bioihbjkbjnl/mcl2 huggingface dataset:
Oral LAT8881 in Neuropathic Pain
Condition: Neuropathic Pain; Diabetic Peripheral Neuropathy (DPN); Post Herpetic Neuralgia (PHN)
MeSH terms: Neuralgia; Peripheral Nervous System Diseases; Neuralgia, Postherpetic
Intervention: LAT8881; Placebo
Intervention description: LAT8881 oral capsule; Placebo oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is the first study with LAT8881 in subjects with neuropathic pain. As such, it has been designed to evaluate, in a well-defined patient group, the concept that LAT8881 is safe and effective in this indication.
Subjects enrolled into this study have been diagnosed with Post Herpetic Neuralgia (PHN) or Diabetic Peripheral Neuropathy (DPN), both conditions being well accepted examples of neuropathic pain. Because the pain is chronic, without a period effect, and treatment is symptomatic rather than curative, a crossover study is considered appropriate. Studies with other agents have successfully demonstrated analgesic effects in PHN and DPN with a crossover study design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to
      investigate the efficacy and safety of oral LAT8881 in neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3
             months after the onset of herpes zoster rash OR

          2. Clinical diagnosis of distal painful polyneuropathy due to Type I or Type II diabetes
             mellitus with:

               1. symmetrical, bilateral pain in the lower extremities for at least 3 months and

               2. diabetes under control for at least 3 months prior to randomisation, as indicated
                  by a glycated haemoglobin level (HbA1c) of ≤ 11% (97 mmol/mol) and on a stable
                  dose of insulin or oral diabetic medication for 3 months prior to screening, and

               3. no change in diabetic medication planned for the duration of the study

          3. Positive sensory symptoms (mechanical or thermal) associated with neuropathic pain,
             confirmed by:

               1. painDETECT questionnaire (PD-Q) and

               2. Clinical assessment, showing signs of neuropathic pain in either a dermatomal
                  (PHN) or distal symmetrical distribution (DPN)

        8. An average daily pain score on the numeric pain rating scale (NPRS) of at least 4 and no
        more than 8 in the last five diary entries before randomisation

        Exclusion Criteria:

          1. Presence of moderate to severe pain from other causes that may confound assessment or
             self-evaluation of NP.

          2. Subjects with both DPN and PHN
Mitigation of Radiation Pneumonitis and Fibrosis
Condition: Lung Cancer; Radiation Pneumonitis
MeSH terms: Pneumonia; Radiation Pneumonitis
Intervention: Enalapril; placebo
Intervention description: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer; Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
Intervention MeSH terms: Enalapril
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 50.0
Sex: All
Minimum age: 35 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: lung cancer; radiation pneumonitis; mitigation; enalapril; placebo

Summary:

      This project will test the effect of enalapril to mitigate the lung damage that can occur as
      a side effect of radiation therapy for lung cancer or other intrathoracic cancers. Thousands
      of Veterans develop lung cancer every year, and are treated by radiation therapy. Studies of
      lung radiation injury in laboratory animals show that with enalapril, investigators can
      significantly reduce the severity of radiation injury to the lung. Enalapril is FDA approved
      and in common use for treatment of hypertension, kidney disease, and heart failure. These
      studies will advance that work to human use. Successful mitigation of lung radiation damage
      will improve the quality of life in Veterans and non-Veterans who are treated for lung cancer
      by radiation, and may also improve cure rates of radiation therapy for lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women undergoing radiation therapy to the chest for cancer at the Baltimore,
             the Milwaukee, and Ann Arbor Veterans Affairs Hospital are eligible.

          -  Subjects who require radiation therapy to attempt to cure or to palliate their disease
             will be eligible for this study.

        Exclusion Criteria:

          -  Subjects eligible for surgical resection and who do not need radiation therapy will
             not be eligible for this study.

          -  Subjects who must remain on ACE inhibitors, angiotensin blockers, or renin antagonists
             will be excluded.
A Clinical Trial to Assess Subjects With Dry Eye Disease.
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Reproxalap Ophthalmic Solution (0.25%); Vehicle Ophthalmic Solution
Intervention description: Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days.; Vehicle Ophthalmic Solution administered 7 times over two consecutive days.
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2
      Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution
      Compared to Vehicle in Subjects with Dry Eye Disease
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age (either gender and any race);

          2. Reported history of dry eye for at least 6 months prior to Visit 1;

          3. Reported history of use or desire to use eye drops for dry eye symptoms within 6
             months of Visit 1.

        Exclusion Criteria:

          1. Clinically significant slit lamp findings at Visit 1 that may include active
             blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active
             ocular allergies that require therapeutic treatment, and/or in the opinion of the
             investigator may interfere with study parameters;

          2. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1;

          3. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during
             the trial;

          4. Eye drop use within 2 hours of Visit 1;

          5. Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12
             months;

          6. Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days
             of Visit 1;

          7. Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids)
             within 14 days of Visit 1 or anticipate such therapy throughout the study period;

          8. Planned ocular and/or lid surgeries over the study period or any ocular surgery within
             6 months of Visit 1;

          9. Temporary punctal plugs during the study that have not been stable within 30 days of
             Visit 1.
Behavioral Economic Analysis of Demand for Marijuana
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Intervention: Smoked marijuana cigarettes: High THC dose (6% THC)
Intervention description: Smoked marijuana cigarettes (High THC dose [6% THC])
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This laboratory study will employ a multi-session experimental design to examine the
      behavioral economic demand for marijuana, by studying effect of marijuana administration
      (High THC) on demand for marijuana, and marijuana smoking topography. The study will recruit
      100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  marijuana use at least 8 times in the past month on average and at least monthly for
             the past 6 months

          -  English-speaking

          -  negative urine toxicology screen for drugs other than marijuana

          -  non-treatment seeking

          -  purchase of marijuana at least twice in the past 6 months to confirm familiarity with
             the construct to be measured

        Exclusion Criteria:

          -  positive pregnancy test

          -  nursing

          -  inability to use contraception during the study

          -  poor physical health

          -  positive breath alcohol concentration

          -  diagnosis of a current affective disorder, psychosis, and panic disorder

          -  self-report of past serious adverse reaction to marijuana

          -  current psychotropic drug use

          -  smoking more than 20 tobacco cigarettes per day

          -  inability to abstain from marijuana for 15 hours

          -  body mass index outside 18.5-30 kg/m2 range
A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies
Condition: Various Advanced Cancer
MeSH terms: Neoplasms
Intervention: Nivolumab; Ipilimumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 6 Months
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and effectiveness of nivolumab alone and
      in combination with ipilimumab in pediatric patients with high grade primary central nervous
      system (CNS) malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have received standard of care therapy, and there must be no potentially-curative
             treatment available, in one of the following cohorts:

          -  A newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) that has been treated with
             radiation therapy (RT) but no chemotherapy

          -  A histologically confirmed recurrent or progressive non-brainstem High Grade Glioma
             (HGG) previously treated with surgical resection and RT

          -  A histologically confirmed medulloblastoma that has relapsed or is resistant to at
             least one line of prior therapy including surgery, RT, and chemotherapy

          -  A histologically confirmed ependymoma that has relapsed or is resistant to at least
             one line of prior therapy including surgical resection and RT

          -  A histologically-confirmed high grade CNS malignancy "other than above" which is
             recurrent or progressive after at least one line of prior therapy

          -  Lansky play score (LPS) for ≤ 16 years of age or Karnofsky performance scale (KPS) for
             > 16 years of age assessed within two weeks of enrollment must be >= 60

          -  A tumor sample must be available for submission to central laboratory (not required
             for DIPG)

        Exclusion Criteria:

          -  An active, known, or suspected autoimmune disease

          -  A concurrent condition requiring systemic treatment with either corticosteroids or
             other immunosuppressive medications within 14 days of start of study treatment

          -  Known history of positive test for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency syndrome (AIDS).

        Other protocol defined inclusion/exclusion criteria apply
Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy
Condition: Pain; Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: DS-5565; DS-5565; DS-5565; Placebo; Pregabalin capsules
Intervention description: Oral tablets administered twice daily; Oral tablets administered twice daily; Oral tablets administered twice daily; DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day; Pregabalin oral capsules 150 mg administered twice a day
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 450.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Pain; Diabetic Peripheral Neuropathy

Summary:

      The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared
      to placebo, in subjects with pain associated with diabetic peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or Type 2 diabetes mellitus

          -  Painful distal symmetric polyneuropathy

          -  Average daily pain score is great than or equal to 4

        Exclusion Criteria:

          -  HbA1c greater than 9.0
A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Intervention: ATR-101
Intervention description: 125-1000 mg twice per week
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single treatment arm with up to 5 planned dosing periods with escalating doses. Subjects were dosed with each dose level for 2 weeks, followed by 2 weeks of matching placebo (subjects blinded).
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ATR-101; classic congenital adrenal hyperplasia; 21-hydroxylase deficiency; CAH

Summary:

      This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and
      efficacy of orally administered ATR-101 in subjects with classic congenital adrenal
      hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to
      6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of
      5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based
             on: Documented genetic mutation in the CYP21A2 enzyme consistent with a diagnosis of
             classic CAH, or historical documentation of elevated 17-hydroxyprogesterone

          -  Biochemical marker of disease status of 17-hydroxyprogesterone ≥ 4 times the upper
             limit of normal

          -  Chronic glucocorticoid replacement therapy for at least 6 consecutive months

          -  Stable glucocorticoid and mineralocorticoid regimen for at least 1 month

        Exclusion Criteria:

          -  Non-classic CAH

          -  Other causes of adrenal insufficiency

          -  Surgery within the previous 3 months prior to screening or planned surgery during
             study participation

          -  History of active cancer requiring medical or surgical therapy within the past 6
             months
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab
Intervention description: Bimekizumab will be administered subcutaneously in 2 different doses.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Psoriasis; Chronic Plaque Psoriasis; Bimekizumab

Summary:

      This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have completed all dosing requirements in PS0016 without meeting any
             withdrawal criteria

          -  Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
             potential, must be willing to use a highly effective method of contraception up till
             20 weeks after last administration of study drug, and have a negative pregnancy test
             at Visit 1 (Screening) and immediately prior to first dose

          -  Male subjects with a partner of childbearing potential must be willing to use a condom
             when sexually active, up till 20 weeks after the last administration of study
             medication (anticipated 5 half-lives)

        Exclusion Criteria:

          -  Subjects previously participating in this study

          -  Subject has any medical or psychiatric condition that, in the opinion of the
             Investigator, could jeopardize or would compromise the subject's ability to
             participate in this study. Note: For any subject with an ongoing serious adverse event
             (SAE), or a history of serious infections (including herpes zoster or
             hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the
             subject's entry into PS0018

          -  Subject has any current sign or symptom that may indicate a medically significant
             infection

          -  Subject has current clinically active infection with Histoplasma, Coccidiodes,
             Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria
             (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with
             Histoplasmosis, Coccidiodes, Paracoccidioides, Pneumocystis, TB, NTMB, Blastomyces,
             Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if
             treatment has been completed.

          -  Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded
             from participating in the open-label extension study (PS0018)
Topical Rapamycin to Erase Angiofibromas in TSC
Condition: Angiofibromas; Tuberous Sclerosis
MeSH terms: Tuberous Sclerosis; Angiofibroma; Sclerosis
Intervention: Placebo; Rapamycin; Rapamycin
Intervention description: Study cream is applied nightly to the affected areas on the face.; Study cream is applied nightly to the affected areas on the face. Low Dose; Study cream is applied nightly to the affected areas on the face. High Dose
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: All
Healthy volunteers: No
Keywords: Angiofibroma; Tuberous Sclerosis; Rapamycin; Sirolimus; mTOR

Summary:

      The study is a multi-center prospective, randomized, double-blind, placebo-controlled
      evaluation of the safety and efficacy of a topically applied formulation of rapamycin to
      cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will
      apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to
      their angiofibromas for six months.

      The primary goal of this study is to evaluate the efficacy of the topical medication for
      reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study
      is to confirm the safety of the topical medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be willing and able to comply with all trial requirements.

          -  Subject has a diagnosis of TSC and has visible facial angiofibromas.

          -  Female subjects of child bearing potential must not be pregnant and must agree to use
             appropriate contraceptive methods .

        Exclusion Criteria:

          -  Subject is currently receiving therapy with Rapamycin.

          -  Subject is receiving any form of immunosuppression or has previously experienced
             immune dysfunction.

          -  Subject is currently participating in or has participated within the last 30 days in a
             clinical trial involving an investigational drug.

          -  Subject has a known hypersensitivity to either the vehicle or Rapamycin.

          -  Subject is a pregnant or nursing female.

          -  Subject has other dermatologic conditions that would preclude or prevent adequate
             assessment of changes to their facial angiofibromas.

          -  Subject has had laser surgery, cryotherapy, or other dermatologic treatment to their
             facial angiofibromas within the previous 6 months.