bioihbjkbjnl/mcl2 huggingface dataset:
A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Rotigotine 1 mg/24 h; Rotigotine 2 mg/24 h; Rotigotine 3 mg/24 h
Intervention description: Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 mg/24 h (5 cm^2 patch size).; Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 mg/24 h (10 cm^2 patch size).; Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 3 mg/24 h (15 cm^2 patch size).
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: RLS; Neupro; Rotigotine

Summary:

      The purpose of this study is to assess the long-term safety, tolerability and the long-term
      efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject weighs >=40 kg

          -  Subject has completed at least one dose step in SP1006, a previous study of rotigotine
             in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria

          -  Female subjects must be surgically incapable of childbearing, or effectively
             practicing an acceptable method of contraception (oral/parenteral/implantable hormonal
             contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an
             acceptable method. Subjects must agree to use adequate contraception during the study
             and for 4 weeks after their final dose of study drug

          -  Subject is expected to benefit from participation, in the opinion of the investigator

        Exclusion Criteria:

          -  Subject is experiencing an ongoing serious Adverse Event (SAE) that is assessed to be
             related to rotigotine by the investigator or Sponsor

          -  Subject has active suicidal ideation as indicated by a positive response ("Yes") to
             either Question 4 or Question 5 of the "Since Last Visit" version of the electronic
             Columbia Suicide Severity Rating Scale (eC-SSRS) at the final evaluation visit of the
             previous rotigotine study (ie, Visit 10 of SP1006)
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
Condition: Neoplasms, Glandular and Epithelial; Diphtheria; Tetanus; Whooping Cough; Poliomyelitis
MeSH terms: Tetanus; Diphtheria; Poliomyelitis; Whooping Cough; Neoplasms, Glandular and Epithelial
Intervention: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF); Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF); Comparator: REPEVAX™ (Concomitant); Comparator: REPEVAX™ (Non-Concomitant)
Intervention description: GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.; GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.; REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.; REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 843.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus
      [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined
      diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic
      and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be healthy boys or girls, 11-17 years of age

          -  Must be a virgin with no intention of becoming sexually active during the study period

          -  Must have been properly vaccinated against diphtheria, tetanus, pertussis and polio

        Exclusion Criteria:

          -  Must not have received a vaccine against diphtheria, tetanus, pertussis and polio in
             the past 5 years

          -  Must not have received any prior human papillomavirus (HPV) vaccine
Bexagliflozin Efficacy and Safety Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Bexagliflozin; Placebo
Intervention description: 20 mg, tablet; 20 mg tablet to match active comparator
Intervention MeSH terms: Bexagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1700.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the effect of bexagliflozin in lowering
      hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased
      risk of cardiovascular adverse events.

      The data from this study will be combined with the data from other bexagliflozin studies in a
      meta-analysis of CV safety outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of T2DM

          -  Subjects who have had a stable treatment regimen for T2DM for the past 3 months

          -  Subjects who present with at least one of the following 3 histories:

        Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure
        Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently
        smoking, reduced kidney function, or cholesterol problems

        Exclusion Criteria:

          -  Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young

          -  History of genitourinary tract infections

          -  Evidence of abnormal liver function

          -  History of MI, stroke or hospitalization for heart failure in the past 3 months

          -  Prior kidney transplant or evidence of kidney problems

          -  Prior or planned pace maker implantation

          -  Pregnant or nursing
LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: Placebo; Afatinib
Intervention description: Once daily; Once daily
Intervention MeSH terms: Afatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomised, double-blind phase III trial will be performed in patients with head and
      neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy
      and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have
      received definitive chemo-radiotherapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically or cytologically confirmed loco-regionally advanced head and neck
             squamous cell carcinoma (HNSCC), stage III to IVb

          -  Unresected tumour prior to chemo-radiotherapy (CRT)

          -  Concomitant CRT completed prior to randomisation

          -  After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and
             radiographic examinations

          -  Eastern cooperative oncology group (ECOG) performance status 0 or 1

        Exclusion criteria:

          -  Patients with smoking history of less than or equal to 10 pack years and with primary
             tumour site of base of tongue and/or tonsil

          -  Cancer of nasopharynx, sinuses, and/or salivary glands

          -  Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules,
             EGFR-targeted antibodies, and/or any investigational agents for HNSCC

          -  Known pre-existing Interstitial Lung Disease (ILD)

          -  Any past or present history of areca/betel-nut chewing or its derivatives for a
             cumulative duration of more than 3 months
An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
Condition: Diabetic Autonomic Neuropathy
MeSH terms: Diabetic Neuropathies
Intervention: ORAL ANTIOXIDANT
Intervention description: Comparison of triple antioxidant combination therapy vs placebo.
Intervention MeSH terms: Niacinamide; Allopurinol; Antioxidants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 1 Diabetes; Oxidative Stress; Diabetic Complications; Neuropathy

Summary:

      The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects
      the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN
      may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.
      Three medications will be tested for their effectiveness in DAN.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes

          -  A1C <9%

          -  Mild neuropathy

          -  Mild retinopathy

          -  Mild nephropathy

        Exclusion Criteria:

          -  History of drug or alcohol dependence, heart disease, viral illness, liver disease,
             advanced kidney disease

          -  Pregnant or nursing

          -  Severely overweight
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Pegylated Interferon Alfa 2a; Telaprevir; Ribavirin; Placebo
Intervention description: subcutaneous injection, 180 micrograms once per week; 375 mg tablets administered orally every 8 hours at a dose of 750 mg; 200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg; Telaprevir matching placebo
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1095.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Genotype 1

Summary:

      A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in
      combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).
    

Eligibility criteria:

        Inclusion Criteria

          -  Has not received any previous treatment with any approved or investigational drug or
             drug regimen for the treatment of hepatitis C

          -  Male and female subjects, 18 to 70 years of age, inclusive

          -  Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic
             Acid (RNA)

          -  Screening laboratory values, tests, and physical exam within acceptable ranges

          -  Able and willing to follow contraception requirements

          -  Able to read and understand, and willing to sign the informed consent form and abide
             by the study restrictions

        Exclusion Criteria

          -  Subject has any contraindications to Pegasys® or Copegus® therapy

          -  Evidence of hepatic decompensation in cirrhotic subjects

          -  History of organ transplant

          -  History of, or any current medical condition which could impact the safety of the
             subject in participation in the study
Buprenorphine Treatment for Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Buprenorphine
Intervention MeSH terms: Buprenorphine; Naloxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Opioid Dependence; Buprenorphine

Summary:

      Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription
      opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this
      patient population. The goal of this study is to determine if there are differences in
      clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high
      dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will
      be treatment retention, use of opioids, and the use of other drugs of abuse.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females between the ages of 18 to 65, current dependence on prescription
             opioids as evidenced by documented prior treatment for opioid dependence, signs of
             opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or
             greater, self-reported history of opioid dependence, and a positive urine toxicology
             for opiates;

          2. willingness to be detoxified from opioids for buprenorphine maintenance ;

          3. for women of childbearing age, a negative pregnancy test at screening with agreement
             to use adequate contraception to prevent pregnancy, with monthly pregnancy tests
             obtained during study participation.

        Exclusion Criteria:

          1. use of heroin for more than 4 days in the past month;

          2. lifetime history of opioid dependence due to heroin alone;

          3. ever used heroin intravenously;

          4. requirement for current ongoing opioid treatment for adequate pain management;

          5. current alcohol, benzodiazepine, barbiturate use with physiologic dependence as
             determined during screening history and physical,

          6. serious unstable medical illness including bradycardia or other arrhythmias, major
             cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine
             treatment is contraindicated or which at the determination of the MD is medically
             dangerous;

          7. serious psychiatric illness including psychosis, bipolar disorder with psychosis:

          8. or significant current suicidal or homicidal thoughts necessitating a higher level or
             care;

          9. known allergy or intolerance to buprenorphine.
Duloxetine for the Treatment of Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Duloxetine; Placebo
Intervention description: 60 to 120 mg, capsules, oral, once a day for 15 weeks; placebo capsules, oral, once a day for 15 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anxiety

Summary:

      This is a 15 week study comparing how well duloxetine and placebo treatments improve
      generalized anxiety disorder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Psychiatric Diagnosis of generalized anxiety disorder (GAD)

          -  Outpatients

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
             diagnosis for GAD

          -  Clinical Global Impression (CGI) of Severity Score of at least moderate

          -  Sheehan Disability Scale (SDS) Global Functioning Impairment Score >= 12

        Exclusion Criteria:

          -  Pregnancy or breast feeding

          -  Serious medical illness

          -  Other primary psychiatric diagnoses, such as major depressive disorder or substance
             abuse disorder within the past 6 months

          -  panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last
             year

          -  lifetime history of bipolar or psychosis

          -  Any unstable serious medical condition for which duloxetine would not be allowed

          -  Any use of medications that are not allowed
Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Atenolol; Hydrochlorothiazide (HCTZ)); Valsartan
Intervention description: 100 mg tablets orally once a day (od) in the morning.; 12.5 or 25 mg tablets orally once a day (od) in the morning.; 80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
Intervention MeSH terms: Atenolol; Valsartan; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hypertension; valsartan; atenolol; hydrochlorothiazide; microcirculation; arterial compliance; pulse wave analysis

Summary:

      This study evaluated the effect of valsartan on small vessel blood flow in patients with
      mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Caucasian; male or female outpatients and age between 40-65 years of age, inclusive.

          -  At Visit 2 all patients must have a mean sitting diastolic blood pressure (msSBP) of ≥
             90 mmHg and < 110 mmHg.

        Exclusion Criteria:

          -  If a single reading for arterial hypertension in msSBP > 180 mmHg or msDBP > 110 mmHg
             at any visit after randomization.

          -  Inability to discontinue all prior antihypertensive medications safely for a period of
             2 weeks prior to randomization.

          -  Known history of hypotensive symptoms or orthostatic hypotension.

          -  Concomitant use of statins or statin intake during the four weeks prior to Visit 1.

          -  Known Keith-Wagener grade III or IV hypertensive retinopathy.

          -  A history of heart failure (NYHA II-IV).
A Study for the Treatment of Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Neuropathies
MeSH terms: Neuralgia; Diabetic Neuropathies
Intervention: Duloxetine hydrochloride - 40 mg; placebo; Duloxetine hydrochloride - 60 mg
Intervention description: duloxetine 40 mg taken orally every day; placebo taken orally every day; duloxetine 60 mg taken orally every day
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 339.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if duloxetine can help patients with painful
      diabetic neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with pain due to bilateral peripheral neuropathy induced by type 1 or 2
             diabetes mellitus. The pain must have been present for at least 6 months and be
             evaluable in feet, legs, or hands.

          -  Participants with hemoglobin A1c (HbA1c) less than or equal to 9.0 percent at Visit 1.

          -  Participants in whom HbA1c had been measured 42-70 days before Visit 1 and subsequent
             HbA1c levels have been within +/- 1.0 percent of the level at Visit 1.

          -  Participants with a mean of the 24-hour average pain severity scores (round off to a
             whole number) of 4 or higher, as calculated from the patient diary for 7 days
             immediately before Visit 2

        Exclusion Criteria:

          -  Participants who have undergone renal transplant or who are currently on renal
             dialysis.

          -  Participants who have a history requiring pharmacotherapy within the past year or
             current history of psychiatric disease, such as mania, bipolar disorder, depression,
             anxiety disorder, or eating disorder.

          -  Participants with hypertension with poor control of blood pressure (systolic blood
             pressure greater than or equal to 180 millimeters of mercury (mmHg) or diastolic blood
             pressure greater than or equal to 110 mmHg

          -  Participants with alanine transaminase (ALT) or aspartate transaminase (AST) greater
             than or equal to 100 Units per Liter (U/L) at Visit 1.

          -  Participants unable to discontinue prohibited concomitant drugs or concomitant
             therapies after Visit 1.