bioihbjkbjnl/mcl2 huggingface dataset:
Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Lidocaine; Ketamine; Saline
Intervention MeSH terms: Lidocaine; Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study has been designed as a controlled clinical trial to evaluate the efficacy of brief
      lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when
      added to conventional opioid therapy following major spine surgery, as well as to evaluate
      the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine
      intraoperative neurophysiology during spine surgery in adults and determine whether this
      infusion protocol is compatible with intraoperative neurophysiology on spine surgery
      patients. If one or more of the approaches is confirmed as efficacious and safe, it could
      have a significant impact on the routine management of postoperative pain in this context.
    

Eligibility criteria:

        Inclusion Criteria:

        Male and Female >/= 18 years of age Patients undergoing first-time fusion surgery or
        surgery to revise a prior fusion Able to read, write and speak in English, and able to give
        informed consent for the study

        Exclusion Criteria:

        Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction
        cardiac dysfunction
Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Tanezumab; Tanezumab; Placebo
Intervention description: IV, 5 mg dose, q 8 weeks, for up to 80 weeks; IV, 10 mg dose, q 8 weeks, for up to 80 weeks; IV, q 8 weeks, for up to 80 weeks
Intervention MeSH terms: Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      Tanezumab, administered for up to 1 1/2 years, reduces the pain of osteoarthritis without
      affecting how nerve impulses are transmitted in sensory nerves
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must consent in writing to participate in the study.

          -  Patients must be willing to comply with study visit schedule and study requirements,
             including, for women of child-bearing potential or male patients with female partners
             of child-bearing potential, the use of 2 forms of birth control, one of which is a
             barrier method.

          -  Patients must have participated in the A4091026 study.

        Exclusion Criteria:

          -  Withdrawn from the A4091026 study for an adverse event or serious adverse event.

          -  Pregnant women, lactating mothers, women suspected of being pregnant, and women who
             wish to be pregnant during the course of clinical study.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the patient
             inappropriate for entry into this study.
Clinical Evaluation of Patient Preoperative Prep
Condition: Surgical Skin Preparation
Intervention: ZuraPrep; ChloraPrep; ZP Vehicle
Intervention description: Apply topically.; Apply topically.; Apply topically.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 640.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to demonstrate the antimicrobial efficacy of the ZP
      Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race.

          -  Subjects in good health.

          -  Minimum skin flora baseline requirements on abdomen and groin.

          -  Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder
             near or on the applicable test area.

        Exclusion Criteria:

          -  Topical or systemic antimicrobial exposure within 14 days prior to screening and
             treatment days, including antibiotics.

          -  Subjects with a history of skin sensitivity, skin allergies, or skin cancer.

          -  Subjects who are pregnant, attempting pregnancy, or nursing.
Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Alisporivir; Peginterferon alfa-2a; Ribavirin
Intervention description: ALV 200 mg soft gel capsules administered orally; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C; PI treatment failure

Summary:

      This study is to evaluate the overall efficacy, and safety profile of the triple combination
      therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV)
      patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease
      inhibitor (PI).
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with chronic HCV genotype 1 infection with previous PI treatment failure

          2. Three months minimum time from the last dose of previous PI treatment to the first
             dose of study medication

        Exclusion criteria:

          1. Use of other investigational drugs at the time of enrollment

          2. History of hypersensitivity to PEG or RBV

          3. Any null non-responders to prior PEG/RBV treatment

        Other protocol-defined inclusion/exclusion criteria may apply.
A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Saxagliptin; Dapagliflozin; Glimepiride; Placebo
Intervention MeSH terms: Dapagliflozin; Glimepiride; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 444.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin,
      in addition to metformin, results in better glycemic control, as measured by HbA1c, over a
      treatment period of 52 weeks, compared to the addition of glimepiride to metformin in
      subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin
      Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in
      co-administration with dapagliflozin, added to current background therapy with metformin
      compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week
      52.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects must be willing and able to give signed and dated written informed consent

          -  Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control

          -  Subjects should have been taking the same daily dose of metformin ≥ 1500 mg

          -  Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)

          -  Males and females, aged ≥18 years old at time of screening visit

          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
             test

          -  WOCBP and males must agree to follow instructions for method(s) of contraception for
             the duration of treatment with study drug

        Exclusion Criteria:

          -  Clinical diagnosis of type I diabetes

          -  History of diabetic ketoacidosis

          -  Cardiovascular/vascular diseases within 3 months of the enrollment

          -  Renal disease

          -  Hepatic diseases

          -  History of, or currently, acute or chronic pancreatitis

          -  Hematological and oncological disease/conditions

          -  Patients who have contraindications to therapy being studied

          -  Patients on weight loss program(s)

          -  Replacement or chronic systemic corticosteroid therapy
Ocular Hypertension Treatment Study (OHTS)
Condition: Ocular Hypertension; Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Topical ocular hypotensive eye drops.
Intervention description: Topical ocular hypotensive eye drops.
Intervention MeSH terms: Antihypertensive Agents; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1636.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To determine whether medical reduction of intraocular pressure prevents or delays the onset
      of glaucomatous visual field loss and/or optic disc damage in ocular hypertensive
      participants judged to be at moderate risk for developing open-angle glaucoma.

      To produce natural history data to assist in identifying patients at most risk for developing
      open-angle glaucoma and those most likely to benefit from early medical treatment.

      To quantify risk factors for developing open-angle glaucoma among ocular hypertensive
      individuals.
    

Eligibility criteria:

        Men and nonpregnant women between the ages of 40 and 80 with IOP greater than or equal to
        24 mm Hg but less than or equal to 32 mm Hg in at least one eye and IOP greater than or
        equal to 21 but less than or equal to 32 mm Hg in the fellow eye, as well as normal visual
        fields and optic discs are eligible for the trial. Patients presenting with best-corrected
        visual acuity worse than 20/40 in either eye, previous intraocular surgery, a
        life-threatening or debilitating disease, secondary causes of elevated IOP, angle-closure
        glaucoma or anatomically narrow angles, other diseases that can cause visual field loss,
        background diabetic retinopathy, optic disc abnormalities that can produce visual field
        loss or obscure the interpretation of the optic disc, or unwillingness to undergo random
        assignment are excluded from the trial.
A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adalimumab
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Dose Escalation; Crohn's Disease

Summary:

      The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after
      dose escalation in Japanese subjects with Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject ≥ 15 years of age at the time of informed consent.

          -  Subject with Crohn's disease who received induction treatment of commercially
             available Humira® (160 mg initially and 80 mg at 2 weeks after initial dose), achieved
             response after initial dose, and then lost response during maintenance treatment with
             Humira®.

          -  Subject with elevated C-reactive Protein (CRP) at Screening.

          -  If female, subject is either not of childbearing potential, defined as postmenopausal
             for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
             oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an
             approved method of birth control throughout the study and for 150 days after the last
             dose of study drug.

          -  Subject has a negative tuberculosis (TB) screening assessment. If the subject has
             evidence of a latent TB infection; the subject must initiate and complete a minimum of
             21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged
             until 21 days past after initiation of prophylaxis and study drug is administered) or
             have documented completion of a full course of TB prophylaxis, prior to Week 0.

        Exclusion Criteria:

          -  Subject with suspicion of colitis other than Crohn's disease.

          -  Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal
             anastomosis are not excluded).

          -  Subject with abscess or suspicion of abscess, or subject with infection(s).
The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer
Condition: Recurrent or Metastatic NPC
MeSH terms: Recurrence
Intervention: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy; Placebos
Intervention description: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy; placebo combine with chemotherapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 289.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to
      determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with
      gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as
      first-line treatment in patients with histological/cytological confirmation of recurrent or
      metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who
      fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized
      in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the
      combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3
      weeks (Q3W) in 3-week cycles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Age ≥ 18 years and ≤75 years.

          -  2. Histological/cytological confirmation of NPC.

          -  3. Primarily metastatic (stage IVB as defined by the International Union against
             Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition)
             or recurrent NPC that is not amenable for local regional treatment or curative
             treatment.

          -  4. At least 1 measurable lesion according to RECIST version 1.1.

          -  5. Life expectancy ≥ 3 months

        Exclusion Criteria:

          -  1. History of severe hypersensitivity reactions to other mAbs or any ingredient of
             JS001.

          -  2. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T
             lymphocyte associated protein 4 (CTLA4) receptor.

          -  3. Major surgical procedure other than for diagnosis of NPC within 28 days prior to
             randomization or anticipation of need for a major surgical procedure during the study

          -  4. History of hypersensitivity to gemcitabine or cisplatin or to any of the
             excipients.

          -  5. Female patients who are at pregnancy or lactation.
A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
Condition: Uveitis
MeSH terms: Uveitis; Panuveitis
Intervention: adalimumab
Intervention description: Adalimumab, pre-filled syringe, administered by SC injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intermediate-Uveitis; Non-infectious Uveitis; Posterior-Uveitis; Active Uveitis; Pan-uveitis; Uveitis

Summary:

      The purpose of this study is to evaluate the long term efficacy and safety of adalimumab
      participants with non-infectious intermediate-, posterior- or pan-uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have successfully enrolled in either study M10-877 or M10-880 and
             either met the endpoint of "Treatment Failure" or completed the study

        Exclusion Criteria:

          -  A participant will be excluded from this study if the participant discontinued from
             study M10-877 or M10-880 for any reasons other than having a Treatment Failure event

          -  Participant with corneal or lens opacity that precludes visualization of the fundus or
             that likely requires cataract surgery during the duration of the trial

          -  Participants with intraocular pressure of >= 25 mmHg and on >= 2 glaucoma medications
             or evidence of glaucomatous optic nerve injury

          -  Participant with proliferative or severe non-proliferative diabetic retinopathy or
             clinically significant macular edema due to diabetic retinopathy

          -  Participant with neovascular/wet age-related macular degeneration

          -  Participant with abnormality of vitreo-retinal interface (i.e., vitreomacular
             traction, epiretinal membranes, etc.) with the potential for macular structural damage
             independent of the inflammatory process

          -  Participant with a systemic inflammatory disease that requires therapy with a
             prohibited immunosuppressive agent at the time of study entry
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Benefix
Intervention description: BeneFIX for on-demand treatment of bleeding episodes were according to investigator prescription. FIX recovery was assessed by determining the FIX activity (FIX:C) levels in individual subjects. BeneFIX dosage for recovery assessments: single 75 IU/kg (±5 IU/kg) IV bolus infusion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: On-demand treatment; Hemostatic efficacy; Factor IX activity; Factor IX recovery; Factor IX inhibitor; Chinese

Summary:

      This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in
      Chinese hemophilia B subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B
             (FIX activity: more than 5%, 1-5%, or less than 1%, respectively)

          -  Subjects with previous exposure to FIX replacement therapy

          -  If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry

        Exclusion Criteria:

          -  Diagnosed with any bleeding disorder in addition to hemophilia B

          -  Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting
             laboratory)

          -  Subject has no history of exposure to FIX products (previously untreated patient
             [PUP])

          -  Subject is currently utilizing primary FIX prophylaxis

          -  Subjects anticipating elective surgery that may be planned to occur in the 6 months
             following study entry

          -  Treated with immunomodulatory therapy within 30 days prior to study entry or planned
             use for the duration of their study participation

          -  Participated in another investigational drug or device study within 30 days prior to
             study entry or planned participation for the duration of their study participation

          -  Subjects with a known hypersensitivity to hamster protein

          -  Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or
             serum creatinine >1.25 x ULN)

          -  Prothrombin Time >1.5 x ULN

          -  Platelet count <80,000/µL

          -  Pregnant or breastfeeding women

          -  Unwilling or unable to follow the terms of the protocol

          -  Any condition which may compromise the subject's ability to comply with and/or perform
             study-related activities or that poses a clinical contraindication to study
             participation, in the opinion of the Investigator or Sponsor