bioihbjkbjnl/mcl2 huggingface dataset:
Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Virus Diseases; Respiratory Syncytial Virus Infections
Intervention: JNJ-53718678 250 mg; Placebo; JNJ-53718678 125 mg
Intervention description: JNJ-53718678 250 mg will be administered orally.; Matching placebo will be administered orally.; JNJ-53718678 125 mg will be administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 13 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of
      respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult
      hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using
             any conditioning regimen

          -  Absolute lymphocyte count (ALC) less than (<) 1,000 cells/microliter (mL)

          -  Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization

          -  New onset of at least 1 of the following respiratory symptoms within 4 days prior to
             the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis
             (sore throat), and/or worsening of one of these chronic (associated with previously
             existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung
             disease) respiratory symptoms within 4 days prior to the anticipated start of dosing

          -  Peripheral capillary oxygen saturation (SpO2) greater than or equal to (>=) 92 percent
             (%) on room air

        Exclusion Criteria:

          -  Admitted to the hospital primarily for a lower respiratory tract disease of any cause
             as determined by the investigator

          -  Requires supplemental oxygen at Screening or any time between Screening and
             randomization

          -  Documented to be positive for other respiratory viruses (limited to influenza,
             parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus)
             within 7 days prior to or at the Screening visit, if determined by local SOC testing
             (additional testing is not required)

          -  Clinically significant bacteremia or fungemia within 7 days prior to or at Screening
             that has not been adequately treated, as determined by the investigator
A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: GLPG1690
Intervention description: film-coated tablets of GLPG1690 to be administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The
      main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic
      sclerosis and whether there were any side effects in a long-term treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants who completed the 24-week treatment period of Study
             GLPG1690-CL-204 and who according to the investigator's judgment may benefit from
             long-term treatment with GLPG1690.

        Exclusion Criteria:

          -  Any condition or circumstances that, in the opinion of the investigator, may make a
             participant unlikely or unable to complete the study or comply with study procedures
             and requirements.
Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy
Condition: Chemotherapy Induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Olanzapine; Aprepitant
Intervention MeSH terms: Olanzapine; Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 4 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: olanzapine; Nausea and vomiting; aprepitant; pediatrics

Summary:

      The purpose of this study is to determine the feasibility of a larger trial comparing
      olanzapine and aprepitant and to obtain preliminary data on the effectiveness of these two
      medications to treat nausea and vomiting in children receiving chemotherapy. Children
      receiving 2 cycles of chemotherapy with a high risk of causing nausea and vomiting will
      receive olanzapine in one cycle and aprepitant in another cycle. Children will be randomized
      to see which medicine they receive first. The investigators will record the number of extra
      medications used for nausea, the number of times a child vomits, and the amount of nausea the
      child feels each day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age greater than 4 years and less than 21 years

          -  patient will receive at least two cycles of the same regimen of highly emetogenic
             chemotherapy

          -  adequate liver function - defined as total bilirubin less than or equal to 1.5 times
             the upper limit of normal for age and AST/ALT less than or equal to upper limit of
             normal for age

          -  adequate kidney function - defined as creatinine clearance or GFR greater than or
             equal to 70mL/min/1.73m2 or a serum creatinine based on age/gender as follows: Maximum
             serum creatinine

               -  2- <6 years: Male & Female 0.8

               -  6- <10 years: Male & Female 1

               -  10- <13 years: Male & Female 1.2

               -  13- <16 years: Male 1.5 Female 1.4

               -  >16 years: Male 1.7 Female 1.4

        Exclusion Criteria:

          -  known QTc prolongation or other cardiac arrhythmia

          -  current treatment with another antipsychotic (for example: risperidone, quetiapine,
             clozapine)

          -  prior adverse reaction to either olanzapine or aprepitant

          -  the planned two cycles of chemotherapy include ifosfamide (a patient may receive
             ifosfamide as a part of his/her overall treatment plan but not during study cycles)
Clinical Trial of High Dose CoQ10 in ALS
Condition: Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: coenzyme Q10; Placebo
Intervention description: antioxidant and mitochondrial cofactor, given in capsules three times daily; Placebo capsules, indistinguishable from CoQ10 capsules, given three times daily
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 185.0
Sex: All
Minimum age: 21 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: amyotrophic lateral sclerosis; ALS; Lou Gehrig's disease; CoQ10; coenzyme Q10; antioxidants; free radicals; mitochondrial dysfunction

Summary:

      The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in
      individuals with ALS for a possible future phase III study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of definite, probable, or laboratory-supported probable ALS

          -  Negative pregnancy test for women of childbearing age and adequate birth control
             measures

          -  Subjects must be able and willing to give informed consent and must be capable of
             complying with the trial procedures

          -  Forced Vital Capacity (FVC) >/= 60% of predicted

          -  Age 21 to 85 years, inclusive

          -  Disease duration of less than 5 years

          -  Subjects may take riluzole (without change in dose for more than 30 days before
             enrollment)

          -  Patients who have taken CoQ10 in the past will be eligible if they stop at least 30
             days before enrollment

          -  Patients who have taken vitamin E in the past will be eligible if they stop at least
             14 days before enrollment

        Exclusion Criteria:

          -  Dependency on mechanical ventilation (non-invasive ventilation > 23 hours)

          -  Severe and unstable concomitant medical or psychiatric illness

          -  Insufficiently controlled diabetes mellitus

          -  Concomitant warfarin therapy

          -  Women who are breast feeding or have a high likelihood of pregnancy

          -  Significant hepatic dysfunction

          -  Forced Vital Capacity (FVC) less than 60%

          -  Exposure to CoQ10 within 30 days of enrollment

          -  Exposure to other experimental medications within 30 days of enrollment

          -  Exposure to vitamin E within 14 days of enrollment

          -  Sensitivity to color additive FD&C Yellow No. 5

          -  Sensitivity to aspirin
Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury
Condition: Neurogenic Bladder
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Neurogenic
Intervention: Autologous neobladder construct
Intervention description: augmentation cystoplasty with autologous neo-bladder construct
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
Masking: None (Open Label)
Masking description: Note: Tengion no longer exists following Chapter 7 bankruptcy in 2014. No further information is available. No data are available to be reviewed or re-analyzed.
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Subjects with neurogenic bladder secondary to spinal cord injury that is refractory to
      medical treatment and requires augmentation cystoplasty will be enrolled. The hypothesis is
      that augmentation cystoplasty using an autologous neo-bladder construct will reduce maximum
      detrusor pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subjects with neurogenic bladders secondary to spinal cord injury

        Exclusion Criteria:

          -  prior augmentation procedures or urinary diversion

          -  recent urologic or intraperitoneal surgery or device implantation

          -  recent history of spinal cord injury of less than a year

          -  recent neurologic surgery

          -  requirement for concomitant urological surgical procedures
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury
Condition: Critically Ill; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Critical Illness; Wounds and Injuries
Intervention: Calcifediol; Calcitriol; Placebos
Intervention description: Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4; Calcitriol 4mcg orally daily x 5; Placebo (medium chain triglyceride oil) orally daily x 5
Intervention MeSH terms: Calcitriol; Calcifediol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and
      calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney
      injury (AKI) in critically ill patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18

          -  Admitted to the ICU within 48h prior to enrollment

          -  Likely to remain in the ICU (alive) for ≥72h

          -  Naso/orogastric tube or ability to swallow

          -  High risk of severe AKI

        Exclusion Criteria:

          -  Serum total calcium > 9.0 mg/dl or phosphate > 6.0 mg/dL within previous 48h

          -  Currently receiving oral calcium supplementation

          -  Ingestion of vitamin D3 >1,000 IU/day or any 25-hydroxyvitamin D or
             1,25-dihydroxyvitamin D during the previous 7 days

          -  AKI stage 2 or 3 (based on KDIGO serum creatinine and/or urine output criteria)

          -  History of transplantation or receiving chronic (>7days) of immunosuppressive
             medications (not including glucocorticoid steroids at a dose less than or equivalent
             to prednisone 20 mg/day)

          -  Neutropenia in the previous 48h

          -  Active primary parathyroid disease, active granulomatous disease, or symptomatic
             nephrolithiasis in the previous 3 months

          -  Receiving cytochrome P450 inhibitors

          -  Chronic Kidney Disease stage V or End Stage Renal Disease

          -  Hemoglobin < 7 g/dL

          -  GI malabsorption

          -  Prisoner

          -  Pregnancy or breast feeding
Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: IGE025; placebo
Intervention description: Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.; Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic idiopathic urticaria; CIU; Xolair; IGE025; FcεRI; IgE

Summary:

      The study is designed to explore the mode of action for omalizumab therapy in patients with
      chronic idiopathic urticaria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamines at Baseline

        Exclusion Criteria:

          -  Clearly defined underlying etiology for chronic urticarias other than CIU (main
             manifestation being physical urticaria). This includes the following urticarias:
             Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact, as well
             as the following diseases as these diseases may have symptoms of urticaria or
             angioedema: Urticarial vasculitis, urticaria pigmentosa, erythema multiforme,
             mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized
             cancer.

          -  Previous treatment with omalizumab.

          -  A history or presence of atopic dermatitis, bullous pemphigoid, dermatitis
             herpetiformis, senile pruritus or other skin disease associated with itch.

        Other protocol-defined inclusion/exclusion criteria may apply.
Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: dimethyl fumarate
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatrics

Summary:

      The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate)
      on brain magnetic resonance imaging (MRI) lesions in pediatric participants with
      relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to
      characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to
      evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability of parents or legal guardians to understand the purpose and risks of the study
             and provide signed and dated informed consent and authorization to use protected
             health information in accordance with national and local subject privacy regulations.
             Subjects will provide assent in addition to the parent or legal guardian, as
             appropriate, as per local regulations.

          -  Must have a body weight of ≥30 kg at Screening and Day 1.

          -  Must have a diagnosis of RRMS according to McDonald criteria for MS (2010) [Polman
             2011] and International Pediatric Multiple Sclerosis (MS) Study Group criteria for
             pediatric MS (2013) [Krupp 2013].

        Key Exclusion Criteria:

          -  Primary progressive, secondary progressive, or progressive relapsing MS (as defined by
             [Lublin and Reingold 1996]). These conditions require the presence of continuous
             clinical disease worsening over a period of at least 3 months. Subjects with these
             conditions may also have superimposed relapses but are distinguished from
             relapsing-remitting subjects by the lack of clinically stable periods or clinical
             improvement.

          -  Disorders mimicking MS, such as other demyelinating disorders (e.g., acute
             disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease,
             lupus erythematosus, and neuromyelitis optica), metabolic disorders (e.g.,
             dystrophies), and infectious disorders.

          -  History of severe allergic or anaphylactic reactions or known drug hypersensitivity to
             dimethyl fumarate or fumaric acid esters.

        NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Certolizumab Pegol (Cimzia®)
Intervention description: Pharmaceutical Form: Solution for injection in pre-filled syringe
Route of Administration: Subcutaneous use
Dose and Administration details :
2 x 1 mL Certolizumab Pegol at Week 0, followed by
1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10
2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate to severe chronic plaque psoriasis; anti TNF α; CDP 870; Cimzia®; certolizumab pegol; retreatment

Summary:

      The primary objective is to assess differences in PASI scores between Week 12 of Study C87040
      [NCT00245765] and Week 12 of re-treatment in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject having responded to treatment at Week 12 in study C87040 and having relapsed
             during the follow-up period

          -  Female subjects either postmenopausal for at least one year, surgically incapable of
             childbearing, or effectively practising an acceptable method of contraception.Subjects
             agreed to continue using adequate contraception during the study and for 12 weeks
             after the last dose of CDP870

        Exclusion Criteria:

          -  Subjects with erythrodermic, guttate, generalized pustular form of psoriasis

          -  Any recent serious or life-threatening infection or any current sign or symptom that
             may indicate an infection (e.g., fever, cough)

          -  Positive hepatitis B surface antigen test and /or hepatitis C antibody test results

          -  Positive human immunodeficiency virus (HIV) test result

          -  White blood cell counts less than 4000 per cubic millimeter or more than 20000 per
             cubic millimeter

          -  Suspected or diagnosed demyelinating disease of the central nervous system (e.g.
             multiple sclerosis or optic neuritis)

          -  Systemic Lupus Erythematosus

          -  Participation in a clinical study within the past 3 months except Study C87040

          -  Any other condition, which in the Investigator's judgment would make the subject
             unsuitable for inclusion in the study
Patient Anxiety During Radiological Examination
Condition: Anxiety
MeSH terms: Anxiety Disorders
Intervention: Hand Massage
Intervention description: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial design evaluates whether hand massage reduces anxiety levels in cancer
      patients as they undergo radiological examination to evaluate tumor response. Anxiety levels
      will be investigated before massage, after massage, and following the completion of the
      radiological exam. The Visual Analog Scale (VAS), a validated anxiety assessment tool, will
      be used to measure anxiety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Age ≥ 18 years

          -  Scheduled to undergo radiologic imaging evaluation of a tumor

        Exclusion Criteria:

          -  Known hand injury within 30 days prior to study participation

          -  Known pregnancy

          -  Mental disability as determined by the treating physician

          -  Actively receiving radiation therapy

          -  Actively receiving chemotherapy