bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: Men ACWY CRM; 4CMenB
Intervention description: A single dose of a 0.5 mL injectable solution; All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease; prevention; vaccination

Summary:

      This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of
      Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to
      healthy at-risk adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults,18 through 50 years of age, who were or might be routinely exposed to
             N. meningitidis cultures

        Exclusion Criteria:

          -  Previous ascertained or suspected disease caused by N. meningitidis;

          -  Pregnancy or breastfeeding;

          -  History of any anaphylactic shock, asthma, urticaria or other allergic reaction after
             previous vaccinations or known hypersensitivity to any vaccine component;

          -  Any present or suspected serious acute or chronic disease

          -  Known or suspected autoimmune disease or impairment /alteration of immune function
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Intervention: Serelaxin; Placebo
Intervention description: Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen; Matching placebo i.v infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Serelaxin,; Chronic heart failure,; Spiroergometry,; Troponin,; New York Heart Association (NYHA) functional Class II/III,; Left ventricular ejection fraction,

Summary:

      This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II
      clinical study that evaluated the effect of serelaxin versus placebo (both in addition to
      SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female ≥ 18 years of age, with body weight ≤ 160 Kg

          -  Diagnosis of stable CHF:

               -  New York Heart Association (NYHA) functional Class II/III.

               -  Receiving guideline-recommended treatment for CHF.

          -  Left ventricular ejection fraction < 45%, obtained within the last 3 months prior to
             screening.

          -  NT-proBNP > 300 ng/L in sinus rhythm or > 900 ng/L if not in sinus rhythm (determined
             locally).

          -  Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.

          -  Systolic BP ≥ 125 mmHg at randomization

          -  Renal function defined as an eGFR of ≥ 25 mL/min/1.73 m^2 at screening (sMDRD
             formula).

        Key Exclusion Criteria:

          -  Dyspnea primarily due to non-cardiac causes.

          -  Increased risk of developing hypotension during vasodilator therapy according to
             investigators judgement.

          -  Any contraindication for exercise testing and spirometry.

          -  Stopping of the spiroergometry at screening according to the stopping rules, unless
             the patient has reached maximum exercise capacity defined as carbon dioxide
             production/oxygen consumption (VCO2/VO2) > 1.05.

          -  Change in guideline-recommended CHF treatment within 1 month prior to screening.
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
Condition: Bacterial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial
Intervention: ceftaroline; linezolid; Aztreonam
Intervention description: 600 mg injected every 12 hours for at least 5 but not more than 14 days; 600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days; 1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.
Intervention MeSH terms: Linezolid; Ceftaroline fosamil; Cephalosporins; Aztreonam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: complicated skin and skin structure infections; linezolid; ceftaroline; clinical response; microbiological response; Cellulitis; Abscess; Wound infection; Deeper soft tissue; Significant surgical intervention; Gram-positive bacterial infection; Gram-negative bacterial infection; bacterial infection; cephalosporin; broad-spectrum activity

Summary:

      The purpose of this study is to determine whether ceftaroline is effective and safe in the
      treatment of complicated skin and skin structure infections in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Complicated skin and skin structure infection (cSSSI)

          -  Require initial hospitalization, or treatment in an emergency room or urgent care
             setting

        Exclusion Criteria:

          -  Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid,
             aztreonam, or to their components

          -  Concomitant use of adrenergic or serotonergic agent

          -  Uncomplicated skin and skin structure infection

          -  Concomitant therapy with any drug known to exhibit a contraindicated drug-drug
             interaction

          -  More than 24 hours of treatment with an antimicrobial within 96 hours before
             randomization

          -  Known or suspected endocarditis, osteomyelitis, or septic arthritis

          -  Severely impaired renal function

          -  Evidence of significant hepatic, hematologic, or immunologic disease
Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)
Condition: Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
Intervention: XOPH5 Ointment; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: steatoblepharon; blepharoptosis; dermatochalasis; blepharoplasty; periorbital; orbital; eyelid; eyebags; eye bags

Summary:

      This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids
      for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe
      steatoblepharon (excess eyelid fat).
    

Eligibility criteria:

        Inclusion Criteria (abbreviated):

          -  Moderate to severe lower eyelid steatoblepharon (LESS score of 2-4 bilaterally)

          -  Men and women 40-70 years old

          -  Healthy facial skin

          -  Must understand and provide informed consent

        Exclusion Criteria (abbreviated):

          -  Best corrected visual acuity worse than 20/40 in either eye

          -  Regular use of ophthalmic medication in either eye

          -  Planned use of contact lenses during the study

          -  Any history of lower eyelid surgery
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: PEP005 Topical Gel; PEP005 Topical Gel; PEP005 Topical Gel; Vehicle gel; PEP005 Topical Gel; PEP005 Topical Gel; PEP005 Topical Gel; Vehicle gel
Intervention description: 0.005%, two days treatment; 0.01%, two days treatment; 0.015%, two days treatment; two days treatment; 0.005%, three days treatment; 0.01%, three days treatment; 0.015%, three days treatment; three days treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peplin; Actinic keratosis; PEP005

Summary:

      This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and
      0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the
      face or scalp.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be male or female

          -  Female patients must be of

          -  Non-childbearing potential;

          -  Childbearing potential, provided negative pregnancy test and using effective
             contraception

          -  4 to 8 AK lesions on the face or scalp

        Exclusion Criteria:

          -  Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected
             treatment area.

          -  Treatment with immunomodulators, or interferon/ interferon inducers or systemic
             medications that suppress the immune system: within 4 weeks.

          -  Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy:

        within 8 weeks and 2 cm of treatment area
SB1518 for Patients With Myelodysplastic Syndrome (MDS)
Condition: Leukemia
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Intervention: SB1518
Intervention description: 400 mg taken orally, once daily without regard of food, 28 day cycle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Myelodysplastic syndrome; MDS; SB1518

Summary:

      The goal of this clinical research study is to learn if SB1518 can help to control
      myelodysplastic syndrome. The safety of the drug will also be studied.

      SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain
      leukemias, myelofibrosis, and lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with MDS by the IPSS classification including low, int-1, int-2, and high
             risk are eligible. Patients should have received at least one line of prior therapy
             including growth factors, lenalidomide, or hypomethylating agents.

          2. Signed informed consent.

          3. Age >/= 18 years old.

          4. Patients must have the following non-hematologic values: Aspartate aminotransferase
             (AST/SGOT) and alanine aminotransferase (ALT/SGPT) </= 2.5 x Upper Limit of Normal
             (ULN) if both are available or </= 5.0 x ULN if hepatic involvement is present as
             determined by the investigator; Serum bilirubin </=2 x ULN; Serum creatinine </= 2 x
             ULN or 24-hour creatinine clearance >/= 50 ml/min

          5. Patients, if sexually active, must agree to use appropriate forms birth control.

        Exclusion Criteria:

          1. Uncontrolled intercurrent illness, including but not limited to ongoing active
             infection or psychiatric illness or social situations that the treating physician
             judges would limit compliance with study requirements. Patients receiving antibiotics
             for infections that are under control may be included in the study.

          2. History of myocardial infarction, severe/unstable angina, or symptomatic congestive
             heart failure within 6 months prior to study enrollment;

          3. New York Heart Association Class III or IV congestive heart failure;

          4. Ongoing cardiac dysrhythmias of Grade >/= 2, atrial fibrillation of any grade, QTc
             prolongation > 470 ms or other factors that increase the risk of QT prolongation
             (e.g., heart failure; hypokalemia, defined as serum potassium < 3.0 mEq/L; family
             history of long QT interval syndrome);

          5. Required use of a concomitant medication known to prolong the QT interval
             significantly.

          6. Known HIV seropositivity;

          7. Known active hepatitis A, B, or C;

          8. Women who are pregnant or lactating.
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: NOV-002; Carboplatin
Intervention description: 60 mg / mL / day / 20-23 Days; AUC 5 following IV bolus administration of NOV-002
Intervention MeSH terms: Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Platinum Resistant Tumors of Ovarian Origin

Summary:

      The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin
      in a cohort of women with platinum resistant cancer of ovarian origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube
             cancer

          -  ECOG 0-1

          -  Platinum resistant or refractory disease defined as progressive disease within 6
             months of completing or while receiving their last platinum containing regimen

          -  Measurable disease

        Exclusion Criteria:

          -  History of other malignancies within 2 years except for adequately treated carcinoma
             in situ of the cervix, ductal carcinoma in situ of the breast, incidental stage I
             endometrial cancer, basal or squamous cell skin cancer

          -  Major surgery within 2 weeks of study entry

          -  History of anaphylactic shock with prior platinum chemotherapy

          -  Known history of central nervous system (CNS) metastases unless subject has had
             treatment with surgery or radiation therapy and is neurologically stable

          -  Treatment with more than 3 lines of chemotherapy

          -  Chronic use of systemic corticosteroids
Treatment of Moderate to Severe Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Doxycycline 0.6 mg/kg/day; Doxycycline 1.2 mg/kg/day; Doxycycline 2.4 mg/kg/day; Placebo
Intervention description: doxycycline 40 mg/day, oral, 12 weeks; doxycycline 80 mg/day, 12 weeks; doxycycline 160 mg/day, 12 weeks; Placebo, 12 weeks
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 257.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety
      and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the
      Investigator's Global Assessment (IGA) score and the absolute change from baseline in
      inflammatory lesion count in patients with moderate to severe facial acne vulgaris.
      Additionally, the absolute change from baseline in non-inflammatory and total lesions of the
      active study medication to placebo will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be between 12 and 45 years of age.

          -  Has a diagnosis of moderate to severe facial acne vulgaris with no more than two
             nodules on the face

        Exclusion Criteria:

          -  Is allergic to tetracycline-class antibiotics or to any ingredient in the study
             medication.

          -  Has a history of pseudomembranous colitis or antibiotic-associated colitis.

          -  Has a history of hepatitis or liver damage or renal impairment.
A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Placebo; OBE2109
Intervention description: Placebo tablets for oral administration once daily; OBE2109 tablets for oral administration once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 328.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Pelvic Pain; Endometriosis; Dysmenorrhea; Dyspareunia

Summary:

      The primary objective of this study is to assess the efficacy and safety of a range of oral
      doses of OBE2109 versus placebo, in reducing endometriosis associated pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  The subject must have had her most recent surgical and - if available - histological,
             diagnosis of pelvic endometriosis up to 10 years before screening.

          -  The subject has moderate to severe endometriosis-associated pain during the screening
             period.

          -  The subject has regular menstrual cycles.

          -  The subject has a BMI ≥ 18 kg/m2 at the screening visit.

        Key Exclusion Criteria:

          -  The subject is pregnant or breast feeding or is planning a pregnancy within the
             duration of the treatment period of the study.

          -  The subject had an interventional surgery for endometriosis performed within a period
             of 60 days before screening.

          -  The subject did not respond to prior treatment with gonadotropin releasing hormone
             (GnRH) agonists or GnRH antagonists for endometriosis.

          -  The subject has a history of, or known osteoporosis or other metabolic bone disease.

          -  The subject has chronic pelvic pain that is not caused by endometriosis and requires
             chronic analgesic / therapy, or that would interfere with the assessment of
             endometriosis related pain.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients
Condition: Hepatitis C; Pharmacokinetics
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: ribavirin (RBV); pegylated interferon (PegIFN) alfa-2a; pegylated interferon (PegIFN) alfa-2a; ribavirin (RBV); BI 201335 NA low placebo; pegylated interferon (PegIFN) alfa-2a; ribavirin (RBV); BI 201335 NA high; BI 201335 NA low; BI 201335 NA high placebo; BI 201335 NA high; Placebo
Intervention description: ribavirin (RBV); pegylated interferon (PegIFN) alfa-2a; pegylated interferon (PegIFN) alfa-2a; ribavirin (RBV); Placebo; pegylated interferon (PegIFN) alfa-2a; ribavirin (RBV); BI 201335 NA high; BI 201335 NA; placebo; BI 201335 NA high
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 22.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The current Standard of Care (SOC) for chronic HCV infection, which is pegylated
      interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is
      effective in only part of the patients and is often associated with severe adverse effects
      leading to discontinuation of treatment and dose modifications.

      A number of compounds with direct activity are currently under clinical development, incl. BI
      201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to
      the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see
      how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN
      and RBV in HCV infected patients
    

Eligibility criteria:

        Inclusion criteria:

          -  chronic HCV genotype-1;

          -  high viral load

        Exclusion criteria:

          -  Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening

          -  Previous treatment with protease inhibitor
Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: Bevacizumab; Conventional Laser for ROP
Intervention description: Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.; Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 4 Weeks
Maximum age: 22 Weeks
Healthy volunteers: No
Keywords: Vascular Endothelial Growth Factor; Angiogenesis Inhibitor; Premature infants; Bevacizumab; Zone I or Posterior Zone II ROP; Aggressive Posterior ROP; Stage 3 ROP; Neonatal Intensive Care Unit

Summary:

      The purpose of this study was to determine the efficacy and additional advantages of
      intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Infants who have been screened by the American Academy of Ophthalmology, the American
             Academy of Pediatrics, and the American Association for Pediatric Ophthalmology and
             Strabismus guidelines (≤1500 grams at birth and ≤30 weeks gestation) who develop Stage
             3 ROP in zone I or posterior zone II.

          2. Informed Consent from a parent or guardian.

        Exclusion Criteria:

          1. Infants who have a congenital systemic anomaly or have a congenital ocular
             abnormality.

          2. Infants who cannot be treated by conventional laser therapy because of problems with
             media clarity. Generally, blind external cryotherapy would be utilized as an initial
             therapy and the infant would be excluded from the study even if the media clear
             subsequently.

          3. Informed Consent from a parent or guardian refused. This will mean that an infant
             automatically will receive laser therapy. Bevacizumab (Avastin®) treatment cannot be
             given outside of the Protocol. No data will be used from an infant without Informed
             Consent.