bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: olanzapine; haloperidol; placebo
Intervention description: 5-20 mg, oral, once daily (evening), for 6 weeks; 2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.; placebo, oral tablets, twice daily (morning and evening), for 3 weeks
Intervention MeSH terms: Haloperidol; Olanzapine; Haloperidol decanoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Manic or mixed episode associated with bipolar I disorder

Summary:

      The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic
      or mixed symptoms associated with bipolar I disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet the criteria for manic or mixed episodes according to the Diagnostic and
             Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and
             have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x
             Bipolar I Disorder, Most Recent Episode Mixed".

          -  Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1
             and Visit 2.

        Exclusion Criteria:

          -  Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.

          -  The duration of the current episode is more than 90 days at Visit 1.

          -  Have a history or a diagnosis of diabetes mellitus.

          -  Have received any psychotropic medication within 2 days prior to Visit 2 (except for
             benzodiazepines).
Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 862.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug known as
      galcanezumab in participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of episodic migraine as defined by International Headache Society
             (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1
             or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior
             to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 Migraine
             Headache Days (MHD).

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to Galcanezumab or another CGRP antibody.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to Galcanezumab.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267, ABT-333; Ribavirin; Placebo for ABT-450/r/ABT-267; Placebo for ABT-333; Placebo for ribavirin
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Capsule (double-blind treatment period), tablet (open-label treatment period); Tablet; Tablet; Capsule
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C; Treatment-Experienced; Null responder; Partial Responder; Chronic Hepatitis; Hepatitis C Genotype 1; Interferon-Free; Hepatitis C Virus; Relapser; Non responder; Viekira Pak; ombitasvir; ribavirin; ritonavir; paritaprevir; dasabuvir

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and
      ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as
      dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected
      treatment-experienced adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be post-menopausal for at least 2 years or surgically sterile or
             practicing specific forms of birth control.

          -  Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL
             at screening.

          -  Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).

          -  No evidence of liver cirrhosis.

        Exclusion Criteria:

          -  Positive screen for drugs or alcohol.

          -  Significant sensitivity to any drug.

          -  Use of contraindicated medications within 2 weeks of dosing.

          -  Certain predefined abnormal laboratory tests.

          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
Insomnia and Drug Relapse Risk
Condition: Poor Quality Sleep; Opiate Addiction
MeSH terms: Opioid-Related Disorders
Intervention: Trazodone; Placebo
Intervention description: 50 mg 1-3 capsules at bedtime for 3 months; 1-3 at bedtime
Intervention MeSH terms: Trazodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: sleep quality; methadone; substance use

Summary:

      The purposes of this study are:

        1. to evaluate the relationship between subjective complaints of sleep and objective
           measures of sleep quality, as measured through polysomnography, and

        2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in
           methadone maintenance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent methadone maintenance enrollment

          -  Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)

          -  No medical contraindications to trazodone

        Exclusion Criteria:

          -  Methadone maintenance enrollment not recent

          -  No sleep complaints as measured by the PSQI

          -  Medical contraindications to trazodone
A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: TRV130
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 768.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with moderate to severe pain caused by medical conditions or surgery, who require IV
      opioid therapy may be enrolled in this open label safety study. Patients will be treated with
      TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined
      by the investigator, for a duration not to exceed 14 days.
    

Eligibility criteria:

        Inclusion Criteria include:

          -  Moderate to severe acute pain for which parenteral opioid therapy is warranted

          -  Able to understand and comply with the procedures and study requirements, and to
             provide written informed consent before any study procedure.

        Exclusion Criteria include:

          -  Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse
             condition or history of such condition that would confound the interpretation of
             safety, tolerability, or efficacy data in the study.

          -  Hemodynamic instability or respiratory insufficiency.

          -  Advanced cancer in palliative or end-of-life care.

          -  Another current painful condition (other than acute pain for which parenteral opioid
             therapy is warranted) that would confound the interpretation of safety, tolerability,
             or efficacy data in the study.

          -  Clinically significant, immune-mediated hypersensitivity reaction to opioids.
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
Condition: Sexual Dysfunction, Physiological
MeSH terms: Premature Birth; Premature Ejaculation; Sexual Dysfunction, Physiological
Intervention: Dapoxetine
Intervention description: Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity, may be increased after 4 weeks to 60mg, taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 285.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sexual Dysfunction, physiological; R096769; Dapoxetine; Phase 3b; Premature Ejaculation

Summary:

      The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a
      setting similar to routine clinical practice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be heterosexual males and in a stable monogamous, sexual
             relationship with a female partner for at least 6 months

          -  must score =11 in the Premature Ejaculation Diagnostic Tool (PEDT)

          -  Must have a self-estimated intravaginal ejaculatory latency time (IELT) of = 2 minutes

          -  Must have an International Index of Erectile Dysfunction (IIEF) score a total of > or
             = to 21 in 6 questions from the IIEF used to assess for the absence of moderate to
             severe erectile dysfunction (ED)

          -  Premature ejaculation is not exclusively due to the direct effects of a substance
             (e.g., withdrawal from opioids)

          -  Must be in good general health with no clinically significant abnormalities as
             determined by medical history, physical examination, and clinical lab results

          -  Must have a blood pressure =180 mmHg systolic and =100 mmHg diastolic at screening and
             at the baseline visit

          -  Patient's partner must not be pregnant at screening as pregnancy might affect sexual
             activity

          -  Participants and partners must agree to attempt sexual intercourse at least 2 times
             (with a minimum of 24 hours between each event) during the 2-week baseline period and
             at least 4 times per month during the remainder of the study.

        Exclusion Criteria:

          -  History of or current major psychiatric disorder such as mood disorder, anxiety
             disorder, schizophrenia, mania, suicidal ideation, other psychotic disorder

          -  History of alcohol abuse and dependence, non-alcohol psychoactive substance use
             disorder (except for caffeine or nicotine/tobacco)

          -  Suspected history of illicit or recreational drug use

          -  Known history of moderate to severe renal impairment
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Glycopyrronium bromide; Placebo
Intervention description: Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI); Placebo inhalation capsules were provided for use via a SDDPI
Intervention MeSH terms: Glycopyrrolate; Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1324.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; NVA; FEV1

Summary:

      A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients
      with moderate-to-severe chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

        1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic
        Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

          -  Smoking history of at least 10 pack-years

          -  Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value

          -  Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

        Exclusion Criteria:

          1. Patients who have had a lower respiratory tract infection within 6 weeks prior to
             Visit 1

          2. Patients with concomitant pulmonary disease

          3. Patients with a history of asthma

          4. Any patient with lung cancer or a history of lung cancer

          5. Patients with a history of certain cardiovascular comorbid conditions

          6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

          7. Patients in the active phase of a supervised pulmonary rehabilitation program

          8. Patients contraindicated for tiotropium or ipratropium treatment or who have shown an
             untoward reaction to inhaled anticholinergic agents Other protocol-defined
             inclusion/exclusion criteria may apply
3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection
Condition: Hepatitis C
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis
Intervention: No treatment
Intervention description: No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen.
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C; Hepatitis; TMC435; Liver disease; Virus Infection

Summary:

      The purpose of this study is to investigate durability of SVR in chronic HCV patients who
      achieved SVR in the previous study with TMC435-containing regimen and time for resistance
      associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in
      the previous study with TMC435-containing regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have previously participated in a Phase IIb or Phase III study

          -  Must have received at least one dose of TMC435 in that study

          -  Has completed the last post-therapy follow-up visit of the previous (LPVPS) study

        Exclusion Criteria:

          -  Must be currently enrolled or plan to enroll in another study with an investigational
             drug or invasive investigational medical device

          -  Have received antiviral or immunomodulating treatment, including therapeutic vaccines,
             for hepatitis C virus (HCV) between LPVPS and the screening visit of present study
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
Condition: Menopause
MeSH terms: Atrophy
Intervention: DR-2041a; DR-2041b; Placebo; Placebo
Intervention description: 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter; 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter; 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter; 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP); Estrogens, conjugated synthetic A
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 622.0
Sex: Female
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: vaginal atrophy; vaginal dryness; vaginal itching; vaginal pain

Summary:

      This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to
      compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream
      on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or
      oophorectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naturally or surgically menopausal

          -  Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain,
             uncomfortable intercourse)

        Exclusion Criteria:

          -  Known sensitivity or contraindication to estrogens or progestins

          -  History or current diagnosis endometrial hyperplasia

          -  Recent history of vaginal bleeding of unknown cause

          -  Recent history or diagnosis of endometriosis

          -  Any contraindication to estrogen therapy
Intraoperative Trocar Slippage Study
Condition: Trocar Slippage
Intervention: LaproStop
Intervention description: One of the subject's trocars will be randomized to be used with a LaproStop device.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to find out how much a trocar might slide during a typical
      laparoscopic hysterectomy. We also want to find out if there is a difference between how much
      three commonly used trocars slide and if a device called LaproStop has an effect on the
      slippage.

      Patients will be randomly assigned into the different trocar groups. After this assignment
      has been made, we will then assign the Laprostop to one of the two trocars by chance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing a hysterectomy at Brigham and Women's Hospital and Faulkner Hospital.

        Exclusion Criteria:
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
Condition: Proctitis; Proctosigmoiditis
MeSH terms: Proctitis; Proctocolitis; Ulcer
Intervention: Budesonide Foam
Intervention description: Topical
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-label; Proctitis; Proctosigmoiditis; Ulcerative; Salix; Budesonide foam; Budesonide; Rectal; Gastrointestinal; Colitis; UC; UP; UPS; Additional relevant MeSH terms:; Proctocolitis; Ulcer; Colitis, Ulcerative; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Intestinal Diseases; Colonic Diseases; Sigmoid Diseases; Pathologic Processes; Inflammatory Bowel Diseases; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses; Glucocorticoids; Hormones; Hormones, Hormone Substitutes and Hormone Antagonists; Anti-inflammatory Agents

Summary:

      The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal
      budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative
      proctosigmoiditis (UPS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-breast-feeding females ≥18 years old.

          -  Participant was previously diagnosed with active mild to moderate UP/UPS and was
             currently experiencing symptoms of active UP/UPS disease after having completed
             participation in Salix's BUCF3001 (NCT01008410) or BUCF3002 (NCT01008423) study.

          -  Willingness to undergo sigmoidoscopy.

        Exclusion Criteria:

          -  Active systemic, ocular, or cutaneous infection (for example, parasitic, fungal,
             amoebic, viral, or bacterial disease).

          -  History of sclerosing cholangitis, cirrhosis, or hepatic impairment, including chronic
             hepatitis of any etiology.

          -  Participant took systemic, inhaled, oral, topical, or rectal corticosteroids (other
             than budesonide rectal foam) within 7 days of starting a treatment cycle.

          -  Participant took ketoconazole and other potent CYP3A4 inhibitors within 7 days of
             starting a treatment cycle.

          -  Participant took diuretics with cardiac glycosides.

          -  Unstable significant cardiovascular, hepatic, renal, endocrine, neurologic, or
             pulmonary disease.