bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
Condition: Chronic Non-malignant Pain
Intervention: Buprenorphine transdermal patch; Placebo to match BTDS
Intervention description: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.; Placebo to match buprenorphine transdermal patch applied for 7-day wear.
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 267.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic pain; opioid; transdermal; Butrans™ [BTDS]

Summary:

      The objective of this study is to demonstrate the effectiveness and tolerability of the
      buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal
      system in subjects with chronic nonmalignant pain syndromes currently controlled by oral
      opioids. The double-blind treatment intervention duration is 2 weeks during which time
      supplemental analgesic medication (acetaminophen) will be provided to all subjects in
      addition to study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 2 month's history of nonmalignant pain, currently in stable pain control on
             opioid therapy.

          -  Good, very good or excellent pain control on current opioid therapy.

          -  Willing and able to use a telephone interactive voice response service.

        Exclusion Criteria:

          -  Currently receiving daily morphine or oxycodone monotherapy.

          -  Scheduled for surgery of the disease site (eg, major joint replacement surgery), or
             any other major surgery, which would fall within the study period.

        Other protocol-specific exclusion/inclusion criteria may apply.
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Ultra-Rapid Lispro; Insulin Lispro
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 471.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog)
      when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with T1D and continuously using insulin for at least 1 year

          -  Have been using CSII therapy for a minimum of 6 months

          -  Currently treated with <100 Units of one of following rapid-acting analog insulin via
             CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting
             insulin aspart, insulin glulisine

          -  Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and
             Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump
             for at least the past 90 days

        Exclusion Criteria:

          -  Have hypoglycemia unawareness

          -  Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening

          -  Have had more than 1 emergency room visit or hospitalization due to poor glucose
             control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
Adductor Canal Block Versus Femoral Nerve Block for Total Knee Arthroplasty
Condition: Arthropathy of Knee
MeSH terms: Joint Diseases
Intervention: Adductor Canal Nerve Block; Femoral Nerve Block
Intervention description: Adductor Canal never technique; Traditional technique
Intervention MeSH terms: Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The first two groups will have 50 participants each (100 total) the "Adductor Canal Nerve Catheter" group and the "Femoral Nerve Catheter," group. Participants will be randomized using block randomization. The blocks will be assigned randomly based on computer generated numbers.
Masking: Single (Participant)
Enrollment: 94.0
Sex: All
Minimum age: 19 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adductor Canal Block; Femoral Canal Block

Summary:

      Peripheral nerve blocks catheters of the femoral nerve have long been used for perioperative
      analgesia in total knee arthroplasty (TKA). These blocks provide effective analgesia and
      patient satisfaction for surgical pain relief. However, one of the main drawbacks to the
      femoral nerve block (FNB) is a denser motor block of the quadriceps muscle that can delay
      aggressive physical therapy and subsequent recovery from surgery. (1) Recently, there has
      been increasing interest in performing adductor canal blocks (ACB) with the aim of less motor
      blockade while providing commensurate analgesia compared to the FNB. (1,2) Current
      investigative reports have provided only preliminary data, and there is potential to change
      the standard of care for TKA as more data mounts in favor of ACBs. The goal of this study is
      to verify the analgesic equivalence of the two blocks, compare patient satisfaction, surgeon
      satisfaction, and physical therapy grading between the two blocks. Potentially, this would
      change the standard of care for TKA patients at this institution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient undergoing total knee arthroplasty with regional anesthesia planned for
             postoperative analgesia.

          -  Adult, 19 years of age or older

          -  Patient classified as American Society of Anesthesiology (ASA) class I, II, or III

        Exclusion Criteria:

          -  Any subject not classified as an ASA I, II, or III

          -  Allergy/intolerance to local anesthetic

          -  Pre-existing neurologic or anatomic deficit in lower extremity on the side of the
             surgical site

          -  Coexisting coagulopathy such as hemophilia or von Willebrand disease
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
Condition: Central Precocious Puberty
MeSH terms: Puberty, Precocious
Intervention: Histrelin Subcutaneous Implant
Intervention description: histrelin subcutaneous 50 mg implant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: puberty; precocious puberty; early puberty; early onset puberty; histrelin; histrelin subcutaneous implant; implant therapy

Summary:

      The purpose of this study is to follow and collect additional medical and developmental
      information on children after histrelin subcutaneous implant therapy is discontinued.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-treated or treatment naive patients with gonadotropin-dependent precocious puberty

          -  Pre-treatment pubertal type response of LH to a stndard GnRH stimulation test before
             initiation of treatment

        Exclusion Criteria:

          -  Children who are less than 2 years of age at enrollment

          -  Children whose chronological age is greater than 8 years (naive) and 10 years
             (pre-treated) for girls or 9 years (naive) and 11 years (pre-treated) for boys at the
             onset of the study
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: Metformin; Oral Contraceptive Pill; Lifestyle Management Program; Quality of Life Questionnaire; Oral Glucose Tolerance Test; Blood work; Abdominal Ultra Sound; Dual-energy x-ray absorptiometry (DEXA scan); placebo
Intervention description: Metformin 500 mg. tabs 2 tabs BID for duration of study; Yasmin, drospirenone and ethinyl estradiol 28 tablets
1 tab daily for duration of study; Subjects and a parent/guardian will participate in a series of classes for training in diet, exercise & behavior modification skills on a regular weekly basis over the 24 week study; Quality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion; Insulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance.
Performed twice during study, at baseline and conclusion; Initial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids.; transabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume.
Performed twice during study, at baseline and conclusion; Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion; placebo capsules, two capsules BID
Intervention MeSH terms: Metformin; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: Female
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Polycystic Ovary Syndrome; Overweight Adolescent Girls; Irregular Menstrual Cycles

Summary:

      Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may
      increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic
      state. This study is to determine whether metformin added to oral contraceptive therapy in
      adolescent women with PCOS improves metabolic state.The study will also test a lifestyle
      improvement program to reduce weight.
    

Eligibility criteria:

        Inclusion Criteria:Age 12-18 years; Menstrual irregularity; Overweight; Must be able to
        swallow capsules; At lease 6 months since onset of first menstrual cycle.

        Exclusion Criteria:Diabetes; Kidney or Liver disease; Tobacco use; Depression or Bipolar
        Disease; Contraindication to exercise; Weight > 300 lbs.
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Condition: Behavioral Symptoms; Autistic Disorder
MeSH terms: Autistic Disorder; Behavioral Symptoms
Intervention: Aripiprazole; Placebo
Intervention description: Tablets, Oral, once daily, 8 weeks; Tablets, Oral, once daily, 8 weeks
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 218.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Serious behavioral problems in children and adolescents with AD

Summary:

      This study will compare the effectiveness (how well the drug works) of aripiprazole with
      placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with
      a diagnosis of autistic disorder (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,
             Text Revision (DSM-IV-TR) diagnostic criteria for AD and demonstrates serious
             behavioral problems; diagnosis confirmed by Autism, Diagnostic Interview-Revised
             (ADI-R).

          -  CGI score > = 4 AND an ABC Irritability/Agitation subscale score > = 18 at screening
             and baseline (randomization)

          -  Mental age of at least 18 months

          -  Male or female 6 to 17 years of age inclusive, at the time of randomization

        Exclusion Criteria:

          -  Patients considered treatment resistant to neuroleptic medication based on lack of
             therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks
             each

          -  Patients previously treated and not responding to aripiprazole treatment

          -  The patient is currently diagnosed with another disorder on the autism spectrum,
             including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or
             Childhood Disintegrative Disorder

          -  Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression

          -  A seizure in the past year

          -  History of severe head trauma or stroke

          -  Non-pharmacologic therapy (e.g., psychotherapy, behavior modification) should be
             stable prior to screening and consistent throughout the study
The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Pegylated-interferon Alfa-2a; Ribavirin
Intervention description: Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.; Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
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: None (Open Label)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy and safety of treatment with pegylated-interferon
      alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study
      treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than
      or equal to (>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive
      pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400
      milligram [mg]) orally daily for the specified duration, followed by 24 weeks of
      treatment-free follow-up. Participants with detectable HCV-RNA and less than (<) 2 log10 drop
      in HCV-RNA at week 12 will discontinue therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  evidence of CHC;

          -  evidence of hepatitis C non-genotype 2 or 3;

          -  compensated liver disease.

        Exclusion Criteria:

          -  infection with HCV genotype 2 or 3;

          -  history of having received systemic antiviral therapy with activity against CHC <=3
             months prior to start of study;

          -  hepatitis A, hepatitis B or human immunodeficiency virus (HIV) infection;

          -  history or evidence of a medical condition associated with chronic liver disease other
             than CHC.
12-Week Study of Plecanatide for CIC (The National CIC3 Study)
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Plecanatide; Placebo
Intervention MeSH terms: Plecanatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1410.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: CIC; Constipation; Chronic Constipation; Synergy; Plecanatide

Summary:

      The purpose of this study is to confirm that the investigational medication, plecanatide, is
      safe and effective in treating chronic idiopathic constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18-80, inclusive

          -  Meets modified Rome III criteria for functional chronic idiopathic constipation for at
             least 3 months with symptom onset for at least 6 months

          -  Completed a colonoscopy in accordance with American Gastroenterological Association
             (AGA) colon cancer screening guidelines (5 years), with no clinically significant
             findings

          -  Willing to maintain a stable diet during the study

        Exclusion Criteria:

          -  Loose stool (mushy) or watery (Bristol score 6 or 7) stool in the absence of any
             laxative or prohibited medicine for > 25% of Bowel Movements (BMs) during the 3 months
             prior to screening visit OR during the 14 day pre-treatment assessment

          -  Active peptic ulcer disease, diabetes or hypertension not adequately treated or not
             stable

          -  History of cathartic colon, laxative, enema abuse, or ischemic colitis

          -  Fecal impaction within 3 months of screening

          -  Patient has had /has any: diseases or conditions associated with constipation (GI or
             CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor
             dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal
             fissures or any disease or condition that can affect GI motility or defecation or can
             be associated with abdominal pain

          -  Unexplained and clinically significant "alarm symptoms" including lower GI bleeding,
             iron-deficiency anemia, weight loss or systemic signs of infection or colitis

          -  Major surgery, stroke or myocardial infarction (MI) within 60 days of screening

          -  Participated in a previous plecanatide clinical trial
Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Org 50081
Intervention description: One tablet daily
Intervention MeSH terms: Mirtazapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 346.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fifty two weeks; Open label; extension

Summary:

      This trial is a 52-week, open-label extension trial to investigate safety and to explore
      efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706)
      (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol
      P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate
      in Protocol 176004 (P05708) after signing informed consent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  sign written informed consent after the scope and nature of the investigation have
             been explained to them, before any trial-related evaluations;

          -  completed Protocol P05706 or P05707;

          -  Have safety and efficacy assessments conducted per protocol P05706 or P05707.

        Exclusion Criteria:

          -  clinically relevant electrocardiogram (ECG) abnormalities as judged by the
             investigator;

          -  clinically relevant abnormal laboratory values as judged by the investigator;

          -  any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the
             investigator or,

          -  were significantly non compliant with protocol criteria and procedures of Protocol
             P05706 or P05707, as judged by the investigator.
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Intervention: Sufentanil NanoTab PCA System/15 mcg; morphine IV PCA
Intervention description: 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours; 1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours
Intervention MeSH terms: Sufentanil; Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adult post-operative inpatients who; are expected to require parenteral; opioid analgesia for at least 48; hours after open abdominal surgery; or hip/knee replacement surgery

Summary:

      The study is intended to show that the Sufentanil NanoTab PCA System is as effective as
      morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery.
      Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat
      their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients who are 18 years or older

          -  Patients who are scheduled to undergo an open abdominal surgery (including
             laparoscopic-assisted), total knee or total hip replacement surgery under general
             anesthesia or spinal anesthesia that does not include intrathecal opioids during the
             operation.

          -  Post-surgical patients who have been admitted to the PACU and are expected to remain
             hospitalized and to have acute post-operative pain requiring parenteral opioids for at
             least 48 hours after surgery.

        Exclusion Criteria:

          -  Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
             of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
             surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg
             hydrocodone per tablet).

          -  Patients with an allergy or hypersensitivity to opioids

          -  Female patients who are pregnant or breast-feeding