bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
Condition: Systemic Sclerosis
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: Pirfenidone
Intervention description: Pirfenidone will be administered orally at a dose of 267 mg one oral capsule TID (801 mg/day) for 1 or 2 weeks followed by two 267 mg oral capsules TID (1602 mg/day) for 1 or 2 weeks (titration period) and then three 267 mg oral capsules TID (2403 mg/day) for 12 weeks (maintenance period).
Intervention MeSH terms: Pirfenidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: pirfenidone; SSc-ILD; scleroderma; systemic sclerosis; interstitial lung disease

Summary:

      PSSc-001 (LOTUSS)

      This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and
      tolerability study of pirfenidone in participants with systemic sclerosis-related
      interstitial lung disease (SSc-ILD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of systemic sclerosis-related (SSc) confirmed by the American College of
             Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of
             diagnosis less than (<) 7 years

          2. Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan

          3. Screening forced vital capacity (FVC) greater than equal to (>=) 50 percent (%) of the
             predicted value, and screening carbon monoxide diffusing capacity (DLCO) >=40% of the
             predicted value

          4. At study entry, the participant either was not taking SSc-ILD medication or was taking
             cyclophosphamide or mycophenolate

        Exclusion Criteria:

          1. Clinically significant pulmonary hypertension

          2. Known underlying liver disease

          3. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux

          4. History of clinically significant asthma or chronic obstructive pulmonary disease

          5. Active infection

          6. Diagnosis of another connective tissue disorder

          7. Evidence of a malignancy that is likely to result in significant disability or require
             significant medical or surgical intervention

          8. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD)

          9. Pregnancy or lactation

         10. Creatinine clearance <40 milliliters per minute (mL/min)

         11. Prior use of pirfenidone

         12. Unsuitable for enrollment or unlikely to comply with study requirements
Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients
Condition: Liver Disease; Liver Transplantation
MeSH terms: Liver Diseases
Intervention: Alemtuzumab; Cyclosporine; Mycophenolate mofetil; Tacrolimus; Liver transplant; Immunosuppression withdrawal
Intervention description: T-cell depleting monoclonal antibody; two doses by intravenous infusion on Days 0 and 4; Oral immunosuppressant; Oral immunosuppressant; Oral immunosuppressant; Occurs at study entry; Beginning no earlier than Year 1
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Alemtuzumab; Tacrolimus; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: transplantation; liver transplant; rejection; tolerance; antibody induction

Summary:

      Alemtuzumab is a man-made antibody used to treat certain blood disorders. Tacrolimus is a
      drug used to decrease immune system activity in people who have received organ transplants so
      that the new organ will not be rejected. This study will determine whether treatment with
      alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the
      recipient's health after liver transplantation in patients with end-stage liver disease, and
      whether gradual tapering of tacrolimus treatment is safe for these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of nonimmune, nonviral, end-stage liver disease

          -  Need liver transplant

          -  Willing to use acceptable means of contraception for the duration of the study

        Exclusion Criteria:

          -  Previous transplant

          -  Multiorgan transplant or living donor transplant

          -  Donor liver from a donor positive for antibody against hepatitis B core antigen or
             hepatitis C virus

          -  Donor liver from a non-heart-beating donor

          -  Liver failure due to autoimmune disease, such as autoimmune hepatitis, primary
             sclerosing cholangitis, or primary biliary cirrhosis

          -  Hepatitis B or C virus infection

          -  HIV infection

          -  Stage III or higher hepatocellular cancer based on pre-transplant imaging

          -  History of cancer. Patients with hepatocellular cancer, adequately treated in situ
             cervical carcinoma, or adequately treated basal or squamous cell carcinoma of skin are
             not excluded.

          -  Active systemic infection at the time of transplantation

          -  Clinically significant chronic renal, cardiovascular, or cerebrovascular disease

          -  Any investigational drug within 6 weeks of study entry

          -  Hypersensitivity to alemtuzumab or tacrolimus
An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis
Condition: Endometriosis, Pain
MeSH terms: Endometriosis
Intervention: Elagolix; placebo
Intervention description: Elagolix tablets administered orally; Placebo tablet administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: bone mineral density; Pelvic Pain; estradiol; NBI-56418

Summary:

      This study is designed to see how elagolix works compared to placebo in women with
      endometriosis and to see the effect, if any, on bone mineral density.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be female, aged 18 to 49 years, inclusive

          -  Have moderate to severe pelvic pain due to endometriosis

          -  Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8
             years and have recurrent or persistent endometriosis symptoms

          -  Have regular menstrual cycle

          -  Have a body mass index (BMI) of 18 to 36 kg/m², inclusive

          -  Agree to use two forms of non-hormonal contraception during the study

        Exclusion Criteria:

          -  Are currently receiving gonadotropin-releasing hormone (GnRH) agonist or GnRH
             antagonist or have received any of these agents within 6 months of the start of
             screening

          -  Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or
             intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these
             agents within 3 months of the start of screening

          -  Are currently using hormonal contraception or other forms of hormonal therapy or
             received such treatment within the last month

          -  Have had surgery for endometriosis within the last month

          -  Have had a hysterectomy or bilateral oophorectomy

          -  Are using systemic steroids on a chronic or regular basis within 3 months

          -  Have uterine fibroids ≥ 3 cm in diameter

          -  Have pelvic pain that is not caused by endometriosis

          -  Have unstable medical condition or chronic disease

          -  Have been pregnant within the last six months

          -  Currently breast feeding
Study of Alwextin® Cream in Treating Epidermolysis Bullosa
Condition: Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Intervention: Alwextin cream
Intervention description: Alwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration.
Intervention MeSH terms: Allantoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: Epidermolysis bullosa

Summary:

      The purpose of this study is to determine how safe and effective allantoin 3% cream
      (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall
      blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically
      to the entire body once daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of epidermolysis bullosa

        Exclusion Criteria:

          -  use of any skin product containing allantoin for 30 days prior to enrollment
Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by
      independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in
      subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating
      agent.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Grade 1, 2, or 3a FL without pathologic evidence of transformation

          -  Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or
             =2 prior treatment lines; each of the 2 prior treatment lines must include at least
             CD20 antibody and/or an alkylating agent

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

        Exclusion Criteria:

          -  Known central nervous system lymphoma

          -  History of interstitial lung disease

          -  Subjects with active, known or suspected autoimmune disease

          -  Prior allogeneic stem cell transplant

          -  Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone: Influenza virus vaccine; Fluzone: Influenza virus vaccine
Intervention description: 0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid; 0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza virus

Summary:

      To describe any degree of preference for the route of administration of Fluzone influenza
      vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.

      To collect safety data, injection site reactions, and systemic reactions, through Day 7
      post-vaccination; SAEs through day 28 post-vaccination
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subject (can have underlying medical condition, as long as they
             are stable), greater than or equal to 18 to < 50 years of age on the day of inclusion.

          -  Informed consent form signed.

          -  Able to attend both scheduled visits and to comply with all trial procedures.

          -  For a woman of child-bearing potential, avoid becoming pregnant (use of an effective
             method of contraception or abstinence) for at least 4 weeks prior to vaccination,
             until at least 4 weeks after vaccination.

        Exclusion Criteria:

          -  Subject currently breast-feeding.

          -  Participation in another investigational clinical trial in the 4 weeks preceding and
             during the trial period.

          -  Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine
             components, or history of a life-threatening reaction to the trial vaccine or a
             vaccine containing any of the same substances.

          -  Thrombocytopenia or bleeding disorder contraindicating IM vaccination.

          -  Any other condition which in the opinion of the Investigator would pose a health risk
             to the subject or interfere with the evaluation of the vaccine.

          -  Personal history of Guillain-Barre syndrome.

          -  Current use of alcohol or recreational drugs that in the opinion of the Investigator
             might interfere with the subject's ability to comply with trial procedures.

          -  Febrile illness (oral temperature greater than or equal to 99.5 degrees F) on day of
             inclusion (temporary deferral).

          -  Influenza vaccination received this season (2007-2008).
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
Condition: Cushing's Syndrome
MeSH terms: Cushing Syndrome; Syndrome
Intervention: CORT125134
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cushing's Syndrome; Cushing's Disease; Cushing's; Hypercortisolemia; Cushingoid; Type 2 Diabetes; Impaired Glucose Intolerance; Hypertension; Adrenal Corticotrophic Hormone (ACTH); Adrenocortical Carcinoma; Primary Pigmented Nodular Adrenal Disease (PPNAD); Moon Facies; Dorsocervical Fat Pad; Adrenal Adenoma; Adrenal Carcinoma; Adrenal Autonomy; Cortisol

Summary:

      Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels
      of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated
      endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from
      cortisol overproduction by the adrenal glands is the subject of this protocol.

      Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic
      administration of high doses of glucocorticoids, were not eligible for enrollment in this
      study.

      The purpose of this study was to evaluate the safety and efficacy of CORT125134 for treatment
      of endogenous Cushing's syndrome. The multicenter study was conducted in the United States
      and in Europe.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a confirmed diagnosis of endogenous Cushing's syndrome.

          2. Requires medical treatment of hypercortisolemia.

          3. Meets at least one of the following criteria:

               1. Has type 2 diabetes mellitus.

               2. Has impaired glucose tolerance.

               3. Has hypertension.

        Exclusion Criteria:

          1. Has non-endogenous source of hypercortisolemia

          2. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

          3. Has poorly controlled hypertension

          4. Has Stage ≥ 4 renal failure
Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents
Condition: Prevention of Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM conjugate vaccine, adjuvanted; MenACWY-CRM conjugate vaccine, unadjuvanted; MenACWY polysaccharide vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 524.0
Sex: All
Minimum age: 11 Years
Maximum age: 17 Years

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of Novartis
      Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide
      vaccine administered to healthy adolescents ages 11 to 17 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adolescents between and including 11-17 years of age, who provide written
             informed consent

        Exclusion Criteria:

          -  Subjects with a previous or suspected disease caused by N. meningitidis; or previous
             immunization with a meningococcal vaccine or vaccine containing meningococcal
             antigen(s); Any serious acute, chronic or progressive disease
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Intervention: ADX-N05; Placebo
Intervention description: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks; One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in
      the treatment of excessive daytime sleepiness in adults with narcolepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of narcolepsy

          -  Good general health

          -  Willing and able to comply with the study design and schedule and other requirements

        Exclusion Criteria:

          -  If female, pregnant or lactating

          -  Customary bedtime later than midnight

          -  History of significant medical condition, behavioral, or psychiatric disorder
             (including suicidal ideation), or surgical history

          -  Any other clinically relevant medical, behavioral or psychiatric disorder other than
             narcolepsy that is associated with excessive sleepiness

          -  History of significant cardiovascular disease

          -  Body mass index > 34

          -  Excessive caffeine use - > 600 mg/day of caffeine or > 6 cups of coffee/day

          -  History of alcohol or drug abuse within the past 2 years

          -  Nicotine dependence that has an effect on sleep
Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: LiRIS 400 mg; LiRIS Placebo
Intervention description: LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.; LiRIS Placebo contains lactose, inactive substance.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system,
      is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in
      IC symptoms following LiRIS administration.
    

Eligibility criteria:

        Inclusion Criteria

        Blinded study:

          -  Women age 18 and over

          -  Diagnosed with Interstitial Cystitis as defined by protocol

          -  Able to report IC symptoms of bladder pain, voiding habits, as required by protocol,
             and record in diary

          -  Able to comply with visit schedule and diary completion at home

        Open-label Extension:

          -  Must have completed the blinded study prior to screening for the Open-label extension

        Exclusion Criteria (Blinded and Open-Label Extension):

          -  Pregnant or lactating women

          -  History or presence of any condition that would make it difficult to accurately
             evaluate bladder symptoms

          -  Bladder or urethral abnormality that would prevent safe insertion of investigational
             product

          -  Requiring medication not allowed per study protocol
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
Condition: Amputation
Intervention: Traditional fabricated prosthetic socket; Direct manufactured (DM) prosthetic socket
Intervention description: A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.; A prosthetic socket constructed from direct manufacturing technique. The socket will be tested under both diagnostic and definitive environments. Diagnostic testing will span several hours (4-6 hours) and definitive testing will span several months (3-6 months)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lower extremity amputation; Prosthetic Sockets; Direct Manufactured (DM)

Summary:

      The purpose of this study is to evaluate a new prosthetic socket construction technique in
      order to improve the quality of care to lower extremity amputees.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a lower extremity amputee longer than one year

          -  Be a consenting adult (at least 18 years or age or older)

          -  Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30
             minutes without rest

          -  Currently using a liner with prosthesis

          -  Be available during regular business hours for appointments

        Exclusion Criteria:

          -  An inability to give informed consent

          -  Presence of any sores, lacerations or rashes on the residual limb

          -  Impaired contra lateral foot

          -  Poor distal sensation