bioihbjkbjnl/mcl2 huggingface dataset:
Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
Condition: Carcinoma, Squamous Cell; Adenocarcinoma of the Esophagus and Gastric Cardia
MeSH terms: Adenocarcinoma; Carcinoma, Squamous Cell; Esophageal Neoplasms
Intervention: Chemotherapy; Radiochemotherapy
Intervention description: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.; Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
Intervention MeSH terms: Cisplatin; Carboplatin; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Histologically confirmed squamos cell carcinoma or adenocarcinoma of the esophagus and gastric cardia.Suitable for surgery.

Summary:

      The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a
      higher degree of complete histological response than neoadjuvant chemotherapy before surgery
      in patients undergoing treatment for cancer of the esophagus or cardia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically verified squamos cell carcinoma, adenocarcinoma of the esopohagus or
             gastric cardia (type II)

          -  Tumor located in cervical oesophagus, not requiring laryngo-esophagectomy. Patients
             with performance status 0-1 axxording to WHO scale and with resectable tumours, as
             assessed at the prerandomisation evaluation

          -  Adequate haemotological function, defined as having WBC > 3 x 10(9)/litre and
             platelets > 100 x 10 (9)/litre.

          -  Adequate renal function defined as having normal serum creatinine level and/or
             calculated glomerular filtration rate > 60 ml/min.

          -  Tumour stage: T1Ni, T2N0, T2N1, T3N0, T3N1, M1a

        Exclusion Criteria:

          -  Pregnancy and/or lactation. Women of childbearing ages can be included and provided
             that adequate contraceptive methods are used

          -  Patients with diabetes complications (e.g. rethinopathy, neuropathy) as well as
             patients with uncontrolled cardiac disease or myocard infarction within 12 months are
             considered unsuitable for chemoradiotherapy.

          -  Concomitant malignancy (< 5 years since diagnosis) that can interfere the
             interpretation of study results, ongoing antitumoral treatment.

          -  Patients being unable tom comply with the protocol

          -  Tumor stage T1 N0, T4 NX or TXNXM1b
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
Condition: Retinopathy of Prematurity (ROP)
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: rhIGF-I/rhIGFBP-3
Intervention description: Continuous intravenous infusion
Intervention MeSH terms: Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 121.0
Sex: All
Maximum age: 1 Day
Healthy volunteers: No
Keywords: insulin-like growth factor; ROP; IGF-I; BPD; bronchopulmonary dysplasia; retinopathy of prematurity

Summary:

      To compare the severity of retinopathy of prematurity (ROP) among treated infants with an
      untreated control population, matched for gestational age at birth while confirming the dose
      of rhIGF-1/rhIGFBP-3 is safe and efficacious.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent from parents/guardians;

          -  Subject must be between GA of 26 weeks + 0 days and 27 weeks + 6 days (Study Section
             A) or between GA of 23 weeks + 0 days and 27 weeks + 6 days (Study Sections B, C, and
             D), inclusive

        Exclusion Criteria:

          -  Subjects born small for gestational age (SGA), ie, body weight at birth <-2 standard
             deviation score (SDS) (Study Section A only)

          -  Detectable gross malformation

          -  Known or suspected chromosomal abnormality, genetic disorder, or syndrome, according
             to the Investigator's opinion

          -  Persistent blood glucose level <2.5 mmol/L or >10 mmol/L at Study Day 0 (day of birth)
             to exclude severe congenital abnormalities of glucose metabolism

          -  Anticipated need of administration of erythropoietin (rhEPO) during treatment with
             study drug.

          -  Any maternal diabetes requiring insulin during the pregnancy

          -  Clinically significant neurological disease according to the Investigator's
             opinion(Stage 1 IVH allowed)

          -  Any other condition or therapy that, in the Investigator's opinion, may pose a risk to
             the subject or interfere with the subject's ability to be compliant with this protocol
             or interfere with interpretation of results

          -  Monozygotic twins

          -  Subject participating or plans to participate in a clinical study of another
             investigational study drug
ProQuad Dose Selection Study (V221-011)(COMPLETED)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Intervention: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Comparator: M-M-R II; Comparator: PUVV
Intervention description: a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90; A single 0.5 mL subcutaneous injection at Day 0; A single 0.5 mL subcutaneous injection at Day 0
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1551.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II
      and PUVV (Process Upgrade Varicella Vaccine) vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health

          -  Negative clinical history of measles, mumps, rubella, varicella, and zoster

        Exclusion Criteria:

          -  Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or
             in combination

          -  Any immune impairment or deficiency

          -  Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to
             vaccination

          -  Vaccination with an inactive vaccine with in the past 14 days

          -  Vaccination with a live vaccine within the past 30 days

          -  Immune globulin or any blood product administered in the past 3 months
A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: ALX-0061; 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: 312.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Primary objective:

      To assess the efficacy and safety of different dose regimens of ALX-0061 administered
      subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus
      erythematosus (SLE) compared to placebo.

      Secondary objectives:

      To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate,
      steroid reduction and health-related quality of life, with different dose regimens of
      ALX-0061.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Man or woman ≥ 18 years and < 65 years of age

          2. Have a diagnosis of SLE for at least 6 months prior to screening and fulfill the 1997
             American College of Rheumatology (ACR) or 2012 Systemic Lupus International
             Collaborating Clinics (SLICC) classification criteria

          3. Have moderate to severe active SLE

          4. Have seropositive disease at screening

          5. Subject must be at least on one or more of the treatments for SLE as listed in the
             protocol

          6. Others as defined in the protocol

        Exclusion Criteria:

          1. Have an A score on the revised BILAG-2004 other than in the mucocutaneous and/or
             musculoskeletal system at screening and at baseline for the organ systems that can be
             clinically assessed

          2. Have a systemic inflammatory disease other than SLE

          3. Clinically significant infection treated or needing treatment

          4. Any active or recurrent viral infection that based on the Investigator´s clinical
             assessment makes the subject unsuitable for the study

          5. Have received prior therapy blocking the interleukin-6 (IL-6) pathway

          6. Others as defined in the protocol
Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Intervention: Botulinum toxin A
Intervention description: BoNT-A (BOTOX 300U)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Nerve growth factor; P2X3 receptor; Transient Receptor Potential Vanilloid 1 (TRPV-1) receptor; Bladder function; Glomerular filtration rate; Detrusor overactivity; Spinal cord injury

Summary:

      To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on
      neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of
      expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of
      patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI)
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with age of 19 years old or above

          -  Patients with chronic suprasacral cord SCI will be enrolled.

          -  Patients will be proven having NDO by videourodynamic study during the screening
             period.

          -  They also receive 99mTc-DTPA renal scanning for GFR at baseline.

          -  Patients with NDO induced urinary incontinence who have adequate hand function or have
             a care-giver available for CIC, and the baseline total GFR of less than 80 mL/min are
             main inclusion criteria

        Exclusion Criteria:

          -  Patients with detrusor underactivity and large bladder compliance, patients proven to
             have intrinsic sphincteric deficiency

          -  Patients who have hypersensitivity to BTX-A or constituent ingredients of BTX-A.
Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: ecabet ophthalmic solution; placebo
Intervention description: sterile ophthalmic solution; sterile ophthalmic solution
Intervention MeSH terms: Ecabet; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Efficacy study of ecabet ophthalmic solution in dry eye disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with dry eye disease

        Exclusion Criteria:

          -  Dry eye disease secondary to surgery
Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: dabigatran etexilate
Intervention description: Experimental dose chosen based on age and weight
Intervention MeSH terms: Dabigatran
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      To investigate the safety and tolerability of dabigatran etexilate solution in children and
      to obtain preliminary pharmacokinetic/pharmacodynamic data
    

Eligibility criteria:

        Inclusion criteria:

          1. males or females 1 to less than 12 years of age

          2. objective diagnosis of primary VTE

          3. completion of planned treatment course with LMWH or OAC for primary VTE

          4. written informed consent by parent (legal guardian) and patient assent (if applicable)

        Exclusion criteria:

          1. weight less than 9 kg

          2. conditions associated with increased risk of bleeding

          3. patients who have any condition that would not allow safe participation in study Note:
             Further exclusion criteria apply
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD1236; Placebo
Intervention description: oral tablet, 75 mg, twice daily during 6 weeks; Dosing to match AZD1236
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 74.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The primary aim of this study is to investigate the tolerability and safety of AZD 1236
      compared with placebo ("inactive substance") in COPD patients by assessment of Adverse
      Events, vital signs and laboratory safety assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of COPD for 1 month

          -  Men or postmenopausal women

          -  Spirometry values indicating reduced lung function

          -  Smoking history equivalent to using 20 cigarettes a day for 10 years

        Exclusion Criteria:

          -  Any current respiratory tract disorders other than COPD

          -  Requirement for regular oxygen therapy

          -  Use of oral or parenteral glucocorticosteroids within 30 days prior to the study
A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
Condition: Chronic Lymphocytic Leukemia With 17p Deletion; Small Lymphocytic Lymphoma With 17p Deletion
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ibrutinib
Intervention description: All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLL; SLL

Summary:

      An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase
      Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or
      Small Lymphocytic Lymphoma with 17p Deletion
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documentation of del (17p13.1)

          -  Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of
             systemic therapy.

          -  Measurable nodal disease by computed tomography (CT)

        Key Exclusion Criteria:

          -  History or current evidence of Richter's transformation or prolymphocytic leukemia

          -  Prior hematologic stem cell transplantation <6 months from study enrollment or any
             ongoing GVHD

          -  Prior exposure to ibrutinib
Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Intervention: Simvastatin; Placebo
Intervention description: One topical application in peri-implant gingival crevice; One topical application in peri-implant gingival crevice
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Only the study coordinator will know whether the intervention is simvastatin or control.
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: topical; subgingival; simvastatin

Summary:

      This study seeks to test the recently discovered anti-inflammatory action of statins on
      inflamed mucosa surrounding dental implants.

      Hypothesis: The application of 1.2% simvastatin gel will decrease peri-implant inflammation.

      The pilot study will involve 44 subjects divided into a test and control group. The test
      group shall receive topical simvastatin gel administered around the implant with a blunt
      tipped needle. The control group will receive a placebo.

      Inflammatory state shall be determined at baseline as well as follow up visits at 24 hours, 1
      week, and 1 month by clinical indices of inflammation as well as biochemical markers of
      inflammation gathered from around the implants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Read, understand, and sign the informed consent forms

          -  Have at least 1 dental implant

          -  Have no evidence of peri-implantitis as evidenced by mesial and distal bone loss more
             than 1 mm from the accepted reference point round the implants on the periapical
             radiograph

          -  Demonstrate peri-implant mucositis as evidenced by bleeding on probing with 0.25 N/cm

        Exclusion Criteria:

          -  Have allergic reactions to simvastatin

          -  Have peri-implantitis as evidenced by more than 1 mm of mesial and distal bone loss
             from an accepted reference point on the implants on the periapical radiograph

          -  Demonstrate no bleeding on probing with 0.25 N/ cm

          -  Have uncontrolled systemic disease

          -  Pregnancy or females who suspect/may be pregnant, as well as nursing and breast
             feeding mothers

          -  Take statin / HMG-CoA reductase inhibitor medications

          -  Smokers

          -  Require antibiotic prophylaxis

          -  Take anti-inflammatory medication, immunosuppressive medications or immunosuppressed
             patients

          -  Have paraben allergies

          -  Have soybean allergies
A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Ipatasertib; Paclitaxel; Placebo
Intervention description: Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.; Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) as IV infusion QW for 3 cycles.; Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.
Intervention MeSH terms: Paclitaxel; Ipatasertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II
      study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy
      versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa
      triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal or postmenopausal women

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Histologically documented, Stage Ia to operable Stage IIIa, triple-negative carcinoma
             of the breast with primary tumor greter than or equal to (>/=) 1.5 centimeters (cm) in
             largest diameter (cT1-3) by MRI

          -  Adequate hematologic and organ function within 14 days before the first study
             treatment

          -  Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy
             of breast primary tumor

          -  For female participants of childbearing potential, agreement to use highly effective
             form(s) of contraception for the duration of the study and for at least 6 months after
             last dose of study treatment

        Exclusion Criteria:

          -  Known human epidermal growth factor 2 (HER2)-positive, estrogen receptor
             (ER)-positive, or progesterone receptor (PgR)-positive breast cancer

          -  Any prior treatment for the current primary invasive breast cancer

          -  Participants with cT4 or cN3 stage breast tumors

          -  Metastatic (Stage IV) breast cancer

          -  Bilateral invasive breast cancer

          -  Multicentric breast cancer

          -  Any disease, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding that contraindicates the use of an investigational drug or that may
             affect the interpretation of the results or render the participant at high risk from
             treatment complications