bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain
Condition: Pain
MeSH terms: Ankle Injuries
Intervention: 1% diclofenac sodium plus 3% menthol; 1% diclofenac sodium plus 0.09% menthol; 3% menthol; Placebo with 0.09% menthol gel
Intervention description: To be applied four times daily for 10 days.; To be applied four times daily for 10 days.; To be applied four times daily for 10 days.; To be applied four times daily for 10 days.
Intervention MeSH terms: Diclofenac; Menthol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 385.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of
      MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in
      participants with an ankle sprain to support topical MFC51123 gel registration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 16-65 years

          -  Good general and mental health

          -  Grade I or Grade II acute sprain of the lateral ankle within 24 hours of Visit 1, a
             pain intensity score of the ankle sprain that is ≥ 5 as measured on an 11-point
             numerical rating scale, and a peri-malleolar edema (sub-malleolar perimeter difference
             of ≥ 20mm between injured and uninjured ankle

          -  Females of child-bearing age practicing a reliable method of contraception

        Exclusion Criteria:

          -  Pregnant or breast-feeding females

          -  If participant has treated the ankle sprain with treatment such as oral or other
             topical pain relief medications, massage or physical therapy since experiencing the
             ankle sprain

          -  Acute or chronic pain disorders, which may confound the study pain evaluations

          -  Participant has has injury to both ankles or to both medial and lateral ligaments of
             the same ankle

          -  Known or suspected hypersensitivity, allergy, intolerance or contraindication to the
             use of any of the study medications

          -  Participant has a medical history of renal or hepatic disease, a current active peptic
             ulcer or a history of upper gastrointestinal bleeding or perforation related to
             previous NSAID therapy
Remission in Subjects With Crohn's Disease, 1 Year Phase
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Double-blind (DB) adalimumab placebo; DB adalimumab 40 mg eow; DB adalimumab 40 mg ew; OL adalimumab 40 mg
Intervention description: Double-blind nonactive matching subcutaneous injection; Double-blind adalimumab 40 mg every other week by subcutaneous injection; Double-blind adalimumab 40 mg every week by subcutaneous injection; Open-label adalimumab every other week or every week by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of
      clinical remission up to 56 weeks in participants with Crohn's disease who participated in
      NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with
      Crohn's disease up to 56 weeks.
    

Eligibility criteria:

        Inclusion:

          -  Patient must have successfully completed the induction study NCT00055523

          -  Diagnosis of Crohn's disease

          -  Willing and able to give informed consent

        Exclusion:

          -  Diagnosis of ulcerative colitis

          -  Pregnancy or breastfeeding

          -  Previous use of infliximab or other anti-TNF antagonists

          -  Previous history of active tuberculosis or listeria infection

          -  Previous history of cancer other than successfully treated skin cancer
The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
Condition: Delayed Sleep Phase Syndrome
MeSH terms: Sleep Disorders, Circadian Rhythm
Intervention: Melatonin 0.5 MG; Dim Light Melatonin Onset (salivary)
Intervention description: Melatonin tablet; Test to determine the time of melatonin onset in saliva under dim light conditions
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will test whether measuring the circadian clock during treatment of delayed
      sleep-wake phase disorder results in greater improvements in sleep compared to estimating the
      circadian clock.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet diagnostic criteria for delayed sleep wake phase disorder

          -  Female participants of childbearing potential must agree to use a reliable method of
             contraception from the screening visit until 4 weeks after the study has completed.

        Exclusion Criteria:

          -  Hypersensitivity to melatonin or any other component of the product

          -  Sleep disorder other than delayed sleep wake phase disorder

          -  Medical and psychiatric conditions that may influence sleep or be affected by
             melatonin

          -  Current use of medications which may have interactions with melatonin

          -  Pregnancy or breastfeeding

          -  Routine night shift work

          -  Past month travel or planned travel during the study across more than one time zone

          -  Use of melatonin in the past month

          -  Current use of medications that may interfere with the measurement of melatonin
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Condition: Metastatic Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Rucaparib; Abiraterone acetate or Enzalutamide or Docetaxel
Intervention description: Rucaparib will be administered daily.; Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Intervention MeSH terms: Docetaxel; Abiraterone Acetate; Rucaparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CRPC; PARP inhibitor; PARPi; BRCA; ATM; HRD; TRITON; homologous recombination; DNA repair; DNA defect; DNA anomaly; germline; somatic; mCRPC

Summary:

      The purpose of this study is to determine how participants with metastatic
      castration-resistant prostate cancer, and evidence of a homologous recombination gene
      deficiency, respond to treatment with rucaparib versus treatment with physician's choice of
      abiraterone acetate, enzalutamide, or docetaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 18 years old at the time the informed consent is signed

          -  Have a histologically or cytologically confirmed adenocarcinoma or poorly
             differentiated carcinoma of the prostate that is metastatic

          -  Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL
             (1.73 nM)

          -  Be eligible for treatment with physician's choice of comparator treatment (abiraterone
             acetate, enzalutamide or docetaxel)

          -  Experienced disease progression after having received 1 prior next generation androgen
             receptor-targeted therapy

          -  Have a deleterious mutation in a BRCA1/2 or ATM gene

        Exclusion Criteria:

          -  Active second malignancy, with the exception of curatively treated non melanoma skin
             cancer, carcinoma in situ, or superficial bladder cancer

          -  Prior treatment with any PARP inhibitor

          -  Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer

          -  Symptomatic and/or untreated central nervous system metastases

          -  Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would,
             in the opinion of the investigator, interfere with absorption of study drug
Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 13-valent pneumococcal conjugate vaccine; 13vPnC + TIV
Intervention description: Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later.; Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1185.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal Disease; Pneumococcal Conjugate Vaccine

Summary:

      The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to
      prevent pneumococcal diseases such as meningitis (inflammation of the brain lining),
      septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent
      influenza vaccine (TIV) is frequently given to adults, it is important to show that both
      vaccines can safely be given together without affecting the immune response (body's ability
      to protect against disease).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy male or female adults 65 years of age or older.

          -  Available for the duration of the trial - approximately 2 months.

          -  No previous vaccination with any pneumococcal vaccine.

          -  No history of severe adverse reaction associated with a vaccine.

          -  No allergy to egg proteins (eggs or egg products) and chicken proteins.
Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Placebo; Dexketoprofen-single dose; Tramadol-single dose; Dexketoprofen/Tramadol-single dose; Dexketoprofen-multiple doses; Tramadol-multiple doses; Dexketoprofen/Tramadol-multiple doses
Intervention description: Placebo single oral dose (first 8 hours); Dexketoprofen single oral dose (first 8 hours); Tramadol single oral dose (first 8 hours); Dexketoprofen/Tramadol single oral dose (first 8 hours); Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses); Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses); Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
Intervention MeSH terms: Dexketoprofen trometamol; Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 606.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Moderate to severe acute pain; Postoperative pain; Abdominal hysterectomy; Analgesics; Dexketoprofen; Tramadol

Summary:

      This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed
      combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison
      to the single agents (and placebo for the single dose phase only).

      Approximately 600 female patients presenting moderate to severe pain after a total/subtotal
      abdominal hysterectomy are eligible to be randomised provided that they experience moderate
      to severe pain on the day after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients aged 18 to 75 years.

          -  Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without
             salpingo-oophorectomy) for benign conditions.

          -  Patients experiencing pain at rest of at least moderate intensity the day after
             surgery.

        Exclusion Criteria:

          -  Patients not suitable for study treatments and rescue medication (RM) or those for
             whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid,
             pyrazolones or pyrazolidines are contraindicated.

          -  Patients with clinically significant abnormalities in vital signs, safety laboratory
             tests and 12-lead ECG at screening.

          -  Patients with history of any illness or condition that might pose a risk to the
             patient or confound the efficacy and safety study results.

          -  Patients using and not suitable to withdraw analgesics other than those specified in
             the protocol.

          -  Patients using and not suitable for withdrawing any of the prohibited medication
             specified in the protocol.

          -  Breastfeeding women.
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267, ABT-333; Ribavirin; Placebo for Ribavirin
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Capsule; Capsule
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Hepatitis C Virus; Hepatitis C Genotype 1a; Hepatitis C; Treatment-Naïve; Interferon-Free; Paritaprevir; Ombitasvir; Dasabuvir; Ribavirin; Viekira PAK

Summary:

      The purpose of this study is to evaluate the safety and antiviral activity of
      ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267
      also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin
      (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without
      cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be practicing specific forms of birth control on study treatment, or be
             post-menopausal for more than 2 years or surgically sterile

          -  Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to
             10,000 IU/mL at screening)

          -  Subject has never received antiviral treatment for hepatitis C infection

          -  No evidence of liver cirrhosis

        Exclusion Criteria:

          -  Significant liver disease with any cause other than HCV as the primary cause

          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

          -  Positive screen for drugs or alcohol

          -  Significant sensitivity to any drug

          -  Use of contraindicated medications within 2 weeks of dosing

          -  Abnormal laboratory tests
Dane County Drug Court Study for Addicted Offenders
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: buprenorphine/naloxone
Intervention description: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The proposed work addresses critical health and public safety issues in the U.S. and in
      Wisconsin: the intersection of addiction and crime and the prevention of associated
      individual and public health complications. The results will provide justification for the
      expanded involvement of primary care in the treatment of substance-related disorders (opioid
      dependence in particular) and the prevention of their complications. As such, the project
      answers to federal calls for the expansion of substance abuse treatment into primary care
      settings and to objectives within the Alcohol and Drug Focus Area of Healthiest Wisconsin
      2020.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Enrollment in the Drug Treatment Court

          -  diagnosis of opioid dependence using the Addiction Severity Index-Lite and diagnosis
             by clinical staff of referring units

          -  opioid positive urine drug screen at baseline

          -  women of childbearing potential who have a negative screening urine pregnancy test and
             are willing to use reliable birth control methods throughout the duration of the
             study.

        Exclusion Criteria:

          -  pregnancy

          -  women who are currently breastfeeding

          -  complex psychiatric co-morbidity (e.g. suicidality, psychosis)

          -  complex medical co-morbidity (e.g. major cardiovascular, renal, or
             gastrointestinal/hepatic disease)

          -  or current pharmacotherapy with an agent which is contraindicated in combination with
             buprenorphine/naloxone according to drug labeling (

          -  Specific medical conditions, to be identified via initial medical history and
             examination, which would necessitate exclusion from study participation include:
             paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury,
             obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe
             morbid obesity.
Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD5789 (trifarotene) 50µg/g Cream; Placebo Cream
Intervention description: CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.; Placebo cream applied once daily during 12 weeks.
Intervention MeSH terms: Trifarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1212.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: Efficacy; Safety; Acne vulgaris

Summary:

      Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily
      for 12 weeks in subjects with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is a male or female, 9 years of age or older, at Screening visit.

          -  The Subject has moderate acne at Screening and Baseline.

          -  The subject is a female of non childbearing potential

          -  The subject is a female of childbearing potential with a negative pregnancy test and
             who is strictly abstinent or who agrees to use an effective and approved contraceptive
             method for the duration of the study and at least 1 month after the last study drug
             application.

        Exclusion Criteria:

          -  The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or
             secondary acne form (e.g.,chloracne, drug-induced acne, etc.).

          -  The subject has any uncontrolled or serious disease or any medical or surgical
             condition that may either interfere with the interpretation of the trial results
             and/or put the subject at significant risk (according to the Investigator's judgment)
             if the subject takes part to the trial.

          -  The subject has been exposed to excessive ultraviolet (UV) radiation within one month
             prior to the Baseline visit or the subject is planning intense UV exposure during the
             study (i.e., occupational exposure to the sun, sunbathing, tanning salon use,
             phototherapy, etc.)

          -  The subject is unwilling to refrain from use of prohibited medication during the
             clinical trial