bioihbjkbjnl/mcl2 huggingface dataset:
Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy
Condition: Malignant Head and Neck Neoplasm; Mucositis; Radiation-Induced Disorder
MeSH terms: Head and Neck Neoplasms; Mucositis
Intervention: Educational Intervention; Gabapentin; Pain Therapy; Quality-of-Life Assessment; Questionnaire Administration; Oxycodone/Acetaminophen; Hydrocodone/Acetaminophen; Fentanyl; Ibuprofen; Magic Mouthwash
Intervention description: Undergo oral care and pain management education session; Given PO; Receive usual oral health care; Ancillary studies; Ancillary studies; Analgesia; Analgesia; Transdermal Analgesia; NSAID Analgesia; Oral Solution to treat mucositis
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Fentanyl; Oxycodone; Hydrocodone; Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well gabapentin plus standard of care work
      compares to standard of care without Gabapentin in preventing inflammation of the mucous
      membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing
      primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and
      neck may cause a burn involving the inside of the mouth, throat, and nasal passages,
      resulting in pain. Gabapentin may help prevent (or minimize) pain associated with
      radiation-induced mucositis in patients with head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven cancer of the head and neck cancer

          -  Stage 3 or 4

          -  Planned primary or adjuvant chemoradiation therapy

          -  Willing and able to provide informed consent

          -  English speaking

        Exclusion Criteria:

          -  Currently on gabapentin

          -  Prior non-tolerance of gabapentin

          -  History of seizure disorder
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
Condition: Sprain of Ankle
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: Traumeel S ointment; Traumeel S gel; Diclofenac gel
Intervention description: 2 g, 3 times daily topical during 14 days; 2 g, 3 times daily topical during 14 days; 2 g, 3 times daily topical during 14 days
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: ankle sprain; traumeel; diclofenac; antiinflammatory; time to normal function

Summary:

      The objective of this study is to determine the efficacy of Traumeel S (both ointment and
      gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained
      ankle.
    

Eligibility criteria:

        Inclusion criteria:

          -  Athletes with an acute unilateral ankle sprain of the lateral ligaments of the ankle
             joint both male and female

          -  Moderate (30-60 mm) to severe (>60 mm) pain according to the patient's assessment of
             ankle pain visual analogue scale (VAS) on weight bearing, unable to perform normal
             training / sports activities

          -  18 - 40 years of age

          -  injury occurred within 24 hours of the first dose of study medication

          -  Willing and able to give written informed consent

          -  Available for the duration of the study

        Exclusion Criteria:

          -  Similar injury affecting the same joint within the past 6 months

          -  bilateral ankle injury

          -  bed rest, hospitalization, surgery use of a non-removable rigid cast

          -  Clinically important abnormality for screening laboratory tests

          -  Debilitating acute or chronic illness

          -  Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6
             hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or
             tramadol

          -  History of sensitivity to any component of the study drugs

          -  Unwilling or unable to comply with all the requirements of the protocol

          -  Participation in other studies within 4 weeks prior to study entry and or during the
             study participation

          -  Current substance or alcohol abuse that in the opinion of the investigator would
             interfere with compliance or with interpretation of the study result
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: High Dose ALKS 5461; Low Dose ALKS 5461; Placebo
Intervention description: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant); Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant); Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Intervention MeSH terms: Naltrexone; Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Alkermes; ALKS 5461; Samidorphan

Summary:

      This study will evaluate the efficacy and safety of ALKS 5461.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive

          -  Agree to use an acceptable method of contraception for the duration of the study

          -  Have a Major Depressive Disorder (MDD) primary diagnosis

          -  Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the
             current Major Depressive Episode (MDE)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Have a current primary Axis-I disorder other than MDD

          -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days

          -  Have received electroconvulsive therapy treatment within the last 2 years or received
             more than one course of electroconvulsive treatment during lifetime

          -  Have attempted suicide within the past 2 years

          -  Have a positive test for drugs of abuse

          -  Are pregnant, planning to become pregnant, or breastfeeding

          -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
             antagonists (eg, naltrexone, naloxone)

          -  Have had a significant blood loss or blood donation within 60 days

          -  Additional criteria may apply
A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-661/Ivacaftor; Ivacaftor; Placebo matched to VX-661/ ivacaftor; Placebo matched to Ivacaftor
Intervention description: Fixed dose combination tablet, oral use; Tablet, oral use; Fixed dose combination tablet, oral use; Tablet, oral use
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 248.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination
      with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF)
      who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation
      predicted to have residual function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heterozygous for F508del-CFTR and a second allele with a CFTR mutation predicted to
             have residual function

          -  Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to (≥) 40 percent
             (%) and less than or equal to (≤) 90% of predicted normal for age, sex, and height
             during screening

          -  Sweat chloride value ≥60 millimole per liter (mmol/L) during screening OR as
             documented in the participant's medical record

          -  Stable CF disease as judged by the investigator

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             participant

          -  An acute upper or lower respiratory infection, pulmonary exacerbation

          -  History of solid organ or hematological transplantation

          -  Ongoing or prior participation in an investigational drug study (including studies
             investigating VX-661, lumacaftor [VX-809], and/or ivacaftor) within 30 days of
             screening

          -  Pregnant and nursing females

          -  Sexually active participants of reproductive potential who are not willing to follow
             the contraception requirements
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
Condition: Gout
MeSH terms: Gout
Intervention: Febuxostat; Febuxostat; Febuxostat; Allopurinol; Placebo
Intervention description: Febuxostat 80 mg, orally, once daily for up to 28 weeks.; Febuxostat 120 mg, orally, once daily for up to 28 weeks.; Febuxostat 240 mg, orally, once daily for up to 28 weeks.; Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.; Placebo, orally, once daily for up to 28 weeks.
Intervention MeSH terms: Allopurinol; Febuxostat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1072.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Uric Acid, gout, xanthine oxidase, febuxostat, tophi

Summary:

      The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD),
      in subjects with gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association
             Criteria

          -  Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine
             clearance of > 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

        Exclusion Criteria:

          -  History of xanthinuria

          -  Intolerance to allopurinol

          -  Presence of renal calculi,

          -  Alcohol intake of ≥ 14 drinks/week

          -  Clinically significant medical condition
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
Condition: Primary Immunodeficiency (PID)
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: IgPro20
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 2 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Immune globulin subcutaneous; SCIG; primary immunodeficiency; PID

Summary:

      This study is a continuation of the study ZLB06_001CR with the objective of assessing
      efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life
      in patients with PID.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common
             variable immunodeficiency (CVID) as defined by the Pan-American Group for
             Immunodeficiency (PAGID) and the European Society for Immunodeficiencies (ESID), or
             X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or autosomal recessive
             agammaglobulinemia who have participated in the study ZLB06_001CR and who have
             tolerated IgPro well

          -  Written informed consent

        Exclusion Criteria:

          -  Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as total
             urine protein concentration > 0.2g/L)

          -  Other significant medical conditions that could increase the risk to the subject

          -  Females who are pregnant, breast feeding or planning a pregnancy during the course of
             the study

          -  Participation in a study with an investigational medicinal product within three months
             prior to enrollment, except for ZLB06_001CR

          -  Evidence of uncooperative attitude

          -  Any condition that is likely to interfere with evaluation of the IMP or satisfactory
             conduct of the study

          -  Subjects who are employees at the investigational site, relatives or spouse of the
             investigator
A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
Condition: Hysterectomy; Postoperative
Intervention: Morphine; CG5503 IR; CG5503 IR; CG5503 IR; Placebo
Intervention description: 20 mg IR; 4 - 6 hourly; Total 72 hours; 50mg; 4 - 6 hourly; Total 72 hours; 75mg; 4 -6 hourly; Total 72 hours; 100mg, 4 - 6 hourly; Total 72 hours; 4 - 6 hourly; Total 72 hours
Intervention MeSH terms: Morphine; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 854.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Opioid; Central acting analgesic; Pain postoperative; Abdomen acute; CG5503 IR; Morphine; Placebo

Summary:

      The main objective of this study is to demonstrate the efficacy and safety of multiple-dose
      application of three different oral doses of CG5503 IR (tapentadol immediate release)
      compared to placebo in women undergoing abdominal hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female between 18 and 80 years of age;

          -  Scheduled to undergo an abdominal hysterectomy with or without bilateral
             salpingo-oophorectomy due to uterine leiomyomas, or dysfunctional uterine bleeding or
             endometrial hyperplasia;

          -  Anesthesiological and surgical procedures performed according to protocol;

          -  Moderate or severe baseline pain following hysterectomy on a Verbal Rating Scale (VRS)
             within 6 hours following the last possible application of morphine subcutaneous;

          -  Pain following hysterectomy of at least 4 on an 11-point Numeric Rating Scale (NRS)
             within 6 hours following the last possible application of morphine subcutaneous;

          -  American Society of Anesthesiologists (ASA) classification I-III.

        Exclusion Criteria:

          -  Vaginal hysterectomy;

          -  Ongoing or known history of painful endometriosis;

          -  Known or suspected chronic pelvic pain syndrome;

          -  Previous abdominal or pelvic open surgery;

          -  History of seizure disorder or epilepsy;

          -  History of alcohol or drug abuse;

          -  Evidence of active infections that may spread to other areas of the body;

          -  severely impaired renal function, moderately or severely impaired hepatic function,

          -  Allergy or hypersensitivity to oxycodone, morphine, fentanyl hydromorphone, heparin,
             or any compound planned to be used during the anesthesia;

          -  Serious complication during surgery and up to randomization;

          -  Pre-operative use within 12hours prior to surgery or peri-operative use of
             non-steroidal anti-inflammatory drugs (NSAIDs);

          -  Treated regularly with opioid analgesic or non-steroidal anti-inflammatory drugs
             (NSAIDs) within 30 days prior to screening;
MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: rizatriptan benzoate (MK0462); Comparator: sumatriptan; Comparator: Placebo
Intervention description: single dose 5 mg rizatriptan p.o.; single dose 50 mg sumatriptan p.o.; Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
Intervention MeSH terms: Sumatriptan; Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 933.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for
      the acute treatment of a migraine attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had at least a 6-month history of migraine, with or without aura

          -  Participant was male, or if female, must have been postmenopausal, surgically
             sterilized, or taking adequate contraceptive precautions

          -  Participant was judged to be in good health, apart from migraine

        Exclusion Criteria:

          -  Participant was Pregnant or a nursing mother

          -  Participant had a history or current evidence of drug or alcohol abuse

          -  Participant had a history or clinical evidence of cardiovascular disease

          -  Participant had a clinically significant Electrocardiography (ECG) abnormality

          -  Participant had a resting systolic blood pressure of greater than 145 mm Hg or
             diastolic of less than 95 mm Hg at screening

          -  Participant had received treatment with an investigational device or compound within
             30 days of the study

          -  Participant typically suffered from less then 1 or more than 8 attacks of migraine per
             month

          -  Participant had difficulty in distinguishing his/her migraine attacks from tension or
             interval headaches

          -  Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: dalcetrapib; Placebo
Intervention description: Cholesterol Ester Transfer Protein inhibitor; matching placebo tablets
Intervention MeSH terms: Dalcetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6147.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study
      in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects
      will provide informed consent before any study-specific procedures are performed. Subject
      enrollment may begin in the hospital and will continue following release from the hospital.
      Screening procedures may be performed at the time of the index ACS event or anytime
      thereafter, with the condition that randomization must occur within the mandated window (4-12
      weeks after the index event). Subjects will be assessed based on their medical history. Those
      who are likely to qualify will undergo Genotype Assay testing to evaluate genetic
      determination for the presence of AA genotype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with the appropriate genetic background and recently hospitalized for ACS
             (between 4 and 12 weeks following the index event), will be enrolled in this trial.

          -  AA genotype at variant gene as determined by Genotype Assay testing, conducted at a
             designated investigational testing site (ITS)

          -  Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for
             at least 1 week prior to randomization

          -  Prior to randomization, subject must have evidence of guidelines-based management of
             LDL-C, at a minimum to include medical and dietary treatment to a target level of
             LDL-C <100 mg/dl (<2.6 mmol/L).

        Exclusion Criteria:

          -  Females who are pregnant (negative pregnancy test required for all women of
             child-bearing potential at Visit 2, Day 0) or breast-feeding

          -  Women of childbearing potential (women who are not surgically sterile or
             postmenopausal defined as amenorrhea for >12 months) who are not using at least one
             method of contraception*

          -  New York Heart Association (NYHA) Class III or IV heart failure

          -  Last known hemoglobin <10 g/dL

          -  Index ACS event presumed due to uncontrolled hypertension

        (*) Varies by region