bioihbjkbjnl/mcl2 huggingface dataset:
Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block
Condition: Perianal Surgery
Intervention: Dixon's up-and-down method
Intervention description: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.
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
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Perianal surgery; hyperbaric bupivacaine; saddle block

Summary:

      The optimal anesthetic technique would provide excellent operating conditions, rapid
      recovery, early discharge, no postoperative side effects, and high patient's satisfaction. In
      addition to increasing the quality and decreasing the costs of the anesthetic services (1).
      Selective spinal anesthesia (SSA) -spinal block with minimal effective doses for a specific
      type of surgery - has become very popular technique) 2(for some orthopedic and gynecological
      surgeries [3-9].

      Saddle anesthesia is a SSA directs a small bolus of hyperbaric local anesthetic, towards
      S4-S5 and coccygeal nerve roots (11), and is commonly utilized for perianal surgeries
      (11-14). Hyperbaric bupivacaine has been safely, replaced hyperbaric Lidocaine for saddle
      block (11, 12).

      Although Saddle blocks at different low doses of hyperbaric bupivacaine (1.5- 4 mg) have been
      used previously for mi¬nor perianal surgeries (11, 13, 14), the optimal effective dose has
      yet to be determined.

      The objective of this study is to determine the minimal effective dose of hyperbaric spinal
      bupivacaine required to induce a reliable and satisfactory saddle block for perianal
      surgeries (using a modified Dixon's up-and-down method.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists physical Status I and II patients.

          -  Scheduled for outpatient elective perianal surgery.

        Exclusion Criteria:

          -  Patients unwilling to participate.

          -  Contraindications to regional anesthesia.

          -  Morbid obesity.

          -  Bleeding disorders.

          -  Mental health problems.

          -  Language barrier.

          -  Taking psychotropic or analgesic medication.

          -  History of allergic reactions to amide local anesthetics.
European Phase III Study of APD421 in PONV
Condition: PONV
Intervention: APD421; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 368.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at
      moderate-to-high risk of PONV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥ 18 years of age

          -  Patients undergoing elective surgery (open or laparoscopic technique) under general
             anaesthesia, expected to last at least one hour from induction of anaesthesia to wound
             closure and expected to require at least one overnight stay in hospital

        Exclusion Criteria:

          -  Patients scheduled for outpatient/day case surgery

          -  Patients scheduled to undergo intra-thoracic, transplant or central nervous system
             surgery

          -  Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal
             or epidural) block

          -  Patients who are expected to remain ventilated for a period after surgery

          -  Patients who are expected to need a naso- or orogastric tube in situ after surgery is
             completed
Brexpiprazole in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Brexpiprazole
Intervention description: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To determine the safety and efficacy of brexpiprazole during long-term treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has completed the lead-in study 14644A.

          -  The patient is judged to potentially benefit from 52-week treatment with brexpiprazole
             according to the clinical opinion of the investigator.

          -  The patient agrees to protocol-defined use of effective contraception.

        Exclusion Criteria:

          -  The patient has been diagnosed with a primary psychiatric disorder other than
             schizophrenia during Study 14644A.

          -  The patient has a clinically significant unstable illness diagnosed during Study
             14644A.

          -  The patient, in the opinion of the investigator or according to Columbia-Suicide
             Severity Rating Scale (C-SSRS), is at significant risk of suicide.

          -  The patient has an abnormal ECG or other abnormal ECG tests that are, in the
             investigator's opinion, clinically significant.

          -  The patient is, in the investigator's opinion, unlikely to comply with the protocol or
             is unsuitable for any reason.

        Other inclusion and exclusion criteria may apply.
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Olaparib; Paclitaxel; Placebo
Intervention description: Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily.; IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.; Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.
Intervention MeSH terms: Paclitaxel; Olaparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 525.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This study is a phase III, multi-centre study of olaparib in combination with paclitaxel,
      compared with placebo in combination with paclitaxel in patients with advanced gastric cancer
      who have progressed following first-line therapy. Patients will be from China, Japan , Korea
      and Taiwan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced gastric cancer (including GEJ) that has progressed following first-line
             therapy.

          -  Patients must be ≥18 years of age. Age ≥20 if Japanese

          -  Provision of tumour sample (from either a resection or biopsy).

          -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed
             by imaging (CT/MRI) at baseline and following up visits.

        Exclusion Criteria:

          -  More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy
             with more than 6 month wash out period) for the treatment of gastric cancer in the
             advanced setting.

          -  Any previous treatment with a Polyadenosine 5'-diphosphoribose [poly-(ADP-ribose)]
             polymerisation (PARP) inhibitor, including olaparib.

          -  Patients with second primary cancer, except: adequately treated non-melanoma skin
             cancer, curatively treated in-situ cancer of the cervix, or other solid tumours
             curatively treated with no evidence of disease for ≥5 years.

          -  Human Epidermalgrowth Factor Receptor-2 (HER2) positive patients.
Efficacy and Safety of XP12B in Women With Menorrhagia
Condition: Menorrhagia; Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Intervention: Tranexamic acid tablets; Tranexamic acid tablets; Placebo tablets
Intervention description: 3900 mg/Day; 1950 mg/Day
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Menorrhagia; Heavy Menstrual Bleeding

Summary:

      The purpose of this study is to determine whether XP12B is effective and safe in the
      treatment of women with heavy menstrual bleeding associated with menorrhagia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with menorrhagia

          -  18-49 years of age

          -  Regularly occurring menstrual periods

        Exclusion Criteria:

          -  History or presence of clinically significant disease or abnormalities that may
             confound the study

          -  History of bilateral oophorectomy or hysterectomy

          -  Hormone therapy for birth control
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Condition: Clostridium Infections; Diarrhea
MeSH terms: Clostridium Infections; Diarrhea
Intervention: PAR-101/OPT-80; Vancomycin
Intervention description: capsules; Capsules
Intervention MeSH terms: Vancomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 535.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: CDAD, Clostridium difficile, diarrhea; Clostridium difficile-Associated Diarrhea

Summary:

      This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80
      (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea
      (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males/females with CDAD

          -  Females must use adequate contraception

          -  Signed informed consent

        Exclusion Criteria:

          -  Life-threatening CDAD

          -  Toxic megacolon

          -  Pregnant

          -  Concurrent use of diarrheal agents

          -  Participation in other trials
A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)
Condition: Hepatitis A Virus Infection
MeSH terms: Hepatitis A; Hepatitis
Intervention: Hepatitis A Vaccine, Purified Inactivated (VAQTA™)
Intervention description: Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the
      vaccine in Chinese children between 12 and 23 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Chinese children 12 to 17 months old at receipt of the first study vaccination

        Exclusion Criteria:

          -  Subject is Hepatitis A virus antibody positive at screening or has a history of
             Hepatitis A infection

          -  Subject has a fever 72 hours prior to first injection

          -  Subject has already been vaccinated for Hepatitis A

          -  Subject is allergic to aluminum, formaldehyde, sodium borate, latex, or any component
             of the vaccine

          -  Subject has received inactivated vaccines within 14 days of screening or live vaccines
             within 30 days of screening
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: CTP-543 matching placebo; CTP-543
Intervention description: Administered as tablets.; Administered as tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 517.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alopecia; Hair loss; Hair disease; CTP-543

Summary:

      This study evaluates the safety and effectiveness of an investigational study drug (called
      CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical presentation compatible with alopecia areata with a current episode lasting
             at least 6 months and not exceeding 10 years at the time of Screening. Total disease
             duration greater than 10 years is permitted.

          -  At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score
             ≥50, at Screening and Baseline.

          -  Willing to comply with the study visits and requirements of the study protocol.

        Exclusion Criteria:

          -  Treatment with other medications or agents within 1 month of Baseline or during the
             study that may affect hair regrowth or immune response.

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or other scalp condition that
             may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the
             body at Screening and/or Baseline.

          -  Treatment with systemic immunosuppressive medications within 3 months of Screening or
             during the study, or biologics within 6 months of Screening or during the study.

          -  Females who are nursing, pregnant, or planning to become pregnant while in the study,
             and for 30 days after last dose of study drug.

          -  Clinically significant medical condition, psychiatric disease, or social condition, as
             determined by the Investigator, that may unfavorably alter the risk-benefit of study
             participation, adversely affect study compliance, or confound interpretation of study
             results.
A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg intravenously every 4 weeks for 104 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This extension study of WA19926 will assess the long-term safety and the efficacy of
      RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis.
      Participants who have completed the core study WA19926 are eligible to participate.
      Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The
      anticipated time on study drug is 104 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, >/=18 years of age who have completed the core study WA19926 and
             according to the investigator may benefit from RoActemra/Actemra treatment

          -  No current or recent adverse event or laboratory finding preventing the use of the
             study drug dose at baseline

          -  Receiving treatment on an outpatient basis

        Exclusion Criteria:

          -  Females who are pregnant

          -  Participants who have prematurely withdrawn from the core study WA19926 for any reason

          -  Treatment with any investigational drug since the last administration of the study
             drug in the core study WA19926

          -  Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell
             costimulation modulator since the last administration of the study drug in the core
             study WA19926

          -  Immunization with live/attenuated vaccine since the last administration of the study
             drug in the core study WA19926

          -  Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory
             joint disease other than rheumatoid arthritis

          -  Abnormal laboratory values
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Placebo; TMC435; Peginterferon alpha-2a (PegIFN alpha-2a); Ribavirin (RBV)
Intervention description: 150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 48 weeks; 150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 24 or 48 weeks; One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.; 200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; TMC435; HCV; Hep C; Genotype 1

Summary:

      The purpose of this study is to investigate the effectiveness and safety of TMC435 compared
      with placebo in participants who are infected with genotype 1 hepatitis C virus who have
      never received treatment before. Participants will also receive peginterferon alpha-2a and
      ribavirin as part of their treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 1 hepatitis C infection (confirmed at screening)

          -  Patient has not received any prior treatment for hepatitis C

          -  Patient must have had a liver biopsy within 3 years before screening (or between the
             screening and baseline visit) showing chronic hepatitis C infection

          -  Must agree to use 2 forms of effective contraception throughout study (both males and
             females)

        Exclusion Criteria:

          -  Infection with HIV or non genotype 1 hepatitis C

          -  Liver disease not related to hepatitic C infection

          -  Hepatic decompensation

          -  Significant laboratory abnormalities or other active diseases

          -  Pregnant or planning to become pregnant
A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267, ABT-333; Ribavirin
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Tablet
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C virus; Hepatitis C Genotype 1; Hepatitis C; Interferon-Free; Chronic Hepatitis C; Ombitasvir; Ribavirin; Viekira PAK; Dasabuvir; Paritaprevir

Summary:

      The purpose of this study is to evaluate the safety and antiviral activity of
      ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267
      also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin
      (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without
      cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be practicing specific forms of birth control on study treatment, or be
             post-menopausal for more than 2 years or surgically sterile

          -  Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to
             10,000 IU/mL at screening)

          -  Subject's hepatitis C virus genotype is subgenotype 1b at Screening without co
             infection with any other genotype/subgenotype.

        Exclusion Criteria:

          -  Significant liver disease with any cause other than HCV as the primary cause

          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

          -  Positive screen for drugs or alcohol

          -  Use of contraindicated medications within 2 weeks of dosing