bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
Condition: Thyroid Neoplasm; Goiter
MeSH terms: Thyroid Neoplasms
Intervention: Ropivacaine with epinephrine injection; Placebo
Intervention description: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection for the experiment group.; 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.
Intervention MeSH terms: Epinephrine; Racepinephrine; Ropivacaine; Epinephryl borate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ropivacaine; Epinephrine; Endoscopy; Robotics; Thyroidectomy

Summary:

      To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in
      BABA endoscopic and robotic thyroidectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of thyroid neoplasm or benign goiter

          -  Scheduled for BABA endoscopic or robotic thyroidectomy

        Exclusion Criteria:

          -  Completion thyroidectomy

          -  Modified radical neck dissection

          -  Allergy history

          -  Stroke history

          -  Uncontrolled hypertension

          -  Uncontrolled diabetes

          -  Coagulopathy

          -  Severe cardiovascular disease

          -  Severe pulmonary disease

          -  Chronic kidney disease

          -  Pregnant
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Condition: Meconium Aspiration
MeSH terms: Meconium Aspiration Syndrome
Intervention: Lucinactant; Standard Care
Intervention description: Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other.; The Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC
Intervention MeSH terms: Pulmonary Surfactants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Maximum age: 48 Hours
Healthy volunteers: No
Keywords: cardiovascular and respiratory diseases; meconium aspiration syndrome; rare disease

Summary:

      OBJECTIVES:

      Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL)
      in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of meconium aspiration syndrome (MAS)

          -  Continuous mechanical ventilation (CMV) at time of entry

          -  Enrollment within 48 hours of birth

          -  Gestational age of ≥ 37 weeks

          -  Oxygenation index of ≥ 5 and ≤ 30

          -  Written informed consent signed and dated by the infant's parent(s) or legal
             guardian(s)

        Exclusion Criteria:

          -  Congenital anomalies likely to affect any primary or secondary endpoints

          -  Uncontrollable air leaks

          -  Hydrops fetalis

          -  Rupture ≥ 3 weeks of the fetal membranes

          -  Evidence of overwhelming bacterial infection at time of randomization

          -  Markedly labile persistent pulmonary hypertension at time of randomization

          -  Profound neurologic manifestations

          -  Sustained postductal SpO₂of < 87% for ≥ 15 minutes at an FiO₂of 1.00
Dysport® Adult Upper Limb Spasticity
Condition: Nervous System Disorders
MeSH terms: Nervous System Diseases
Intervention: Botulinum toxin type A; Botulinum toxin type A; Placebo
Intervention description: 500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.; 1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.; I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to assess the efficacy of Dysport compared to placebo
      in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or
      traumatic brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients - post stroke or brain injury

          -  Modified Ashworth Scale ≥ 2

          -  Ambulatory patients

        Exclusion Criteria:

          -  Previous treatment with botulinum toxin of any type within 4 months prior to study
             entry for any condition

          -  Physiotherapy initiated less than 4 weeks before inclusion

          -  Previous surgery, alcohol, phenol in upper limb

          -  Neurological/neuromuscular disorders which may interfere with protocol evaluations
Clinical Trial in Females for Female Pattern Hair Loss
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: 5% Minoxidil Topical Foam; Vehicle Topical Foam
Intervention description: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks; Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks
Intervention MeSH terms: Minoxidil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 404.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Female Pattern Baldness

Summary:

      This is a six month clinical trial to evaluate the effectiveness and safety in women with
      Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation
      applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  females, age 18 or older in general good health

          -  exhibits female pattern hair loss

          -  signs and dates an informed consent document

          -  agrees to use an adequate method of birth control; if of childbearing potential

          -  shows a negative urine pregnancy test at Screening Visit

          -  is willing to maintain the same hair style, hair color, and hair regimen throughout
             the study

          -  is willing and able to comply with scheduled visits, treatment plan, laboratory tests
             and other trial procedures

        Exclusion Criteria:

          -  hypersensitivity to the (study product), or any ingredients of the (study product)

          -  known allergy to hair dye, or hair dye components

          -  clinically relevant history of hypotension

          -  untreated or uncontrolled hypertension

          -  pregnant, planning a pregnancy or nursing a child

          -  history of hair transplants

          -  currently use hair weaves or non-breathable wigs

          -  dermatologic disorders of the scalp that require chronic use of medication for control

          -  other types or history of hair loss

          -  enrolled in any other investigational medication (drug) study currently, or within the
             last 6 months
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
Condition: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Evolocumab; Atorvastatin; Placebo
Intervention description: Administered by subcutaneous injection; Administered orally once a day; Placebo to evolocumab administered by subcutaneous injection
Intervention MeSH terms: Atorvastatin; Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 986.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous
      evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from
      baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with
      hyperlipidemia or mixed dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females with type 2 diabetes (receiving pharmacologic treatment for at least
             6 months or longer) with stable diabetes therapy

          -  Lipid-lowering therapy must be unchanged for at least 4 weeks or more

          -  Subjects receiving statin therapy at screening must have a fasting LDL-C of greater
             than or equal to 100 mg/dL

          -  Subjects not receiving statin therapy at screening must have a fasting LDL-C of
             greater than or equal to 130 mg/dL

        Exclusion criteria:

          -  New York Heart Association (NYHA) class III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Type 1 diabetes or poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism.
Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: adalimumab; placebo
Intervention description: Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week; Prefilled syringe, matching placebo administered subcutaneously every other week
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: ankylosing spondylitis; China

Summary:

      Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese
      participants with ankylosing spondylitis (AS) who have had an inadequate response to or who
      are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 65 years

          -  Has a diagnosis of ankylosing spondylitis (AS) based on the Modified New York Criteria

          -  Has active AS, as defined by fulfillment of at least 2 of the following 3 conditions
             at both Screening and Baseline visits:

               -  BASDAI score at least 4 cm

               -  Total back pain on a visual analog scale (VAS) at least 40 mm

               -  Morning stiffness at least 1 hr

          -  Has inadequate response to or intolerance to one or more non-steroidal
             anti-inflammatory drugs (NSAIDs) as defined by the Investigator

        Exclusion Criteria:

          -  Has total spinal ankylosis (bamboo spine)

          -  Has undergone spinal surgery or joint surgery involving joints assessed within 2
             months prior to Baseline

          -  Has extra-articular manifestations (i.e., psoriasis, uveitis, inflammatory bowel
             disease) that is not clinically stable, as defined by the Investigator's best clinical
             judgment, for at least 28 days prior to Baseline

          -  Has received intra-articular joint injection(s), spinal or paraspinal injection(s)
             with corticosteroids within 28 days prior to Baseline

          -  Has prior exposure to any biologic therapy with potential therapeutic impact on AS,
             including anti-TNF (tumor necrosis factor) therapy
Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Intervention: beta blockers; amiodarone; ascorbic acid
Intervention description: metoprolol 25mg by mouth every 6 hours; amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively; ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days
Intervention MeSH terms: Ascorbic Acid; Amiodarone; Metoprolol; Adrenergic beta-Antagonists
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; cardiac surgery; open heart surgery

Summary:

      Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring
      in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart
      valve repair/replacement patients. Efforts to decrease the high rates of AF have not made
      great inroads to the problem. The current standard of care is the use of preoperative and
      postoperative beta blockers. We propose to compare the use of prophylactic oral ascorbic acid
      with and without prophylactic oral amiodarone, in combination with oral beta blockers, for
      the prevention of atrial fibrillation after open heart surgery. The hypothesis is that either
      drug, or a combination of the two drugs, will be superior and safe when compared to beta
      blockers alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults (18 years of age or older)

          -  all comers for elective or urgent open heart surgery ( CABG, Valve repair or
             replacement, Combined CABG/Valves, CABG/other, Other)

        Exclusion Criteria:

          -  patients who refuse to participate

          -  patients with a history of atrial fibrillation or atrial flutter

          -  pediatric patients (under 18 years of age)

          -  Emergency surgery

          -  patients with contraindications to study medications

          -  patients with untreated thyroid disease, hepatic failure, pregnancy
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
Condition: HIV-1 Infection
Intervention: B/F/TAF
Intervention description: 50/200/25 mg FDC tablet administered orally once daily without regard to food.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to characterize the virologic efficacy of switching
      virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir
      alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil
      fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide
      (B/F/TAF) FDC.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine
             [FTC]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826
             [NCT02616783]) for ≥ 3 months

          -  Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with
             E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study
             GS-US-292-1826 [NCT02616783]) for the last 2 visits preceding the screening visit (or
             undetectable HIV-1 RNA level according to the local assay being used if the limit of
             detection is ≥ 50 copies/mL)

          -  Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
             according to the Cockcroft-Gault formula for creatinine clearance

        Key Exclusion Criteria:

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening

          -  Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)

          -  Current alcohol or substance use judged by the investigator to potentially interfere
             with participant study compliance

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: TMC435; Peginterferon alfa-2b (pegIFN alfa-2b); Ribavirin (RBV)
Intervention description: 100 mg capsule taken by mouth once daily for 12 weeks; PegIFN alfa-2b will be supplied as a vial containing dried and frozen powder with 74,148 or 222 mcg pegIFN alpha-2b attached to 0.7 ml injection water (50, 100 or 150 mcg/0.5mL pegIFN alpha-2b) and will be administered according to the manufacturer's prescribing information as 1.5 mcg/kg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks.; The dose of RBV given will be based on body weight. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 capsules of 200 mg) after breakfast and 600 mg (3 capsules of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 capsules of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 capsule of 200 mg) after breakfast and 400 mg (2 capsules of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; TMC435; Hepatitis C; Hepatitis C virus; Interferon Alfa-2b; Ribavirin; Viral ribonucleic acid

Summary:

      The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination
      with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus
      (HCV)-infected participants who are treatment-naive or treatment-experienced (prior relapser
      or non-responder to Interferon-based therapy) in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have chronic genotype 1 HCV infection with HCV RNA level >= 5.0 log10
             IU/mL

          -  Patient has never received treatment for HCV (treatment-naive), relapsed after
             previous IFN-based therapy (prior relapser) or failed to respond to previous IFN-based
             therapy (non-responder)

          -  Patient must be willing to use contraceptive measures from the time of informed
             consent to 6 months after last dose of study medication.

        Exclusion Criteria:

          -  Co-infection with any other HCV genotype or co-infection with the human
             immunodeficiency virus (HIV)

          -  Diagnosed with hepatic cirrhosis or hepatic failure

          -  A medical condition which is a contraindication to peg-IFN or ribavirin therapy

          -  History of, or any current medical condition, which could impact the safety of the
             patient in the study
AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: bevacizumab [Avastin]; cisplatin; pemetrexed
Intervention description: 7.5mg/kg iv on day 1 of each 3-week cycle; 75mg/m2 iv on day 1 of each 3-week cycle; 500mg/m2 iv on day 1 of each 3-week cycle
Intervention MeSH terms: Bevacizumab; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label study will assess the efficacy and safety of Avastin with or without
      pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent
      non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with
      Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of
      each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive
      further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed
      (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease
      progression. Target sample size is <500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults >/=18 years of age

          -  inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung
             cancer (NSCLC)

          -  at least 1 measurable lesion meeting RECIST criteria

          -  ECOG performance status 0-2

          -  adequate hematological, liver and renal function

        Exclusion Criteria:

          -  prior chemotherapy or treatment with another systemic anti-cancer agent

          -  malignancies other than NSCLC within 5 years prior to randomization, except for
             adequately treated carcinoma in situ of the cervix, basal or squamous cell skin
             cancer, localized prostate cancer or DCIS

          -  evidence of tumor invading major blood vessels

          -  current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or
             thrombolytic agents for therapeutic purposes

          -  history of haemoptysis >/=grade 2

          -  clinically significant cardiovascular disease