bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Condition: Candida Vulvovaginitis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Vulvovaginitis
Intervention: Ibrexafungerp; Placebo
Intervention description: Ibrexafungerp 300mg BID for one day; Matching Placebo
Intervention MeSH terms: Ibrexafungerp
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blind study
Masking: Double (Participant, Investigator)
Enrollment: 455.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vaginitis; Yeast infection

Summary:

      This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to
      evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in
      female subjects 12 years and older with AVVC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a postmenarchal female subject 12 years and older

          -  Subject has a diagnosis of symptomatic AVVC at baseline including a positive
             microscopic examination with 10% Potassium Hydroxide (KOH) in a vaginal sample
             revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

        Exclusion Criteria:

          -  Subject has any vaginal condition other than AVVC that may interfere with the
             diagnosis or evaluation of response to therapy, such as suspected or confirmed
             concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)

          -  Need for systemic and/or topical (vaginal) anti fungal treatment, including
             prescription or over-the-counter products during the study and treatment for
             vulvovaginal candidiasis (VVC) 28 days prior to randomization.

          -  Subject has uncontrolled diabetes mellitus.

          -  Subject has a vaginal sample with pH >4.5.

          -  Subject has a history of or an active cervical/vaginal cancer.
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: BMS-188667; Mycophenolate mofetil; Prednisone; Placebo matching with BMS-188667
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 695.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when
      used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)
    

Eligibility criteria:

        For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching
        Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on
        clinical trial participation.

        Note: Subjects > 16 are eligible for enrollment at selected centers

        Inclusion Criteria:

          -  Potential subjects must have active lupus nephritis

          -  Biopsy within 12 months prior to screening visit indicating active Class 3 or 4
             proliferative lupus glomerulonephritis (lupus effecting your kidney)

          -  Urine protein creatinine ratio (UPCR) ≥ 1 at Screening

          -  Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)

          -  There must also be evidence of active disease within 3 months of Screening, based on
             at least one of the following:

               -  Worsening of lupus nephritis OR

               -  UPCR ≥ 3 at Screening OR

               -  Active urine sediment OR

               -  Biopsy within 3 months prior to screening visit indicating active Class 3 or
                  Class 4 active proliferative lupus glomerulonephritis

        Inclusion Criteria for the Long-Term Extension Period:

          -  Signed Written Informed Consent

          -  Subjects who achieve a complete or partial renal response after completing 2 years of
             double-blind treatment

        Exclusion Criteria:

          -  Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis

          -  Current symptoms of severe, progressive, or uncontrolled non-SLE related renal,
             hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
             cerebral disease, or other concomitant medical conditions that, in the opinion of the
             Investigator, might place the subject at unacceptable risk for participation in this
             study

          -  Significant active Central nervous system (CNS) lupus with the exception of fatigue or
             mild stable cognitive

          -  Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too
             significant and irreversible
An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan.
Condition: Heart Failure With Preserved Ejection Fraction (HFpEF)
MeSH terms: Heart Failure
Intervention: LCZ696
Intervention description: Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: heart failure with preserved ejection fraction, Japanese patients, extension study, long-term safety and tolerability, open-label

Summary:

      This study evaluated the safety and tolerability of LCZ696 treatment in Japanese heart
      failure patients (NYHA Class II-IV) with preserved ejection fraction after CLCZ696D2301
      (PARAGON-HF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent must be obtained before any assessment is performed.

          -  Patients who have completed LCZ696D2301 and are able to be safely enrolled into this
             study as judged by the investigator.

        Exclusion Criteria:

          -  Patients who discontinued study drug treatment during LCZ696D2301 due to an event or
             intercurrent illness. Eligibility can be re-considered if the event has resolved and
             no longer represents a risk to the patient and the patient can safely tolerate the
             administration of LCZ696 per the investigator's assessment.

          -  Any medical condition that in the opinion of the investigator is likely to prevent the
             patient from safely tolerating LCZ696 or complying with the requirements of the study.

          -  Patients who have experience of angioedema event(s) which occurred and reported by the
             investigator during LCZ696D2301.

          -  Pregnant or nursing (lactating) women.

          -  Women of childbearing potential unless they are using highly effective methods of
             contraception.

        Other protocol-defined inclusion/exclusion may apply.
Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Meniscal Allograft
Intervention description: Meniscal allograft
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: allograft; great toe

Summary:

      Using the concept of an implant acting as a spacer and stabilizer, the proposed study will
      evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of
      the great toe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  symptomatic of stage 3 osteoarthritis of the great toe

          -  symptoms recalcitrant to nonoperative management as determined clinically by the
             principal investigator

        Exclusion Criteria:

          -  diabetes mellitus

          -  kidney insufficiency

          -  oa in the adjacent joints

          -  malignancy with in the past 10 yrs

          -  minors (< 18 yrs of age)

          -  pregnant women and fetus

          -  mentally disabled or cognitively impaired individuals
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Condition: Myasthenia Gravis, Generalized
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: zilucoplan (RA101495); Placebo
Intervention description: Daily subcutaneous (SC) injection; Daily subcutaneous (SC) injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to
      confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized
      Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of
      0.3 mg/kg zilucoplan or placebo for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IV] at
             Screening

          -  Positive serology for acetylcholine receptor (AChR) autoantibodies

          -  MG-ADL Score of ≥ 6 at Screening and Baseline

          -  QMG score ≥ 12 at Screening and Baseline

          -  No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated
             to occur during the 12-week Treatment Period

          -  No change in immunosuppressive therapy, including dose, for at least 30 days prior to
             Baseline or anticipated to occur during the 12-week Treatment Period

        Exclusion Criteria:

          -  Thymectomy within 12 months prior to Baseline or scheduled to occur during the 12 week
             Treatment Period

          -  History of meningococcal disease

          -  Current or recent systemic infection within 2 weeks prior to Baseline or injection
             requiring intravenous (IV) antibiotics within 4 weeks prior to Baseline
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
Condition: Precocious Puberty, Central
MeSH terms: Puberty, Precocious
Intervention: Leuprolide Acetate 45 mg
Intervention description: Subcutaneous injection
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 2 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension
      for treatment of children with Central Precocious Puberty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)

          -  Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not
             received prior GnRH agonist treatment for CPP

          -  Pubertal-type LH response following an abbreviated GnRHa stimulation test before
             treatment initiation

          -  Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in
             females or testicular volume ≥ 4 mL in males

          -  Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year

        Exclusion Criteria:

          -  Gonadotropin-independent (peripheral) precocious puberty

          -  Prior or current GnRH treatment for CPP

          -  Prior or current therapy with medroxyprogesterone acetate, growth hormone or
             insulin-like growth factor-1 (IGF-1)

          -  Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height
             for age)

          -  Known history of seizures, epilepsy, and/or central nervous system disorders that may
             be associated with seizures or convulsions

          -  Any other medical condition or serious intercurrent illness that, in the opinion of
             the Investigator, may make it undesirable for the subject to participate in the study
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands
Condition: Scabies; Head Lice
MeSH terms: Lice Infestations; Scabies
Intervention: Ivermectin; Permethrin 5%; Malathion Shampoo 0.5%
Intervention description: A single weight based dose of ivermectin; Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated; Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
Intervention MeSH terms: Ivermectin; Permethrin; Malathion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a pilot study evaluating if treatment for scabies also treats headlice in the same
      community
    

Eligibility criteria:

        Inclusion Criteria:

          -  All participants living in the community will be offered treatment

        Exclusion Criteria:

          -  Patients with a contradindication to study medication

          -  Patients unable to provide consent
Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: indocyanine green; isotope
Intervention description: One injection, 2.5 milligrams per patient, intradermal use; One injection, 20 MBq techntium99, intradermal use
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sentinel lymph node; indocyanine green; fluorescence method; radioisotope conventional method; breast cancer

Summary:

      The sentinel node has a fundamental role in the management of early breast cancer.

      Currently, the double detection of blue and radioisotope is recommended. A radioactive
      material requires the presence of a nuclear medicine department and the approval of health
      authorities. In many centers, this technique is not available. The use of blue is easier to
      implement technique. However, allergic reactions and prolonged breast tattoo led many teams
      to stop the practice.

      So in common practice, many center use a single method. However, with a single detection, the
      risk of false negatives and the identification failure rate increased to a significant extent
      and the number of sentinel lymph node detected and removed is not enough.

      Under these conditions, find another method of detection seems crucial. According to the
      literature, the fluorescence method (ICG) is a technique that seems safe and reliable.

      The investigators therefore propose a prospective, randomized study to investigate the
      interest of fluorescence associated with the isotopic method.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a
             carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis,
             radiologically evaluated size more than 40mm, or immediate mastectomy…)

          -  Unifocal or multifocal but in same quarter

          -  Size < 5cm clinically palpable or not

          -  Clinically or ultrasound axillary N0

          -  Isotopic sentinel node detection

          -  Adult patient

          -  Signed informed consent by patient or legally responsable authority

          -  Patient registered to a social security system

          -  No surgical contra-indication

        Exclusion Criteria:

          -  Mammary carcinoma recurrence

          -  Previous same side mammary reduction

          -  Previous lumpectomy

          -  Contra-indication to surgery

          -  Pregnant or breast feeding patient

          -  Denial of participation
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Omalizumab; Placebo
Intervention description: injection of 150mg or 300 mg; Injection of placebo
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic spontaneous urticaria; ISS7; UAS7; omalizumab; China

Summary:

      The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared
      with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering
      from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Symptomatic CSU patients with CSU diagnosis for at least 6 months.

          -  Patients must have been on an approved dose of an H1AH for CSU for at least the 3
             consecutive days immediately prior to the Day -14 screening visit

          -  Patients must have documented current use on the day of the initial screening visit

        Main Exclusion Criteria

          -  Clearly defined underlying etiology for chronic urticarias other than CSU (main
             manifestation being physical urticaria)

          -  Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa,
             erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma,
             leukemia, or generalized cancer
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
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Fostamatinib Disodium; Placebo
Intervention description: Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.; Placebo tablet PO bid (morning and evening)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether fostamatinib is safe and effective in the
      treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of persistent/chronic ITP for at least 3 months

          -  Average platelet count< 30,000/µL (and none > 35,000 unless as a result of rescue
             therapy) from at least 3 qualifying counts

        Exclusion Criteria:

          -  Clinical diagnosis of autoimmune hemolytic anemia

          -  Uncontrolled or poorly controlled hypertension

          -  History of coagulopathy including prothrombotic conditions
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Condition: Peripheral Nerve Discontinuities
Intervention: Processed Nerve Allograft (human); Collagen Nerve Cuff
Intervention description: Bovine collagen based nerve cuff
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and
      functional outcomes for the repair of nerve injuries in the hand.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peripheral Nerve Injury

        Exclusion Criteria:

          -  Peripheral Neuropathy

          -  Allergic to Bovine products such as Bovine Collagen Nerve Cuff