bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Who Have Been Treated With Ataluren
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Ataluren
Intervention description: Ataluren will be administered as per the dose and schedule specified in the arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Healthy volunteers: No

Summary:

      This study is designed to generate additional data on the effect of ataluren for producing
      dystrophin protein in nonsense mutation nmDMD participants. This study will evaluate
      dystrophin levels from participants with nmDMD who currently have been receiving ataluren for
      ≥9 months.

      The study will have a single visit (Visit 1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of signed and dated informed consent/assent document(s) indicating that the
             participant (and/or his parent/legal guardian) has been informed of all pertinent
             aspects of the trial.

          -  Ambulatory (10 meters walk/run in less than [<] 30 seconds) and functional grade on
             the Brooke Upper Extremity Scale of a 1 or a 2.

          -  Currently being treated with ataluren 10, 10, 20 mg/kg for >=9 months, with no gap in
             treatment of greater than (>) 1 month, in an ongoing PTC-sponsored nmDMD clinical
             trial prior to study entry.

          -  Phenotypic evidence of duchenne muscular dystrophy (DMD) based on the onset of
             characteristic clinical symptoms or signs (for example, proximal muscle weakness,
             waddling gait, and Gowers' maneuver) by 6 years of age and an elevated serum creatine
             kinase (CK). Medical documentation of phenotypic evidence of DMD needs to be provided
             upon request by the medical monitor.

          -  Willing to undergo muscle biopsy.

        Exclusion Criteria:

          -  Known contra-indication to muscle biopsy (such as bleeding or clotting disorders).

          -  Exposure to another investigational drug within 2 months prior to study enrollment or
             ongoing participation in any non-ataluren interventional clinical trial.

          -  Requirement for daytime ventilator assistance or any use of invasive mechanical
             ventilation via tracheostomy. Note: Evening non-invasive mechanical ventilation such
             as use of bilevel positive airway pressure (Bi-PAP) therapy is allowed.

          -  Prior or ongoing medical condition (for example, concomitant illness, psychiatric
             condition, behavioral disorder), medical history, physical findings or laboratory
             abnormality that, in the investigator's opinion, could adversely affect the safety of
             the participant, makes it unlikely that the course of treatment or follow-up would be
             completed, or could impair the assessment of study results.
A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Tremelimumab; Durvalumab; Bevacizumab
Intervention description: Tremelimumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.; Durvalumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.; Bevacizumab 15 mg/kg will be administered by IV infusion every 3 weeks until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Intervention MeSH terms: Bevacizumab; Durvalumab; Tremelimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 433.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma; Immunotherapy; Antibodies, Monoclonal; Tremelimumab; MEDI4736; Durvalumab

Summary:

      This is a multicenter, open-label, stratified, randomized study to evaluate the safety,
      tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of
      durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or
      bevacizumab in advanced hepatocellular carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female participants

          2. 18 years and older (Japan-20 years and older)

          3. Confirmed hepatocellular carcinoma (HCC) based on histopathological findings from
             tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with
             noninvasive methods.

          4. Immunotherapy-naïve

          5. Have either progressed on, are intolerant to, or refused treatment with sorafenib or
             another approved TKI. For arm 5 only: Have not received any prior systemic therapy for
             HCC.

        Exclusion Criteria:

          1. Prior exposure to immune-mediated therapy

          2. Hepatic encephalopathy within past 12 months or requirement for medications to prevent
             or control encephalopathy

          3. Gastrointestinal bleeding (eg, esophageal varices or ulcer bleeding) within 12 months

          4. Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain
             symptomatic control, within 6 months prior to the first scheduled dose.

          5. Main portal vein thrombosis (Vp4) as documented on imaging

          6. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer
             treatment

          7. Active or prior documented autoimmune or inflammatory disease with some exceptions

          8. Current or prior use of immunosuppressive medication within 14 days with some
             exceptions
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461; Placebo
Intervention description: Two active tablets, given daily; Two placebo tablets, given daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to
      adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with a major depressive episode (MDE)

          -  Body mass index less than or equal to 40 kg/m2

          -  Have been treated with an adequate dose of SSRI/SNRI during the current MDE for at
             least 8 weeks, with the same, adequate dose over the last 4 weeks that is expected to
             remain stable throughout the study

          -  History of inadequate response during the entire current MDE to 1 or 2 adequate
             antidepressant treatments, including current treatment

          -  Be otherwise physically healthy

        Exclusion Criteria:

          -  Have an axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder,
             schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder,
             obsessive-compulsive disorder, panic disorder, acute stress disorder, or posttraumatic
             stress disorder

          -  Have a clinically significant current axis II diagnosis of borderline, antisocial,
             paranoid, schizoid, schizotypal, or histrionic personality disorder

          -  Are experiencing hallucinations, delusions, or any psychotic symptomatology in the
             current MDE

          -  Receive new onset psychotherapy within 6 weeks of screening

          -  Use of opioid agonists (eg, codeine, oxycodone, morphine) within 14 days before
             screening

          -  Have received electroconvulsive therapy during the current MDE

          -  Have attempted suicide within the past 2 years

          -  Have a thyroid pathology

          -  Have a history of a seizure disorder or of neuroleptic malignant syndrome/serotonin
             syndrome

          -  Have a positive test for human immunodeficiency virus (HIV)

        Additional inclusion/exclusion criteria may apply
A Study of DER 45-EV Gel to Treat Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: DER 45 EV; Vehicle
Intervention description: Topical application to face for 12 weeks; Topical application to face for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients
      with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 18 years of age or older

          -  Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)

          -  Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA

          -  Females of child-bearing potential must have negative urine pregnancy test result at
             baseline and must be willing to use an effective form of contraception throughout the
             study

        Exclusion Criteria:

          -  Subjects who are pregnant, breast feeding, or planning a pregnancy during the study

          -  Allergy or sensitivity to ingredients in test product

          -  Any dermatological conditions of the face that may interfere with study evaluations

          -  Subjects unable to avoid or minimize exposure to factors that may exacerbate or
             trigger rosacea
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
Condition: Gastroparesis
MeSH terms: Gastroparesis; Nausea; Vomiting
Intervention: Aprepitant; Placebo
Intervention description: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks; Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Intervention MeSH terms: Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gastroparesis; nausea; vomiting

Summary:

      The principal objective of this multicenter, randomized, placebo-controlled trial is to
      evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with
      placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older at registration

          -  Gastric emptying scintigraphy within 2 years of registration

          -  Normal upper endoscopy or upper GI series within 2 years of registration

          -  Symptoms of chronic nausea or vomiting compatible with gastroparesis or other
             functional gastric disorder for at least 6 months (does not have to be contiguous)
             prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of
             greater than or equal to 21

          -  Significant nausea defined with a visual analog scale (VAS) score of greater than or
             equal to 25 mm on a 0 to 100 mm scale

        Exclusion Criteria:

          -  Another active disorder which could explain symptoms in the opinion of the
             investigator

          -  Use of narcotics more than 3 days per week

          -  Significant hepatic injury as defined by significant alanine aminotransferase (ALT)
             and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of
             normal (ULN) or a Child-Pugh score of 10 or greater

          -  Contraindications to aprepitant such as hypersensitivity or allergy

          -  Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride

          -  Pregnancy or nursing

          -  Any other condition, which in the opinion of the investigator would impede compliance
             or hinder the completion of the study

          -  Failure to give informed consent
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
Condition: A/Vietnam/H5N1 Influenza Virus
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: 7.5 mcg H5N1 (stored as monobulk); 15 mcg H5N1 (stored as monobulk); 90 mcg H5N1 (stored as monobulk); 90 mcg H5N1 (stored in vials); MF59; MF59 (stored as monobulk)
Intervention MeSH terms: MF59 oil emulsion
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 422.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to assess the usability of long-term stored H5N1 antigen
      and adjuvant. The study is designed to assist in stockpile management by assessing the
      safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine
      when administered with or without MF59® adjuvant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or nonpregnant female

          -  Provide written informed consent prior to study-related procedures

          -  Stable health status

          -  Access to consistent and reliable means of telephone contact

          -  Able to understand and comply with planned study procedures

          -  Agree to stay in contact with site, and no plans to move from study area for study
             duration

        Exclusion Criteria:

          -  Allergic to eggs, other vaccine components, or squalene-based adjuvants

          -  Women with positive pregnancy test within 24 hours of vaccination, or are
             breastfeeding

          -  Females of childbearing potential who refuse acceptable birth control, if sexually
             active, have not used birth control for 2 months prior to study entry

          -  Have immunosuppression or use anticancer chemotherapy or radiation therapy within
             preceding 36 months

          -  Have an active neoplastic disease or history of hematologic malignancy

          -  Have long term use (≥14 consecutive days) of glucocorticoids (>20 mg/day) or high-dose
             inhaled steroids (>800 mcg/day) within preceding 6 months

          -  Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis

          -  Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to
             self or others within past 10 years
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
Condition: Renal Transplant
Intervention: Belatacept; Cyclosporine A; Tacrolimus
Intervention description: IV, IV Infusion, 5 mg/kg once every 28 days for one year; Tablets, Oral, Trough of 100-250 ng/mL, 2* daily for one year; Tablets, Oral, Trough of 5-10 ng/mL, 2* daily for one year
Intervention MeSH terms: Cyclosporine; Abatacept; Tacrolimus; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn if conversion to belatacept from cyclosporine or
      tacrolimus will preserve kidney function in people who have had a kidney transplant. The
      safety and tolerability of this treatment will also be studied
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men and women age 18 and older

          -  6-36 months after kidney transplant receiving cyclosporine or tacrolimus

          -  calculated GFR ≥35 and ≤75mL/min/1.73 m²

          -  subjects must have completed 1 year in the IM103-010ST and remained on study treatment
             (Long Term Extension)

        Key Exclusion Criteria:

          -  Significant infection

          -  acute rejection within 3 months

          -  prior graft loss due to rejection

          -  pregnancy

          -  positive crossmatch
A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Desvenlafaxine Sustained Release (DVS SR); Lyrica® (Pregabalin); Placebo
Intervention MeSH terms: Pregabalin; Desvenlafaxine Succinate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 125.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of
      pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.
    

Eligibility criteria:

        Inclusion Criteria:

        - Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria

        Exclusion Criteria:

          -  Unstable medical or psychological conditions that would compromise the subject's
             safety or put the subject at greater risk during study participation

          -  Other painful conditions that may confound the diagnosis or assessment of fibromyalgia

          -  Treatment with other drugs for fibromyalgia with 14 days of study start or during the
             study
Safety and Efficacy of AGN201781 in Neuropathic Pain
Condition: Neuralgia
MeSH terms: Neuralgia
Intervention: AGN201781; placebo
Intervention description: AGN201781 50 mg capsules three-times daily for 2 weeks; placebo 50 mg capsules three-times daily for 2 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will explore the safety and efficacy of AGN201781 in patients with postherpetic
      neuralgia or post-traumatic peripheral neuralgia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia

          -  Moderate or severe pain associated with postherpetic neuralgia or post-traumatic
             peripheral neuralgia

        Exclusion Criteria:

          -  Women of child-bearing potential

          -  Any other uncontrolled diseases
Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
Condition: Dental Pain
MeSH terms: Toothache
Intervention: Pre-Op pregabalin; Pre-Op Placebo 1; Post-Op pregabalin; Post-Op Placebo 1; Post-Op Placebo 2; Post-Op acetaminophen
Intervention description: Pre-op pregabalin will be administered 60 min prior to surgery.; Placebo 1 will be administered 60 min prior to surgery.; Post-op pregabalin will be administered Post-operatively.; Placebo 1 will be administered post-operatively.; Placebo 2 will be administered post-operatively.; Acetaminophen will be administered Post-operatively.
Intervention MeSH terms: Acetaminophen; Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: The sponsor, patients, investigators and study staff involved in the protocol procedures or those involved in data collection, data entry, data analysis will be blinded.
Enrollment: 115.0
Sex: All
Minimum age: 17 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      -  Accessing the efficacy and safety of pregabalin when used alone and in combo with
           acetaminophen in a dental pain model.

        -  To test whether pre-operative dose of pregabalin increases the time to significant
           post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed
           post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are scheduled to undergo the surgical removal of up to 4 third molars of
             which at least 2 have to be mandibular molars with a difficulty rating of 4 or 5.

          -  Patient must have a negative urine drug screen for drugs of abuse (including tobacco)
             at screening and at the day of surgery.

          -  No alcohol for a minimum of 1 day prior to the surgery.

        Exclusion Criteria:

          -  Patients should not be experiencing oral infections or symptoms of concomitant illness
             at the time of a scheduled surgery.

          -  Patients with a history of any type of malignancy within the past 5 years other than
             minor skin related cancers.

          -  Patients who currently have or have had a history of uncontrolled hypertension.

          -  Patients with a known allergy or hypersensitivity to any local anesthetic drug,
             NSAIDs, gabapentin or pregabalin;.

          -  Patients with conditions that affect the absorption, metabolism, or passage of drugs
             out of the body (e.g., sprue, celiac disease, crohn's disease, etc.)
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Calcitriol 3mcg/g
Intervention description: Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.
Intervention MeSH terms: Calcitriol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Calcitriol; Psoriasis; PK; Adolescents

Summary:

      This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the
      adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied
      twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous
      areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will
      be collected during the first 3 weeks of the study; safety and efficacy data will be
      collected for the 8 weeks of the treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic plaque psoriasis

          -  10 - 35% BSA of involved skin

          -  Age 12 - 17

        Exclusion Criteria:

          -  Other type of psoriasis (other than plaque)

          -  Significant abnormal lab findings

          -  Vit D insufficiency