planning to become pregnant

          -  planning to move from study area within 18 months
Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Elderberry Extract; Placebos
Intervention description: Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry); Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Elderberry; Influenza

Summary:

      This research is being done to determine if an extract of cooked elderberries will help
      decrease the duration and severity of influenza symptoms in patients with confirmed
      influenza. Involvement in this study requires an initial patient screening at the time of
      their Emergency Department visit in order to confirm eligibility for the study. Once patients
      have been consented and enrolled as a participant, they will be randomized to take by mouth
      either Elderberry Extract or a placebo (a similar appearing and tasting liquid without
      elderberry) for a duration of 5 days. Study information regarding medication adherence, body
      temperature, symptoms, severity of symptoms, and any possible side effects will be collected
      from daily phone surveys conducted by the study coordinator. Participation in the study will
      end after at least 5 days once the patient has not had a temperature above 100°F and has had
      no influenza symptoms for at least 24 hours, or after 21 days in the study, whichever occurs
      first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  With 48 hours or less of an influenza illness documented by polymerase chain reaction

          -  Have AT LEAST 2 of the following 7 influenza symptoms (nasal congestion, sore throat,
             cough, aches and pains, fatigue, headaches, and chills or sweats) graded as either
             moderate or severe

          -  Have access to a phone

          -  Subjects are capable of giving informed consent or have an acceptable legally
             authorized representative capable of giving consent on the subject's behalf with
             informed assent given by subject.

          -  Have been prescribed or offered a prescription for oseltamivir (Tamiflu)

        Exclusion Criteria:

          -  Known allergy to elderberry extract or oseltamivir

          -  Use of antibiotic or antiviral medication on presentation to the study

          -  Women who are pregnant, breastfeeding women, or do not agree to appropriate
             contraception (abstinence, hormonal, intrauterine device, and barrier) to prevent
             pregnancy during the study.

          -  Patients with HIV

          -  Patients with cystic fibrosis

          -  Patients taking elderberry extract
Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: silk suture; VICRYL* Plus suture
Intervention description: skin closure; skin closure
Intervention MeSH terms: Triclosan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: wound healing

Summary:

      This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in
      approximately 100 patients from 6 centers in China undergoing scheduled modified radical
      mastectomy for breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older with written informed consent

          -  Scheduled for a modified radical mastectomy

          -  Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound
             Classification

        Exclusion Criteria:

          -  Unable to give consent and unlikely to comply with study requirements and complete the
             90-day follow up visit

          -  Undergoing surgery for modified radical mastectomy with immediate breast
             reconstruction, cosmetic breast operations, reduction, expansion, insertion of
             prothesis, duct ectasia or infective breast disease or implant

          -  Surgical wounds classified as Class II, III or IV using CDC SSI Surgical Wound
             Classification

          -  Has inflammatory cancers or skin ulceration

          -  Has known allergy or intolerance to triclosan

          -  Has compromised wound healing or chronic immune deficiency, for example diabetes,
             prolonged steroid use, AIDS or substance abuse

          -  Has serious heart and/or lung disease

          -  Has skin scar history or family history

          -  Has direct relationship to or involvement in this or other studies under the direction
             of the investigator or center

          -  Received an experimental drug or device within 30 days prior to the planned start of
             treatment
Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Condition: Pancreatic Cancer; Bile Duct Cancer
MeSH terms: Bile Duct Neoplasms; Cholangiocarcinoma
Intervention: Oral IMPACT
Intervention description: oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: immunonutrition; pancreaticoduodenectomy; Th1; Th2

Summary:

      The purpose of this study is to determine whether preoperative immunonutrition is effective
      on infectious complication and Th1/Th2 differentiation in patients with
      pancreaticoduodenectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients underwent pancreaticoduodenectomy

        Exclusion Criteria:

          -  age younger than 18 years

          -  ongoing infection

          -  gastrointestinal obstruction

          -  respiratory dysfunction

          -  cardiac dysfunction

          -  hepatic dysfunction

          -  renal failure

          -  history of recent immunosuppressive or immunological diseases

          -  preoperative evidence of widespread metastatic disease
Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention description: three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis B, Vaccine; Immunogenicity; methadone maintenance treatment; Randomized Controlled Trial

Summary:

      This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune
      persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three
      injections at months 0, 1, and 6 in methadone maintenance treatment patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged between 18 and 70 years at the enrolment

          -  Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface
             antibody (anti-HBs) at enrollment

          -  Willing to adhere to the study protocol

        Exclusion Criteria:

          -  Being pregnant

          -  Intolerance or allergy to any component of the vaccine

          -  Any vaccination during the month preceding enrollment

          -  Ongoing opportunistic infection

          -  Liver disease

          -  Hematological disorder

          -  Cancer

          -  Unexplained fever the week before enrollment