bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Trial of Testosterone Undecanoate
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Intervention: Oral testosterone undecanoate
Intervention description: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: testosterone; male hypogonadism; low testosterone

Summary:

      The purpose of the study is to determine if oral testosterone undecanoate is effective and
      safe in the treatment of low testosterone in men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples
             collected 1 hour apart in the morning between 6:00 and 10:00 AM)

        Exclusion Criteria:

          -  Significant intercurrent disease of any type, in particular liver, kidney,
             uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or
             psychiatric illness including depression.

          -  Recent history of stroke, including transient ischemic attack (TIA) or acute coronary
             event

          -  Untreated, severe obstructive sleep apnea

          -  Hematocrit <35% or >48%

          -  Serum transaminases >2 times upper limit of normal, serum bilirubin >2.0 mg/dL, and
             serum creatinine >2.0 mg/dL

          -  BMI > or equal to 38

          -  Stable doses of lipid-lowering medication for less than three months

          -  Stable doses of oral medication for diabetes for less than two months

          -  Abnormal prostate digital rectal examination [palpable nodule(s)], elevated PSA (serum
             PSA >3.9 ng/mL), IPSS score > or equal to 19 points, and /or history of prostate
             cancer.

          -  History of breast cancer

          -  Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary
             supplements that may increase serum T, such as androstenedione or DHEA with the
             previous 4 weeks

          -  Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors

          -  Known history of abuse of alcohol or any drug substance with the previous 2 years

          -  Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or
             long-acting opioid analgesics

          -  Receipt of any drug as part of a research study within 30 days of initial dose
             administration in this study

          -  Blood donation within the 12 week period before initial dose administration in this
             study
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab; Secukinumab; Placebo
Intervention description: Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio; Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio; Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, secukinumab, self-injection

Summary:

      The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus
      placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration
      with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and
      to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite
      current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.
    

Eligibility criteria:

        Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the
        Modified NY Criteria (1984), inadequate response to NSAIDs.

        Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a
        chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous
        exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell
        depleting therapy.

        Other protocol-defined inclusion/exclusion criteria do apply.
Lidocaine Patches After Cesarean Section
Condition: Postoperative Pain; Obstetric Pain; Opioid Use
MeSH terms: Labor Pain
Intervention: Lidocaine patch
Intervention description: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a prospective randomized non-blinded controlled trial. All cesarean sections for women undergoing their first or second cesarean delivery will be included. Patients will be approached and consented during the pre-operative period when presenting for scheduled surgery or at the time of consent for a non-scheduled cesarean section. The lidocaine patch would be placed on the superior-lateral aspect of the Pfannenstiel incision in the PACU prior to being transferred to the postpartum floor.
Masking: Single (Outcomes Assessor)
Masking description: Outcomes assessor/statistician will not be made aware of the treatment group of the patients.
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Maximum age: 52 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to investigate the impact of using lidocaine patches after cesarean
      section on pain control and opioid use in the immediate post-operative period. The hypothesis
      is the use of lidocaine patches in the immediate post-operative period will lead to a
      decrease in the use of opioids as pain control compared to patients that do not have a
      lidocaine patch in place. Additionally, the a decrease in the visual analog pain score
      compared to women who do not use a lidocaine patch in the immediate post-operative period
      following cesarean delivery is anticipated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Primary or secondary cesarean delivery

          -  Able to consent to research study

        Exclusion Criteria:

          -  3 or more prior cesarean deliveries

          -  History of abdominoplasty

          -  History of abdominal hernia repair with mesh

          -  Allergy to lidocaine

          -  Allergy to adhesives in medical tape

          -  Women who received general anesthesia for their cesarean delivery

          -  Women with active substance abuse

          -  Women methadone or suboxone for a history of opiate abuse
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo
Intervention description: 70 mg/mL pre-filled syringe administered subcutaneously; Matching placebo in pre-filled syringe administered subcutaneously
Intervention MeSH terms: Erenumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 900.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: AMG334; erenumab; episodic migraine; headache; CGRP; Calcitonin Gene-related; migraine; adult

Summary:

      This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic
      migraine
    

Eligibility criteria:

        Key inclusion criteria:

          1. Documented history of migraine in the 12 months prior to screening

          2. 4-14 days per month of migraine symptoms

          3. >=80% diary compliance during the Baseline period

        Key exclusion criteria:

          1. >50 years old at migraine onset

          2. Pregnant or nursing

          3. History of cluster or hemiplegic headache

          4. Evidence of seizure or major psychiatric disorder

          5. Score of 19 or higher on the BDI

          6. Active chronic pain syndrome

          7. Cardiac or hepatic disease
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Plecanatide
Intervention MeSH terms: Plecanatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2370.0
Sex: All
Minimum age: 18 Years
Maximum age: 81 Years
Healthy volunteers: No
Keywords: Plecantaide; Chronic Idiopathic Constipation; Chronic; Idiopathic; Constipation; Synergy; CIC; CIC study; CIC OLE; CIC OLE study; OLE; OLE CIC; OLE CIC3; Open label; Open label study; Long term; Long term study; Extension; Extension study

Summary:

      This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in
      patients with Chronic Idiopathic Constipation (CIC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient completed a previous double-blind plecanatide study and was compliant with the
             study requirements.

          -  Patient is in good health without unstable acute illness or exacerbation of an
             unstable chronic illness or chronic disease that may affect study assessments,
             particularly if there has been a significant change to health status since the
             previous plecanatide study.

        Exclusion Criteria:

          -  Patient has had major surgery including laparoscopic procedures requiring general
             anesthesia within 60 days of Day 1.

          -  Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency
             virus (HIV) infection.

          -  Patient has taken a protocol-prohibited drug without the appropriate washout period.
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.
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Condition: Vaginitis Trichomonal or Due to Trichomonas
MeSH terms: Trichomonas Infections; Trichomonas Vaginitis; Vaginitis
Intervention: MTZ 500 mg twice daily x 7 days; MTZ 2 g
Intervention description: MTZ 500 mg twice daily x 7 days; MTZ 2 g
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: This was an open label study
Enrollment: 623.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Trichomonas vaginalis; metronidazole

Summary:

      The overall goal of this project is to determine the influence of patient treatment and host
      factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women
    

Eligibility criteria:

        Inclusion Criteria:

          -  female

          -  English speaking

          -  >= 18 years old

        Exclusion Criteria:

          -  HIV-infected

          -  unable to provide informed consent

          -  pregnant

          -  breast feeding

          -  treated by their provider for Bacterial vaginosis (BV) at visit
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267; ABT-333; Ribavirin (RBV)
Intervention description: Tablet for oral use; Tablet for oral use; Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1596.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Hepatitis C Genotype 1; Compensated Cirrhosis; Cirrhosis; Naive; Hepatitis C; Hepatitis C Virus; Treatment-Experienced; Relapser; Null responder; Non responder

Summary:

      The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated
      with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without
      ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females at least 18 years old at screening

          2. Females must be post-menopausal for more than 2 years or surgically sterile or
             practicing acceptable forms of birth control

          3. Chronic hepatitis C, genotype 1 infection

          4. Males must be surgically sterile or agree to practice acceptable forms of birth
             control

          5. Screening laboratory result indicating HCV genotype 1 infection

        Exclusion Criteria:

          1. Use of contraindicated medications within 2 weeks of dosing

          2. Abnormal laboratory tests

          3. Current or past clinical evidence of Child-Pugh B or C classification or history of
             liver decompensation

          4. Confirmed presence of hepatocellular carcinoma

          5. History of solid organ transplant
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal Atrophy
Condition: Atrophy
MeSH terms: Atrophy
Intervention: estrace cream (Perrigo); estrace cream (Reference); Placebo cream
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 695.0
Sex: Female
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug
      product in the treatment of vulvar and vaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postmenopausal female and otherwise healthy, 30 - 75 years of age.

          -  ≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.

          -  vaginal pH > 5.0 at Visit 1/Screening

          -  Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal
             Atrophy identified by the subject as being the most bothersome

          -  For women with an intact uterus, vaginal ultrasonography confirmation at Visit
             1/Screening of an inactive endometrial lining with an endometrial thickness less than
             4 mm.

          -  Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no
             greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization

        Exclusion Criteria:

          -  Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial
             cancer.

          -  Known, suspected, or history of cancer of the breast or mammogram indicating any
             abnormalities or subject has a history of cervical cancer.

          -  Vaginal ultrasonography for all women with an intact uterus confirming endometrial
             thickness of 4mm or more

          -  History of hypersensitivity or allergy to estradiol or any of the other study
             medication ingredients.

          -  Known or suspected estrogen-dependent neoplasia.

          -  Has deep vein thrombosis, pulmonary embolism or history of these conditions.

             • Subject has active arterial thromboembolic disease (e. g. stroke, myocardial
             infarction) or history of these conditions.

          -  Known acute or chronic hepatic disease or dysfunction
A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone; Laser Photocoagulation
Intervention description: Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10.; Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 284.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser
      photocoagulation in participants with diabetic macular edema (DME).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of diabetes mellitus (type 1 or type 2)

          -  Presence of macular edema

        Exclusion Criteria:

          -  Anticipated need for ocular surgery in the study eye during the study

          -  Laser photocoagulation in the study eye within 3 months

          -  Cataract surgery within 3 months