bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Diagnostic HIV Ag/Ab Combo Assay
Condition: Human Immunodeficiency Viruses
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: ARCHITECT HIV Ag/Ab Combo; ARCHITECT HIV Ag/Ab Combo
Intervention description: Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.; Test blood samples with investigational HIV assay. If results for specimens from the at risk population are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw when possible.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 635.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To test blood specimens using a new investigational test that detects antigen and antibody to
      human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test
      and supplemental testing performed to determine HIV status.
    

Eligibility criteria:

        Normal Healthy Population:

        Inclusion Criteria:

          -  Apparently healthy individual at the time of enrollment as affirmed by the subject

        Exclusion Criteria:

          -  HIV infection as affirmed by the subject

        Pregnant Female Population at Risk for HIV Infection:

        Inclusion Criteria:

          -  Subject is a pregnant female

          -  Subject has risk factor for HIV infection

        Exclusion Criteria:

          -  HIV infection as affirmed by the subject

        HIV-1 Positive Pregnant Female Subjects

        Inclusion Criteria:

          -  Subject is a pregnant female in first, second, or third trimester

          -  Subject must have documented HIV infection

        Exclusion Criteria:

          -  None

        HIV-1 Positive Pediatric Subjects

        Inclusion Criteria:

          -  Subject must be 2 years to 16 years of age

          -  Subject must have documented HIV infection (e.g., Western blot positive or HIV RNA
             positive/detectable)

        Exclusion Criteria:

          -  None
Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
Condition: Pregnancy
Intervention: DHA; Placebo
Intervention description: Docosahexaenoic Acid (DHA) from algal oil; Placebo capsule
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: Female
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: DHA

Summary:

      DHA, a type of fatty acid, is important in early development, both in terms of reproductive
      physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA
      has been shown to lower triglycerides and is important to cardiovascular health and autonomic
      control, lowering heart rate and blood pressure and increasing heart variability. Little is
      known about how fatty acids impact cardiac control in infants, children or the fetus. Our
      hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase
      fetal HRV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant females 16.0-35.99 years of age who are 12 to 20 weeks gestation at the time
             of enrollment (by dates or ultrasound)

          -  Agree to consume study capsules from enrollment until delivery

          -  BMI <40 at baseline or weight does not exceed 300 pounds

          -  No serious illnesses likely to confound study outcomes

          -  Available by phone

        Exclusion Criteria:

          -  Less than 16 or greater than 35.99 years of age at enrollment

          -  BMI >40 at baseline

          -  Any serious illness likely to confound primary study outcomes

          -  Expecting multiple infants

          -  Diabetes (Type I, II or gestational) at baseline

          -  Elevated blood pressure due to any cause (systolic BP >= 140 mm Hg

          -  Gestational age at baseline < 12 weeks or > 20 weeks

          -  Unable to provide informed consent in English
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.
Condition: Colorectal Cancer
MeSH terms: Neoplasm Metastasis; Colonic Neoplasms
Intervention: Bevacizumab; Fluoropyrimidine-based Chemotherapy
Intervention description: 5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen.; Fluoropyrimidine-based chemotherapy administered according to standard of care.
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5
      mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based
      chemotherapy as first line treatment in participants with metastatic cancer of the colon or
      rectum. The anticipated time on study treatment is 3-12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated metastatic colon or rectal cancer;

          -  Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.

        Exclusion Criteria:

          -  Prior chemotherapy for metastatic colon or rectal cancer;

          -  Planned radiotherapy for underlying disease;

          -  central nervous system metastases;

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             before study start.
Japanese P III vs Voglibose and Placebo
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI 1356; BI 1356; voglibose placebo; BI 1356 placebo; voglibose
Intervention description: 5 mg/daily; 10 mg/daily; three times daily; once daily; 0.6 mg/daily
Intervention MeSH terms: Inositol; Linagliptin; Voglibose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 561.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the efficacy, safety and tolerability of
      Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and
      voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with
      insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension
      treatment to 52 weeks.
    

Eligibility criteria:

        Inclusion criteria:

          1. Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy
             has to be stable for at least 10 weeks before Visit 1.

          2. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week
             placebo run-in phase)

          3. Age: >= 20 and <= 80

          4. Body Mass Index (BMI) <= 40 kg/m2

        Exclusion criteria:

          1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months
             before Visit 1

          2. Impaired hepatic function

          3. History of severe allergy/hypersensitivity

          4. Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1

          5. Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3
A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
Condition: Overactive Bladder; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Intervention: BOTOX®; solifenacin; Botox placebo (normal saline); solifenacin placebo
Intervention description: BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.; Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks.; Botox placebo (normal saline) intradetrusor injection at Day 1.; Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.
Intervention MeSH terms: Solifenacin Succinate; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with
      overactive bladder (OAB) and urinary incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence for
             at least 6 months

          -  Inadequate response or limiting side effects with anticholinergics for the treatment
             of OAB

        Exclusion Criteria:

          -  Overactive Bladder caused by neurological condition

          -  Patient has predominance of stress incontinence

          -  Use of anticholinergics or other medications to treat OAB symptoms in the 7 days prior
             to screening

          -  Previous use of solifenacin

          -  History or evidence of pelvic or urological abnormality

          -  Previous use of any botulinum toxin of any serotype for any urological condition

          -  Previous use of any botulinum toxin of any serotype for any non-urological condition
             within 12 weeks of randomization

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Remdesivir; Standard of Care
Intervention description: Administered as an intravenous infusion; Standard of Care Treatment for COVID-19 Infection
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1113.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV)
      regimens compared to standard of care (SOC), with respect to clinical status assessed by a
      7-point ordinal scale on Day 11.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent prior to performing study
             procedures (participants ≥ 18 years of age) or assent (participants ≥ 12 and < 18
             years of age) prior to performing study procedures. For participants ≥ 12 and < 18
             years of age, a parent or legal guardian willing and able to provide written informed
             consent prior to performing study procedures

          -  Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
             polymerase chain reaction (PCR) test ≤ 4 days before randomization

          -  Currently hospitalized and requiring medical care for COVID-19

          -  Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening

          -  Radiographic evidence of pulmonary infiltrates

        Key Exclusion Criteria:

          -  Participation in any other clinical trial of an experimental treatment for COVID-19

          -  Concurrent treatment or planned concurrent treatment with other agents with actual or
             possible direct acting antiviral activity against SARS-CoV-2

          -  Requiring mechanical ventilation at screening

          -  Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit
             of normal (ULN)

          -  Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥
             18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of
             age

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Leuprorelin; Bicalutamide
Intervention description: Solution for injection; Bicalutamide tablets
Intervention MeSH terms: Bicalutamide; Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: Male
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess two treatment strategies (leuprorelin treatment and
      active surveillance without androgen deprivation) for indolent prostate cancer and to compare
      their therapeutic benefit for management of patients with low-risk, localized prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is an out-patient 50 to 80 years old.

          2. Has read, understood, signed and dated the informed consent.

          3. Has indolent prostate cancer defined by:

               -  Clinical Stage T1c or T2a.

               -  Biopsy cores of which at least 12 reveal the presence of positive cores and the
                  absence of cores with tumor length > 3 mm.

               -  Absence of Grade 4 cells (Gleason <7).

               -  Prostate specific antigen (PSA) levels <10 ng/ml.

          4. Has a life expectancy > 5 years.

          5. Has accepted the principle of active surveillance.

          6. Is willing to participate in the study for a minimum of fifteen months.

        Exclusion Criteria:

          1. Has prior androgen deprivation including a 5-alpha reductase inhibitor (finasteride or
             dutasteride) within the last 6 months.

          2. Has psychological failure related to prostate cancer therapy.

          3. Has any active disorder likely to affect the conduct of the study or the patient's
             prognosis during the study.

          4. Has a mental deficiency or any other reason that may hinder the understanding or
             strict application of the protocol.

          5. Is under judicial protection, tutorship or curatorship.

          6. Is unlikely to attend control visits.

          7. Is currently enrolled in an investigational study or has participated in another
             investigational study within the last 3 months.

          8. Has an allergy or hypersensitivity to any components of leuprorelin (Enantone LP)
             11.25 mg or Casodex® 50 mg.

          9. Has a medical history of severely impaired hepatic function linked to bicalutamide or
             a pathological cause.

         10. Has testosterone level < 0.5 ng/ml.
A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain
Condition: Post Operative Dental Pain
MeSH terms: Toothache
Intervention: Diclofenac potassium; Ibuprofen; Placebo to ibuprofen; Placebo to diclofenac potassium
Intervention description: Single dose of diclofenac 50 mg soft gelatin capsule; Single dose of ibuprofen 400 mg tablet; Single dose of placebo to ibuprofen 400 mg tablet; Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule
Intervention MeSH terms: Ibuprofen; Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diclofenac potassium; Post-operative dental pain; Moderate to severe pain

Summary:

      The study is designed to assess the efficacy and tolerability of diclofenac potassium soft
      gelatin capsules compared with ibuprofen tablets in patients with moderate to severe
      postoperative dental pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients requiring surgical removal of 2 ipsilateral third molars, of which the
             mandibular must be fully or partially impacted. The ipsilateral maxillary third molar
             may be of any impaction level.

          -  Patients having a moderate to severe Baseline pain intensity as assessed by a score of
             2 (moderate) or 3 (severe) on the 4-point categorical pain intensity VRS, confirmed by
             a VASPI score of ≥ 50 mm within 5 hours of surgical completion, after local anesthetic
             dissipation.

        Key Exclusion Criteria:

          -  Patients who require the removal of a single third molar, or 2 ipsilateral third
             molars where mandibular molar is not fully or partially impacted.

          -  Patients with active peptic ulcer disease or a history of significant gastrointestinal
             disease or any gastrointestinal bleeding.

          -  Patients with coagulation or bleeding disorders.

          -  Patients with a positive drug or alcohol screen.

          -  Patients who have received an anti-inflammatory agent, analgesic, sedative, hypnotic,
             muscle relaxant, or tranquilizer within 5 elimination half-lives before administration
             of study drug (other than surgical anesthetic prior to and during dental surgery).
An Implantable Spinal Cord Stimulation Pain Management System
Condition: Chronic Pain; Pain, Intractable; Pain; Back Pain; Failed Back Surgery Syndrome
MeSH terms: Chronic Pain; Failed Back Surgery Syndrome; Pain, Intractable
Intervention: Precision SCS
Intervention description: Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Chronic Pain; Neurostimulation

Summary:

      There are many treatment options available for the management of chronic pain . Some include,
      but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs,
      Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks.
      Historically, the mainstay of pain treatment has been pharmacotherapy. However,
      pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable
      side effects. Although many patients are successfully treated, for those who fail some of
      these more conservative therapies the remaining option is limited to spinal cord stimulation
      (SCS), proven to be an effective therapy to more than half of those failing conservative
      treatments . Over 50% of those who have failed these more conservative methods of pain
      management, can now, under the guidance of a clinician utilizing SCS, have their pain levels
      successfully managed. SCS is a less invasive therapy that is a reversible treatment with
      greater long-term benefits than more permanent, radical approaches and one that deserves
      greater consideration in the management of chronic, intractable pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but
             is not limited to, unilateral or bilateral pain associated with any of the following:
             failed back surgery syndrome, intractable low back pain and leg pain.

          2. Be an appropriate candidate for surgery.

          3. Be capable of giving informed consent.

          4. Be capable and willing to follow all study related procedures.

        Exclusion Criteria:

          1. Have an inability to operate the system either by self or care-giver.

          2. Are currently participating or have participated within the past 30 days in any
             clinical investigation that could conflict with the requirements of this study.

          3. Have any implanted electrical devices, regardless of whether active or inactive.

          4. Have any active implantable device regardless of whether stimulation is ON or OFF.