bioihbjkbjnl/mcl2 huggingface dataset:
Glenohumeral Cortisone Injection
Condition: Humeral Fractures
MeSH terms: Humeral Fractures
Intervention: kenalog; Lidocaine
Intervention description: Cortisone injection into shoulder; Lidocaine injection into shoulder
Intervention MeSH terms: Triamcinolone Acetonide; Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The objective of this project is to determine if giving a cortisone injection to patients
      with proximal humerus fractures who have stiff shoulders recover their range of motion.
    

Eligibility criteria:

        Inclusion Criteria:

        1.18-90

        2. Proximal Humerus Fracture

        3. Decreased range of motion at 6 wk follow-up

        4. Likely to be available for follow up for 26 wks

        Exclusion Criteria:

          1. Known drug allergy to kenalog or lidocaine

          2. Unable to complete functional outcome

          3. Pregnant Women
Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
Condition: Acute Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections
Intervention: Mucinex; Placebo
Intervention description: Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study; Placebo given as 2 tablets
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute Respiratory Infection; Mucociliary; Cough Clearance; Guaifenesin

Summary:

      The purpose of this research study is to explore the mechanism of action of Mucinex, an oral,
      over-the-counter, FDA approved expectorant in patients with acute respiratory tract
      infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of cough, thickened mucus and chest congestion

          -  Able to produce sputum

          -  Non Smoker

        Exclusion Criteria:

          -  Pregnant

          -  Smokers

          -  Fever above 101°F

          -  Any chronic illness
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SPD489 (Lisdexamfetamine dimesylate); Matching placebo
Intervention description: Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily; oral, once daily
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder

Summary:

      To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI)
      when used as an adjunct to stable, standard therapy in the setting of partial or full
      remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive
      Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult
      Version (BRIEF-A).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression

        Exclusion Criteria:

          -  Current co-morbid psychiatric disorder
Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload
Condition: Iron Overload Due to Repeated Red Blood Cell Transfusions
MeSH terms: Iron Overload
Intervention: Deferiprone DR tablets 1000 mg (Low dosage); Deferiprone DR tablets 1000 mg (High dosage)
Intervention description: Deferiprone DR tablets 1000 mg; Deferiprone DR tablets 1000 mg
Intervention MeSH terms: Deferiprone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iron overload; chelation; deferiprone; Ferriprox

Summary:

      Safety, tolerability, and acceptability of twice-daily dosing with deferiprone
      delayed-release (DR) tablets in patients with systemic iron overload.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged ≥ 18 years.

          2. Diagnosis of thalassemia syndrome, sickle cell disease, or other disorder requiring a
             regular regimen of red blood cell transfusions.

          3. On a stable regimen (≥3 months) of Ferriprox tablets for the treatment of systemic
             iron overload.

          4. Absolute neutrophil count ≥1.5 x 10^9/L at screening.

          5. A record of at least 12 measured alanine aminotransferase (ALT) and aspartate
             aminotransferase (AST) levels.

        Exclusion Criteria:

          1. Receipt of any iron chelator other than Ferriprox (i.e., combination therapy) in the
             last 3 months, or planning to receive it at any time during the period of the study.

          2. ALT and/or AST value > 5 times the upper limit of normal (ULN) at screening

          3. Active case of hepatitis B or C at screening.
Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OC-02 (simpinicline) nasal spray; Placebo (vehicle) nasal spray
Intervention description: OC-02 (simpinicline) nasal spray, 11.1 mg/ml; Placebo (vehicle) nasal spray
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and effectiveness of OC-02 nasal spray
      compared to placebo on signs and symptoms of dry eye disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have used and/or desired to use an artificial tear substitute for dry eye symptoms
             within 60 days prior to Visit 1

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such
             as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser
             epithelial keratomileusis, laser-assisted in-situ keratomileusis, photorefractive
             keratectomy or corneal implant) within twelve months of Visit 1

          -  Have a history or presence of any ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with dry eye
             disease are allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject
Compatibility of C7 With Ketogenic Diet in Patients Diagnosed With G1D
Condition: GLUT1DS1
Intervention: Triheptanoin
Intervention description: Dietary supplementation with triheptanoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 30 Months
Maximum age: 35 Years
Healthy volunteers: No
Keywords: G1D, glucose, transporter

Summary:

      To explore triheptanoin (C7 oil) compatibility with the ketogenic diet by evaluating EEG, and
      seizure rate, glycemia and ketosis in proven G1D patients receiving a ketogenic diet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of glucose transporter type 1 deficiency (G1D), confirmed by clinical
             genotyping at a CLIA-certified laboratory.

          -  Stable on ketogenic diet at 2.5:1 to 4:1 ratio (i.e., no changes in ratio will have
             taken place for 2 months). The initiation of a ketogenic diet is previous to - and
             thus is not part of this study.

          -  Males and females 30 months to 35 years and 11 months old inclusive.

        Exclusion Criteria:

          -  Subjects with evidence of independent, unrelated metabolic and/or genetic disease.

          -  Subjects with a chronic gastrointestinal disorder, such as irritable bowel syndrome,
             crohn's disease, or colitis that could increase the subject's risk of developing
             diarrhea or stomach pain.

          -  Subjects with a BMI (body mass index) greater than or equal to 30.

          -  Subjects currently not on ketogenic diet.

          -  Women who are pregnant or breast feeding may not participate. Women who plan to become
             pregnant during the course of the study, or who are unwilling to use birth control to
             prevent pregnancy (including abstinence) may not participate. Females age 10 and over
             will be asked to provide a urine sample for a pregnancy test via dipstick. Subjects
             will be asked to agree to abstinence or another form of birth control for the duration
             of the study.

          -  Allergy/sensitivity to C7

          -  Previous use of triheptanoin less than 1 month prior to study initiation.

          -  Treatment with medium chain triglycerides in the last 24 hours.

          -  Subjects exhibiting signs of dementia, or diagnosed with any degenerative brain
             disorder (such as Alzheimer's disease) that would confound assessment of cognitive
             changes, in the opinion of the investigator.

          -  Active drug or alcohol use or dependence that, in the opinion of the investigator,
             would interfere with adherence to study requirements.

          -  Inability or unwillingness of subject or legal guardian/representative to give written
             informed consent, or assent for children age 10-17,

          -  Addition of a new antiseizure drug in the previous 3 months.
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
Condition: Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: omalizumab
Intervention description: SC repeating dose
Intervention MeSH terms: Omalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 6 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: TOPS; Peanut allergy; Peanut-induced allergy; Allergy

Summary:

      This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control
      (placebo) subjects who have completed their final visit (or early termination visit, if
      applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who
      provide consent to participate in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of last visit (or early termination visit, if applicable) for Study Q2788g

          -  Signed Informed Consent Form

          -  Use of an effective method of contraception for females of childbearing potential

          -  Body weight ≥ 20 kg and ≤ 150 kg

          -  IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE < 30 IU/mL will be dosed at the
             lowest level on the dosing table [30 IU/mL], thus enabling better understanding of the
             role of Xolair in peanut allergic subjects who have low total IgE levels.)

        Exclusion Criteria:

          -  Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)

          -  Current participation in another investigational study

          -  Pregnancy or lactation

          -  History of brittle asthma

          -  Aspirin-sensitive asthma

          -  Known hypersensitivity to any ingredients of Xolair, including its excipients
             (sucrose, histidine, polysorbate 20)

          -  Have a polymorrphonuclear count <1500/uL

          -  Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or
             ticlopidine

          -  Current diagnosis of cancer, current investigation for possible cancer, or history of
             cancer (not including non-melanoma skin cancer)

          -  Thrombocytopenia as evidenced by a platelet count < 100,000/uL

          -  Any systemic condition requiring regular administration of an immunoglobulin
A Study To Assess the Effects Of PF-04457845 On BOLD fMRI In Subjects With Post Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: PF-04457845; Placebo
Intervention description: 4mg PF-04457845 tablet taken once daily for 7 days.; Matching placebo tablet taken once daily for 7 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate proof of mechanism of PF-04457845, using a
      well-established neuroimaging paradigm including behavioral tasks selected to activate
      neuro-circuitry relevant to Post Traumatic Stress Disorder. It is hypothesized that
      PF-04457845 will modulate the Blood-oxygen-level dependent Functional Magnetic Resonance
      Imaging signal from the relevant neuro-circuits in patients with Post Traumatic Stress
      Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women 18-60 years of age with a primary psychiatric diagnosis of Post
             Traumatic Stress Disorder

        Exclusion Criteria:

          -  Other psychiatric illness requiring current treatment with medication.
Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Cediranib; Cediranib Placebo
Intervention description: 45 mg oral tablet; oral tablet
Intervention MeSH terms: Cediranib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: cancer; tumour; advanced cancer; Metastatic renal cell carcinoma; kidney cancer; RECENTIN

Summary:

      Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours
      and also how well it is tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmation of metastatic or recurrent renal cell carcinoma

        Exclusion Criteria:

          -  Certain types of previous anti-cancer therapy for Renal Cell Carcinoma

          -  Patients with type I insulin-dependent diabetes or poorly-controlled type II
             insulin-independent diabetes

          -  Patients with a history of poorly controlled high blood pressure
The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: N-acetyl-l-cysteine
Intervention description: 1200 mg BID x 4 weeks
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: uncontrolled; neuropathic pain

Summary:

      This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases
      pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will
      be a useful adjunct to opioid treatment in chronic neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years old

          -  non-cancer neuropathic pain

          -  stable dose of opioids for pain

          -  using breakthrough pain meds

          -  still with persistent pain per VAS

        Exclusion Criteria:

          -  pregnant or nursing

          -  serious medical or psychiatric illness (including uncontrolled hypertension)

          -  active stomach ulcer, history or seizures or asthma

          -  breakthrough pain meds other than opioids

          -  using illicit drugs
Topical ASC-J9 Cream for Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: ASC-J9
Intervention description: Cream for twice daily topical application to the face
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: androgen receptor degradation enhancer

Summary:

      To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice
      daily for facial acne compared to vehicle control.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  At least 12 years of age at the time of enrollment

          -  Facial acne, with:

               1. 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts);

               2. 20-100 noninflammatory facial lesions (open and closed comedones);

               3. No more than 2 nodules/cysts on the face (defined as an inflammatory lesion
                  greater than or equal to 5 mm in diameter);

               4. Investigator's Global Assessment (IGA) acne score of 3 or 4.

        Key Exclusion Criteria:

          -  Females who are pregnant or breast-feeding

          -  Skin diseases other than acne vulgaris

          -  Use of other topical or systemic treatments for acne

          -  Other significant medical conditions or clinically significant abnormal laboratory
             test results.
Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Immunochemotherapy, in vivo purging and autrotransplant
Intervention description: 2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 10^9/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day subcutaneously) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: follicular lymphoma; rituximab; immunochemotherapy; peripheral blood stem cells (PBSC) mobilization; in vivo purging; autotransplant; bcl-2 rearrangement; molecular response

Summary:

      The purpose of this study is to determine the rate and duration of complete remission and
      molecular response in patients with relapsed/refractory follicular lymphoma, using a combined
      treatment with rituximab plus chemotherapy followed by in vivo purged peripheral blood stem
      cells (PBSC) mobilization and autotransplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with relapsed or refractory follicular lymphoma after chemotherapy

          -  Patients with relapsed or refractory follicular lymphoma after rituximab as single
             agent or with chemotherapy

          -  Patients with transformed follicular lymphoma

          -  CD20-positivity

          -  Age between 18 and 60 years

          -  Advanced Ann Arbor stage

          -  Normal cardiac, renal and hepatic functions

          -  Negativity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and
             hepatitis C virus (HCV)

          -  Total amount of anthracycline previously received < 300 mg/m^2

        Exclusion criteria:

          -  Creatinine > 2 mg/dl

          -  Alanine transaminase (ALT) and alkaline phosphatase > 2N

          -  Cardiac or pulmonary disease

          -  Severe organic or psychiatric disease

          -  Positivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and
             hepatitis C virus (HCV)

          -  Pregnancy, breastfeeding

          -  Cancer diagnosis in the 5 years before lymphoma diagnosis, except of non-melanoma skin
             cancer and Cervical Intraepithelial Neoplasia (CIN)