bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain
Condition: Low Back Pain; Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Intervention: NKTR-181 BID tablets; Placebo to match NKTR-181 BID tablets
Intervention description: NKTR-181 tablets 100-400 mg twice daily (BID); Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1189.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is
      effective for the relief of moderate to severe chronic low back pain as compared to a
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-nursing female aged 18 to 75 years old

          -  Clinical diagnosis of moderate to severe, chronic non-neuropathic low back pain for at
             least six months

          -  Not experiencing adequate pain relief or have failed previous treatment with
             non-opioid analgesics

          -  Opioid analgesia is necessary

          -  Currently taking no more than 10 mg morphine sulfate equivalents per day of short
             acting opioids for 14 days prior to entry

          -  Females of child bearing potential must be using a highly effective form of birth
             control. All subjects must agree to use double-barrier contraception during
             participation in this study and for at least 2 months after the last dose of the study
             drug.

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  Taking extended release or long-acting opioids within 6 months

          -  History of hypersensitivity, intolerance, or allergy to opioids

          -  Compression of spinal nerve root; spinal fracture, tumor, or abscess

          -  Surgical procedures on the low back in the last 12 months or facet nerve root block or
             radiofrequency ablation in the last 3 months

          -  Untreated moderate to severe sleep apnea
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
Condition: Lung Disease
MeSH terms: Lung Diseases
Intervention: Nitric oxide; Placebo
Intervention description: Nitric Oxide vapour (gas) for inhalation (400 ppm); Placebo gas for inhalation
Intervention MeSH terms: Nitric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 800.0
Sex: All
Maximum age: 26 Hours
Healthy volunteers: No
Keywords: Preemie, Inhaled Nitric Oxide

Summary:

      The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to
      reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to
      assess the long-term effects of the therapy on the development of these children over 7 years
      of clinical follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inborn preterm infants 24+0 weeks-28+6 days weeks gestational age (defined by first
             trimester ultrasound or if not available based on the last menstrual period) who
             requires the use of surfactant within 24 hours of birth (either prophylactically, or
             for signs of developing respiratory distress), or who requires the use of continuous
             positive airway pressure (CPAP) (fraction of inspired oxygen concentration (FiO2) ≥
             0.30 on a mean airway pressure ≥ 4cm water (H2O)) within 24 hours of birth in order to
             maintain an oxygen saturation (SpO2) ≥ 85%.

          -  Informed consent of the guardian.

        Exclusion Criteria:

          -  Outborn infants.

          -  Infants ≥ 29 weeks gestational age.

          -  Infants requiring FiO2 >0.5 to maintain SpO2 >85%, on a sufficient mean airway
             pressure (e.g., > 8 cm H2O on controlled mechanical ventilation (CMV)) in order to
             achieve adequate chest inflation (8-9 ribs on Chest X-ray) two hours after the proper
             administration of exogenous surfactant.

          -  Any suspected congenital heart disease other than patent ductus arteriosus or atrial
             septal defect.

          -  Any infant with severe bleeding or coagulation abnormalities at high-risk of
             diathesis, e.g., platelet <50,000 per millimeter cube (mm³), fibrinogen <0.5 gram per
             liter (g/L), other clotting factors <10%.

          -  Any infant in whom a decision has been made not to provide full treatment, e.g.,
             chromosomal abnormalities, severe multiple abnormalities, severe birth asphyxia, etc.

          -  Use of another investigational drug or device before or during the active study
             period.
A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Oxybutynin topical gel; Placebo topical gel
Intervention description: 1 application daily to skin for 12 weeks; 1 application daily to skin for 12 weeks
Intervention MeSH terms: Mandelic Acids; Oxybutynin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 789.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OAB, anticholineric, oxybutynin, urge urinary incontinence

Summary:

      A new drug for overactive bladder is compared to placebo to determine if it is safe and
      effective. The study lasts approximately 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females and males, 18 years of older with overactive bladder symptoms

        Exclusion Criteria:

          -  Treatable conditions that may cause urinary incontinence

          -  Medical conditions in which it would be unsafe to use an anti-cholinergic agent.

          -  The use of concomitant drugs that would confound the efficacy evaluation.

          -  The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.
A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
Condition: Dementia With Lewy Bodies (DLB)
MeSH terms: Dementia; Lewy Body Disease
Intervention: Donepezil 5 mg; Donepezil 10 mg; Donepezil matched placebo
Intervention description: Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg; Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Intervention MeSH terms: Donepezil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: DLB; Dementia with Lewy bodies; Lewy Body Disease; Dementia; E2020; Donepezil; Aricept

Summary:

      The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with
      Lewy bodies (DLB).
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the
             consensus diagnostic criteria for DLB

          2. Patients having caregivers throughout the study who submited written consent to
             cooperate with this study, who routinely stayed with patients 3 days or more a week
             (at least 4 hours a day), provided patients' information necessary for this study,
             assisted treatment compliance, and escorted the patients on required visits to study
             institution

          3. Clinical Dementia Rating (CDR) score ≥ 0.5

          4. Mini-Mental State Examination (MMSE) score of 10 to 26

        Exclusion Criteria

          1. Patients diagnosed with Parkinson's disease with dementia (PDD)

          2. Patients who received anti-dementia drug therapy at the same institution

          3. Patients who received anti-dementia drug therapy within 12 weeks before start of
             Screening

          4. Patients with a complication of serious neuropsychiatric disease(s) such as stroke,
             brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental
             retardation, brain trauma with unconsciousness, or a history of brain surgery causing
             unrecovered deficiency

          5. Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)

          6. Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less
             than 50 bpm at screening
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
Condition: Coronary Artery Disease; Sternal Pain
MeSH terms: Coronary Artery Disease
Intervention: Bupivacaine Group; Placebo
Intervention description: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).; 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiopulmonary Bypass; Cardiac Surgery; Sternotomy

Summary:

      The purpose of this study is to determine whether administration of a pecto-intercostal
      fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative
      analgesia after cardiac surgery as compared to patients who receive a sham block of normal
      saline.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients 18 years of age or older

          -  Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and
             isolated valve surgeries.

        Exclusion Criteria

          -  Current participation in another interventional study

          -  Preoperative LVEF < 30%

          -  Use of mechanical circulatory support

          -  Emergent procedures

          -  Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts

          -  Minimally invasive cardiac procedures or those with thoracotomy approach

          -  Patients receiving other modalities of regional anesthesia like intrathecal morphine

          -  Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an
             opioid at or more than 30 mg morphine equivalent for more than one month within the
             past year)

          -  Current use of TCA, gabapentin, or pregabalin

          -  Hypersensitivity to bupivacaine

          -  Women who are pregnant or breastfeeding

          -  Non English speaking
Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Memantine
Intervention description: 20 mg oral tablets once daily
Intervention MeSH terms: Memantine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 297.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease

Summary:

      The primary objective of the study was to examine the safety and tolerability of memantine in
      outpatients with moderate to severe Alzheimer's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory outpatients with moderate to severe dementia of the Alzheimer's type who
             have completed the 24-week Study 10158 and who have a knowledgeable and reliable
             caregiver who will accompany the patient to all clinic visits during the course of the
             study.

        Exclusion Criteria:

          -  Diseases/medication which judged by the investigator could interfere with the
             assessments of safety, tolerability or efficacy.
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: GDC-229; Metronidazole Vaginal Gel 0.75%; Placebo
Intervention description: GDC-229 is a vaginal gel.; Metronidazole Vaginal Gel 0.75% is an FDA-approved drug; Inactive arm of the study
Intervention MeSH terms: Metronidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 871.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bacterial vaginosis; vaginal infection; BV

Summary:

      This research study is being done to compare the safety and efficacy of GDC-229 (test drug)
      against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to
      establish that these two drugs work better than placebo in subjects with BV.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Non-pregnant female aged ≥ 18 years who is in good general health

          2. Diagnosis of BV

          3. Willing to refrain from using any intravaginal product (e.g., spermicide, tampon,
             douche, feminine deodorant spray, diaphragm, vaginal ring birth control, or condom
             with spermicide or insertion into the vagina of any drug or non-drug product during
             treatment), other than study treatment for the duration of the trial

          4. Subjects of childbearing potential who have a negative urine pregnancy test at the
             Entry Visit (Visit 1) and agree to use an acceptable form of birth control throughout
             the study

          5. Able to understand and willing to sign the informed consent form (ICF) and able to
             comply with the requirements of the protocol

        Exclusion Criteria:

          1. History of alcohol or substance abuse

          2. Experienced a clinically significant medical event within 90 days

          3. Abnormal pap or high risk human papillomavirus (HPV)

          4. History or presence of clinically significant central nervous system (CNS),
             cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine,
             immunologic, gynecologic, dermatologic, neurologic, oncologic, or psychiatric disease

          5. Pregnant, lactating, or planning to become pregnant or breastfeed during the study
             period

          6. Primary or secondary immunodeficiency

          7. Evidence of any vulvovaginitis at screening other than BV

          8. History of hypersensitivity or allergy to metronidazole, parabens, other
             nitroimidazole derivatives, or other ingredients of the GDC 229 (metronidazole 0.75%
             vaginal gel), metronidazole 0.75% vaginal gel (Oceanside Pharmaceuticals), or vehicle
             gel

          9. Participating in another clinical trial
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally once daily; Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 4 (GT-4); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; GS-5885; Ribavirin; Sofosbuvir; ledipasvir; Hepatitis C; Hepatitis C, Chronic; Liver Diseases; Virus Diseases; Antiviral Agents

Summary:

      The primary objective of this study was to evaluate the efficacy, safety, and tolerability of
      ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV)
      in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy

          -  HCV genotype 4 at screening

          -  HCV treatment naive or prior participation in this study or study GS-US-334-0138
             (Cohorts 1 and 2 only)

          -  Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV
             infection with an interferon (IFN)-containing regimen, with or without RBV and/or an
             HCV NS3/NS4A protease inhibitor (PI)

          -  Body mass index (BMI) ≥ 18 kg/m^2

          -  Screening laboratory values within defined thresholds

          -  Use of effective protocol-approved contraception methods

        Key Exclusion Criteria:

          -  History of clinically-significant illness or any other major medical disorder that may
             interfere with treatment, assessment or compliance with the protocol

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Pregnant or nursing females or male with pregnant female partner

          -  Clinically-relevant drug or alcohol abuse within 12 months of screening

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Coinfection; Hepatitis
Intervention: SOF/VEL
Intervention description: 400/100 mg fixed-dose combination (FDC) tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety and tolerability of
      treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV
      infection who were coinfected with HIV-1.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  HCV genotype 1, 2, 3, 4, 5, 6

          -  Cirrhosis determination, a fibroscan or liver biopsy may be required

          -  HIV-1 infection

          -  Use of protocol specified method(s) of contraception

          -  Screening laboratory values within defined thresholds

        Key Exclusion Criteria:

          -  Clinically-significant illness (other than HCV or HIV) or any other major medical
             disorder that may interfere with individual's treatment, assessment or compliance with
             the protocol

          -  Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma
             (HCC) or other malignancy (with the exception of certain resolved skin cancers)

          -  Screening ECG with clinically significant abnormalities

          -  Pregnant or nursing female or male with pregnant female partner

          -  Infection with hepatitis B virus (HBV)

          -  Use of any prohibited concomitant medications as described in the protocol

          -  Chronic use of systemically administered immunosuppressive agents

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: T-614; Placebo
Intervention description: T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.; Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 253.0
Sex: All
Minimum age: 20 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when
      added to ongoing, stable-dose methotrexate therapy in patients with persistently active
      rheumatoid arthritis
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria

          -  Age greater or 20 years and less than 70 years old

        Exclusion criteria:

          -  Subject who is considered by the investigator, for any reason, to be an unsuitable
             candidate for the study

          -  Women of childbearing potential who are not practicing a successful method of
             contraception, or wish to become pregnant
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Timolol; latanoprost
Intervention description: Timolol 0.5% dosed twice-daily; Latanoprost 0.005% ophthalmic solution dosed once-daily
Intervention MeSH terms: Timolol; Latanoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 36 Weeks
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and
      timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are
      diagnosed with glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of 18 years of age or under

          -  Diagnosis of glaucoma

          -  IOP of 22 mmHg or above in at least 1 eye

        Exclusion Criteria:

          -  Require surgery for acute angle closure

          -  Have had prior cyclodestructive procedures

          -  Have a history of ocular trauma or surgery in either eye within 3 months of the
             baseline visit