bioihbjkbjnl/mcl2 huggingface dataset:
Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: glycopyrronium Topical Wipes; Vehicle
Intervention description: Topical wipes containing glycopyrronium; Vehicle (placebo) topical wipes
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 353.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The study is a randomized, double-blind, vehicle controlled, parallel group study, designed
      to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to
      vehicle in subjects with axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 9 years of age.

          -  Primary, axillary hyperhidrosis of at least 6 months duration.

          -  Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline.

          -  Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline.

          -  Sweat production of at least 50 mg over 5 minutes in each axilla assessed
             gravimetrically.

        Exclusion Criteria:

          -  Prior surgical procedure for hyperhidrosis.

          -  Prior axillary treatment with an anti-hyperhidrosis medical device (approved or
             investigational).

          -  Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within
             1 year of Baseline/Day 1.

          -  Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.

          -  Axillary use of nonprescription antiperspirants within 1 week or prescription
             antiperspirants within 2 weeks of Baseline.

          -  Subjects on new or regimens of psychotherapeutic medications that have changed within
             2 months of baseline.

          -  Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless
             dosing has been stable for at least 4 months.

          -  Other treatment with glycopyrrolate within 4 weeks prior to Baseline.

          -  Secondary axillary hyperhidrosis or presence of a condition that may cause secondary
             hyperhidrosis.

          -  History of Sjögren's syndrome or Sicca syndrome.

          -  History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.

          -  Men with a history of urinary retention requiring catheterization due to prostatic
             hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

          -  History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.

          -  Other systemic diseases or active uncontrolled infections, or any other condition
             which, in the judgment of the Investigator, would put the subject at unacceptable risk
             for participation in the study.
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Oral Cavity and Oropharynx; Oral Mucositis
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Mucositis; Stomatitis
Intervention: SGX942; Placebo
Intervention description: 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.; Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OM; Head and Neck Cancer; SGX942; Dusquetide; Squamous Cell Carcinoma

Summary:

      To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe
      oral mucositis in patients receiving chemoradiation treatment for the treatment of head and
      neck cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant
             organ metastases

          -  Scheduled to receive cisplatin chemotherapy of 80-100 mg/m²

          -  Scheduled to receive a continuous course of fractionated, conventional external beam
             with a cumulative radiation dose between 55 and 72 Gy at each site

        Exclusion Criteria:

          -  Current mucositis

          -  Current, clinically significant, active infection that in the opinion of the
             Investigator would make them an unfit participant in the trial

          -  Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline
             and 6 weeks post-RT

          -  Prior radiation to the head and neck

          -  Chemotherapy treatment within the previous 12 months

          -  Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx

          -  Evidence of significant renal, hepatic, hematologic, or immunologic disease determined
             by any one of the following: Estimated creatinine clearance <30 mL/min; ALT or AST
             level greater than 10-fold the upper limit of normal or total bilirubin greater than
             3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as
             ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200
             cells per μL

          -  Evidence of immediate life-threatening disease or a life expectancy of less than 3
             months

          -  Women who are pregnant or breast-feeding

          -  Participation in any study involving administration of an investigational agent within
             30 days of randomization into this study
Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine (Lu AA21004); Venlafaxine extended release
Intervention description: 10 mg/day; 150 mg/day
Intervention MeSH terms: Vortioxetine; Venlafaxine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 437.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MDD

Summary:

      This study will be conducted with the aim of investigating the efficacy, safety and
      tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active
      comparator (venlafaxine extended release 150 mg/day).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™
             criteria. The current Major Depressive Episode (MDE) should be confirmed using the
             Mini International Neuropsychiatric Interview (MINI)

          -  The patient has a MADRS total score ≥26

          -  The patient has a CGI-S score ≥4

          -  The reported duration of the current MDE is ≥3 months.

        Other inclusion criteria may apply.

        Exclusion Criteria:

        - The patient meets any of the exclusion criteria listed in the protocol or, in the
        investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any
        reason.
Pregabalin Peripheral Neuropathic Pain Study
Condition: Diabetic Neuropathies; Neuralgia
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: pregabalin; Placebo
Intervention description: 150-600mg/day, BID; Placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose
      adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with
      peripheral neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral
             neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain
             (including post-surgical), confirmed by a qualified pain specialist.

          -  Subjects must have completed at least 4 daily pain diaries during the 7 days prior to
             Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2
             (randomization).

        Exclusion Criteria:

          -  Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain
             (including post-surgical), that may confuse or confound the assessment of neuropathic
             pain.

          -  Presence of any severe pain associated with conditions other than DPN, PHN, or
             post-traumatic neuropathic pain (including post-surgical) that may confound the
             assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic
             neuropathic pain (including post-surgical).

          -  Creatinine clearance < 30 mL/min (estimated from serum creatinine, body weight, age,
             and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for
             subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day
Obese Hypertension Study (0954-315)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Comparator: losartan +/- HCTZ; Comparator: Placebo
Intervention description: Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.; Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.
Intervention MeSH terms: Losartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 261.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a 16-week study to evaluate high systolic and diastolic blood pressure following
      treatment in obese, hypertensive, adult patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese male and female patients, ages 21-75 years, with high blood pressure

        Exclusion Criteria:

          -  Patients cannot have any other severe cardiac conditions
Study of Milnacipran for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Placebo; Milnacipran 100mg
Intervention description: Placebo, oral administration, twice daily for 12 weeks; Milnacipran 100mg per day (50mg BID [twice a day])
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1025.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Fibromyalgia

Summary:

      The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a
      dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with
      fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR)
             Criteria

        Exclusion Criteria:

          -  psychiatric illness,

          -  depression,

          -  suicidal risk,

          -  substance abuse,

          -  pulmonary dysfunction,

          -  renal impairment,

          -  active cardiac disease,

          -  liver disease,

          -  autoimmune disease,

          -  cancer,

          -  inflammatory bowel disease
Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Metformin XR; Placebo matching Metformin XR; Metformin XR; Placebo matching Saxagliptin
Intervention description: Tablets, Oral, 5 mg, once daily, 4 weeks; Tablets, Oral, 1500 mg, once daily, 4 weeks; Tablets, Oral, 0 mg, once daily, 4 weeks; Tablets, Oral, 500 mg, once daily, 4 weeks; Tablets, Oral, 0 mg, once daily, 4 weeks
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on
      24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with
      T2DM inadequately controlled on metformin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  18-78 years of age

          -  Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as
             monotherapy for at least 8 weeks prior to screening

          -  Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening

          -  Fasting C-peptide: ≥1.0 ng/mL

          -  FPG≥126 mg/dl obtained at the Day -7 visit

          -  Body mass index (BMI): ≤ 40kg/m²

          -  A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization

        Exclusion Criteria:

          -  Women of childbearing potential unable or unwilling to use acceptable birth control

          -  Women who are pregnant or breastfeeding

          -  Significant cardiovascular history

          -  Active liver disease

          -  Renal impairment
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Moderate to Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DMB-3115; Stelara
Intervention description: 45mg or 90mg dose subcutaneous administration; 45mg or 90mg dose subcutaneous administration
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 598.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity
      of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate
      to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.

        Exclusion Criteria:

          -  Patients with hypersensitivity to ustekinumab or any of the product excipients.
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Desvenlafaxine Succinate Sustained-Release; Desvenlafaxine Succinate Sustained-Release; Placebo
Intervention description: Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.; Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.; Subjects randomized to the Placebo treatment arm will receive placebo tablets
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 363.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression

Summary:

      This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR)
      versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive
      Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >=7 and <18 years of age

          -  Primary diagnosis of major depressive disorder (MDD)

          -  CDRS-R score >40

        Exclusion Criteria:

          -  History of suicidal behavior or requires precaution against suicide

          -  Not in generally healthy medical condition

          -  History of psychosis or bipolar disorder

          -  Seizure disorder
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
Condition: Hypercholesterolaemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Alirocumab; Placebo (for alirocumab); Lipid Modifying Therapy (LMT)
Intervention description: Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).; Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).; Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9
      (proprotein convertase subtilisin/kexin type 9).

      Primary Objective of the study:

      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels
      after 24 weeks of treatment in comparison with placebo.

      Secondary Objectives:

        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time
           points

        -  To evaluate the effects of alirocumab on other lipid parameters

        -  To evaluate the safety and tolerability of alirocumab
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with heterozygous familial hypercholesterolemia who were not adequately
             controlled with their lipid-modifying therapy.

        Exclusion criteria:

          -  Age < 18 years

          -  LDL-C < 160 mg/dL (< 4.14 mmol/L) at the screening visit (Week-3).

          -  Fasting serum triglycerides > 400 mg/dL (> 4.52 mmol/L) during the screening period.

          -  Known history of homozygous familial hypercholesterolemia.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Epoetin alfa 3 times weekly /once weekly; Epoetin alfa once weekly; Epoetin alfa once every two weeks
Intervention description: Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks); Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks).; Epoetin alfa will be administered as a SC injection at initial dose of 20000 IU (once every 2 weeks for 44 weeks).
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anemia; Chronic Kidney disease; Kidney disease; Epoetin alfa; Procrit

Summary:

      The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment
      with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not
      less effective than the approved treatment with epoetin alfa that is given 3 times weekly
      with respect to changes in hemoglobin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular
             filtration rate (GFR) more than or equal to 15 mL/min per 1.73 m2 and less than 60
             mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory

          -  Require support of an erythropoietin receptor agonist

        Exclusion Criteria:

          -  Uncontrolled hypertension

          -  Serum ferritin level less than 50 ng/mL

          -  Serum iron overload

          -  Severe congestive heart failure

          -  Active infection