bioihbjkbjnl/mcl2 huggingface dataset:
Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
Condition: Pancreatic Fistula
MeSH terms: Pancreatic Fistula; Fistula
Intervention: closed suction drainage of pancreatic duct; natural drainage of pancreatic duct
Intervention description: A Fr 5-8 silastic polyethylene pediatric feeding tube with multiple side-holes is inserted 2 cm into the pancreatic duct. The catheter exited via a small enterotomy in the jejunal loop of the distal portion of the hepaticojejunostomy. Totally externalized pancreatic stents were connected to the aspiration bag of a Jackson-Pratt drain to generate negative pressure or to a bile bag for natural drainage.; Natural drainage group
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Pancreatic fistula; Pancreatic duct stent; Closed suction drainage

Summary:

      Pancreaticojejunal anastomosis leakage is a major complication after pancreatoduodenectomy
      and various technical methods have been examined to improve the situation.However, none of
      methods have been successful at improving results according to the findings of prospective
      randomized studies. We propose that active drainage of pancreatic juice using suction
      drainage might maximize the advantage of a stent and finally reduce pancreaticojejunal
      anastomosis leakage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients who undergo duct-to-mucosa pancreaticojejunostomy reconstruction after
             pancreatoduodenectomy in our institution

        Exclusion criteria:

          -  less than 15 years old, or older than 85 years old
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis (SAR)
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: GSP 301 NS; GSP 301 Placebo NS
Intervention description: 1 spray in each nostril twice daily for 14 days; 1 spray in each nostril twice daily for 14 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 446.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis

Summary:

      Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared
      with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic
      Rhinitis (SAR).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects aged ≥6 to <12 years

          2. Clinical history of SAR (at least 2 years) with exacerbations during the study season
             for the relevant seasonal allergen (e.g., tree/grass pollen)

          3. Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick
             test within 12 months prior to screening

          4. A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening

          5. Signed informed consent/assent form (subject and parent/caregiver/legal guardian)

        Exclusion Criteria:

          1. Females of childbearing potential or pregnant

          2. Plans to travel outside the known pollen area for the investigational site for 24
             hours or longer during the last 7 days of the run-in period.

          3. History of anaphylaxis and/or other severe local reaction(s) to skin testing

          4. History and evidence of acute or significant chronic sinusitis or chronic purulent
             post nasal drip

          5. Subjects with an active pulmonary disorder or infection.

          6. Subjects with posterior subcapsular cataracts or glaucoma
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: EM-100; Zaditor®; Vehicle
Intervention description: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.; Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.; Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the
      treatment of ocular itching.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be at least 18 years old

          -  have a positive history of allergic conjunctivitis and positive skin test reaction to
             allergens

          -  be willing to avoid disallowed medications for the appropriate washout period and
             throughout the trial

          -  be willing to avoid contact lens use

          -  be willing to have a pregnancy test

          -  must be able to read an eye chart from 10 feet away

        Exclusion Criteria:

          -  must not have any allergies to the study medications

          -  must not have any ocular or non ocular condition that investigator feels will
             interfere with study parameters

          -  must not have used an investigational drug or device in the past 30 days or currently
             be enrolled in another investigational trial
Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
Condition: Rotavirus; Gastroenteritis
MeSH terms: Gastroenteritis
Intervention: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™); Comparator: Comparator: Placebo (unspecified)
Intervention description: Rotateq orally administered 3 times; Placebo orally administered 3 times
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 762.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gastroenteritis; Rotavirus

Summary:

      The purpose of the study is to evaluate whether V260 is effective and well tolerated in
      Japanese healthy infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age

        Exclusion Criteria:

          -  History Of Known Prior Rotavirus Gastroenteritis

          -  Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In
             Other Studies Of Investigational Products At Any Time During The Study Period
Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial
Condition: Thoracic Diseases; Postoperative Pain; Opioid Use
MeSH terms: Thoracic Diseases
Intervention: Liposomal bupivacaine; Bupivacaine Injection
Intervention description: 5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.; 5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Syringe with Obscuring Over-Wrap
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Liposomal Bupivacaine; Intercostal Nerve Block; Minimally Invasive Thoracic Surgery

Summary:

      The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center,
      double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic
      efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in
      subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Robotic or Video-Assisted Lung Resection for All Indications

        Exclusion Criteria:

          -  Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)

          -  Extra-Thoracic Procedures

          -  Hypersensitivity to Amide Local Analgesia

          -  Cardiac Conduction Abnormalities

          -  Hepatic Dysfunction

          -  Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Prasugrel; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 341.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The main purpose of the study is to evaluate the efficacy and safety of the study drug known
      as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants with
      sickle cell disease. The study will also investigate reduction in daily pain in children who
      have sickle cell disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have SCD [homozygous sickle cell (HbSS) or hemoglobin (HbS) Beta^0 thalassemia]

          -  Are participants with SCD who have had ≥2 episodes of vaso-occlusive crisis (VOC) in
             the past year

          -  Have a body weight ≥19 kilograms (kg) and are ≥2 and <18 years of age, inclusive at
             the time of screening

          -  If participants are ≥2 and ≤16 years of age, must have had a transcranial Doppler
             within the last year

        Exclusion Criteria:

          -  History of: transient ischemic attack (TIA)/ ischemic or hemorrhagic stroke, severe
             head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous
             malformation, or aneurysm

          -  History of abnormal or conditional [velocity in middle or anterior cerebral, or
             internal carotid artery ≥170 centimeter per second (cm/sec)] transcranial Doppler
             within the last year

          -  History of, or are undergoing treatment with, chronic red blood cell (RBC) transfusion
             therapy

          -  Are at an increased risk for bleeding complications

          -  Are receiving chronic treatment with nonsteroidal anti-inflammatory drug (NSAID)s and
             cannot be switched to another analgesic
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Intervention: Valganciclovir; Valganciclovir
Intervention description: 900 mg orally daily for up to 100 days; 900 mg orally daily for up to 200 days
Intervention MeSH terms: Valganciclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 326.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This study will determine the relative efficacy and safety of up to 100 days Valcyte
      prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of
      CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study
      treatment is 3-12 months and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 16 years of age

          -  CMV seronegative recipient of primary or secondary renal allograft from a living or
             cadaveric seropositive donor

          -  Adequate hematological and renal function

          -  Patients and partners must agree to maintain effective birth control for 90 days
             following cessation of study medication

        Exclusion Criteria:

          -  CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening

          -  Multi-organ transplant recipient

          -  Hepatitis B, hepatitis C or HIV positive

          -  Women who are pregnant or lactating
12 / 48 wk Pivotal PFT vs PBO in COPD II
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Olodaterol (BI 1744); Olodaterol (BI 1744); Placebo
Intervention description: Comparison of low and high doses on efficacy and safety in COPD patients; Comparison of low and high doses on efficacy and safety in COPD patients; Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler
Intervention MeSH terms: Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 644.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This primary objective of this study is to compare two doses of BI 1744 CL inhalation
      solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic
      obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion criteria:

          -  All patients must have a diagnosis of chronic obstructive pulmonary disease

          -  Male or female patients, 40 years of age or older Patients must be current or
             ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1
             <80% predicted and post-bronchodilator FEV1/FVC <70%

        Exclusion criteria:

          -  Patients with a significant disease other than COPD

          -  Patients with a history of asthma

          -  Patients with any of the following conditions:

        a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or
        life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the
        past year. known active tuberculosis a malignancy for which patient has undergone
        resection, radiation therapy or chemotherapy within last five years (patients with treated
        basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a
        history of cystic fibrosis
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Condition: Opioid-Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: CB-5945; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Opioid; Constipation; Chronic; Pain

Summary:

      The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment
      of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer
      pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily
             dose (METDD) for chronic non-cancer pain

          -  Has constipation that is caused by the chronic use of opioids

          -  Is willing to use only the study provided laxative(s) and to discontinue use of all
             other laxatives, enemas, stool softeners, and other medications to treat constipation
             (e.g., lubiprostone) from Screening until the last study assessment

        Key Exclusion Criteria:

          -  Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for
             example [e.g.], obstruction) or contribute to bowel dysfunction

          -  Has evidence of intestinal obstruction

          -  Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of
             screening

          -  Has an active malignancy of any type (participants with a history of successfully
             treated malignancy >5 years before the scheduled administration of study medication
             and participants with treated basal or squamous cell cancer may be enrolled)

          -  Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide),
             prokinetics (e.g., metoclopramide), or locally acting chloride channel activators
             (e.g., lubiprostone)

          -  Is taking non-opioid medications known to cause constipation (e.g., iron sulfate
             therapy, tricyclic antidepressants)
Experimental Medication For the Treatment of Generalized Anxiety Disorder
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: experimental anti-anxiety drug
Intervention MeSH terms: Anti-Anxiety Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Double Blind, Placebo controlled, Safety and Efficacy; Generalized Anxiety Disorder

Summary:

      The purpose of this study is to determine whether an experimental anti-anxiety medication is
      effective in the treatment of Generalized Anxiety Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 to 65 years of age will be eligible to participate if they satisfy the
             DSM-IV-TR criteria for the diagnosis of GAD.

        Exclusion Criteria:

          -  No other primary psychiatric diagnosis besides GAD.
Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME)
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU); Platinum (Cisplatin or Carboplatin) + 5-FU
Intervention description: Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks; All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks
Intervention MeSH terms: Cisplatin; Carboplatin; Fluorouracil; Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 442.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer

Summary:

      The purpose of this trial is to investigate the efficacy of cetuximab in combination with
      chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic
      head and neck cancer. Overall survival will be taken as the primary measure of efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the
             head and neck (SCCHN)

          -  Recurrent and/or metastatic SCCHN, not suitable for local therapy

        Exclusion Criteria:

          -  Prior systemic chemotherapy, except if given as part of a multimodal treatment for
             locally advanced disease which was completed more than 6 months prior to study entry

          -  Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before
             study entry

          -  Nasopharyngeal carcinoma