bioihbjkbjnl/mcl2 huggingface dataset:
Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)
Condition: Neuromuscular Blockade
Intervention: sugammadex
Intervention description: Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The objective of the trial is to determine the relationship within a participant between the
      time to manual detection of the reappearance of the fourth twitch (T4) measured using a
      peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch
      (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex
      administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last
      maintenance dose of 0.15 mg/kg rocuronium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 or 2 or 3

          -  between the ages of 18 to 64 years, inclusive

          -  scheduled for a surgical procedure under general anesthesia requiring

        neuromuscular relaxation with the use of rocuronium

          -  scheduled for a surgical procedure in supine position

          -  have given written informed consent

        Exclusion Criteria:

          -  participants with a difficult intubation because of expected anatomical

        malformations

          -  known or suspected to have neuromuscular disorders impairing

        neuromuscular blockade and/or significant hepatic and/or renal

        dysfunction

          -  medical or physical condition that is expected to interfere

        with the proper conduct of simultaneous neuromuscular monitoring on

        both arms

          -  known or suspected to have a (family) history of malignant

        hyperthermia

          -  known or suspected to have arthritis or another disease that will

        cause the thumb not to move freely

          -  known or suspected to have an allergy to narcotics, muscle

        relaxants or other medication used during general anesthesia

          -  is receiving medication in a dose and/or at a time point known to

        interfere with neuromuscular blocking agents (NMBAs), such as antibiotics, anticonvulsants
        and Mg2+

          -  already participated in a sugammadex trial

          -  participated in another clinical trial, not pre-approved, within prior 30 days

          -  pregnant females

          -  breast-feeding females
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: fesoterodine fumarate; placebo; tolterodine tartrate
Intervention description: 4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks; once daily (OD)for 12 weeks; 4 mg once daily (OD) for 12 weeks
Intervention MeSH terms: Tolterodine Tartrate; Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1712.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo
      for overactive bladder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult overactive bladder (OAB) patients who present with OAB symptoms, including
             urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

        Exclusion Criteria:

          -  Patients with conditions that would contraindicate for fesoterodine use, e.g,
             hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of
             the excipients, urinary retention, and gastric retention.

          -  Patients with significant hepatic and renal disease or other significant unstable
             diseases.

          -  OAB symptoms caused by neurological conditions, known pathologies of urinary tract,
             etc.
An Open, Uncontrolled Study of GK567 in the Deodorization of Malodorous Fungating Neoplastic Tumours
Condition: Malodorous Infected Cutaneous Ulcer
MeSH terms: Skin Ulcer
Intervention: GK567
Intervention description: Once or twice daily, for 14 days, up to 30 g per day
Intervention MeSH terms: Metronidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate
      malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days
      of treatment.

      The clinical hypothesis is that the success rate is no worse than 70% in the population of
      interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of
      treatment, as assessed by the Study Investigator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is a male or female aged between 20 years or older.

          -  The subject has a cutaneous fungating neoplastic tumour with a smell that suggests
             established or early infection, with a minimum score of 2 (i.e. mildly offensive
             smell) on a 0-4 smell scale, (based on the Study investigator's assessment)

        Exclusion Criteria:

          -  The subject is currently receiving systemic antibiotics or received in the last 2
             weeks,

          -  The subject is currently receiving systemic or topical Metronidazole or received in
             the last week,

          -  The subject is currently receiving topical antibiotics or received such treatment
             applied on cutaneous fungating neoplastic tumour in the last 1 week,

          -  The subject already receives any topical treatment on the cutaneous fungating
             neoplastic tumour
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: ZD9393 (Zoladex) 10.8 mg; ZD9393 (Zoladex) 3.6 mg
Intervention description: 10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).; 3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
Intervention MeSH terms: Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: Female
Minimum age: 20 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: ZOLADEX; Pre-menopausal; Oestrogen Receptor; Advanced Breast Cancer; Progression Free Survival

Summary:

      The purpose of this study is to examine the efficacy and safety as well as the
      characteristics of the female hormone and study medications after administration in
      pre-menopausal women with estrogen receptor positive advanced breast cancer who were
      randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot
      group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1
             year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of
             randomisation.

          -  Hormone sensitivity (ER positive) of primary or secondary tumour tissue.

          -  Histological/cytological confirmation of breast cancer and are candidates to receive
             hormonal therapy as therapy for advanced breast cancer.

        Exclusion Criteria:

          -  Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy
             for breast cancer within 24 weeks before randomisation and/or who have received prior
             treatment with hormonal therapies for advanced breast cancer

          -  Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks
             before randomisation

          -  Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after
             completion of adjuvant hormonal therapy and/or
Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Plecanatide; Placebo
Intervention MeSH terms: Plecanatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1135.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,
      parallel-group clinical trial with 12 weeks of study drug therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        • Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS
        based on ROME III diagnostic criteria and meeting criteria for diagnosis of the
        constipation predominant subtype - IBS-C

        Exclusion Criteria:

          -  Refusal or inability to sign informed consent for the trial

          -  Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day
             daily Calls, and/or complete electronic questionnaires

          -  BMI ≥ 40 or < 18

          -  Women of child bearing potential who refuse to use an acceptable method of birth
             control for the duration of the trial

          -  Women who are pregnant or lactating

          -  Diagnosis of IBS-D or IBS-M

          -  Organic or obstructive disease of the small or large intestine

          -  Use of laxatives other than the study-supplied rescue medication (Dulcolax®,
             bisacodyl)

          -  Use of a prohibited concomitant medication within the time frame prior to screening
             outlined in the study protocol for that medication

          -  Unstable medical illness

          -  Bilirubin > 3X ULN in the absence of a conjugation defect

          -  Any laboratory value > 3X ULN unless discussed and approved by the study Medical
             Monitor
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
Condition: Allergic Asthma
MeSH terms: Asthma
Intervention: Depigoid; Omalizumab; Placebo
Intervention description: Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL); anti-IgE (Omalizumab) given during the 2006 core study; Placebo given during the 2006 core study
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy
      (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid
      seasonal allergic rhinoconjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females of any race who are 12-45 years of age with a body weight ≥ 20 kg and
             ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml (suitable weight for
             dosing)

          -  Patients with the diagnosis of not adequately controlled seasonal grass pollen (and/or
             rye pollen) and allergic asthma with concomitant seasonal allergic rhinoconjunctivitis
             within > 2 previous seasons

          -  patients with a positive RAST (>CAP2) result for grass pollen (and/or rye pollen)
             specific IgE at screening (Visit 1 (V1) or within the previous 12 months.

          -  Patients with FEV1 > 80% of the predicted normal value for the patient at screening
             [V1](demostrable at least 6 hours after last short acting B-2 agonist use or 12 hours
             after last long B-2 acting agonist use).

        Exclusion Criteria:

          -  Females of childbearing potential: pregnancy, birth control,breast-feeding

          -  Concurrent diseases/conditions and history of other diseases/conditions

               1. patients who have a positive history of significant clinical manifestations of
                  allergy as a result of sensitization against tree pollen allergens, weed
                  allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house
                  dust mite).

               2. patients with a history of food or drug related severe anaphylactoid or
                  anaphylactic reaction(s).

          -  Ingredient hypersensitivity

               1. patients with known hypersensitivity to any ingredients, including excipients
                  (sucrose, histidine, polysorbate 20) of the study medication, any immunotherapy,
                  or drugs related to Omalizumab (e.g., monoclonal antibodies, polyclonal gamma
                  globulin).

               2. patients with hypersensitivity to the trail's asthma rescue- or
                  escalation-medication or related drugs.
Endometrial Safety Study
Condition: Postmenopause
Intervention: 0.25mg DRSP / 0.5mg E2 (BAY86-4891); 0.5mg NETA / 1.0mg E2 (Activella)
Intervention description: One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).; One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 662.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Postmenopausal Symptoms e.g.; Hot flushes; Sweating episodes; Vaginal dryness

Summary:

      The study is designed to investigate the safety of the investigational product for the lining
      of the uterus (endometrium).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women between 40 and 65 years of age with hormone therapy indication
             (symptoms and need for treatment)

          -  Non-hysterectomized women.

        Exclusion Criteria:

          -  Usual exclusion criteria for hormone therapy apply.
Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)
Condition: Anesthesia, General
Intervention: Sugammadex; Rocuronium
Intervention description: At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.; Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.
Intervention MeSH terms: Rocuronium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio
      of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes
      after the last administration of rocuronium in a wide range of surgical procedures and
      anesthetic regimens (routine use). Safety evaluation is part of the study.
    

Eligibility criteria:

        Inclusion criteria:

          -  American Society of Anesthesiologists (ASA) Class 1-3 participants who are scheduled
             to undergo an elective surgical procedure under general anesthesia requiring
             neuromuscular relaxation with the use of rocuronium.

        Exclusion criteria:

          -  Participants with neuromuscular disorders, significant renal dysfunction, malignant
             hyperthermia, allergy to medications used in general anesthesia and in whom difficult
             intubation is expected.

          -  Participants taking medications known to interfere with neuromuscular blocking agents.

          -  Participants who are of child-bearing potential, pregnant, and breast feeding
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Condition: Myeloid Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: Dasatinib; Imatinib
Intervention description: Tablets, oral, dasatinib 50-140 mg once daily (QD); Tablets, oral, imatinib 200-800 mg, QD
Intervention MeSH terms: Imatinib Mesylate; Dasatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 547.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Summary:

      The purpose of this clinical research study is to compare the confirmed complete cytogenetic
      response of dasatinib with that of imatinib within 12 months after randomization in patients
      with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety
      of this treatment will also be studied.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, aged 18 years and older

          -  Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)

          -  Eastern Cooperative Oncology Group Performance Status score of 0-2

        Key Exclusion Criteria:

          -  Pleural Effusion

          -  Uncontrolled cardiovascular disease

          -  Significant bleeding disorder unrelated to CML

          -  Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except
             anagrelide/hydroxyurea
An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165
Intervention description: Oral tablet administration
Intervention MeSH terms: Deucravacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate BMS-986165 given to Japanese participants with
      moderate-to-severe psoriasis.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

        a. For participants with plaque psoriasis: i. Stable plaque psoriasis for at least 6 months
        ii. Moderate to severe disease iii. Candidate for phototherapy or systemic therapy b.
        Additional protocol-specified inclusion criteria apply for subjects with psoriatic
        arthritis, erythrodermic psoriasis, or generalized pustular psoriasis

        Exclusion Criteria:

          1. Guttate, inverse, or drug-induced psoriasis at Screening or Baseline

          2. History of recent infection

          3. Prior exposure to BMS-986165

        Other protocol defined inclusion/exclusion criteria could apply
Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics
Condition: Liver Transplantation; Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Intervention: standard; extended; liver transplant
Intervention description: peri-operative antibiotic regimen only; extended three-day course of antibiotics; orthotopic liver transplantation
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will be to prospectively determine differences in Surgical Site Infection (SSI) if
      a prolonged course of post-operative antibiotics are used following liver transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients ≥ 18 years of age.

          -  Eligible for liver transplantation by UVA standard protocol.

          -  First-time transplantation.

          -  No active infections - requiring antibiotics - excluding antifungals.

        Exclusion Criteria:

          -  All patients < 18 years of age.

          -  Previous liver transplantation.

          -  Active infections - requiring antibiotics.

          -  Allergy to all standard peri-operative antibiotics (piperacillin/tazobactam or UVA
             standard alternatives for Penicillin allergic patients: ciprofloxacin and vancomycin).