bioihbjkbjnl/mcl2 huggingface dataset:
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 Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Tislelizumab; Paclitaxel; Nab-paclitaxel; Carboplatin
Intervention description: Administered intravenously as described; Administered intravenously as described; Administered intravenously as described; Administered intravenously as described
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Tislelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and
      safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line
      treatment in advanced squamous non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Age 18-75 years old, male or female, and signed informed consent form (ICF)

          2. Advanced NSCLC diagnosed by pathological or clinical physicians

          3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1

          4. Participants must have ≥ 1 measurable lesion as defined per Response Evaluation
             Criteria in Solid Tumors (RECIST) v1.1

          5. Must be treatment-naive for locally advanced or metastatic squamous NSCLC

          6. Life expectancy ≥ 12 weeks

          7. Participants must have adequate organ function

          8. Male/Female is willing to use a highly effective method of birth control

        Key Exclusion Criteria:

          1. Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing
             mutation or anaplastic lymphoma kinase (ALK) gene translocation

          2. Received any approved systemic anticancer therapy

          3. Received prior treatment with EGFR inhibitors or ALK inhibitors

          4. Received prior therapies targeting programmed death 1 (PD-1) or programmed death
             ligand 1 (PD-L1)

          5. With history of interstitial lung disease

          6. Clinically significant pericardial effusion

          7. Severe infections, active leptomeningeal disease or uncontrolled, untreated brain
             metastasis

          8. Any major surgical procedure before randomization

          9. Human immunodeficiency virus infection

         10. Untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)

         11. Active autoimmune diseases or history of autoimmune diseases

         12. History of allergic reactions to chemotherapy

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
Condition: Delirium
MeSH terms: Delirium
Intervention: Ketamine (0.5 mg/kg); Normal Saline (placebo); Ketamine (1 mg/kg)
Intervention description: Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.; Normal saline IV following induction of anesthesia or administration of sedative medications; Low dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
Intervention MeSH terms: Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 746.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Delirium; ketamine; surgery; neurological complications

Summary:

      Delirium is a medical term or condition that includes a temporary inability to focus
      attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than
      60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug
      called ketamine can decrease the chance that patients will experience delirium after their
      surgery. The investigators are also testing whether ketamine decreases postoperative pain,
      postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length
      of stay, and adverse outcomes (e.g. hallucinations and nightmares).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 60 and older

          -  Competent to provide informed consent

          -  Undergoing major surgery (e.g., open cardiac surgery, open or thoracoscopic thoracic
             surgery, abdominal surgery, open urological surgery, open gynecological surgery, major
             orthopedic surgery, major vascular surgery including endovascular procedures, major
             ear, nose and throat surgery).

        Exclusion Criteria:

          -  Patients with an allergy to ketamine

          -  Those in whom a significant elevation of blood pressure would constitute a serious
             hazard (e.g., pheochromocytoma, aortic dissection)

          -  Unable to provide informed consent

          -  Patients with drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine,
             methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin)

          -  Patients taking anti-psychotic medications (e.g., chlorpromazine, clozapine,
             olanzapine, risperidone, haloperidol, quetiapine, risperidone, paliperidone,
             amisulpride, sertindole)

          -  Patients with a weight outside the range 50 kg - 200 kg (110 lbs - 440 lbs)
Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
Condition: Blepharoptosis
MeSH terms: Blepharoptosis
Intervention: RVL-1201; Vehicle ophthalmic solution
Intervention description: RVL-1201 ophthalmic solution 0.1%; Vehicle placebo ophthalmic solution
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 164.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to
      placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2
      treatment arms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female 9 years of age or older

          2. Females must not be pregnant or planning to get pregnant and must use acceptable form
             of contraception

          3. Must be able to self-administer study medication

          4. Must be able to understand and sign an informed consent form. For minor subjects, the
             subject's parent or legal guardian must provide permission by signing an ICF on behalf
             of the subject and the subject should provide assent.

        Exclusion Criteria:

          1. Congenital ptosis

          2. Horner syndrome

          3. Myasthenia gravis

          4. Mechanical ptosis

          5. Previous ptosis surgery

          6. Resting heart rate outside the normal range

          7. Hypertension with resting diastolic blood pressure

          8. Pregnancy or lactation
Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 1% OPA-15406; Placebos
Intervention description: Twice daily; Twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 364.0
Sex: All
Minimum age: 15 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when
      administered twice daily for 4 weeks using success rate in Investigator's Global Assessment
      (IGA) at Week 4 as the primary endpoint in adult patients with AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AD based on the Japanese Dermatological Association's criteria

          -  History of AD for at least 3 years

          -  Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of
             body surface area (BSA, excluding scalp) at the screening and baseline examinations

          -  IGA score of 2 or 3 at the screening and baseline examinations

        Exclusion Criteria:

          -  Subjects who have an AD or contact dermatitis flare-up defined as a rapid
             intensification of AD, within 28 days prior to the baseline examination
DS-5565 Phase III Study for Renal Impairment in Japanese Subjects
Condition: Diabetic Peripheral Neuropathic Pain; Post-herpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic; Diabetic Neuropathies; Renal Insufficiency
Intervention: DS-5565
Intervention description: DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Diabetic peripheral neuropathic pain; post-herpetic neuralgia; renal impairment

Summary:

      Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral
      Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal
      impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At screening, creatinine clearance (using the Cockcroft-Gault equation): 15-59 mL/min

          -  At screening, a pain scale of ≥ 40 mm

          -  Type 1 or type 2 diabetes mellitus at screening (for patients with diabetic peripheral
             neuropathic pain DPNP only)-. Painful distal symmetric polyneuropathy (for patients
             with DPNP only)

          -  post-herpetic neuralgia PHN defined as pain present for more than 3 months after
             herpes zoster skin rash at screening (for patients with PHN only)

        Exclusion Criteria:

          -  HbA1c (National Glycohemoglobin Standardization Program) > 10.0% (for patients with
             DPNP only)

          -  Previous use of neurolytic block (for patients with PHN only)
Nitrous Oxide for External Cephalic Version
Condition: External Cephalic Version
Intervention: Nitrous Oxide; Placebo
Intervention description: 50% nitrous oxide/50% oxygen via Nitronox delivery device; 100% oxygen via Nitronox delivery device
Intervention MeSH terms: Nitrous Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The Nitronox device will be covered. The person setting up the device with either 100% oxygen or 50% nitrous/50% oxygen, will not be participating in the study. The patient, investigator and labor and delivery personnel (obstetrician and nursing staff) will be blinded as to the medication being administered during the procedure.
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: breech presentation; nitrous oxide; analgesia; pregnancy

Summary:

      This study seeks to determine the effectiveness of nitrous oxide in reducing the anxiety and
      pain associated with external cephalic version (ECV); a maneuver to turn the fetus from
      breech to cephalic position.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female 18 years or greater

          -  Scheduled to undergo external cephalic version due to singleton breech presentation

          -  Not scheduled to have spinal or epidural anesthesia during the version procedure

          -  American Society of Anesthesiology (ASA) Physical Status 1, 2 or 3.

          -  Able to provide informed consent and adhere to study protocol

        Exclusion Criteria:

          -  Current or historical evidence of any clinically significant disease or condition,
             especially cardiovascular or neurological conditions that, in the opinion of the
             Investigator, may increase the risk of exposure to nitrous oxide or complicate the
             subject's post-procedural course.

          -  Significant medical conditions or laboratory results that, in the opinion of the
             Investigator, indicate an increased vulnerability to study drugs and procedures.
A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab; Dacarbazine
Intervention MeSH terms: Ipilimumab; Dacarbazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Ipilimumab will extend the life of chinese
      patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to
      examine safety in this patient population.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Chinese males and females ≥ 18 years of age

          -  Histologic diagnosis of malignant melanoma

          -  Chemotherapy naive Stage IV melanoma (AJCC 2010)

          -  Life expectancy of ≥ 16 weeks

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Evidence of brain metastases on brain imaging

          -  Primary ocular or mucosal melanoma

          -  Any other malignancy from which the patient has been disease-free for less than 5
             years

          -  BRAF status cannot be determined by Screening test

          -  Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg)
             positive, or active Hepatitis C infection
Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hypersensitivity
Intervention: Farletuzumab; Carboplatin; Taxane; Farletuzumab-matched placebo
Intervention description: Farletuzumab IV infusion.; Carboplatin IV infusion.; Taxane (Paclitaxel or Docetaxel) IV infusion.; Farletuzumab-matched placebo IV infusion.
Intervention MeSH terms: Carboplatin; Taxane; Farletuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; relapsed ovarian cancer; Platinum-sensitive Ovarian Cancer

Summary:

      This research is being done to find out if Carboplatin and Taxane works better alone or when
      given with an experimental drug called MORAb-003(farletuzumab) in subjects with first
      platinum sensitive relapsed ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A histologically or cytologically confirmed diagnosis of non-mucinous epithelial
             ovarian cancer including primary peritoneal or fallopian tube malignancies

          -  Must have measurable disease by CT or MRI scan

          -  Must have relapsed radiologically with a randomization date within ≥6 and < 24 months
             of completion of first-line platinum chemotherapy

          -  Have been treated with debulking surgery and first-line platinum and taxane based
             chemotherapy.

          -  Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been
             at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or
             cancer vaccine therapy is allowed.

          -  Must be a candidate for carboplatin and taxane therapy

          -  Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

        Exclusion Criteria:

          -  Subjects who never responded to first-line platinum-based therapy or whose first
             relapse occurs <6 months or >24 months from the last platinum therapy

          -  Subjects who have received other therapy to treat their ovarian cancer since relapse

          -  Known central nervous system (CNS) tumor involvement

          -  Evidence of other active invasive malignancy requiring treatment in the past 5 years

          -  Known allergic reaction to a prior monoclonal antibody therapy or have any documented
             HAHA

          -  Previous treatment with MORAb-003 (farletuzumab)

          -  Clinical contraindications to use of a taxane
A Study of Fibrocaps™ in Surgical Bleeding
Condition: Mild or Moderate Surgical Bleeding
MeSH terms: Hemorrhage
Intervention: Fibrocaps; Gelatin sponge
Intervention description: Human fibrinogen and thrombin powder, for topical administration.; Absorbable gelatin sponge for topical administration.
Intervention MeSH terms: Fibrin Tissue Adhesive; Fibrin Foam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 721.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fibrin sealant; thrombin; fibrinogen; hemostasis

Summary:

      The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as
      compared to gelatin sponge alone, for achieving hemostasis.

      The investigational products were used in participants with mild to moderate surgical
      bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to
      moderate bleeding by standard surgical techniques is ineffective and/or impractical.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has signed an institutional review board/independent ethics committee
             (IRB/IEC)-approved informed consent document

          2. Is undergoing one of the 4 surgical procedures described

          3. Is at least 18 years old at time of consent

          4. If female and of child-bearing potential, has negative pregnancy test during screening
             and is not breast-feeding

          5. If able to reproduce, agrees to use a medically accepted form of contraception from
             the time of consent to completion of all follow-up study visits when engaging in
             heterosexual intercourse

          6. Has not received blood transfusion between screening and study treatment

          7. Has mild to moderate surgical bleeding

          8. Does not have intra-operative complications

          9. Has not used a topical hemostat containing thrombin prior to study treatment

         10. Has an approximate bleeding site surface area of less than or equal to 100 cm^2

        Exclusion Criteria:

          1. Has known antibodies or hypersensitivity to thrombin or other coagulation factors

          2. Has history of heparin-induced thrombocytopenia (only for vascular subjects where
             heparin use is required)

          3. Has known allergy to gelatin sponge

          4. Is unwilling to receive blood products

          5. Has liver enzymes appropriate for the study, considering their disease

          6. Has appropriate level of platelets per liter (PLT/L) during screening

          7. Has any clinically-significant coagulation disorder that may interfere with the
             assessment of efficacy or pose a safety risk to the subject according to the
             Investigator, or baseline abnormalities during screening that are not explained by
             current drug treatment (e.g., warfarin, heparin)