bioihbjkbjnl/mcl2 huggingface dataset:
Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Intervention: LPCN 1021
Intervention description: Oral testosterone undecanoate
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021
      in adult hypogonadal male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6
             and 10 AM, on two separate days at approximately the same time of day, following an
             appropriate washout of current androgen replacement therapy.

          2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary
             hypogonadal (congenital or acquired).

          3. Naïve to androgen replacement or has discontinued current treatment and completed
             adequate washout of prior androgen therapy. Washout must be completed prior to
             collection of baseline serum T samples to determine study eligibility.

        Exclusion Criteria:

          1. History of significant sensitivity or allergy to androgens, or product excipients.

          2. Clinically significant findings in the pre-study examinations including abnormal
             breast examination requiring follow-up.

          3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).

          4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.

          5. Clinically significant abnormal laboratory value, in the opinion of the investigator,
             in serum chemistry, hematology, or urinalysis

          6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human
             immunodeficiency virus antibodies (HIV Ab).

          7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical
             procedure that might interfere with gastrointestinal motility, pH or absorption.

          8. History of any clinically significant illness, infection, or surgical procedure within
             1 month prior to study drug administration.

          9. History of stroke or myocardial infarction within the past 5 years.

         10. History of or current or suspected prostate or breast cancer.

         11. History of untreated and severe obstructive sleep apnea.

         12. History of long QT syndrome (QTc > 450) or unexplained sudden death in a first degree
             relative (parent, sibling, or child).
Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
Condition: Elevated Prostate Specific Antigen
Intervention: Ciprofloxacin
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Men with Elevated PSA

Summary:

      The purpose of this study is to assess the impact of an empiric course of antibiotics for men
      with an elevated prostate-specific antigen (PSA) level.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 18 yrs. or older

          -  An elevated PSA (>2.5 ng/ml) and normal digital rectal exam

          -  Have elected to proceed with a diagnostic 12-core prostate biopsy

        Exclusion Criteria:

          -  Previous prostate biopsy

          -  History of prostate cancer

          -  Urinary tract infections or prostatitis within one year of study entry

          -  antibiotic use within one month prior to PSA level

          -  pyuria or bacteruria on urinalysis

          -  allergy to fluoroquinolones
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks
Condition: Bronchospasm; Bronchiolitis; Bronchospasm; Bronchitis
MeSH terms: Bronchiolitis; Bronchitis; Bronchial Spasm; Respiratory Sounds
Intervention: Biological vaccine
Intervention description: daily spray (2 puff of 100 µL) for six months
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 12 Months
Maximum age: 36 Months
Healthy volunteers: No
Keywords: Vaccine; Bronchospasm

Summary:

      The study will be conducted in two hospitals of the same geographic area. It will be included
      children <3-years-old with recurrent wheezing attacks, confirmed by the review of the medical
      records, in the previous 12 months or a shorter time for those younger than one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects whose parents /legal representative have given written informed consent.

          -  Both gender

          -  Subject up to 36 months of age.

          -  Subjects with recurrent bronchospasms (wheezing attacks); 3 or more exacerbations in
             the last 12 months

        Exclusion Criteria:

          -  Subjects whose parents/legal representative have not given written informed consent.

          -  Subjects out of aged range

          -  Subjects with malignancies or chemotherapy treatment

          -  Subjects included in another clinical trial in the last 12 months.

          -  Subject in immunosuppressive or immunostimulatory treatment

          -  Subjects who have received iv gamma globulin in the past 12 months.

          -  Subjects diagnosed with candidiasis or fungal recurrent infections.

          -  Subjects diagnosed with malabsorption syndrome

          -  Subjects with clinical allergy to common aeroallergens in the geographical area.

          -  Subjects with hepatitis virus infections, HIV and tuberculosis
Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis (SAR)
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: GSP 301 NS; GOM-NS; GMM-2 NS; GSP 301 placebo NS
Intervention description: 2 spray in each nostril twice daily for 14 days; 2 spray in each nostril twice daily for 14 days; 2 spray in each nostril twice daily for 14 days; 2 spray in each nostril twice daily for 14 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1176.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo
      NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis
      (subjects 12 years of age and older)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and non-pregnant females who are 12 years of age and older.

          -  Documented clinical history of SAR (for at least 2 years preceding the Screening Visit
             [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant
             seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or
             mountain cedar pollen)

          -  A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM
             assessment at the Screening Visit (Visit 1).

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  History of anaphylaxis and/or other severe local reaction(s) to skin testing.

          -  History of positive test for HIV, Hepatitis B or Hepatitis C infection.

          -  Documented evidence of acute or significant chronic sinusitis or chronic purulent
             postnasal drip.

          -  Subjects with an active pulmonary disorder or infection.

          -  Subjects with posterior subcapsular cataracts or glaucoma

          -  Plans to travel outside the known pollen area for the investigational site for 24
             hours or longer during the last 7 days of the run-in period.
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Intervention: Voriconazole
Intervention description: All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy.
Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator.
Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing <50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension.
Intervention MeSH terms: Voriconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized

Summary:

      The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal
      drug) when used in children who have invasive aspergillosis (IA) and other rare systemic
      fungal infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Immunocompromised with clinically compatible illness.

          -  Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a
             modified version of the revised EORTC/MSG consensus definitions).

          -  Diagnosis of infection due to Scedosporium or Fusarium species.

          -  Male and female from 2 to 17 years of age.

          -  Females with childbearing potential must have negative pregnancy test and be using
             appropriate contraception.

        Exclusion Criteria:

          -  Allergy or hypersensitivity to the azole drugs.

          -  Female subjects who are pregnant or lactating.

          -  Patients who received more than four days of antifungal drugs to treat the current
             episode of invasive aspergillosis or rare mold infection.

          -  Received within 24 hours prior to enrollment drugs that may cause QT interval
             prolongation.

          -  Significant liver, kidney or heart dysfunction.

          -  Not expected to survive for at least 5 days.
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Condition: Locally Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: Durvalumab; Cisplatin; Carboplatin; external beam radiation therapy (EBRT) + brachytherapy
Intervention description: IV infusion every 4 weeks; Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy; For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy; Radiation therapy per standard of care
Intervention MeSH terms: Carboplatin; Durvalumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 770.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Durvalumab; Chemoradiotherapy; Locally Advanced Cervical Cancer

Summary:

      This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study
      to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus
      Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer
    

Eligibility criteria:

        Inclusion Criteria:

        For inclusion in the study, patients should fulfill the following criteria:

          1. Female

          2. Aged at least 18 years

          3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009)
             Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node

          4. No prior chemotherapy or radiotherapy for cervical cancer

          5. WHO/ECOG performance status of 0-1

          6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target
             Lesion at baseline.

        Exclusion Criteria:

        Patients should not enter the study if any of the following exclusion criteria are
        fulfilled:

          1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical
             cancer

          2. Intent to administer a fertility-sparing treatment regimen

          3. Undergone a previous hysterectomy

          4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short
             axis) above the L1 cephalad body, in the inguinal region or outside the planned
             radiation field.

          5. History of allogeneic organ transplantation

          6. Active or prior documented autoimmune or inflammatory disorders

          7. Uncontrolled intercurrent illness

          8. History of another primary malignancy and active primary immunodeficiency
Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq
Condition: Turner Syndrome; Renal Insufficiency, Chronic; Pituitary Diseases; Dwarfism
MeSH terms: Dwarfism; Pituitary Diseases; Renal Insufficiency; Turner Syndrome; Gonadal Dysgenesis; Renal Insufficiency, Chronic
Intervention: Somatropin (rDNA origin)
Intervention description: Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: growth; child development; growth hormone; inadequate growth hormone secretion; growth failure

Summary:

      The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq
      treated children, using newly developed capillary blood spot IGF-1 measurement technology.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children under 18 with growth failure associated with inadequate growth hormone
             secretion, or Turner syndrome or chronic renal insufficiency.

        Exclusion Criteria:

          -  Children with closed epiphyses

          -  Children with active neoplasm

          -  Children with acute critical illness
Pentoxifylline Treatment in Acute Pancreatitis (AP)
Condition: Acute Pancreatitis (AP); Gallstone Pancreatitis; Alcoholic Pancreatitis; Trauma Acute Pancreatitis; Hypertriglyceridemia Acute Pancreatitis; Idiopathic (Unknown) Acute Pancreatitis; Medication Induced Acute Pancreatitis; Cancer Acute Pancreatitis; Miscellaneous (i.e. Acute on Chronic Pancreatitis)
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Gallstones; Pancreatitis, Alcoholic; Hypertriglyceridemia
Intervention: Pentoxifylline; Placebo
Intervention description: Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits Tumor Necrosis Factor (TNF) and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors; A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug
Intervention MeSH terms: Pentoxifylline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) pancreatitis

Summary:

      The purpose of this study was to determine the effects (good and bad) of giving a drug called
      pentoxifylline to patients with acute pancreatitis.
    

Eligibility criteria:

        Inclusion criteria

          -  Enrollment within 72 hours of diagnosis of acute pancreatitis (AP)

          -  Ability to give informed consent or a Legal Adult Representative (LAR) able to give
             informed consent for subject when needed as defined buy LAR use guidelines.

          -  Adult subjects of age ≥18 years.

        Exclusion Criteria:

          -  Moderate or severe congestive heart failure

          -  History of seizure disorders or demyelinating disease

          -  Nursing mothers

          -  Pregnancy

          -  History of prior tuberculosis or risk factors for tuberculosis

          -  Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal
             failure, chemotherapy within 60 days, and HIV)

          -  Evidence of active hemorrhage

          -  Paralytic ileus with severe nausea and vomiting
Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: SPD503 (Guanfacine hydrochloride) (2 mg); SPD503 (3 mg); SPD503 (4 mg); Placebo
Intervention MeSH terms: Guanfacine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 345.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine
      hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged
      6-17
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a primary diagnosis of ADHD

          -  Male or non-pregnant female subject who agrees to comply with any applicable
             contraceptive requirements

        Exclusion Criteria:

          -  Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD) with
             significant symptoms

          -  History of seizure during the last 2 years

          -  Subject has any specific cardiac condition or family history of significant cardiac
             condition

          -  Subject is pregnant or lactating
A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vilazodone
Intervention description: Vilazodone tablets, once daily, oral administration
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone
      for the treatment of MDD in pediatric outpatients (7-17 years).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female outpatients betw een 7-17 years of age

          -  Primary diagnosis of major depressive disorder (MDD)

          -  Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater

          -  Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

        Exclusion Criteria:

          -  Current (past 3 months) principal Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition, Text Revision based diagnosis of an Axis I disorder other
             than MDD that is the primary focus of treatment (de novo patients only)

          -  History of suicidal behavior, or requires precaution against suicide

          -  Not generally healthy medical condition

          -  Seizure disorder
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Intervention: Ospemifene 60 mg; Placebo
Intervention description: 60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed; oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 919.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vulvar and vaginal atrophy in postmenopausal women; Menopausal symptoms; Vaginal atrophy; Urogenital atrophy

Summary:

      The purpose of this study is to determine the safety and efficacy of ospemifene in
      postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain
      associated with sexual activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naturally or surgically menopausal

          -  Moderate or severe symptoms of vaginal atrophy

          -  5% or fewer superficial cells in maturation index of vaginal smear

          -  Vaginal pH greater than 5.0

          -  Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated
             with sexual activity, with a severity of moderate or severe at randomization

        Exclusion Criteria:

          -  Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine
             fibroids

          -  Current vaginal infection requiring medication

          -  Clinically significant abnormal gynecological findings other than signs of vaginal
             atrophy (e.g.

        uterine or vaginal prolapse of Grade 2 or higher)

          -  Previous participation in any other ospemifene study