bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Condition: HIV-1 Infection
Intervention: ABC/DTG/3TC; B/F/TAF; ABC/DTG/3TC Placebo; B/F/TAF Placebo
Intervention description: 600/50/300 milligrams (mg) tablets administered orally, once daily; 50/200/25 mg tablets administered orally, once daily, without regard to food; Tablets administered orally, once daily; Tablets administered orally, once daily
Intervention MeSH terms: Lamivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 631.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      The primary objective of this study is to evaluate the efficacy of a fixed dose combination
      (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC
      containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral
      treatment naive-adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral
             agent following a diagnosis of HIV-1 infection) except the use for pre-exposure
             prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to
             screening

          -  Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at
             screening

          -  Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per
             minute (mL/min) (≥ 0.83 milliliter per second [mL/sec]) according to the
             Cockcroft-Gault formula

          -  Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by
             Gilead Sciences

        Key Exclusion Criteria:

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening (refer to study protocol)

          -  Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance

          -  Females who are pregnant (as confirmed by positive serum pregnancy test)

          -  Females who are breastfeeding

          -  Chronic Hepatitis B Virus (HBV) infection

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Phase III Study of ASP2151 in Herpes Zoster Patients
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: ASP2151; valaciclovir
Intervention description: 200 mg once daily or 400 mg once daily; 1000 mg three times daily
Intervention MeSH terms: Valacyclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 751.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with
      valaciclovir (VACV) 3000 mg in patients with herpes zoster.
    

Eligibility criteria:

        Inclusion Criteria:

        (1) Patients who have a rash associated with herpes zoster, and who can start receiving the
        study drug within 72 hours after onset of the rash

        Exclusion Criteria:

          1. Patients who are not expected to have an adequate response to oral antiviral
             medication

          2. An extreme decline in immune function

          3. Presence of serious complications

          4. Patients found to meet any of the following conditions based on laboratory tests
             performed within 14 days before informed consent:

               -  AST or ALT ≥ 2.5 x upper limit of normal

               -  Platelet count < lower limit of normal

               -  Serum creatinine ≥ 1.5 mg/dL

               -  Creatinine clearance < 50 mL/min

          5. Current or previous history of malignant tumor within 5 years before informed consent

          6. Diagnosis of autoimmune disease

          7. Evidence of bone marrow suppression
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
Condition: Pediatrics; Muscle Spasticity; Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: Botulinum Toxin Type A
Intervention description: Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 370.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the
      treatment of pediatric lower limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum weight of 10 kilograms (kg)/22 pounds (lb)

          -  Cerebral palsy with dynamic muscle contracture of the ankle

        Exclusion Criteria:

          -  Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
             sclerosis, or mitochondrial disease

          -  Uncontrolled epilepsy

          -  Botulinum Toxin therapy of any serotype for any condition within the last 3 months

          -  History of surgical intervention of the lower study leg within 1 year, or planned
             surgery of any limb during the study
A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: fitusiran; Bypassing agents
Intervention description: solution for injection; by subcutaneous (SC) injection; solution for injection; by intravenous (IV) injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No
Keywords: RNAi therapeutic; Hemophilia A; Hemophilia B; Hemophilia A, Severe; Hemophilia B, Severe; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Factor VIII; Factor IX; Inhibitor; Bypassing agents; Coagulants; Fitusiran

Summary:

      The purpose of this study was to determine the frequency of bleeding episodes in participants
      receiving fitusiran as prophylactic treatment of hemophilia compared to participants who were
      assigned to continue with their regular medication. In addition, the study assessed safety,
      quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males, greater than or equal to (>=) 12 years of age.

          -  Severe hemophilia A or B with inhibitors.

               -  (Severity confirmed by a central laboratory where coagulation factor VIII (FVIII)
                  level was less than (<)1% or factor IX (FIX) level was less than or equal to
                  [<=]2% at Screening; Inhibitors defined as inhibitor titer of >=0.6 Bethesda
                  units per milliliter [BU/mL] or as evidenced by medical records).

          -  A minimum of 6 bleeding episodes requiring BPA treatment within the last 6 months
             prior to screening.

          -  Willing and able to comply with the study requirements and to provide written informed
             consent and assent.

        Exclusion Criteria:

          -  Known co-existing bleeding disorders other than hemophilia A or B.

          -  Antithrombin (AT) activity <60% at Screening.

          -  Co-existing thrombophilic disorder.

          -  Clinically significant liver disease.

          -  Active hepatitis C virus infection.

          -  HIV positive with a cluster of differentiation-4 count of <200 cells/microliter.

          -  History of arterial or venous thromboembolism.

          -  Inadequate renal function.

          -  History of multiple drug allergies or history of allergic reaction to an
             oligonucleotide or N-Acetylgalactosamine.

          -  History of intolerance to SC injection(s).

          -  Any other conditions or comorbidities that would make the participant unsuitable for
             enrollment or could interfere with participation in or completion of the study, per
             Investigator judgement.
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
Condition: Dental Pain
MeSH terms: Pain, Postoperative
Intervention: Diclofenac HPBCD; Diclofenac HPBCD; Diclofenac HPBCD; Placebo s.c.
Intervention description: 1 single injection at day of dental surgical extraction; 1 single injection at day of dental surgical extraction; 1 single injection at day of dental surgical extraction; 1 single injection at day of dental surgical extraction
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The present study is proposed to evaluate the efficacy and safety of single doses of
      Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute
      moderate-to-severe pain after dental impaction surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing surgical extraction of a single fully or partially impacted
             mandibular 3rd molar requiring bone removal.

          -  Patients experiencing moderate to severe post-operative pain within 6 hours from end
             of surgery.

          -  Pre-operative laboratory tests in the reference ranges or without clinically
             significant abnormalities as judged by the Investigator.

        Exclusion Criteria:

          -  Surgery performed under general anaesthesia, or sedation.

          -  Complications occurring during the surgical procedure or in the period before
             randomisation as judged by the investigator.

          -  Acute local or systemic infection at the time of surgery that could confound the
             post-surgical evaluation.

          -  Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other
             GI disturbances or disease that in the opinion of the investigator could be negatively
             affected by the administration of NSAIDs.

          -  Clinical signs or history of coagulation disorders that could be negatively affected
             by NSAIDs administration.

          -  Hepatic or renal impairment.

          -  Patients with significant cardiac impairment, history of cerebrovascular disease,
             history or peripheral arterial disease, uncontrolled hypertension.

          -  Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication
             components.

          -  Patients under chronic treatment with topical or systemic analgesics/NSAIDs.

          -  Patients under treatment with any medication that may affect the treatment efficacy
             evaluation.

          -  Patients under treatment with any medication whose concomitant use may be susceptible
             to interactions with diclofenac or may affect safety.
A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren; Ramipril; Hydrochlorothiazide; Amlodipine
Intervention description: Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning; Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning; Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning; Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Ramipril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 901.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Systolic hypertension; hypertension; aliskiren; blood pressure; ramipril; HTN

Summary:

      Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to
      ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients ≥ 65 years old.

          -  Patients with essential hypertension with an msSBP ≥ 140 mmHg and < 180 mmHg, and
             msDBP < 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative
             Changes document.)

          -  Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the
             visit immediately prior to Visit 3.

          -  Patients who were eligible and able to participate in the study, and who consented to
             do so after the purpose and nature of the investigation had been explained to them
             (written informed consent).

        Exclusion Criteria:

          -  History of renal artery stenosis.

          -  Known Keith-Wagener grade III or IV hypertensive retinopathy.

          -  History of hypertensive encephalopathy.

          -  Current diagnosis of heart failure (New York Heart Association Class III-IV).

          -  History of transient ischemic cerebral attack or cerebrovascular accident within 6
             months.

          -  History of myocardial infarction, bypass surgery, or any percutaneous coronary
             intervention within 6 months.

          -  Current unstable angina pectoris. Patients on a stable dose of oral or topical
             nitrates or beta blockers for angina were acceptable.

          -  Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.

          -  Clinically significant valvular heart disease.

          -  Concurrent use of any antihypersensitive medications except a stable dose 3 months
             prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g.,
             Flomax for BPH), beta blockers for angina, or beta blockers ophthalmic preparations.
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: Econazole Nitrate Cream, 1%; Placebo
Intervention MeSH terms: Econazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 876.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the therapeutic equivalence of the Test formulation, econazole nitrate cream, 1%
      to the Reference product, econazole nitrate cream, 1% in the treatment of tinea pedis.

      To demonstrate the superiority of the Test and Reference (active) treatments over Placebo
      treatment in patients with tinea pedis.

      To compare the safety of Test, Reference and Placebo treatments in patients with tinea pedis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or non-pregnant, non-lactating female ≥ 18 years of age.

          -  Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or
             predominantly interdigital, but may extend to other areas of the foot (the
             non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea
             pedis moccasin).

          -  Provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount
             preparation

          -  Total score ≥ 4 for the clinical signs and symptoms of tinea pedis in the target area.
             In addition the target area must have a minimum score of at least 2 for erythema and a
             minimum score of at least 2 for either pruritus or scaling.

        Exclusion Criteria:

          -  Presence of any other infection of the foot or other disease process that, in the
             Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis

          -  History of or current psoriasis, Lichen planus or contact dermatitis involving the
             feet within the previous 12 months.

          -  Past history of dermatophyte infections with a lack of response to antifungal therapy

          -  Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface or
             onychomycosis involving ≥ 20% of the area of either great toenail and/or involving
             more than five toenails in total or other concurrent dermatophytoses (e.g., tinea
             cruris) and any other skin disease to an extent that, in the opinion of the
             investigator, might interfere with the evaluation of tinea pedis or study results
Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: tadalafil; tadalafil
Intervention description: 20 milligram (mg) tablet, taken by mouth once a day for 52 weeks for the phase 1 portion. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of Pulmonary Arterial Hypertension (PAH).; 40 mg tablet taken by mouth once a day for 52 weeks in phase 1. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of PAH.
Intervention MeSH terms: Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 357.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Study to determine the long term safety of tadalafil in patients with increased blood
      pressure in the blood vessel that carries blood from the right heart to the lungs and to see
      if it will keep the disease from getting worse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have participated and discontinued in the previous PAH placebo controlled study
             due to clinical worsening on placebo or tadalafil 2.5 mg, 10mg, or 20 mg

          -  Must have completed Week 16 of the previous PAH study and had either no clinical
             worsening or became clinically worse at the Week 16 visit on placebo or tadalafil 2.5
             mg, 10mg, or 20 mg

          -  Females who have a negative urine pregnancy test and are willing to use 2 types of
             birth control

          -  Be 12 years or older (country specific regulations apply) with parental approval

        Exclusion Criteria:

          -  Participated in the placebo controlled study and had clinical worsening on 40 mg
             tadalafil

          -  Have left-sided heart disease

          -  Have a musculoskeletal disorder that limits being able to get around

          -  Nitrate use

          -  Certain current systemic treatments
Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain
Condition: Post-operative Dental Pain
MeSH terms: Toothache
Intervention: Test naproxen sodium tablet; Commercial naproxen sodium tablet; Commercial naproxen sodium liquid gels capsule; Placebo tablet
Intervention description: Single dose of 2 test naproxen sodium 220 mg tablets; Single dose of 2 naproxen sodium 220 mg tablets; Single dose of 2 naproxen sodium 220 mg liquid gel capsules; 2 placebo tablets
Intervention MeSH terms: Naproxen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Post-operative dental pain following third molar extraction.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 501.0
Sex: All
Minimum age: 17 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen
      sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial
      naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg
      liquid gels capsules) and placebo in the dental pain model following third-molar extractions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 17 - 50 years old

          2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4
             (inclusive) at screening

          3. Dental extraction of three or four third molars

          4. Meets post-surgical pain

          5. Females of childbearing potential and males agree to contraceptive requirements of
             study

          6. Have a negative urine drug screen at screening, and on day of surgical procedure

        Exclusion Criteria:

          1. Pregnant female, breastfeeding, trying to be pregnant or male with pregnant partner or
             partner currently trying to become pregnant

          2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including
             aspirin, or to acetaminophen, hydrocodone or other opioids

          3. Not able to swallow large tablets or capsules

          4. History of any condition (s) in investigator's opinion, may jeopardize subject safety,
             well-being and integrity of study

          5. Use analgesics 5 or more times per week

          6. History of chronic tranquilizer use, heavy drinking, substance abuse as judged by
             investigator site staff within last 5 years

          7. Use of immunosuppressive drugs within 2 weeks of screening

          8. History of endoscopically documented peptic ulcer disease or bleeding disorder in last
             2 years